Note: Descriptions are shown in the official language in which they were submitted.
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INSERTION DEVICE
AND METHOD OF USE
BACKGROUND
Technical I ield
(0002] The present disclosure relates to devices for accessing the abdominal
cavity. More
particularly, the present disclosure relates to apparatus and methods for
safely inserting an access
assembly into an abdominal cavity.
Background of Related Art
(00031 Assemblies configured for accessing a body cavity are known. Many of
such access
assemblies include a rigid cannula or sleeve that is inserted through an
incision created by a
surgeon in the tissue of a patient. The incision into the abdominal cavity may
be created by the
surgeon using a scalpel or other bladed instrument. Alternatively, the cannula
may include a
piercing tip, i.e., a blade or pointed distal end. Creating an incision
through skin into the
abdominal cavity using a scalpel risks damaging underlying internal organs.
Creating an incision
using a scalpel may also result in plane shifting of the tissue layers around
the incision. Plane
shifting of the tissue makes inserting of a non-cutting cannula through the
incision more difficult.
Although using a piercing cannula eliminates the possibility of tissue plane
shifting, forcing a
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caiunula through the abdominal wail and into the abdominal cavity may result
in puncturing of
internal organs and other peripheral tissue damage.
[0004] Therefore, it would be beneficial to have a device and method for
safely inserting an
access device through the tissue and into the abdominal cavity of a patient.
SUMMARY
[0005] An insertion device for safely creating an incision through tissue is
provided. The device
includes a tubular member and a cutting assembly. The tubular member includes
proximal and
distal ends and defines a passageway therethrough. The tubular member includes
at least one
longitudinal slot extending proximally from a distal end thereof The cutting
assembly includes
a blade assembly mounted on a distal end thereof. The distal end of the
cutting assembly is
configured for sliding reception within the passageway of the tubular member.
The blade
assembly includes at least one blade movable between a retracted position and
an extended
position. The blade assembly is configured such that the at least one blade is
received through
the at least one longitudinal slot of the tubular member when the at least one
blade is in an
extended position.
[0006] In one embodiment, the proximal end of the tubular member is configured
to facilitate
engagement by a user. The proximal end of the tubular member may include a
handle. The
blade assembly may include two blades. In another embodiment, at least one
blade is biased to
an extended position. A proximal end of the cutting assembly may be configured
to facilitate
engagement by a user. A cutting surface of the at least one blade may face
proximally when the
at least one blade is in an extended position. The tubular member may be
configured to receive
an access device thereabout. The cutting assembly may include a handle
configured to move the
at least one blade between the extended and retracted positions. The distal
end of the tubular
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member may include a piercing tip. The at least one blade may be configured to
pierce tissue
when in the retracted position. The longitudinal slot may extends
substantially along a length
thereof.
100071 Also provided is a method of creating an incision in tissue. The method
includes the step
of providing an insertion device having a tubular member and a cutting
assembly, wherein the
tubular member includes at least one longitudinal slot extending proximally
from a distal end
thereof and is configured to be received through tissue, wherein a blade
assembly of the cutting
assembly is configured to be slidingly received through the longitudinal slot
of the tubular
member. The method further includes the steps of inserting a distal end of the
tubular member
through tissue of a patient and into a body cavity, inserting the cutting
assembly through the
tubular member such that the at least one blade of the blade assembly is
received within the
longitudinal slot of the tubular member, retracting the cutting assembly
relative to the tubular
member to create an incision about the tubular member.
[00081 The method may further include the steps of inserting an access port
through the tissue
about the tubular member and removing the tubular member from within the
access port. The
method may also include the steps of moving the at least one blade from a
retracted position to
an extended position and retracting the cutting assembly from within the
tubular member. The
method may additional include the step of removing the access port from within
the tissue and
closing the incision.
BRIEF DESCRIPTION OF THE DRAWINGS
[00091 The accompanying drawings, which are incorporated in and constitute a
part of this
specification, illustrate embodiments of the disclosure and, together with a
general description of
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the disclosure given above, and the detailed description of the embodiment(s)
given below, serve
to explain the principles of the disclosure, wherein:
[(1010] FIG. 1 is as a separated perspective view of an embodiment of an
insertion device
according to the present disclosure;
(0011] FIG. 2 is a side view of the sleeve of the insertion device of FIG. 1
received through
tissue;
[0012] FIG. 3 is a side view of the insertion device of FIG. I with the
cutting assembly shown at
various stages of insertion through the sleeve;
[0013] FIG. 4 is a side view of the insertion device of FIG. I with the
cutting assembly shown at
various stages of withdrawal from the sleeve;
100141 FIG. 5 is a side view of an access assembly received about the sleeve
of the cutting
assembly of FIG. I and through tissue;
[0015] FIG. 6 is a side view of the access assembly of FIG. 5 received through
tissue;
[0016] FIG. 7 is a separated side view of an alternative embodiment of an
insertion device
according to the present disclosure with the blade assembly of the cutting
assembly in a first or
retracted position; and
[0017] FIG. 8 is a separated side view of the insertion device of FIG. 7 with
the blade assembly
in a second or deployed position.
DETAILED DESCRIPTION
(00181 With reference to FIG. 1, an apparatus for safely inserting an access
assembly into an
abdominal cavity of a patient is shown generally as insertion device 100.
Insertion device 100
includes a sleeve or cannula 110 and a cutting assembly 120. It is envisioned
that sleeve 110 and
cutting assembly 120 maybe separable, as shown, or cutting assembly 120 may be
operably
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secured within sleeve 110. Either or both of sleeve 110 and cutting assembly
120 may be
disposable or sterilizable for reuse.
[00191 Still referring to FIG. 1, sleeve 110 defines a tubular member 112
having proximal and
distal ends i i 2a, 112b and defining a passageway 113 therebetween. Although
shown having a
substantially cylindrical cross-section, tubular member 112 may include
alternative cross-
sectional configurations, including rectangular, oval and triangular. Tubular
member 112 may
be constructed metal, plastic or other suitable material. Tubular member 112
may be transparent,
translucent or otherwise configure for viewing cutting assembly 120
therethrough. As will be
discussed in further detail below, passage 113 is configured to receive at
least a distal end 120b
of cutting assembly 120 in a sliding manner. In one embodiment, tubular member
112 is
substantially similar in size to a large needle, i.e. Veress needle. In this
manner, member 112
may be received through the tissue of a patient with minimal force and with
minimal risk of
damaging internal organs. As will be discussed in further detail below,
tubular member 112 is
also slim enough to be received through a cannula 52 (FIG. 5) of an access
assembly 50.
Tubular member 112 is of a sufficient length to be received through the tissue
of the abdominal
wall of a patient and to extend through access assembly 50 when access
assembly 50 is received
thereabout.
[0020] With reference still to FIG. 1, proximal end I12a of tubular member 112
includes a
flange 117 thereabout. Flange 117 may facilitate engagement of tubular member
112 by a
surgeon. Alternatively, flange 117 may be configured for selective engagement
with a handle
member 118 (shown in phantom). As will be discussed in further detail below,
flange 117 is
sized to be received with cannula 52 of an access assembly 50. Proximal end
112a may instead
or may also include knurling, ridges or other suitable configuration to
facilitate engagement by a
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clinician during use. Proximal end 112a of tubular member 112 may instead, or
additionally
include a handle. Proximal end 112a may include a tapered outer surface to
facilitate reception
of access assembly "A" thereover during insertion of access assembly "A" into
the abdominal
cavity of the patient. Proximal end II 2a may also include a tapered inner
surface for facilitating
reception of cutting assembly 120 therethrough.
[00211 Still referring to FIG. 1, distal end 112b of tubular member 112
includes a piercing tip
114. As shown, piercing tip 114 is integrally formed with tubular member 112;
however, it is
envisioned that that piercing tip 114 may be removably or fixedly secured with
tubular member
112. Piercing tip 114 may be conical, as shown, or include one or more blade
members. Distal
end 112b of tubular member 112 defines a longitudinal slot 115 extending
across and proximally
along a length thereof Longitudinal slot 115 may extend through piercing tip
114_ Longitudinal
slot 115 extends proximally along tubular member 112 to a point distal of
proximal end 112a.
Tubular member 112 is configured such that a proximal end of longitudinal slot
115 extends
beyond tissue "T" after tubular member 112 has been received through tissue
"T" of a patient.
As will be discussed in further detail below, longitudinal slot 115 is
configured to slidingly
receive of a pair of cutting blades 132 of cutting assembly 120 as cutting
assembly 120 is
withdrawn through passage 113.
[0022] With reference still to FIG 1, cutting assembly 120 includes an
elongated shaft 122
having proximal and distal ends 122a, 122b. A handle member 124 is mounted on
proximal end
122a of elongated shaft 122 and a blade assembly 130 is operably mounted on
distal end 122b
thereof As shown, handle member 124 is integrally formed with elongated shaft
122; however,
handle member 124 may be removably or fixedly secured with elongated shaft
122. When
integrally formed with or fixedly secured to elongated shaft 122, and
therefore, not removable,
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handle member 124 must be small enough to be received through the cannula of
the access
assembly being used to access the abdominal cavity. Handle member 124 is
configured to
facilitate engagement of cutting assembly 120 by a user during reciprocation
of cutting assembly
120 within sleeve 110.
[0023] Still referring to FIG. 1, blade assembly 130 includes a pair of blade
members 132, 134.
Although shown including a pair of blades, it is envisioned that blade
assembly 130 may include
only a single blade or may include three or more blades. Blade members 132,
134 each include a
cutting surface 132a, 134a. Blades 132, 134 are pivotably secured to distal
end 122b of
elongated shaft 122. In a first or retracted position, blades 132, 134 (shown
in phantom) are
turned upwards to permit reception through tubular member 112. In a second or
extended
position, blades 132, 134 are pivoted outwardly, as indicated by arrows "A".
In the extended
position, cutting surfaces 132a, 134a of blades 132, 134, respectively, are
oriented in a proximal
direction. Blades 132, 134 may be spring loaded to bias blades 132, 134 into
the second position
once completely received through tissue "T". Alternatively, blades 132, 134
may be weighted
and/or otherwise configured to pivot outwardly to the extended position once
distal end 122b of
cutting assembly 120 has been completely received through tissue "T".
[0024] The use of insertion assembly 100 will not be described with reference
to FIGS. 2-5.
Initially, sleeve 110 is inserted through tissue "T", as indicated by arrow
"B", such that piercing
tip 114 of sleeve 110 is received within the abdominal cavity of a patient and
a sufficient portion
of longitudinal slot 115 is exposed to permit extension of blades 132, 134
when distal end 122b
of cutting assembly 120 is received through sleeve 110 (FIG. 3). Cutting
assembly 120 may be
received within sleeve 110 during insertion of sleeve 110 through tissue "T".
Alternatively, and
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as shown, cutting assembly 120 is inserted into sleeve 110 once sleeve 110 has
been properly
positioned through tissue "T".
100251 With reference now to FIG. 3, to be received within passageway 113 of
sleeve 110, blade
assembly 130 of cutting assembly 120 must be in a first or retracted position
(shown in
phantom). As discussed above, proximal end l 12a of sleeve 110 may include a
tapered inner
surface to facilitate reception of distal end 122b of cutting assembly 120
therein. To prevent
blades 132, 134 from prematurely extending to the second position, cutting
assembly 120 may be
rotated along its longitudinal axis, as indicated by arrow "C", within
passageway 113 sufficiently
such that blades 132, 134 are misaligned with longitudinal slot 115. In this
manner, a clinician
would be required to rotate cutting assembly 120 back to its initial
orientation to align blades
132, 134 of blade assembly 130 with longitudinal slot 115 for proper
deployment of blades 132,
134. Cutting assembly 120 is received through sleeve 110, as indicated by
arrows "D". Once
blades 132, 134 of blade assembly 130 clear tissue "T" and are aligned with
longitudinal slot
115, blades 132, 134 move from the first or retracted position to the second
or extended position,
as indicated by arrows "E".
[00261 With reference now to FIG. 4, retraction of cutting assembly 120
relative to sleeve 110,
as indicated by arrows "F", causes engagement of blade assembly 130 with
tissue "T". Cutting
assembly 120 is then retracted through sleeve 110 until blades 132, 134 of
blade assembly 130
completely cut through tissue "T". Cutting assembly 120 may then be removed
from sleeve 110
(not shown), or, as discussed above, cutting assembly 120 may remain secured
within sleeve
I 10. If removable handle 118 (FIG. 1) has been used to facilitate operation
of insertion device
100, handle 118 is disengaged from flange 117 (FIG. 1) and is removed from
sleeve 110 to
permit the passage of cannula 52 thereover.
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[00271 Turning now to FIG. 5, cannula 52 of an access assembly 50 is received
about proximal
end I 12a of sleeve 110 and is inserted through incision "I" created in tissue
"T", as indicated by
arrows "G". Cannula 52 may have a tapered distal end (not shown) to facilitate
reception
through tissue "T". As discussed above, caimula 52 of access assembly 50 may
also be received
about cutting assembly 120. Once cannula 52 has been received through tissue
"T", sleeve 120
is removed from within access assembly 50, in the direction indicated by arrow
"H".
[00281 With reference now to FIG. 6, access assembly 50 may then be used in a
conventional
manner. Access assembly 50 may include one or more seals "S" configured for
receiving
instruments therethrough in a sealing manner. Although shown used for
inserting access
assembly 50, it is envisioned that the devices and methods of the present
disclosure may be used
for inserting access assemblies of alternate sizes and configurations. Upon
completion of a
procedure, access assembly 50 is removed from tissue "T" and incision "I" is
closed in a
conventional manner.
[00291 Although shown and described as making a single pass through tissue
"T", thereby
creating a single incision "I", it is envisioned that cutting assembly 120 of
insertion device 100
may be passed through tissue "T" multiple times to make multiple incisions.
When used to make
multiple incisions in tissue "T", cutting assembly 120 is reinserted through
sleeve 110 in the
manner described above. Then, either cutting assembly 120 or cutting assembly
120 and sleeve
110 are rotated along a longitudinal axis thereof to reoriented blades 132,
134 of blade assembly
130 relative to tissue "T" and initial incision "I". Cutting assembly 120 is
then retracted in the
manner described above. This process may be repeated one or more times to
create one or more
additional incisions through tissue "T", thereby easing the force required the
insertion of cannula
"C" about sleeve 110 and through tissue "T".
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[0030] With reference now to FIGS. 7 and 8, an alternative embodiment of an
insertion device
according to the present disclosure is shown generally as insertion device
200. Insertion device
200 is substantially similar to insertion device 100 described hereinabove and
will only be
described as relates to the differences therebetween. Insertion device 200
includes a sleeve 210
and a cutting assembly 220.
[0031] With reference still to FIGS. 7 and 8, sleeve 210 of insertion device
200 defines a tubular
member 212 having proximal and distal ends 212a, 212b and defining a
passageway 213
therebetween. Proximal end 212a of tubular member 212 includes handle assembly
218. Handle
assembly 218 includes a pair of handle member 218a, 218b that are pivotably
connected to
proximal end 212a of tubular member 212. Handle members 218a, 218b are
configured to
facilitate engagement of tubular member 212 by a user. Handle members 218a,
218b are
configured to pivot, in the direction indicated by arrows "J", towards tubular
member 212 to
reduce the profile handle assembly 218, thereby permitting the passage of
cannula 52 of access
assembly 50 thereabout. is removable to permit an access assembly to be
received about tubular
member 212. Distal end 212b of tubular member 212 includes a plurality of
longitudinal slots
215 formed along a length thereof
[0032] Still referring to FIGS. 7 and 8, cannula assembly 220 includes an
elongated shaft 222
having proximal and distal ends 222a, 222b. Elongated shaft 222 includes a
handle assembly
224 operably mounted on proximal end 222a thereof and a blade assembly 230
operably
mounted on distal end 222b thereof. Handle assembly 224 includes a fixed
handle 226 and a
movable handle 228. Movable handle 228 is operably connected to blades 232,
234 of blade
assembly 230 and is configured to move blades 232, 234 between retracted (FIG.
7) and
extended positions (FIG. 8). An activation shaft 229 extends the length of
elongated shaft 222
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and operably connects movable handle 228 with blade assembly 230. Movement of
movable
handle 228 towards fixed handle 226, in the direction indicated by arrows "K",
causes blades
232, 234 of blade assembly 230 to pivot upwards, in the direction indicated by
arrows "L", into a
extended or deployed position. It is envisioned that in alternate embodiments,
blades 232, 234
may be spring loaded in one of the retracted or extended positions and
operation of moveable
handle 228 causes the respective extension or retraction of blades 232, 234.
[00331 With continued reference to FIG. 7, in the retracted position, blades
232, 234 of blade
assembly 230 extend outwardly along elongated shaft 222. In this retracted
position, blade
assembly 230 is configured to pierce tissue "T". As such, when in the
retracted position, blade
assembly 230 may be used to pierce tissue "T" during insertion of sleeve 210
through tissue "T".
In this manner, tubular member 212 may have a blunt or atraumatic distal end
212b.
[00341 With reference still to FIGS. 7 and 8, insertion device 200 operates in
a manner similar to
insertion device 100 described hereinabove and will only be described as
relates to the
differences therebetween. As discussed above, when received through sleeve
210, blade
assembly 230 may be used to pierce tissue "T". Upon complete reception of
sleeve 210 and
distal end 222b of cutting assembly 220 through tissue "T", moveable handle
228 is
approximated towards fixed handle 226 to move blades 232, 234 from the
retracted position
(FIG. 7) to the extended position (FIG. 8). Once blade assembly 230 has been
completely
received through tissue "T", moveable handle 228 may be approximated away from
fixed handle
226 to cause the retraction of blades 232, 234 and pen-nit the withdrawal of
cutting assembly 220
from sleeve 210.
[00351 Although the illustrative embodiments of the present disclosure have
been described
herein with reference to the accompanying drawings, it is to be understood
that the disclosure is
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not limited to those precise embodiments, and that various other changes and
modifications may
be effected therein by one skilled in the art without departing from the scope
or spirit of the
disclosure. For example, the cutting assembly may have a removable or
collapsible handle to
facilitate reception of an access assembly thereover and thereabout.
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