Note: Descriptions are shown in the official language in which they were submitted.
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APPLIER FOR A SURGICAL DEVICE
[0001] Background of the Invention
[0002] The present invention relates, in general, to devices and methods
for surgically
modifying organs and vessels. More particularly, it relates to anastomosis
devices
for joining two organs such as, for example, two separate lengths of small
bowel to
each other, a section of small bowel to the stomach, or the common bile duct
to the
duodeneum in a procedure called a choledochoduodenostomy.
[0003] Creating an anastomosis, or the surgical formation of a passage
between two
normally distinct vessels, is a critical step of many surgical procedures.
This is
particularly true of gastric bypass procedures in which two portions of small
intestine are joined together and another portion of small intestine is joined
to the
stomach of the patient. This is also true of surgery to alleviate blockage in
the
common bile duct by draining bile from the duct to the small intestine during
surgery for pancreatic cancer.
[0004] For many anastomosis, surgeons use circular staplers, linear
staplers, or manual
sutures. However, to reduce incision size and to make the surgical process
less
technically demanding and time consuming, an expandable medical device that
deforms to hold tissue portions together when the device is ejected from a
constraining enclosure has been described. United States Published Patent
Application 2003/0120292 to Adrian Park et al, describes such a device.
[0005] The expandable medical device disclosed in US 2003/0120292 is
constrained by a
sleeve to an advantageous small-diameter tubular shape. A surgeon applies the
expandable medical device by maneuvering the sleeve through the tissue
portions
requiring anastomosis, moving a nose assembly distally away from the sleeve,
and
ejecting the device with a ram. Ejecting the device removes the constraint on
the
device, allowing the device to assume a roughly ring shape. The larger ends of
the
ring shape hold the two tissue portions together in an effective anastomosis.
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[0006] The constrained expandable medical device, which may be made of a
shape
memory material such as nitinol, exerts a force against the inner diameter of
the
sleeve and tends to warp towards its roughly ring-shaped deployed position.
When the device is ejected, the forces generated by the device in transition
from a
tubular shape to a ring shape urge the expandable medical device distally.
This
device movement makes surgical control harder to achieve when placing the
device
through the otomies of two tissue portions requiring anastomosis. Applicants
have
recognized a need to apply a restraining force to the distal end of the
expandable
medical device to improve surgical control when applying it. An applier to
place
the expandable medical device while restraining the tendency of the device to
move
distally during ejection, and a method of using the applier would be
desirable. It
would be further advantageous to provide a flexible force element urging the
distal
nosepiece, or cover, towards the ejecting device as the device is ejected to
control
distal movement of the device. The present invention provides such an applier
and
method.
[0007] Summary of the Invention
[0008] In one embodiment, there is provided a use of an applier for an
expandable medical
device that provides improved control when the expandable medical device is
applied, comprising a tube having a distal end, a proximal end and a
longitudinal
axis therebetween, and a pusher rod having a distal end and a proximal end and
having a cap attached to its distal end and a restraint element disposed on
the
pusher rod proximal to the cap, the pusher rod disposed within the tube such
that
the cap is distal to and spring biased towards the distal end of the tube, and
the
expandable medical device disposed within the distal end of the tube between
the
restraint element and the cap, the expandable medical device having distal and
proximal ends; wherein the use is such that the tube can be arranged to be
moved
proximally, with respect to the pusher rod, a predetermined distance so as to
deploy
the distal end of the expandable medical device while the cap remains biased
towards the tube.
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[0009] Brief Description of the Figures
[0010] The novel features of the invention are set forth with particularity
in the appended
claims.
[0011] The invention itself, however, both as to organization and methods
of operation,
together with further objects and advantages thereof, may best be understood
by
reference to the following description, taken in conjunction with the
accompanying
drawings in which:
[0012] Figure 1 is an isometric view of an applier according to an
embodiment of the
invention containing an expandable medical device.
[0013] Figure 2 is an isometric of an applier according to a second
embodiment of the
invention.
[0014] Figure 3 is an isometric view of the applier of Figure 2 with
interior portions
revealed.
[0015] Figure 4 is an isometric view of the distal side of the handle of
the applier of Figure
3.
[0016] Figure 5 is an isometric view of an applier according to a third
embodiment of the
invention.
[0017] Figure 6 is an isometric view of the interior portions of the
embodiment of Figure
5.
[0018] Figure 7 is an isometric view of the path retainer on the applier of
Figure 5
depicting details of the guide path.
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[0020] Figure 8 is a cross-sectional view of the embodiment of Figure 1 in
the loaded position.
[0021] Figure 9 is an isometric view of embodiment of Figure 1 with the
device in the flared
position.
[0022] Figure 10 is a cross-sectional view of the embodiment of Figure 1
with the device in the
flared position.
[0023] Figure 11 is an isometric view of the embodiment of Figure 1 after
the device has been
applied.
[0024] Figure 12 is a cross-sectional view of the embodiment of Figure 1
after the device has
been applied.
[0025] Figure 13 is a cross-section view of the embodiment of Figure 2 with
the device in the
loaded position.
[0026] Figure 14 is an isometric view of the applier of Figure 2 with the
device in the flared
position.
[0027] Figure 15 is a cross-sectional view of the applier of Figure 2 with
the device in the flared
position.
[0028] Figure 16 is an isometric view of the applier of Figure 2 after the
device has been applied.
[0029] Figure 17 is a cross-section view of the applier of Figure 2 after
the device has been
applied.
[0030] Figure 18 is a cross-sectional view of the applier of Figure 5 with
the device in the loaded
position.
[0031] Figure 19 is an isometric view of the path retainer of Figure 7
showing the relationship
between the guide path and the guide clip when the device is being flared.
[0032] Figure 20 is a cross-sectional view of the applier of Figure 5
flaring the device.
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[0033] Figure 21 is a cross-sectional view of the applier of Figure 5 with
the device flared and
restrained by the bullet nose.
[0034] Figure 22 is an isometric view of the path retainer of Figure 7
showing the relationship
between the guide path and the guide clip when the device is flared and
restrained by the
bullet nose.
[0035] Figure 23 is a cross-sectional view of the applier of Figure 5 with
the device being
ejected.
[0036] Figure 24 is a cross-sectional view of the retainer of Figure 7
showing the relationship
between the guide path and the guide clip when the device is being ejected.
[0037] Figure 25A is an isometric view of a distal end of an applier
showing a bullet nose having
a blunt surface.
[0038] Figure 25B is an isometric view of a distal end of an applier
showing a bullet nose having
a fluted surface.
[0039] Figure 25C is an isometric view of a distal end of an applier
showing a bullet nose having
a convex surface.
[0040] Figure 25D is an isometric view of a distal end of an applier
showing a bullet nose having
a concave surface.
[0041] Figure 25E is an isometric view of a distal end of an applier
showing a bullet nose having
an offset swept, asymmetric surface.
[0042] Figure 25F is an isometric view of a distal end of an applier
showing a bullet nose
having a spherical surface.
[0043] Detailed Description of the Invention
[0044] Figure 1 depicts an applier 10 configurable to apply an expandable
medical device 12.
Applier 10 has an enclosure, or a tube 14 for containing expandable medical
device 12
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and internal components of applier 10. Tube 14 may be created from a moldable
plastic,
and at least a portion of tube 14 may be translucent or transparent to allow
visualization
of device 12 or other internal components. Translucency or transparency could
also
allow light from a light source placed internal to tube 14 to pass externally
to tube 14 to
illuminate a work area. Guide slot 16 is positioned on tube 14 near the
proximal end of
tube 14. Guide slot 16 may have a shape to present stop positions or cam
surfaces to the
user to guide the user in proper placement of the components of applier 10
during
actuation of applier 10. In applier 10 as depicted in Figure 1, the shape of
guide slot 16
roughly approximates the letter "Z" and extends about at least a portion of
the
circumference of tube 14. A locator pin 18 moves within guide slot 16 and
locates
portions of components of applier 10. Figure 1 depicts locator pin 18 as a
socket-head
cap screw; however, locator pin 18 and guide slot 16 may comprise any cam-
follower
mechanism able to direct movement of components of applier 10. Knob 20 extends
from
the proximal end of applier 10 for control by the user. Tube handle 24
attaches to tube
14, also for grasping by the user to manipulate applier 10. A cap in the form
of bullet
nose 22 is placed at the distal end of tube 14. Bullet nose 22 protrudes from
the distal
end of tube 14, and has a distal end shaped to engage and dilate small stoma
in tissue.
This distal end shape may be conical, but could also be rounded, asymmetrical,
pointed,
or any shape to facilitate entry into tissue. Bullet nose 22 also possesses on
its proximal
surface a device taper 70. Device taper 70 is shown substantially conical in
shape with
the taper facing proximally towards expandable medical device 12 when
expandable
medical device 12 is loaded within applier 10. Device taper 70 may also take
different
surface shapes, such as, for example, a convex curved shape, which may
facilitate flaring
and deployment of expandable medical device 12.
100451
Figure 1 further displays the internal mechanism 26 of applier 10 in
isometric view.
Pusher rod 28 extends distally from knob 20 and is hollow for at least a
portion of its
length to enclose other components. Pusher rod slot 30 opens into the internal
portions of
pusher rod 28 and is elongated to allow differential motion between pusher rod
28 and
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other components of internal mechanism 26, as will be seen. Pusher rod 28
possesses a
guide bushing 32 near its proximal end to mate with tube 14 in such a way as
to allow
longitudinal movement and rotational movement between pusher rod 28 and tube
14.
Locator pin 18 extends from guide bushing 32. A restraint element, called
device pusher
34, is affixed to pusher rod 28 near the distal end of pusher rod 28, and
restrains
expandable medical device 12 from proximal movement when tube 14 moves
proximally.
[0046] Although device pusher 34 is shown with a substantially flat distal
surface, device pusher
34 may alternately possess a tapered distal surface to assist in deploying
device 12.
[0047] Bullet nose rod 36 is attached to and extends from bullet nose 22
proximally through
pusher rod 28. A slip-fit clearance between bullet nose rod 36 and pusher rod
28 allows
longitudinal movement between bullet nose rod 36 and pusher rod 28. Bullet
nose rod
slot 38 is cut into bullet nose rod 36 and aligns in operation with pusher rod
slot 30.
[0048] Bullet nose rod 36 may take any of several configurations to
facilitate manufacture and
use. For example, bullet nose rod 36 may be integrally molded with bullet nose
22 to
become one component. Alternatively, bullet nose rod 36 may have a threaded
attachment to bullet nose 22 or may itself be composed of two components that
are
extendable for adjustability..
[0049] A force element embodied by spring 40 connects bullet nose rod 36 to
tube handle 24 by
engaging bullet nose rod slot 38. Spring 40 applies mechanical force urging
bullet nose
rod 36 and bullet nose 22 proximally. Since tube handle 24 affixes to tube 14,
spring 40
applies mechanical force tending to hold bullet nose 22 and tube 14 together,
but
allowing relative displacement of bullet nose 22 away from tube 14 under a
force
opposing and greater than the force generated by spring 40.
[0050] Figure 2 displays another embodiment of applier 10. As in the
embodiment of applier 10
seen in Figure 2, tube handle 24 attaches at the proximal end of tube 14.
However, in the
embodiment of Figure 2, tube handle 24, rather than tube 14, carries guide
slot 16. A
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leg 41 extending from spring 40 fastens to tube handle 24 through a small
opening of
tube handle 24, and may curve about a portion of tube handle 24 to locate it
into position.
[0051] Figure 3 shows internal mechanism 26 of the embodiment of Figure 2.
Tube 14 has been
shown in phantom in Figure 3 for clarity, however, tube handle 24 remains to
show
positional relationships of components. Pusher rod 28 extends distally from
knob 20
similarly to the embodiment of Figure 2. Device pusher half 35 locates at the
distal end
of pusher rod 28, affixed to pusher rod 28 by a snap ring 46. A second device
pusher half
35, omitted for better visibility of associated components, mates with device
pusher half
35 to enclose the distal end of pusher rod 28 and to form device pusher 34. A
cover rod
shown as bullet nose rod 36, extending from the cover shown as bullet nose 22,
inserts
into a distal end of device pusher 34. Clearance exists between device pusher
34 and
pusher rod 28 so that longitudinal motion can occur between bullet nose rod 36
and
device pusher 34. Bullet nose 22 protrudes from the distal end of bullet nose
rod 36. As
is possible in the embodiment of Figure 1, bullet nose 22 can combine with
bullet nose
rod 36 into one component, or bullet nose 22 can be a separate component
attached to
bullet nose rod 36 in a manner to allow an adjustable length between bullet
nose 22 and
bullet nose rod 36. The design can allow length adjustability by, for example,
a threaded
connection between bullet nose 22 and bullet nose rod 36. Also, as in the
embodiment of
Figure 1, bullet nose rod slot 38 is cut into the end of bullet nose rod 36.
An embodiment
of locater pin 18 extends radially from the surface of pusher rod 28 near the
proximal side
of pusher rod 28. Tube handle 24 attaches to the proximal end of tube 14.
[0052] Spring 40 hooks to bullet nose rod slot 38 to connect bullet nose
rod 36 and tube handle
24. Spring 40 applies mechanical force urging bullet nose rod 36 and bullet
nose 22
proximally. Since tube handle 24 affixes to tube 14, spring 40 applies
mechanical force
tending to hold bullet nose 22 and tube 14 together, but allowing relative
displacement of
bullet nose 22 away from tube 14 under an opposing force greater than that
applied by
spring 40. In the embodiment of Figure 3, spring 40 passes through a spring
slot 48
created by the mating pusher halves 35.
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[0053] Figure 4 displays a view of tube handle 24 used in the embodiment of
Figure 2. The view
is taken from the distal end of tube handle 24. A guide slot 16 of the tube
handle 24
shown in Figure 3 is also seen in Figure 4. Guide slot 16 comprises a
longitudinal slot 42
following the axis of handle 24 at the proximal side of tube handle 24,
opening into a
horizontal slot 44 near the distal end of handle 24. A pin stop 45, in the
embodiment of
Figure 4, is a wall to prevent further distal movement of locator pin 18
without a
preliminary rotational movement of pusher rod 28. Guide slot 16 has clearance
for
movement of locator pin 18 through longitudinal slot 42 and through horizontal
slot 44,
and so allows translation of locator pin 18 and rotation of locator pin 18
about the axis of
pusher rod 28 when pusher rod 28 is rotated.
[0054] Figure 5 shows a third embodiment of applier 10. As in the other
embodiments, applier
of Figure 5 carries a tube 14 with an attached tube handle 24 at its distal
end. Pusher
rod 28 carries knob 20 at its proximal end and bullet nose 22 at its distal
end. The
embodiment of Figure 5 is shown with an access port 50 open through the entire
length of
applier 10. Other embodiments of applier 10 could have an access port 50 as
well.
Attached to tube 14 at the proximal end of tube 14 is path retainer 52, to
direct
movements of pusher rod 28, as will be seen.
[0055] Access port 50 may be used for placement of a tool to facilitate
surgery. A surgeon may
place, for example, through access port 50, a tool such as a guide wire to
guide applier 10
within the body, a laser or surgical tool to effect further treatment, a fiber
optic to give
light to the surgical site, a fiber optic with an attached camera to visualize
the surgical
site, a wire to convey electrical energy, or a tube to convey pneumatic
energy. Access
port 50 may be sealed by, for example, an elastomeric plug when not in use if
it becomes
necessary to preclude passage of gas for reasons such as, for example,
maintenance of
pneumoperitenium.
[0056] Figure 6 shows the embodiment of Figure 5 with tube 14 in phantom
for clarity. In the
embodiment shown in Figure 6, pusher rod 28 has knob 20 at its proximal end
and bullet
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nose 22 at its distal end. Device pusher 34 attaches near the distal end of
pusher rod 28.
Spring 40 connects to tube 14 through path retainer 52, and to pusher rod 28;
however,
spring 40 could alternately attach directly to tube 14 or to any component
affixed to tube
14. As in previous embodiments, spring 40 applies a force tending to urge
bullet nose 22
towards tube 14, so that bullet nose 22 and tube 14 are engaged with a preload
but can be
deflected apart by a force large enough to overcome the preload. Guide clip 54
affixes to
pusher rod 28 and engages path retainer 52 in a way to permit relative motion
between
guide clip 54 and path retainer 52. Guide clip 54, although affixed to pusher
rod 28, has
stationary guide clip leg 58 and deflectable guide clip leg 59 (Figure 7) to
slidingly
engage portions of path retainer 52. Stationary guide clip leg 58 remains
substantially
fixed relative to pusher rod 28, while deflectable guide clip leg 59 deflects
outward,
guided by cam surfaces on path retainer 52.
[0057]
Figure 7 shows a close view of path retainer 52 used in the embodiment of
applier 10 of
Figure 5. This view shows the face of path retainer 52 that faces the interior
of tube 14.
The proximal end of spring 40 and positioning guide clip 54 are also shown in
Figure 7.
Path retainer 52 has a control path 56 to direct and control movement of
pusher rod 28
through action of guide clip 54. Control path 56 consists of four paths for
guidance and
control of pusher rod 28. The four paths are flair path 60, return path 62,
ejection path
64, and finish path 66. Rails 75 on the surface of path retainer 52 separate
the paths. A
flair stop 61 is at the distal end of return path 62, while clearance slot 63
opens between
return path 62 and ejection path 64 near the proximal end of the paths. A
distal clearance
slot 65 opens between flair path 60 and return path 62 near the distal end of
the paths.
Stationary guide clip leg 58 and deflectable guide clip leg 59 are shown
preloaded and
compressed together by two of rails 75 to ride in flair path 60. In the
relaxed state,
stationary guide clip 58 and deflectable guide clip leg 59 spread to a
distance to
encompass the width between finish path 66 and flair path 60. In actuation of
the
mechanism, control path 56 permits consecutive relaxing and opening of
deflectable
guide clip leg 59 towards the relaxed, non-preloaded state. Stationary guide
clip leg 58
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remains within flair path 60, while deflectable guide clip leg 59 moves
towards and into
finish path 66.
[0058] Each embodiment of applier 10 has an operation sequence, as will be
seen. The
embodiments share commonality in that bullet nose 22 applies force generated
by spring
40 to flair expandable medical device 12. When expandable medical device 12 is
not
extending beyond the distal end of tube 14, bullet nose 22 covers the end of
tube 14 and
is held in position by force applied by spring 40. When a force acts on bullet
nose 22 and
opposes the force of spring 40 and is greater than the force applied by spring
40, spring
40 deflects to allow bullet nose 22 to lift off of tube 40.
[0059] The embodiment of applier 10 shown in Figure 1 operates as shown in
Figures 8 through
12. Figure 8 depicts the Figure 1 embodiment loaded with a medical device,
such as an
expandable medical device 12. Tube 14 contains expandable medical device 12.
Expandable medical device 12 can be used to hold two tissue portions together
to effect a
therapeutic surgical treatment.
[0060] A surgeon can grasp applier 10 and place it into a patient's body.
The surgeon can, for
example, grasp the applier 10 by placing an index and middle finger on tube
handle 24
and a thumb on knob 20. The surgeon maneuvers any embodiment of applier 10 to
a
portion of the body near organs needing surgical treatment, such as
anastomosis. The
surgeon may, for example, first divide a section of small intestine as a part
of a medical
procedure such as a gastric bypass operation. Or, the surgeon may anastomose
bowel left
behind by removal of a cancerous portion of bowel. The surgeon may create an
otomy in
a section of small intestine and extend applier 10 through the section of
small intestine to
a position where another otomy is desired. The surgeon may then make a second
otomy
in the wall of the same section and a third otomy in another section of
intestine to be
anastomosed. Applier 10 then can extend through the second and third otomies
in the
two sections of small intestine. The walls carrying the second and third
otomies can be
shown as proximal tissue portion 68 and distal tissue portion 69. Attaching
these tissue
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portions can create an intestinal anastomosis when the tissue portions are
portions of
lumens of intestine. After extending applier 10 through proximal tissue
portion 68 and
distal tissue portion 69, a surgeon can operate applier 10 to effect a medical
procedure
such as an anastomosis.
[0061] The surgeon urges tube handle 24 towards knob 20. Tube handle 24,
affixed to tube 14,
pulls tube 14 towards knob 20. Reactive force, placed by the surgeon on knob
20,
transfers through pusher rod 28, to device pusher 34, to expandable medical
device 12.
As tube 14 slips proximally, device pusher 34 restrains any proximal movement
of
expandable medical device 12. Spring 40, connected between tube handle 24 and
bullet
nose rod 36, applies a force tending to pull bullet nose rod 36 in a proximal
direction.
With applier 10 in this first position when application is beginning, bullet
nose rod 36
pulls bullet nose 22 proximally to maintain preloaded contact with tube 14, so
that bullet
nose 22 travels proximally with tube 14 as one unit relative to device pusher
34. Bullet
nose rod 36 telescopes into the inner diameter of pusher rod 28. When bullet
nose 22
reaches the distal end of expandable medical device 12, device taper 70
contacts
expandable medical device 12 to flare it. Expandable medical device 12 applies
a
reactive force to bullet nose 22. When the distal reactive force overcomes the
force
applied by spring 40, the reactive force elongates spring 40 and separates
bullet nose 22
slightly from tube 14. Flaring expandable medical device 12 begins to emerge
from the
opening created between tube 14 and bullet nose 22, as shown in Figures 9 and
10.
[0062] Figures 9 and 10 show flared expandable medical device 12 emerging
from applier 10.
As bullet nose 22 moves towards expandable medical device 12, device taper 70
presents
a ramp to facilitate the flaring and opening of expandable medical device 12.
Device
taper 70 applies force to an internal portion of expandable medical device 12
to flare
expandable medical device 12 and increase the diameter of the distal end of
expandable
medical device 12. In addition, the restraint that bullet nose 22 places on
expandable
medical device 12 prevents expandable medical device 12 from ejecting from
tube 14
before expandable medical device 12 is placed into the correct position
adjacent tissue
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portions to be surgically treated. The surgeon can use the flared portion of
expandable
medical device 12, as it is captured by the force exerted by bullet nose 22,
to pull distal
tissue portion 69 towards proximal tissue portion 68 to effect treatment such
as an
anastomosis. Applier 10 with the extending, flared portion of captured
expandable
medical device 12 can be utilized as a tool to manipulate tissue.
[0063] As tube 14 moves towards knob 20, the proximal, axial portion of "Z"-
shaped guide slot
16 moves relative to locator pin 18. When expandable medical device 12 is
flared to the
correct position for tissue manipulation, the circumferential portion of guide
slot 16 abuts
locator pin 18, preventing any further movement of tube 14 towards knob 20. To
continue any further linear movement, the surgeon must now rotate tube 14
relative to
locator pin 18.
[0064] Figure 9 shows that the circumferential portion of guide slot 16
moves relatively past
locator pin 18. When the distal, axial portion of guide slot 16 aligns with
locator pin 18,
further movement of tube 14 towards knob 20 is permitted. After rotating tube
14
relative to knob 20 to produce the relative circumferential motion of guide
slot 16 and
locator pin 18, and placing distal tissue portion 69 and proximal tissue
portion 68 near the
distal end of applier 10 as shown in Figure 10, the surgeon is ready to eject
expandable
medical device 12 from applier 10.
[0065] Figures 11 and 12 show the embodiment of applier 10 shown in Figure
1 with expandable
medical device 12 ejected. To eject expandable medical device 12, the surgeon
continues
movement of tube 14 towards knob 20. Spring 40 continues to pull bullet nose
22
proximally, while bullet nose rod 36, attached to bullet nose 22, slides
freely through
pusher rod 28. Bullet nose 22 is still preloaded against flared expandable
medical device
12, and expandable medical device 12 continues to emerge from the distal end
of tube 14.
When the proximal end of bullet nose rod slot 38, where spring 40 attaches,
reaches the
proximal end of pusher rod slot 30, force is now applied by spring 40 to
pusher rod 28.
Spring 40 now extends between pusher rod 28 and tube handle 24. Further
proximal
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motion of tube 14 relative to pusher rod 28 extends spring 40. Spring 40 no
longer
preloads bullet nose 22 against expandable medical device 12. If the proximal
end of
bullet nose rod slot 30 moves proximal to the proximal end of pusher rod slot
38, force
applied to the proximal end of bullet nose 22 by tissue portions or by
expandable medical
device 12 is no longer overcome by force from spring 40, so bullet nose 22 now
is forced
distally. There is no longer any relative motion between bullet nose 22 and
pusher rod
28, so there is therefore no relative motion between bullet nose 22 and device
pusher 34.
However, in this later advanced position as expandable medical device 12 is
nearing
ejection, tube 14 moves relative to bullet nose 22 and device pusher 34. The
space
between device pusher 34 and bullet nose 22, containing expandable medical
device 12,
emerges from tube 14 to complete ejection of expandable medical device 12 as
tube 14 is
pulled proximally. Expandable medical device 12 assumes the correct
orientation and
geometry to perform a useful surgical procedure. The relative positions of
components of
applier 10 after ejection of expandable medical device 12 are shown in Figures
11 and 12.
100661 Figures 13 through 17 depict the operation of the embodiment of
applier 10 shown in
Figure 2. Figure 13 shows the embodiment of applier 10 loaded with
expandable
medical device 12. To begin to eject expandable medical device 12, the surgeon
urges
tube handle 24 towards knob 20. Tube handle 24, affixed to tube 14, pulls tube
14
towards knob 20. Reactive force placed by the surgeon on knob 20 transfers
through
pusher rod 28, snap ring 46, and device pusher 34 to expandable medical device
12. As
tube 14 slips proximally, device pusher 34 restrains any rearward movement of
expandable medical device 12. Simultaneously, force applied by spring 40,
connected
between tube handle 24 and bullet nose rod 36, urges bullet nose rod 36
proximally
through device pusher 34. Bullet nose rod 36 pulls bullet nose 22 proximally
to maintain
preloaded contact with tube 14, so that tube 14 and bullet nose 22 proceed
proximally as
one unit. When bullet nose 22 reaches the distal end of expandable medical
device 12,
device taper 70 contacts expandable medical device 12 to flare it. Expandable
medical
device 12 applies a reactive force to bullet nose 22 greater than that applied
by spring 40
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to elongate spring 40 and separate bullet nose 22 slightly from tube 14.
Flaring
expandable medical device 12 begins to emerge from the opening created between
tube
14 and bullet nose 22, as shown in Figure 14 and 15.
[0067] Figure 15 shows in section view flared expandable medical device 12
emerging from the
embodiment of applier 10. Because spring 40 continues to urge bullet nose 22
proximally
towards tube 14, device taper 70 presents a ramp to facilitate the flaring and
opening of
expandable medical device 12. In addition, the restraint that bullet nose 22
places on
expandable medical device 12 prevents expandable medical device 12 from
ejecting from
tube 14 before expandable medical device 12 is placed into the correct
position adjacent
to tissue portions to be surgically treated. The surgeon can use the flared
portion of
expandable medical device 12, as it is captured by the force exerted by bullet
nose 22, to
pull a distal tissue portion 69 towards a proximal tissue portion 68 to effect
treatment
such as an anastomosis. Applier 10 with the extending, flared portion of
captured
expandable medical device 12 can be utilized as a tool to manipulate tissue
during a
surgical procedure.
[0068] As tube handle 24 moves proximally, guide slot 16 within tube handle
24 moves
proximally relative to locator pin 18 through longitudinal slot 42. When
expandable
medical device 12 is flared to the correct position, pin stop 45 abuts locator
pin 18,
preventing any further movement of tube 14 towards knob 20. To continue any
further
linear movement, the surgeon must now rotate tube 14 relative to locator pin
18.
Horizontal slot 44 (Figure 5) has clearance to allow this rotation. After
locator pin 18 has
rotated past pin stop 45, further movement of tube 14 towards knob 20 is
permitted, and
the surgeon is ready to completely eject expandable medical device 12 from
applier 10.
[0069] Figure 16 and 17 show cross-sectional views of expandable medical
device 12 ejected
from applier 10 and engaging proximal tissue portion 68 to distal tissue
portion 69. To
finish ejection of expandable medical device 12, the surgeon continues
movement of tube
14 towards knob 20. Spring 40 continues to pull bullet nose 22 proximally,
while bullet
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nose rod 36, attached to bullet nose 22, slides freely through device pusher
34. Bullet
nose 22 is still preloaded against flared expandable medical device 12 by
force exerted by
spring 40. When the proximal end of bullet nose rod 36, where spring 40
attaches,
reaches the distal end of pusher rod 28, force is now applied to pusher rod
28. Bullet
nose 22 can no longer follow tube 14 proximally, and is no longer preloaded to
tube 14.
Further proximal motion of tube 14 relative to pusher rod 28 extends spring
40. There is
no longer relative motion between bullet nose 22 and device pusher 34. Tube
14,
however, moves relative to bullet nose 22 and device pusher 24. The space
between
device pusher 34 and bullet nose 22, containing expandable medical device 12,
emerges
from tube 14 to eject expandable medical device 12 as tube 14 is pulled
proximally.
[0070] Figures 18 through 23 demonstrate the operation of the embodiment of
applier 10 shown
in Figure 5. Figure 18 shows the Figure 5 embodiment of applier 10 in the
loaded
position with expandable medical device 12 placed within tube 14. Force
applied by
spring 40 holds bullet nose 22 against the distal end of tube 14. A surgeon
moves tube 14
proximally towards knob 20 against the force of spring 40 by grasping tube
handle 24 as
in previous embodiments. Tube 14 moves proximally relative to pusher rod 28
and
device pusher 34. Device pusher 34 restrains proximal movement of expandable
medical
device 12. As tube 14 moves proximally, a gap opens between tube 14 and bullet
nose
22. Expandable medical device 12 begins to emerge from the distal end of tube
14.
[0071] Figure 19 also shows an isometric view of path retainer 52 and guide
clip 54. Path
retainer 52 is attached to tube 14 and moves proximally with guide clip 54. As
path
retainer 52 moves proximally, control path 56 moves relative to guide clip 54
to control
movements of tube 14. When tube 14 moves proximally from the position shown in
Figure 18, flair path 60 moves past stationary guide clip leg 58 and
deflectable guide clip
leg 59 until flair stop 61 abuts guide clip 54. Flair stop 61 prevents further
proximal
motion of tube 14. When flair stop 61 abuts guide clip 54, the deflectable
guide clip leg
59 will move through distal clearance slot 65 to return path 62. Applier 10
now takes the
position shown in Figure 20, with expandable medical device 12 emerging from
the distal
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end of tube 14. Releasing force from tube 14 will allow spring 40 to move tube
14
distally into the position shown in Figure 21.
[0072] Figure 21 shows a sectional view of the embodiment of applier 10 of
Figure 6 with
expandable medical device 12 flared from the distal end of tube 14. When the
surgeon
releases force from tube handle 24, spring 40 pulls tube 14 distally towards
bullet nose
22. Device taper 70 contacts expandable medical device 12 to assist in flaring
expandable medical device 12. Force from spring 40 is applied to device 12.
[0073] This embodiment of applier 10 in the configuration of Figure 21,
much like previous
embodiments, may be used to capture distal tissue wall 69 to approximate it to
a proximal
tissue wall to perform a surgical procedure such as an anastomosis. A surgeon
can use
applier 10 with the flared expandable medical device 12 as a tool to
manipulate tissue.
[0074] Figure 22 shows path retainer 52 and guide clip 54 as applier 10 is
in the flared position
of Figure 21. Path retainer 52 has moved to the initial position relative to
guide clip 54
while deflectable guide clip leg 59 was within return path 62. Deflectable
guide clip leg
59 then moved through clearance slot 63 to ejection path 64 when path retainer
52
reached the initial position with guide clip 54 at its proximal end. .
[0075] Figure 23 shows expandable medical device 12 ejected by applier 10.
After expandable
medical device 12 has been placed into position, the surgeon may now eject
device 12 by
pulling tube handle 24 towards knob 20 to again urge tube 14 proximally
relative to
pusher rod 28. When device pusher 34 contacts the proximal end of expandable
medical
device 12, expandable medical device 12 is prevented from further proximal
movement.
Tube 14 moves proximally from expandable medical device 12 to deploy it.
[0076] Figure 24 depicts the action of path retainer 52 moving proximally
past guide clip 54
while applier 10 deploys expandable medical device 12. Ejection path 64 moves
proximally past deflectable guide clip leg 59. As there exists no stop at the
distal end of
ejection path 64, tube 14 can move further proximally to a position allowing
device
pusher 34 to completely eject expandable medical device 12. The curve of guide
rail 75
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adjacent to ejection path 64 places a side force on deflectable guide clip leg
59, moving it
closer to stationary guide clip leg 58. The force generated by moving
deflectable guide
clip leg 59 can give tactile feedback to the surgeon that tube 14 is
approaching the end of
its allowable proximal movement. After tube 14 has reached its most proximal
position
and device 12 has been ejected, the surgeon may now release any force pulling
tube
handle 24 towards knob 20. Spring 40 will pull tube 14 distally relative to
knob 20,
while finish path 66 moves distally past deflectable guide clip leg 59.
Applier 10 has
ejected expandable medical device 12.
[0077] One will recognize that these descriptions of movement of portions
of applier 10 describe
relative movement of the elements with respect to each other. For example,
movement of
tube 14 proximally towards knob 20 can also be described as movement of knob
20
distally towards tube 14. As another example, movement of tube 14 proximally
past
device pusher 34 could also be described as distal movement of device pusher
34 within a
stationary tube 14. In the latter example, expandable medical device 12 is
described as
restrained from proximal movement by device pusher 34 when tube 14 moves
proximally
past. Changing the stationary element from device pusher 34 to tube 14 changes
the
description to one of expandable medical device 12 urged distally by distally
advancing
device pusher 34.
[0078] It will be recognized that equivalent structures may be substituted
for the structures
illustrated and described herein and that the described embodiment of the
invention is not
the only structure that may be employed to implement the claimed invention. As
one
example of an equivalent structure that may be used to implement the present
invention,
hydraulics, electronics, or pneumatics may be used to move tube 14 relative to
device
pusher 34. Computer control could be used with electronics and a feedback loop
to move
tube 14 and to selectively tension a force element based on the amount of
tissue force
applied. As a further example of an equivalent structure that may be used to
implement
the present invention, robotics could be used with applier 10 attached to a
controlled
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robotic arm that moves the mechanism of applier 10 to effect an anastomosis.
Robotics
would allow a surgeon distant from the surgical site to perform a procedure.
[0079] As a further example of an equivalent structure, tube 14 could
become a flexible tube,
and the mechanisms within applier 10 may become flexible to maneuver through a
long
lumen, such as a section of small bowel, to effect an anastomosis through a
long, flexible
lumen. Such a long, flexible tube may be used laproscopically or
endoscopically.
[0080] As a further example of an equivalent structure, applier 10 could
have a long, rigid,
curved tube, or a long, rigid, straight tube, and applier 10 could be placed
through an
obturator port and used laproscopically or endoscopically. Length and
curvature
becomes advantageous in endoscopic or laproscopic surgery, especially when
performing
a surgical procedure on a bariatric patient. In either a rigid or a flexible
form of an
applier 10, restriction of gas flow through the instrument becomes
advantageous when
maintenance of a pneumoperiteneum is desired as in, for example, endoscopic
surgery.
[0081] As a further example of an equivalent structure and method that may
be used to
implement the present invention, applier 10 may have a geometry small enough
to be
conveniently placed through the opening of a hand port used for hand-assisted
laproscopic surgery, such as, for example, the Lap-Disk hand port sold by
Ethicon
Endo-Surgery in Cincinnati, Ohio. A surgeon using applier 10 through a hand
port may
use an endoscope through a secondary port for visualization, and may also
maintain a
pneumoperiteneum. The surgeon may also make use of trocars, graspers, cutters,
and
other endoscopic instruments inserted through auxiliary ports to assist in
grasping lumens
or creating otomies in lumens to perform surgical procedures such as
anastomosis.
[0082] As a further example of an equivalent structure and method that may
be used to
implement the present invention, a long, rigid version of applier 10, or a
long, flexible
embodiment of applier 10 may be used through an auxiliary port while tissue is
manipulated by the surgeon using a hand placed through a hand port.
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[0083] As other examples of equivalent structures, the surface of distal
taper 71 on bullet nose
22 may take many forms advantageous for various types of tissue manipulation,
as
illustrated in Figures 25A through 25F. Figure 25A represents a conical tipped
nose that
is blunted for low tissue trauma and for good visibility past the distal end.
Figure 25B
depicts a nose that is fluted to allow torque to be applied to tissue. Figure
25B depicts
four flutes, although three or any other number of flutes may suffice.
Figure 25C
depicts a nose having a convex curve for rapid dilation of an otomy in a short
space,
while Figure 25D shows a nose having a concave surface for gentle dilation of
friable
tissue. An offset swept nose, shown in Figure 25E, may be used because of its
asymmetry for better visibility to one side and may be used to assist in
manipulation by
using its asymmetry to minimally grasp tissue. Figure 25F shows a spherical
nose to
produce a short length for operation in limited space and to reduce the chance
of tissue
trauma. Combinations of these surfaces may also be advantageous, for example,
a nose
having a concave surface as depicted in Figure 25D may also posses flutes as
depicted in
Figure 25B. Other combinations may occur to one skilled in the art.
[0084] While preferred embodiments of the present invention have been shown
and described
herein, it will be obvious to those skilled in the art that such embodiments
are provided
by way of example only. Numerous variations, changes, and substitutions will
now occur
to those skilled in the art without departing from the invention.
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