U.S. patent application number 14/515915 was filed with the patent office on 2015-02-05 for implant for hernia repair.
The applicant listed for this patent is Insightra Medical, Inc.. Invention is credited to Giuseppe Amato, Stephen Graham Bell, Wayne A. Noda.
Application Number | 20150038781 14/515915 |
Document ID | / |
Family ID | 46796147 |
Filed Date | 2015-02-05 |
United States Patent
Application |
20150038781 |
Kind Code |
A1 |
Bell; Stephen Graham ; et
al. |
February 5, 2015 |
IMPLANT FOR HERNIA REPAIR
Abstract
A hernia repair implant includes a first layer for facing a body
structure having a hernia defect to cover the defect while
promoting tissue growth into the first layer from the body
structure. The implant also includes a second layer opposed to the
first layer and made of anti-adhesion material to prevent growth of
tissue into the second layer from body structures contacting the
second layer. Furthermore, the implant includes at least one
engagement strap connected to the first layer and extending
therefrom to terminate at a free end. The engagement strap defines
opposed the edges and opposed flat surfaces extending between the
edges. At least one barb extends from at least one edge and/or at
least one flat surface of the strap and is configured to impede
motion of the strap in only a single direction.
Inventors: |
Bell; Stephen Graham; (Rome,
IT) ; Noda; Wayne A.; (Mission Viejo, CA) ;
Amato; Giuseppe; (Palermo, IT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Insightra Medical, Inc. |
Irvine |
CA |
US |
|
|
Family ID: |
46796147 |
Appl. No.: |
14/515915 |
Filed: |
October 16, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13476202 |
May 21, 2012 |
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14515915 |
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12183930 |
Jul 31, 2008 |
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13476202 |
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61030439 |
Feb 21, 2008 |
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61013619 |
Dec 13, 2007 |
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Current U.S.
Class: |
600/37 |
Current CPC
Class: |
A61B 2017/00358
20130101; A61B 2017/3419 20130101; A61M 2039/0673 20130101; A61B
2017/3466 20130101; A61B 2017/00951 20130101; A61B 2017/00889
20130101; A61M 39/02 20130101; A61B 2090/309 20160201; A61M
2039/066 20130101; A61B 2017/00362 20130101; A61B 17/3468 20130101;
A61M 39/0613 20130101; A61B 17/3423 20130101; A61F 2/0063 20130101;
A61B 90/30 20160201; A61F 2002/0072 20130101 |
Class at
Publication: |
600/37 |
International
Class: |
A61F 2/00 20060101
A61F002/00; A61B 17/34 20060101 A61B017/34 |
Claims
1. Apparatus comprising: an implant body to cover a hernia defect;
plural engagement straps connected to the implant body and
extending therefrom to terminate at respective free ends; and
plural centering straps connected to the implant body and extending
therefrom to terminate at. respective free ends, the centering
straps being attached to the implant body at radial locations that
are less distanced front a center of the first layer than radial
locations at which the engagement straps are attached to the
implant body, the implant body defining a plane, the engagement
straps and centering straps having a configuration in which the
engagement straps and centering straps lie lengthwise parallel to
the plane.
2. The apparatus of claim 1, comprising the engagement strap
defining opposed thin edges and opposed flat surfaces extending
between the edges, at least one barb extending from, at least, one
edge and/or at least one flat surface and configured to impede
motion of the strap in only a single direction, comprising plural
barbs on the strap.
3. The apparatus of claim 1, comprising plural straps connected to
the implant body.
4. The apparatus of claim 2, wherein the barbs are a thin filament
oriented at an oblique angle relative to a long axis of the
strap.
5. The apparatus of claim 2, wherein the barbs are generally
triangular and oriented on the strap parallel to a long axis of the
strap.
6. The apparatus of claim 2, wherein the opposed thin edges define
a width of the strap, wherein the width becomes progressively more
narrow longitudinally along the strap from the end of the strap
connected to the first layer to the free end.
7. The apparatus of claim 3, wherein each strap has a different
color on at least a respective portion thereof such that the straps
are distinguishable from each other to at least partially establish
a color code, wherein none of the straps include the same color
establishing the color code as any other strap on any respective
portion thereof.
8. The apparatus of claim 3, wherein each strap has a different
marking on at least a respective portion thereof such that the
straps are distinguishable from each other, wherein each marking is
established by a structural difference and/or visual difference
relative to the other straps.
9. The apparatus of claim 1, wherein the implant body comprises: a
first layer for facing a body structure having the hernia defect to
cover the hernia detect, while promoting tissue growth into the
first layer from the body structure.
10. The apparatus of claim 1, wherein the implant body comprises: a
first layer made of anti-adhesion material to prevent growth of
tissue into the first layer from body structures contacting the
first layer.
11. The apparatus of claim 9, wherein the implant body comprises: a
second layer opposed to the first layer and made of anti-adhesion
material to prevent growth of tissue into the second layer from
body structures contacting the second layer.
12. Assembly comprising: hernia implant body defining a major
surface in turn defining a plane, the body defining a center;
plural elongated engagement straps engaged with the body and having
a configuration in which the engagement straps lie lengthwise
parallel to the plane; plural elongated centering straps engaged
with the body and having a configuration in which the centering
straps lie lengthwise parallel to the plane; at least one of the
engagement straps having a fixed end engaged with the body at a
first location, a first distance being defined from the first
location to the center; at least one of the centering straps having
a fixed end engaged with the body at a. second location, a second
distance being defined from the first location to the center, the
second distance being less than the first distance.
13. The assembly of claim 12, wherein the body defines at least
first and second layers.
14. The assembly of claim 13, wherein the first layer is for facing
a body structure having a hernia defect to cover the defect while
promoting tissue growth into the first layer front the body
structure and the second layer is opposed to the first layer and is
made of anti-adhesion material to prevent growth of tissue into the
second layer from body structures contacting the second layer.
15. The assembly of claim 12, wherein all centering straps are
engaged with the body at locations distanced from the center a
lesser distance than locations at which the engagement straps are
engaged with the body.
16. The assembly of claim 12, wherein all engagements straps and
centering straps are engaged with the body inboard of an outer
border of the body such that when the assembly is positioned to
cover a hernial defect, a protective margin of an antiadhesion
layer of the body prevents abdominal viscera from contacting any
portion of the engagement straps and centering straps.
Description
[0001] This application is a continuation in part of U.S. patent
application Ser. No. 12/183,930, filed Jul. 31, 2008 and published
as USPP 2009/0216253, incorporated herein in its entirety.
FIELD OF THE APPLICATION
[0002] The present application relates generally to the repair of
defects in muscular structures, and more particularly to implants
to address ventral wall hernias, inguinal hernias, and methods for
advancing the implants into a patient less invasively.
BACKGROUND OF THE INVENTION
[0003] The above-referenced patent publication discloses a surgical
implant with both a tension free and fixation free implant mesh
having multiple straps extending radially outward from the implant
mesh. The straps are pulled through the ventral (abdominal) wall
musculature to fix the implant mesh to the ventral wall such that
when implanted the implant mesh is in a slackened condition
relative to the ventral wall. The implant mesh is sized to be
substantially larger than the hernia. To permit tissue ingrowth
from the ventral wall into the mesh while preventing undesirable
ingrowth of structures in the peritoneal space such as the bowel
into the mesh, the mesh is backed with an anti-adhesion layer or
substance. A non-adhesion mesh can be used in the preperitoneal
space.
[0004] While the structures in the above-referenced patent
publication prove effective, present principles understand that
delivering the mesh laparoscopically, positioning the mesh within
the patient and indicating locations outside the patient at which
strap retrieval tools should be advanced, and securing strap
fixation within the patient all pose challenges that are addressed
herein.
SUMMARY OF THE INVENTION
[0005] Accordingly, in one embodiment a hernia repair implant
includes a first layer for facing a body structure having a hernia
defect to cover the defect while promoting tissue growth inks the
first layer from the body structure. The implant also includes a
second layer opposed to the first layer that is made of
anti-adhesion material to prevent growth of tissue into and/or
prevent adhesions with the second layer from body structures such
as abdominal viscera contacting the second layer. Furthermore, the
implant includes at least vine engagement strap connected to the
first layer and extending therefrom to terminate at a free end.
Note that the engagement strap defines opposed thin edges and
opposed flat surfaces extending between the edges. Additionally, at
least one barb extends from at least one edge and/or at least one
flat surface of the strap and is configured to impede motion of the
stop in only a single linear direction.
[0006] If desired, the strap may include plural barbs that may each
extend away from a respective edge of the strap. Even further, it
is to be understood that there may be plural straps connected to
the first layer. In some embodiments, the barb may be a thin
filament oriented at an oblique angle relative to a long axis of
the strap. Also in some embodiments, the barb may be generally
triangular and may be oriented on the strap parallel to a long axis
of the strap. Further still, if desired the barb may extend away
from at least one edge of the strap and/or the barb may extend away
from a flat surface of the strap.
[0007] In another aspect, a pneumatic seal for laparoscopic surgery
includes a patient adhesion side positionable against a patient's
insufflated abdomen to hold the seal onto the patient. The seal
also includes a puncture membrane opposed to the patient adhesion
side. In addition to the above, the seal includes a sealant chamber
containing sealant that is disposed under the puncture membrane.
Thus, a piercing instrument can be advanced through both the
puncture membrane and sealant and into the patient's insufflated
abdomen with the sealant sealing around the piercing instrument to
impede leakage of insufflation gas from inside the patient's
abdomen along the piercing instrument to an area external to the
patient.
[0008] In still another aspect, a method for laparoscopic
implantation of a hernia repair implant having fixation straps with
respective ends includes laying the implant, or a pattern thereof,
on a patient's abdomen. The method then includes indicating on the
pattern's abdomen respective strap end retrieval piercing locations
for at least some respective strap ends. Then the method includes
advancing the implant into the patient's insufflated abdomen
through a trocar and unfolding the implant inside the patient.
Thereafter, the method includes using the piercing locations
indicated on the patient's abdomen, retrieving snaps up into the
patient's tissue by advancing a snaring installment into the
patient through a piercing location, snaring the end of the strap,
and pulling the strap outwardly.
[0009] In yet another aspect, a method for laparoscopic
implantation of a hernia repair implant having fixation straps with
respective ends includes advancing the implant into the patient's
insufflated abdomen through a trocar and unfolding the implant
inside the patient The method also includes retrieving a strap up
into the patient's tissue by first advancing a snaring instrument
into the patient along a path that is not parallel to an
anterior-posterior dimension defined by the patient's body and then
snaring the end of the strap using the snaring instrument. The
method then includes pulling the strap outwardly along the path
such that the strap is disposed in the patient in an orientation
not parallel to the anterior-posterior dimension. Thereafter the
method includes disengaging the instrument from the strap such that
at least a segment of the strap remains implanted in the patient in
the orientation not parallel to the anterior-posterior
dimension.
[0010] In still another aspect, a snaring instrument for snaring a
snap of a hernia repair implant disposed in a patient's abdomen
includes an elongated tube assembly defining a distal end segment
terminating at an open distal end. The instrument also includes a
guide wire opening in the distal end segment for receiving a guide
wire therethrough such that the distal end segment can ride along
the guide wire extending through the open distal end and guide wire
opening. Further still, the tube assembly also defines a proximal
segment. The distal and proximal segments are movable relative to
each other between a juxtaposed configuration and a separated
configuration. In the juxtaposed configuration, the proximal
segment is closely juxtaposed with the distal segment and a movable
grasping jaw within the assembly is oriented longitudinally within
the assembly. In the separated configuration, the proximal segment
is distanced from the distal segment to permit the movable grasping
jaw within the assembly to assume, under material bias, a grasping
position in which the grasping jaw is oriented at an oblique angle
relative to a long axis defined by the assembly and a tree distal
end of the jaw is disposed radially outward of the segments. This
permits the strap to be positioned between the jaw and the long
axis so that the assembly can then be moved to the juxtaposed
configuration to trap the strap for retrieval.
[0011] In another aspect, a snaring instrument for snaring a strap
of a hernia repair implant disposed in a patient's abdomen includes
an elongated tube assembly defining a distal end segment
terminating at an open distal end. The instrument also includes a
curved hook member pushable out of the distal end. The curved hook
member has first and second co-parallel legs joined together by a
curved distal bight. It is to be understood that the first leg
terminates at a proximal end. Additionally, the hook member is
movable between an extended position and a refracted position. In
the extended position, the proximal end of the first leg is exposed
such that the strap can be passed proximal to the proximal end of
the first leg dispose the strap between the legs. In the retracted
position, the proximal end of the first leg is not exposed to trap
the strap between the legs for retrieval.
[0012] In another aspect, a snaring instrument for snaring a strap
of a hernia repair implant disposed in a patient's abdomen includes
an elongated tube assembly defining a distal end segment
terminating at an open distal end. The instrument also includes a
snare member extending out of the distal end. The snare member has
first and second legs. The first leg is movable between a closed
configuration, in which the legs form a completely enclosed loop,
and an open configuration, in which a gap is established through
the first leg to permit the strap to pass therethrough.
[0013] In yet another aspect, a snaring instrument for snaring a
strap of a hernia repair implant disposed in a patient's abdomen
includes an elongated tube assembly defining a distal end segment.
The instrument further includes a magnet disposed on the distal
segment to attract a magnet on the strap. Furthermore, the
instrument includes a grasping member on the distal end segment
movable to grasp and then hold the strap.
[0014] In still another aspect, a snaring instrument for snaring a
strap of a hernia repair implant disposed in a patient's abdomen
and then partially retracting the strap and transecting the strap
to reside in patient tissue includes an elongated tube assembly
defining a distal end segment terminating in an open distal end.
The snaring instrument also includes a hypotube slidably disposed
in the assembly. The snaring instrument further includes a loop
connected to a loop line disposed in the hypotube. The loop is
disposed on a distal end of the hypotube such that pushing the
hypotube distally in the assembly pushes the loop out of the open
distal end and pulling on the loop line cinches the loop against
the distal end of the hypotube to shrink the loop. Furthermore, a
guard shaft is also slidably disposed in the assembly and includes
a cutter guard/cover on a distal end thereof. The instrument also
includes a cutter formed with a cutting edge (e.g., a blade). The
cutter is positioned inside the tube assembly at or near the distal
end to transect, using the cutting edge, a strap cinched by the
loop and retracted into the tube assembly by the loop line. Thus,
note that the guard shaft is slidably movable within the assembly
such that the cutter guard covers and hence guards the cutter and
cutting edge when the cutter and edge are not transecting the
strap.
[0015] In another aspect a method for laparoscopic placement of a
hernia repair implant includes advancing a hollow tunneling
catheter through a patient's skin into an insufflated abdomen of a
patient to form a path. The method further includes advancing an
illumination catheter through the tunneling catheter. The
illumination catheter has a light source at a distal end and/or tip
thereof to thus illuminate at least a portion of the illumination
catheter to thereby provide a visible indication from inside the
abdomen and appreciable outside the patient of the intramuscular
position and/or structure of the patient's abdominal wall being
transilluminated through tissue layers of the abdominal wall. The
illumination catheter is advanced between a fat layer and a muscle
layer but not through the muscle layer to a muscle layer piercing
location under visualization of light from the light source
propagating through the skin. The method then includes removing the
illumination catheter from the tunneling catheter and advancing a
snare catheter through the tunneling catheter to the piercing
location. The snare catheter has a puncturing distal segment
pushable out of an open distal end of the snare catheter to assume
a curved configuration under material bias. The method then
includes advancing the puncturing distal segment through the muscle
and fascia layers into the insufflated abdomen to establish a
retrieval path through which a portion of the implant can be
retrieved.
[0016] In yet another aspect, a method for laparoscopic advancement
of a hernia repair implant Into a patient includes insufflating the
abdomen of the patient and establishing laparoscopic access into
the abdomen through a trocar assembly. The method further includes
pushing a center portion of the implant into an open proximal
funnel removably housing a flexible hollow sheath using a grasper
such that the center portion of the implant is thus pushed into the
sheath inside the funnel. The method then includes continuing to
push the implant further into the sheath to cause the implant to
fold inwardly on itself as it enters the sheath. The sheath is
removed from the funnel and advanced into the trocar assembly.
[0017] In another aspect, a snaring instrument for snaring a strap
of a hernia repair implant disposed in a pattern's abdomen includes
an elongated tube assembly defining a distal end segment
terminating at an open distal end. The instrument also includes a
curved snare member extending out of the distal end of the assembly
and cord attached to the snare member at or near a distal end of
the snare member. The cord extends through the assembly to a
proximal end segment of the assembly. Furthermore, the snare member
and cord are movable between a closed configuration, in which the
snare member and cord are proximate to each other and have
substantially the same degree of curvature, and an open
configuration, in which the snare member and cord are distanced
front each other to establish a gap to allow a strap to pass
therethrough.
[0018] In still another aspect, a method for laparoscopic
advancement of a hernia repair implant into a patient includes
insufflating the abdomen of the patient and establishing
laparoscopic access into the abdomen through a trocar assembly.
Then, using a cord, a center portion of the implant may be pulled
into an open proximal funnel. The method then includes continuing
to pull the implant further into the funnel, thus causing the
implant to fold inwardly on itself as if enters the funnel. Then
the method includes advancing the funnel with the implant into the
trocar assembly.
[0019] The details of the present invention, both as to its
structure and operation, can best be understood in reference to the
accompanying drawings, in which like reference numerals refer to
like parts, and in which:
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1A is a cross-sectional view of a ventral portion of an
anterior abdominal wall;
[0021] FIG. 1B is a cross-sectional view of FIG. 1A showing a
herniation in the ventral wall;
[0022] FIGS. 2-5 are schematic diagrams illustrating the
implantation of a mesh with centering straps;
[0023] FIG. 6 is a plan view of an example mesh shown in FIGS. 2-5
suitably configured for ventral wall hernia repair, showing four
centering straps and eight fixation straps;
[0024] FIGS. 7 and 8 show alternate straps that are barbed to
permit easy insertion of the straps into and optionally out of the
patient but to impede withdrawal of the straps from the abdominal
wall of a patient;
[0025] FIGS. 9 and 10 are perspective and partial cross-sectional
views, respectively, of a skin seal through which strap retrieval
tools and straps can be advanced without causing an undue loss of
laparoscopic insufflation of the abdomen;
[0026] FIGS. 11-17 schematically illustrate strap insertion tool
advancement and strap retrieval steps of an example embodiment;
[0027] FIG. 18 shows a guide wire introducer tool configured for
effecting a lateral (relative to the anterior-posterior dimension)
strap channel in the patient;
[0028] FIGS. 19-23 illustrate a strap retrieval tool that can be
advanced over the wire inserted by means of the guide wire
introducer tool of FIG. 18, in various operational configurations
to retrieve a strap;
[0029] FIG. 24 is a schematic view of a first strap retrieval
element that can be used in the strap retrieval tool of FIGS.
19-23;
[0030] FIGS. 25 and 26 are schematic views of a second strap
retrieval element that can be used in the strap retrieval tool of
FIGS. 19-23;
[0031] FIGS. 27 and 28 are schematic views of a third strap
retrieval element that can be used in the strap retrieval tool of
FIGS. 19-23;
[0032] FIGS. 29 and 30 are schematic views of a fourth strap
retrieval element that can be used in the strap retrieval tool of
FIGS. 19-23;
[0033] FIGS. 31-36 are schematic views of a strap retrieval tool
lit various operational configurations retrieving and transecting a
strap;
[0034] FIG. 37 shows a tunneling cannula with a sharp piercing
distal tip;
[0035] FIG. 38 shows an illuminating cannula that can be advanced
through the tunneling cannula of FIG. 37 to illuminate tissue below
the surface of the skin which can be perceived by the surgeon for
purposes of establishing a position at which a strap insertion tool
can be advanced into the patient;
[0036] FIG. 39 shows a snare cannula that can be advanced through
the tunneling cannula of FIG. 37 to snare a strap of a hernial
implant within the abdomen of a patient in accordance with present
principles;
[0037] FIGS. 40-42 illustrate a strap insertion tool that can be
advanced through the tunneling cannula of FIG. 37 to retrieve a
strap;
[0038] FIGS. 43-45 illustrate steps in the procedure for using the
tools of FIGS. 37-42;
[0039] FIGS. 46-49 illustrate operational steps and tools for
advancing the mesh laparoscopically into a patient;
[0040] FIGS. 50-52 are schematic views of a fifth strap retrieval
element that can be used in the strap retrieval tool of FIGS.
19-23;
[0041] FIGS. 53-55 illustrate operational steps and tools for
advancing the mesh laparoscopically into a patient; and
[0042] FIGS. 56 and 57 are perspective and partial cross-sectional
views, respectively, of an alternate skin seal through which strap
retrieval tools and straps can be advanced without causing an undue
loss of laparoscopic insufflation of the abdomen.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0043] Initially, it is to be understood that although the repair
of ventral hernias is particularly referenced herein, the apparatus
and methods described herein may be used for other surgical or
laparoscopic procedures such as, but not limited to, other
instances where a tissue structure of the human body requires
strengthening and/or supporting. Furthermore, although shown in the
ventral portion of the abdominal wall and although so described for
treatment of ventral hernias, the apparatus and methods described
hereto may be used for inguinal hernias, pelvic support, and other
procedures and/or areas of the body.
[0044] Now initially referring to FIG. 1A, a cross-sectional view
of a normal, anterior abdominal wall of the ventral region of the
body is shown. As shown, the abdominal wall includes left and right
rectus muscles 10 and 12 enclosed and held in place by posterior
layers of fascia 14 and anterior layers of fascia 16. These layers
of fascia, which are thin, strong fibrous tissue, merge together in
the region intermediate the rectus muscles 10 and 12. Lateral to
the rectus muscles 10 and 12 are the external oblique 11, internal
oblique 13, and transverse muscle 15. A thin layer 18, called the
peritoneum, covers the posterior side of the posterior fascia 12.
The peritoneum 18 is a soft, pliable layer of tissue material and
provides an enclosure for the intestines and other internal
viscera. Anterior to the peritoneum 18 is the preperitoneal fat 19
A layer of skin composed of the sub dennis 20 and dermis 22 covers
the subcutaneous fat 17 and exterior of the anterior fascia 16.
[0045] FIG. 1B illustrates a condition where a hernia has formed in
the wall of the abdomen. The hernial opening is shown at 24. In
this example, the hernia is formed by the rupture of the fascia
layers 14 and 16 in the region intermediate the rectus muscles 10
and 12. Note that a visceral protrusion can occur not only in the
midline but also in the lateral aspect of the abdominal wall. In
this case the viscera protrudes across the lateral wall musculature
being composed by the external and internal oblique muscles and the
transverse muscles. In any case, the rupture permits the internal
viscera to push the peritoneum 18 in an outward direction, creating
a bulge 24 in the stun layers 20 and 22. It is to be understood
that if not treated, the condition will only worsen with time, with
the peritoneal bulge becoming larger.
[0046] Now referring to FIGS. 2-5, schematic diagrams illustrating
the implantation of a mesh with centering straps are shown. It is
to be understood that the figures below generally show methods
steps in conjunction with the devices disclosed herein. Thus, FIGS.
2-5 show advancing an implant into a patient through an incision
adjacent to a portion of a muscle wall to be repaired using a
suitable surgical instrument. As shown and described below, the
implant includes centering straps connected to a mesh and fixation
straps connected to the mesh outboard of where the centering straps
are connected. In other words, the centering straps are connected
to the mesh closer to the geometric center of the mesh than are the
fixation snaps. The centering straps are thus advanced through the
muscle wall to partially deploy the mesh in a centered positioned
relative so a defect in the muscle wall, and the fixation straps
are then advanced through the muscle wall to complete the fixation
of the mesh to the muscle wall.
[0047] With the centering straps, no sutures or other tacking
structure need be used to center the mesh over the defect other
than the centering straps themselves, which are understood to also
fix the mesh to the wall. This advantageously eliminates a separate
suturing step during surgery, and furthermore permits improved
manipulation when centering the mesh compared to suturing a central
part of the mesh on or near the defect since the centering straps
permit the surgeon to move the mesh laterally as needed to center
the mesh by cinching the straps to center the mesh.
[0048] Additionally, note that the meshes described herein,
including skeleton mesh portions of the implants described herein
and the mesh straps described herein, may be constructed of a solid
or a permeable material such that they are receptive to tissue
ingrowth. Suitable materials for making the meshes may include, but
are not limited to, the following: a knitted polypropylene mesh
such as that distributed by C. R. Bard, Inc. of Murray Hill, N.J.
under the trade name "Marlex"; laminar polypropylene mesh such as
that distributed by Dipromed S.r.l, Settimo Tonnese Italy, a
polyethylene mesh material of the type distributed by E. I. Du Pont
de Nemours and Company of Wilmington, Del. under the trade name
"Alathon"; a Dacron mesh material or a Nylon mesh material of the
type distributed by E. I. Du Pont de Nemours and Company of
Wilmington, Del.; Teflon; and silicone.
[0049] Additionally, the meshes described herein may be constructed
from a metallic mesh or a polymer mesh having interwoven metallic
filaments if desired. These filaments may provide additional
strength to the meshes and/or make the meshes radiopaque for later
visualization. The meshes may be a single layer or have a
multilayer construction. The meshes may have one or more layers
constructed from a bioabsorbable material such that the meshes may
be reabsorbed by the body over time.
[0050] Now particularly with respect to FIG. 2, it may be
appreciated that an implant 26 has been advanced into a patient
through, e.g., an incision next to a hernia 30 to be repaired
-using a suitable medical device 28 (such as, e.g., a trocar and/or
protective sheath). It is to be understood that the implant 26 as
shown in FIG. 2 is compressed (e.g., rolled in a cigar-style
fashion) to allow advantageous advancement using the device 28.
Compressing an implant such as the implant 26 into a device such as
the device 28 will be described further below in reference to FIGS.
46-49. Regardless, the implant 20 can be advanced into the patient
using, e.g., laparoscopic techniques and toward the hernia 30 in
the ventral wall via the abdominal cavity 32. The hernia 30 has
characteristics related to similar to the hernial opening 24
described above. It may be appreciated from FIG. 2 that the implant
26 can include plural centering straps 34.
[0051] If desired, the centering straps 34 may be advanced into the
patient first, with the remaining portions of the implant delivered
via, e.g., the trocar and sheath, after the straps 34 have been at
least partially advanced into the patient having the hernia 30.
Advancing the straps 34 first may make advancement of the straps 34
into the abdominal wall 38 less complicated since, e.g., the
remaining portions of the implant 26 are less likely to get in the
way and obscure a surgeon's view while performing a procedure in
accordance with present principles and anchoring the centering
straps 34 to place the implant 26 at a desired orientation.
[0052] As may be appreciated from the upward arrows 36 shown in
FIG. 2, the centering straps 34 are advanced at least partially
into the abdominal wall 38. If desired, the centering straps 34 may
be advanced completely through the abdominal wall 38 such that they
are advanced outwardly through the skin of the patient having the
hernia 30, including being advanced through the sub dermis and
dermis.
[0053] Accordingly, it may be appreciated from FIG. 3 that the
centering straps 34 are at least partially disposed in the
abdominal wall 38 and, owing to being advanced into the abdominal
wall 38 at a location radially distant from the hernia 30 itself,
the straps 34 at least partially ensure that no excess mesh or
other portion of the implant 26 migrates up into the hernia 30.
Furthermore, when advanced into the abdominal wall 38, the straps
34 prevent the implant 26 from sagging when, e.g., pneumoperitoneum
is released and thus it at least partially eliminates the chances
of hernia recurrence and the potential for seroma. As may also be
appreciated from FIG. 3, the device 28 is withdrawn from the area
of the hernia 30, allowing the implant 26 to begin to expand,
unfold, deploy, and/or otherwise assume its intended shape to cover
the detect in the abdominal wall 38 caused by the herna 30 and
facilitate tissue growth in accordance with present principles.
[0054] Given that FIG. 3 shows the implant 26 being fully removed
from the device 28, it may be appreciated that plural fixation
straps 40 are also evident on the implant 26. Example fixation
straps 40 will be described further in reference to FIG. 5. But
first, note that as shown in FIG. 4, the implant 26 at least
partially covers/blocks/obscures the hernia 30 in the abdominal
wall 38, it being understood that the implant 26 shown in the
configuration of FIG. 4 has at least partially assumed its intended
shape.
[0055] Now in reference to FIG. 5, it may be appreciated that the
fixation straps 40 have now been advanced at least partially into
the abdominal wall 38. If desired, the fixation straps 40 may be
advanced completely through the abdominal wall 38 such that they
are advanced through the skin of the patient with the hernia 30. It
may be further appreciated from FIG. 5 that a parietal surface of
the implant 26 is now disposed against the abdominal wall 38 to
fully cover the hernia 30, thereby facilitating tissue growth in
accordance with the principles set forth herein while also
advantageously blocking passage of objects, fluid, organs, tissue,
etc. from passing through the hernia 30 at least partially due to
the visceral surface of the implant 26 (which may have
anti-adhesion characteristics as set forth herein).
[0056] Note that either or both of the centering straps 34 and
fixation straps 40 may be secured into abdominal wall 38 by way of
friction between the straps 34 and 40 and the wall 38 to minimize
patient discomfort while still ensuring that the implant 26 remains
in its intended position/orientation, and also does not migrate
within the abdominal cavity 32. This provides a relatively
tension-free anchoring means while also obviating the need to use
other tacking methods that may otherwise provide potential points
of adhesion and/or tension during the healing process of the
patient, which is undesirable due to, e.g., patient discomfort.
Eliminating sutures or other tacking devices also enables the
implant to move with expansion or contraction of the surrounding
tissue as part of the healing process due to tissue changes over
time as the wall 38 heals and as incorporation tissue invades the
implant 26. In essence, securing the implant using only snap
friction better accommodates tissue movement and/or expansion.
However, if deemed necessary additional forms of fixation may
nonetheless be used, such as, but not limited to, racking, sutures,
fasteners, and clamps.
[0057] Notwithstanding the foregoing, it may be appreciated that
using only the friction means of abdominal wall attachment provides
a relatively tension-free condition in which the implant 26 is
secured into its position with sufficient slack so that as
surrounding tissue expands or moves, the implant slack helps avoid
pulling and possible tearing of surrounding tissue that may
otherwise result from an implant that is secured too tightly or
does not have any residual slack due to, e.g., tacking or clamps.
Accordingly, it may be appreciated that by virtue of the friction
created between the abdominal wall 38 and straps 34 and 40, the
straps 34 and 40 secure and stabilize the implant 26 while also
permitting a desired level of movement the straps 34 and 40
relative to surrounding tissues over time. The relatively
tension-free straps 34 and 40, as well as the configuration of the
implant 26 that completely covers the hernia 30, provides for
substantial slack allowing for long-term natural abdominal wall
remodeling which present principles recognize as being particularly
important to reducing and fixing hernias, it is to be understood
that this type of tension free and fixation free implant may
promote better healing, reduce premature tear-out, dislodgement, or
dislocation and provide increased comfort and acceptance by the
patient.
[0058] Still addressing the straps 34 and 40, note that while FIGS.
2-5 show that the straps 34 and 40 are shown attached to the
implant 26 when advanced into the patient having the hernia 30, in
other embodiments the implant 26 may be advanced into the abdominal
cavity 32 with the straps 34 and 40 unattached thereto. Thus, the
straps 34 and 40 may be advanced at least partially into the
abdominal wall 38 while unattached from the implant 26 and then
subsequently be coupled/attached to the implant 26. Alternatively
or in any desired combination, the implant 26 may be advanced into
the abdominal cavity 32 with the straps 34 and 40 unattached, and
then subsequently the straps may be attached to the implant 26
prior to the straps 34 and 40 being advanced into the abdominal
wall 38. It may be appreciated that advantages of advancing the
implant 26 into the abdominal cavity 32 with the straps 34 and 40
unattached may be desired for reasons such as, but not limited to,
ease of advancement of the implant 26 into the patient (e.g., if
the implant is relatively large and difficult to place into or
maneuver using the device 28) and ease of placement of the implant
26 against the abdominal wall 28 to thereby cover the henna 30.
[0059] Continuing in reference to the straps 34 and 40, the straps
may be made of a mesh such as a polypropylene mesh that facilitates
tissue growth in accordance with present principles. The straps 34
and 40 may be made of any other suitable synthetic materials,
biological materials, or combination of materials, if desired.
Regardless, it is to be understood that to further facilitate
advancement of the straps 34 and 40 at least partially into the
abdominal wall 38, the straps 34 and 40 may include surgical
needles (not shown in FIGS. 2-5) engaged with respective ends of
the straps to facilitate advancement of the straps 34 and 40 into
the abdominal wall 38. In some embodiments, the needles are
removably engaged with the straps 34 and 40 such that the needles
may be disengaged with straps 34 and 40 after the snaps 34 and 40
have been at feast partially advanced into the abdominal wall.
[0060] Also note that in some embodiments, the straps 34 and 40 may
be tapered at the ends to be advanced into the abdominal wall 38.
This may facilitate advancement of the straps 34 and 40 through
various tissue structures. Accordingly, the reduced lateral profile
may reduce friction and the resultant force required to, e.g., pull
or push the straps 34 and 40 into the abdominal wall 38. The
tapered nature may thus, e.g., ease the initial penetration through
tissue structures, but once the tapered ends are advanced out of
the patient, a firm grasp and/or hold of the strap(s) may be gained
by a physician. The wider portion(s) of the strap(s) may then be
advanced in accordance with present principles when making
adjustments, it being understood that the wider portion(s) are more
capable of inducing friction with the abdominal wall, also in
accordance with present principles. Note that the straps 34 and 40
may be made out of polyethylene, polypropylene, Teflon, nylon,
silicone or other suitable polymer in accordance with present
principles that may be useful to reduce friction as the straps 34
and 40 pass through tissue in the abdominal wall 38.
[0061] Now addressing FIG. 6, a plan view of an example mesh
implant such as the one shown in FIGS. 2-5 suitably configured for
ventral wall henna repair is shown. FIG. 6 shows, for non-limiting
illustration, four centering straps 44 and eight fixation straps 46
attached to the mesh implant 42. It is to be understood that the
centering straps 44 may be substantially similar in function and
configuration to the centering straps 34 described above, while the
fixation straps 46 in FIG. 6 may be substantially similar in
function and configuration to the fixation straps 40 described
earlier. Note that while FIG. 6 shows four straps 44 and eight
straps 46, more or fewer straps may be used as desired.
[0062] Further, it may be appreciated front FIG. 6 that the body 48
of the implant 42 may be generally circular/radial in shape, though
any other desired shape may be used to sufficiently cover a hernial
opening such as, e.g. an oval. Still, it is noted that in FIG. 6,
which shows the generally circular/radial implant 42, the centering
straps 44 are attached to the implant 42 at radial locations that
are less distanced from the center of the implant than where the
fixation straps 46 are attached to the implant 42. It is to be
understood that the straps 46 (and indeed the straps 44) are
mounted inboard of the outer border of the body 48 such that when
the implant 42 is positioned in its final Intended position to
cover a hernial defect, a protective margin of an antiadhesion
layer in accordance with present principles prevents the abdominal
viscera from contacting any portion of straps 46.
[0063] Referring to FIGS. 7 and 8, embodiments of one or more of
the above-described centering and/or fixation straps are shown,
generally designated 50, in which anchoring and/or adhesion spikes
52 are formed along one or both side edges of the strap 50 (FIG. 7)
and/or along the flat face of the strap 50 that extends between the
side edges (FIG. 8). The spikes 52 may be formed, e.g., by cutting
the strap 50 and/or by using reinforced (molded) polypropylene. The
spikes 52 as shown are equidistant from each other, but other
spacings may also be used. The arrows 54 in FIGS. 7 and 8 indicate
the direction of motion of the strap 50 being advanced into a
patient to give perspective to the fact that the spikes 52 are
barbed to permit easy movement of the strap 50 into the patient
along the arrows 54 but to grip tissue when force is exerted on the
strap 50 in a direction opposite the arrows 54.
[0064] Further describing the spikes 52, the strap 50 may define
opposed thru edges and opposed flat surfaces extending between the
edges such that at least one barbed spike extends from at least one
edge and/or at least one flat surface. Only one spike may be
included on the strap 50, or plural spikes 52 may be included on
the strap 50 as shown in FIGS. 7 and 8. Additionally, note that the
spikes 52 may be thin filaments oriented at oblique angles relative
to a long axis of the strap 50. It may be appreciated that the long
axis of the strap 50 is generally indicated by the arrows 54.
However, the spikes 52 may be oriented at other angles depending on
a specific implementation of the implant including the straps 50.
Thus, e.g., the spikes 52 may be oriented perpendicular to a long
axis of the strap 50 in some implementations.
[0065] Furthermore, the spikes 52 may be generally triangular to
establish the barbed structure of the spikes 52 in some
embodiments, but other shapes may be used in addition to or in lieu
of the triangular structure such as, but not limited to, a
double-barbed configuration established by two generally triangular
structures jointly defining one spike 52. In essence, two
triangular structures of a single "spike" are oriented at the same
angle relative to the strap 52 and are connected to each other to
establish a generally "M"-shape when the spike 52 is observed from
a top-plane view in the double-barbed configuration. As an example
of another exemplary configuration, a generally triangular spike
may itself include relatively smaller spikes along respective edges
thereof that are oriented at a similar angle as the larger spike
relative to the strap 50.
[0066] In addition, note that any of the straps disclosed in the
present application may have opposed thin edges that define a width
of the strap. In some embodiments, the width may become
progressively more narrow longitudinally along the strap from the
end of the strap connected to the implant to a free end of the
strap.
[0067] Now in cross-reference to FIGS. 9 and 10, a pneumatic seal
56 for laparoscopic surgery is shown in both perspective and
partial cross-sectional views, respectively. Note that the seal 56
acts as a skin seal through which strap retrieval tools and straps
such as the strap 57 shown so FIG. 10 can be advanced through,
e.g., the abdominal wall of a patient without causing an undue loss
of laparoscopic insufflation of the abdomen. Note that the
pneumatic seal 55 may function not only as a seal for the strap 57
while being advanced out of the patient but also as a size marker,
wound dressing, and/or skin lifter during hernia repair.
[0068] Regardless, the seal 56 includes a patient adhesion side 58
that is positionable against a patient's insufflated abdomen 60 to
hold the seal 56 onto the patient. The adhesion side 58 may be made
of an acrylic material in exemplary embodiments. The seal 56 also
includes a puncture membrane 62 opposed to the patient adhesion
side 58, which will be discussed further below.
[0069] Nonetheless, the seal 56 includes a sealant chamber 64
containing sealant 66 that is disposed under the puncture membrane
62, as may best be appreciated from FIG. 10. Thus, a piercing
instrument (not shown) can be advanced through the puncture
membrane 62 and sealant 66 in the sealant chamber 64 and into the
patient's insufflated abdomen 60 such that the sealant 66 seals
around the piercing instrument to impede leakage of insufflation
gas from inside the patient's abdomen 60 along the piercing
instrument to an area external to the patient. Thus, the sealant
chamber 64 is under the puncture membrane 62 such that the puncture
membrane 62 at least partially covers the sealant chamber 64 to
thereby cause the sealant chamber 64 to be completely surrounded by
the both puncture membrane 62 and adhesion side 58.
[0070] Furthermore, note that to aid a physician in advancing the
piercing instrument and/or strap 57 through the seal 56 as
described immediately above, gripping tabs 59 may be provided on
the puncture membrane 62 or any other suitable portion of the seal
56 such that the labs 59 may be gripped using a physician's hands
and/or a surgical tool to facilitate advancement of the piercing
instrument and/or strap 57 through the seal 56, and thus into the
abdominal wall of the patient as shown. Also note that the tabs 59
may be foldable such that they may be easily folded against the
puncture membrane 62 when desired as shown in FIG. 9 but still
folded orthogonally away from the puncture membrane 62 as shown in
FIG. 10 to facilitate gripping using, e.g., a surgical tool.
[0071] Also, it is to be understood that the puncture membrane 62
and/or sealant 66 may be made of high density closed cell foam,
though other suitable materials may also be used, it is to be
further understood that the sealant 66 may be made of a
biocompatible substance including an antibiotic in exemplary
embodiments. Even further, the sealant 66 may be made of a
hydrogel, a biocompatible cream, grease, or jelly, and/or any
combination of mixtures thereof.
[0072] Moving on, reference is now made to FIGS. 11-17. These
figures schematically illustrate strap insertion tool advancement
and strap retrieval steps of an example embodiment. Present
principles recognize that a suitable hernial implant for any
particular hernia repair may vary in size depending on, e.g., the
size of the hernia sought to be repaired or the location of the
hernia. As such, a physician may be required lo detennme what size
implant should be used for a particular hernia repair as well as
the position in which the implant should be placed prior to
inserting the implant into the abdominal cavity of a patient.
[0073] Accordingly, as may be appreciated from FIG. 11, an implant
68 with plural straps 70 in accordance with present principles may
be laid on top of a patient 72 to assist a physician in determining
a proper implant size and position. However, present principles
also recognize that instead of laying the implant 68 on top of the
patient 72, a pattern and/or template of the implant may instead be
laid atop the abdomen of the patient 72 so that, e.g., the implant
68 is not exposed to elements that would otherwise render the
implant 68 non-sterile and/or no longer useful for hernial
repair.
[0074] Regardless, as may be appreciated from FIG. 11, the implant
68 (or alternatively, a pattern of the implant) is laid on top of
the abdomen 90 of the patient 72 to cover a hernia (not shown). A
physician may indicate on the exterior surface of the abdomen 90 a
strap end retrieval piercing location 80 for at least some ends of
respective straps 70. If desired, to facilitate proper placement of
the implant 68 (or alternatively a pattern) to ensure proper
marking of the location 80, an abdominal space inside the patient
may be illuminated such that light from the space propagates
through the patient's abdominal wall layers to give a visual
indication outside the patient of interior tissue of the patient
including blood vessels to thus facilitate appropriate marking of
the location 80. Visual indication of, e.g., blood vessels allows a
physician to perform strap retrieval/insertion through the
abdominal wall without transecting the vessels.
[0075] A physician may then advance the implant 68 into the
insufflated abdomen of the patient 72 through a trocar and unfold
the implant inside the patient 72. The physician may thus use the
piercing locations 80 indicated on the abdomen of the patient 72 to
retrieve straps 70 up into the patient's tissue by advancing a
snaring instrument into the patient 72 through one of the piercing
locations 80. The end of a strap 70 is then snared and the strap
may then be pulled outwardly away from the patient's abdominal
cavity.
[0076] Furthermore, if desired the straps 70 may have different
colors on respective portions thereof and the marking locations may
be respectively colored to correspond to the different colors of
the straps 70 such that a physician may discern which strap should
be advanced through a particular marking location. Put another way,
a color code may be established wherein each respective strap and
its corresponding marking location have substantially the same
color such that they are distinguishable over other straps and
marking locations to provide a color-coding means by which a
physician may associate each one of the straps 70 with a particular
piercing location for the strap. Furthermore, if desired, none of
the straps and marking locations may have the same color from the
color code as any other respective strap or marking location.
[0077] Alternatively or in addition to the color-coding described
above, each strap may be marked, notched, folded, etc., differently
from the other straps on at least respective portions thereof to
distinguish them from each other and further assist a physician
when retrieving the straps 70 through the piercing locations 80 to,
e.g., prevent crossover or sequencing errors. Note that in some
embodiments the marking may be defined by a structural difference
and/or visual difference on the strap relative to the other
straps.
[0078] Regardless of the foregoing discussion on strap color-coding
and/or marking, in exemplary embodiments the step of indicating on
the abdomen of a patient 72 a strap end retrieval piercing location
80 may also include disposing a pneumatic seal 76 (such as the one
described above) on the abdomen of the patient 72 to help determine
the piercing location 80, as illustrated by FIG. 12. Thus, it may
be appreciated from FIG. 12 that the pneumatic seal 76 may be
positioned on the patient 72, e.g., three to five centimeters
inboard of the periphery 78 of the implant 68 such that it may,
e.g., accommodate tunneling length. As shown in both FIGS. 11 and
12, note that an "X" denotes the piercing location 80. Also note
that the piercing location 80 may be indicated using any suitable
ink such as surgical ink.
[0079] Regardless, the seal 76 is positioned inboard of the
periphery 78 to assist a physician in properly marking the piercing
location 80. More specifically, the seal 76 gives a physician a
frame of reference for the lateral distance in a patient's
abdominal wall through which the strap 70 will be advanced before
being advanced toward the exterior of the patient's abdominal wall
after entering the abdominal wall from the patient's abdominal
cavity orthogonal to the piercing location 80. Thus, placing the
seal 76 inboard of the periphery 78 facilitates proper marking of
the piercing location. However, note that in other implementations
the seal 76 may be placed outboard of the periphery 78 such that
the strap 70 may be advanced through the abdominal wall laterally
away from the body of the implant 68. Either way, it is to be
understood that the seal 76 may be positioned closer or farther
away from the periphery 78 as desired.
[0080] Moving on to FIG. 13, it may be further appreciated that the
pneumatic seal 76 is positioned external to the skin and/or
abdominal wall of a patient. More specifically, the pneumatic seal
76 is positioned external to a skin/fat/fascia layer 84 (referred
to herein` as the "skin layer" 84 for convenience). It may also be
appreciated that the abdominal wall 74 includes a muscle layer 86
and peritoneum layer 88. Note that the layers 84, 86, and 80 at
least partially define the abdominal wall 74. It may also be
appreciated from FIG. 13 that the seal 76 is not positioned
directly over the strap end retrieval piercing location 80 but
rather distanced from it as set forth herein. Further, FIG. 13 also
shows that the hernial implant 68 is already advanced into the
abdominal cavity 94 of the patient 72.
[0081] As indicated above, the seal 76 is not positioned directly
over the piercing location 80 but rather is positioned laterally
distanced from the location 80. It may be appreciated that a curved
retraction path/channel 98 to retract an end of a strap 70 may be
established by, e.g., a physician as described further below.
Accordingly, note that the path 98 may be curved and is formed
through tissue of the patient 72 (such as the layers 84, 86, and
88) by advancing a curved piercing instrument through the layers
84, 86, and 88 to establish the path 98.
[0082] With more specificity, the piercing instrument may be
advanced into the patient 72 from a location external to the skin
layer 84 and inboard of the piecing location 80, such as the
location 82 under the pneumatic seal 76, to establish the curved
retraction path 98. Note that the piercing instrument may first be
advanced through the seal 76 to impede leakage of insufflation gas
front inside the patient's abdomen 90 prior to being advanced into
the skin layer 84 and hence into the abdominal wall 74. Put another
way, the piercing instrument is passed through the seal 76,
tunneled through the skin layer 84, tunneled through the
subcutaneous tissue, tunneled outwardly and/or laterally through
the abdominal rectus muscles, and then exits through the peritoneum
layer 88 into the abdominal cavity 94 at a location parallel to an
anterior-posterior dimension defined by the body of the patient 72,
and indeed a location substantially posterior (e.g., under) to the
piercing location 80 as indicated by the axis 102. Thereafter, a
snaring instrument may be advanced into the patient along the
curved path 98 to retrieve an end of the strap 70 inside the
abdominal cavity 94.
[0083] Note that to facilitate advancing the piercing and snaring
instruments into the patient 72, the abdominal cavity/space 94 may
be illuminated in accordance with present principles such that
light from, e.g., the cavity 94 propagates through the skin layer
84 to give visual indication outside the patient 72 of interior
tissue of the patient including blood vessels to thereby facilitate
advancing of the piercing and snaring instruments into the patient
72. It may now be appreciated from FIG. 13 that the path 98 is a
path for the strap 70 of the implant 68 to be advanced through as
shown in FIG. 14, preferably under illuminated conditions, such
that the strap 70 enters the peritoneum layer 88 from inside the
abdominal cavity 94 at a location at least substantially posterior
to the piercing location 80 and is advanced at least partially
laterally through the path 98 toward the skin layer 84 using a
snaring instrument.
[0084] Accordingly, to facilitate strap engagement/securement with
the abdominal wall 74 of the patient 72 by way of friction in
accordance with present principles to, e.g., minimize patient
distention while still ensuring that the implant 68 remains in its
intended position/orientation when so placed, it may be further
appreciated from FIG. 14 that after the strap 70 has been snared in
the abdominal cavity 94 by a snaring instrument, the strap 70 is
advanced into the peritoneum layer 88 from inside the abdominal
cavity 94 when guided by the snaring instrument. The snaring
instrument may thus advance the strap 70 at least somewhat
laterally through the muscle layer 86 through the path 98 as shown
in FIG. 14. After being advanced laterally through the muscle layer
86, the strap 70 is then passed through the skirt layer 84 and
through the pneumatic seal 76 to impede leakage of insufflation gas
from the abdominal cavity 94, as may also be appreciated from FIG.
14.
[0085] To reiterate, it may be appreciated from FIGS. 13 and 14
that the pneumatic seal 76 through which the strap 70 is to be
passed is laterally distanced front the piecing location 80. Thus,
after an end of the strap 70 is pulled at least partially through
the skin layer 84 and through the seal 76, and hence pulled away
from the abdominal cavity 94, the strap 70 still at least partially
resides in a lateral orientation along the path 98 relative to the
anterior-posterior dimension defined by the body of the patient
72.
[0086] Furthermore, it may be appreciated that by advancing the
strap 70 laterally through the muscle layer 86 relative to an
anterior-posterior dimension defined by the body of the patient 72
using, e.g., a snaring instrument (as opposed to advancing the
strap 70 more centrally along a path parallel to the
anterior-posterior dimension such as, e.g., along the axis 102),
friction between the abdominal wall 74 of the patient 72 and the
strap 70 is increased even further (and further still if spikes
such as the ones described above are included on the strap 70).
However, the use of friction rather than, e.g., sutures,
nonetheless provides a relatively more tension-free condition
between the strap 70 and abdominal wall 74 while still securing and
stabilizing the implant 68.
[0087] Also, note that if desired the end of the strap 70 may be
pulled through the seal 76 and completely out of the patient as
shown in FIG. 14, though it is to be understood that the end of the
strap 70 may instead be pulled outwardly yet still allowed to
reside in subcutaneous tissue such as, e.g., the muscle layer 86,
without pulling the strap end all the way out of the patient 72.
Additionally, note that even should the end of the strap 70 be
pulled completely out of the patient 72, the abdomen 90 of the
patient 72 may then be tented as described below to cause the end
of the strap 70 to slip below the surface of the skin layer 84 such
that the end of the trap 70 is thereafter allowed to reside in
subcutaneous tissue of the patient 72.
[0088] Regardless, an increased area of friction between the strap
70 and layers 84, 86, and 88 of the patient 72 may be appreciated
from the arrows 104 of FIG. 14. It may also be appreciated that the
increased area of friction indicated by the arrows 104 (and thus
increased friction between the strap 70 and abdominal wall 74 of
the patient 72) created by advancing the strap 70 laterally through
the layer 86 is relatively larger than if the strap 70 were instead
only advanced centrally through an anterior-posterior dimension
defined by the body of the patient 72, such as along the axis
102.
[0089] Even further, due to intra-abdominal pneumoperitoneum
pressure, note that tissue around the mesh strap 70 may be
tightened and/or squeezed and thus further impede leakage of
insufflation gas from inside the patient's abdomen 90. Also note
that the seal 76 conforms so the mesh structure of the strap 70
when the strap 70 is advanced therethrough, which further impedes
leakage of insufflation gas. The tissue compression around the
strap may in some instances minimize or eliminate the need for a
pneumatic seal, but the remaining structures and methods described
herein are understood to nonetheless apply even if a physician
determines that a seal need not be used. Furthermore, note that if
a seal is to not be used in certain instances, a surgical clamp
such as, e.g., a bulldog, may be used to clamp the skin around the
strap end until trimming and surgical skin closure is accomplished
in accordance with present principles.
[0090] Now in reference to FIG. 15, it may be appreciated that
plural pneumatic seals 106 are shown on a patient's abdomen 110
with plural ends of straps 108 advanced from the abdomen 110
through the seals 106. It is to be understood that the straps 108
have been advanced through the abdomen 110 and seals 106 as set
forth in reference to FIGS. 11-14. Note that subsequent adjustment
of an implant's position may be performed incrementally as each end
of a strap is advanced through a respective seal 106, or a "final"
adjustment may be performed, after all ends of straps 108 have been
advanced through their respective seals 106 as shown in FIG. 15.
However, it is to be understood that still other adjustment after
the "final" adjustment may nonetheless be made as needed.
[0091] As may be better appreciated from FIG. 16, a strap 108 is
pulled externally away from the abdomen 110 as indicated by arrow
112 to thereby adjust an implant (not shown) having the strap 108.
An adjustment may be made to, e.g., position the implant up against
the inside of the abdominal wall as closely as possible to a
patient's hernia such that there is little or no space between the
implant and hernial area. This adjustment may be made using a
surgical tool, or the physician may do so simply by using his or
her hands. Scissors 114 or any other suitable cutter or surgical
instrument may then be used to cut off and/or remove excess
material from the strap 108.
[0092] Then, as shown best in FIG. 17, gripping tabs 116 on the
seal 506 substantially similar in configuration to the gripping
tabs 59 described above may be pulled away from the skin 120 of a
patient by a physician using his or her hands or alternatively
using a surgical tool, as indicated by arrows 118. The force
pulling the seal 106 away from the skin 120 thus causes the now
trimmed/cut strap 10S to be positioned subcutaneously. This occurs
at least partially due to a tenting of the skin 120, as shown in
FIG. 17, caused by the force pulling the seal 106 away from the
skin 120. After the "final" adjustment described in reference to
FIGS. 15-17, the seal 106 may be left as a dressing after hernia
repair surgery, or if may be removed so that a more conventional
dressing may be applied subsequent to surgery.
[0093] Turning now to FIG. 18, a guide wire introducer tool
configured for effecting a lateral (relative to the
anterior-posterior dimension) strap channel/path in the pattern is
shown. Accordingly, a guide wire introducer tool 122 includes a
hollow tube assembly 124 defining a curved distal end segment 126
terminating at an open distal end 128. The assembly 124 may be made
of metal in exemplary embodiments. The curved distal end segment
126 directs the open distal end 128 through abdominal wall tissue
to establish a channel/path such as the path 98 described above
under manipulation of, e.g., a physician. The curved distal end
segment 126 may be of any suitable degree of curvature.
[0094] The tool 122 also includes a septum seal 130 to prevent gas
loss in accordance with present principles. Note that, if desired,
the assembly 124 may include a substantially straight proximal end
segment 132 between the curved distal end segment 126 and septum
seal 130. If desired, the proximal end segment 132 may extend into
the septum seal 130, or alternatively the septum seal 130 may
attach to the end of the proximal end segment 132 distanced from
the distal end segment 126. It may be appreciated that owing at
least in part to the curved distal end segment 126, the open distal
end 128 may be relatively easily rotated to exit an abdominal wall
of a patient and enter the patient's abdominal cavity.
[0095] Furthermore, note that the open distal end 128 is understood
to be sharp enough to puncture the skin of a patient and then
establish a guide wire path/channel such that a strap may then be
advanced through path/channel in accordance with present
principles. Also note that a laparoscope may be used for
illumination such that light from inside the abdominal cavity
propagates through the patient's skin to give visual indication
outside the patient of interior tissue of the patient to assist a
physician in avoiding blood vessels when advancing the tool 123
through the abdominal wall of a patient.
[0096] It is to be understood that a guide wire may then be
inserted through the tool 122 including assembly 124 and then the
tool 122 may be removed from the patient, leaving the guide wire in
place such that it extends from outside the abdominal wall of a
patient, through the channel/path established by the tool 122, and
into the abdominal cavity. Thereafter, a strap passer may be
introduced over the guide wire in accordance with the principle set
forth below. In this way, a channel/path as described above may be
established and a guide wire may be advanced therethrough, as set
forth more specifically below.
[0097] Thus, in cross-reference to FIGS. 19-23, these figures
illustrate a strap retrieval tool that can be advanced over a guide
wire, it being understood that the guide wire was inserted by means
of, e.g., the guide wire introducer tool 122 of FIG. 18.
Accordingly, the tool described in reference to FIGS. 19-23 may be
referred to as a transcutaneous "strap-passer" that uses an
over-wire style.
[0098] Regardless, FIGS. 19-23 show various operational
configurations to retrieve a strap in accordance with present
principles. Accordingly, a snaring instrument 134 for snaring a
strap of a hernia repair implant disposed in a patient's abdomen
such as those described above includes an elongated tube assembly
136. The assembly 136 defines a distal end segment 138 that may be
tapered and/or dilating in some embodiments. The distal end segment
terminates at an open distal end 140. The assembly 136 also
includes a guide wire opening 142 in the distal end segment 138 for
receiving a guide wire 144 therethrough such that the distal end
segment 138 can ride along the guide wire 144 extending through the
open distal end 138 and guide wire opening 140.
[0099] However, note that in other embodiments the guide wire 144
may be received by a proximal segment 146 and extend at least
partially through the proximal segment 146, entirely through the
distal segment 138, and thus exit the guide wire opening 140 such
that both the segments 138 and 146 can ride along the guide wire
144. Regardless, as shown in FIGS. 19-23, the snaring instrument
134 is understood to be inside the abdominal cavity of a hernia
repair patient such that it may retrieve a centering or fixation
strap after the instrument 134 is advanced into the abdominal
cavity of a patient through a channel/path using the guide wire
144.
[0100] Additionally, note that once the snaring instrument 134 is
advanced through the desired channel/path and into the abdominal
cavity of the patient at least in part using the guide wire 144,
the guide wire 144 may be withdrawn front the instrument 134 and
advanced back through the channel/path and out of the patient
since, in exemplary embodiments, the instrument 134 may itself be
advanced back through the channel/path once a strap has been snared
without assistance of the guide wire. This may be appreciated from
FIGS. 22 and 23, still showing the instrument 134 in the abdominal
cavity but not showing the guide wire 144.
[0101] For completeness, note that the tube assembly 136 of FIGS.
19-23 also defines the proximal segment 146 and a connecting
segment 162 between the distal segment 138 and proximal segment
146. As may be appreciated by comparing FIG. 19 with FIGS. 20-23,
the segments 138 and 146 are movable relative to each other between
a juxtaposed configuration as shown in FIG. 19 in which the
proximal segment 146 is closely juxtaposed with the distal segment
138, and a separated configuration as shown in FIGS. 20-23 in which
the proximal segment 146 is distanced the distal segment 138 yet
still mechanically connected thereto at least partially due to,
e.g., the connecting segment 162. FIG. 20 thus shows the segments
138 and 146 as they are being transitioned into the separated
configuration, and FIG. 21 shows the segments 138 and 146
substantially positioned into the separated configuration.
[0102] Furthermore, a movable grasping jaw 148 is shown in FIGS.
30-23. The jaw 148 is understood be within the assembly 136 as
shown in FIG. 19 but is not shown in that figure since the assembly
136 is in the juxtaposed position. Thus, the grasping jaw 148,
while the assembly 136 is in the juxtaposed configuration, is
understood to be oriented longitudinally within the assembly 136.
This may indeed be appreciated from FIG. 20, where the segments 138
and 146 are being moved from the juxtaposed configuration to the
separated configuration and the jaw 148 is still at least somewhat
oriented longitudinally within the assembly 136. Regardless, it is
to be understood that the jaw 148 is used to grasp a strap 152 so
that the strap 152 may be advanced with the instrument 134 through
a channel/path toward an anterior portion of the patient's
abdominal wall. Grasping the strap 152 with the grasping jaw 148 in
accordance with present principles may best be appreciated from
FIGS. 22 and 23.
[0103] Note that in some embodiments, the grasping jaw 148 may have
more than one tooth and the teeth may be located longitudinally
along the grasping jaw 148. Further still, the teeth may be
equidistant from each other if desired. However, as may be
appreciated from FIG. 21, a single tooth 154 is shown in the
present embodiment. The tooth 154 is located at a distal end 156 of
the grasping jaw 148 and may extend substantially orthogonally away
from to a distal end 156 toward the distal segment 138.
Additionally, the tooth 154 may be generally triangular, as may
also be appreciated from FIG. 21. Nonetheless, it is to be
understood that the tooth 154 may instead extend at an oblique
angle away front the distal end 156 in other embodiments, if
desired.
[0104] Furthermore, note that in exemplary embodiments, when the
assembly 136 is in the separated configuration show in, e.g., FIG.
21, the proximal segment 146 is distanced from the distal segment
138 to permit the movable grasping jaw 148 to assume, under
material bias (or alternatively/additionally, under spring bias), a
grasping position to grasp at least part of a lateral segment of
the strap 152. Moreover, note that a separate element not shown,
such as a wire, rod, or string, may be disposed within the proximal
segment 146 and attached to an end of the jaw 148 disposed within
the segment 146 (i.e. opposite the end having the tooth 154) to
facilitate manipulation the jaw 148 to move it from the relatively
open grasping position back toward a closed position and vice
versa. Note that the closed position of the jaw 148 alter grasping
the strap 152 may best be appreciated best from FIG. 23.
[0105] Momentarily reverting back to FIG. 21, it is to be
understood that when in the grasping position, the grasping jaw 148
is oriented at an oblique angle relative to a long axis 150 defined
by the assembly, and a free distal end of the jaw 148 is disposed
radially outward of the segments 138 and 146. Accordingly, the
strap 152 can be positioned between the jaw 148 and connecting
segment 162, as shown in FIG. 22. The assembly 136 can then be
moved back substantially to the juxtaposed configuration to trap
the strap 152 for retrieval, as shown in FIG. 23.
[0106] Notwithstanding the foregoing, it is to be understood that
the strap 152 may prevent the assembly 136 from being moved back
completely to the juxtaposed configuration in some embodiments due
to an area within the assembly 136 being occupied by the strap 152.
Whether or not the assembly 136 is moved completely back to the
juxtaposed configuration may indeed be dependent on the dimensions
of the strap 152. Nonetheless, note that either way the assembly
136 is moved back substantially to the juxtaposed configuration
such that it is no longer in the separated configuration.
[0107] It may now be appreciated that the snaring instrument 134
may be used to snare a strap so that the strap may then be advanced
from the abdominal cavity of a patient through a channel/path,
where the channel/path has at least one portion extending laterally
through the patient's abdominal wall in accordance with present
principles. Furthermore, if desired a surgical tool 158 having a
grasping distal end 160 (as shown best in FIG. 22) including
opposing grasping edges 164 with teeth may be used by a physician
to move the strap 152 toward the instrument 134 so that the jaw 148
may more easily receive the strap 152.
[0108] Moving on to FIG. 24, a schematic view of a strap retrieval
element that can be used in the strap retrieval tool of FIGS. 19-23
is shown. Thus, rather than using the grasping jaw 148 described
above, an elongated tube assembly 166 defining a distal end segment
168 terminating in an open distal end 170 includes a loop 172
extending out of the open distal end 170. In exemplary embodiments,
the loop 172 is made of nitinol, though other suitable materials
may be used. Note that the loop 172 is shown in an extended
position in FIG. 24. It may thus, grasp a strap, such as the
centering and fixation straps discussed above, by receiving an end
of the strap through the loop 172 and using friction to advance the
strap out of the patient's abdomen. Alternatively, the loop 172 may
be at least partially refracted into the elongated tube assembly
166 such that the loop 172 shrinks, cinches, and/or closes around
the strap to grip it. When retracted, it is noted that at least pan
of the loop 172 is oriented longitudinally within the elongated
tube assembly 166.
[0109] Furthermore, though not shown in FIG. 24, a separate element
such as a wire, rod, or string may be disposed within the assembly
166 and attached to the end of the loop 172 (or alternatively may
define the end portion of the loop 172) closest to the distal
segment 168 to facilitate extension and retraction of the loop 177
to move it from the relatively extended position shown to a
relatively retracted position. It may now be appreciated that FIG.
24 provides yet another instrument for grasping a strap and hence
facilitating strap retrieval.
[0110] Turning now to FIGS. 25 and 26, schematic views of another
strap retrieval element that can be used in the strap retrieval
tool of FIGS. 19-23 are shown. Thus, a snaring instrument 173 for
soaring a strap of a hernia repair implant disposed in a patient's
abdomen in accordance with present principles includes an elongated
tube assembly 174 defining a distal end segment 176 terminating at
an open distal end 178. Differing from the embodiments discussed
above, FIGS. 25 and 26 show a curved hook member 180 pushable out
of the distal end 178.
[0111] It is to be understood that the curved hook member 180 has a
first leg 182 and a second leg 184 that are co-parallel to each
other and are joined together by a curved distal bight 186. The
first leg 182 terminates at a proximal end 188 thereof. Thus, the
hook member 180 is movable between an extended position, as shown
in FIG. 26, and a retracted position, as shown in FIG. 25. In the
extended position shown in FIG. 26, the proximal end 188 is exposed
such that a strap can be passed proximal to the proximal end 188 of
the first leg 182 to dispose the strap between the legs 182 and
184, in the retracted position shown in FIG. 25, the proximal end
188 of the first leg 182 is not exposed to thereby trap the strap
between the legs 182 and 184 for retrieval. Note that, when in the
retracted position, the proximal end 188 may either terminal at the
open distal end 178 or may advance at least partially through the
open distal end 178 into the a distal end segment 176 as desired
to, e.g., advance the instrument 173 into and out of a patient with
greater ease.
[0112] In other words, in exemplary embodiments the assembly 174
may be advanced through a channel/path in the retracted position of
FIG. 25. It can then be placed in the extended position of FIG. 26
while at least partially in the patient's abdomen by pushing on the
leg 184, where the leg 184 is understood to extend into the
assembly 174, to place the assembly 174 in a configuration to grasp
a strap. Once a strap has been passed proximal to the proximal end
188 and is between the legs 182 and 184, the leg 184 may be pulled
to return the assembly 174 to the retracted position, this time
with the strap trapped in the curved hook member 180 at least
partially due to the curved distal bight 186 enclosing the strap.
Note that another element such as a wire or rod may be attached to
the leg 184 inside the distal segment 176 to help perform the
pushing and pulling disclosed above and facilitate strap
retrieval.
[0113] Now in cross-reference to FIGS. 27 and 28, schematic views
of yet another strap retrieval element that can be used in the
strap retrieval tool of FIGS. 19-23 are shown. Accordingly, a
snaring instrument for snaring a strap of a hernia repair implant
disposed in a patient's abdomen includes an elongated tube assembly
190 defining a distal end segment 102 terminating at an open distal
end 194. The assembly 190 also includes a snare member 100
extending out of the distal end 194. It is to be understood that
the snare member 196 has a first leg 198 and a second leg 200.
[0114] Furthermore, note that the first leg 198 is movable between
a closed configuration, as shown in FIG. 27, and an open
configuration, as shown in FIG. 28. When the assembly 190 is in the
closed configuration, the legs 198 and 200 form a completely
enclosed loop. If desired, the assembly may be advanced through a
channel/path and into a patient's abdominal cavity in a retracted
configuration such that the snare member 196 is retracted partially
or completely within distal segment 192 in accordance with present
principles. Regardless, when the assembly 190 is in the open
configuration as shown in FIG. 28, a gap is established through the
first leg to permit a strap to pass therethrough. The assembly 190
may then be returned to the closed configuration shown in FIG. 27
to trap a strap to be retrieved. Again note that, e.g., one or more
wires or rods may be used in accordance with present principles to
facilitate the transition ft cm the closed configuration to the
open configuration, and vice versa.
[0115] Moving on, reference is now made to FIGS. 29 and 30, which
are schematic views of another snaring element that can be used in
the strap retrieval tool of FIGS. 19-23. Thus, a snaring instrument
for snaring a strap of a hernia repast implant disposed in a
patient's abdomen includes an elongated rube assembly 202 defining
a distal end segment 204. FIGS. 29 and 30 also show a magnet 206
disposed on the distal segment 204 to attract a magnet 208 on a
strap 210 of a hernial implant 212. Even further, a grasping member
214 is located on the distal end segment 204 and is understood to
be movable between an open position and a closed position to grasp
and then hold the strap 210. It is to be understood that in some
exemplary embodiments, the magnetic properties of the magnet 206 on
the assembly 202 may be operator-controlled using electromagnetics
understood by those within the art such that only an intended strap
of an implant having plural straps may be isolated and/or captured
using magnetism when desired.
[0116] As may be appreciated from FIG. 29, in exemplary embodiments
the grasping member 214 has opposing grasping blades 216 extending
orthogonally away from the distal segment 204. The grasping blades
216 have plural teeth 218 as shown, though it is to be understood
that each blade 216 may only have one tooth if desired. If only one
tooth is used, the tooth may be located at or near a distal end of
the grasping blade 216 relative to the assembly 202, though not
required.
[0117] Moreover, note that while the teeth 218 at least somewhat
resemble triangular geometric figures, in other embodiments or in
addition to the triangular teeth 218, still other shapes for the
teeth 218 may be used, such as generally rectangular teeth and/or
hooks. Regardless, it may be appreciated from FIGS. 29 and 30 that
strap retrieval is facilitated both due to the ability of grasping
member 214 to grasp the strap 210 and due to the attraction of the
magnets 206 and 208 to more easily guide the strap 210 between the
opposing blades 216 of the grasping member 214. The strap may then
continue to be grasped as it is advanced through a channel/path
toward an anterior surface of the patient's abdomen in accordance
with present principles.
[0118] Now cross-referencing FIGS. 31-36, schematic views of a
strap retrieval tool in various operational configurations for
retrieving and transecting a strap are shown. Accordingly, it is to
be understood that the snaring instrument referenced with respect
to FIGS. 31-36 is for snaring a strap of a hernia repair implant
(not shown) disposed in a patient's abdomen, then partially
retracting the strap into the instrument, and subsequently
transecting the strap so that it may reside in patient tissue.
[0119] Thus, a snaring instrument 220 includes an elongated tube
assembly 222 defining a distal end segment 224 terminating in an
open distal end 226 as shown in FIG. 31. The snaring instrument 220
also includes a hypotube 228 that is slidably disposed in the
assembly 222 and includes a hypotube handle 250 at an end of the
assembly 222 opposite the distal segment 224. The hypotube handle
250 is connected to the hypotube 228 at an end of the hypotube 228
closest to a proximate end 225 of a proximate segment 223 of the
assembly 222 The hypotube handle 250 may be used to slide the
hypotube 228 as set forth herein. In addition, a loop 230 connected
to a loop line 232 is disposed in the hypotube 228. The loop 230
and loop line 232 may be made of, e.g., monofilament. Note that a
stabilizer/gripping handle 252 may also be connected to the
assembly 222 to, e.g., stabilize the assembly 222 as a physician
executes any of the other motions described herein, such as the
sliding and cutting motions.
[0120] Furthermore, note that the loop 230 is disposed at a distal
end 234 of the hypotube 228 such that pushing the hypotube 228
distally in the assembly 222 toward the distal end 226 using, e.g.,
the handle 250 pushes the loop 230 out of the open distal end 234.
This may be appreciated from FIGS. 31 and 32. FIG. 31 shows the
loop line within the assembly 222 and the handle 250 of the
hypotube 228 relatively more distanced from the distal end 224 than
in FIG. 32. FIG. 32 shows the loop 230 pushed out of the distal end
234. Note that the handle 250 is relatively closer to the distal
end 224 in FIG. 32 than the handle 250 was in FIG. 31 since it, and
hence the hypotube 228, have been pushed toward the distal end 224
such that the loop 230 at least partially protrudes from the distal
end 224.
[0121] Even further, note that pulling on the loop line 232 cinches
the loop 280 against the distal end 234 of the hypotube 228 to
shrink the loop 230. As may be appreciated from FIG. 33, a strap
236 of a hernial implant is cinched by the loop 230 when the loop
line 232 is pulled using, e.g., a cinch handle 246 connected to an
end of the loop line 232 opposite the end of the line 232 having
the loop 230. As shown in FIG. 33, the cinch handle 246 is
proximate to the proximate end 225 of the proximate segment
223.
[0122] Continuing in cross-reference to FIGS. 31-36, the assembly
222 also includes a cutter guard shaft 238. It is to be understood
that the cutter guard shaft 238 is slidably disposed in the
assembly 222 and includes a cutter guard/cover 240 on a distal end
244 of the shaft 238. The cutter guard 240 may thus abut and/or
cover a cutter 242 formed with a cutting edge such as, but not
limited to, a blade and/or sharp pointed member. As may be
appreciated from FIGS. 31-36, the cutter 242 is positioned inside
the assembly 222 at or near the distal end 224. Accordingly, note
that the guard shaft 238 is slidably movable within the assembly
such that the cutter guard 240 may cover and hence guard the cutter
242 when, e.g., the cutter is not being used for transecting a
strap in accordance with present principles, but may nonetheless
expose the cutter 242 when desired to transect a strap.
[0123] Thus, as may be appreciated from FIG. 34, the hypotube 228
has been pulled toward the proximate end 225 such that the loop 230
has been retracted at least partially into the distal segment 224
and hence the strap 236, being cinched by the loop 230, has also
been retracted at least partially into the distal segment 224.
Again, note that one or both of the hypotube 228 and loop line 232
may be pulled using their respective handles 2S0 and 246 to retract
the loop 230 at least partially into the distal segment 224.
[0124] Further, note that the cutter guard shaft 238 is movable by
manipulating a cutter shaft handle 248. Manipulation of, e.g., the
assembly 222 and/or loop line 232 having the cinched loop 230, and
hence the strap 236, may serve 10 position the now tensioned strap
236 such that the cutter 242 may transect the strap. This may be
accomplished by, e.g., moving the strap 236 at least somewhat
linearly and/or laterally across the cutter 242 to facilitate
transection of the strap 236. Other motions may be used, such as,
but not limited to, exerting angular motion (e.g., twisting) on the
assembly 222 to transect the strap 236. However, it is to be
understood that still other motion may be employed to transect a
portion of the strap 236, such as other rotational motions.
[0125] Thus, as shown in FIG. 35 a motion arrow 254 illustrates
that the handle 248 has been pulled longitudinally toward the
proximate end 225 (and may even be palled beyond the proximate end
225, if desired) such that the cutter guard shaft 238 and hence the
cutter guard 240 are pulled longitudinally away from the cutter 242
at the distal end 226. Note that also as shown in FIG. 35 (as well
as FIG. 34), the strap 236 has been cinched by the loop 230 and
retracted into the tube assembly 222 using the loop line so that it
may be positioned within the assembly 222 to be transected.
[0126] Then, as shown in FIG. 36, the strap 236 may be transected
by affecting, e.g., angular motion on the handle 252 to thereby
rotate the assembly 222 and hence the cutting edge 242 to thereby
transect a portion of the strap 236. The remaining portion of the
strap 236 connected to the hernial implant may then be withdrawn
from the assembly 222, e.g., by way of tension from the hernial
implant, when a physician moves the assembly 222 away from the
implant, etc.
[0127] Though not shown, note that in other embodiments, a cutter
may additionally or alternatively be positioned on the distal end
244 of the shaft 238. In such an embodiment, linear motion, angular
motion, etc., by the shaft 238 could be used by manipulating the
handle 248 to transect the strap 236 within the assembly 222.
[0128] Continuing the detailed description in reference to FIG. 37,
a hollow tunneling cannula 256 that may create a channel, path,
and/or tunnel in accordance with present principles is shown. To
more easily establish a channel/path, the tunneling cannula 256 has
a sharp piercing distal tip 258 at a distal end 262 that may be
beveled, yet note that it is still substantially hollow. An
elongated shaft 260 of the cannula 256 is understood to be rigid in
exemplary embodiments. Even further, the cannula 256 has a receiver
264 at a proximate end 266 to facilitate receipt of the instruments
of FIGS. 38 and 39 (which will be described shortly) and guide them
into and through the interior of the hollow cannula 256. Note that
the receiver 264 may include a seal (now shown) in accordance with
present principles to prevent leakage of insufflation gas. Depth
markings 257 are also shown and may provide a visual indication of
the length of the channel/path under the skin.
[0129] FIG. 38 shows an illuminating cannula 268 that can be
advanced through the tunneling cannula 256 of FIG. 37 to illuminate
tissue below the surface of a patient's skin, which can be
perceived by a physician for purposes of establishing a position at
which a strap insertion/retrieval tool can be advanced into the
patient. It is to be understood that the illuminating cannula 268
has a rigid, elongated shaft 282 and a light source 270 at a distal
end 272 of the illuminating cannula 268. In exemplary embodiments,
the light source 270 is a light emitting diode (LED). The light
source 270 may thus illuminate the insufflated abdomen of a patient
from inside the patient to provide a visible indication from
outside the patient of, e.g., the intramuscular position and/or
structure of the patient's abdominal wall being transilluminated
through the skin of the abdominal wall. In some embodiments, the
light source 270 may be shaped, e.g., as an atraumatic tip such
that it serves as an obturator tor the tunneling cannula 256 for
the purposes of, e.g., blunt dissection as opposed to sharp
dissection in accordance with present principles.
[0130] Also note that the illuminating cannula 268 includes a
handle 274 at a proximate end 278 of the shaft 282 for a physician
to grip when, e.g., inserting the illuminating cannula 268 into the
tunneling cannula 256. The handle 274 may house a power source
(e.g., batteries) to power the light source 270 and may further
include an on/off switch 276 to turn the light source 270 on and
off as desired. Last, note that the illuminating cannula 268 may
also include a stopper 280 if desired so that the illuminating
cannula 268 may only be advanced into the tunneling cannula 256 so
far, it being understood that the stopper 280 may ride against the
receiver 264. Furthermore, the stopper 280 may optionally be
movable longitudinally along the shaft 282 so that the illuminating
cannula 268 may be advanced into the tunneling cannula 256 as much
or little as desired.
[0131] Now in reference to FIG. 39, a snare cannula 284 that can be
advanced through the tunneling cannula 256 of FIG. 37 to snare a
strap of a hernial implant within an abdominal cavity of a patient
in accordance with present principles is shown. The snare cannula
284 has an elongated, rigid shaft 286 that may be made of steel in
exemplary embodiments. The snare cannula 256 also includes a
puncturing distal tip 288 that is curved under material bias but is
flexible to become at least partially linear when it is inserted
through the tunneling cannula 256 as shown in FIG. 40. Note that in
exemplary embodiments the tip 288 is made of nitinol or is
spring-loaded steel. Regardless, it is to be understood that the
distal tip 288 is pushable out of the open distal tip 256 of the
tunneling cannula 256 to assume a curved configuration under
material bias, as may be appreciated from FIG. 39.
[0132] Additionally, the snare cannula 284 also includes a handle
290 at a proximate end 292 of the shaft 286 for a physician to grip
when, e.g., inserting the snare cannula 284 into the tunneling
cannula 256 and snaring a strap in accordance with present
principles. Furthermore, note that the snare cannula 284 may
include a stopper 294 if desired so that the snare cannula 284 may
only be advanced into the tunneling cannula 256 so far, it being
understood that the stopper 294 may ride against the receiver 264.
Even further, the stopper 294 may optionally be movable
longitudinally along the shaft 286 so that the snare cannula 284
may be advanced into the tunneling cannula 256 as much or little as
desired.
[0133] FIG. 40 illustrates the snare cannula 284 being advanced
through the tunneling cannula 256 of FIG. 37 to retrieve a strap.
More specifically, it may be appreciated front FIG. 40 that the
snare cannula 284 is advanced through the tunneling cannula 256
from the proximate end 266 of the tunneling cannula 256. Note that
the puncturing distal tip 288 is flexible such that it is
substantially co-linear with the shaft 286 while being advanced
through the tunneling cannula 256.
[0134] Cross-referencing FIGS. 41 and 42, another exemplary
embodiment of a snare cannula in accordance with present principles
is shown. Thus, a snare cannula 295 includes a control tube 296
extending at least partially through an elongated, rigid shaft 297,
wherein the shaft 297 is understood to at least partially define
the snare cannula 295. It is to be further understood that the
shaft 297 is substantially similar in function and configuration to
the shaft 286 described above such that it may be advanced through
a tunneling cannula, such as, e.g., the tunneling cannula 256 in
accordance with present principles. Note that the control tube 296
may be movable under manipulation of, e.g., a physician such that
it may be retracted at least partially into the shaft 297 and/or
protrude at least partially out of a distal end 299 of the shaft
297 when e.g., at least a portion of a distal end 299 of the shaft
297 is disposed in a patient in accordance with present
principles.
[0135] Furthermore, a snaring member 298 is at least partially
disposed in the control tube 296 and may at least partially
protrude from a distal end of the control tube 296. The member 298
may protrude from the control tube 296 when the control tube 296 is
manipulated as set forth above, and/or the snaring member 298 may
itself be movable within the control tube 296 under manipulation of
e.g., a physician such that it may be retracted into or protrude
from the control tube 296.
[0136] Additionally, as may be appreciated from FIG. 42 in
particular, an open eye member 300 may be included at a distal end
of the snaring member 298 (e.g., at the distal end/tip of the
snaring member 298). The open eye member 300 includes a penetrating
tip 308 at a distal end 309 of the open eye member 300. Further,
note that both the control tube 296 and snaring member 298
including the open eye 300 may be be curved under material bias yet
still be flexible to become at least partially linear when inserted
through a tunneling cannula in accordance with present
principles.
[0137] Further describing the open eye member 300, reference is
still made to FIG. 42. If may be appreciated from FIG. 42 that a
portion of a strap may be positioned through the open eye 300 in
accordance with present principles. More specifically, the open eye
300 has two optionally curved members 302 and 304 (in exemplary
embodiments the members 302 and 304 may be curved under material
bias yet still be manipulable by a physician to snare a strap) that
that separate at a proximate end 306 the eye 300 (i.e. the end
opposite the tip 308), and then rejoin at the tip 308. In other
words, the end 306 is understood to be proximate to the control
tube 296 while the tip 308 is understood to be distal to the
control tube 296. Regardless, the members 302 and 304 may snare a
strap in the configuration shown in FIG. 42, and/or may also be
cinched by a physician in accordance with present principles to
snare the strap.
[0138] Therefore, in accordance with the principles set forth
above, it may now be appreciated that the control tube 296 may be
refracted into the shaft 297 after the top 308 at least partially
penetrates a muscle layer of the patient's abdominal wall without
the snaring member 298 being retracted with it, thereby further
exposing the open eye member 300 and tip 308 such that it may
better and/or more easily be used for snaring/retrieving a
centering or fixation strap in accordance with present principles.
Also note that when the control tube 296 is retracted, the members
302 and 304, if partially disposed with in the control tube 296
prior to being refracted, may go from being substantially straight
while in the tube 296 to being curved under material bias as shown
in FIG. 42. Thus, it may be further appreciated that the eye 300
with members 302 and 304 facilitates strap retrieval since it can
capture and/or cinch a strap between the members 302 and 304 under
manipulation of a physician, and may be even further facilitated by
retracting the control tube 296 as disclosed above.
[0139] Moving on, FIGS. 43-45 illustrate steps in the procedure for
using the tools of FIGS. 37-42. Beginning with FIG. 43, the hollow
tunneling cannula 256 described above is shown as being advanced
through a single incision site 322 in a patient's skin and into an
insufflated abdomen of the patient to form a path. It may also be
appreciated from FIG. 43 that the illuminating cannula 268, being
advanced through the tunneling cannula 256, is likewise advanced at
least partially into the patient's abdominal wall 318, in this case
through a skin layer 310 and into the fat layer 312. However, the
illuminating cannula 268 and tunneling cannula 256 are notably not
advanced into the muscle layer 314.
[0140] Accordingly, it may be appreciated from FIG. 43 that the
light source 270 of the illumination cannula 268 protrudes from the
distal end 262 of the tunneling cannula 256 and trans-illuminates
at least a portion of the insufflated abdomen front inside the
patient viewable at least through a laparoscope when the light
source 270 is powered on. The light source 270 thus provides a
visible indication appreciable from outside the patient to help
establish a position at which a strap insertion/retrieval tool can
be advanced into the patient. As noted above, it is to be
understood that the illumination cannula 268 is advanced between a
fat layer 312 and a muscle layer 214 of the patient's abdominal
wall 318, but not through the muscle layer 314 to a muscle layer
piercing location 320. using visualization of light from the light
source 270 propagating through the skin.
[0141] Next, as shown in FIG. 44, the illumination cannula 268 has
been removed from the tunneling cannula 256 and the snare cannula
284 is advanced into the tunneling cannula 256 toward the piercing
location 320. The puncturing distal tip 288 of the snare cannula
284 is push-able out of an open distal end of the snare cannula
284. As shown in FIG. 44, the tip 288 is substantially linear while
being advanced through the tunneling cannula 256 but assumes a
curved configuration under material bias as shown in FIG. 45 once
it has been at least partially advanced beyond the distal tip 258.
The tip 288 of the snare cannula 284 may then be advanced through
the muscle layer 314 and into the insufflated abdomen of a patient
to establish a retrieval channel/path through which a portion of
hernial implant 326 can be retrieved such as, e.g., a strap 324 The
tip 288 may then be manipulated to retrieve the strap 324.
[0142] Now addressing FIGS. 46-46, operational steps and tools for
advancing the mesh laparoscopically into a patient are shown.
Present principles recognize that the size and/or dimensions of a
hernial implant sometimes make it difficult to be advanced into a
trocar, which in turn is advanced into the abdomen of a patient.
The description of FIGS. 46-49 addresses this concern.
[0143] Accordingly, beginning with FIG. 46, a hernial implant 328
having plural straps 330 in accordance with present principles is
shown. Note that as shown in FIG. 46, the implant 328 is
substantially unfolded when initially grasped by a flexible
endoscopic grasper/pusher 332. Note that the implant 328 is grasped
at least somewhat centrally by the grasper/pusher 332. The grasper
332 includes a handle 340 and a grasping element 342 at a distal
end 344 of a grasper shaft 346 of the grasper 332. The grasping
element 342 may be, e.g., a movable grasping jaw, may include a
semi-adhesive material, may include hooks, spikes, and/or barbs,
etc. It is to be understood that the implant 328 may be advanced
into a patient as set forth below after the patient's abdomen is
insufflated and laparoscopic access into the abdomen through a
surgical trocar assembly (not shown).
[0144] Nonetheless, referring hack to FIG. 47, a endoscopic grasper
332 is shown. The grasper 332 may grasp and/or receive a center
portion of the implant 328. The implant 328 is then pushed into an
open proximal funnel 338 holding a flexible hollow sheath 336
therein using the grasper 332. Then as shown in FIG. 48, the
implant 328 continues to be pushed further into the funnel 338 and
hence into the sheath 336 inside the funnel 338, thus causing the
implant 328 to fold inwardly on itself as it enters the sheath
336.
[0145] This inward-folding of the implant 328 may be appreciated
from both FIGS. 48 and 49. Note that pushing of the implant 328
into the funnel 338 and sheath 536 may be facilitated using many
different motions, including linear motion, oscillating pushing and
pulling motion, and/or angular motion such as twisting of the
grasper 332 and hence twisting of the implant 328 while being
pushed inward.
[0146] Thereafter, the sheath 336 having tire implant 328 may be
removed from the funnel 338 using, e.g., the grasper 332 so that it
may be advanced into a surgical trocar assembly which may in turn
be advanced into the insufflated abdomen of a patient. The implant
328 may then be removed from the sheath 336 while inside the
abdominal cavity of the patient so that it may be unfolded to cover
a hernia detect in accordance with present principles. It may be
thus appreciated from the description of FIGS. 46-49 that the
implant 328 may more easily be advanced into the abdomen of a
patient when folded into a sheath as set forth herein.
[0147] However, note that in other embodiments, the sheath 336 and
funnel 338 may be integrated to form a unitary body such that both
the sheath 336 and funnel 338 are not removable from each other and
the unitary body may be advanced into a patient using a trocar
assembly. In still other embodiments, a sheath 336 need not be used
and the implant 328 may simply be advanced into an open ended
funnel which in turn is advanced into the patient in accordance
with present principles.
[0148] Now in cross-reference to FIGS. 50-52, schematic views of
another strap retrieval element that may be used in accordance with
present principles is shown. Thus, a snaring instrument 348 that
may be used for snaring a strap of a hernia repair implant disposed
in a patient's abdomen includes an elongated tube assembly 350 that
defines a distal end segment 352 terminating at an open distal end
354. The instrument also includes a snare member 356 extending out
of the distal end 352 of the assembly 350. In addition, a cord 358
is attached to the snare member 356 at a location 360 understood to
be at or near a distal end 362 of a distal segment 366 of the snare
member 356. It is to be understood that the distal end 362 may in
some embodiments act as a piercing element in accordance with
present principles.
[0149] Note that both the snare member 356 and cord 358 may extend
front the distal end 354 through the assembly 350 to a proximal end
segment 364 of the assembly 550. Also note that the distal segment
366 of the snare member 356 extending out of the distal end 354 may
be curved, e.g., under material bias and/or spring bias. Even
further, a distal segment 368 of the cord 358 also extending out of
the distal end 354 may be curved, e.g., under material anchor
spring bias, and/or nonetheless assume a degree of curvature
substantially similar to the degree of curvature of the distal
segment 366. This may be appreciated from FIG. 50, where the distal
segment 366 and distal segment 368 have a similar degree of
curvature and are proximate to each other.
[0150] As may be appreciated by comparing FIG. 50 with FIG. 51, the
distal segment 366 of the snare member 356 and the distal segment
368 of the cord 358 are movable between a closed configuration
(FIG. 50) as described above (e.g., the distal segments 366 and 368
having a similar degree of curvature and being proximate to each
others and an open configuration (FIG. 51). As may be appreciated
from the open configuration of FIG. 51, the distal segment 366 of
the snare member 356 and the distal segment 368 of the cord 358 are
distanced from each other to establish a gap and/or loop 370.
[0151] Then, as may be appreciated by FIG. 52, the gap 370 allows a
strap 372 to pass through the loop to be snared and/or cinched
between the distal segments 366 and 368. Note that the distal
segments 366 and 368 are movable between the open and closed
configurations by, e.g., manipulating tension in the cord 358.
Thus, for example, the cord 358 may have relatively less tension
exerted on it as shown in FIG. 50 and thus may conform to a degree
of curvature similar to the degree of curvature of the distal
segment 566, and also be proximate to the segment 366. Yet as shown
in FIGS. 51 and 52, the cord 358 may have relatively more tension
exerted on it when pulled by, e.g., a physician from the proximal
segment 364 of the assembly 350 to thereby pull the distal segment
368 of the cord 358 away from the distal segment 366 of the snare
member 356 to thus cause the distal segment 368 to have less of a
degree of curvature than the distal segment 366 and create the gap
370. Also note that in some embodiments, tension in the cord 358
may cause the distal segment 366 to have a greater degree of
curvature such that it may bend under the tension from the cord
358.
[0152] Then, after the strap 372 has passed at least partially
through the gap 370 as shown in FIG. 52, tension in the cord 358
may be eased and/or released such that the distal segment 368 of
the cord 558 again becomes proximate to the distal segment 366 and
also assumes a degree of curvature similar to the degree of
curvature of the distal segment 366. Retrieval of distal segment
366 and cord 358 into tube assembly 350 causes the strap 373 to
become trapped against distal end 354 and cinched for retrieval in
accordance with present principles.
[0153] Reference is now made to FIGS. 53-55, which illustrate
operational steps and tools for advancing the mesh laparoscopically
into a patient. These operational steps and tools may be used in
accordance with present principles, but are understood to be
particularly useful when an implant is too voluminous to be used
with the operational steps of FIGS. 46-49 when, e.g., a grasper
used in accordance with those operational steps and tools may not
be able to concurrently fit inside a tunnel with a relatively more
voluminous implant.
[0154] Accordingly, FIG. 53 shows an implant 374 with plural straps
376, where the implant 374 and straps 376 are understood to be
similar in function and configuration to the implants and straps
described above. A cord and/or string 378 are also shown in FIG.
53. A loop 380 may be formed with the cord 378 and may grasp a
center portion 390 of the implant 374 by, e.g., cinching it.
[0155] Still in reference to FIG. 53, the cord 378 extends away
from the loop 380 and into an open proximal funnel 382, and may in
fact extend through the funnel 382 and out of a distal end 284 of
the funnel 382. Thus, the loop 380 may cinch the center portion 300
and then, e.g., a physician may begin pulling the cord 378 and
hence the center portion 390 of the implant 374 into a proximal end
386 of the funnel 382. It is to be understood that the proximal end
586 has a wider diameter than the end 384 to thereby establish the
funnel shape.
[0156] Then, as may be appreciated from FIG. 54, the implant 374
continues to be pulled into the funnel 382, thereby causing the
implant 374 to fold inwardly on itself as it progressively enters
the funnel 382. In some embodiments, the implant 374 may assume a
cigar-like shape and may be advanced more easily info the funnel
882 by exerting, e.g., an angular and/or twisting motion on the
implant 374 as it is advanced into the funnel 882, Once
substantially advanced into the funnel 382 as shown in FIG. 54, the
funnel 382 and hence the implant 374 may be advanced into a trocar
assembly that itself is advanced into the insufflated abdomen of a
patient.
[0157] Accordingly, as shown in FIG. 55, the cord 378 may then be
pulled inside the patient's abdomen to pull the implant 374 through
the funnel 382 such that it completely exits the distal end 384 and
exits a trocar 388 at least partially surrounding the funnel 382.
Once advanced out of both the funnel 382 and trocar 384, the
implant 374 may unfold under material bias and/or be unfolded by,
e.g., a physician for positioning to cover a hernial defect in
accordance with present principles.
[0158] Last, note that in other exemplary embodiments, the cord 378
may not be used. Instead, the loop 380 may be secured to the center
portion 390 and then a surgical tool and/or cord may be advanced
from the end 284 through the funnel 382 to grasp the loop 380. The
surgical tool and/or cord may their be advanced back out of the end
284, thereby pulling the implant 374 through the funnel 382 in
accordance with present principles. Also, the cord 378 may be
removed after loading into funnel 382 and once inside the trocar
384, an instrument can be used to push the implant 374 into the
patient's abdomen.
[0159] Now in cross-reference to FIGS. 56 and 57, a pneumatic seal
400 is shown which in all essential respects is identical in
configuration and operation to the seal 56 shown in FIGS. 9 and 10,
with the following exceptions. The seal 400 is formed as s disk
with a flat top so that it appears rectangular in cross-section as
shown in FIG. 57. A disk-shaped patient adhesion side 402 is formed
opposite to a flat top 404, and an opening 406 may be centrally
formed in the top 404 as shown. The opening 406 may be covered by a
membrane if desired. The adhesion side 402 may be made of an
acrylic material in exemplary embodiments and may be disposed on an
adhesive pad 408 as shown.
[0160] The seal 400 includes a sealant chamber 410 which may be
empty or which may contain sealant according to description above
in relation to FIGS. 9 and 10. Additionally, disposed in the
chamber 410 just below the top is a valve 412 such as the duckbill
valve shown, in which sides 414 taper downwardly toward each other
to essentially establish a one-way valve from top to bottom through
which a puncturing instrument may be advanced. The sides 414 may be
circumscribed by a disk-shaped valve skirt 416 formed integrally
With the sides 414, and the skirt can be trapped between the top
404 and a circular flange 418 formed around the periphery of the
chamber 410 to hold the valve 412 in place within the chamber
410.
[0161] While the particular IMPLANT FOR HERNIA REPAIR is herein
shown and described in detail, it is to be understood that the
subject matter which is encompassed by the present invention is
limited only by the claims.
* * * * *