U.S. patent application number 13/365818 was filed with the patent office on 2013-02-07 for dual insufflation and wound closure devices and methods.
This patent application is currently assigned to Suture Ease, LLC. The applicant listed for this patent is Scott Heneveld. Invention is credited to Scott Heneveld.
Application Number | 20130035702 13/365818 |
Document ID | / |
Family ID | 47627436 |
Filed Date | 2013-02-07 |
United States Patent
Application |
20130035702 |
Kind Code |
A1 |
Heneveld; Scott |
February 7, 2013 |
DUAL INSUFFLATION AND WOUND CLOSURE DEVICES AND METHODS
Abstract
A dual functioning instrument set, comprising a needle and
guide, has not only the capabilities to enter and insufflate the
abdominal cavity but also the ability of a suture passer to carry
and retrieve suture for closure of the incision sites at the end of
the procedure. The needle contains a deployable snare that is used
to pass and retrieve suture. The guide is used to repeatedly locate
the needle relative to the inner abdominal wall allowing for
consistent placement of sutures. For insufflation purposes,
obturator tips having different distal structures are provided for
shielding the sharp needle tip after insertion through a body
wall.
Inventors: |
Heneveld; Scott; (Whitmore,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Heneveld; Scott |
Whitmore |
CA |
US |
|
|
Assignee: |
Suture Ease, LLC
Whitmore
CA
|
Family ID: |
47627436 |
Appl. No.: |
13/365818 |
Filed: |
February 3, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61574455 |
Aug 4, 2011 |
|
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|
Current U.S.
Class: |
606/144 ;
606/185 |
Current CPC
Class: |
A61B 17/0485 20130101;
A61B 17/0482 20130101; A61B 2017/00867 20130101; A61B 2017/00637
20130101; A61B 2017/00663 20130101; A61B 2017/2911 20130101; A61B
2017/3484 20130101; A61B 17/0057 20130101 |
Class at
Publication: |
606/144 ;
606/185 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61B 17/34 20060101 A61B017/34 |
Claims
1. A wound closure apparatus for use in connection with a surgery
involving a body cavity having an inner wall, comprising: a
puncture closure device including a shaft and a retractable snare
disposed adjacent to a shaft distal end; a guide configured to
direct the puncture closure device into the body cavity, the guide
including a radially expandable securing mechanism configured to be
secured to the inner wall and a track for receiving the puncture
closure device.
2. The apparatus of claim 1, wherein the guide comprises: a tubular
barrel including an axis, a barrel proximal portion defining an
entry, and a barrel distal portion defining an exit; and a plunger
coupled to the securing mechanism and axially movable with respect
to the barrel, the plunger defining at least one track that is in
communication with both the entry and the exit when the plunger is
in an operative position.
3. The apparatus of claim 1, wherein: the track comprises a first
track having a first guide exit; and the guide comprises a second
track having a second guide exit substantially opposite to the
first guide exit.
4. The apparatus of claim 3, wherein: the first guide exit and the
second guide exit are configured to direct the puncture closure
device to traverse the inner wall at an equal lateral distance from
the guide.
5. The apparatus of claim 1, wherein: the guide comprises a distal
portion having a sidewall defining a side opening; and the closure
device exits the guide through the side opening.
6. The apparatus of claim 1, wherein: the path comprises a first
path; and the guide comprises a second path that is off-axis with
respect to the guide axis and non-parallel to the first path, the
second path being configured to direct the closure device to exit
the guide through a second side opening.
7. The apparatus of claim 6, wherein the guide comprises: a barrel
having a side entry and a side exit; and a plunger axially movable
with respect to the barrel, the plunger defining a track that is
communication with the side entry and side exit when the plunger is
in an operative position, wherein the track, side entry and side
exit collectively form the path.
8. The apparatus of claim 7, wherein the radially expandable
securing mechanism is moved to an expanded configuration when the
plunger is in the operative position.
9. The apparatus of claim 1, wherein the radially expanding
securing mechanism comprises a living hinge.
10. An obturator apparatus for use in connection with a surgery
involving penetration through a body wall, comprising: a shaft
including a sharp needle tip having a needle peak at a distal end;
an obturator comprising a pointed yet blunt distal obturator peak
movable between a proximal rest position and a distal operative
position distal to the needle peak, the obturator peak being biased
to the operative position; wherein the obturator peak in the rest
position is located less than one mm from the sharp needle tip.
11. The apparatus of claim 10, wherein: the sharp needle tip
comprises a first cutting edge and a second cutting edge, both the
first and second cutting edges leading distally to the needle peak;
the obturator comprises a first ramped surface and a second ramped
surface, both the first and second ramped surfaces leading distally
to the obturator peak, wherein the first ramped surface is
positioned proximally to the first cutting edge and the second
ramped surface is positioned proximally to the second cutting edge
even where the obturator peak distally traverses the needle
peak.
12. The apparatus of claim 13, wherein the first and second ramped
surfaces are positioned proximally to the first and second cutting
edges, respectively, when the obturator peak distally passes the
needle peak up to 5 mm.
13. The apparatus of claim 10, wherein the obturator comprises a
generally triangular shape with ramped portions tapering distally
to the obturator peak.
14. An obturator apparatus for use in connection with a surgery
involving penetration through a body wall, comprising: a shaft
including a sharp needle tip at a distal end, the sharp needle tip
comprising at least one cutting edge extending distally to a
pointed needle peak; an obturator comprising a pointed yet blunt
distal obturator peak movable between a proximal rest position and
a distal operative position distal to the needle peak, the
obturator tip being biased to the operative position, the obturator
comprising at least one ramped surface extending from a base to the
obturator peak, wherein the ramped surface is positioned proximally
to the cutting edge when the obturator peak distally traverses the
needle peak up to 5 mm.
15. The apparatus of claim 14, wherein: the obturator peak is
spaced less than 1 mm from the needle peak when the obturator peak
is in the rest position.
16. The apparatus of claim 14, wherein the obturator peak defines a
tip surface area less than 0.1 square mm.
17. The apparatus of claim 14, wherein the obturator comprises a
generally triangular shape with ramped portions tapering distally
to the pointed distal tip.
18. The apparatus of claim 14, wherein: the at least one cutting
edge comprises a first cutting edge; the sharp needle tip further
comprises a second cutting edge extending distally to the needle
peak; the at least one ramped surface comprises a first ramped
surface; and the obturator further comprises a second ramped
surface extending distally to the obturator peak.
19. A method of shielding a sharp needle tip of a surgical
instrument after insertion through a body wall, comprising:
distally biasing an obturator having an obturator body and a
obturator peak to an operative position where the obturator peak is
distal to a needle peak of the sharp needle tip; limiting a
proximal movement of the obturator with respect to the sharp needle
tip such that the obturator peak is never positioned more than 1 mm
from the needle peak upon insertion of needle tip through the body
wall; and automatically moving the obturator peak distally past the
needle peak upon a drop in resistance from the body.
20. The method of claim 19, wherein the step of automatically
moving the obturator peak distally past the needle peak upon the
drop in resistance from the body comprises exposing at least one
cutting edge of the needle tip while the obturator peak is distal
to the needle peak.
Description
RELATED APPLICATIONS
[0001] This application relates to, claims priority from, and
incorporates herein by reference, as if fully set forth, U.S.
Provisional Patent Application Ser. No. 61/574,455 filed on Aug. 4,
2011 and entitled "INSUFFLATION/CLOSURE DEVICE AND GUIDE."
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to surgical instruments for
approximation, ligation and fixation of tissue using a suture, and
particularly to the approximation of tissue separated by means of
an endosurgical trocar being inserted into a body cavity. This
invention also relates to the access to an anatomic cavity or space
during a medical procedure, and particularly to insufflations of
the abdominal cavity for laparoscopic surgery.
[0004] 2. Description of Prior Art and Related Information
[0005] Numerous methods currently exist for performing laparoscopic
procedures. One of the more commonly used methods is known as
closed laparoscopy which utilizes a sharp needle (eg. Veress
needle) to puncture the abdominal wall and insufflate the abdominal
cavity with an inert gas such as carbon dioxide through the needle.
This process of insufflating the cavity separates the abdominal
wall from the underlying organs creating a gap for the surgeon to
work within. A trocar/cannula system is then used to maintain the
insufflated cavity and provide a working portal for which
instruments can be passed into and out of the abdominal cavity to
perform various surgical procedures. When the procedure is
completed, it is desirable for the surgeon to close the incision
site using suture material to minimize the risk of adverse
post-operative events.
[0006] Insertion of the needle into the abdomen is performed
without any visual aid to facilitate location of the sharp
needlepoint. In order to reduce the probability of inadvertent
penetration of delicate internal organs in this "blind" procedure,
the sharp insufflation needle contains a rounded member disposed
within the lumen of the needle, and biased by a spring to an
extended position beyond the needle tip.
[0007] The conventional insufflation needle also includes a means
for introducing an inert gas into the abdominal cavity through a
channel or opening within the lumen of the needle. A luer or other
quick connect type adapter is typically housed within the proximal
handle of the needle to connect a gas source to the needle. The gas
then travels from the handle through the length of the needle and
exits into the body cavity from the distal tip of the needle.
[0008] One of the post-operative complications associated with this
procedure is the incidence of trocar site hernias, where a portion
of an organ or fatty tissue protrudes out through the hole in the
abdominal wall created by the trocar access portal. It is believed
that improper closure, or complete lack of closure, of the incision
site at the peritoneum is the primary cause of these hernias which
form during the post-operative period ranging from several days to
several months following the procedure. Traditional methods of
wound site close require an additional set of instruments (suture
passers, guides, etc.) to be introduced into the surgery. A number
of these instruments have been previously disclosed. However, the
prior art related to trocar wound site closure instrumentation are
typically cumbersome to use and do not provide for a simple,
reproducible, and reliable means of closing the wound site.
[0009] In order to safely perform a closed laparoscopic procedure,
both a Veress needle and a suture passing device may be purchased
and used for the completion of the procedure. This can be both
expensive and create additional waste, unnecessarily. The present
invention comprises a combination device that can provides the
multiple functions that were not previously offered in the prior
art.
BRIEF SUMMARY OF THE INVENTION
[0010] In accordance with the present invention, structures and
associated methods are disclosed which address these needs and
overcome the deficiencies of the prior art. A preferred system
according to the invention comprises a surgical instrument as well
as a surgical instrument set that may have one or two basic
functions.
[0011] First, the system may have the capabilities to provide entry
into the abdominal cavity and subsequently insufflating the cavity
for use in laparoscopic surgical procedures. In the preferred
embodiment, the system comprises a needle apparatus having a sharp
needle tip and an insufflation channel to facilitate penetration
into the abdominal cavity and insufflation. A unique obturator tip
is provided to shield the sharp needle tip upon insertion into the
cavity.
[0012] Second, the system may have the capabilities to close the
fascial/peritoneal layer at the trocar wound site in a quick,
consistent and reproducible manner at the end of the procedure. To
facilitate closure of the wound, the system includes a guide used
in combination with the same needle apparatus which also serves as
a suture engaging device. In the preferred embodiment, the system
would have both of the capabilities described above.
[0013] The needle apparatus may be able to function like a suture
passer, in that it has the ability to carry and retrieve suture
through tissue layers for suturing closed the wound site. The
needle also has the ability to insufflate the abdomen during the
laparoscopic procedure. The needle apparatus may comprise several
components including: a handle, actuation mechanisms, means for
connecting the needle to a gas line, a deployable snare, a needle
tip, a hollow inner shaft inside the needle tip, and a safety
mechanism plunger disposed within the needle tip.
[0014] In a preferred embodiment, a handle at the proximal end of
the needle apparatus allows for single-handed or double-handed use.
An actuator mechanism is disposed adjacent to the handle and
configured for the deployment and retraction of the snare used to
pass and retrieve the suture material. The preferred actuator
mechanism may include a first actuator comprising sliding trigger
that translates along the long axis of the handle that locks the
snare against the needle when it is in one position, and partially
deploys the snare loop when the trigger is set into a second
position. This trigger may be spring loaded to ease the deployment
of the snare from within the needle. A second actuator may comprise
a sliding plunger, or extender rod, that exits from the proximal
end of the handle and translates along the long axis of the handle.
This extender rod would be used to fully deploy the snare. The
handle and actuator means may be constructed from metals (such as
stainless steel, titanium, or aluminum) or plastics (such as
polyacetal, nylon, PEEK, or polycarbontae), or any combination of
the two.
[0015] The snare accomplishes the suture passing capabilities of
the needle apparatus. As previously stated, the snare may be
actuated between three different positions: (1) completely
retracted into the needle shaft, (2) partially deployed, and (3)
fully deployed. When the snare is completely retracted into the
needle shaft, the suture material would be captured between the
snare and the inner shaft of the needle apparatus. When the snare
is partially deployed, a small loop section of the snare would be
exposed. This partial deployment of the snare may allow for certain
simple suture passing steps to be accomplished without having to
fully deploy the snare. When the snare is fully deployed, a larger
loop section of the snare would be exposed that is significantly
greater in size than the partially deployed loop. The fully
deployed snare would be most useful when trying to retrieve the
free end of the suture within the body cavity by providing a large
target in which the suture can be grasped. Optimally, the snare
would be deployed perpendicular to the long axis of the needle to
simplify the suture passing process, however the snare may be
deployed over a broader range of angles from the needle ranging
from 0-180 degrees relative to the long axis of the needle. The
snare would most optimally be manufactured from a shape memory
alloy material such as Nitinol, but may also be made from other
metallic or polymeric wire materials.
[0016] A long outer needle shaft may be connected to the proximal
handle and extends distally over a length that may range from 1-15
inches. The outer needle shaft may have a sharp tip, or needle
peak, at the distal-most point to ease the insertion of the needle
through the various tissue layers. The outer shaft may house an
inner shaft that has a hollow, unobstructed inner lumen. This
unobstructed inner lumen may allow for the passage of an inert gas
for insufflation of the abdomen. A luer connector or other quick
connect type device may be disposed on the proximal handle to
provide an entry passageway for the gas to enter into the needle.
The unobstructed inner lumen may also provide a passageway for the
snare material to travel up through the needle portion and into the
handle so that it can be connected to the actuator mechanism.
[0017] The distal-most end of the inner shaft may have a blunt
obturator attached to the tip. The entire inner shaft may be spring
loaded to allow for the blunt obturator to translate away from the
tip of the needle when it is loaded, and passively travel back to
the tip of the needle when it is unloaded. The obturator spring may
be housed within the handle. The spring loaded obturator would
serve as a safety mechanism for protecting the internal organs
within the abdomen. The inner and outer needle shafts would
optimally be constructed from metallic tubes such as stainless
steel. The obturator tip may be manufactured from a number of
different materials including, but not limited to, metals and
plastics.
[0018] In another preferred embodiment, the needle apparatus may
have a single actuator to control the snare between a fully exposed
position and a fully retracted position. The single actuator may
comprise a lockout trigger similar to the first preferred
embodiment, except that the lockout trigger can proximally
translate with respect to the housing a greater distance so as to
proximally push the slide rod connected to snare all the way to
fully expose the snare.
[0019] The guide apparatus may be used to guide the needle through
the abdominal wall in a repeatable manner. The guide may comprise
an outer housing, or barrel, and an inner plunger used to actuate
the guide.
[0020] The barrel may have two or more counterforce tabs, or
extension tabs, at the proximal end to aid in the handling and
insertion of the guide into the abdomen. These counterforce tabs
may provide surfaces for the user to utilize two fingers to hold
the barrel. For example, the index finger would be placed under one
tab, and the middle finger is placed under the second tab. The
thumb may then be used to actuate the proximal surface of the
plunger and secure the guide within the user's grasp.
[0021] The distal end of the barrel would have a blunt tip to
minimize the potential of harm or damage to the adjacent tissue
during insertion. Just proximal to the blunt tip the barrel may
have a deformable securing mechanism that may have two
configurations. The first configuration of the deformable section
would be aligned with the wall of the outer housing such that the
structure has a slender, continuous outer diameter. This first
slender position would be utilized during the insertion of the
guide into the cavity. The deformable section can then be deformed
to a second flared out position where securing mechanism extends
beyond the outer diameter of the outer housing. The securing
mechanism, comprising expanding feet in the preferred embodiment,
is used to place the guide against the inner wall of the abdomen to
provide a reference point for the needle to be repeatedly placed in
the same location of the abdominal wall that is required to be
sutured for closure of the portal site.
[0022] Along the central portion of the shaft of the barrel are
multiple slots in the shaft wall. These slots serve to provide a
passageway for the needle apparatus to travel to the appropriate
location of the abdominal wall for the placement of sutures. Two
slots may be placed opposing each other near the proximal end of
the shaft, and two additional slots may be placed opposing each
other near the distal end of the shaft. The proximal slots may
serve as the entry points for the needle, while the distal slots
may serve as the exit points for the needle. The guide also
includes axial wings, which may be extruded, extending away from
the central axis of the shaft to aid in pushing away fatty tissue
that is undesirable tissue for the suture to pass through.
Particularly if these features are located near the distal slots
where the needle is exiting the guide, the risk of suturing
unwanted fatty tissue is minimized.
[0023] The guide may comprise a plunger slidably disposed within
the barrel. The plunger may be used to actuate the expanding feet,
comprising living hinges in the preferred embodiment, on the
barrel. This plunger may be spring loaded such that the plunger is
biased to the radially expanded position. When the plunger is in
the biased flared out position, the feet would be in the expanded
position. When the plunger is pressed to the first position, the
feet would be retracted back to a position that aligns the outer
diameter of the outer housing in a continuous slender fashion. The
plunger may be attached to the distal end of the barrel. Along the
shaft of the plunger would be through holes that align with the
outer housing slots to accommodate passage of the needle apparatus
through the guide. These through holes may intersect each other, or
may be offset such that the holes do not intersect one another. All
of the guide components would preferably be made from an injection
moldable polymer (such as polycarbonate, polyacetal, nylon, or ABS)
but the guide may be machined from other plastics and/or
metals.
[0024] The basic procedural steps for abdominal entry and
insufflation of the cavity may flow as follows. The needle is used
to enter the abdominal cavity using standard closed laparoscopic
techniques. A gas line is connected to the handle allow for an
inert gas to be passed into the abdominal cavity. The inert gas is
then turned on until the cavity reaches an appropriate level of
insufflation to allow for the procedure to be performed with
appropriate visualization. The needle is then removed, and a trocar
is inserted into the puncture site to perform the procedure.
[0025] The basic procedural steps of the utilization of the
suturing system may flow as follows. At the end of the surgical
procedure, the trocar is removed and the needle guide is placed
into the wound. The expandable feet are deployed against the inner
wall of the peritoneum. A short end of a suture tail is captured
within the snare, while outside the body cavity. Then the needle
apparatus is advanced through the needle guide and tissue layers
into the abdominal cavity, carrying the suture with it. The snare
is expanded to release the suture. The needle apparatus is then
removed from the guide and reinserted through the opposite side of
the guide on the opposite side of the puncture wound. When the
distal end of the assembly is exposed in the abdominal cavity, the
snare is expanded to provide an easy target to secure the existing
suture tail inside the abdominal cavity. Once the suture has been
secured within the wire snare, the needle apparatus is removed to
outside the body cavity, bringing the suture along with it. The
suture is then released from the snare wire. The suture is in place
to be tied with a knot to provide closure the trocar puncture site.
This suturing procedure may also be accomplished without the use of
the needle guide.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIGS. 1A-1B show a preferred embodiment of a needle guide in
an actuated position with a securing mechanism not expanded;
[0027] FIGS. 1C-1D show the preferred needle guide in the resting
position with the securing mechanism expanded;
[0028] FIG. 2 is a cross sectional view of the preferred needle
guide showing the needle tracks;
[0029] FIG. 3 shows the guide as it is placed through a section of
tissue with the expanded feet resting against the inner peritoneal
wall;
[0030] FIG. 4A shows an oblique view of the needle with the snare
fully retracted into the needle;
[0031] FIG. 4B shows an oblique view of the needle with the snare
partially extended;
[0032] FIG. 4C shows an oblique view of the needle with the snare
fully extended;
[0033] FIG. 5A is a cross-sectional view of the needle housing
showing the internal components of the needle corresponding to the
fully retracted snare position in FIG. 4A;
[0034] FIG. 5B is a cross-sectional view of the needle
corresponding to the partially extended snare position shown in
FIG. 4B;
[0035] FIG. 5C is a cross-sectional view of the needle
corresponding to the fully extended snare position shown in FIG.
4C;
[0036] FIG. 6A is a detail view of the distal tip of the needle
with the spring loaded safety obturator;
[0037] FIG. 6B is a cross-sectional view of the distal tip of the
needle;
[0038] FIG. 6C is a close-up perspective of the housing of the
needle apparatus showing a preferred lockout trigger;
[0039] FIG. 7A is an oblique view of a standard retractable
obturator tip design;
[0040] FIG. 7B demonstrates the relative distance from the tip of
the needle to the tip of the obturator;
[0041] FIG. 7C is an oblique view of an alternative retractable
obturator tip design;
[0042] FIG. 7D demonstrates the relative distance from the tip of
the needle to the tip of the alternative obturator;
[0043] FIGS. 8A-C show various alternative embodiments of the
handle portion of the needle;
[0044] FIG. 9 shows the suture being loaded into the snare;
[0045] FIG. 10 shows the needle passing suture through the guide
and tissue;
[0046] FIG. 11 shows the needle being used to retrieve the free end
of the suture;
[0047] FIG. 12 illustrates a preferred method for insufflating a
body cavity and engaging a suture to close a wound using a single
device; and
[0048] FIG. 13 illustrates a preferred method for closing a
surgical wound using a system comprising preferred embodiments of a
guide and a suture engaging device disclosed above.
[0049] FIG. 14 is a perspective view of a second preferred
embodiment of a needle apparatus comprising a single actuator
mechanism with the snare in the fully exposed position;
[0050] FIG. 15 is a perspective view of the second preferred needle
apparatus showing the snare in the fully retracted position.
[0051] The various embodiments of the invention can now be better
understood by turning to the following detailed description wherein
illustrated embodiments are described. It is to be expressly
understood that the illustrated embodiments are set forth as
examples and not by way of limitations on the invention as
ultimately defined in the claims.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE OF
INVENTION
[0052] In a preferred embodiment, a system 100 is provided for
insufflating an abdominal cavity and closing a trocar wound site.
The system 100 comprises a guide and a single device having dual
functionalities of insufflation and suture engagement.
[0053] FIGS. 1A-1D illustrate a preferred embodiment of a surgical
guide apparatus, or simply guide, 10 for directing surgical
instruments through a body wall. The guide 10 may be particularly
useful for directing suturing devices used in closing wounds, or
openings through body walls, made in surgical procedures to access
internal body cavities. The guide 10 comprises a radially
expandable securing mechanism 26 at a distal end 16 that is
configured to secure the guide 10 to the inner wall of a body
cavity, such as the peritoneum surrounding an abdominal cavity in
the case of a laparoscopic procedure.
[0054] In FIG. 1A, a plunger 21 is slidably disposed within a
barrel 23 having a barrel proximal portion 15 and a barrel distal
portion 17. The plunger 21 and barrel 23 may be connected to each
other by deformable locking tabs 29 at a distal end 12 of the
plunger 21, that lock within the blunt distal end cap 30 of the
barrel 23. At a proximal end 14 of the plunger 21 is an actuation
surface 22 that may be flat or contoured that allows for the
plunger to be pressed down to slide the plunger 21 within the
barrel 23.
[0055] As the plunger 21 translates with respect to the barrel 23,
the radially expandable securing mechanism 26 at the distal end 16
of the barrel 23 moves between two positions of radially expanded,
or flared out, as shown in FIGS. 1C and 1D, and radially
contracted, or slender, as seen in FIGS. 1A and 1B. In the
preferred embodiment, the internal cavity securing mechanism 26
comprises two or more expanding feet 26 radially spaced apart from
each other. The expanding feet 26 each preferably comprise a living
hinge section composed of the same material as the barrel 23, where
the material is cut thin at specific locations allowing for the
material to flex. It is to be expressly understood that the
radially expandable securing mechanism 26 may comprise a variety of
structures capable of moving between slender and flared-out
configurations. Radially adjacent to the expanding feet 26 may be
one or more distally extending stop tabs 31 on the barrel, as shown
in FIGS. 1A and 1B. The stop tabs 31 are configured to provide a
mechanical stop for the distal end cap 30 of the barrel 23 to
collide against to prevent the plunger 21 from over-translating and
potentially damaging the thin section of material within the
expanding feet 26.
[0056] In FIGS. 1B and 1D, wwo counterforce tabs, or extension
tabs, 24 are preferably disposed near a proximal end 18 of the
barrel 23 and configured to be grasped with one or more fingers
while the thumb may be used to press down on the actuation surface
22. The counterforce tabs 24 facilitate ease of handling of the
guide 10. The guide 10 comprises at least one needle entry slot 27
in the barrel proximal portion 15 preferably distal to the
counterforce tabs 24.
[0057] In the preferred embodiment, the guide 10 provides two
different, diagonal pathways for a needle apparatus and thus
comprises first and second entry slots 27a, 27b as more clearly
shown in FIG. 2. These barrel entry slots 27a, 27b provide for
entry points for a suture engaging device, or needle apparatus, to
enter the guide 10. The two barrel entry slots 27a, 27b are
preferably axial in that they 27a, 27b extend over a length that is
parallel to a long axis "A" of the guide 10. The barrel entry slots
27a, 27b are preferably equally spaced apart in a radial manner
from each other, i.e., 180 degrees apart if there are two slots,
120 degrees apart if there are three slots, etc. The guide 10
comprises barrel exit slots 28a, 28b equal in number to the entry
slots 27a, 27b and located distally along the barrel 23.
[0058] The guide 10 is useful for directing suture engaging
devices, and particularly a preferred embodiment of a suture
engaging device discussed further below and identified simply as a
needle apparatus. Accordingly, the guide 10 preferably comprises
two pathways diagonal to each other and oriented to direct a needle
apparatus to both a first internal location to carry and release a
suture, and a second internal location preferably horizontally
opposite to the first internal location in order to facilitate
retrieval of the suture using the preferred suture engaging device
discussed further below.
[0059] FIG. 2 is a cross sectional view of the guide 10 showing the
preferred dual pathways that a surgical instrument, such as a
needle apparatus or suture engaging device, can take through the
guide 10. The guide 10 preferably comprises first and second
plunger entry points 33a, 33b adjacent to the plunger proximal end
14 and first and second plunger exit points 34a, 34b adjacent to
the plunger distal end 16. A first tunnel, or first track, 35a
defines a first track axis "A1" and is in communication with both
the first plunger entry 33a formed on a first side of the plunger
21 and the first plunger exit 34a which is preferably formed on an
opposing side of the plunger 21. The first entry 33a, first tunnel
35a and first exit 34a collectively form a first needle pathway
that is preferably oblique to the guide axis "A."
[0060] A second tunnel, or second track, 35b is in communication
with both the second plunger entry 33b formed on the second side of
the plunger 21 and the second plunger exit 34n which is preferably
formed on the opposing first side of the plunger 21. Thus, the
first and second tunnels 35a, 35b are preferably off-axis and
diagonal to each other. These tunnels 35a, 35b may intersect each
other as shown, or have their paths offset such that they do no
intersect. The second entry 33b, second tunnel 35b and second exit
34b collectively form a second needle pathway oblique to the guide
axis "A" and diagonal to the first pathway. The plunger 21 on the
guide 10 may be passively controlled by a spring 32 that is housed
between the plunger 21 and barrel 23 to keep the guide in the
biased open position with the feet 26 expanded. It will be
appreciated that biasing the guide 10 to this hands-free operative
configuration with the feet 26 expanded and the pathways open frees
up both of the surgeon's hands to work with other instruments when
the guide 10 is inserted into the trocar wound.
[0061] The barrel needle exit slots 28 may be surrounded by up to
two opposing tissue distraction wings 25. These wings 25 help
separate unwanted tissue away from the needle exit slots 28.
[0062] In the case of a laparoscopic surgery involving use of a
trocar, the guide 10 may be placed through the tissue layers of the
open trocar wound site as shown in FIG. 3 after the trocar has been
removed. This tissue may consist of the skin 36, adipose tissue 37,
muscle and fascia 38 and peritoneal layer 39. Prior to insertion of
the guide 10, the feet 26 are in the slender, non-expanded position
with the plunger 21 pressed. Once the distal end 12 of the guide 10
is appropriately placed under the peritoneal layer, the plunger 21
is released and spring-biased to the operative configuration
causing the living hinges 26 to expand as shown in FIG. 3. With the
radially expandable securing mechanism 26 in the flared out
configuration, the guide 10 can then be pulled up against the inner
peritoneum to align the needle tunnels 35a, 35b with the
appropriate tissue layers for suturing. The plunger entry holes 33
for the needle apparatus are positioned above the outer skin layer
36, while the plunger exit holes 34 for the needle apparatus should
be positioned just above the muscle and fascia layer 38 to be
sutured. The tissue distraction wings 25 aid in pushing away
unwanted adipose 37 or fatty tissue from the needle exit holes 34
such that primarily muscle and fascia tissue 38 is sutured.
[0063] FIGS. 4A-4C illustrate a preferred embodiment of a dual
insufflation and wound closure device, or simply needle apparatus,
49 which may be used in connection with the preferred guide
discussed above. The needle apparatus 49 serves the dual purposes
of insufflating an abdominal cavity as well as engaging and passing
suture to close a wound.
[0064] The needle apparatus 49 includes a puncture closure
mechanism, or suture engaging mechanism, preferably comprising a
deformable snare 57 movable between three functional positions as
depicted in FIGS. 4A-4C. The suture snare 57 may be fully retracted
within a needle shaft assembly, or simply needle shaft, 55 (FIG.
4A), partially extended (FIG. 4B) to a temporary fixed position, or
fully extended (FIG. 4C). The snare 57 may comprise a single wire
or, preferably, a plurality of interwoven strands to reduce strain
and allow for a greater angle of flexure. The snare may also
include in curvature in shape to reduce stain and prevent the snare
from experiencing permanent deformation. In the preferred
embodiment, the deformable snare 57 is composed of a shape memory
alloy material such as Nitinol, but may also be made from other
metallic or polymeric wire materials.
[0065] In the preferred embodiment, a rod assembly, or slide rod,
53 is coupled to the snare 57. The rod assembly 53 comprises a rod
distal portion 53-1 connected to the snare 57 and disposed within
the shaft assembly 55 and a rod proximal portion 53-2 protruding
out from the housing proximal portion 46. In the preferred
embodiment, the rod distal portion 53-1 is integral with the rod
proximal portion 53-2, although the two rod portions 53-1, 53-2 may
comprise separate pieces axially coupled to each other.
[0066] In the preferred embodiment, a dual actuator mechanism 45
disposed adjacent to a proximal end of the needle housing 50
controls the position and configuration of the snare 57. The dual
actuator mechanism 45 preferably comprises a first actuator 53
configured to move the snare 57 between the fully exposed position
and the fixed partially exposed position, and a second actuator 52
configured to move the snare 57 between the fixed partially exposed
position and a fully retracted position. The needle housing 50
comprises a housing proximal portion 46 and a housing distal
portion 47.
[0067] The first actuator 53 preferably comprises a slide rod, or
extender rod, 53, axially protruding out from the housing proximal
portion 46. A knob 54 may be coupled to the proximal end of the rod
proximal portion 53-2 to facilitate use of the first actuator 53.
In the preferred embodiment, the slide rod 53 is slidably disposed
within the needle housing 50, and coupled to the snare 57 that
travels through the needle housing 50 and needle shaft 55 to the
distal tip of the needle 56. When the slide rod 53 is fully pushed
into the needle housing 50 in a distal direction, the snare 57 is
fully extended (as in FIG. 4C).
[0068] Since the deformable snare 57 is composed of a material
having shape memory characteristics, the snare 57 is preconfigured
to form a loop that is substantially perpendicular to the shaft
axis A when fully exposed. In this fully exposed configuration as
shown close-up in FIG. 11, the snare 57 forms an elongate loop
having a distal loop tip 61 connected to a pair of distal loop
sections 62, which are preferably linear, which are connected to
arched majority loop sections 63. As the snare 57 is moved from the
partially exposed position to the fully exposed position, the snare
57 forms a loop that not only increases in size, but also curves
back towards the shaft 55 to form a perpendicular orientation with
respect to the shaft axis "A." Thus, the snare 57 travels an
arcuate path bent towards the shaft 55 as the snare 57 moves from
the partially deployed to the fully deployed configuration.
[0069] When the slide rod 53 is proximally pulled toward an
extended, protruding position as shown in FIG. 4B, the deformable
loop decreases in size as the snare 57 is retracted into the needle
distal tip 56. When pulled in the proximal direction, the slide rod
53 will continue to retract the snare 57 until the distal loop tip
61 contacts the exit ramp of the obturator. The first actuator 53
is partially spring loaded in a manner that only when the slide rod
53 nears the fully extended proximal position, the slide rod 53
engages the first spring mechanism 64 which biases the slide rod 53
distally to a rest position. This spring-biased rest position
corresponds to the fixed partially exposed position of the snare
57, shown in FIGS. 4B and 9. It will be appreciated that the
partially exposed position as shown in FIG. 4B is fixed in the
sense that further retraction of the snare 57 beyond this point
requires actuation of the second actuator, which in the preferred
embodiment comprises proximal movement of the thumb slide 52 as
discussed further below.
[0070] This partial spring loading of the slide rod 53 allows for
the snare 57 to rest in the fixed partially exposed without
actuation. In this fixed partially exposed configuration, the snare
57 protrudes sideways from the needle shaft 55 and forms a
substantially planar loop where the two linear loop sections 62 are
substantially parallel to each other as shown in FIG. 6A. This
planar loop is off-axis with respect to the shaft axis "A." Thus,
in either the partially exposed or fully exposed position, the
deformable loop is slanted with respect to the axis "A" of the
shaft assembly 55. Since the snare 57 is substantially planar in
this fixed, partially exposed position, the loop snare 57 travels
linearly as it is further retracted into a fully hidden, retracted
position.
[0071] The second actuator 52, which comprises a lockout trigger or
thumb slide in the preferred embodiment, controls movement of the
snare 57 from the fixed partially exposed configuration to the
fully retracted position, and locks the snare 57 in the fully
retracted configuration. When the slide rod 53 is proximally
extended to the spring biased rest position, a mating mechanism is
provided between the slide rod 53 and the trigger 52 such that
proximal actuation of the trigger 52 moves the slide rod 53
proximally which further retracts the snare 57. In the preferred
embodiment, the mating mechanism comprises a notch 66 formed in the
slide rod 53 which is configured to mate with an inwardly
protruding fin 67 of the trigger 52.
[0072] When the slide rod 53 is in the spring-biased rest position,
the notch 66 is aligned with the fin 67 such that proximal movement
of the trigger 52 engages the slide rod 53 and pulls the slide rod
53 out to its most extended proximal position which fully retracts
the snare 57. The lockout trigger 52 is then locked to the needle
housing 50 by mating features between the two. In the preferred
embodiment, a tongue 68 on the trigger 52 mates with a groove 69
formed in the sidewall of the housing 50. To unlock the trigger 52,
the distal end 71 of the trigger 52 can be slightly lifted away
from the needle housing 50 to release the tongue 68 from the groove
69. A second spring mechanism 73 biases the trigger 52 distally and
moves the unlocked trigger 52 to its proximal most position, at
which point the trigger 52 is released from the slide rod 53. When
the trigger 52 is unlocked from the housing 50 disengaged by the
user, the first and second spring mechanisms 64, 72 distally urge
the first and second actuators 53, 52, respectively, thereby
returning the extender to the rest position allowing for partial
exposure of the wire snare 57 (as in FIG. 4B).
[0073] In the preferred embodiment shown in FIG. 6C, the lockout
trigger 52 is disposed on an outer surface 73 of the cylindrical
housing sidewall 74 opposite to the exit of the snare and
constrained by side tracks 75 and a top slot 76. Other features on
the housing outer wall 74 may be employed to constrain the trigger
52. As the trigger 52 is pushed distally by the second spring
mechanism 72, the trigger 52 rides along the ramped tracks 75 and
through the top slot 76 formed in the housing sidewall 74 which
separate the slide 52 from the rod 53 and facilitates disengagement
thereof.
[0074] Referring back to FIG. 4A, the needle housing 50 may also
have a quick connect mechanism, such as a luer connection 51
somewhere along its length. The luer connector 51 allows for an
inert gas line to be connected to the needle apparatus 49. As the
gas enters the needle apparatus 49, it flows distally through the
hollow insufflation lumen, or insufflation channel, 41 of the
needle shaft 55 and exits the needle apparatus 49 at the distal
tip. This allows for insufflation of the abdominal cavity. FIG. 5A
is a detailed view of the needle apparatus 49 showing a first
preferred embodiment of a blunt obturator assembly 77 of particular
use when the needle apparatus 49 is used as an insufflation
device.
[0075] In FIG. 6A, the obturator assembly 77 comprises a first
preferred blunt obturator tip 78 having a generally flat top 79 at
a distal end. The needle shaft 55 has a sharp needle tip 82 at a
distal end preferably comprising a needle peak 83 and a pair of
blade edges 84 extending proximally and laterally therefrom, as
shown in FIGS. 7A-7D. The needle tip 82 facilitates insertion of
the needle shaft 55 through the tissue layers. In order to prevent
damage to the underlying organs, the spring loaded blunt obturator
tip 78 is slidably disposed within the needle shaft 55. The blunt
obturator tip 78 is connected to an obturator shaft 86 by a dowel
pin 87. A window cutout 88 in the obturator shaft 86 provides a
location for the snare 57 to exit the needle apparatus 49. The
blunt obturator tip 78 partially extends up the length of the
obturator shaft 86. An exit section 90 adjacent to the window
cutout 88 has two tracks, or exit slots, 92 to accommodate the
passage of the snare 57. The preferably two distinct tracks 92
prevent the snare 57 from being pulled all the way up the needle
shaft 55, or becoming twisted as it is retracted and extended from
the shaft 55.
[0076] FIG. 6B shows a cross-sectional view of the distal tip of
the needle instrument. One of the needle tracks 92 is shown to
guide the wire snare 57 distally out the window cutout 88 in the
obturator shaft 86. The needle tracks 92 also guide the snare 57
proximally into the push rod 93 that extends proximally.
[0077] In the preferred embodiment, the shaft assembly 55 comprises
an inner snare push rod 93 disposed within the obturator shaft 86,
which is disposed with an outer shaft 43 that forms the distal
needle tip. The inner obturator shaft 86 defines the insufflation
lumen 41.
[0078] Referring back to FIG. 5A, the internal workings of the
needle apparatus 49 are shown in FIG. 6. The needle shaft 43 is
connected to the distal end 58 of the needle housing 50 via a
needle hub 94. The obturator shaft 86 which is slidably disposed
within the needle shaft 55, connects to a obturator hub 95 that is
proximal to the needle hub 94.
[0079] The obturator hub 95 is slidably disposed within the needle
housing 50 and spring loaded by a spring 96 that allows the
obturator shaft 86 to translate as the obturator tip 78 is pressed
against.
[0080] The snare push rod 93 is slidably disposed within the needle
housing 50 and the obturator shaft 86 and fixed to the slide rod
53. The snare 57 is fixed to the proximal end 59 of the slide rod
53 and travels through the slide rod 53, through the snare push rod
86, and ultimately out through the obturator tip 78 (as shown in
FIG. 5). Since the snare 57 is flexible, it requires passage
through rigid structures so that it can extend and retract at the
needle tip.
[0081] At the proximal end of the slide rod 53 is a slide rod pin
65 that may serve multiple purposes. The pin 65 helps to maintain
the rotational alignment of the slide rod 53 within needle housing.
The pin 65 also engages the first spring mechanism, or the slide
rod spring, 64 when the snare 57 approaches retraction back into
the needle, partially spring loading the travel of the slide rod 53
distally back to the rest position.
[0082] As discussed above, the trigger 52 is also spring loaded by
a second spring mechanism, or trigger spring, 72, causing the
trigger 52 to be biased in the distal direction. As the trigger 52
is pulled proximally, it engages with the slide rod 53, and pulls
it back against the force of the slide rod spring 64. The lockout
trigger 52 can then be locked to the needle housing 50, locking out
the snare 57 in the fully retracted position. Both the trigger
spring 72 and slide rod spring 64 are constrained to the needle
housing 50 by proximal plugs 98 that may be pinned to the needle
housing 50.
[0083] FIGS. 7A and 7B provide close-up view of the obturator
assembly 77 with the flattop obturator tip 78. The flattop
obturator tip 78 has a flat front 95 with rounded corners 102.
[0084] FIGS. 7C and 7D show a second preferred obturator assembly
110 having a unique ramped obturator tip 112. The ramped tip
obturator tip 112 comprises an obturator peak 114 with a smaller
cross sectional area "C", allowing for more exposure of the
sharpened blade edges 84 of the outer needle shaft 55. In the
preferred embodiment, the ramped surfaces 116 are positioned
proximally to the blade edges 84 when the obturator peak 114
distally traverses the needle peak 83 up to 5 mm. The obturator
peak 114 defines a surface area preferably less than 0.1 square mm.
In the preferred embodiment, the surface area of the obturator peak
114 is 0.06 square mm or less. Moving proximally away from the
distal obturator peak 91, the cross-sectional area of a tapered
section 116 increases in area, until the area at the base 118 of
the tapered section 116 is equivalent to the distal end 121 of the
obturator tube 123. FIG. 7B shows the distance "D1" the flattop
distal tip 85 needs to be from the needle peak 83 to expose the
sharp needle edges 84. FIG. 7D shows this a shortened distance "D2"
with the ramped obturator tip design 110 between the needle peak 83
and the obturator peak 114. This preferred ramp obturator tip 110
allows the spring loaded obturator mechanism to advance in a
quicker manner through the tissue layer and thus provide enhanced
safety by reducing the exposure time of the sharp needle peak 83.
The preferred ramp obturator 110 may also facilitate the ease of
insertion of the needle through the tissue layers.
[0085] Alternative ergonomic handle designs are proposed in FIGS.
8A-8C. In FIG. 8A a simplified alternative handle design is shown,
compared to the primary embodiment disclosed above. A handle 130 is
shown with two extension tabs 134 that can be supported in the hand
by two fingers (such as the index and middle finger). The plunger
136 has a surface 138 that can be pressed by another finger (such
as the thumb) in order to advance the plunger 136 and deploy the
snare. The plunger 136 may be spring loaded with respect to the
handle 130, so that the plunger 136 is biased in the direction that
retracts the snare.
[0086] In FIG. 8B, an alternative preferred embodiment of a handle
140 comprises two finger slots 142 each configured to receive a
finger, and a hole 144 formed on the plunger 146 for receiving a
thumb. As the thumb slides distally, the plunger 148 also advances
distally inside the handle 140, deploying the snare.
[0087] In FIG. 8C, a further preferred embodiment of a handle 150
comprises an inverted design with respect to the embodiment shown
in FIG. 8B. Here, two fingers (such as the index and middle
fingers) can be placed inside the finger slots 152 on the plunger
154, while another finger (such as the thumb) can be placed in the
hole 156 of the handle 150. In this embodiment, the two fingers in
the plunger 154 would be advanced distally to deploy the snare.
[0088] The following describes a preferred method of wound closure
or suture passing using the first preferred embodiment of the wound
closure system described above in connection with FIGS. 1-6. The
guide plunger 21 is translated, preferably pressed down, to
contract the feet 26, and causing the guide 10 to take a slender,
continuous profile as shown in FIG. 1B. With the plunger pressed
down and the guide taking a slender profile, the guide 10 is
inserted through the tissue, particularly through a surgical wound
or opening. The plunger 21 is released and the expanding feet 26
are placed against the peritoneal wall (FIG. 3).
[0089] With the guide 10 inserted through the trocar wound and
secured to the inner wall, attention is turned to the needle
apparatus 49 which also functions as a suture engaging device. The
lockout trigger 52 is released to partially extend the snare 57
(FIG. 4B). In FIG. 9, a section of suture 160 is placed into wire
snare 57. As shown in FIGS. 4A and 5A, the lockout trigger 52 is
actuated and the snare 57 is retracted to capture the section of
suture 160 within the distal tip of the needle apparatus 49.
[0090] In FIG. 10, the needle apparatus 49 is then placed through
one of the guide barrel needle entry slots 27, through the needle
tunnels 35 in the plunger 21, out the needle exit slots 28, and
through the tissue 36, 37, 38 into the abdominal cavity 162. The
lockout trigger 52 is released (see FIGS. 4B and 5b), deploying the
snare 57. The needle apparatus 49 can then be further advanced into
the cavity 162 to release the section of suture 160. The lockout
trigger 52 is again actuated to retract the snare 57, and the
needle apparatus 49 is removed from the guide 10 and tissue layers
36, 37, 38. The needle apparatus 49 is then inserted into the
opposing needle entry slots 27 of the guide 10 and through the
tissue layers 36, 37, 38. The lockout trigger 52 is released to
partially deploy the wire snare 57. The slide rod 53 is fully
translated into the needle housing 50 to fully deploy the snare 57.
The needle 49 can then be rotated or manipulated to place the snare
57 underneath the free end of the suture 160.
[0091] In FIG. 11, the needle apparatus 49 is then slightly pulled
proximally to encircle the suture 160 inside the snare 57. The
slide rod 53 is pulled back proximally to the spring-biased rest
position, and the lockout trigger 52 is actuated to capture the
suture 160 in the tip of the needle apparatus 49. The needle
apparatus 49 is then pulled out of the body and guide 10. One last
time the lockout trigger 52 is released to partially extend the
snare 57. The suture 160 is then removed from the snare 57. The
guide is then removed to freely expose the suture ends. A knot is
tied between the two free ends of the suture 160 that is used to
close the wound site.
[0092] FIG. 12 illustrates a preferred method 200 for insufflating
a body cavity and engaging a suture to close a wound using a single
device. The method 200 comprises the step 210 of insufflating the
body cavity with a shaft defining an insufflation channel along an
axis between a shaft distal end and a shaft proximal end. Step 220
comprises securing a suture with a snare disposed adjacent to the
shaft distal end. In step 230, the shaft with the secured suture is
inserted into the body cavity at a desired first location. A guide
may be used in step 230 to direct the device to the desired first
location. In step 240, the suture is released by moving, or
actuating, the snare to an exposed position, which may be a
partially exposed or fully exposed position. Step 250 comprises
removing the shaft from the first location.
[0093] In step 260, the shaft is inserted into the body cavity at a
desired second location spaced apart from the first location. The
guide may be used in step 260 to direct the shaft to the second
location. Step 270 comprises capturing the suture with the snare.
In step 270, the snare may be actuated to a fully exposed position
to enlarge the loop and orient the loop substantially perpendicular
to the axis of the shaft. Step 280 comprises securing the suture to
the shaft by retracting the snare. Step 290 comprises removing the
shaft from the second location with the secured suture to complete
a stitch loop.
[0094] FIG. 13 illustrates a preferred method 300 for closing a
surgical wound using a system comprising preferred embodiments of a
guide and a suture engaging device disclosed above. It will be
appreciated that this method 300 enables an operator to deploy and
capture suture using simply a guide and a suture engaging device
without the need for a grasper. The method 300 comprises the step
310 of actuating a guide into a slender configuration and inserting
the guide through surgical wound. Step 315 comprises radially
expanding a securing mechanism, which may comprise feet or living
hinges, at a distal end of the guide. Step 320 comprises retracting
the guide such that the securing mechanism engages an inner body
cavity wall surrounding the wound. In step 325, unwanted tissue is
separated away from exits formed in the guide in order to prevent
said tissue from being sutured. Step 325 may be accomplished with
axial wings formed on an outer surface of the guide adjacent to the
exit slots.
[0095] Step 330 comprises engaging a suture with a snare disposed
at a distal end of a suture engaging device having a shaft. In step
330, the snare is actuated to a fully retracted position to capture
and lock the suture. Step 335 comprises inserting the suture
engaging device with the secured suture through a first track of
the guide and into the body cavity at a first position. Step 340
comprises releasing the suture in the body cavity and retracting
the suture engaging device from the first track of the guide. Step
345 comprises inserting the suture engaging device through a second
track of the guide and into the body cavity at a second position
laterally spaced from the first position. In Step 350, the snare
may be deployed up to a fully exposed configuration to capture the
suture. In the fully exposed configuration, the loop is
substantially perpendicular to the axis of the shaft of the suture
engaging device. Step 355 comprises retracting the snare to secure
the suture. Step 360 retracting the suture engaging device with the
secured suture from the guide to complete a stitch loop.
[0096] FIG. 14 illustrates a second preferred embodiment of a
needle apparatus 400 comprising a single actuator 452 as opposed to
dual actuators included in the first preferred needle apparatus
discussed above. In this second preferred needle apparatus 400, the
actuator 452 comprises a lockout trigger 452 coupled to a rod
assembly 448 that is coupled to a snare 457. Whereas in the first
preferred needle apparatus, the lockout trigger is capable of
moving the snare between a retracted position to a partially
exposed position, the lockout trigger 452 in the second preferred
needle apparatus 400 is capable of moving the snare 457 between a
retracted position, where the trigger 452 is moved to the most
proximal position as shown in FIG. 15, and a fully exposed
position, where the trigger is moved to the most distal position as
shown in FIG. 14.
[0097] The lockout trigger 452 rides along a top slot 476 and a
pair of side tracks 475 formed in the housing 450. Since the
lockout trigger 452 needs to translate a greater distance with
respect to the housing, particularly in the proximal direction, the
slot 476 and tracks 475 are formed with greater lengths than those
of the first preferred needle apparatus 49.
[0098] Accordingly, the slide rod 53 of the first preferred needle
apparatus 49 shown in FIGS. 6A-6C, has been omitted in the second
preferred needle apparatus 400 and replaced by the single lockout
trigger 452. Furthermore, the second preferred needle apparatus
comprises a 402 which may be formed integrally with or separately
from the housing 450. The handle 402 defines a finger slot 403.
Except for structural differences discussed above with respect to
FIGS. 14-15, all other structures in the second preferred needle
apparatus 400 as well as the principles of operation are
substantially similar to those in the first preferred needle
apparatus 49.
[0099] Many alterations and modifications may be made by those
having ordinary skill in the art without departing from the spirit
and scope of the invention. Therefore, it must be understood that
the illustrated embodiments have been set forth only for the
purposes of examples and that they should not be taken as limiting
the invention as defined by the following claims. For example,
notwithstanding the fact that the elements of a claim are set forth
below in a certain combination, it must be expressly understood
that the invention includes other combinations of fewer, more or
different ones of the disclosed elements.
[0100] The words used in this specification to describe the
invention and its various embodiments are to be understood not only
in the sense of their commonly defined meanings, but to include by
special definition in this specification the generic structure,
material or acts of which they represent a single species.
[0101] The definitions of the words or elements of the following
claims are, therefore, defined in this specification to not only
include the combination of elements which are literally set forth.
In this sense it is therefore contemplated that an equivalent
substitution of two or more elements may be made for any one of the
elements in the claims below or that a single element may be
substituted for two or more elements in a claim. Although elements
may be described above as acting in certain combinations and even
initially claimed as such, it is to be expressly understood that
one or more elements from a claimed combination can in some cases
be excised from the combination and that the claimed combination
may be directed to a subcombination or variation of a sub
combination.
[0102] Insubstantial changes from the claimed subject matter as
viewed by a person with ordinary skill in the art, now known or
later devised, are expressly contemplated as being equivalently
within the scope of the claims. Therefore, obvious substitutions
now or later known to one with ordinary skill in the art are
defined to be within the scope of the defined elements. The claims
are thus to be understood to include what is specifically
illustrated and described above, what is conceptually equivalent,
what can be obviously substituted and also what incorporates the
essential idea of the invention.
* * * * *