U.S. patent application number 15/430092 was filed with the patent office on 2017-08-17 for mesh for hiatal hernia repair and deployment device.
The applicant listed for this patent is Sanford Health. Invention is credited to Curtis Peery.
Application Number | 20170231741 15/430092 |
Document ID | / |
Family ID | 58057356 |
Filed Date | 2017-08-17 |
United States Patent
Application |
20170231741 |
Kind Code |
A1 |
Peery; Curtis |
August 17, 2017 |
MESH FOR HIATAL HERNIA REPAIR AND DEPLOYMENT DEVICE
Abstract
The present disclosure provides a deployment device that
includes (a) an elongate shaft having a first end and a second end,
(b) a grasping assembly coupled to the first end of the elongate
shaft, where the grasping assembly includes a first jaw and a
second jaw rotatable with respect to the elongate shaft, where the
grasping assembly is configured to accept a wound closure device
between the first jaw and the second jaw, where the wound closure
device comprises at least two fixation components connected to and
extending therethrough, where each of the first jaw and the second
jaw include at least one coupling element configured to be
removably coupled to a respective fixation component when the wound
closure device is coupled to the grasping assembly, and (c) an
actuator coupled to the second end of the elongate shaft, where the
actuator is configured to move the grasping assembly between an
open position and a closed position.
Inventors: |
Peery; Curtis; (Sioux Falls,
SD) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sanford Health |
Sioux Falls |
SD |
US |
|
|
Family ID: |
58057356 |
Appl. No.: |
15/430092 |
Filed: |
February 10, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62294504 |
Feb 12, 2016 |
|
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|
Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 34/30 20160201;
A61F 2250/0067 20130101; A61B 2017/0648 20130101; A61B 2017/2926
20130101; A61B 2017/00473 20130101; A61B 2017/00858 20130101; A61B
2017/00477 20130101; A61B 2017/2946 20130101; A61B 17/068 20130101;
A61F 2220/0016 20130101; A61B 2017/00876 20130101; A61F 2220/0008
20130101; A61B 17/29 20130101; A61L 31/146 20130101; A61B 17/2909
20130101; A61F 2002/0068 20130101; A61F 2210/0076 20130101; A61F
2/0063 20130101; A61B 2017/0647 20130101; A61B 17/064 20130101;
A61F 2002/0072 20130101; A61B 17/00234 20130101 |
International
Class: |
A61F 2/00 20060101
A61F002/00; A61B 17/00 20060101 A61B017/00; A61B 34/30 20060101
A61B034/30; A61B 17/29 20060101 A61B017/29 |
Claims
1. A deployment device, comprising: an elongate shaft having a
first end and a second end; a grasping assembly coupled to the
first end of the elongate shaft, wherein the grasping assembly
includes a first jaw and a second jaw rotatable with respect to the
elongate shaft, wherein the grasping assembly is configured to
accept a wound closure device between the first jaw and the second
jaw, wherein the wound closure device comprises at least two
fixation components connected to and extending therethrough,
wherein each of the first jaw and the second jaw include at least
one coupling element configured to be removably coupled to a
respective fixation component when the wound closure device is
coupled to the grasping assembly; and an actuator coupled to the
second end of the elongate shaft, wherein the actuator is
configured to move the grasping assembly between an open position
and a closed position.
2. The deployment device of claim 1, wherein the wound closure
device includes a biocompatible mesh.
3. The deployment device of claim 2, wherein the biocompatible mesh
comprises a microreplicated mesh.
4. The deployment device of claim 2, wherein the mesh comprises a
multilayer mesh, wherein at least one layer of the multilayer mesh
comprises a microreplicated material.
5. The deployment device of claim 1, wherein the fixation component
comprises a tack connected to the wound closure device.
6. The deployment device of claim 1, wherein the fixation component
comprises at least one protrusion configured to penetrate a tissue
surface.
7. The deployment device of claim 6, wherein the at least one
protrusion comprises at least one barb extending away from a body
of the fixation component.
8. The deployment device of claim 1, wherein the at least one
coupling element of the first jaw and the second jaw comprises at
least one pin configured to removably couple with the fixation
component connected to the wound closure device.
9. The deployment device of claim 8, wherein the at least one pin
comprises at least two pins, wherein a first fixation component of
the at least two fixation components is configured to removably
couple with the at least one pin extending from the first jaw and
wherein a second fixation component of the at least two fixation
components is configured to removably couple with the at least one
pin extending from the second jaw.
10. The deployment device of claim 8, wherein each pin is
configured to be received in an axial hole extending through the
fixation component.
11. The deployment device of claim 8, wherein each pin has a
greater length than the fixation component, such that an end of the
pin extends beyond an end of the fixation component when coupled
thereto.
12. The deployment device of claim 11, wherein the end of the pin
that extends beyond the end of the fixation component includes a
tapered end configured to penetrate a tissue surface.
13. The deployment device of claim 12, wherein the tapered end
includes three cutting edges.
14. The deployment device of claim 8, wherein the at least one pin
extending from the first jaw and the at least one pin extending
from the second jaw do not overlap when the grasping assembly is in
the closed position.
15. The deployment device of claim 1, wherein the at least one
coupling element of the first jaw and the second jaw comprises a
hole configured to receive a pin of a respective fixation component
connected to the wound closure device.
16. The deployment device of claim 1, wherein the at least one
coupling element of the first jaw and the second jaw comprises a
first magnet configured to attract a second magnet of a respective
fixation component connected to the wound closure device.
17. The deployment device of claim 1, further comprising a release
mechanism configured to release the fixation component coupled to
the coupling element on each of the first jaw and the second jaw
when the wound closure device is coupled to the grasping
assembly.
18. The deployment device of claim 1, wherein each of the first jaw
and the second jaw rotate with respect to the other.
19. The deployment device of claim 1, wherein each of the first jaw
and the second jaw comprises a proximal jaw segment and a distal
jaw segment, wherein the distal jaw segment is rotatable with
respect to the proximal jaw segment.
20. A method of closing a wound in a tissue surface, the method
comprising: bringing a wound closure device coupled to a deployment
device adjacent to the tissue surface; wherein the wound closure
device comprises at least two fixation components connected to and
extending therethrough; and wherein the deployment device
comprises: an elongate shaft having a first end and a second end, a
grasping assembly coupled to the first end of the elongate shaft,
wherein the grasping assembly includes a first jaw and a second jaw
rotatable with respect to the elongate shaft, wherein the grasping
assembly is configured to accept a wound closure device between the
first jaw and the second jaw; and an actuator coupled to the second
end of the elongate shaft, wherein the actuator is configured to
move the grasping assembly between an open position and a closed
position; with the grasping assembly in the open position, bringing
the wound closure device into abutment with the tissue surface,
bringing the grasping assembly into the closed position around a
portion of the tissue surface such that the at least two fixation
components pierce the tissue surface, thereby affixing the wound
closure device to the tissue surface.
21. The method of claim 20, wherein each of the first jaw and the
second jaw comprise at least one coupling element configured to be
removably coupled to a respective fixation component when the wound
closure device is coupled to the grasping assembly.
22. The method of claim 21, wherein the at least one coupling
element of the first jaw and the second jaw comprises at least two
pins configured to removably couple with a respective fixation
component connected to the wound closure device.
23. The method of claim 21, wherein bringing the grasping assembly
into the closed position around the portion of the tissue surface
causes the at least two pins to pierce the surface tissue.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of priority to U.S.
Provisional Application No. 62/294,504 entitled "Mesh for Hiatal
Hernia Repair and Deployment Device," filed on Feb. 12, 2016, the
contents of which are hereby incorporated by reference in their
entirety.
BACKGROUND THE INVENTION
[0002] The diaphragm is the muscular wall separating the thoracic
cavity from the abdominal cavity. The hiatus is a hole in the
diaphragm through which the esophagus passes. When an internal
tissue expands into an area it does not belong, it is known as a
hernia. In a hiatal hernia, the stomach (which is normally in the
abdominal cavity) extrudes through the hiatus and into the thoracic
cavity. There are two types of hiatal hernias: (i) a sliding hiatal
hernia, and (ii) a paraesophageal hiatal hernia. In a sliding
hernia, the esophagus and stomach both move cranially through the
hiatus. In a paraesophageal hernia, the stomach moves cranially
through the hiatus relative to the esophagus. This movement can
cause pinching or strangulation of the stomach which can cause
localized ischemia which can be life threatening.
[0003] A hiatal hernia is caused by either a naturally large hiatus
or increased abdominal pressure from pregnancy or obesity. In one
example, a hiatal hernia can be diagnosed via x-ray with barium
swallow, which allows visualization of the esophagus. In another
example, a hiatal hernia can be diagnosed with endoscopy. When a
physician believes that the stomach is at risk of constriction or
strangulation, the hiatal hernia needs to be surgically repaired.
The procedure to repair a hiatal hernia is referred to as reducing
the hernia, which essentially entails putting the stomach back
where it belongs. Open surgery is very invasive in this setting and
should be avoided. Laparoscopic approaches allow for a `minimally
invasive` option. In the laparoscopic approach, a laparoscope is
inserted through a 5-10 mm incision, and allows the surgeon to
visualize the hernia while also repairing it. Advantages of
laparoscopic surgery include smaller incision, less risk of
infection, less pain and scarring, and a quicker recovery.
[0004] In paraesophageal hernia repair, a left side transthoracic
laparoscopic access is performed. The hernia sac is dissected off
the intrathoracic structures of the mediastinum. Once the sac is
mobilized, it is excised down to the anterior wall of the esophagus
and around the gastropharangeal junction. The esophagus is
mobilized so that approximately 3 cm of the distal esophagus lies
in the abdomen. Then the enlarged diaphragmic hiatus is closed
primarily with suture for tension repair. The sutures are used to
approximate the cura or pillars of the diaphragm. While such
suturing is effective, it is time consuming and manually
challenging. If this suturing step could be eliminated, it would
greatly improve efficiencies in the operating room.
[0005] Laparoscopic surgery is another method to perform surgery in
a minimally invasive way. A laparoscope is used where a camera is
attached to a rod and passed into the abdominal cavity, allowing
for 2D visualization. The endoscope is passed through a trocar. The
abdominal cavity is insufflated with carbon dioxide. Through other
incision sites various tools can be passed. The surgeon is in the
field directly manipulating the tools, while a technician holds the
endoscope. While this approach is minimally invasive with minimal
cost requirements, the surgeon has limited range of motion at the
surgical site resulting in a loss of dexterity. The surgeon also
has a poor depth perception. Also, the tool endpoints move in the
opposite direction to the surgeon's hands due to the pivot point of
the device, making laparoscopic surgery a non-intuitive motor skill
that is difficult to learn.
[0006] Robotic surgery is another method to perform surgery using
very small tools attached to robotic arms. The surgeon controls the
robotic arm with a computer, where she sits at the computer station
away from the field and directs the movements of the robot with
small surgical tools being attached to the arms of the robot. Small
incisions are made to pass the three trocars into the abdominal
cavity through which the endoscope (camera) allows the surgeon to
see enlarged 3D images within the abdominal cavity of the patient.
The robot matches the surgeon's hand movements to perform the
procedure using the tiny movements. The 3D visualization and
intuitive movement of the robotic arms make hiatal hernia more
manageable. However, such a system comes with a substantial capital
investment. As such, an improved device for repairing a hiatal
hernia may be desirable.
SUMMARY OF THE INVENTION
[0007] The present invention will eliminate suture steps in hiatal
hernia repair, enabling a less costly laparoscopic technique, while
also speeding up robotic surgeries in the setting of hiatal hernia
repair. The present invention includes a deployment system for use
with laparoscopic or robotic surgery in repair of hiatal hernias.
The device actuates to bring the crus of the diaphragm into
apposition and affix them in such a way as to close the hiatus
around the esophagus with a biocompatible material that has affixed
fixation components which pass through the diaphragm and serve as
anchors. The device saves surgical time by eliminating the suturing
of the crus of the diaphragm.
[0008] In particular, in one aspect, the present disclosure
provides a deployment device that includes (a) an elongate shaft
having a first end and a second end, (b) a grasping assembly
coupled to the first end of the elongate shaft, where the grasping
assembly includes a first jaw and a second jaw rotatable with
respect to the elongate shaft, where the grasping assembly is
configured to accept a wound closure device between the first jaw
and the second jaw, where the wound closure device comprises at
least two fixation components connected to and extending
therethrough, where each of the first jaw and the second jaw
include at least one coupling element configured to be removably
coupled to a respective fixation component when the wound closure
device is coupled to the grasping assembly, and (c) an actuator
coupled to the second end of the elongate shaft, wherein the
actuator is configured to move the grasping assembly between an
open position and a closed position.
[0009] In another aspect, the present disclosure provides a method
of closing a wound in a tissue, the method includes (a) bringing a
wound closure device coupled to a deployment device adjacent to the
tissue surface, where the wound closure device includes (i) at
least two fixation components connected to and extending
therethrough, and where the deployment device includes (i) an
elongate shaft having a first end and a second end, (ii) a grasping
assembly coupled to the first end of the elongate shaft, where the
grasping assembling includes a first jaw and a second jaw rotatable
with respect to the elongate, where the grasping assembly is
configured to accept a wound closure device between the first jaw
and the second jaw, and (iii) an actuator coupled to the second end
of the elongate shaft, where the actuator is configured to move the
grasping assembly between an open position and a closed position,
(b) with the grasping assembly in the open position, bringing the
wound closure device into abutment with the tissue surface, and (c)
bringing the grasping assembly into the closed position around a
portion of the tissue surface such that the at least two fixation
components pierce the tissue surface, thereby affixing the wound
closure device to the tissue surface.
[0010] These as well as other aspects, advantages, and
alternatives, will become apparent to those of ordinary skill in
the art by reading the following detailed description, with
reference where appropriate to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a perspective view of a deployment device,
according to an example embodiment.
[0012] FIG. 2A is a perspective view of an example grasping
assembly of the deployment device of FIG. 1 in an open position,
according to an example embodiment.
[0013] FIG. 2B is another perspective view of an example grasping
assembly of the deployment device of FIG. 1 in an open position,
according to an example embodiment.
[0014] FIG. 2C is a side view of an example grasping assembly of
the deployment device of FIG. 1 in an open position with a wound
closure device attached thereto, according to an example
embodiment.
[0015] FIG. 2D is a side view of an example grasping assembly of
the deployment device of FIG. 1 in a closed position, according to
an example embodiment.
[0016] FIG. 3A is a perspective view of an example fixation
component, according to an example embodiment.
[0017] FIG. 3B is a perspective view of an example fixation
component, according to an example embodiment.
[0018] FIG. 3C is a perspective view of an example fixation
component, according to an example embodiment.
[0019] FIG. 3D is a side view of an example fixation component,
according to an example embodiment.
[0020] FIG. 3E is a perspective view of an example fixation
component, according to an example embodiment.
[0021] FIG. 4 is perspective view of a wound closure device with an
example fixation component attached thereto, according to an
example embodiment.
[0022] FIG. 5 is perspective view of a wound closure device with an
example fixation component attached thereto, according to an
example embodiment.
[0023] FIG. 6 is perspective view of a wound closure device with an
example fixation component attached thereto, according to an
example embodiment.
[0024] FIG. 7 illustrates an example deployment device positioning
a wound closure device in a tissue, according to an example
embodiment.
DETAILED DESCRIPTION OF THE INVENTION
[0025] Exemplary devices and methods are described herein. It
should be understood that the word "exemplary" is used herein to
mean "serving as an example, instance, or illustration." Any
embodiment or feature described herein as "exemplary" is not
necessarily to be construed as preferred or advantageous over other
embodiments or features. The exemplary embodiments described herein
are not meant to be limiting. It will be readily understood that
certain aspects of the disclosed systems and methods can be
arranged and combined in a wide variety of different
configurations, all of which are contemplated herein.
[0026] Furthermore, the particular arrangements shown in the
Figures should not be viewed as limiting. It should be understood
that other embodiments may include more or less of each element
shown in a given Figure. Further, some of the illustrated elements
may be combined or omitted. Yet further, an exemplary embodiment
may include elements that are not illustrated in the Figures.
[0027] As used herein, with respect to measurements, "about" means
+/-5%.
[0028] As used herein, "mediastinum" means the mass of tissues and
organs separating the sternum in front and the vertebral column in
back, containing the heart and its large vessels, trachea,
esophagus, thymus, lymph nodes, and other structures and
tissues.
[0029] As used herein, "excise" means to remove by cutting.
[0030] As used herein, "blunt dissection" means a separation of
tissues along natural lines of cleavage by means of blunt
instrument or finger.
[0031] As used herein, "hiatal hernia" means a protrusion of a
portion of the stomach through the esophageal hiatus of the
diaphragm.
[0032] As used herein, "hernia" means an abnormal protrusion of
part of an organ or tissue through the structures normally
containing the organ or tissue.
[0033] As used herein, "esophageal hiatus" means the opening in the
diaphragm for the passage of the esophagus and the vagus nerve.
[0034] As used herein, "esophagus" means the musculomembranous
passage extending from the pharynx to the stomach, 25 cm to 30 cm
long in an adult, consisting of an outer fibrous coat, a muscular
layer, a submucous layer and an inner mucous membrane.
[0035] As used herein, "crus of the diaphragm" means the tendinous
structures that extend inferiorly from the diaphragm to attach to
the vertebral column. The crus of the diaphragm forms a tether for
muscular contraction and runs along the left and right sides of the
esophagus.
[0036] As used herein, "diaphragm" means a sheet of skeletal muscle
that extends across the bottom of the rib cage. The diaphragm
separates the thoracic cavity from the abdominal cavity and
performs the function of respiration.
[0037] As used herein, "stomach" means a muscular hollow dilated
part of the digestive system located between the esophagus and
small intestine. The stomach secretes protein digesting enzymes
called proteases and strong acids to aid in food digestion. Through
smooth muscle contortions (i.e., "segmentation") the esophagus
delivers food to the stomach before the food is sent to the small
intestines as chime.
[0038] As used herein, "strangulated hiatal hernia" means a
paraesophageal hiatal hernia that cuts off blood supply to the
hernia. Without blood and oxygen supply the strangulated tissues
begin to die. Such a condition may be life threatening.
[0039] As used herein, "laparoscopic surgery" means minimally
invasive surgery performed through two small incisions. Such a
procedure includes a laparoscope passed through a 10 mm cannula or
trocar. The abdominal cavity is inflated with CO.sub.2 to create
room to work. A tool is placed through a second incision and is
used to manipulate tissues under 2D visualization.
[0040] As used herein, "laparotomy" means a large surgical incision
into the abdominal cavity for diagnosis or in preparation for
surgery.
[0041] As used herein, "endoscope" means a slender tubular
instrument, such as an athroscope or laparoscope, that is inserted
into a body cavity or body part for the purpose of visual
examination, diagnosis or surgical treatment.
[0042] As used herein, "trocar" means a sharp pointed surgical
instrument used with a cannula to puncture a body cavity for fluid
aspiration
[0043] As used herein, "surgical mesh" means loosely woven sheet
which is used as either a permanent or temporary support for a
midline incision upon closure. A surgical mesh can be created from
inorganic, organic, biological materials or a combination
thereof.
[0044] As used herein, "fixation component" means a single use
device used to fix a biocompatible material of a wound closure
device to the soft tissue, such as the crus of the diaphragm.
[0045] As used herein, "biocompatible material" means any suitable
biocompatible material, either synthetic or biologic, such as
titanium, nitinol, polypropylene, polyethylene terephthalate (PET),
Poly-4-hydroxybutyrate (P4HB) and Polytetrafluoroethylene
(PTFE).
[0046] A deployment device for positioning and affixing a wound
closure device within a body is provided herein. In particular,
FIG. 1 illustrates a deployment device 100, according to an example
embodiment. As shown in FIG. 1, the deployment device 100 includes
an elongate shaft 102 having a first end 104 and a second end 106.
The deployment device 100 also includes a grasping assembly 108
coupled to the first end 104 of the elongate shaft 102. As shown in
FIG. 2, the grasping assembly 108 includes a first jaw 110 and a
second jaw 112 rotatable with respect to the elongate shaft 102.
The deployment device 100 also includes an actuator 114 coupled to
the second end 106 of the elongate shaft 102. The actuator 114 is
configured to move the grasping assembly 108 between an open
position (shown in FIGS. 2A-2C) and a closed position (shown in
FIG. 2D).
[0047] In use, the grasping assembly 108 is configured to accept a
wound closure device 116 between the first jaw 110 and the second
jaw 112, as shown in FIG. 2C. The wound closure device 116 may
include at least two fixation components 118 connected to and
extending through the wound closure device 116 such that a flange
128 of each fixation component 118 resides on one side of the wound
closure device 116 and a pointed tip 127 of each fixation component
118 extends from the other side of the wound closure device 116.
Each of the first jaw 110 and the second jaw 112 include at least
one coupling element 120 configured to be removably coupled to a
respective fixation component 118 when the wound closure device 116
is coupled to the grasping assembly 108. As described in more
detail below, in practice, the coupling element 120 helps hold the
wound closure device 116 in position on the first jaw 110 of the
grasping assembly 108 prior to and during placement of the wound
closure device 116 in vivo.
[0048] As discussed above, the grasping assembly 108 includes a
first jaw 110 and a second jaw 112. In one example, the second jaw
112 is rotatable with respect to the first jaw 110. In some cases,
the first jaw 110 could be stationary while the second jaw 112 is
rotatable, and vice versa. In other cases, the first jaw 110 may be
rotated independently of the second jaw 112, and vice versa. For
instance, the first jaw 110 could be coupled to a first wire that
is movable with one finger (or thumb) and the second jaw 112
coupled to a second wire that is movable with a different finger
(or thumb). In further embodiments, the first jaw 110 and the
second jaw 112 are both rotatable with respect to the other.
[0049] As discussed above, the grasping assembly 108 is configured
to accept a wound closure device 116 arranged between the first jaw
110 and the second jaw 112. Accordingly, the grasping assembly 108
may be sized and shaped to accommodate the size, shape and
implantation characteristics of one or more wound closure devices
116 and the particular requirements or limitations of the surgical
procedure. In one example, the wound closure device 116 may be
deformed into a crescent shape to be received between the two jaws
110, 112 of the grasping assembly 116, as shown in FIG. 2C. The
jaws 110, 112 may be essentially planar, and configured to connect
at a pivot point 122. In one example shown in FIG. 2D, a first
portion of each of the jaws 110, 112 may be arranged parallel to
each other in the closed position to provide clearance room for the
coupling element(s) 120 and a second portion of each of the jaws
110, 112 may be angled from the first portion towards the pivot 122
point.
[0050] The wound closure device 116 may include any device capable
of closing or repairing a tissue wound, for example, as the result
of an injury, defect or a surgical procedure. Generally, the wound
closure device 116 may take the place of or be used in combination
with sutures, staples or other common closure devices. In addition,
the wound closure device 116 may serve as a scaffolding, a
replacement for, or to strengthen an affected tissue surface, such
as the diaphragm. For example, the wound closure device 116 may be
used in abdominal surgery, such as in the repair of a hiatal
hernia. The wound closure device 116 may be made of any
biocompatible material, including bioinert materials, suitable for
introduction into a living body. Generally, the wound closure
device 116 is configured to be brought into abutment with a tissue
surface requiring repair or closure. For example, the wound closure
device 116 may be fabricated from a woven type material, such as a
mesh 124 (described further below), or a solid material. In either
case, the wound closure device 116 may include a number of pores or
holes to allow for tissue ingrowth and the passage of fluid.
Further, the wound closure device 116, which may be provided as a
mesh, may also be capable of eluting one or more drugs or agents
into the tissue. One or more drugs or agents may be coated on or
impregnated in (e.g., loaded in the pores of the mesh) the closure
apparatus material.
[0051] The shape, size, thickness and other characteristics of the
wound closure device 116 may be selected based on the size, shape
and type of wound to be closed, the needs or limitations of the
patient, or surgeon preference, among other things. In some
examples, the wound closure device 116 may be provided in a
predetermined shape. Alternatively, the wound closure device 116
may be provided as a sheet of material capable of being cut to size
by a surgeon. The mesh may be bioabsorbable, partially
bioabsorbable, or non-bioabsorbable (i.e., permanent) and made of
any suitable biocompatible material, either synthetic or biologic,
such as titanium, nitinol, polypropylene, polyethylene
terephthalate (PET), Poly-4-hydroxybutyrate (P4HB) and
Polytetrafluoroethylene (PTFE). Additionally, the mesh may be
flexible and, in some cases, stretchable to conform to the shape of
a tissue surface. Composite meshes, or multilayer meshes, combining
different materials may also be used. The pore and filament size of
the mesh may be customized or selected based on the needs of the
patient or surgeon preference. A mesh having a higher porosity may
promote faster and more extensive tissue integration. For example,
in some cases, a thin filament, large pore construction mesh may be
selected.
[0052] In some embodiments, the mesh is a microreplicated mesh. A
"microreplicated" material may include any material that is
self-fixating and/or increases friction so as to prevent sliding of
the wound closure device 116 along the tissue surface. An exemplary
"microreplicated" mesh includes a mesh having a plurality of
microgrips made of monofilament polylactic acid ("PLA"). Reducing
or prohibiting movement between the wound closure device 116 and
the tissue surface may encourage pervasive and faster tissue
ingrowth into the wound closure device 116, thereby speeding wound
healing and recovery of the patient. Further, the microreplicated
surface may provide stability to the wound area, further reducing
the occurrence of hiatal hernia. The microreplicated mesh may, in
one example, be designed such that the mesh material itself forms a
microreplicated surface and there are no added components to the
mesh. In another embodiment, the microreplicated mesh is
constructed from a separate microreplicated material that is
printed or onlayed onto the mesh surface. The replicated material
can range in size and form. A multilayer mesh may include a
composite mesh having more than one layer of the same or different
materials. In one example, the multilayer mesh may include a
typical surgical mesh with a layer of microreplicated material
coated, applied or laminated thereto. Moreover, the multilayer mesh
may comprise some bioabsorbable and some non-bioabsorbable
materials. The mesh may be used for both contaminated and
non-contaminated wounds.
[0053] Each jaw 110, 112 of the grasping assembly 108 includes at
least one coupling element 120 configured to releasably couple with
a fixation component 118 connected to the wound closure device 116.
The coupling element 120 may comprise any structure capable of
releasably coupling the fixation components 118 of the wound
closure device 116 to the first and second jaws 110, 112 of the
deployment device 108. As shown in FIGS. 2A-2D, and as will be
described further herein, the coupling element 120 may comprise at
least one pin configured to receive a fixation component 118
thereon. The coupling element 120 may also comprise a structure for
physically mating with the head or eyelet of the fixation component
118, such as a flange. The number and size of the coupling elements
120 may affect the size and shape of the jaws 110, 112 of the
grasping assembly 108. In operation, the coupling element 120 and
the tension of the wound closure device 116 (similar to that of a
compressed spring) may act to hold the wound closure device 116
within the grasping assembly 108.
[0054] As discussed above, the wound closure device 116 may include
at least two fixation components 118 connected thereto for affixing
the wound closure device 116 to a tissue surface. Each fixation
component 118 may include any device or structure capable of
penetrating the tissue surface and securing the wound closure
device 116 thereto. In one example, each fixation component 118 may
be in the form of a staple-like device 126, as shown in FIG. 3A.
Alternatively, each fixation component 118 may be a tack 128. The
tack 128 may be provided in a number of various shapes and sizes,
as shown in FIGS. 3B-3E. Other shapes are contemplated.
[0055] In one example, the tack 128 may have a central stem portion
and a head or eyelet. In some embodiments, the tack 128 may include
a pointed tip 127 to facilitate piercing of the tissue. Each of the
tacks 128 may include one or more fins or protrusions 130 tapered
radially outward to permit passage through the tissue and also to
prevent the tacks from pulling or backing out of the tissue. The
size, shape, material, and number and configuration of fins may
provide a tack having a low insertion force and a high pullout
force.
[0056] The fixation components 118 may be connected to the wound
closure device 116, which may be a mesh 124, in any manner that
will prevent the fixation components 118 from separating from the
mesh. In one example, the fixation components 118 may be punctured
through the mesh. In this manner, a flange 125 coupled to the
fixation component 118 remains on one surface of the mesh, while
the central stem of the fixation component 118 extends through the
other surface, as shown in FIGS. 5-6. The eyelet of the fixation
component 118 may act to stabilize it against the surface of the
mesh. In some examples, the wound closure device 116 and fixation
components 118 may be fabricated together such that the fixation
components 118 and wound closure device 116 are formed as a
continuous material. Alternatively, the fixation components 118 and
wound closure device 116 may be fabricated separately, such that
the fixation components 118 are subsequently secured to the wound
closure device 116. In this case, the fixation components 118 and
the wound closure device 116 may be formed from two different
materials. Generally, the fixation components 118 may be formed
from any suitable biocompatible materials, for example, resorbable
poly (D, L)-lactide ("PLA").
[0057] In some examples, the wound closure device 116 may comprise
at least two portions--an edge portion and a middle portion. The
fixation components 118 may be connected to the edge portion. The
middle portion may comprise a first material, and the edge portion
may comprise a second material that is different than the first
material. For example, the edge portion may be provided as a
generally rigid and solid material to provide structural support
for the fixation components 118, while the middle portion may
comprise a mesh 124, as described above.
[0058] In one example, the at least one coupling element 120 of the
first jaw 110 and the second jaw 112 is at least one pin configured
to removably couple with the fixation component 118 connected to
the wound closure device 116. The number of pins provided on each
jaw 110, 112 may correspond to the number of fixation components
118 connected to the wound closure device 116. Accordingly, if the
wound closure device 116 includes four fixation components 118,
then each jaw 110, 112 of the grasping assembly 108 may be provided
with two pins. Each fixation component 118 may, in some examples,
include an axial hole 132 configured to accept a pin. Accordingly,
the size of the axial hole 132 of the fixation component 118 may be
sized and shaped to accommodate the size and shape of a pin, or
vice versa. In some examples, the axial hole 132 of the fixation
component 118 may extend from the flange 125 to the tip 127 of the
fixation component 118, having an opening at both ends of the
fixation component 118. The pin, in these examples, may have a
length that is greater than the length of the fixation component
118, such that a portion of the pin extends beyond the tip 127 of
the fixation component 118. Further, as the pin in this example is
intended to pierce the tissue, it may include a sharp tip. In some
examples, the tip of the pin may be pyramidal in shape, providing
three cutting edges where each face joins. Alternatively, the axial
hole 132 of each tack may not extend fully to the tip 127. In such
cases, the end of the pin will remain concealed with the fixation
component 118. As such, the tip 127 of the fixation component 118
will act to pierce the tissue and, therefore, the fixation
component 118 may be provided with a tapered or pointed tip. In one
example, the at least one pin extending from the first jaw 110 and
the at least one pin extending from the second jaw 112 do not
overlap when the grasping assembly is in the closed position, as
shown in FIG. 2D.
[0059] In another example, the at least one coupling element 120 of
the first jaw 110 and the second jaw 112 comprises a hole 134
configured to receive a pin 136 of a respective fixation component
118 connected to the wound closure device 116. Such an embodiment
is shown in FIG. 6. In another example, the at least one coupling
element 120 of the first jaw 110 and the second jaw 112 comprises a
first magnet configured to attract a second magnet of a respective
fixation component 118 connected to the wound closure device 116.
Such an embodiment provides a temporary, removable connection
between the wound closure device 116 and the grasping assembly
108.
[0060] In some embodiments, the grasping assembly 108 may come
pre-loaded with a wound closure device 116 releasably attached
thereto. The grasping assembly 108 may be disposable and removable
from the rest of the deployment device 100.
[0061] In one example, the wound closure device 116 is provided
with at least two fixation components 118, positioned such that at
least one of the at least two tacks is inserted into the tissue
surface on either side of the wound to be closed. Accordingly, each
jaw 110, 112 of the grasping assembly 108 may be provided with at
least one coupling element 120 configured to receive at least one
fixation component 118 thereon. The deployment device 100 may also
include a release mechanism for releasing the fixation components
118 from the coupling elements 120, once the fixation components
118 have been set in the intended tissue. In one example, where the
coupling element 120 comprises a pin, the deployment device 100 may
further include a catch or hook configured to retain a tack on the
pin. The release mechanism, in this case, may be configured to
withdraw the catch or hook, such that the tack may slide from the
pin and be retained in the tissue. Mechanically, the release
element may comprise a button or a lever. Other examples are
contemplated.
[0062] As discussed above, an actuator 114 is coupled to the second
end 106 of the elongate shaft 102, and is configured to move the
grasping assembly 108 between an open position and a closed
position. The actuator 114 need not be directly attached to the
grasping assembly 108, but may be connected in an indirect manner
with other elements in between them. In the closed position, the
grasping assembly 108, with a wound closure device 116 coupled
thereto, may be inserted into the body and brought into the
vicinity of the wound to be closed. In the open position, the wound
closure device 116 is exposed and the grasping assembly 108 may be
used to bring the wound closure device 116 into abutment with the
tissue surface. The actuator 114 may be any mechanism capable of
moving the grasping assembly 108 between the open and closed
positions. In one example, shown in FIG. 1, the actuator 114 may
include a handle for grasping by a surgeon, including a stationary
arm and a lever arm. The lever arm is coupled to a rod, which
extends through the elongate shaft of the deployment device and is
coupled to the grasping assembly at its distal end. Squeezing the
handles of the actuator closed causes the rod to slide in the
proximal direction and the jaws 110, 112 of the grasping assembly
108 to close. Opening the handles causes the jaws 110, 112 of the
grasping assembly 108 to open. The handle may also be a ratcheting
handle, as shown in FIG. 1, to lock the handle, and the grasping
assembly in place. In further examples, the handle of the actuator
114 may be spring biased, such that the grasping assembly 108 is
biased in a closed position. Other configurations and examples of
the actuator 114 are contemplated.
[0063] In one example, each of the first jaw 110 and the second jaw
112 comprises a proximal jaw segment 138 (closest to the first end
104 of the elongate shaft 102) and a distal jaw segment 140. The
distal jaw segment 140 may rotate with respect to the proximal jaw
segment 138 at the hinge point, such that the distal jaw segment
rotates 140 away from the closed position of the jaws. Each of the
proximal jaw segment 138 and the distal jaw segment 140 may have
approximately the same length. Other configurations are possible.
The distal jaw segment 140 of each of the first and second jaws
110, 112 may be actuated independently of the proximal segment 138,
and vice versa. Both the distal and proximal segments 138, 140 of
each jaw 1102, 112 may be coupled to the same actuator 114. In use,
operation of the actuator 114 may cause the proximal jaw segment
138 of each jaw to open to a maximum opening position. Once the
proximal jaw segments 138 reach the maximum opening position,
operation of the actuator 114 may then engage the distal jaw
segments 140 and cause the distal jaw segments 140 to rotate. In
another embodiment, both the distal and proximal jaw segments 138,
140 may be operated by separate actuators. For example, the
actuator 114 may include two lever arms, one in communication with
the distal jaw segments 140 and another in communication with the
proximal jaw segments 138. In such a configuration, the jaws 110,
112 may be configured to open in a two-step phase, thereby allowing
the jaws 110, 112 to open at a wider angle.
[0064] In one embodiment, the wound closure device 116 comprises at
least two pins 136 positioned on a first side of the wound closure
device 116, and the at least one coupling element 120 of the first
jaw 110 and the second jaw 112 comprises a hole 134 configured to
receive a respective pin 136 of the wound closure device 116. In
such an embodiment, the second side of the wound closure device 116
may include an adhesive. The adhesive is positioned on the wound
closure device 116 (e.g., the mesh 124) on the surface that is
configured to contact the tissue surface. Once the deployment
device 100 positions the wound closure device 116 is in the desired
position, the adhesive material of the wound closure device 116 can
thereby be brought into abutment with the intended tissue surface.
In one example, the adhesive comprises a microreplicated mesh or
includes a microreplicated surface, as discussed above in relation
to the mesh 124.
[0065] In another embodiment, the wound closure device 116
comprises a first surface configured to at least partially contact
the first jaw 110 and the second jaw 112 of the grasping assembly
108, and a second surface configured to contact the tissue surface.
In such an example, the at least one coupling element 120 of the
first jaw 110 and the second jaw 112 may comprise a first adhesive
positioned between the first surface of the wound closure device
116 and a respective jaw 110, 112. The first adhesive may be
coupled to the first jaw 110 and/or the second jaw 112, or the
first adhesive may be coupled to the first surface of the wound
closure device 116. The first adhesive provides a removable
connection between the wound closure device 116 and the jaws 110,
112. As such, in such an embodiment no pins are required to hold
the wound closure device 116 to the deployment device 100. The
wound closure device 116 may further include a second adhesive
positioned on the second surface of the wound closure device 116.
Once the deployment device 100 positions the wound closure device
116 is in the desired position, the second adhesive material of the
wound closure device 116 can thereby be brought into abutment with
the intended tissue surface. The second adhesive may be stronger
than the first adhesive, such that the wound closure device 116
remains in abutment with the intended tissue surface and is
released from the jaws 110, 112. In one example, the first adhesive
and/or the second adhesive comprises a microreplicated mesh or
includes a microreplicated surface, as discussed above.
[0066] In yet another embodiment, the wound closure device 116
comprises at least two fixation components 118 connected to and
extending therethrough that removably couple with at least one
coupling element 120 positioned on each of two jaws 110, 112 of a
grasping assembly 108 of the deployment device 100. In such an
example, the at least one coupling element 120 of the first jaw 110
and the second jaw 112 may comprise an adhesive positioned between
a respective fixation component 118 and a respective jaw 110, 112.
The adhesive may be coupled to the first jaw 110 and/or the second
jaw 112, or the adhesive may be coupled to the respective fixation
component 118, for example the flange 128 of the fixation component
118. The adhesive provides a removable connection between the
fixation components 118 and the jaws 110, 112. Once the deployment
device 100 positions the wound closure device 116 is in the desired
position, the wound closure device 116 can thereby be brought into
abutment with the intended tissue surface so that the fixation
components 118 pierce the tissue surface. The securing force of the
fixation components 118 once they pierce the tissue surface may be
stronger than the adhesive, such that the wound closure device 116
remains in abutment with the intended tissue surface and is
released from the jaws 110, 112.
[0067] An example method for repairing a wound in a tissue using
the deployment device 100 is provided. In particular, the method
may be used to repair a hiatal hernia. The wound closure device 100
includes at least two fixation components 118 connected to and
extending therethrough that couple with at least one coupling
element 120 positioned on each of two jaws 110, 112 of a grasping
assembly 108 of the deployment device 100. In operation, once the
distal end of the deployment device 100 is inserted into the body,
with the grasping assembly 108 in an open position, so as to expose
the wound closure device 116, the wound closure device 116 is
brought into abutment with a tissue surface at the location of a
wound, such as a hiatal wound. Generally, at least one fixation
component 118 is positioned on each side of the wound closure
device 116. As such, the grasping assembly 108 will position the
wound closure device 116 such that at least one fixation component
118 is positioned on either side of the wound. The wound closure
device 116 is affixed to the tissue surface by bringing the
grasping assembly 108 into a closed position around a portion of
the tissue such that the at least two fixation components 118
pierce the tissue surface, thereby affixing the wound closure
device 116 to the tissue surface.
[0068] In particular, an example method for closing a wound in a
tissue surface may include (a) bringing a wound closure device 116
coupled to a deployment device 100 adjacent to the tissue surface,
where the wound closure device 116 includes (i) at least two
fixation components 118 connected to and extending therethrough,
and wherein the deployment device 100 includes (i) an elongate
shaft having 102 a first end 104 and a second end 106, (ii) a
grasping assembly 108 coupled to the first end 104 of the elongate
shaft 102, wherein the grasping assembling 108 includes a first jaw
110 and a second jaw 112 rotatable with respect to the elongate
shaft, where the grasping assembly 108 is configured to accept a
wound closure device between the first jaw 110 and the second jaw
112, and (iii) an actuator 114 coupled to the second end 106 of the
elongate shaft 102, wherein the actuator 114 is configured to move
the grasping assembly 108 between an open position and a closed
position, (b) with the grasping assembly 108 in the open position,
bringing the wound closure device into abutment with the tissue
surface, and (c) bringing the grasping assembly 108 into the closed
position around a portion of the tissue surface such that the at
least two fixation components 118 pierce the tissue surface,
thereby affixing the wound closure device 116 to the tissue
surface.
[0069] In one embodiment, each of the first jaw 110 and the second
jaw 112 include at least one coupling element 120 configured to be
removably coupled to a respective fixation component when the wound
closure device 116 is coupled to the grasping assembly 108. In
another embodiment, the at least one coupling element of the first
jaw 110 and the second jaw 112 includes at least two pins
configured to removably couple with a respective fixation component
118 connected to the wound closure device 116. In yet another
embodiment, bringing the grasping assembly 108 into the closed
position around the portion of the tissue surface causes the at
least two pins to pierce the surface tissue.
[0070] It will be appreciated that other arrangements are possible
as well, including some arrangements that involve more or fewer
steps than those described above, or steps in a different order
than those described above.
[0071] While various aspects and embodiments have been disclosed
herein, other aspects and embodiments will be apparent to those
skilled in the art. All embodiments within and between different
aspects of the invention can be combined unless the context clearly
dictates otherwise. The various aspects and embodiments disclosed
herein are for purposes of illustration and are not intended to be
limiting, with the true scope and spirit being indicated by the
claims.
* * * * *