U.S. patent application number 17/157504 was filed with the patent office on 2021-05-27 for device for delivering grafts at a surgical site and method.
This patent application is currently assigned to Park Surgical Innovations, LLC. The applicant listed for this patent is Park Surgical Innovations, LLC. Invention is credited to Ashley B. Hancock, Tanner Hargens, David Park, Byron F. Smith.
Application Number | 20210153996 17/157504 |
Document ID | / |
Family ID | 1000005358856 |
Filed Date | 2021-05-27 |
![](/patent/app/20210153996/US20210153996A1-20210527-D00000.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00001.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00002.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00003.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00004.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00005.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00006.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00007.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00008.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00009.png)
![](/patent/app/20210153996/US20210153996A1-20210527-D00010.png)
View All Diagrams
United States Patent
Application |
20210153996 |
Kind Code |
A1 |
Park; David ; et
al. |
May 27, 2021 |
DEVICE FOR DELIVERING GRAFTS AT A SURGICAL SITE AND METHOD
Abstract
A device and method for delivering a synthetic mesh or graft for
anatomical repair at a defect site. A plurality of flexible arms is
connected to the synthetic mesh or graft. Grasping jaws are
individually controlled at or near a proximal end of the device for
connection of the graft and release of the graft at the surgical
site. The flexible arms, with graft attached are positioned through
a surgical incision to the defect site. An actuator positions the
flexible arms to assume a radial array at the surgical site,
unfolding and spreading the graft for attachment. The length of
each flexible arm is individually adjustable to adapt to the size
and shape of the graft selected for installation at the defect site
to repair the defect.
Inventors: |
Park; David; (Peachtree
Corners, GA) ; Hancock; Ashley B.; (Atlanta, GA)
; Smith; Byron F.; (Nashville, TN) ; Hargens;
Tanner; (Brentwood, TN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Park Surgical Innovations, LLC |
Peachtree Corners |
GA |
US |
|
|
Assignee: |
Park Surgical Innovations,
LLC
Peachtree Corners
GA
|
Family ID: |
1000005358856 |
Appl. No.: |
17/157504 |
Filed: |
January 25, 2021 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16029447 |
Jul 6, 2018 |
10898310 |
|
|
17157504 |
|
|
|
|
62529262 |
Jul 6, 2017 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2090/037 20160201;
A61B 17/0057 20130101; A61F 2002/0072 20130101; A61B 17/3468
20130101; A61F 2/0063 20130101; A61B 2017/00305 20130101; A61B
2017/00336 20130101; A61B 2017/0042 20130101; A61B 2017/00367
20130101; A61B 2017/00323 20130101 |
International
Class: |
A61F 2/00 20060101
A61F002/00; A61B 17/34 20060101 A61B017/34 |
Claims
1. A device for delivery of a graft for attachment to tissue,
comprising: an actuator; a plurality of flexible arms, wherein the
plurality of flexible arms is in communication with and moves in
response to movement of the actuator, wherein distal ends of the
plurality of flexible arms extend out of an opening in a distal end
of a shaft and movement of the actuator forms the plurality of
flexible arms as divergent from each other and divergent from a
center to form the distal ends of the plurality of flexible arms in
a radial array, wherein the center is the opening in the distal end
of the shaft; wherein a distal end of a first flexible arm of
plurality of flexible arms is length adjustable relative to a
length of a distal end of another flexible arm of the plurality of
flexible arms to differentiate a length of the distal end of the
first flexible arm from the length of the distal end of the another
flexible arm of the plurality of flexible arms.
2. A device for delivery of a graft for attachment to tissue as
described in claim 1, further comprising a brake, wherein each of
the plurality of flexible arms frictionally engages the brake, and
wherein the brake contacts the plurality of flexible arms and
resists length adjustability of the plurality of flexible arms.
3. A device for delivery of a graft for attachment to tissue as
described in claim 1, further comprising a brake, wherein the brake
comprises a plurality of channels formed therein, and each of the
plurality of flexible arms engages a channel of the plurality of
channels of the brake, and wherein each of the plurality of
flexible arms frictionally engages the brake, and wherein the brake
contacts the plurality of flexible arms and resists length
adjustability of the plurality of flexible arms.
4. A device for delivery of a graft for attachment to tissue as
described in claim 1, the plurality of flexible arms comprising
three flexible arms, wherein each of the three flexible arms
comprises a connector at the distal end of each of the three
flexible arms, and wherein each connector is constructed to open
and close, and each connector is constructed to close on a graft,
and the three flexible arms hold the graft in the radial array when
the actuator forms the distal ends of the plurality of flexible
arms into the radial array.
5. A device for delivery of a graft for attachment to tissue as
described in claim 1, the plurality of flexible arms comprising
three flexible arms, wherein each of the three flexible arms
comprises a connector at the distal end of each of the three
flexible arms, wherein each connector is constructed to open and
close, and each connector is constructed to close on a graft, and
the connectors and the three flexible arms hold the graft in the
radial array when the actuator forms the distal ends of the
plurality of flexible arms into the radial array, wherein each
connector of each of the three flexible arms is constructed to open
and close separately from every other connector, and a housing in
which the actuator is contained comprising three connector
actuators, wherein closing of each connector is remotely actuated
by a corresponding connector actuator of the three connector
actuators.
6. A device for delivery of a graft for attachment to tissue as
described in claim 1, the plurality of flexible arms comprising
three flexible arms, wherein each of the three flexible arms
comprises a connector at the distal end of each of the three
flexible arms, and wherein each connector is constructed to open
and close, and each connector is constructed to close on a graft,
and the connectors and the three flexible arms hold the graft in
the radial array when the actuator forms the distal ends of the
plurality of flexible arms into the radial array, wherein each
connector of each flexible arm of the three flexible arms is
constructed to open and close separately from every other
connector, a housing in which the actuator is contained comprising
three connector actuators, wherein opening of each connector is
remotely actuated by a corresponding connector actuator of the
three connector actuators, and each of the three connector
actuators operates independently of each of the other connector
actuators and independently of the actuator that forms the distal
ends of the plurality of flexible arms into the radial array,
wherein the housing comprises a release actuator, wherein the
release actuator actuates tension on a connector linkage and causes
the connector to close.
7. A device for delivery of a graft for attachment to tissue as
described in claim 1, wherein the actuator comprises a rack and
pinion, and rotation of the pinion by a lever of the actuator
actuates movement of the rack, and wherein the rack communicates
with the plurality of flexible arms and movement of the lever and
the rack of the actuator forms the distal ends of the plurality of
flexible arms into the radial array.
8. A device for delivery of a graft for attachment to tissue as
described in claim 1, further comprising a sheath positioned at an
end of the shaft and having a longitudinal split along a length
thereof, wherein the sheath is constructed to accommodate and
surround the distal ends of the plurality of flexible arms
positioned generally parallel to each other and a graft connected
to the plurality of flexible arms.
9. A device for delivery of a graft for attachment to tissue as
described in claim 1, the plurality of flexible arms comprising
three flexible arms and a connector at the distal end of each of
the three flexible arms, wherein each connector is constructed to
open and close, and each connector is constructed to close on a
graft, the device for delivery of a graft for attachment to tissue
further comprising a sheath having a longitudinal split along a
length thereof, wherein the sheath is constructed to accommodate
and surround the distal ends of the three flexible arms and a graft
connected to the three flexible arms; and wherein the distal ends
of each of the three flexible arms are positioned within the sheath
in a generally parallel relationship, and the sheath is constructed
and arranged to be inserted into a trocar.
10. A device for delivery of a graft for attachment to tissue as
described in claim 1, wherein the plurality of flexible arms are
positioned as a radial array as the shaft is removed from a
surgical site to remove the flexible arms from the surgical
site.
11. A device for delivery of a graft for attachment to tissue,
comprising: an actuator; a plurality of flexible arms and a
plurality of sleeves, wherein each sleeve of the plurality of
sleeves surrounds a portion of one of the flexible arms of the
plurality of flexible arms, and a distal end of each of the
flexible arms extends out of a distal end of the sleeve of the
plurality of sleeves that surrounds the flexible arm; wherein the
plurality of sleeves are in communication with and move in response
to movement of the actuator, wherein distal ends of the sleeves
extend out of an opening in a distal end of a shaft, and movement
of the actuator forms the distal ends of the plurality of sleeves
as divergent from a center to form the distal ends of the plurality
of flexible arms in a radial array, wherein the center is the
opening in the distal end of the shaft; wherein a distal end of a
first flexible arm of plurality of flexible arms is length
adjustable relative to a length of a distal end of another flexible
arm of the plurality of flexible arms to differentiate a length of
the first flexible arm from the length of the another flexible arm
of the plurality of flexible arms.
12. A device for delivery of a graft for attachment to tissue as
described in claim 11, further comprising a brake, wherein each of
the plurality of flexible arms frictionally engages the brake, and
wherein the brake contacts the plurality of flexible arms and
resists length adjustability of the plurality of flexible arms.
13. A device for delivery of a graft for attachment to tissue as
described in claim 11, further comprising a brake, wherein the
brake comprises a plurality of channels formed therein, and each of
the plurality of flexible arms engages a channel of the plurality
of channels of the brake, and wherein each of the plurality of
flexible arms frictionally engages the brake, and wherein the brake
contacts the plurality of flexible arms and resists length
adjustability of the plurality of flexible arms.
14. A device for delivery of a graft for attachment to tissue as
described in claim 11, the plurality of flexible arms comprising
three flexible arms, wherein each of the three flexible arms
comprises a connector at the distal end of each of the three
flexible arms, and wherein each connector is constructed to open
and close, and each connector is constructed to close on a graft,
and the three flexible arms hold the graft in the radial array when
the actuator forms the distal ends of the plurality of flexible
arms into the radial array.
15. A device for delivery of a graft for attachment to tissue as
described in claim 11, the plurality of flexible arms comprising
three flexible arms, wherein each of the three flexible arms
comprises a connector at the distal end of each of the three
flexible arms, wherein each connector is constructed to open and
close, and each connector is constructed to close on a graft, and
the connectors and the three flexible arms hold the graft in the
radial array when the actuator forms the distal ends of the
plurality of flexible arms into the radial array, wherein each
connector of each of the three flexible arms is constructed to open
and close separately from every other connector, and a housing in
which the actuator is contained comprising three connector
actuators, wherein closing of each connector is remotely actuated
by a corresponding connector actuator of the three connector
actuators.
16. A device for delivery of a graft for attachment to tissue as
described in claim 11, the plurality of flexible arms comprising
three flexible arms, wherein each of the three flexible arms
comprises a connector at the distal end of each of the three
flexible arms, and wherein each connector is constructed to open
and close, and each connector is constructed to close on a graft,
and the connectors and the three flexible arms hold the graft in
the radial array when the actuator forms the distal ends of the
plurality of flexible arms into the radial array, wherein each
connector of each flexible arm of the three flexible arms is
constructed to open and close separately from every other
connector, a housing in which the actuator is contained comprising
three connector actuators, wherein opening of each connector is
remotely actuated by a corresponding connector actuator of the
three connector actuators, and each of the three connector
actuators operates independently of each of the other connector
actuators and independently of the actuator that forms the distal
ends of the plurality of flexible arms into the radial array,
wherein the housing comprises a release actuator, wherein the
release actuator actuates tension on a connector linkage and causes
the connector to close.
17. A device for delivery of a graft for attachment to tissue as
described in claim 11, wherein the actuator comprises a rack and
pinion, and rotation of the pinion by a lever of the actuator
actuates movement of the rack, and wherein the rack communicates
with the plurality of flexible arms and movement of the lever and
the rack of the actuator forms the distal ends of the plurality of
flexible arms into the radial array.
18. A device for delivery of a graft for attachment to tissue as
described in claim 11, further comprising a sheath positioned at an
end of the shaft and having a longitudinal split along a length
thereof, wherein the sheath is constructed to accommodate and
surround the distal ends of the plurality of flexible arms
positioned generally parallel to each other and a graft connected
to the plurality of flexible arms.
19. A device for delivery of a graft for attachment to tissue as
described in claim 11, the plurality of flexible arms comprising
three flexible arms and a connector at the distal end of each of
the three flexible arms, wherein each connector is constructed to
open and close, and each connector is constructed to close on a
graft, the device for delivery of a graft for attachment to tissue
further comprising a sheath having a longitudinal split along a
length thereof, wherein the sheath is constructed to accommodate
and surround the distal ends of the three flexible arms and a graft
connected to the three flexible arms; and wherein the distal ends
of each of the three flexible arms are positioned within the sheath
in a generally parallel relationship, and the sheath is constructed
and arranged to be inserted into a trocar.
20. A device for delivery of a graft for attachment to tissue as
described in claim 11, wherein the actuator applies a pulling force
to the plurality of sleeves, and the pulling force forms the distal
ends of the plurality of sleeves as divergent from the center to
form the distal ends of the plurality of flexible arms into the
radial array.
Description
[0001] This Application is a continuation of application Ser. No.
16/029,447 filed Jul. 6, 2018, which claims the benefit of U.S.
Provisional Application Ser. No. 62/529,262 filed Jul. 6, 2017.
BACKGROUND OF THE INVENTION
[0002] Biological grafts and synthetic mesh are used to repair
anatomical defects, such as hernias. Delivery of the mesh or graft
into body cavities either requires invasive surgery, or heretofore
unsatisfactory laparoscopic methods.
[0003] Hernias are structural defects most commonly involving the
musculofascial tissues of the abdominal and pelvic regions within
the human body. Most hernias eventually require surgical repair.
Surgical repair of ventral incisional hernias may be accomplished
via an "open method." This method involves making a sizable
incision directly over the tissue defect, separating the contents
of the hernia away from the musculofascial defect, and repairing
the defect primarily using sutures, or more commonly, sewing a
graft to the defect edge in tension-free manner. This is done in an
effort to minimize the recurrence of hernia formation which may
occur with some frequency. The recurrence may be due to multiple
factors including general health of the patient, surgical
technique, and types of mesh or graft utilized. Overall, this
traditional method is effective, but also often involves more pain,
long periods of disability following the surgery, higher
perioperative infection rates, and an established hernia recurrence
rate.
[0004] Alternatively, ventral incisional hernias may be repaired
using the "laparoscopic method." However, this method has its own
set of major shortcomings principally related to higher degree of
difficulty in performing this procedure. One of the major
challenges involve graft introduction into the abdominal cavity.
Typically, a graft is rolled tightly into a cylindrical
configuration and subsequently, pushed/pulled through the trocar
which can be both time consuming and frustrating, especially when a
larger graft is needed to cover the defect. This maneuver can also
damage the graft during the delivery due to excessive force used or
needed during the delivery process. Some surgeons also elect to
place multiple sutures within the periphery of the graft for
transfascial securement. This is often done prior to introduction
of the graft. Once delivered into the abdominal cavity, the rolled
graft/suture combination is unrolled, sutures isolated into
respective corresponding abdominal quadrants, and the graft is
centered over the defect prior to fixation. These steps are often
very challenging and frustrating to accomplish in an efficient
manner due to the pliable property of the graft and sutures which
is a desired characteristic.
SUMMARY OF THE INVENTION
[0005] The present invention is a device and method for delivering
a synthetic mesh or graft for anatomical repair at a defect site. A
plurality of flexible arms is connected to the synthetic mesh or
graft. Grasping jaws are individually controlled at or near a
proximal end of the device for connection of the graft and release
of the graft at the surgical site. The flexible arms, with graft
attached are positioned through a surgical incision to the defect
site. An actuator positions the flexible arms to assume a radial
array at the surgical site, unfolding and spreading the graft for
attachment. The length of each flexible arm is individually
adjustable to adapt to the size and shape of the graft selected for
installation at the defect site to repair the defect.
BRIEF DESCRIPTIONS OF THE DRAWINGS
[0006] FIG. 1 is a side elevation of an embodiment of the
invention.
[0007] FIG. 2 shows the embodiment of FIG. 1 with the flexible arms
4 in a deployed position.
[0008] FIG. 3 shows flexible arms of the embodiment of FIG. 1 with
the grasping jaws 24 at an end of each flexible arm in an open
position for receiving a graft.
[0009] FIG. 4A is a sectioned view in an embodiment similar to that
of FIG. 1 showing the actuation mechanism for extending and
retracting the flexible arms with the flexible arms extended.
[0010] FIG. 4B is a sectioned view of the embodiment of the
invention shown in FIG. 4A with the flexible arms retracted.
[0011] FIG. 5 is a sectioned view of an embodiment of the invention
showing actuators in housing 16.
[0012] FIG. 6A is an elevation of an embodiment of the invention
taken from a proximal end of the invention.
[0013] FIG. 6B demonstrates a cover for the housing removed from
the device.
[0014] FIG. 7 is an elevation of one side of an embodiment of the
invention with the cover removed from housing 16.
[0015] FIG. 8 is an enlarged isolation of a portion of the
actuators for grasping jaws 24.
[0016] FIG. 9 is an isolation of an embodiment of a grasping jaw
24.
[0017] FIG. 10A and FIG. 10B are isolations of a portion of the
actuator for the grasping jaws sectioned to demonstrate the action
of release button 32.
[0018] FIG. 11A shows the device according to an embodiment of the
invention with a graft affixed to it.
[0019] FIG. 11B is a side sectioned view of a seal that slidably
attaches to a shaft of the device for sealing a trocar.
[0020] FIG. 12 demonstrates attachment of the graft to the
embodiment of the device as shown in the drawing figures.
[0021] FIG. 13A shows a sheath that covers the graft to facilitate
insertion of the graft and a portion of the device through a trocar
and into the surgical site.
[0022] FIG. 13B demonstrates a step of opening of a split in the
sheath for insertion of the device with graft into the sheath.
[0023] FIG. 13C shows the step of positioning the device with graft
into the sheath.
[0024] FIG. 13D shows the device with graft in the sheath and
surrounding the sheath.
[0025] FIGS. 14A-14C demonstrate deployment of the graft through a
trocar and into the surgical site using the device according to an
embodiment of the device.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0026] Turning now to the drawing figures, FIG. 1 shows an
embodiment of a delivery device for delivering a graft or synthetic
mesh for attachment to tissue. The term "graft" is used herein to
indicate either a graft formed of biological material, or a
synthetic mesh. The graft is connected to a plurality of flexible
arms 4. The flexible arms as shown in FIG. 1 extend from in a tube
or shaft 6. The flexible arms are shown as being generally parallel
to a central axis of the shaft. Since the flexible arms are
flexible, some bending of the flexible arms means that they may not
be strictly parallel, but are generally parallel, to the axis of
travel of the rack 22 of the actuator while the flexible arms are
in the position shown in FIG. 1.
[0027] FIG. 1 and FIG. 2 show the device for delivery of graft for
attachment to tissue, according to an embodiment, prior to
deployment of the graft. Control wires 10 are actuated to pull
against sleeves 8 that surround a portion of the flexible arms 4.
The control wires extend through the shaft but may be external to
the flexible arms as shown in FIG. 1 and FIG. 2, or they may be
internal to the flexible arms. The control wires are connected to
the sleeves at or near a distal end of the sleeves and control
wires. In a preferred embodiment, each of the plurality of control
wires is associated with one of the plurality of the flexible arms.
Upon actuation, the control wires pull against the sleeves at the
point of attachment to the sleeves. The force of the control wires
acting on the sleeves pulls the flexible arms from the position
shown in FIG. 1 and into a radial array as demonstrated in FIG. 2.
The control wires are preferred to be nitinol wires, but the
control wires may be formed of other metals, or plastics, textile
materials or polymers, or similar materials having sufficient
strength and flexibility.
[0028] As used herein, "proximal" is closest to the operator of the
device and "distal" will typically be away from the operator and
toward the patient when the device is in use.
[0029] The actuator construct shown in FIG. 4A and FIG. 4 B pulls
the control wires 10, moving the flexible arms 4 to form a radial
array (FIG. 2). This action unfolds the graft to a spread and
generally planar position. In a preferred embodiment, when the
travel of the actuator lever 18 is fully exhausted, the flexible
arms may be positioned at an angle of somewhat more than 90.degree.
from the axis of travel of the actuator, or the central axis of the
shaft. FIG. 14 shows the flexible arms as positioned at an angle of
more than 90.degree. from the central axis of the shaft. In some
embodiments, this angle could be up to 120.degree. from the
generally parallel position of the flexible arms shown in FIG. 1.
The actuator may be designed to allow the operator to set the
desired angle. In some embodiments, the angle may be at least
100.degree. and perhaps more, so that the edges, or periphery, of
the graft are pulled against the defect of the patient for
subsequent securing or suturing of the graft.
[0030] According to one embodiment of the invention, the device may
comprise a housing 16 having a trigger or actuator lever 18. The
housing may form a housing for the mechanism of the invention,
including the actuator construct for the control wires 10. At the
distal end of the device is the plurality of spaced-apart flexible
arms 4 that terminate at the connectors for the graft, which may be
grasping jaws 24.
[0031] The flexible arms 4 are preferred to be formed of a flexible
cable. The cable may be a hollow cable formed of coiled or
spirally-wound material which is capable of repetitive flexing and
bending. The cable may comprise stainless steel suitable for use in
surgical applications. The cables are sufficiently flexible to form
the radial array shown in FIG. 2 when a force is applied by the
control wires to the sleeves 8, but return to a flaccid condition
as shown in FIG. 1 as the control wires cease pulling the flexible
arms to the radial array. The flexible arms are preferred to be
flexible along their entire length, without having preformed bends
or angles that may tend to dictate a path of travel as the flexible
arms are withdrawn from the surgical site. The flexible cables used
with the sleeves (that are also flexible) and the control wires
allow the cables to follow the anatomical structure or host tissue,
or a trocar, as a path of travel as the flexible arms are pulled
away from the graft. The sleeves may also be formed of hollow cable
that is constructed and arranged to surround the flexible arms as
shown in the drawing figures. Rigid members, rather than flexible
cables, may tend to resist removal, due to anatomical structure or
host tissue interfering with the path of travel. The flexible arms
and the sleeves are preferred to have shape memory that allows them
to return to about the shape shown in FIG. 1 or FIG. 14A when the
control wires are not actuated to apply a force upon the flexible
arms,
[0032] The embodiment as shown in FIGS. 1 and 2 has four (4)
flexible arms 4. At least three (3), and preferably four (4) or
more, flexible arms are employed. The flexible arms must be able to
deploy and spread out the graft for attachment to tissue as shown
in FIG. 14C.
[0033] The flexible arms are formed in a radial array by force
applied by the plurality of control wires 10. One control wire is
associated with each flexible arm. The control wires pull against
the sleeves 8 and the flexible arms to form the radial array. FIG.
2. As shown in FIG. 1, the flexible arms are substantially parallel
to each other as they extend from shaft 6 of housing 16. No
substantial tension is applied to the control wires in this
configuration. The device with graft attached may be inserted into
the surgical site incision in this configuration.
[0034] In FIG. 2, the control wires 10 are actuated to pull against
the sleeves 8, forming the flexible arms 4 into a radial array. In
use, the graft 2 is positioned on the flexible arms and the graft
expanded for attachment by movement of the flexible arms into the
radial array.
[0035] In an embodiment as shown in FIGS. 4A and 4B, the control
wires are actuated simultaneously by the actuator construct
contained in housing 16. An actuation lever 18 engages and rotates
the ideal gear 22. The ideal gear 22 moves the rack gear 20
upwardly, applying a pulling pressure to the control wires 10 to
form the flexible arms into the radial array. The ideal gear and
the rack gear form a rack and pinion construct.
[0036] Latch 26 has interlocking members that engage with each
other to hold the flexible arms in the radial array when the rack
gear reaches its fully upward position. The interlocking members
each comprises hook that interlocks with the corresponding hook.
The graft is thereby held in a position for surgical attachment. A
flexible arm release lever 28 pushes an interlocking member of the
latch away from an interlocking member that may be formed on the
rack gear 20 to release the control wires. With no tension or
pulling force on the control wires, the flexible arms return to
generally the position of FIG. 1. With tension released on the
control wires, the flexible arms may be withdrawn through a trocar
and/or surgical incision.
[0037] In the embodiment of the device shown in FIGS. 1 through 3,
connectors 24 are positioned at or near the end of the flexible
arms and are used to hold the graft for deployment. The connectors
close upon the graft 2 to hold the graft. The connectors may be in
the form of grasping jaws 24 in one embodiment that are actuated to
close and open by pulling and releasing a connector strand, which
may be a wire activation cable, or pull wire 56. A connector
actuator construct as shown in FIG. 7, FIG. 8 and FIG. 10
communicates with the pull wire to open and close the connectors or
grasping jaws for attachment and release of the graft. The
connector actuator comprises a shuttle 40 in a preferred embodiment
that ends with a control button 30 that extends from an end of the
housing. The control button may be unitary with the shuttle, since
depressing the control button (FIG. 8) moves the shuttle to open
the connectors or grasping jaws. In this embodiment, each control
button and shuttle is associated with one flexible arm 4 and its
associated grasping jaw. Each control button is associated with one
grasping jaw. Actuating, or depressing, a control button associated
with a grasping jaw causes it to open. Preferably, the control
buttons are formed to individually lock the grasping jaws in an
open position when the control button in depressed (FIG. 3).
[0038] FIG. 5 is a top, sectioned view of the housing 16, showing
two compartments, with one compartment on each side. The
compartments may be separated by a divider 34. The lower
compartment of the housing, when viewing FIG. 5, contains the
mechanism of FIG. 4A and FIG. 4B and applies a force to sleeves 8
by control wires 10. This mechanism actuates the flexible arms 4 to
pull the flexible arms into the radial array, or release the
flexible arms.
[0039] The upper side of the housing as shown in FIG. 5 has a
cavity 36 to store a portion of the flexible arms as the length of
the flexible arms is adjusted for the specific application of a
graft. The length of the flexible arms 4 may be adjusted by
manually pulling or pushing the flexible arms into or out of the
housing 16. Cavity 36 of the housing stores excess length of the
flexible arms. The length adjustment feature is useful to adjust
the size of the arm array to the dimensions, and particularly the
perimeter, of the graft, so that the radial array of the device
fits the graft and pulls the graft tight, but not tight enough to
deform the flexible arms of the radial array. A frictional braking
device 38 (FIG. 6B) is preferred to be positioned near the
entry/exit of the cavity 36 of the housing to apply friction to the
flexible arms. The frictional braking device applies friction to
each flexible arm that is sufficient to allow a length of each of
the flexible arms to be pushed into or pulled from the housing,
while preventing unwanted withdrawal or insertion of the flexible
arms relative to the housing. The frictional braking device may be
opposing sheets of vinyl, rubber, or similar compressible materials
through which the flexible arms pass, and which applies a
frictional force on the flexible arms. In a preferred embodiment,
the frictional braking device has openings or conduits equal in
number to the number of flexible arms. Each flexible arm engages
one of the conduits and the conduit applies a frictional force to
the flexible arm to retard but not prevent movement of the flexible
arm into and out of the cavity as described. A cover of the housing
may have protrusion(s) or boss(es) 72 formed thereon that applies
pressure to deform the braking device and conduits for the
application of frictional pressure to the flexible arms.
[0040] By the control wires 10 acting on the sleeves, with the
flexible arms 4 being slidable relative to the sleeves 8, the
length of the portion of the flexible arms that extend from the
distal end of the device may be altered while still providing a
workable mechanism for forming the radial array irrespective of the
length of each flexible arm that is chosen. Separate mechanisms are
provided for controlling the length of the flexible arms and
opening and closing of the grasping jaws on one side of the housing
16 and the actuation of the sleeves to form the radial array on the
other side of the housing.
[0041] The graft 2 is attached about its perimeter to each of the
flexible arms 4. The graft is attached at spaced apart intervals so
that the graft is formed in a radial array when the control wires
are actuated. A portion of the graft is inserted between each open
connector, which is a grasping jaw 24 in the embodiment shown.
After insertion of a portion of the graft into the open grasping
jaw, the grasping jaw is closed by releasing tension on the
connector strand to hold the graft. The control buttons 30 are
released from their locked positions by one or more release buttons
32. FIG. 10A, 10B. In a preferred embodiment, the grasping jaws 24
each have a separate control button 30 and release button 32 so
that the grasping jaws can each be independently opened and
closed.
[0042] FIG. 7 shows housing 16 with flexible arms 4 attached to the
grasping jaws 24, and extending from the cavity 36 of the housing
and though shaft 6. This construct communicates with control
buttons 30 to open the grasping jaws, which are normally closed.
Anchor sites 46 for the flexible arms 4 are shown.
[0043] FIG. 8 is enlarged to show the detail of a preferred
structure of the anchor sites. Shuttle 40 communicates with an
associated control button 30. A set screw 42 connects pull wire 56
to the shuttle. A compression spring 44 tensions the control wire
to hold the grasping jaw closed. An anchoring collar 46 for the
flexible arm is provided. Depressing release button 32 (FIG. 10B)
allows the shuttle to be pushed proximally to compress the spring
44 and close the grasping jaws by providing tension on the pull
wire.
[0044] FIG. 9 shows detail of an embodiment of the grasping jaws
24. The grasping jaws may have an upper tooth 48 and a lower tooth
50 as shown, each of which pivot about a pivot pin 52. The upper
tooth and the lower tooth may be housed in the jaw housing 54. A
pair of pull wires 56 that may be internal to the flexible arm 4
contract to open and close. The grasping jaws are preferred to be
normally closed. Springs 44 apply tension to the pull wires so that
the grasping jaws are closed until the shuttle 40 via control
buttons 30 push the springs forward to relieve tension on the pull
wires.
[0045] FIGS. 10A, 10B show the interaction between an embodiment of
the shuttle 40 and release button 32. As shown in FIG. 10A, the
shuttle is pushed forward by pressing control button 30. This
action depresses spring 44 and opens the grasping jaw. An end of
release button 32 engages an opening in the shuttle due to shape
memory properties of the release button, locking the shuttle in
place with the grasping jaw open.
[0046] Depressing release button 32 disengages the end of the
release button. Spring 44 causes the shuttle to move from the
position of FIG. 10A to the position of FIG. 10B. Expanded spring
44 applies tension to the pull wires 56 to close the grasping jaws
24. In the embodiment shown, a release button 32 is provided for
each flexible arm and associated grasping jaw. However, a bridge
could be provided so that the grasping jaws may be universally
closed at once. After the grasping jaws are closed on the graft 2,
the graft is held in place by the grasping jaws 24. After surgical
attachment of the graft, the control buttons are actuated to
release the graft from the grasping jaws. The control wires 10 are
also released from tension by the actuator construct, and the
device is removed through the surgical site incision.
[0047] FIG. 12 demonstrates the graft being attached to the device.
The grasper jaws are opened using the control buttons 30. In this
embodiment, the graft is connected at four (4) points to the
flexible arms using the grasper jaws and generally about the
perimeter of the graft. The grasper jaws are closed on the graft to
hold the graft. The actuator is used to place the flexible arms in
an orientation with the flexible arms generally parallel to each
other for insertion through a trocar and into the surgical
site.
[0048] A sheath 64 for facilitating insertion of the flexible arms
and graft into the trocar and to the surgical site is shown.
Figs.13A-13D. The sheath in this embodiment is a split tube that
may be transparent or translucent. The sheath is preferred to be
tapered, or have a frusto-conical shape that tapers or
progressively reduces in diameter from left to right when viewed as
in the drawing figures. A stand 68 holds an end of the sheath open
at the split. A bullet shaped tool 66 having a diameter that is
larger than the middle of the sheath may be used to slide from the
end of the sheath that is adjacent to the stand and along the
sheath to the opposite end, forcing the sheath to open about the
split. FIG. 13B. The sheath is open at the split to a width that
permits insertion of the flexible arms and the graft. The sheath,
attached to the device, is placed into the sheath through the
split. The sheath and the device are removed from the stand for
insertion into a trocar.
[0049] FIGS. 11A, 14A show a seal 62 mounted to the shaft 6. The
seal engages the trocar and the shaft to form a seal, inhibiting
gasses from escaping the belly of the patient. FIG. 14B. An O-ring
may be present about a circumference 70 of the seal to improve
sealing.
[0050] In use, according to one embodiment, a section of graft 2 of
appropriate size to repair the subject hernia is selected and/or
formed. FIG. 12. The graft may be formed (of various biological
materials or, synthetic materials, including, but not limited to
polypropylene or polytetrafluoroethylene (PTFE). The graft is
connected near its perimeter to the connectors near the distal ends
of the flexible arms. Each flexible arm is preferred to have a
connector, such as grasping jaws 24. The activation lever 18 is in
the position shown in FIG. 1, with the flexible arms positioned
generally parallel to the axis of travel of the actuator. The graft
is held by the flexible arms and folded. The graft is preferred to
be covered by the sheath 64 for insertion into the trocar.
[0051] An incision in tissue 84 of the patient is made at the
approximate center of the defect. Preferably, a trocar 82 is
present within the incision. FIGS. 14A-C. The flexible arms of the
device in a generally parallel orientation are inserted through the
approximate center of the defect. FIG. 14A. The sheath 64
facilitates insertion of the graft 2 into the trocar, and protects
the graft as it moves through the trocar to the surgical site. FIG.
14B. After the distal end of the device with graft attached travels
through the trocar, and sufficient clearance through the defect 80
is obtained, the actuator, such as the gear train of FIG. 4A, is
actuated causing the actuator to pull the control wires 10, the
flexible arms 4 and associated graft to the position shown in FIG.
14. The graft is pulled up against the tissue by means of the
handle of the device to cover the hernia defect 80. Graft
attachment to the tissue may be provided by known methods of
attachment of grafts at surgical sites such as hernia defects. The
procedure may be monitored by use of a laparoscope for proper
positioning, and securing, of the graft.
[0052] The graft is formed to generally a planar form when the
flexible arms form the radial array. As noted, the flexible arms
may move through an arc that is more than 90.degree.. Therefore,
the surface of the graft may be somewhat curved or non-planar, so
that the edges or periphery of the graft is pushed against the
tissue and secured to the tissue to cover the defect. However, the
graft is still considered to be in a generally planar position.
[0053] After the connectors 24 are released from the graft as
described above, tension is released from the control wires 10. The
flexible arms return to the position shown in FIG. 1, FIG. 14A. The
device may now be removed by pulling it upwardly through the trocar
and away from the incision. The flexible arms, by being flexible
along their length, with no preformed angles, kinks or similar
geometry, are sufficiently flexible to follow a path of retreat
from the fully extended position of FIG. 2 to the position shown in
FIG. 1, without disrupting the sutured graft, while also being
sufficiently rigid to support the graft for positioning and
securement at the defect site.
* * * * *