Note: Descriptions are shown in the official language in which they were submitted.
1
~~°~4442$
Automatic Retractable Safety Penetrating Instrument
BACKGROUND OF THE INVENTION
Field of the Invention:
The present invention pertains to safety penetrating
instruments and, more particularly, to automatic
retractable safety penetrating instruments having sleeves
for introduction into anatomical cavities and penetrating
members with sharp tips disposed within the sleeves for
penetrating cavity walls with automatic retraction of the
penetrating members into the sleeves on penetration to
protect tissues and organ structures within the cavities
from the sharp tips of the penetrating members.
Discussion of the Prior Art:
Penetrating instruments are widely used in medical
procedures to gain access to anatomical cavities ranging in
size from the abdomen to small blood vessels, such as veins
and arteries, epidural, plural and subachroniad spaces,
heart ventricles and spinal and synovial cavities, with
access being established via a sleeve positioned during
penetration into the
A
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cavity with the penetrating instrument. Use of penetrating
instruments has become an extremely popular and important first
step in endoscopic, or least invasive, surgical procedures to
establish an endoscopic portal for many various procedures with
access being established via portal sleeves of the penetrating
instruments. Such penetrating instruments typically include a
portal sleeve and a penetrating member disposed within the
portal sleeve and having a sharp tip or point to pierce or
penetrate the tissue forming the cavity wall with the force
required to penetrate the cavity wall being dependent upon the
type and thickness of the tissue of the wall. Once the wall is
penetrated, it is desirable to prevent the sharp tip of the
penetrating member from inadvertent contact with or injury to
tissue or organ structures in or forming the cavity, and a
particular problem exists where substantial force is required
to penetrate the cavity wall or the cavity is very small in
that, once penetration is achieved, the lack of tissue
resistance can result in the sharp tip traveling too far into
the cavity and injuring adjacent tissue or organ structures.
Safety trocars having a spring-biased protective shield
disposed between an outer sleeve and an inner trocar are
marketed by Ethicon, Inc. as the Endopath and by United States
Surgical Corp. as the Surgiport. U.S. Patents No. 4,535,773 to
Yoon, No. 4,601,710 to Moll and No. 4,654,030 to Moll et al are
illustrative of such safety trocars. A trocar disposed within
a portal sleeve and retractable within the sleeve when force
from tissue contact is removed from the sharp tip of the trocar
is set forth in U.S. Patent No. 4,535,773 to Yoon.
SUMMARY OF THE INVENTION
It is a primary object of the present invention to provide
improved, simplified automatic retractable safety penetrating
instruments capable of use in a wide variety of procedures.
A further object of the present invention is to provide an
automatic retractable safety penetrating instrument having a
locking and releasing mechanism rotatable or pivotal around an
axis in parallel and spaced from a longitudinal axis of the
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automatic retractable safety penetrating instrument for
automatically releasing a retracting mechanism to permit
retraction of a penetrating member upon entry of the instrument
into an anatomical cavity.
An additional object of the present invention is to
,) position a rotatable locking and releasing mechanism within a
shaft of a penetrating member of an automatic retractable safety
penetrating instrument to reduce the size of the proximal hub
or handle for the penetrating member.
A further object of the present invention is to form a
penetrating member of an automatic retractable safety
penetrating instrument of telescoping parts such that the distal
end can be moved proximally relative to the shaft upon
retraction thereby reducing the length of the hub or handle for
the penetrating member.
Yet another object of the present invention is to
automatically trigger retraction of a penetrating member within
a sleeve upon movement of an operating member distally of a rest
position after initial movement of the operating member
proximally of the rest position during penetration of tissue.
A further object of the present invention is to combine
trigger mechanisms in an automatic retractable safety
penetrating instrument such that retraction can be triggered by
distal movement of an operating member at a position rearward
of a rest position of the operating member and/or a position
forward of the rest position.
Another object of the present invention is to configure a
safety penetrating instrument to allow the safety penetrating
instrument to have various optional modes of operation including
retraction of the penetrating member, retraction of the
penetrating member along with a safety shield or probe, the
penetrating member locked against retraction to operate as a
standard penetrating instrument, the penetrating member retracts
while the safety shield or probe remains extended, or the
penetrating member locked against retraction while safety shield
or probe moves distally.
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Some of the advantages of the present invention over the
prior art are that small or narrow anatomical cavities can'be
safety penetrated, sleeves can safely be introduced into
anatomical cavities of various sizes to expand the use of least n
invasive procedures in many areas including, for example,
cardiac, brain, vascular, chest, genitourinary system, breast
and spinal fields, safe penetration of cavities can be
accomplished with no parts of the safety penetrating instrument
other than the sleeve protruding beyond the sharp tip of the
penetrating member as is particularly desirable where organ
structures adhere to cavity walls, the automatic retractable
safety penetrating instrument encourages the use of a smooth,
continuous penetration motion by the surgeon thereby reducing
trauma, tears and irregular surfaces in the tissue of the cavity
wall, the automatic retractable safety penetrating instrument
can be used to penetrate anatomical cavities of the type
containing organ structures that could be injured by contact
with even a blunt instrument part such as a safety shield, the
automatic retractable safety penetrating instrument can be
economically made of plastic with relatively few components,
safe penetration is achieved while permitting injection or
evacuation of fluids, a single puncture can be used for both
insufflation and forming an endoscopic portal thereby
simplifying diagnostic and surgical procedures, trauma and
damage to tissue is minimized, tissue jamming and trapping are
avoided and automatic retractable safety penetrating instruments
according to the present invention can be inexpensively
manufactured to be reusable or disposable for universal use.
These and other objects and advantages of the present
invention will become apparent from the following description
of the preferred embodiments taken in conjunction with the
accompanying drawings wherein identical reference numbers p
indicate identical parts or parts providing identical functions.
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BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a broken side view, partly in section, of an
automatic retractable safety penetrating instrument according
ri to the present invention in a rest state.
Figs. 2, 3 and 4 are broken side views, partly in section
of the automatic retractable safety penetrating instrument of
Fig. 1 in various states of operation.
Fig. 5 is a broken perspective view of an end cap release
mechanism for use with the automatic retractable safety
penetrating instrument of the present invention.
Fig. 5A is a perspective view of an end cap release
mechanism carrying a locking and releasing mechanism for use
with the automatic retractable safety penetrating instrument of
the present invention.
Fig. 5B is a perspective view of an end cap release
mechanism carrying a modified locking and releasing mechanism
for use with the automatic retractable safety penetrating
instrument of the present invention.
Fig. 5C is a section taken along lines 5C-5C of Fig. 5B
with the addition of a retraction plate and an operating member.
Fig. 5D is a broken side view, partly in section, of a
modified locking and releasing mechanism for use with the
automatic retractable safety penetrating instrument of the
present invention wherein the trigger is formed by an angled
flat spring member.
Fig. 6 is a broken side view, partly in section, of an
automatic retractable safety penetrating instrument according
to the present invention having a modified locking and releasing
mechanism.
Figs.-6A~ 6B--and 6C are broken side views, partly in
section, showing a modified locking and releasing mechanism for
use with the instrument of Fig. 6.
Fig. 7 is a broken side view, partly in section, of an
. automatic retractable safety penetrating instrument according
to the present invention having a safety shield.
Fig. 8 is a broken view, partly in section, showing
interconnection of the shield and penetrating member of Fig. 7
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to allow retraction of the shield and penetrating member
together or the penetrating member alone.
Fig. 9 is a side view, partly in section, of another
embodiment of an automatic retractable safety penetrating
instrument according to the present invention in a rest state
utilizing a probe for triggering retraction.
Figs. 10, 11, 12 and 13 show operating states for the
instrument of Fig. 9.
Figs. 14, 15, 16 and 17 are end views of the trocar
penetrating member of the instrument of Fig. 9 showing various
positions of the probe.
Fig. 18 is a side view, partly in section, of a
modification of the automatic retractable safety penetrating
instrument of Fig. 9 wherein the penetrating member triggers
retraction.
Fig. 19 is a broken perspective of the locking and
releasing mechanism of the instrument of Fig. 18.
Fig. 20 is a broken side view, partly in section, of
another embodiment of an automatic retractable safety
penetrating instrument according to the present invention having
a safety shield for triggering retraction.
Figs . 21 and 22 are broken perspective views of distal ends
for the instrument of Fig. 20.
Fig. 23 is a broken perspective view of the locking and
releasing mechanism of the instrument of Fig. 20.
Fig. 24 is a broken side view, partly in section, of the
instrument of Fig. 20 in the operative position.
Figs. 25 and 26 are a broken side view, partly in section,
and a broken top view, respectively, of the hub of the
instrument of Fig. 20.
Fig. 27 is a broken side view, partly in section, of a
modified distal end for an automatic retractable safety
penetrating instrument according to the present invention.
Fig. 28 is a broken side view, partly in section, of the
distal end of an automatic retractable safety penetrating
instrument according to the present invention having a
cannulated penetrating member.
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Figs. 29 and 30 are exploded views of the distal ends of
automatic retractable safety penetrating instruments according
to the present invention having cannulated penetrating members.
,. Fig. 31 is a side view of the distal ends of Figs. 29 and
30 with the safety probe in the extended position.
.. Fig. 32 is a perspective view of the cannulated penetrating
members of Figs. 29 and 30 with the probe in a retracted
position.
Fig. 33 is a side view of a trocar-like cannulated
penetrating member for use with the automatic retractable safety
penetrating instrument of the present invention.
Figs. 34, 35 and 36 are perspective top and bottom views
of the penetrating member of Fig. 33 with the probe in a
retracted position.
Fig. 37 is a broken side view, partly in section, of an
automatic retractable safety penetrating instrument according
to the present invention wherein retraction is triggered by a
shield.
Fig. 38 is a broken side view, partly in section, of an
automatic retractable safety penetrating instrument according
to the present invention having a modified locking and releasing
mechanism.
Figs. 39 and 39a are side and perspective views of locking
and releasing members for use with the instrument of Fig. 38.
Fig. 40 is an end view of the locking and releasing member
for use with the instrument of Fig. 38.
Figs. 41, 42 and 43 are broken views showing operation of
the locking and releasing mechanism of the instrument of Fig.
38.
Fig. 44 is a broken view, partly in section, of a
modification of the locking and releasing mechanism of Fig. 38.
Fig. 45 is a broken side view, partly in section, of the
locking and releasing mechanism of Fig. 38 triggered by a safety
shield.
Fig. 46 is a broken side view of a modified locking and
releasing member of the type illustrated in Fig. 38.
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Fig. 47 is a side view, partly in section, of an automatic
retractable safety penetrating instrument according to the
present invention having a penetrating member formed of a distal
end telescoping with respect to a shaft. .
Figs . 48 and 49 are perspective views of retracting springs
for the instrument of Fig. 47.
Figs. 50 and 51 are broken side views, partly in section,
of modifications of the instrument of Fig. 47.
Fig. 52 is a broken side view, partly in section, of an
automatic retractable safety penetrating instrument according
to the present invention in combination with a multi-lumenal
member in the portal sleeve housing.
Fig. 53 is a broken side view, partly in section, of an
automatic retractable safety penetrating instrument according
to the present invention wherein the locking and releasing
mechanism is disposed within a control tube.
Fig. 54 is a side view, partly in section, of an automatic
retractable safety penetrating instrument according to the
present invention wherein the distal end of a penetrating member
telescopes with respect the shaft and is triggered for
retraction by a safety shield for a probe.
Fig. 55 is a broken side view, partly in section, of an
automatic retractable safety penetrating instrument according
to the present invention wherein the locking and releasing
mechanism is located partly in the hub and partly in the shaft
of the penetrating member.
Figs. 56, 57, 58, 59 and 60 are broken side views, partly
in section, of modifications of the automatic retractable safety
penetrating instrument according to the present invention with
various locking and releasing mechanisms.
DESCRIPTION OF THE PREFERRED EMBODIMENTS _
An automatic retractable safety penetrating instrument 60
according to the present invention is illustrated in Fig. 1 and
includes an elongate penetrating member 62, an outer sleeve or
cannula, such as portal sleeve 64, concentrically disposed
around the penetrating member, a hub 66 mounting penetrating
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member 62 and a valve housing 68 mounting portal sleeve 64. The
hub 66 can be latched to housing 68 with the use of any suitable
releasable mechanism, such as detents operated by buttons,
allowing the hub to be removed from the housing withdrawing the
penetrating member from the portal sleeve. Accordingly, the
automatic retractable safety penetrating instrument 60 can be
considered to be formed of a portal unit and a penetrating unit,
the portal unit including portal sleeve 64 and housing 68 and
the penetrating unit including penetrating member 62 and hub 66.
The penetrating member 62 is preferably made of a medical
grade material, such as stainless steel, and has an outer
diameter or size dependent upon the surgical procedure to be
performed and the anatomical cavity to be penetrated. The
penetrating member 62 is made up of a distal part 70 and a
tubular end part 72 concentrically disposed around the distal
part with the distal part mounted for longitudinal telescoping
movement relative to the end part. Distal part 70 includes an
elongate body 74 which can be cylindrical or have any desired
configuration in cross-section terminating distally at a distal
end 76 of the penetrating member. ~ Distal end 76 terminates
distally at a tip 78 for penetrating anatomical tissue and
proximally at an end wall or shoulder 80 joining the distal end
to body 74. The distal end 76 can have various solid or hollow
geometric configurations including various trocar, blade and
needle distal end configurations such as conical and pyramidal,
and the tip 78 can be sharp or blunt and provided with an
external thread. As shown in Fig. 1, distal end 76 is formed
as a trocar having a pyramidal configuration with equally spaced
end surfaces or facets 82 tapering distally to a sharp tip 78
and proximally-joined-at-a-junct-ibrf-8-4--to a--cylindrical-neck 86
terminating proximally at shoulder 80. Body 74 terminates
proximally at an operating member or flange 88 at a proximal end
of the penetrating member, the proximal end being disposed in
hub 66 with body 74 passing through an opening in a front wall
of the hub. The distal end 76 can be formed integrally,
unitarily with body 74 or the distal end can be formed
separately from body 74 and removably mounted thereon, such as
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with threads 90, allowing various distal ends of diverse
configurations to be interchangeably mounted on body 74. Body
74 has an outer diameter or size that is less than the outer
diameter of neck 86 with end part 72 having an inner diameter
sized to closely receive the outer diameter or size of body 74.
End part 72 has an outer diameter that is the same as the outer
diameter of neck 86 such that the neck and end part are closely
received by the inner diameter of the portal sleeve 64. End
part 72 terminates distally at a stop or abutment 92 proximally
spaced from shoulder 80 with the instrument in an extended
position as shown in Fig. 1 and proximally at a retraction
member including a retraction plate or flange 94 disposed in hub
66 with the end part passing through the opening in the front
wall of the hub and body 74 passing through an opening in the
retraction plate. Body 74 can be hollow or tubular along the
length thereof, or the body can be partly hollow or tubular to
receive a control tube 96 extending distally from a rear wall
of hub 66 and into the proximal end of the penetrating member.
Where body 74 is hollow or tubular or formed with an internal
passage along the length thereof communicating with the lumen
of the control tube, a channel (not shown) can be disposed in
distal end 76 in communication with the lumen or passage of the
body to provide fluid communication entirely through the
instrument 60. A valve (not shown), which can be of any
conventional design, can be mounted in communication with the
lumen of the control tube, such as along the rear wall of hub
66, to control fluid flow through the instrument. A cautery
attachment can be provided on the penetrating member for
electric cautery procedures. A helical coil operating spring
98 is disposed concentrically around the control tube and
connected between operating flange 88 and the rear wall of the
hub to bias the penetrating member in a distal direction. A
helical coil balancing, cushion or positioning spring 100 is
disposed concentrically around body 74 and connected between _
retraction plate 94 and the operating flange 88 to bias the
penetrating member in a proximal direction such that the
operating flange is maintained at an initial, rest or balanced
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position with the instrument in the extended position as shown
in Fig. 1. A retracting mechanism engages the proximal end of
the penetrating member and includes the retraction member,
. retraction plate 94 in Fig. 1, and a helical coil retracting
spring 102 connected between retraction plate 94 and the rear
. wall of the hub. If required, a guide rod 104 can extend from
the rear wall of the hub to the front wall thereof passing
through the retraction plate with the retracting spring
concentrically disposed around the guide rod to provide a guide
to maintain the retracting spring in axial alignment.
Hub 66 can be made of any suitable material to be
disposable or reusable and has an external configuration to
cooperate with housing 68 to facilitate grasping by a surgeon
with one hand for use in penetrating tissue. Hub 66 can have
any desired configuration in cross-section and is shown in Fig.
h as being substantially rectangular. An end cap 106 of hub 66
has a skirt 108 extending distally through an opening in the hub
rear wall, the end cap being mounted for longitudinal movement
relative to the hub by a mounting member including a helical
coil mounting spring 1~.0 connected between the hub rear wall and
a rear wall of the end cap rear wall to bias the end cap in a
proximal direction. If needed, various mechanisms can be
provided in the hub or end cap to limit proximal movement of the
end cap relative to the hub.
A locking and releasing or trigger mechanism 112 actuates
the retracting mechanism and includes a latch or locking spring
having a substantially flat base 114 secured to an inner surface
of skirt 108 to extend through the opening in the hub rear wall
and a U-shaped bend 116 disposed in the end cap and proximally
joining base 114 to an arm 118. Arm 118 extends distally from
bend 116 through a slot 120 in the rear wall of the hub, the arm
extending in the direction of the retraction plate 94
substantially parallel with a longitudinal axis of the
instrument. A bent locking finger or member 122 is carried on
a distal end of the artn to engage the retraction plate 94 when
the locking spring is in its normal condition as illustrated in
Fig. 1. A trigger or releasing member 124 including a cam or
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bend in arm 118 is disposed distally of the operating flange 88
in the initial position the trigger member 124 being angled 'in
a distal direction from the arm to cause bending or flexing of
the arm in a direction outwardly from the instrument
longitudinal axis when the operating flange is moved distally
of the initial position as will be explained further below. One
or more than one additional trigger or releasing members 126 are
disposed on arm 128 proximally of the operating flange 88 in the
initial position; and where a plurality of trigger members 126
are provided, it is preferred that the trigger members be
closely spaced to extend longitudinally along the arm as shown
in Fig. 1. The trigger members 126 are angled in a proximal
direction from arm 118 to allow movement of the operating flange
thereby in a proximal direction to a set position without
causing bending or flexing of arm 118 and to cause bending or
flexing of arm 118 in a direction outwardly from the instrument
longitudinal axis when the operating flange is moved distally
from the set position toward the initial position. A detent
including a bump, protrusion or cam 128 is provided on arm 118
distally of bend 116 and proximally of the trigger members 126.
Protrusion 128 has a forward portion angled from arm 118 in a
proximal direction to permit distal movement of the protrusion
through slot 120 and a transverse rear portion joined to the
forward portion to prevent proximal movement of the protrusion
through the slot to lock the end cap relative to the hub when
the instrument is in the extended position. An end cap release
mechanism for releasing the detent from the hub is provided in
instrument 60 and includes an actuating device made up of a pair
of actuating buttons 130 externally mounted on end cap 106 at
diametrically opposing locations with release arms 132 extending
from buttons 130 through skirt 108 in a direction transverse to
the instrument axis to be disposed on opposite sides of bend
116. Buttons 130 can have various configurations to move the
release arms to squeeze, flatten or compress bend 116 inwardly
to align protrusion 128 with slot 120, the release arms being
moved in a direction aligned with the direction of squeezing of
bend 116 when the buttons are pressed inwardly in the direction
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of the instrument axis as will be explained further below. As
shown in Fig. 1, buttons 130 are in the nature of springs 131
made of resilient strips of metal, plastic or other spring
material forming lobes having a bulging configuration in a
direction outwardly from the instrument axis with the release
arms extending therefrom to be moved by the lobes when the lobes
are flattened or collapsed. One or more than one button 130 can
be provided on end cap 106; and, where two buttons are provided
at diametrically opposing locations, bilateral actuation of the
end cap release mechanism is facilitated. The release arms 132
can be arranged in many ways to be aligned with or offset from
one another; and, where only a single button and release arm are
provided, the bend can be compressed between the release arm and
the skirt.
Sleeve 64 can be a portal sleeve or cannula as shown in
Fig. 1 or any other tubular structure, such as a catheter for
intravenous use, designed to establish communication with an
anatomical cavity. Sleeve 64 is preferably made of a
substantially cylindrical length of rigid or flexible and
transparent or opaque material, such as stainless steel or other
suitable, medically acceptable, plastic or metal material; and,
where the sleeve is made of a flexible material, the penetrating
member can also be made of a flexible material. The sleeve has
an outer diameter dependent upon the size of the penetrating
member and the surgical procedure to be performed, the sleeve
typically ranging in size from portal sleeve size to intravenous
tube size, with an inner diameter sized to closely receive the
outer diameters of neck 86 and end part 72. Portal sleeve 64
has a distal end 134 with a configuration to produce a smooth
profile with the distal end 70 of the penetrating member when
the instrument is in an operative position to penetrate tissue
as will be explained further below, a proximal end mounted in
or formed with a front wall of valve housing 68 and a lumen
extending between the distal and proximal ends.
Housing 68 can be made of any suitable material to be
disposable or reusable and has a configuration in cross-section
corresponding to the cross-sectional configuration of hub 66.
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A wall 136 extends inwardly from housing 68 at a position
distally spaced from the rear end thereof to produce a recess
suitable for receiving detents (not shown) releasably securing
the hub and housing, the wall 136 having a central passage for
receiving a valve assembly. The valve assembly can have any
conventional configuration to produce a closed or sealed
condition upon removal of the penetrating unit. As shown in
Fig. 1, the valve assembly is formed as a unitary, one-piece
integral construction of rubber or soft plastic to facilitate
sealing to prevent fluid flow through the instrument when the
penetrating unit is removed. The valve assembly is formed of
a valve body 138 having a passage therethrough and a proximal
flange extending outwardly therefrom to be received in the
recess at the rear end of the housing. The valve body 138 has
a peripheral configuration to fit snugly within the passage
through wall 136, and a valve member extends distally from valve
body 138 and has a normally sealed position with a hemispherical
bulging end received in a valve seat formed at an end of the
passage to produce a normally closed, sealed configuration. To
provide assisted bias toward the sealed configuration, a spring
member 140 can be imbedded within the valve assembly to bias the
valve member toward the valve seat. While the face of the valve
seat is illustrated as being transverse to the longitudinal axis
of the automatic retractable safety penetrating instrument 60,
the valve seat can be angularly oriented.
In use, the automatic retractable safety penetrating
instrument 60 is normally provided in a rest state wherein the
distal end 76 of penetrating member 62 is retracted within
portal sleeve 64 to be in a safe, protected position, the rest
state coinciding with the retracted position for the penetrating
member. In the rest state, retracting spring 102 is in a
relaxed, unbiased or unloaded state causing retraction plate 94
to be moved proximally carrying with it penetrating member 62.
Springs 131 are in relaxed states forming lobes extending in a
direction outwardly from the instrument axis. Operating spring
98 and cushion spring 100 are also in relaxed, unloaded or
unbiased states; and, accordingly, with the automatic
WO 94/06681 PCT/US93/08477
retractable safety penetrating instrument 60 initially provided
in a rest state, no loading of the springs 98, 100, 102 and 131
exists such that the strength of the springs is not weakened and
shelf life is increased. Where it is desired to supply the
instrument 60 in as small a configuration as possible, end cap
106 can be supplied in a locked position with protrusion 128
locked within the hub and locking and releasing mechanism 112
disengaged from the retracting mechanism in the rest position
for the instrument. Where the instrument 60 can be supplied
in a ready position with end cap 106 biased proximally relative
to the hub as illustrated in Fig. 2, mounting spring 110 can be
in an unloaded or relaxed state with protrusion 128 disposed
proximally of the hub rear wall, and the locking and releasing
mechanism 112 can be in a relaxed state with the locking spring
in the normal condition with locking member 122 engaged with
retraction plate 94. Where the instrument is supplied with the
end cap locked within the hub, buttons 130 are depressed causing
release arms 132 to move toward each other squeezing bend 116
to align the rear portion of protrusion 128 with slot 120 such
that mounting spring 110 automatically moves the end cap
proximally, and the instrument will be in the ready position
shown in Fig. 2. When it is desired to utilize the instrument
60 to penetrate tissue and enter an anatomical cavity, the hub
and housing are grasped by a surgeon, and the end cap 106 is
squeezed causing movement of the end cap distally relative to
the hub such that arm 118 functions as a push member to move the
retraction plate 94 and with it end part 72 distally carrying
distal part 70 in the distal direction. Continued squeezing of
the end cap causes the forward portion of protrusion 128 to be
engaged by the hub rear wall such that arm 118 is bent or flexed
a small amount allowing the protrusion 128 to pass through the
slot 120 and into the hub while the retraction plate 94 remains
held by the locking member 122. Once protrusion 128 has entered
the hub, arm 118 returns to the normal condition, and the rear
portion of the protrusion engages the rear wall of the hub to
lock the end cap against proximal movement at which time the end
part 72 will be locked against proximal movement with the
,.
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retraction plate 94 locked in place adjacent the front wall of
the hub as shown in Fig. 1. With the instrument 60 in the
extended position shown in Fig. 1, the operating flange 88 will
be in the initial position disposed proximally of trigger member
124 and distally of trigger members 126 and the distal end
junction 84 of the penetrating member will be spaced from the
distal end 134 of the portal sleeve by a distance that is the
same as the spacing between shoulder 80 and abutment 92.
The instrument can now be utilized to penetrate tissue and
enter an anatomical cavity. The hub and housing are grasped by
the surgeon, and the instrument is forced against tissue, such
as tissue T forming a wall of an anatomical cavity, causing
distal part 70 of penetrating member 62 to move proximally
relative to end part 72 against the bias of operating spring 98.
Abutment of shoulder 80 with stop 92 limits proximal movement
of the distal part at which time the instrument will be in an
operative position illustrated in Fig. 3 with the distal end
junction 84 aligned with the distal end 134 of the portal sleeve
to form a substantially smooth profile. As distal part 70 moves
proximally, operating flange 88 moves proximally deflecting
trigger members 126 in the proximal direction such that the
operating flange moves proximally therepast to a set position
without disengaging the locking member 122 from the retraction
plate 94. Once the distal end 134 of the portal sleeve has
passed through the tissue T and entered the anatomical cavity,
operating spring 98 will move distal part 70 distally relative
to end part 72 causing the operating member 88 to be moved
distally from the set position toward the initial position to
engage a trigger member 126 distally closest thereto such that
arm 118 is flexed or bent in a direction outwardly from the
instrument axis causing locking member 122 to be moved out of
engagement with retraction plate 94. Accordingly, retracting
spring 102 will automatically move the retraction member 94 and
with it the end and distal parts of the penetrating member to
the retracted position with the distal tip 78 of the penetrating
member in a safe, protected position within the portal sleeve
as shown in Fig. 4. By providing a plurality of closely spaced
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trigger members 126, the distance that the operating member must
be moved distally from the set position prior to retraction can
be minimized. Where the operating member is moved to a set
position that is not proximal of a trigger member 126 due to the
resistance of the tissue being small or where trigger members
126 are not provided, operating spring 98 will move the distal
part of the penetrating member distally from the set position
upon the portal sleeve distal end entering the anatomical
cavity, and the momentum of the operating spring will override
the bias of the cushion spring 100 such that the operating
member 88 will be moved distally of the initial position to
engage trigger member 124 and flex arm 118 in a direction
outwardly from the instrument axis such that the locking member
122 is moved out of abutment with retraction plate 94. By
providing both trigger members 124 and 126, redundant protection
is provided for the automatic retractable safety penetrating
instrument 60 in that triggering can be obtained via either
distal movement of the operating member from the set position
toward the initial position or distal movement of the operating
member past the initial position.
Once the distal end of the instrument 60 has entered the
anatomical cavity and the penetrating member has moved to the
retracted position, the portal sleeve will have been introduced
into the cavity such that the penetrating unit can be withdrawn
from the portal unit. When the penetrating unit is withdrawn,
the valve member will return to the biased position such that
the bulging end will engage the valve seat to seal the portal
unit from fluid flow therethrough from insufflation pressure.
Additionally, the axial length of the passage produces an
elongated seal with penetrating member 62 minimizing escape of
fluid during cavity penetration; and, if an instrument of a
different size than the penetrating member is to be introduced
after withdrawal of the penetrating unit, the valve assembly can
be easily interchanged to install a valve assembly having a
passage of a diameter to seal along the different size
instrument.
WO 94/06681 ~ = PCT/US93/08477
18
The instrument 60 can be reusable or disposable for single
patient use; and, where reusable, instrument 60 can be moved
from the retracted position to the ready position by pushing or
depressing buttons 130 causing release arms 132 to move toward
each other. Accordingly, bend 116 will be compressed or
flattened such that the rear portion of protrusion 128 is
aligned with the slot 120 in the hub rear wall causing mounting
spring 110 to automatically move the end cap 10 proximally
relative to the hub. The locking spring will return to the
normal condition with locking member 112 engaged with retraction
plate 94, and the instrument will be in the ready position to
be reset in the extended position via squeezing operation of the
end cap.
Various mechanisms can be utilized in the automatic
retractable safety penetrating instrument in place of or in
addition to the end cap for use in setting the instrument in the
extended position. As one example, a pin and slot arrangement
can be used as the resetting mechanism with a pin provided on
the penetrating member or the retracting mechanism, such as in
the periphery of the retraction plate, to extend through a
longitudinal slot in the hub allowing the retracting mechanism
to be moved via manual movement of the pin along the slot when
setting the instrument in the extended position.
While coiled springs are shown in the instrument 60 for the
operating, retracting, cushion and mounting springs, many
different arrangements and types of springs or other bias
devices can be utilized with the present invention, and the bias
devices can be arranged in instrument 60 in many various ways.
Where springs are utilized, the springs can be tension,
compression or torsion springs. When the operating member is
proximally spaced from the trigger member 124 in the initial
position, the cushion and operating springs can be of equal
strength, ~ and where the operating member is engaged with the
trigger member 124 in the initial position, the cushion spring
can be of lesser strength than the operating spring due to the
increased resistance provided by the trigger member 124. The
cushion spring can be disposed at various locations in the
WO 94/06681 ~ ~ ~ ~° ~ ~ ~' PCT/US93/08477
19
instrument including within the shaft of the penetrating member
to position the operating member in the initial position.
Various single or multiple piece devices can be utilized as the
locking and releasing mechanism to lock the retracting mechanism
against movement and to be released in response to distal
movement of an operating member. The locking and releasing
Ttechal'I35~I't Can- be-tittTUnt2d-~vr~'i't3~eiiieWt -~rviific'~ an 3x~s -i
ia~'is-i~Gr~e
to the instrument axis as shown in Fig. 1, parallel with the
instrument axis, aligned with the instrument axis and in many
other ways. Various types of trigger members including cams,
springs with bumps or springs cut to provide extending leaves
or triggers, linkages and many other types of devices can be
utilized to trigger retraction in response to distal movement
of the operating member, and the trigger members can be provided
at any suitable location including on the locking member or the
operating member. Where provided on the locking member, the
trigger members can be formed integrally, unitarily with the
locking spring or separately therefrom. As shown in Fig. 1,
locking member 122 and trigger members 124 and 126 are
unitarily, integrally formed of a single strip of resilient,
spring material such as metal or plastic. In addition to the
penetrating member, various other parts of the instrument
including the sleeve can be utilized to trigger retraction; and,
where the instrument is supplied with a safety shield or probe,
movement of the probe or shield trigger release of the
retracting mechanism. Where movement of the shield or probe is
utilized to trigger retraction, retraction can be triggered via
movement of an operating member from the set position toward the
initial position or distally of the initial position. The
locking and releasing mechanism can be arranged in the
instrument 60 in many ways; and, depending on the size of the
instrument, the locking and releasing mechanism can be mounted
within or externally of the penetrating member, within the
control tube, the hub or the housing. Where disposed within the
penetrating member, the locking and releasing mechanism can be
mounted at any location along the shaft of the penetrating
member including the penetrating member distal end to be
WO 94/06681 ~ ~ ~ i~ ~ PCT/US93/08477
disposed entirely or partially within the penetrating member.
The end cap can be mounted on the hub in many ways with the
skirt disposed within or externally of the hub, and various bias
members can be utilized to bias the end cap. Where secured to
the end cap, the locking and releasing mechanism can be provided
as a module facilitating assembly of the automatic retractable .
safety penetrating instrument. The locking and releasing
mechanism can be utilized as the push member or the push member
can be a separate device . Various release mechanisms can be
utilized in the instrument 60 to be manually actuated to release
the end cap from the hub, and the release mechanisms can be
mounted on the instrument in many various ways in accordance
with the structure of the locking and releasing mechanism or
push member with the release mechanism of Fig. 1 being
particularly advantageous for bilateral operation with right and
left hand compatibility. The distance that the end cap must be
moved proximally in the ready position will be in accordance
with the distance that the push member must be moved proximally
to be in a position to move the retracting mechanism distally.
Accordingly, the length of skirt 108 will depend upon the
distance that the end cap must be moved proximally, and various
devices such as a bellows can be provided in the instrument to
bridge any longitudinal gap or space between the skirt and the
hub where the skirt is moved outside of the hub in the ready
position. Instrument 60 can be provided with or without a
control tube, although a control tube is desirable to allow
fluid flow through the instrument. Control tube 96 can be
rotatably mounted and can extend through the end cap to
terminate at the end cap rear wall. A valve can be disposed
along the rear wall of the end cap in communication with the
lumen of the control tube to control fluid flow through the
instrument where the inner member is hollow or formed with an
internal passage.
A modified locking and releasing mechanism and end cap
release arm for the automatic retractable safety penetrating
instrument according to the present invention are illustrated
in Fig. 5 at 160 wherein the locking and releasing mechanism 212
WO 94/06681 ~ ~ ~ ~ .~ ~ ~ PCT/US93/08477
21
is shown without a trigger member. Locking and releasing
mechanism 212 is similar to locking and releasing mechanism 112
and includes a latch or locking spring having a base 214 for
being secured to the end cap of the automatic retractable safety
penetrating instrument, a U-shaped bend 216 and an arm 218
. joined to base 214 by bend 216. Arm 218 has a locking member
222 at a distal end thereof to engage the retracting member for
locking the retraction mechanism of the automatic retractable
safety penetrating instrument against movement; and, if desired,
arm 218 can be used as the push member for use in setting the
automatic retractable safety penetrating instrument in the
extended position via squeezing operation of the end cap. A
detent or protrusion 228 is disposed on arm 218 distally of bend
216 for locking the end cap relative to the hub of the automatic
retractable safety penetrating instrument in the extended
position. Various trigger members can be provided on the
locking spring to be actuated by the operating member to trigger
retraction, or the locking spring can be designed to cooperate
with a trigger member provided on the operating member as will
be explained further below. Release arm 218 extends into the
end cap to terminate at a tapered end 219 for compressing or
squeezing bend 216 when the release arm is moved toward the
locking spring by an actuating device, such as buttons 130, in
a direction transverse to the direction of squeezing.
Accordingly, by moving the release arm 218 into the end cap in
a direction transverse to the desired direction of flattening
or squeezing of the bend, the tapered configuration of the
release arm will progressively flatten or compress the bend
allowing protrusion 228 to move through the slot in the hub rear
wall thusly releasing the end cap.
A modification of the locking and releasing mechanism for
the instrument 60 is illustrated in Fig. 5A wherein triggers 124
and 126 are mounted on a substrate 121 laminated to arm 118 with
triggers 126 and 127 cut from substrate 121 as indicated by
apertures 127 to be bent upwardly therefrom. Accordingly,
triggers 126 will flex distally and downwardly looking at Fig.
during proximal movement of the operating member; and, during
a ~ f:
WO 94/06681 ~ ~ ~ ~ ~ ~ ~ ~ PCT/US93/08477
22
distal movement of the operating member, the triggers 126 will
cause the arm 118 to flex to release the retracting mechanism,
the substrate providing additional strength to allow repetitive
operation of the triggers 126.
In the modified locking and releasing mechanism illustrated
in Figs. 5B and 5C, the arm 118 is cut at 119 to allow triggers
124 and 126 to extend therethrough angled proximally to allow
operating member 88 to pass thereby while flexing the triggers
126 without flexing the arm 118, the operating member having a
beveled ends 89 to facilitate proximal movement thereof. The
triggers 124 and 126 extend from a member 123 disposed below arm
118 and having a lip 125 engaging the edge of arm 118 such that
member 123 can flex downwardly looking at Fig. 5C without
w movement of arm 118 with proximal movement of operating member
88. Upward movement of member 123 is prevented during distal
movement of operating member 88 such that the arm 118 is caused
i
to deflect downwardly moving lock 122 from the locked position
to a release position actuating the retraction mechanism. '
In the modified locking and releasing mechanism illustrated
in Fig. 5D, no trigger members 126 are utilized and the trigger
124 is formed of an angled portion of arm 118. The rest
position is illustrated in Fig. 5D; and, after movement of
operating member 88 rearwardly from the rest position, the
operating member will be subsequently moved distally past the
rest position due to the force from operating spring 98
compressing spring 100. As the operating member 88 moves
forwardly of the rest position, the peripheral edge of the
operating member, which is preferably angled at the same angle
as the trigger 124, engages the trigger 124 to move the lock 122
to the release position allowing retraction.
A modification of the automatic retractable safety
penetrating instrument according to the present invention is
illustrated at 360 in Fig. 6, only the penetrating unit of the
instrument 360 being shown. The automatic retractable safety
penetrating instrument 360 is similar to automatic retractable
safety penetrating instrument 60; however, the operating member
or flange 388 for the automatic retractable safety penetrating
~1~~~28
WO 94/06681 ' ~~ PGT/US93/08477
23
instrument 3.60 has a trigger member 326 extending from the
periphery thereof, the trigger member 326 being angled outwardly
from the operating member in a distal direction. The locking
and releasing mechanism 312 for the automatic retractable safety
penetrating instrument 360 includes a latch or locking spring
similar to that described for locking and releasing mechanism
112; however, arm 318 for locking and releasing mechanism 312
has a plurality of spaced barbs, ratchet teeth or serrations 321
extending longitudinally therealong for being successively
engaged by trigger member 326.
Operation of automatic retractable safety penetrating
instrument 360 is similar to that described for automatic
retractable safety penetrating instrument 60 in that the
operating flange is positioned by the operating and balancing
springs 398 and 400 in an initial position with trigger 326
disposed distally of some of the barbs 321. Where the initial
position for the trigger member is such that at least one barb
is disposed distally of the trigger member, the trigger member
can be maintained in engagement with the nearest distal barb as
illustrated in Fig. 6 allowing the cushion spring to be of
lesser strength than the operating spring and for further
stability in the initial position. During penetration of
anatomical tissue, operating member 388 will be moved proximally
causing trigger member 326 to move proximally past and engage
successive barbs 321 such that the penetrating member moves
incrementally-in a controlled manner until the operating member
has moved to the set position with the trigger engaged with a~
distally closest barb. Once the distal end of the portal sleeve
has entered the anatomical cavity, operating spring 398 will
move operating flange 388 distally from the set position such
that trigger member 326, via engagement with the distally
nearest barb, causes arm 318 to be pivoted and locking member
~a= r
~~3'2 to be released from engagement with retraction plate 394 for
immediate retraction upon penetration with minimal distal
movement of the operating flange. By providing a plurality of
closely spaced barbs, trigger member 326 will be engaged with
a nearest distal barb for various set positions ensuring
WO 94/06681 c PC'T/US93/08477
24
immediate retraction upon distal movement of the operating
member. Where momentum triggering is desired, one or more barbs
321 can be disposed distally of the initial position to be
utilized to pivot the arm 318 upon distal movement of the
operating member distally of the initial position. Where
momentum triggering is utilized, one barb disposed distally of
the initial position should be sufficient to trigger retraction;
however, more than one barb can be provided for increased
safety. The automatic retractable safety penetrating instrument
360 can be used with or without momentum triggering; and, where
momentum triggering is provided in addition to triggering by
distal movement of the operating member from the set position
toward the initial position, redundant protection is provided.
A modification of the instrument 360 is shown in Fig. 6A
wherein teeth or barbs 321 are formed of flexible members while
operating member 388 has a beveled end 389 whereby the
configuration of the teeth 321 and the operating member 388
allows flexing of the teeth as the operating member moves
proximally thereby but, during distal movement of the operating
member upon entry into an anatomical cavity, the arm 318 will
be flexed to release lock 322 and actuate retraction.
In the modification of Figs. 6B and 6C for use with
instrument 360, the trigger 326 is replaced with a pivotal
member 327 having an angled surface to facilitate movement past
teeth 321. The pivotal member 327 shown in Fig. 6B is mounted
on a pivot 329 on the peripheral edge of operating member 388
and the pivotal member has a triangular shape such that the
member can pivot only counterclockwise looking at Fig. 6B.
Accordingly, the pivotal member 328 can pivot to allow proximal ,
movement of the operating member 388 but, upon distal movement
of the operating member, will cause the arm 318 to flex to
actuate the retraction mechanism. In Fig. 6C, pivotal member
327' is mounted on a pivot 331 to form a transversely extending
operating member which can pivot only counterclockwise looking _
at Fig. 6C due to a protrusion 333 preventing clockwise
pivoting. Accordingly, member 327' will pivot during proximal
WO 94/06681 ~ ~ ,I~ ~ ~ '~ ~ PCT/US93/08477
movement but will cause arm 318 to deflect to actuate the
retracting mechanism upon distal movement.
Another modification of the automatic retractable safety
penetrating instrument according to the present invention is
illustrated at 460 in Fig. 7, only the penetrating unit of the
instrument 460 being shown. The automatic retractable safety
penetrating instrument 460 is similar to automatic retractable
safety penetrating instrument 60 except that a safety shield 463
is concentrically disposed around the penetrating member 462
with the penetrating member including a body 474 terminating
proximally retraction plate or flange 494 disposed in hub 466.
Safety shield 463 has a distal end 467 disposed beyond the tip
478 of the penetrating member when the instrument is in an
extended position as shown in Fig. 7 and a proximal end
terminating at an operating member or flange 488 disposed in hub
466. A helical coil operating spring 498 is concentrically
disposed around the penetrating member and connected between
operating flange 488 and retraction plate 494 to bias the safety
shield in a distal direction. A helical coil cushion spring 500
is disposed concentrically around the safety shield and
connected between the front wall of the hub and the operating
flange 488 to bias the safety shield in a proximal direction
such that the operating flange is maintained at an initial
position with the instrument in the extended position as shown
in Fig. 7. A helical coil retracting spring 502 disposed around
guide rod 504 is connected between retraction plate 494 and the
front wall of the hub. Hub 466 and end cap 506 are similar to
hub 66 and end cap 106 with end cap 506 being mounted for
longitudinal movement relative to the hub and biased in a
proximal direction by a bias member including a mounting spring
510. A locking and releasing or trigger mechanism 512 for
actuating the retracting mechanism includes a latch or locking
spring similar to that described for locking and releasing
. mechanism 112 except that arm 518 for locking and releasing
mechanism 512 includes a proximal portion angled from the
protrusion 528 to extend distally in the direction of a
longitudinal axis of the instrument and a distal portion bent
WO 94/06681 _ ' ~ PCT/US93/08477
' 26
from the proximal portion to extend distally in a direction
outwardly from the longitudinal axis, the distal portion
terminating distally at the locking finger or member 522 engaged
with the retraction plate 494 when the locking spring is in its
normal condition as illustrated in Fig. 7. An extension 523 of
arm 518 extends distally from the locking member substantially
parallel with the instrument longitudinal axis. A plurality of
trigger members 524 are disposed longitudinally along the
extension at spaced locations therealong with a most proximal
one of the trigger members 524 positioned distally of the
operating member in the initial position as illustrated in Fig.
7. A plurality of trigger members 526 extend longitudinally
along extension 523 at spaced locations therealong with a most
distal one of the trigger members 526 disposed proximally of the
operating member in the initial position. When the trigger
members are formed of or cut from the material of the locking
spring as shown in Fig. 7, an extra layer or strip of material
525 can be provided on arm 518 including extension 523 for
additional strength. As best illustrated in Fig. 8, a nub 489
extends radially inwardly from an inner surface of the wall of
the safety shield 463, the nub extending from the operating
flange 488. A longitudinal slot 491 is formed in the
penetrating member 462 to receive the nub such that, with the
operating flange in the initial position, the nub is disposed
at a distal end of the slot in engagement with the wall of the
penetrating member.
Operation of the automatic retractable safety penetrating
instrument 460 is similar to that previously described for
automatic retractable safety penetrating instrument 60 in that
the instrument 460 is normally provided in a rest state and is
moved to the ready position by releasing end cap 506 from hub
466 via actuation of buttons 530. The instrument is moved to
the extended position illustrated in Fig. 7 via squeezing
operation of the end cap 506 causing the retracting mechanism
to be moved distally by the arm 518 to lock the retraction plate
494 in place against the locking member 522 with the end cap
held in place by protrusion 528 within the hub. With the
WO 94/06681 ~ ~ ~ ~ ~ PCT/US93/08477
27
instrument 460 in the extended position, the operating member
488 will be in the initial position disposed proximally of a
most proximal one of the trigger members 524 and distally of a
most distal one of the trigger members 526, the distal end
junction 484 of the penetrating member will be substantially
aligned with the distal end of the portal sleeve and the distal
end 467 of the safety shield will extend beyond the tip 478 of
the penetrating member such that the penetrating member is in
a safe, protected position. When the instrument 460 is forced
against tissue to enter an anatomical cavity, the safety shield
463 will be moved proximally against causing the operating
member 488 to move to a set position with trigger members 526
deflecting proximally allowing movement of the operating member
therepast. Movement of the safety shield causes nub 489 to be
moved proximally within the longitudinal slot 491 as shown in
dotted lines in Fig. 8, and a proximal end of the slot can serve
as a stop or abutment limiting proximal movement of the safety
shield. Once the distal end of the portal sleeve 464 has
entered the anatomical cavity, the operating spring 498 will
move the safety shield distally causing the operating member 488
to move distally toward the initial position and engage the
distally closest trigger member 526 to flex the locking spring
and release the retraction plate 498 from the locking member
522. Once the retraction plate is released, retracting spring
502 will automatically move the penetrating member 462
proximally to a retracted position, the penetrating member
carrying with it the safety shield 463 due to engagement of the
penetrating member wall with the nub 489. Accordingly, both the
penetrating member and safety shield distal ends can be
retracted within the portal sleeve minimizing extension of the
automatic retractable safety penetrating instrument into the
anatomical cavity. Where trigger members 526 are not provided
or the set position is such that there is no trigger member 526
between the initial and set positions, trigger members 524 can
be utilized to trigger retraction in that the momentum of the
operating spring upon penetration into the anatomical cavity
overrides the bias of the cushion spring to move the operating
WO 94/06681 PCT/US93/0847 7
~~.~~~28 28
member distally of the initial position causing the operating
member to engage a trigger member 524 and flex the locking
spring to release the retraction plate. Where the nub 489 and
slot 491 are not provided, the penetrating member alone will be
retracted upon penetration through the issue with the safety
shield remaining extended. Instrument 460 can be designed to .
allow removal of the penetration member and the safety shield
together or individually from the portal sleeve.
Another modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated in Fig. 9 at 560. The automatic retractable safety
penetrating instrument 560 includes a penetrating member 562,
a portal sleeve 564 concentrically disposed around the
penetrating member, a probe 565 disposed within the penetrating
member, a hub 566 mounting penetrating member 562 and probe 565
and a valve housing 568 mounting portal sleeve 564. The hub 566
can be latched to housing 568 with detents formed on the hub at
a forward end thereof, the detents being in the nature of beads
or protrusions for being snapped or locked in place in recesses
formed along an inner surface of the wall of the housing at a
rear end thereof. The detents can be frictionally retained in
the recesses allowing the hub to be removed from the housing
with manual force such that the penetrating unit can be removed
from the portal unit. The penetrating member 562 is similar to
penetrating members 462 and has a distal end 576 with a
pyramidal configuration defined by equally spaced end surfaces
or facets 582 tapering distally to a tip 578 and terminating
proximally at a scalloped junction 584 joining the facets to an
elongate body 574, the body 574 terminating proximally at a
retraction plate 594 disposed in hub 566. Probe 565 includes
an elongate member which can be cylindrical or have any other
desired configuration in cross section terminating distally at
a blunt tip 569 extending through an aperture in one of the
facets and proximally at an operating member 588. The probe can
be solid, hollow or tubular or partly hollow or tubular; and,
as shown in Fig. 9, the probe 565 is in the nature of a solid,
cylindrical rod, bar or wire having a minimal outer diameter or
WO 94/06681 ~ ~ ~ ~ ~ ~ ' PCT/US93/08477
29
size with a relatively thicker piece of material joined
proximally to the bar at a right angle thereto to define the
operating member 588. Body 574 can be hollow or tubular or
- formed with an internal passage along the length of the
penetrating member with the probe disposed in the lumen or
~ passage of the body to be laterally offset from a longitudinal
axis of the instrument 560 as shown in Fig. 9 or aligned with
the instrument axis including being concentrically disposed
within the penetrating member. A push member 571, which can be
solid or tubular, extends distally through a rear wall of hub
566 and into a proximal end of the penetrating member for
setting the instrument in the extended position shown in Fig.
9, the push member being aligned with the instrument
longitudinal axis with the probe laterally offset therefrom.
A helical coil operating spring 598 is connected between
operating flange 588 and the rear wall of the hub laterally
offset from the push member to bias the probe in a distal
direction. A helical coil cushion 600 is connected between the
operating flange 588 and the retraction plate 594 to bias the
probe in a proximal direction against the distal bias of the
operating spring such that the operating member is maintained
at an initial position with the instrument in the extended
position as illustrated in Fig. 9. A helical coil retracting
spring 602 is connected between retraction plate 594 and a rear
wall of the hub to bias the retraction member proximally. The
hub rear wall has an opening therein allowing passage
therethrough by the push member 571, and a tubular collar 573
extends proximally, externally from the hub rear wall with the
push member 571 extending proximally through the collar to
terminate at an external knob 575 for rotating the push member
around an axis aligned with the instrument longitudinal axis.
A helical or spiral-like groove 577 is formed in an outer
surface of the push member to receive a cam or pin 579 mounted
externally along the hub rear wall and extending into the lumen
of the collar such that rotation of the push member around the
instrument axis produces longitudinal movement of the push
member relative to the hub. With the push member fully inserted
WO 94/06681 ~ ~ ~ ~ ' ' PCT/US93/08477
in the hub such that knob 575 abuts the collar 573 as shown in
Fig. 9, the pin 579 is received in a proximal end of the groove
577, and a nub 581 protruding from the control tube distally of
the groove is longitudinally aligned with a longitudinal slot
583 in the penetrating member, the slot extending through the
retraction plate 594. The locking and releasing mechanism 612
for actuating the retracting mechanism includes a latch or
locking spring similar to the locking spring for locking and
releasing mechanism 112 except that no trigger members 126 are
provided and trigger member 624 is made from a portion of arm
618 angled in a distal direction toward the instrument
longitudinal axis to be disposed distally of the operating
member in the initial position.
In use, the automatic retractable safety penetrating
instrument 560 is normally provided in a rest state with the
distal end 576 of the penetrating member 562 retracted within
portal sleeve 564 to be in a safe, protected position, the rest
state coinciding with the retracted position for the penetrating
member illustrated in Fig. 12. In the rest state, push member
571 is fully inserted in hub 566 with pin 579 disposed at a
proximal end of the groove 577 and nub 581 disposed in the
longitudinal slot 583 at a distal end thereof. When it is
desired to utilize the instrument 560 to penetrate tissue and
enter an anatomical cavity, knob 575 is rotated counterclockwise
looking distally at Fig. 12 such that pin 579 and groove 577
cause the push member 571 to move proximally, longitudinally
relative to the hub withdrawing the push member therefrom until
a distal end of the groove 577 is disposed in the collar 573
with the pin 579 received therein in a ready position for the
instrument as illustrated in Fig. 13. With the push member 571
withdrawn, the nub 581 is no longer longitudinally aligned with
the slot 583 but, rather, is aligned with a solid portion of the
retraction plate 594 offset 180° from the slot. The knob 575
is then rotated clockwise looking distally at Fig. 13 causing
movement of the push member 571 longitudinally into the hub with
movement of the retraction plate distally via engagement with
nub 581. Once the push member has been fully inserted in the
WO 94/06681 ~ ~ ~ ~ ~~ ~ ~ PCT/US93/08477
31
hub, the instrument will be in the extended position shown in
Fig. 9 with the retraction plate 594 locked in place against the
locking member 622 and the nub 581 longitudinally aligned with
the slot 583. In the extended position, the junction 584 will
be substantially aligned with the distal end of the portal
sleeve and the distal end 569 of the probe 565 will be disposed
beyond the facet or end surface 582 with the cushion and
operating springs positioning the operating member in the
initial position proximally of the trigger member 624. When the
instrument 560 is forced against tissue, such as tissue T
forming a wall of an anatomical cavity, the probe 565 will be
moved proximally as shown in Fig. 10 causing the operating
member 588 to be moved proximally without bending or flexing the
arm 618. Once a distal end of the sleeve 564 has entered the
anatomical cavity, the probe 565 will be moved distally, and the
momentum of the operating spring 598 moves the operating member
588 distally of the initial position to engage trigger member
624 and flex arm 618 in a direction outwardly from the
instrument axis to release the retraction plate 594 as
illustrated in Fig. 11. Once the retraction plate is released,
retracting spring 602 automatically moves the penetrating member
and with it the probe to a retracted position with the slot 583
moving along the nub 581. In the retracted position, the tip
578 of the penetrating member is disposed within the portal
sleeve and the tip of the probe is disposed within the
penetrating member as illustrated in Fig. 12. the instrument
560 can be reset in the extended position by withdrawing push
member 571 from the hub to align nub 581 with the solid portion
of the retraction plate and reinserting the push member in the
hub-to-move the--retracting-Mechanists distaiiy.
The probe 565 can be arranged in the penetrating member 562
in many various ways, and Figs. 14 - 17 illustrate by way of
example alternative arrangements for the probe within the
penetrating member where the probe is offset from a longitudinal
axis of the penetrating member. In Fig. 14, the penetrating
member distal end includes three equally spaced end surfaces or
facets 582 joined along three edges 585 terminating distally at
~~.~~~~~z~
WO 94/06681 ' ~ PCT/US93/08477
32
tip 578 and proximally at a junction joining the facets to body
574 with the probe 565 protruding through one of the end
surfaces inwardly of the junction, i.e. inwardly of the
circumference of body 574, a substantially equal angular
distance from the edges 585 of the one end surface. The
penetrating member of Fig. 15 includes three equally spaced end
surfaces 582 joined along edges 585 with the probe 565
protruding in part through two adjoining end surfaces 582
inwardly of the circumference of the body 574 and along the edge
585 joining the two end surfaces. In Fig. 16, the penetrating
member includes three equally spaced end surfaces 582 joined
along edges 585 with the probe 565 protruding in part through
two adjoining end surfaces along the edge 585 joining the two
end surfaces and along the circumference of the body 574. The
penetrating member of Fig. 17 includes three equally spaced end
surfaces 582 joined along edges 585 with the probe 565
protruding through one of the end surfaces along the
circumference of the body 574 a substantially equal angular
distance from the edges of the one end surface. It will be
appreciated that the arrangements for the probe illustrated in
Figs. 14 - 17 are exemplary only and that the probe can be
arranged in the penetrating member in many various ways in
accordance with the structure for the probe and the
configuration of the penetrating member. By positioning the
probe to protrude from the penetrating member close to the
junction 584 and the circumference of body 574, retraction of
the penetrating member immediately upon the sleeve distal end
entering the anatomical cavity can be realized.
Another modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated at 660 in Fig. 18. Penetrating member 662 of
instrument 660 is made up of a distal part 670 and an end part
672, the distal part 670 having a distal end 676 defined by end
surfaces 682 tapering distally to tip 678 and terminating
proximally at a scalloped junction 684 joining the facets to a
cylindrical neck 686 which in turn is joined to an elongate body
674 having an outer diameter or size less than the outer
WO 94/06681
PGT/US93/08477
33
diameter of neck 686. Body 674 extends proximally from neck 686
to terminate at an end flange 687 disposed in the end part with
body 674 passing through an opening in a forward wall of the end
part. The end part forward wall is rigidly held between the end
flange and a projection or plate 693 on body 674 such that the
distal and end parts move together as a unit. End part 672
terminates proximally at an operating member or flange 688 at
a proximal end of the penetrating member disposed in hub 666,
the end part being hollow or tubular or formed with an internal
passage to receive a push member 671 that is the same as push
member 571 for setting the instrument in the ready and extended
positions as was described for automatic retractable safety
penetrating instrument 560. Operating spring 698 is connected
between operating flange 688 and the rear wall of the hub to
bias the penetrating member in a distal direction, and cushion
spring 700 is connected between the operating flange and a
retraction plate 694 disposed in the hub distally of the
operating member to maintain the operating member at an initial
position with the instrument in the extended position as shown
in Fig. 18. As best illustrated in Fig. 19, retraction plate
694 has an opening therein allowing passage therethrough by the
end part 672 with a leg 695 and an extension 697 extending
proximally from the retraction plate at diametrically opposing
locations. The leg 695 and extension 697 extend through
respective slots in the operating flange 688 with retracting
spring 702 connected between the leg 695 and the rear wall of
the hub to bias the retraction plate in a proximal direction.
A locking and releasing mechanism 712 for actuating retraction
of the penetrating member includes a locking spring similar to
that described for locking and releasing mechanism 612 except
that trigger member 724 is disposed distally of locking member
722, the trigger member 724 being disposed on an extension 723
of arm 718. Extension 723 extends distally from locking member
722 with trigger member 724 disposed distally of the operating
member in the initial position and the locking member in
engagement with the extension 697 of the retraction plate in the
normal condition for the locking spring illustrated in Fig. 18.
WO 94/06681 ~ ~ ~ ~ PGT/US93/08477
34
Operation of the automatic retractable safety penetrating
instrument 660 is similar to that previously described for
instrument 560 in that the push member 671 can be utilized to
move the instrument from the rest to the ready position and
thereafter to the extended position illustrated in Fig. 18 with
the junction 684 of the penetrating member disposed beyond a
distal end of the portal sleeve and the retraction plate 694
locked in place via engagement of extension 697 with the locking
member 722 and the operating member 688 in the initial position
disposed proximally of the trigger member 724. When the
instrument 660 is forced through tissue to enter an anatomical
cavity, the penetrating member 662 will be moved proximally
causing proximal movement of the operating flange 688 to a set
posit~Lon with the locking member 722 serving as a stop or
abutment limiting proximal movement of the operating flange.
Upon the portal sleeve distal end entering the anatomical
cavity, the operating flange will move distally, and the
momentum of the operating spring 698 will cause movement of the
operating member distally of the initial position to engage
trigger member 724 and flex the locking spring to release the
retraction plate 794.
An additional modification of an automatic retractable
safety penetrating instrument according to the present invention
is illustrated at 760 in Fig. 20, the instrument 760 being
similar to automatic retractable safety penetrating instrument
460 in that movement of a safety shield distally upon a distal
end of the portal sleeve entering an anatomical cavity is
utilized to trigger retraction. As illustrated in Figs. 20 and
22, the penetrating member 762 for automatic retractable safety
penetrating instrument 760 has a distal end 776 defined by a
plurality of facets 782 terminating distally at tip 778 and
proximally at a junction 784 joining the facets to a body 774.
As illustrated in Figs. 20 and 21, the safety shield 763 has a
distal end 767 joined to an elongate body concentrically
disposed around the body of the penetrating member, the safety
shield distal end being defined by one or more end surfaces 801
for being disposed along a corresponding facet or facets 782 of
WO 94/06681 ~ ~ (~ ~ L~ ~ ~ . PCT/US93/08477
the penetrating member when the instrument is in an operative
position during penetration of tissue as shown in Fig.. 21. The
end surfaces 801 of the safety shield are disposed at an angle
with a longitudinal axis of the instrument 760 that is the same
as the angle that the corresponding facet or facets 782 are
. disposed with the longitudinal axis such that the safety shield
distal end completes or conforms to the geometric configuration
of the penetrating member in the operative position. The
penetrating member and safety shield distal ends can have
various configurations to produce a predetermined solid or
hollow geometric configuration in the operative position. Body
774 terminates proximally at a retraction plate 794 disposed in
hub 766, and one or more than one retracting spring 802 is
connected between retraction plate 794 and the rear wall of the
hub to bias the penetrating member in a proximal direction, one
retracting spring being illustrated in Fig. 20 and two
retracting springs being illustrated in Fig. 24. The safety
shield terminates proximally at an operating member 788 disposed
in hub 766 with an operating spring 798 disposed concentrically
around the penetrating member and connected between the
retraction plate 794 and the operating flange 788 to bias the
safety shield in a distal direction. An end cap 806 similar to
end cap 106 is mounted for longitudinal sliding movement
relative to the hub by bias members including mounting springs
810 connected between the hub rear wall and the rear wall of the
end cap to bias the end cap in a proximal direction. As best
illustrated in Figs. 20 and 23, a locking and releasing
mechanism 812 for the instrument 760 includes a locking spring
similar to that described for locking and releasing mechanism
712 in that arm 818 has an extension 823 extending distally from
the locking member 822 to carry a trigger member 826 pivotally
mounted on extension 823. Trigger member 826 includes a trigger
cam 827 angled in a proximal direction and a leg 829 disposed
parallel with extension 823 to allow proximal movement of the
operating flange past the trigger cam without causing flexing
of arm 818 and to cause flexing of arm 818 in response to distal
movement of the operating member against the trigger cam. A
WO 94/06681 '~ ~ ~ PCT/US93/08477
'. 3 6
notch or slot 833 can be formed in the retraction plate 794 to
facilitate assembly of the instrument 760.
Operation of the automatic retractable safety penetrating
instrument 760 is similar to that previously described for
automatic retractable safety penetrating instrument 460 in that
the instrument can be supplied in a rest state and moved to a
ready position illustrated in Fig. 20 by releasing the end cap
806 from the hub 766. In the ready position, the penetrating
member 762 and safety shield 763 are in a retracted position
with end cap 806 biased proximally. End cap 806 is moved
distally to set the instrument in the extended position
illustrated in Fig. 24, the arm 818 serving as a push member for
moving the retracting mechanism distally via engagement of the
locking member 822 with the retraction plate 794. Once the
protrusion 828 has entered the hub through the slot in the hub
rear wall, the end cap will be locked in place at which time the
retraction plate 794 is locked or held in place against the
locking member 822. With the instrument in the extended
position, the junction 784 of the penetrating member will be
aligned with the distal end of the portal sleeve, and the distal
end of the safety shield will be disposed beyond the tip 778 of
the penetrating member. When the instrument 760 is forced
through tissue forming a wall of an anatomical cavity, the
safety shield will move proximally causing proximal movement of
the operating member 788 past the trigger cam 827 without
causing flexing of arm 818. In the operative position, the end
surfaces 801 of the safety shield will be disposed along the
corresponding facets 782 of the penetrating member to produce
a predetermined geometric configuration. Once the distal end
of the portal sleeve has entered the anatomical cavity, the
safety shield 763 will be moved distally causing distal movement
of the operating member 788 to engage trigger cam 827 and pivot
leg 829 causing arm 818 to flex and release the retraction plate
794. Accordingly, retracting spring 802 will move the
penetrating member and with it the safety shield to the
retracted position shown in Fig. 20.
WO 94/06681 ~ PGT/US93/08477
37
As illustrated in Figs. 25 and 26 the hub 766 can have a
side wall thereof formed with a central recessed channel '835
with a slot 837 formed in the hub wall to be disposed in the
recessed channel. The slot 837 includes a longitudinal slot
portion 839, a proximal transverse slot portion 841 and a distal
transverse slot portion 843. A pin 845 is threadedly secured
on the penetrating member, such as in the periphery of
retraction plate 794, the pin 845 extending through the
longitudinal slot portion 839 to terminate at an external knob
818 with the location of the proximal transverse slot portion
841 corresponding to the location of the pin 845 in the
extended position. A pin 847 is secured to the safety shield,
such as in the periphery of the operating flange 788, the pin
847 similarly extending through the longitudinal slot portion
839 to terminate at an external knob with the location of the
distal transverse slot portion 843 corresponding to the location
of the pin 847 in the extended position. The length of the
longitudinal slot portion is sufficient to allow movement of the
safety shield and the penetrating member between the extended
and retracted positions with the knobs moving within the
longitudinal slot portion. Where retraction is not desired, the
pin 845 can be moved into the proximal transverse slot portion
841 preventing retraction of the penetrating member and safety
shield such that the safety shield distal end is disposed beyond
the tip of the penetrating member upon the portal sleeve distal
end entering an anatomical cavity for use as a standard safety
trocar instrument. Where it is desired to penetrate tissue with
the safety shield distal end disposed beyond the tip of the
penetrating member, pin 847 can be moved into the distal
transverse slot portion 843 to lock the safety shield against
proximal movement; and, accordingly, retraction of the
penetrating member will be prevented. Where the safety shield
distal end does not complete the configuration of the
penetrating member distal end in the operative position and it
is desired that the safety shield distal end be locked in a
position substantially aligned with the portal sleeve distal end
for use as a standard trocar instrument, an intermediate
WO 94/06681 ~ ~ '~ ~ PCT/US93/08477
. ~. 3 8
transverse slot portion 849 can be provided along the slot 837
corresponding in location to the location of pin 843 when 'the
safety shield is in the retracted position allowing the pin 847
to be moved into the intermediate transverse slot portion as -
shown in dotted lines in Figs. 25 and 26. A probe can be used
with the instrument 760 to trigger retraction; and, as shown in
Fig. 22, a probe 765 can be mounted within the penetrating
member 762 to extend through a hole in an end surface or facet
782. Various types of release mechanisms can be used with the
instrument 760 to release the end cap from the hub allowing the
instrument to be reset in the extended position.
A modification of the automatic retractable safety
penetrating instrument according to the present invention is
illustrated at 860 in Fig. 27 wherein safety shield 863 includes
a distal end 867 having a configuration that is the same as the
configuration of the distal end 876 of the penetrating member
862 such that the safety shield can be utilized to cut tissue
when disposed beyond the distal end of the penetrating member
as illustrated in Fig. 27. As shown in Fig. 27, distal end 867
of safety shield 863 has a plurality of end surfaces or facets
901 tapering distally to a sharp tip 903, and the penetrating
member distal end 876 includes a plurality of corresponding
facets 882 tapering distally to sharp tip 878 with the facets
901 of the safety shield being disposed at an angle with the
longitudinal axis of the penetrating member that is the same as
the angle that the facets 882 are disposed with the longitudinal
axis. By forming the safety shield distal end of a sewerable
material, the distal end 867 of the safety shield can be cut
prior to use to remove the sharp tip 903 where use of the safety
shield to cut tissue is not desired.
Another modification of the automatic retractable safety
penetrating instrument according to the present invention is
illustrated at 960 in Fig. 28 wherein the penetrating member 962
is in the nature of a cannulated needle having a distal end 976
defined by an angled edge 982 terminating distally at a sharp
tip 978. A safety probe 965 is disposed concentrically within
the penetrating member, the safety probe 965 having a distal end
WO 94/06681 ~ PCT/US93/08477
~1~~~~~ .
969 with an angled end surface 905. The edge 982 of the
penetrating member is disposed at an angle with the longitudinal
axis of the penetrating member that is the same as the angle
that the end surface 905 is disposed with the axis such that the
probe and penetrating member form a substantially smooth, solid
geometric configuration in the operative position. Instrument
960 can be designed to allow removal of the probe and the
penetrating member together or individually from the portal
unit, and the probe can remain extended beyond the distal end
of the portal sleeve upon retraction of the penetrating member
as was described for the safety shield in instrument 760.
Another embodiment of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated in Fig. 29 wherein a hollow penetrating member 1062
is partially solid having a passage 1007 therethrough of a semi-
circular configuration in cross-section. A distal end 1076 of
the penetrating member has a partially conical configuration
terminating at a sharp tip 1078 from which extends a peripheral
edge 1082 forming an opening in the distal end of the
penetrating member. A safety probe 1065 is formed of a solid
elongate member 1009 having a semi-circular configuration in
cross-section and terminating at a distal end 1069 having a
partially conical configuration corresponding to the
configuration of the distal end of the penetrating member.
In the extended position, the distal end 1069 of the safety
probe will protrude beyond sharp tip 1078 to protect the tip as
shown in Fig. 31; and, during penetration of tissue, the safety
probe will move to the retracted position as shown in Fig. 32
such that the distal end 1069 of the safety probe is positioned
within the opening formed by peripheral edge 1082 in substantial
alignment to form, with distal end 1076 of the penetrating
member, a solid geometrical configuration similar to a trocar.
By utilizing the positive stop mechanisms previously
illustrated, the safety probe will be prevented from retracting
further then the position corresponding with the configuration
of the penetrating member such that the conical configuration
WO 94/06681 PCT/LJS93/08477
~~.4~~2g
of the penetrating distal end of the safety penetrating
instrument is assured as shown in Fig. 32.
Fig. 30 shows a modification of the automatic retractable
safety penetrating instrument of Fig. 29 wherein a penetrating
member 1062' has the same external configuration as penetrating
member 1062 but is tubular and the safety probe 1065' has an
elongate member of circular configuration in cross-section
corresponding to the tubular configuration of the penetrating
member. The safety penetrating instrument of Fig. 30 will
assume the same configuration as the safety penetrating
instrument of Fig. 29 in the extended position as shown in Fig.
31 and the retracted position as shown in Fig. 32.
A modification of the automatic retractable safety
penetrating instrument of Fig. 29 is illustrated in Figs. 33,
34, 35 and 36 wherein the safety probe and penetrating member
cooperate to produce a solid geometric pyramid configuration.
More particularly, a hollow penetrating member 1162, which can
be either tubular similar to the penetrating member illustrated
in Fig. 30 or have a passage therethrough similar to the
penetrating member illustrated in Fig. 29, has a distal end 1176
having a partial geometric configuration of a pyramid with sides
or facets 1182 tapering to a sharp tip 1178 while an opening in
the distal end defined by a peripheral edge 1182' terminates at
sharp tip 1178. A safety probe 1165 has a cross-sectional
configuration corresponding to that of the hollow penetrating
member and has a distal end 1169 formed of sides or facets 1201
tapering to a narrow end, the configuration of the distal end
1169 cooperating with the configuration of the distal end 1176
of the penetrating member, when the safety probe is in the
retracted position as illustrated in Figs. 34 and 35, to produce
a substantially complete geometric pyramid configuration having
four sides or facets symmetrically arranged around a sharp point
1178.
Still a further modification of an automatic retractable
safety penetrating instrument according to the present invention
is illustrated in Fig. 37 at 1260, the instrument 1260 being
similar to automatic retractable safety penetrating instrument
WO 94/06681 ~ ,~ (~ ~' '~ ~ PCT/US93/08477
41
760 except that safety shield 1263 for automatic retractable
safety penetrating instrument 1260 terminates distally at a
peripheral scalloped edge 1213 and proximally at an operating
member or flange 1288 disposed in hub 1266 with cushion spring
1300 disposed around the body of the safety shield and connected
between the operating flange 1288 and the front wall of the hub
Operating spring 1298 is disposed around the penetrating
member and connected between the operating member and the
retraction plate 1294 such that the operating member 1288 is
maintained at an initial position with the instrument in the
extended position illustrated in Fig. 37. The locking and
releasing mechanism 1312 for automatic retractable safety
penetrating instrument 1260 is similar to the locking and
releasing mechanism 812; however, the locking spring for locking
and releasing mechanism 1312 has two protrusions 1328 and 1328'
with protrusion 1328' distally spaced from protrusions 1328.
Operation of automatic retractable safety penetrating
instrument 1260 is similar to that previously described in that
instrument 1260 is moved to the extended position via squeezing
operation of end cap 1306 causing arm 1318 to move retraction
plate 1294 distally until protrusion 1328 enters the hub at
which time the end cap 1306 will be locked in place with
protrusion 1328' disposed within the hub distally of protrusion
1328 and the retraction plate 1294 locked in place against the
locking member 1322. In the extended position, operating flange
1288 will be' disposed in the initial position proximally of
trigger cam 1327, and the distal edge 1213 of the safety shield
will be disposed proximally of the tip 1278 of the penetrating
member 1262. When the instrument 1260 is forced through tissue
to enter an anatomical cavity, safety shield 1263 will be moved
proximally causing proximal movement of operating flange 1288;
and, upon the portal sleeve distal end entering the anatomical
cavity, operating flange 1288 will be moved distally of the
initial position to engage trigger cam 1327 and pivot leg 1329
thusly flexing arm 1318 to release retraction plate 1294.
Accordingly, retracting spring 1302 will move the penetrating
member and with it the safety shield proximally causing the
WO 94/06681
1'CT/US93/08477
42
retraction plate 1294 to engage protrusion 1328' such that arm
1398 is pivoted in a direction outwardly from a longitudinal
axis of the instrument causing protrusion 1328 to be aligned
with the slot 1320 in the hub rear wall to automatically release -
the end cap in response to movement of the penetrating member
to the retracted position.
An additional modification of an automatic retractable
safety penetrating instrument according to the present invention
is illustrated at 1360 in Fig. 38. Automatic retractable safety
penetrating instrument 1360 is similar to automatic retractable
safety penetrating instrument 60 except that the operating
member, the retraction member, the locking and releasing
mechanism, the push member and the valve assembly for instrument
1360 are different than those for instrument 60. The
penetrating member 1362 for automatic retractable safety
penetrating instrument 1360 terminates proximally at an
operating member or flange 1388 having an ear 1315 projecting
outwardly therefrom; however, depending on the configuration for
the operating flange, ear 1315 need not be provided. The
retraction member for instrument 1360 is in the nature of a U-
shaped member defining a retraction plate 1394, a forward or
engagement wall 1351 distally spaced from the retraction plate
and a connecting or sidewall 1353 joining the engagement wall
to the retraction plate with the penetrating member 1362 passing
through a hole in the engagement wall 1351. Operating spring
1398 is disposed concentrically around control tube 1396 and
connected between the operating flange 1388 and the retraction
plate 1394 to bias the penetrating member distally with
operating flange 1388 in abutment with the engagement wall 1351.
Retracting spring 1402 is disposed concentrically around control
tube 1396 and connected between the rear wall of the hub 1366
and the retraction plate 1394 to bias the retracting member in
a proximal direction. The locking and releasing mechanism 1412
for automatic retractable safety penetrating instrument 1360 is
best shown in Figs. 39, 39a and 40 and includes a latch or
locking spring having a base 1414 for being secured to a wall
of hub 1366 with arm 1418 joined to base 1414 by a bend or angle
~.~~4~~
WO 94/06681 PCT/US93/08477
43
1416, the arm 1418 being in the nature of a plate or flat piece
of material. A locking member 1422 protrudes beyond a
longitudinal edge of arm 1418 to engage retraction plate 1394
_ and prevent proximal movement thereof in a normal condition for
the latch in the extended position for the instrument
illustrated in Fig. 38. A trigger or release member 1426
protrudes from the longitudinal edge parallel with and distally
spaced from the locking member 1422, the trigger member 1426
being disposed in the normal condition in the path of
longitudinal movement of ear 1315 or operating flange 1388 where
ear 1315 is not provided. Arm 1418 can be bent from base 1414
at a right angle along bend 1416 as shown in Fig. 39, or the arm
can be joined to the base by a curved U-shaped bend 1416 as
illustrated in Fig. 39a allowing arm 1418 to pivot around a
pivot axis extending along the angle or bend. Locking member
1422 is in the nature of a cylindrical protrusion or pin, and
trigger member 1426 is in the nature of a flat strip of material
angled in a proximal direction from arm 1418 to allow proximal
movement of ear 1315 thereby without causing pivoting of arm
1418. Various mechanisms including a pin secured on the
retracting member and projecting through a slot in the hub can
be utilized in the instrument 1360 to set the instrument in an
extended position by moving the retracting mechanism distally
such that retraction plate 1394 is moved distally to be locked
against locking member 1422. As shown in Fig. 38, an end cap
1406 and push member 1471 are provided in the instrument 1360,
the push member being in the nature of a spring arm mounted in
end cap 1406 and having a bent end for engaging the retraction
plate with a protrusion 1428, the push member being similar to
the locking and releasing mechanisms previously described for
use as push members. The valve assembly for instrument 1360
includes a one-piece, hollow cylindrical, truncated conical or
tubular valve body 1438 having a peripheral flange for mounting
in a rear end of housing 1368. Valve body 1438 is made from
flexible, stretchable, elastic or resilient material, such as
silicone or rubber, and is provided with one or more than one
slit 1455 extending longitudinally therealong allowing
WO 94/06681 ~ PCT/US93/08477
44
instrument of various sizes to be inserted through the lumen of
the valve body with the valve body conforming to the size of 'the
instruments to produce a seal therewith.
Operation of automatic retractable safety penetrating
instrument 1360 is similar to that previously described in that
the instrument is moved to the extended position via squeezing .
operation of retracing mechanism distally to the extended
position illustrated in Fig. 38. In the extended position, end
cap 1406 causing push member 1471 to move the junction 1384 of
the penetrating member 1362 is disposed beyond the distal end
of the portal sleeve 1364, operating member 1388 is in the
initial position abutting engagement wall 1351 to be disposed
distally of trigger member 1426, trigger member 1426 is disposed
in the path of longitudinal movement of the ear 1315 and
retraction plate 1394 is locked in place against locking member
1422. In order to facilitate movement of the retraction plate
1394 distally past the locking member when setting the
instrument in the extended position, a forward edge 1457 of the
retraction plate can be angled as shown in Fig. 41. With the
instrument in the extended position, locking member 14322 will
engage the retraction plate 1394 just inwardly of the forward
edge 1457 as best illustrated in Fig. 41. Once the retraction
plate is locked in place against the locking member 1422,
further squeezing of the end cap 1406 causes the angled distal
portion of protrusion 1428 to be engaged by the hub rear wall
causing the push member 1471 to be pivoted in a direction
outwardly form a longitudinal axis of the instrument such that
the bent end is disengaged from the retraction plate. The push
member will be moved out of the path of movement of the
retraction plate with protrusion 1428 locking the end cap
relative to the hub. When instrument 1360 is utilized to
penetrate tissue, penetrating member 1362 will be moved
proximally causing proximal movement of operating flange 1388
and with it ear 1315 to a set position such that junction 1384
is substantially aligned with the distal end of the portal
sleeve in an operative position for the instrument, and
compression of the operating spring can serve as a positive stop
WO 94/06681 PCT/US93/08477
limiting proximal movement of the penetrating member. Ear 1315
moves proximally by trigger member 1326 causing arm 1418 to
pivot around the pivot axis , i . a . over the trigger member as
illustrated in Fig. 42, inwardly toward a longitudinal axis of
the instrument with the pivot axis being parallel with the
instrument axis. Accordingly, locking member 1422 will move
inwardly along the retraction plate 1394 further from the edge
1457 as shown by the arrow in Fig. 42 such that the retraction
plate 1394 remains locked in place. Once the distal end of the
portal sleeve has entered the anatomical cavity, penetrating
member 1362 will be moved distally causing distal movement of
the operating member 1388 toward the initial position with ear
1315 moving distally, i.e. under the trigger member 1426 as
shown in dotted lines in Fig. 43, arm 1418 to pivot around the
pivot axis in a direction outwardly from the instrument axis and
toward base 1416 such that the locking member 1422 is moved
outwardly of the edge 1457 as shown by the arrow in Fig. 43
thusly releasing the retraction plate 1394. Accordingly,
retracting spring 1402 will move the retraction member and with
it the penetrating member to the retracted position. It will
be appreciated that the locking member 1422 can have various
structural configurations to prevent proximal movement of the
retracting mechanism and to release the retraction member in
response to pivoting of the latch around an axis parallel with
the instrument axis. Trigger member 1426 can have various
configurations to allow proximal movement of the operating
member thereby without releasing the retraction plate and to
cause pivoting of arm 1418 around the pivot axis in response to
distal movement of the operating member toward the initial
position. The operating member 1388 can have various
configurations with or without ear 1315 to move proximally by
the trigger member 1426 without causing disengagement of locking
member 1422 from retraction plate 1394 to pivot arm 1418 to
release the retraction plate in response to distal movement of
the operating member toward the initial position. While one
locking and releasing mechanism 1412 is provided in the
instrument 1360, more than one locking and releasing mechanism
WO 94/06f81
PCT/US93/08477
46
can be provided. The locking and releasing mechanism 1412 can
be made in many various ways including a length of wire bent in
a desired configuration to form the locking and trigger members
and an elongated strip or bar with the trigger and locking
members thereon. The locking and releasing mechanism can be
made of a spring material to produce the desired pivotal or
flexing movement or the locking and releasing mechanism can be
pivotably or rotatably mounted in the instrument and biased to
the normal position. Depending upon its configuration, the
locking and releasing mechanism can be pivotally mounted in many
ways; and, where the locking and releasing mechanism is made
from a wire or strip of material, one or both ends of the wire
or strip can be pivotally secured in the instrument to mount the
locking and releasing mechanism for pivotal movement around an
axis parallel with the longitudinal axis of the instrument with
a torsional bias biasing the locking and releasing mechanism to
the normal position.
Another modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated at 1460 in Fig. 44, the instrument 1460 being
similar to the instrument 1360 except that the retraction member
for instrument 1460 includes only the retraction plate 1494 with
the locking member 1522 disposed distally of the trigger member
1526 to lock the retraction plate against a front wall of the
hub 1466 in the'extended position for the instrument.
In use, instrument 1460 is forced through tissue causing
proximal movement of operating member 1488 by trigger member
1526 to the set position to produce pivotal movement of the
locking and releasing mechanism 1512 without disengaging locking
member 1522 from retraction plate 1494. Upon a distal end of
the portal sleeve entering the anatomical cavity, the operating
member 1488 will be moved distally toward the initial position
to engage trigger member 1526 and pivot the locking and
releasing mechanism 1512 around an axis parallel with a
longitudinal axis of the instrument in a direction outwardly
from the longitudinal axis such that the retraction plate is
released for retraction by retracting spring 1502. By forming
WO 94/06681 ~ ~ ~ ~ PCf/US93/08477
47
the locking member as a retraction plate only and by positioning
the locking member distally of and close to the trigger member,
the space required for the locking and releasing mechanism can
be reduced allowing the length of the hub 1466 to be minimized.
A still further modification of an automatic retractable
safety penetrating instrument according to the present invention
is illustrated in Fig. 45 at 1560. Automatic retractable safety
penetrating instrument 1560 is similar to automatic retractable
safety penetrating instrument 1460; however, a safety shield
1563 is utilized in instrument 1560 to trigger retraction, the
safety shield terminating proximally at an operating member
1588. The locking and releasing mechanism 1612 for instrument
1560 is similar to locking and releasing mechanism 1512;
however, the operating member 1588 for automatic retractable
safety penetrating instrument 1560 is positioned by a.n operating
spring 1598 and a cushion spring 1600 in an initial position
disposed proximally of a trigger member 1624 with the instrument
in the extended position illustrated in Fig. 45. The
penetrating member 1562 terminates proximally at retraction
plate 1594 with the operating spring connected between the
retraction plate and the operating member and the cushion spring
connected between the operating member and the front wall of hub
1566. Instead of a spring, the retracting mechanism for
instrument 1560 includes a magnetic bias with magnets 1669 being
mounted in a rear wall of the hub 1566 and the retraction plate
1594 being made of a magnetizable material. Where use of
magnets 1659 in the hub rear wall is not desired, the rear wall
of the hub can be made of a material having one polarity with
the retraction plate being made of a material having the
opposite polarity. End cap 1606 is movably mounted relative ~to
hub 1566 by bias members including mounting springs 1610 secured
between a rear wall of the end cap and attachment blocks 1661
secured to an disposed in hub 1566. A push member 1671 is
mounted in end cap 1600 for setting the instrument in the
extended position the push member 1671 being similar to push
member 1471. An end cap release mechanism for locking the end
cap relative to the hub and for releasing the end cap from the
WO 94/06681 ~ ~ t~ ~ PCT/US93/08477
48
hub includes an actuating button 1630 made up of a spring 1631
externally secured on skirt 1608 of end cap 1606, the spring
1631 having a normal condition defining one or more than one
bump or protrusion for being received in an opening in a wall
of the hub 1566 with the instrument in an extended position as
illustrated in Fig. 45 and for being moved to a collapsed or
flattened position allowing the end cap to be released from the
hub.
Operation of the automatic retractable safety penetrating
instrument 1560 is similar to that previously described in that
the instrument can be moved to the extended position by
squeezing end cap 1606 causing push member 1671, via engagement
with the retraction plate 1594, to move the penetrating member
and with it the safety shield distally such that the retraction
plate is moved past locking member 1622 to be locked in place.
Continued squeezing of the end cap causes protrusion 1628 to
enter the hub such that the push member is flexed in a direction
outwardly from the instrument axis to be disengaged from the
retraction plate. Distal movement of the end cap causes spring
1631 to be collapsed or flattened until it is aligned with the
opening in the hub at which time the push member will be out of
the path of movement of the retraction plate 1594 and the
operating member 1588. Once aligned wit the opening in the hub,
spring 1631 will return to the normal condition locking the end
cap in place. During penetration of tissue, safety shield 1563
will be moved proximally such that operating member 1588 is
moved proximally from the initial position to a set position in
the operative position for the instrument. Upon a distal end
of the portal sleeve entering the anatomical cavity, the safety
shield will be move distally causing operating member 1588 to
be moved distally of the initial position to engage trigger
member 1624 and pivot the locking and releasing mechanism 1612
around an axis parallel with a longitudinal axis of the
instrument to release the retraction plate 1594. Accordingly,
the magnetic bias will move the penetrating member and the
safety shield to the retracted position.
WO 94/06681 6r° ~ ~ ~ ~ PCT/US93/08477
49
A modification of a locking and releasing mechanism for use
with the automatic retractable safety penetrating instruments
according to the present invention is illustrated at 1712 in
Fig. 46, the locking and releasing mechanism 1712 being similar
to locking and releasing mechanisms 1412, 1512 and 1612 except
that locking and releasing mechanism 1712 is made from a length
of metal or plastic wire or filament bent to define a locking
member 1722 and a trigger member 1726. Locking and releasing
mechanism 1712 has ends formed as or secured to coil springs
1799 for torsionally biasing the locking and releasing mechanism
to a normal position when the ends are secured, such as to the
front and rear walls of the hub of an automatic retractable
safety penetrating instrument.
Yet another modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated in Fig. 47 at 1760, only the penetrating unit for
the instrument 1760 being shown. Penetrating member 1762 for
instrument 1760 is made up of a distal part 1770 mounted for
telescoping movement relative to a tubular end part 1772.
Distal part 1770 has a distal end 1776 terminating distally at
tip 1778 and proximally at a junction 1784 joining the distal
end to an elongate outer tubular body 1842. Outer body 1842 is
concentrically disposed around an inner body 1774 extending
proximally from an internal end wall or shoulder 1780 disposed
in outer body 1842 transverse to a longitudinal axis of the
instrument. Inner body 1774 terminates proximally at an
operating member 1788 disposed in end part 1772 with the inner
body passing through an opening in a forward or stop or abutment
wall 1792 at a distal end of the end part 1772. The distal end
of end part 1772 is disposed in outer body 1842 with the end
part terminating proximally at a proximal end joined to or
formed as part of hub 1766. A sheath 1844 is concentrically
disposed around the end part 1772 at the proximal end thereof,
the sheath terminating distally at a forward end spaced from the
outer body 1842 by a distance that is equal to the retraction
distance for the distal part 1770. Outer body 1842 has an outer
diameter that is the same as the outer diameter of sheath 1844
WO 94/06681 ~ PCT/US93/08477
W
to be received by the. inner diameter of the portal sleeve 1764.
A retracting member is disposed in the end part 1772 and
includes a U-shaped or rectangular member defining a retraction
plate 1794, one or more connecting or side walls 1853 extending
distally from the retraction plate and a forward wall 1851
distally joined to side walls 1853 with the forward wall having .
an opening therein allowing passage therethrough by the inner
body 1774. Inner body 1774 is hollow or tubular or partly
hollow or tubular to receive a control tube 1796 extending
distally from a rear wall of the hub, the control tube passing
through an opening in the retraction plate 1794. The retracting
member defines an enclosure or structure for receiving the
operating flange 1788, an operating spring 1798 concentrically
disposed around the control tube and connected between the
operating flange 1788 and the retraction plate 1794 to bias the
distal part 1770 in a distal direction relative to the end part
1772 and a cushion spring 1800 concentrically disposed around
the inner body 1774 and connected between the operating flange
- 1788 and the forward wall 1851 to bias the distal part in a
proximal direction such that the operating flange is maintained
at an initial position with the instrument in the extended
position as illustrated in Fig. 47. One ore more than one
retracting spring 1802 biases the retraction member in a
proximal direction. Various different types of springs as well
as other types of bias devices can be utilized in the instrument
1760 to bias the retracting member; and, as shown in Fig. 48,
the retracting spring can be a torsion spring. As illustrated
in Fig. 48, the retracting spring 1802 is a coil torsion spring
that can be mounted in instrument 1760 with an end of the spring
connected to the retraction plate 1794, such that the spring is
unwound to bias the retraction member proximally in the extended
position as illustrated in Fig. 47 and is rewound to move the
retraction member proximally to a retracted position upon
release of the retraction plate as will be explained further
below. The spring 1802 can be arranged in instrument 1760 in
many ways including within or externally of the penetrating
member or within the control tube, the hub or the valve housing
WO 94/06681 PCT/US93/08477
21~~42~
51
to wind on an axis transverse to the direction of retraction.
Locking and releasing mechanism 1812 for automatic retractable
safety penetrating instrument is similar to locking and
releasing mechanism 512 except that the locking and releasing
mechanism 1812 is mounted within control tube 1796 with trigger
members 1824 and 1826 extending through a longitudinal slot in
the control tube to be disposed in the path of movement of
operating flange 1788, the operating flange projecting inwardly
from an internal surface of the wall of inner body 1774.
Locking member 1822 for locking and releasing mechanism 1812
includes a protrusion on arm 1818 proximally spaced from trigger
members 1826, the locking member having a distal portion
disposed transverse to a longitudinal axis of the instrument to
prevent proximal movement of retraction plate 1794 thereby and
a proximal portion angled in a distal direction to permit distal
movement of the retraction member thereby when setting the
instrument in the extended position. Various different types
of push members can be utilized in the instrument 1760 to move
the retracting mechanism distally when setting the instrument
in the extended position; and, as shown in Fig. 47, a pair of
push members 1871 in the nature of arms connected between a rear
wall of end cap 1806 and the retraction plate 1794 are provided.
End cap 1806 has a skirt 1808 disposed externally of the hub
1766, and the distance that the end cap must be moved proximally
in the ready position will be in accordance with the distance
that the push member must be moved proximally to engage the
retracting mechanism for movement to the extended position.
In use, the automatic retractable safety penetrating
instrument 1760 can be moved to the extended position via
squeezing operation of end cap 1806 causing movement of the
retracting member distally unwinding springs 1802 with the
proximal portion of locking member 1822 allowing the retraction
member to move distally thereby until the retraction plate 1794
is locked in place against the distal portion of the locking
member. With the instrument in the extended position, junction
1784 of the penetrating member 1762 will be disposed beyond the
distal end of the portal sleeve 1764 and the operating member
WO 94/06681 ~ ~ 4 ~ ~ ~ PCT/US93/08477
. .a
52
1788 will be in the initial position disposed proximally of
trigger members 1824 and distally of trigger members 1826.
During penetration of tissue, the distal part 1770 is moved
proximally relative to the end part 1772 causing proximal
movement of operating member 1788 past trigger members 1826 to
a set position without causing flexing of the arm 1818, and the
instrument will be in the operative position with junction 1784
substantially aligned with the distal end of the portal sleeve.
Once the distal end of the portal sleeve has entered the
anatomical cavity, the distal part 1770 will be moved distally
relative to the end part 1772 causing operating member 1788 to
move distally toward the initial position to engage a distally
closest trigger member 1826 causing flexing of arm 1818 such
that locking member 1822 is moved into the control tube thusly
releasing the retraction plate 1794. Once the retraction plate
is released, springs 1802 are rewound moving the retraction
member and with it the distal part 1772 of the penetrating
member in a proximal direction to the retracted position with
the tip 1778 disposed in the portal sleeve in a safe, protected
position. Trigger members 1824 can be utilized to trigger
retraction via movement of the operating member 1788 distally
of the initial position.
Thus, it will be appreciated that in automatic retractable
safety penetrating instrument 1760 the shaft of the penetrating
member is formed of telescoping parts such that the distal end
1776 is retracted by telescoping proximal movement of the distal
part of the penetrating member relative to the end part of the
penetrating member whereby hub 1766 need not house any mechanism
and need not provide any longitudinal space for retraction of
the penetrating member distal end such that the length of the
hub can be minimized. The retracting mechanism retracts the
distal end until shoulder 1780 abuts wall 1792 such that the
distal end is within the portal sleeve, and the sliding or
telescoping movement between the parts of the penetrating member
can be accomplished with other structural arrangements, for
example, by eliminating outer tubular body 1842 to permit the
distal part to telescope only within the end part.
VfO 94: -- _~81 PCT/US93/08477
t
53
Fig. 49 illustrates an alternative arrangement for the
retracting mechanism for the automatic retractable safety
penetrating instrument 1760 wherein the torsion spring 1802 is
connected to a flange 1846 of a spool 1848 having an axle for
winding thereon of a connector 1850 secured between the spool
and the retracting member. The connector can be a length of any
suitable material including wire, synthetic plastic, string
materials and the like for being wound on the spool 1848 in
response to rotation of the spool by torsion spring 1802.
Yet another modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated in Fig. 50 at 1860, only the penetrating unit for
the instrument 1860 being shown. Penetrating member 1862 for
instrument 1860 is made up of a distal part 1870 mounted for
telescoping movement within a tubular end part 1872. Distal
part 1870 includes a distal end 1876 proximally joined to a
cylindrical neck 1886 at a junction 1884, the neck 1886
terminating proximally at a shoulder 1880. A body 1874 having
an outer diameter or size less than the outer diameter of neck
1886 extends proximally from shoulder 1880 to be disposed within
the end part 1872 with the body 1874 extending through an
opening in a forward or abutment wall 1892 at a distal end of
the end part. End part 1872 has an outer diameter that is the
same as the outer diameter of neck 1886 to be received by the
inner diameter of the portal sleeve. Body 1874 terminates
proximally at an end wall 1852, and a tubular neck or extension
1854 extends proximally from the end wall to terminate at an
operating flange 1888 disposed in end part 1872. A coil torsion
operating spring 1898 is connected between operating member 1888
and abutment wall 1892, the spring 1898 being partially unwound
to bias the distal part 1870 in a distal direction relative to
the end part 1872. A retraction plate 1894 is disposed within
the end part and has an opening therein allowing passage
therethrough by the neck 1854. A coil torsion retracting spring
1902 is connected between the retraction plate 1894 and a non-
movable part, such as a wall of end part 1872, of the instrument
1860, the retracting spring being unwound to bias the retraction
~~~4~8
WO 94/06681 PCT/US93/084'7
y
54
plate in a proximal direction to abut the operating flange in
the extended position for the instrument illustrated in Fig. '50.
Connecting walls 1953 extend distally from retraction plate 1894
to terminate at a forward wall 1951 serving as a stop or
abutment limiting proximal movement of the distal part 1870
during penetration of tissue. Locking and releasing mechanism
1912 for instrument 1860 is similar to the locking and releasing
mechanism 112 except that two locking springs are provided in
the instrument 1860 having triggers 1926 disposed proximally of
the operating member 1888 in the initial position illustrated
in Fig. 50. The locking springs for instrument 1860 can be
utilized as push members or the locking springs can be utilized
only for locking and releasing the retracting mechanism with
separate push members provided for moving the instrument.to the
extended position.
Operation of the automatic retractable safety penetrating
instrument 1860 is similar to that previously described in that
the distal part 1870 of the penetrating member 1862 will be
moved proximally relative to the end part 1872 during
penetration of tissue causing proximal movement of operating
member 1888 from the initial position past triggers 1926 to the
set position at which time the instrument will be in the
operative position with junction 1884 substantially aligned with
the distal end of portal sleeve 1864. Movement of the operating
member proximally causes operating spring 1898 to be further
unwound with the forward wall 1951 serving as a positive stop
limiting proximal movement of the distal part. Once the distal
end of the portal sleeve has entered the anatomical cavity,
operating spring 1898 will rewind causing the distal part 1870
to be moved distally relative to the end part 1872 such that the
operating flange 1888 engages the distally closest triggers 1926
to flex the arms 1918 in a direction outwardly from a
longitudinal axis of the instrument such that the retracting
plate 1894 is released from the locking members 1922. .
Accordingly, retracting spring 1902 will rewind causing
telescoping proximal movement of the distal part 1870 relative
to the end part 1872 such that the distal end 1876 of the
WO 94/06681 ~ ~ ~ ~ ~ PCT/US93/08477
penetrating member 1862 is moved to a retracted position within
the portal sleeve with abutment 1892 limiting retraction of the
distal part.
A further modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated in Fig. 51 at 1960. Automatic retractable safety
penetrgting ingitrt~mtvnt 1 O6f1 i~ cymylur t~ ynjtrumeiat 1760 except
that the penetrating member 1962 for instrument 1960 does not
have an outer body and the locking and releasing mechanism 2012
for instrument 1960 includes a latch that is similar to the
latch for instrument 1360. The penetrating member 1962 for
automatic retractable safety penetrating instrument 1960
includes a distal part 1970 mounted for telescoping movement
relative to a tubular end part 1972. Distal part 1970 has a
distal end 1976 terminating distally at tip 1978 and proximally
at a junction 1984 joining the distal end to a cylindrical neck
1986 terminating proximally at an end wall or shoulder 1980.
An elongate body 1974 extends proximally from shoulder 1980 to
terminate at an operating member 1988 disposed in end part 1972,
the neck 1986 having an outer diameter that is the same as the
outer diameter of end part 1972. Body 1974 can be hollow or
tubular or partly hollow or tubular as illustrated in Fig. 51
to receive an extension 1997 extending distally from retraction
plate 1994 of a retraction member. A connecting wall 2053
extends distally from the retraction plate to terminate at a
forward wall 2051 with the operating member 1988 being disposed
between the forward wall and the retraction plate. The
retraction member defines a structure for mounting the operating
member 1988, an operating spring 1998 disposed around the
extension 1967 and connected between the operating member and
the retraction plate 1994 and a cushion spring 2000 disposed
around body 1974 and connected between the operating member 1988
and the forward wall 2051 to position the operating member in
an initial position with the instrument in the extended position
as illustrated in Fig. 51. The latch or locking spring for
locking and releasing mechanism 2012 includes a locking member
2022 engaged with retraction plate 1994 to prevent proximal
WO 94/06681 Q PCf/US93/08477
O
56
movement thereof and a trigger member 2024 disposed distally of
the operating member 1988 in the initial position. A coil
torsion retracting spring 2002 connected with the retraction
member is provided in the instrument 1960 to bias the retraction
plate 1994 in a proximal direction. A push member 1971 can be
provided for setting the instrument in the extended position. .
Operation of automatic retractable safety penetrating
instrument 1960 is similar to that described for instrument 1760
in that the distal part 1970 is moved proximally relative to the
end part 1972 during penetration of tissue causing proximal
movement of the operating member 1988 from the initial position
to a set position at which time the instrument will be in an
operative position with junction 1984 substantially aligned with
the distal end of portal sleeve 1964. Once a distal end of the
portal sleeve has entered the anatomical cavity, the distal part
1970 will be moved distally relative to the end part 1972
causing movement of operating member 1988 distally of the
initial position to engage trigger 2024 such that the locking
and releasing mechanism 2012 pivots around an axis parallel with
a longitudinal axis of the instrument 1960 to release retraction
plate 1994 from locking member 2022.
Another modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated in Fig. 52 at 2060, the instrument 2060 being
similar to automatic retractable safety penetrating instrument
60 except that the end part 2072 of penetrating member 2062 does
not retract with the distal part 2070, and the valve assembly
for instrument 2060 is different than the valve assembly for
instrument 60. End part 2072 for penetrating member 2062
terminates distally at a stop or abutment 2092 and proximally
at a proximal end secured in or formed with a front wall of hub
2066. Distal part 2070 includes a cylindrical body 2074
extending~proximally from shoulder 2080 to terminate at an end
wall 2152 with a tubular neck 2154 extending proximally from end
wall 2152 to terminate at operating member 2088 disposed in hub
2066. A retraction plate 2094 is disposed in hub 2066 and has
an opening therein allowing passage therethrough by neck 2154.
s7 ~'~~~°~~~~3
A retracting spring 2102 is connected between the retraction
plate 2094 and a rear wall of the hub 2066 to bias the
retraction plate in a proximal direction. A locking and
releasing mechanism 2112 is disposed in hub 2066, the locking
and releasing mechanism 2112 being similar to the locking and
releasing mechanism 112 for automatic retractable safety
penetrating instrument 60. End wall 2152 is disposed within
the end part 2072, and an operation spring 2098 is disposed
around neck 2154 and connected between the operating member
2088 and the retraction plate 2094 to bias the distal part 2070
in a distal direction. A cushion spring 2100 is disposed
concentrically around neck 2154 and connected between the
retraction plate 2094 and the end wall 2152 to bias the distal
part in a proximal direction such that operating member 2088 is
in an initial position disposed proximally of trigger member
2124 and distally of trigger members 2126 with the retraction
plate 2094 held against the front wall of the hub via locking
member 2122 in the extended position for the instrument
illustrated in Fig. 52. The valve assembly for instrument 2060
is similar to the valve assemble disclosed in applicant's U.S.
Patent No. 5,395,342, issued March 7, 1995. The valve assembly
includes a valve block 2158 having a peripheral flange for
being disposed in a recess at a rear end of housing 2068 and a
cylindrical member extending distally from the flange to mount
a cylindrical or spherical valve body 2138. Valve body 2138
has a plurality of different size lumens or passages that can
be selectively aligned. with the open proximal end of the-portal
sleeve 2064 and a passage in the valve block to provide
communication through housing 2068. The valve assembly
includes a spring rotationally biased to maintain the valve
body 2138 in a closed position wherein a solid surface of the
valve body is aligned with the passage in the valve block to
close off and seal the valve housing. An external ridge 2160
is provided on the valve body for rotating the valve body to an
open position corresponding to one of the lumens being aligned
with the passage. A pin 2117 protrudes distally from the front
WO 94/06681
~1~4~28
PCT/LTS93/08477
58
wall of hub 2066 for penetrating through the valve block 2158
and into the valve body 2138 when the hub 2066 is combined with
the valve housing 2068 as illustrated in Fig. 52.
In operation, the hub 2066 is combined with the valve
housing 2068 with pin 2117 penetrating the valve assembly to
enter the valve body 2138 thusly preventing rotational movement -
of the valve body toward the closed position such that strain
or friction on penetrating member 2062 is eliminated. When the
instrument 2060 is forced through tissue, distal part 2070 will
be moved proximally relative to end part 2072 causing proximal
movement of operating member 2088 from the initial position to
a set position at which time the instrument will be in the
operative position. Once a distal end of portal sleeve 2064 has
entered the anatomical cavity, distal part 2070 will move
distally relative to end part 2072 causing movement of operating
member 2088 distally toward the initial position to engage a
trigger 2126 or distally of the initial position to engage
trigger 2124 such that arm 2118 will be flexed releasing
retraction plate 2094 from locking member 2122.
A still further modification of an automatic retractable
safety penetrating instrument according to the present invention
is illustrated in Fig. 53 at 2160, wherein only the penetrating
unit for instrument 2160 is shown. Penetrating member 2162 for
instrument 2160 includes a distal end 2176 joined to an elongate
tubular or partly tubular body 2174 terminating proximally at
an operating flange 2188 disposed in hub 2166. A control tube
2196 extends distally from a rear wall of end cap 2206 and into
body 2174, the operating flange 2188 extending inwardly from an
internal surface of the wall of the body to be disposed in a
longitudinal slot 2191 in the control tube. A retraction plate
2194 is disposed in hub 2166, the retraction plate extending
inwardly through a hole in body 2174 to be disposed in the slot
2191. Operating spring 2198 is disposed concentrically around
the control tube and connected between a rear wall of hub 2166
and the operating flange 2188, and a cushion spring 2200 is
disposed concentrically around body 2174 and connected between
the operating flange 2188 and the retraction plate 2194 to
.. , - ,~ a
WO 94/06681 PCT/US93/08477
59
position the operating flange in an initial position with the
instrument in the extended position illustrated in Fig. 53. The
locking and releasing mechanism 2212 for instrument 2160 is
disposed within control tube 2196 and includes a latch or
locking spring having an arm 2218 formed with a protrusion 2228
for locking the end cap 2206 within the hub 2166 in the extended
position for the instrument, a locking member 2222 for holding
the retraction plate 2194 against a front wall of hub 2166 and
triggers 2224 and 2226. A stop or abutment in the nature of an
additional bump or protrusion 2192 formed on arm 2218 serves as
a positive stop limiting proximal movement of operating member
2188 during penetration of tissue. Actuating buttons 2230 for
instrument 2160 are made up of casings or housings mounted in
openings in skirt 2208 with helical springs 2231 disposed in the
casings concentrically around release arms 2232 biasing the
casings in a direction outwardly from a longitudinal axis of the
instrument and allowing the casings to be moved inwardly toward
the instrument axis to compress bend 2116. Although illustrated
in Fig. 53 as extending through skirt 2208 adjacent a rear wall
of the end cap, the buttons 2230 can be mounted at any suitable
location in accordance with the location for the locking and
releasing mechanism. A valve can be provided along the rear
wall of end cap 2206 in communication with the lumen of the
control tube 2196 to provide fluid flow through the instrument.
Automatic retractable safety penetrating instrument 2160
can be utilized to penetrate tissue and enter an anatomical
cavity as previously described with the penetrating member
moving proximally during penetration of tissue causing proximal
movement of operating flange 2188 from the initial position to
a set position at which time the instrument 2160 will be in an
operative position. Upon the portal sleeve distal end entering
the anatomical cavity, the penetrating member 2162 will be moved
distally causing operating flange 2188 to move toward the
initial position to engage trigger 2226 or distally of the
initial position to engage trigger 2224 causing arm 2218 to move
within control tube 2196 releasing locking member 2222 from
retraction plate 2194 while protrusion 2228 remains engaged with
WO 94/06681 ~ PC f/i1S93/08477
~i444~~
the rear wall of the hub. Accordingly, retracting spring 2202
will move the retracting member 2194 and with it the penetrating
"' member to a retracted position.
A still further modification of an automatic retractable
safety penetrating instrument according to the present invention
is illustrated in Fig. 54 at 2260. Penetrating member 2262 for
automatic retractable safety penetrating instrument 2260 is
similar to penetrating member 1962 for automatic retractable
safety penetrating instrument 1960 and includes an elongate body
2274 joined to neck 2286 at shoulder 2280, the body 2274
terminating proximally at a retraction plate 2294 disposed in
end part 2272. Body 2274 can be removably secured to neck 2286
such as by threads 2290 allowing distal end 2276 to be removed
from body 2274 and replaced with various other distal ends of
diverse configurations. A safety shield 2263 is disposed around
the penetrating member 2262 and includes an outer body
concentrically disposed around the neck 2286 and end part 2272
of the penetrating member and an inner tubular body 2274' joined
to the outer tubular body at an internal shoulder or end wall
2280'. Inner body 2274' is concentrically disposed around body
2274 and terminates proximally at an operating member 2288
disposed in end part 2272 distally of retraction plate 2294 with
body 2274' passing through an opening in a forward wall of the
end part. A locking and releasing mechanism 2318 is mounted in
end part 2272, the locking and releasing mechanism 2318 being
similar to the locking and releasing mechanism 1812. A control
tube 2296 extends from a rear wall of end cap 2306 and into body
2274, and a retracting spring 2302 is connected between
retraction plate 2294 and a rear wall of hub 2266 to bias the
distal part 2270 of the penetrating member in a proximal
direction. Control tube 2296 can be rotatably, releasably
mounted in end cap 2306 to be partially withdrawn from body 2274
with ears, nubs or projections provided on the control tube to
allow the control tube to serve as a push member for setting the
instrument in the extended position as disclosed in applicant's
co-pending U.S. Patent Application SN 07/868,578 filed April 15,
1992, the specification of which is incorporated herein by
WO 94/06681 PCT/US93/08477
' 61
reference. An operating spring 2298 is disposed concentrically
around body 2274 and connected between retraction plate 2294 and
operating member 2288, and a cushion spring 2300 is
concentrically disposed around body 2274' and connected between
operating flange 2272 and the forward wall of end part 2278 to
position the operating flange at an initial position in the
extended position for the instrument illustrated in Fig. 54.
In the extended position, operating flange 2288 will be in the
initial position disposed proximally of triggers 2324 and
distally of triggers 2326, and the retraction plate 2294 will
be locked in place against locking member 2322.
Operation of automatic retractable safety penetrating
instrument 2260 is similar to that previously described in that
safety shield 2263 will move proximally during penetration of
tissue causing movement of operating flange 2288 from the
initial position to a set position at which time the instrument
will be in an operative position. Once a distal end of the
portal sleeve has entered the anatomical cavity, the safety
shield will be moved distally causing movement of operating
flange 2288 toward the initial position to engage a trigger 2326
or distally of the initial position to engage a trigger 2324
such that arm 2318 is flexed releasing retraction plate 2294
from locking member 2322. Accordingly, retracting spring 2302
will move the distal part 2270 of the penetrating member and,
via engagement of shoulder 2280 with end wall 2280' , the safety
shield, to a retracted position. A probe can be utilized in the
instrument 2260 in place of the safety shield to trigger
retraction as shown in dotted lines at 2265. By utilizing a pin
and slot arrangement, retraction of the distal part of the
penetrating member and/or the safety shield and the probe where
a probe is provided can be prevented.
Another modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated in Fig. 55 at 2360, the instrument 2360 being
similar to automatic retractable safety penetrating instrument
2260 in that a safety shield 2363 is utilized to trigger
retraction.
WO 94/Obb81 , PCT/US93/08477
~- . ..
62
Penetrating ~~ ~ ~ ~ ~ ~2 for instrument 2360 is made up of a
distal part 2370 and an end part 2372, the distal part including
a distal end 2376 joined to an elongate body 2374 with an
extension 2454 in the form of a plate extending proximally from
an end wall 2452 of body 2374. Extension 2454 terminates
proximally within the body of safety shield 2363 at a bent end
defining a retraction member or including retraction plate 2394.
End part 2372 includes a plate extending distally from a rear
wall of hub 2366 and terminating distally at a bent or angled
end with a retracting spring 2402 connected between the angled
end of end part 2372 and the end wall 2452 of distal part 2370
to bias the distal part in a proximal direction. A locking and
releasing mechanism 2412 similar to locking and releasing
mechanism 2112 is disposed partly in hub 2366 and partly in the
body of safety shield 2363 with a base 2416 of the locking and
releasing mechanism being secured to end part 2372. A locking
member 2422 of locking and releasing mechanism 2412 engages
retraction plate 2394 to prevent proximal movement of the distal
part 2370 when the instrument is in the extended position
illustrated in Fig. 55. Safety shield 2363 is concentrically
disposed around body 2374, the safety shield terminating
proximally at an end flange disposed in hub 2366 with the body
of the safety shield passing through an opening in a front wall
of the hub. An operating member or flange 2388 projects
inwardly from an inner surface of the wall of the safety shield
body for engaging triggers 2424 or 2426 on arm 2418 of locking
and releasing mechanism 2412. An operating spring 2398 is
connected between the end flange and a rear wall of the hub, and
a cushion spring 2400 is connected between the end flange and
a front wall of the hub to position the operating member at an
initial position proximally of triggers 2424 and distally of
triggers 2426 in the extended position for the instrument. A
push member 2371 can be provided in instrument 2360 to be moved
by end cap 2406 to engage the end flange of the safety shield
for use in setting the instrument in the extended position. In
operation, instrument 2360 is forced through tissue causing
safety shield 2363 to be moved proximally such that operating
WO 94/06681
PCT/US93/08477
63
member 2388 is moved proximally from the initial position to a
set position without causing bending or flexing of arm 2418.
Once a distal end of the portal sleeve has entered the
anatomical cavity, the safety shield 2363 will be moved distally
causing operating member 2388 to engage a trigger 2426 in
response to movement of the operating member toward the initial
position or a trigger 2424 in response to movement of the
operating member distally of the initial position to flex arm
2418 and release locking member 2422 from retraction plate 2394.
Accordingly, retracting spring 2402 will move the distal part
2370 of the penetrating member proximally relative to the end
part 2372 to a retracted position. By arranging the operating
member 2388 to be engaged by the retraction plate 2394, the
safety shield 2363 can be moved to a retracted position with the
penetrating member. Push member 2371 can be utilized to set the
instrument in the extended position via squeezing operation of
end cap 2406 causing distal movement of the safety shield and,
via engagement of operating member 2388 with retraction plate
2394, the penetrating member.
Yet another modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated at 2460 in Fig. 56. Penetrating member 2462 for
automatic retractable safety penetrating instrument 2460 is
similar to penetrating member 1862 being made up of a distal
part 2470 and ari end part 2472 with the distal part including
a distal end 2476, a body 2474 and a neck 2554. End part 2472
terminates proximally at a retraction plate 2494 disposed in hub
2466, and a retraction spring 2502 is connected between the
retraction plate and the rear wall of the hub to bias the end
part in a proximal direction. A locking and releasing mechanism
2512 similar to locking and releasing mechanism 1912 is disposed
in hub 2466 for locking the retraction plate 2494 against a
front wall of the hub in an extended position for the instrument
illustrated in Fig. 56. Locking and releasing mechanism 2512
is mounted in end cap 2506 to serve as a push member for setting
the instrument in an extended position, and an additional push
member 2471 can be mounted in end cap 2506 for use in moving the
WO 94/06681 PCT/US93/08477
64
end part 2472 distally when setting the instrument in the
extended position. A plurality of internal walls or shoulders
2552' are disposed within end part 2472 with the walls 2552
having openings therein allowing passage therethrough by the
neck 2554. Neck 2554 terminates proximally at an operating
member or flange 2488 disposed in hub 2466. A helical coil
operating spring 2498 is concentrically disposed around neck
2554 and connected between the neck and a wall 2552' of the end
part to bias the distal part 2470 in a distal direction. More
than one operating spring can be provided; and, as shown in Fig .
56, two operating springs 1498 are provided with each operating
spring connected between the neck 2554 and an internal wall
2252'. A cushion spring 2500 is disposed concentrically around
the neck 2554 and connected between body 2474 and a wall 2552'
to bias the distal part in a proximal direction such that
operating flange 2488 is maintained in an initial position
disposed proximally of trigger 2524 and distally of triggers
2526 with the instrument in the extended position. Protrusions
in the form of nubs or pins 2545' are provided on neck 2554 for
use in mounting the operating and cushion springs between the
neck 2554 and the internal walls 2552' and for compressing or
collapsing the springs upon movement of the distal part in a
proximal direction.
In use, the automatic retractable safety penetrating
instrument 2460 is forced through tissue causing distal part
2470 to be moved proximally relative to end part 2472 such that
operating member 2488 is moved proximally of the initial
position to a set position, the nubs 2545' collapsing the
operating and cushion springs along the neck 2554. With the
operating member in the set position, shoulder 2480 will be in
abutment with stop 2492, and the instrument will be in an
operative position. Once a distal end of the portal sleeve 2464 _
has entered the anatomical cavity, the distal part 2470 will be
moved distally causing operating member 2488 to move toward the
initial position to engage trigger 2526 or distally of the
initial position to engage trigger 2524 and flex arm 2518 thusly
releasing the retraction plate 2494.
WO 94/06681 PCT/US93/08477
65 F~ ~-: ,; ~ ~_ .
An additional modification of an automatic retractable
safety penetrating instrument is illustrated in Fig. 57 at 2560.
Instrument 2560 is similar to automatic retractable safety
penetrating instrument 2460 except that neck 2654 for automatic
retractable safety penetrating instrument 2560 is offset from
and not aligned with a longitudinal axis of the instrument as
is neck 2554 for instrument 2460. The retraction member for
instrument 2560 is formed as an internal wall or shoulder 2652'
extending inwardly from an inner surface of the wall of the end
part 2572 to be engaged, within the end part, by locking member
2622, the retraction member having an opening therein allowing
passage therethrough by the neck 2654. End part 2572 terminates
proximally at a retraction plate or flange disposed in hub 2566
with retracting springs 2602 connected between the retraction
plate and a rear wall of the hub to bias the end.part in a
proximal direction. Accordingly, in the automatic retractable
safety penetrating instrument 2560, the locking member 2622
engages the retraction member, wall 2652', and not the
retraction plate 2594 to hold the end part 2572 against proximal
movement. Locking and releasing mechanism 2612 for automatic
retractable safety penetrating instrument 2560 is mounted in end
cap 2606 for use as a push member, via engagement of locking
member 2622 with wall 2652', for setting the instrument in an
extended position. An additional push member 2571 is mounted
in end cap 2606 for engaging retraction plate 2594 when setting
the instrument in the extended position via squeezing operation
of the end cap. In the automatic retractable safety penetrating
instrument 2560, triggers 2624 and 2626 are disposed within the
end part 2572 such that the length of hub 2566 can be minimized
to be no larger than necessary to allow retraction of end part
2572. Neck 2654 terminates proximally at an operating member
or flange 2588 disposed in end part 2572 with the operating
member having an angled end to facilitate proximal movement past
triggers 2626 and engagement of triggers 2624 or 2626 upon
distal movement of the operating member. An additional internal
wall 2652" is provided in end part 2572, with an operating
spring 2598 disposed around neck 2654 and connected between the
W~ 94/06681 PCf/US93/08.~~7
~ ~ ~ 4 'f 4 ~ ~ 66
internal wall 2652" and the body 2574 to bias the distal part
2570 distally. A cushion spring 2600 disposed around neck 2654
is connected between the neck 2654 and wall 2652' to bias the
distal part proximally such that the operating member is
maintained at an initial position proximally of triggers 2624
and distally of triggers 2626 in the extended position -
illustrated in Fig. 57.
Operation of instrument 2560 is similar to that for
automatic retractable safety penetrating instrument 2460.
During penetration of tissue, distal part 2570 moves proximally
relative to end part 2572 causing proximal movement of operating
member 2588 past triggers 2626. Once a distal end of portal
sleeve 2564 has entered the anatomical cavity, operating member
2588 will move distally engaging triggers 2624 or 2626 to flex
arm 2618 and release the retraction member, wall 2652'.
Accordingly, retracting springs 2602 move the end part 2572 and
with it distal part 2570 to the retracted position.
Yet another modification of an automatic retractable safety
penetrating instrument according to the present invention is
illustrated at 2660 in Fig. 58. Penetrating member 2662 for
automatic retractable safety penetrating instrument 2660 is
similar to penetrating member 1862 and includes an end part 2672
and a distal part 2670 having a distal end 2676, a tubular or
partly hollow or tubular body 2674 and a neck 2754. A
retraction member engages the proximal end of distal part 2670
and includes a retraction plate 2694 disposed in hub 2664 with
an extension 2697 extending distally from the retraction plate
to terminate at a forward wall or end flange 2751 disposed in
body 2674 with the extension 2697 being concentrically disposed
in neck 2654. Neck 2654 terminates proximally at an operating
member or flange 2688 disposed in end part 2672, and an
operating spring 2698 is disposed concentrically around
extension 2697 and connected between operating member 2688 and
retraction plate 2694 to bias the distal part 2670 in a distal
direction. A cushion spring 2700 is concentrically disposed
around the extension 2697 and connected between the forward wall
2751 and an end wall 2752 of body 2674 to bias the distal part
WO 94/06681 ~ ~ ~ ~ ~ ~ ~ PCT/US93/08477
67
in a proximal direction such that operating member 2688 is
maintained in an initial position with the instrument in the
extended position as illustrated in Fig. 58. A retracting
spring 2702 is disposed in hub 2664 and connected between the
retraction plate 2694 and a rear wall of the hub to bias the
retraction member in a proximal direction. Locking and
releasing mechanism 2712 for automatic retractable safety
penetrating instrument 2660 is made up of a linkage arrangement
including a link arm 2718 having an end pivotally connected at
a joint to a trigger 2724 including a trigger cam 2727 and a
trigger leg 2729 and an opposite end pivotally connected at a
joint to a link 2723' pivotally mounted in hub 2664. Link 2723'
is disposed in engagement with the retraction plate in the
extended position for the instrument illustrated in Fig. 58 and
is mounted on a joint in hub 2664 to rotate, such as in a
counterclockwise direction looking at Fig. 58, to be disposed
out of the path of longitudinal movement of retraction plate
2694 in response to proximal movement of link arm 2718. A
locking arm 2718' is pivotally mounted in the hub, such as along
the hub rear wall, and is biased to a locked position wherein
an end or finger 2822 of the locking arm engages a lateral or
upper edge or side of the retraction plate 2694 to prevent
proximal movement thereof . The locking arm 2718' can be biased
to the locked position in various ways, such as by a spring at
the joint mounting the arm 2718' along the hub rear wall. With
the arm 2718' in the locked position, locking member 2822 will
be disposed in the path of movement of link arm 2718. The
linkage can be biased, such as with springs provided at one or
more joints of the linkage, to rotate link 2723' to release
retraction plate 2694 with arm 2718' preventing movement of the
linkage due to the bias. Where the arm 2718' both engages the
retraction plate and holds link 2723' thereagainst, redundant
protection is provided.
Operation of automatic retractable safety penetrating
instrument 2660 is similar to that previously described in that
the distal part 2670 will be moved proximally relative to end
part 2672 during penetration of tissue causing operating member
r
VVO 94/06681 PCT/US93/08477~
68
2688 to be moved proximally from the initial position to the set
position. Once a distal end of the portal sleeve has entered
the anatomical cavity, distal part 2670 will be moved distally
relative to end part 2772 causing operating member 2688 to move
distally of the initial position to engage trigger cam 2727 and
pivot trigger leg 2729 clockwise looking at Fig. 58 moving link
arm 2718 proximally to engage a nub 2710' on locking member 2822
such that the locking arm 2718' is moved laterally, i.e. in a
direction transverse to the direction of proximal movement of
link arm 2718 to be released from retraction plate 2694 allowing
the distal part 2670 of the penetrating member to be moved
relative to the end part 2672 to a retracted position.
An additional modification of an automatic retractable
safety penetrating instrument according to the present invention
is illustrated in Fig. 59 at 2760. Penetrating member 2762 for
automatic retractable safety penetrating instrument 2760 is
similar to penetrating member 2362 except that body 2774 for
penetrating member 2762 is hollow or tubular or partly hollow
or tubular to receive the forward wall 2851 of the retraction
member and the end part 2772 of the penetrating member is
secured in or formed with a front wall of hub 2766. The
retraction member for instrument 2760 includes forward wall
2851, retraction plate 2794 disposed in hub 2766 and a side or
connecting member 2853 joining the retraction plate to the
forward wall with neck 2854 of distal part 2770 extending
through the connecting member to terminate proximally at an
operating flange 2788 disposed in end part 2772. An operating
spring 2798 is connected between the forward wall 2851 and an
end wall 2852 of body 2774 to bias the distal part in a distal
direction, and a cushion spring 2800 is disposed around neck
2854 and connected between forward wall 2851 and an internal
shoulder or abutment 2780 of body 2774 to bias the distal part
in a proximal direction such that operating member 2788 is
maintained in an initial position proximally of trigger 2824
with the instrument in the extended position illustrated in Fig.
59. A retracting spring 2802 is connected between retraction
plate 2794 and a rear wall of hub 2766 to bias the retraction
WO 94/06Ka81 ~ ~ ~ ~ ~ PCf/US93/08477
69
member in a proximal direction. A locking and releasing
mechanism 2812 is disposed in end part 2772 and includes a
linkage arrangement having a link arm 2818 pivotally connected
at a joint at one end to a locking member 2822 engaged with a
bent or angled portion of connecting wall 2853 to prevent
movement of the retracting mechanism proximally. Arm 2818 is
pivotally connected at a joint at an opposite end thereof to
trigger 2824 pivotally mounted in the end part and including a
trigger cam 2827 and a trigger leg 2829. A locking arm 2818'
pivotally mounted at a joint along the rear wall of hub 2766
terminates distally at a locking member 2822' biased to engage
the linkage to prevent proximal movement of link arm 2818 such
that the locking member 2822 is maintained in engagement with
the retraction member in the extended position for the
instrument. The linkage can be biased to rotate locking member
2822 counterclockwise looking at Fig. 59 to release the
retraction member with arm 2818' preventing movement of the
linkage due to the bias.
When automatic retractable safety penetrating instrument
2760 is utilized to penetrate tissue and enter an anatomical
cavity, distal part 2770 of penetrating member 2762 will be
moved proximally during penetration of the tissue causing
movement of operating member 2788 from the initial position to
a set position. The distal part 2770 will be moved distally
upon a distal end of the portal sleeve entering the anatomical
cavity, and the operating member 2788 will be moved distally of
the initial position to engage trigger cam 2827 causing rotation
of trigger 2824 clockwise and movement of link arm 2818
proximally to engage nub 2810' moving locking arm 2818' in a
direction transverse to the direction of proximal movement of
arm 2818 such that the locking member 2822 is released from the
retraction member. Accordingly, retracting spring 2802 will
move the retraction member proximally carrying with it the
distal part 2770 of the penetrating member to a retracted
position.
An additional modification of an automatic retractable
safety penetrating instrument according to the present invention
WO 9.x/06681 PC'T/IIS93/08.~77
is illustrated in Fig. 60 at 2860 wherein the operating spring
and the retracting mechanism are in the nature of a linkage
arrangement. Penetrating member 2862 for automatic retractable
safety penetrating instrument 2860 includes a distal part 2870
terminating proximally at an operating member or flange 2888
disposed in hub 2866 and an end part 2872 terminating proximally
at a retraction plate 2894 disposed in hub 2866. A linkage 2898
including a pair of links 2898' and 2898" pivotally connected
to each other at a central joint is pivotally connected to the
operating flange and the retraction plate at distal and proximal
end joints. A spring mounted at the central joint rotationally
biases the links 2898' and 2989" to a normal position wherein
the operating members 2888 is maintained in an initial position
and the junction of the distal part 2870 is disposed beyond the
distal end of the portal sleeve by a distance equal to the
spacing between shoulder 2880 and abutment 2892 in the extended
position illustrated in Fig. 60. A cross link 2900' is
pivotally connected to linkage 2898 at retraction plate 2894 and
to a linkage 2902. Linkage 2902 includes a distal link 2902°
pivotally connected at a joint to cross link 2900', a proximal
link 2902" pivotally secured to a rear wall of the hub and a
cross link 2902" pivotally connected to the distal and proximal
links at joints. Linkage 2902 is biased, such as with springs
at one or more joints of the linkage, to a collapsed condition
with cross link 2900' moving end part 2872 proximally. A
locking and releasing mechanism 2912 is disposed in hub 2866 and
includes an arm 2918 having a plurality of teeth or barbs 2921
thereon for engaging distal link 2902' to lock the linkage 2902
in an expanded, non-collapsed position in the extended position
for the instrument illustrated in Fig. 60 and a trigger 2926.
Trigger 2926 has a trigger cam 2927 disposed proximally of the
operating flange in the initial position and a bent trigger leg
2929 pivotally mounted in hub 2866 at 2929' to be disposed in
abutment with retraction plate 2894 with the instrument in the
extended position. Trigger leg 2929 is hinged, pivotal or made
flexible at 2929" along a portion of the leg disposed along arm
2918 allowing a forward portion of the trigger leg to rotate,
WO 94/06681 ~; PCT/US93/08477
71
clockwise looking a Fig. 60, around pivot 2929' and a rearward
portion of the trigger leg to rotate, counter-clockwise looking
at Fig. 60, in response to counterclockwise rotation of trigger
cam 2927. A push member 2871 is disposed in end cap 2906 for
moving the linkage 2902, via engagement of protrusion 2928 with
link 2902', distally to engage teeth 2921 when setting the
instrument in the extended position.
During operation, automatic retractable safety penetrating
instrument 2860 is forced through tissue causing proximal
movement of distal part 2870 such that operating member 2888 is
moved proximally by trigger cam 2927 without causing flexing of
arm 2918. Once a distal end of the portal sleeve has entered
the anatomical cavity, the distal part 2870 will be moved
distally causing movement of operating member 2888 toward the
initial position to engage trigger cam 2927 to bend or pivot
trigger leg 2929 at 2929" causing trigger leg 2929 to rotate
around pivot 2929' to be disposed out of the path of movement
of retraction plate 2894 and arm 2918 to be flexed in a
direction outwardly from a longitudinal axis of the instrument
such that link 2902' is released from the barbs causing the
linkage 2902 to move to a collapsed position carrying end part
2872 and with it distal part 2870 to a retracted position.
Inasmuch as the present invention is subject to many
variations, modifications and changes in detail, it is intended
that all subject matter discussed above or shown in the
accompanying drawings be interpreted as illustrative only and
not be taken in a limiting sense.
