U.S. patent application number 14/043255 was filed with the patent office on 2014-01-30 for tissue fasteners and related deployment systems and methods.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. Invention is credited to Robert B. DeVries, Kristian DiMatteo, Kurt A. E. Geitz, Barry N. Gellman, John B. Golden, John E. Hutchins, William J. Shaw, Roy Sullivan, Marc Tassy, JR..
Application Number | 20140031841 14/043255 |
Document ID | / |
Family ID | 31976547 |
Filed Date | 2014-01-30 |
United States Patent
Application |
20140031841 |
Kind Code |
A1 |
DeVries; Robert B. ; et
al. |
January 30, 2014 |
TISSUE FASTENERS AND RELATED DEPLOYMENT SYSTEMS AND METHODS
Abstract
Surgical tissue fasteners and related deployment systems and
methods are disclosed. A tissue fastener used to join multiple
tissue layers includes a first member, a second member, and a
connecting member connecting the first and second members. In some
embodiments, the first and second members are configured to expand
from a delivered state to a deployed state in which the fastener
secures the tissue layers together. Other tissue fastener
embodiments include means for applying a substantially constant
force on the tissue layers and/or means for adjusting a length of
the connecting member between the first and second members.
Inventors: |
DeVries; Robert B.;
(Northborough, MA) ; DiMatteo; Kristian; (Waltham,
MA) ; Sullivan; Roy; (Millville, MA) ; Tassy,
JR.; Marc; (Framingham, MA) ; Gellman; Barry N.;
(Easton, MA) ; Hutchins; John E.; (Attleboro,
MA) ; Golden; John B.; (Norton, MA) ; Geitz;
Kurt A. E.; (Sudbury, MA) ; Shaw; William J.;
(Cambridge, MA) |
Assignee: |
Boston Scientific Scimed,
Inc.
Maple Grove
MN
|
Family ID: |
31976547 |
Appl. No.: |
14/043255 |
Filed: |
October 1, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12379252 |
Feb 17, 2009 |
8579935 |
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14043255 |
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10230672 |
Aug 29, 2002 |
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12379252 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 2017/0443 20130101;
A61B 17/068 20130101; A61B 2017/00867 20130101; A61B 2017/0647
20130101; A61B 2017/0649 20130101; A61B 2017/0641 20130101; A61B
17/0401 20130101; A61B 17/0644 20130101; A61B 17/064 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 17/064 20060101
A61B017/064 |
Claims
1-72. (canceled)
73. A tissue fastener used to join multiple tissue layers within a
body, comprising: a proximal member configured to transform from a
delivered state to a deployed state; a distal member configured to
transform from a delivered state to a deployed state; and a
flexible connecting member connecting the proximal member and the
distal member together, wherein, in the deployed state of each of
the proximal member and the distal member, the proximal member and
the distal member secure the multiple tissue layers together in a
manner that permits the proximal member to articulate with respect
to the distal member.
74. The tissue fastener of claim 73, wherein, in the deployed state
of each of the proximal member and the distal member, the tissue
fastener is configured to permit adjustment of a length of the
connecting member between the proximal member and the distal
member.
75. The tissue fastener of claim 74, wherein the connecting member
extends through at least one of the proximal member and the distal
member.
76. The tissue fastener of claim 73, wherein the connecting member
includes suture material.
77. The tissue fastener of claim 73, wherein the connecting member
includes one of a knit, a woven, or a braided material.
78. The tissue fastener of claim 73, wherein, in the deployed state
of each of the proximal member and the distal member, the tissue
fastener is configured to provide substantially constant force on
the multiple tissue layers as a thickness of the multiple tissue
layers vary.
79. The tissue fastener of claim 73, wherein at least one of the
proximal member and the distal member includes a fabric
material.
80. The tissue fastener of claim 73, wherein at least one of the
proximal member and the distal member is a flexible plate.
81. The tissue fastener of claim 73, wherein at least one of the
proximal member and the distal member has a disk-like shape.
82. The tissue fastener of claim 73, wherein at least one of the
proximal member and the distal member has a braided
configuration.
83. The tissue fastener of claim 74, wherein, at least one of the
proximal member and the distal member in the corresponding deployed
state, is configured to flex and conform to a shape of an
underlying tissue surface.
84. A tissue fastener used to join multiple tissue layers within a
body, comprising: a proximal member configured to transform from a
delivered state to a deployed state; a distal member configured to
transform from a delivered state to a deployed state; and a suture
connecting the proximal member and the distal member together to
secure the multiple tissue layers together, wherein, in the
deployed state of each of the proximal member and the distal
member, a length of the suture extends proximally through the
proximal member.
85. The tissue fastener of claim 84, wherein, in the deployed state
of each of the proximal member and the distal member, the tissue
fastener is configured to permit adjustment of a length of the
suture between the proximal member and the distal member.
86. The tissue fastener of claim 84, wherein at least one of the
proximal member and the distal member includes a fabric
material.
87. The tissue fastener of claim 84, wherein at least one of the
proximal member and the distal member has a disk-like shape.
88. The tissue fastener of claim 84, wherein, in the deployed state
of each of the proximal member and the distal member, at least one
of the proximal member and the distal member is configured to flex
and conform to a shape of an underlying tissue surface.
89. A tissue fastener used to join multiple tissue layers within a
body, comprising: a proximal member configured to transform from a
delivered state to a deployed state; a distal member configured to
transform from a delivered state to a deployed state, wherein at
least one of the proximal member and the distal member includes a
fabric material, and in the corresponding deployed state, is
configured to flex and conform to a shape of an underlying tissue
surface; and a flexible connecting member connecting the proximal
member and the distal member together to secure the multiple tissue
layers together in a manner that permits the proximal member to
articulate with respect to the distal member, and permits
adjustment of a length of the connecting member between the
proximal member and the distal member, wherein a length of the
connecting member extends proximally through the proximal
member.
90. The tissue fastener of claim 89, wherein the connecting member
includes a suture material.
91. The tissue fastener of claim 89, wherein both the proximal
member and the distal member includes a fabric material.
92. The tissue fastener of claim 91, wherein each of the proximal
member and the distal member has a disk-like shape in the
corresponding deployed configuration.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application relates to commonly assigned U.S.
application Ser. No. ______ of Robert Devries et al., filed on the
same date as this application, and entitled "Devices and Methods
for Fastening Tissue Layers." The complete disclosure of that
application is incorporated by reference herein.
DESCRIPTION OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to surgical tissue fasteners
and related deployment systems and methods for delivering the
tissue fasteners. In particular, the present invention relates to
tissue fasteners used in, for example, a fundoplication procedure
for treatment of Gastroesophageal Reflux Disease (GERD).
[0004] 2. Background of the Invention
[0005] Gastroesophageal reflux occurs when stomach acid enters the
esophagus. This reflux of acid into the esophagus occurs naturally
in healthy individuals, but also may become a pathological
condition in others. Effects from gastroesophageal reflux range
from mild to severe. Mild effects include heartburn, a burning
sensation experienced behind the breastbone. More severe effects
include a variety of complications, such as esophageal erosion,
esophageal ulcers, esophageal stricture, abnormal epithelium (e.g.,
Barrett's esophagus), and/or pulmonary aspiration. These various
clinical conditions and changes in tissue structure that result
from reflux of stomach acid into the esophagus are referred to
generally as Gastroesophageal Reflux Disease (GERD).
[0006] Many mechanisms contribute to prevent gastroesophageal
reflux in healthy individuals. One such mechanism is the
functioning of the lower esophageal sphincter (LES). With reference
to FIG. 1, the LES 2 is a ring of smooth muscle and increased
annular thickness existing in approximately the last four
centimeters of the esophagus. In its resting state, the LES creates
a region of high pressure (approximately 15-30 mm Hg above
intragastric pressure) at the opening of the esophagus 3 into the
stomach 7. This pressure essentially closes the esophagus 3 so that
contents of the stomach cannot pass back into the esophagus 3. The
LES 2 opens in response to swallowing and peristaltic motion in the
esophagus 3, allowing food to pass into the stomach. After opening,
however, a properly functioning LES 2 should return to the resting,
or closed state. Transient relaxations of the LES 2 do occur in
healthy individuals, typically resulting in occasional bouts of
heartburn.
[0007] The physical interaction occurring between the gastric
fundus 5 and the esophagus 3 also prevents gastroesophageal reflux.
The gastric fundus 5 is a lobe of the stomach situated at the top
of the stomach 7 distal to the esophagus 3. In asymptomatic
individuals, the fundus 5 presses against the opening of the
esophagus 3 when the stomach 7 is full of food and/or gas. This
effectively closes off the esophageal opening to the stomach 7 and
helps to prevent acid reflux back into the esophagus 3. More
specifically, as the food bolus is immersed in gastric acid, it
releases gas which causes the fundus 5 of the stomach 7 to expand
and thereby exert pressure on the distal esophagus 3 causing it to
collapse. The collapse of the esophagus lumen reduces the space for
the stomach acid to splash past the closed esophagus lumen and
thereby protect the proximal esophagus from its destructive
contact.
[0008] In individuals with GERD, the LES 2 functions abnormally,
either due to an increase in transient LES relaxations, decreased
muscle tone of the LES 2 during resting, or an inability of the
esophageal tissue to resist injury or repair itself after injury.
These conditions often are exacerbated by overeating, intake of
caffeine, chocolate or fatty foods, smoking, and/or hiatal hernia.
Avoiding these exacerbating mechanisms helps curb the negative side
effects associated with GERD, but does not change the underlying
disease mechanism.
[0009] A surgical procedure, known generally as fundoplication, has
been developed to prevent acid reflux in patients whose normal LES
functioning has been impaired, either as a result of GERD or other
adverse effects. This procedure involves bringing the fundus wall 6
into closer proximity of the esophageal wall 4 to help close off
the esophageal opening into the stomach 7. Traditionally, this
procedure has been performed as an open surgery, but also has been
performed laparoscopically.
[0010] As with any surgery, the attendant risks are great. Due to
relatively large incisions necessary in the performance of open
surgery, relatively large amount of blood is lost, the risk of
infection increases, and the potential for postoperative hernias is
high. Further, the relatively large incisions necessary in the
performance of open surgery require extended recovery times for the
incision to heal.
[0011] A laparoscopic procedure may involve performing laparotomies
for trocar ports (penetrations of the abdominal wall), percutaneous
endoscopic gastronomies (incisions through the skin into the
stomach), and the installation of ports through which, for example,
a stapler, an endoscope, and an esophageal manipulator
(invagination device) are inserted. Under view of the endoscope,
the esophageal manipulator is used to pull the interior of the
esophagus 3 into the stomach 7. When the esophagus is in position,
with the fundus 5 of the stomach plicated, the stapler is moved
into position around the lower end of the esophagus and the
plicated fundus is stapled to the esophagus 3. The process may be
repeated at different axial and rotary positions until the desired
fundoplication is achieved. This procedure is still relatively
invasive requiring incisions through the stomach, which has a risk
of infection. The location of the incision in the abdominal wall
presents a risk of other negative effects, such as sepsis, which
can be caused by leakage of septic fluid contained in the
stomach.
SUMMARY OF THE INVENTION
[0012] Therefore, one embodiment of the present invention provides
less invasive devices and methods for performing the fundoplication
procedure. This is achieved by utilizing tissue fasteners and
related deployment systems which can be endoluminally delivered
through the esophagus 3, thereby eliminating the need for highly
invasive, physiologically insulting surgical procedures.
[0013] To attain the advantages and in accordance with the purpose
of the invention, as embedded and broadly described herein, one
aspect of the invention provides a tissue fastener used to join
multiple tissue layers. The tissue fastener includes a proximal
member configured to expand from a delivered state to a deployed
state, a distal member configured to expand from a delivered state
to a deployed state, and a connecting member connecting the
proximal member to the distal member. In the deployed state, the
proximal member and the distal member secure the multiple tissue
layers together.
[0014] Another aspect of the invention provides a tissue fastener
used to join multiple tissue layers that includes a first member, a
second member, a connecting member connecting the first member to
the second member, and means for applying a substantially constant
force on the tissue layers. In some embodiments, the applying means
may be compressible.
[0015] Another aspect of the invention provides a tissue fastener
used to join multiple tissue layers that includes a first member, a
second member, a connecting member connecting the first member to
the second member, and means for adjusting a length of the
connecting member between the first and second members. In some
embodiments, the adjusting means may include structure associated
with the first member for releasably securing the connecting member
to the first member. That structure may be configured to restrict
passage of the connecting member in a direction through the first
member.
[0016] Another aspect of the present invention is to provide a
delivery system configured for deployment of an expandable tissue
fastener. The system includes a flexible tube configured to
accommodate a tissue fastener in a contracted state, a pusher for
guiding the tissue fastener along a lumen of the tube, and a
grasper coupled to a distal end of the pusher and having means to
grasp the tissue fastener.
[0017] In yet another aspect of the present invention, a method of
attaching a first layer of tissue to a second layer of tissue
includes providing an expandable tissue fastener in a contracted
state in a device, the tissue fastener having a proximal member and
a distal member, inserting the device into a body passage leading
to the first tissue wall, placing the device proximate a location
on the first tissue layer, passing the device through the first and
second tissue layers, advancing the tissue fastener toward an
opening of the device, such that the distal member is completely
protruded out of the device and expanded against the second tissue
layer, and withdrawing the device and releasing the tissue
fastener, such that the proximal member is expanded against the
first tissue layer.
[0018] The present invention is depicted in this disclosure and is
particularly suitable in the treatment of GERD, e.g., a
fundoplication procedure. However, the tissue fasteners and related
deployment methods and systems of the present invention can be used
to treat any of a number of different disease conditions, and can
be used for fastening any desired body tissues.
[0019] Additional objects and advantages of the invention will be
set forth in part in the description which follows, and in part
will be obvious from the description, or may be learned by practice
of the invention. The objects and advantages of the invention will
be realized and attained by means of the elements and combinations
particularly pointed out in the appended claims.
[0020] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the invention, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate several
embodiments of the invention and together with the description,
serve to explain the principles of the invention.
[0022] In the drawings:
[0023] FIG. 1 is a cross-sectional view of the gastrointestinal
tract in the region of the lower esophageal sphincter (LES) and the
fundus of the stomach;
[0024] FIG. 2 is a perspective view of a tissue fastener, prior to
deployment into a body, according to an embodiment of the present
invention;
[0025] FIG. 2A is a perspective view of a proximal fastening member
of the tissue fastener of FIG. 2, showing the proximal fastening
member in a deployed state according to an embodiment of the
present invention;
[0026] FIG. 2B is a perspective view of a distal fastening member
of the tissue fastener of FIG. 2 in a deployed state, according to
an embodiment of the present invention;
[0027] FIGS. 3-7C are perspective views of various tissue fasteners
according to various embodiments of the present invention;
[0028] FIGS. 7D-7F are cross-sectional views of tissue fastener
members according to various embodiments of the present
invention;
[0029] FIGS. 8A-8R are perspective views of various designs of
tissue fastening members according to additional embodiments of the
present invention;
[0030] FIGS. 9A-9J are perspective views of various connector post
designs according to still other embodiments of the present
invention;
[0031] FIGS. 10A-10SS are perspective views of fasteners according
to various embodiments of the present invention;
[0032] FIGS. 11A-C are perspective views of an endoluminal
deployment system, illustrating various operational stages of the
system for deployment of a tissue fastener, according to an
embodiment of the present invention;
[0033] FIG. 12A is a schematic illustration of the tissue fastener
deployment for a tissue connection procedure, showing the
deployment system of FIGS. 11A-C containing the tissue fastener of
FIG. 2 and being inserted into the lower esophagus, according to an
embodiment of the present invention;
[0034] FIG. 12B is a schematic illustration of the tissue fastener
deployment, showing the deployment system penetrating the
esophageal wall, according to an embodiment of the present
invention;
[0035] FIG. 13 is a schematic illustration of the tissue fastener
deployment, showing the deployment system penetrating the
esophageal wall and the fundus wall, according to an embodiment of
the present invention;
[0036] FIG. 14 is a schematic illustration of the tissue fastener
deployment, showing the expanded distal fastener member of the
tissue fastener holding the fundus wall, according to an embodiment
of the present invention;
[0037] FIG. 15 is a perspective view of a proximal fastening member
of the tissue fastener of FIG. 2, viewing from inside the
esophagus, after the deployment is complete, according to an
embodiment of the present invention;
[0038] FIG. 16 is a cross-sectional view of the esophageal wall and
the fundus wall, with a tissue fastener in place, after the tissue
connection procedure;
[0039] FIGS. 17A is a perspective view of a deployment system, with
a straight distal tip, according to another embodiment of the
present invention;
[0040] FIG. 17B is a perspective view of a deployment system, with
a curved distal tip, according to still another embodiment of the
present invention; and
[0041] FIGS. 18A and 18B are views of a deployment system
respectively holding and releasing a tissue fastener member.
DESCRIPTION OF THE EMBODIMENTS
[0042] Reference will now be made in detail to the exemplary
embodiments of the invention, examples of which are illustrated in
the accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same
or like parts.
[0043] A newly developed form of fundoplication, referred to as
endoscopic fundoplication, is an endoluminal procedure in which the
fundus wall 6 is folded back onto the esophagus wall 4. The tissue
fold formed between the esophagus 3 and the fundus 5 then is
secured. Endoscopic fundoplication is intended to be performed as
an endoluminal procedure in which insertion of required medical
instruments occurs through the esophagus 3. Such a procedure has
the benefits of being less invasive, quicker, and less expensive as
compared to previous techniques.
[0044] FIG. 2 shows an exemplary embodiment of a tissue fastener 1
for use in a fundoplication procedure. The tissue fastener 1 has a
distal fastening member 13, a proximal fastening member 11, and a
connecting member 12 connecting the distal fastening member 13 and
the proximal fastening member 11 to each other. The distal
fastening member 13, the proximal fastening member 11, and the
connecting member 12 are formed as an integrated unit or two or
more components pieced together. The distal fastening member 13
includes a plurality of anchor hooks or legs 23, and the proximal
fastening member 11 includes a plurality of anchor hooks or legs
21. The plurality of anchor legs 21, 23 are constructed to expand
from a contracted state to an expanded state. When the legs are in
the contracted state, as shown in FIG. 2, the tissue fastener 1 is
low in profile and can be loaded into a narrow lumen of an
endoluminal deployment system for deployment. Once the deployment
system is positioned into a desired location within a body, the
plurality of anchor legs 21, 23 are expanded outwardly to fasten
multiple tissue layers together between the distal and proximal
fastening members 13, 11, thereby enhancing the tissue
connection.
[0045] In this particular embodiment shown in FIG. 2, each of the
distal and proximal fastening members 11, 13 is provided with a
total of six anchor legs 21, 23, that are equally spaced apart.
However, it should be recognized that the fastening members 11, 13
can be provided with more or less number of legs 21, 23 with
different desired spacing therebetween.
[0046] Preferably, the leading edge of the distal fastening member
13 forms a sharp point or edge 15 to assist with penetrating
through the tissue layers. The sharp edge 15 may be a trocar-like
cutting edge to perform the perforation of the layers itself. It
should also be recognized that forming such a sharp cutting edge 15
may not be necessary if an endoluminal deployment system includes a
cutting edge 40 on its distal tip, as shown in FIGS. 17A-B to be
described herein.
[0047] FIGS. 2A and 2B show the expanded state of the proximal and
distal fastening members 11, 13, respectively in an installed
state. When the distal fastening member 13 is freed from a
restraining means of an endoluminal deployment system, the anchor
legs 23 of the distal fastening member 13 expand outwardly to form
an umbrella-shaped fastening member. Sharp edge or tip 15 may be
removed or made of a dissolvable, biodegradable material.
Similarly, when the proximal fastening member 11 is freed from a
restraining means of an endoluminal deployment system, the anchor
legs 21 of the proximal fastening member 11 expand outwardly to
form a fastening member. Each of the anchor legs 21 of the proximal
fastening member 11 may include one or more bending portions 22 at
a location along the length of the leg 21, such that the distal
portion 24 of the leg 21 extends outwardly with respect to the
bending portion 22. The bending portion 22 is a relatively flexible
portion of an otherwise substantially rigid leg 21. The bending
portion 22 may be facilitated by removal of material or change in
geometry along the leg 21. The leg 21 may further comprise a
variable stiffness along the leg 21. For example, the bending
portion 22 may consist of a lower stiffness material to facilitate
the bending.
[0048] FIGS. 3 through 7 are perspective views of various tissue
fasteners in expanded states according to other embodiments of the
invention. In an embodiment shown in FIG. 3, the tissue fastener
101 is formed of at least two elongate members 150, such as wires
or rods, interconnected in the mid-portion by a connecting member
112. The interconnection may be made through any suitable method,
such as welding, brazing, molding, a locking mechanism, etc., or
members may be manufactured as an integral piece. In a contracted
state, each member 150 is preferably substantially straight to
promote easier insertion through the esophagus and deployment. In
an expanded state, shown in the figure, each member 150 bends
outwardly, substantially perpendicular to the connecting member
112, to form the distal and proximal fastening members 113, 111.
The ends of the proximal fastening member 111 could be rounded or
otherwise protected to reduce trauma when in contact with tissue.
Similar to the embodiment shown in FIG. 2, the leading edge of each
member 150 may form a sharp cutting edge 115 to assist with
perforating layers of tissues.
[0049] FIG. 3A illustrates a further embodiment of the fastener of
FIG. 3 wherein the distal and proximal ends of the fastener 101
turn inwards upon deployment through tissue layers. These inward
turns, or hooks 114, would contact tissue and prevent migration of
fastener 101.
[0050] According to another embodiment shown in FIG. 4A, the tissue
fastener 201 is comprised of a single wire 250 or rod. Similar to
the tissue fastener 101 of FIG. 3, the wire 250 preferably forms a
substantially straight wire in a contracted state. In an expanded
state, shown in the figure, the wire 250 forms spiral-shaped distal
and proximal fastening members 213, 211 at both ends of the wire
250, that are substantially perpendicular to the connecting member
212. The wire 250a may also form a spring-shaped fastening member
211a, 213a at both ends of the wire 250a, as shown in FIG. 4B. In
that case, the spring-shaped fastening members 211a, 213a may be
substantially parallel to the connecting member 212a. The leading
edge of the wire 250 may form a sharp cutting edge 215 to assist
with perforating layers of tissues. As a modification and
alternative to fastener 201, a wire fastener may be delivered in a
straight configuration and forms into a coil that may be screwed
into the tissue layers. As described below, a suitable material for
such fasteners is nitinol.
[0051] The tissue fastener 301 shown in FIG. 5A is comprised of
multiple wires integrally attached to a connecting member 312. In a
contracted state, each wire 350 preferably forms a substantially
straight wire and, in an expanded state, shown in the figure, the
wires 350 expand outwardly to form spider-shaped distal and
proximal fastening members 313, 311. While the leading edges of the
wires 350 may form sharp cutting edges to assist with perforating
the tissue layers, it may be most beneficial to use an endoluminal
deployment system with a trocar-like cutting edge, such as the
device shown in FIGS. 17A-B, or other perforating instrument to
form an opening through the tissue layers prior to the deployment
of the tissue fastener 301. In, an alternative embodiment to FIG.
5A, and as shown in FIG. 5B, the fastening members 311,313 may
include inwardly bent hooks 352 at each end portion of the wires
350 to prevent migration of the fastener once deployed onto the
tissue layers.
[0052] As shown in FIG. 6, the tissue fastener 401 has a similar
configuration as the tissue fastener 1 shown in FIG. 2, except that
the distal and proximal fastening member 413, 411 have the same
configuration, much like the fastening member 11 shown in FIG. 2.
In particular, the distal fastening member 413 does not include a
sharp pointed edge. For this tissue fastener 401, an endoluminal
deployment system with a trocar-like cutting edge (e.g., a device
shown in FIGS. 17A-B) can be utilized.
[0053] FIG. 7A shows a tissue fastener 501, also similar to the
tissue fastener 1 shown in FIG. 2 in certain respects. The tissue
fastener 501 has a distal fastening member 513, a proximal
fastening member 511, and an adjustable connecting member 512. The
distal fastening member 513 and the proximal fastening member 511
function in a similar manner as these corresponding structures of
the tissue fastener 1 shown in FIG. 2. In the embodiment shown in
FIG. 7A, the tissue fastener 501 includes an adjustable connecting
member 512. Once fastener 501 has been placed through the tissue
layers to be connected, tail 520 of fastener 501 is pulled taut as
illustrated in FIG. 7B and fastening member 511 is advanced
forward. This action creates a compressive force on the tissues
between the fastening members 511 and 513. Alternatively, the
connecting member 512 has an elastic compressive spring force which
exerts pulling force between the distal and proximal fastening
members 513, 511 so that the fastening of the multiple tissue
layers is enhanced.
[0054] The elastic compressive force may be further combined with
the adjustable system as described. FIGS. 7C through 7F illustrate
adjustable fasteners of the present invention. FIG. 7C illustrates
a fastener 520 have fastening members 513 and 511 and an adjustable
connecting member 521. Member 521 further includes bumps (or
notches) 514 which allow fastening member 511 to ratchet forward as
either member 511 is advanced or connecting member 521 is pulled
taut to connect tissue layers. FIGS. 7D through 7F illustrate
cross-sectional views of two ratcheting systems as described. In
FIG. 7D, the ratcheting action is created by virtue of flexible
tabs 515 located inside fastening member 511. FIGS. 7E and 7F
illustrate friction based or infinite ratcheting systems wherein
the interference fit of a single tab 515 of FIG. 7E or of multiple
tabs 515 of FIG. 7F serve to keep connecting member 521 from
slipping once fastening member 511 is advanced forward onto tissue
or connecting member 521 is pulled taut. If connecting member 521
is at least partially elastic, the fastener may be self adjusting
once in place or the force within the fastener upon the tissues may
be controlled.
[0055] FIGS. 8A through 8O show various other exemplary fastening
members according to various embodiments of the present invention.
As shown in the figures, the fastening member can be formed of a
flat plate 601 of virtually any geometric shape, a semispherical
domed button 602, a flexible plate 603, a malecot 604, a ratchet
606, a non-orthogonal button 607, interconnectable multiple pieces
608, a foldable T-shaped bar 609, a twisted or tied coil, string,
or other flexible elongate member 610, a stent-like configuration
611 wherein the connecting member has a crimped, braided
configuration, a cotterpin 612, a rivot 613, a V-shaped clip 614,
615 with or without a flattened top (FIGS. 8N and 8P), a
staple-like configuration (FIG. 8O), and stent-like connectors with
dogbone or flared ends (FIGS. 8Q and 8R). Each fastening member
connects to or comprises a connecting member 650.
[0056] These various fastening member embodiments will now be
described in more detail. In an embodiment shown in FIG. 8D, the
malecot 604 includes a plurality of legs or rods 604a that assume a
cage-like shape when in its normal, expanded position. In another
embodiment shown in FIG. 8F, the fastening member 606 includes at
least one skirt-like or frustoconical-shaped ratchet 606 which
permits movement only in one direction. In yet another embodiment
shown in FIG. 8G, a non-orthogonal connection between the
connecting member 650 and the fastening member 607, which may
include any of the described fastening members, is provided. In
still another embodiment shown in FIG. 8H, the fastening member 608
is formed of multiple pieces that are attached through any suitable
means, such as piercing members or barbs. In still another
embodiment shown in FIG. 81, the fastening member 609 is pivotally
coupled to the connecting member 650 to form a T-shaped
configuration. Any conventional connecting devices and methods may
be used to couple the fastening member 609 and the connecting
member 650. In still another embodiment shown in FIG. 8J, the
fastening member 610 is formed of a twisted or tied element.
Preferably, the member 610 is made of a single piece and
double-looped. In still another embodiment shown in FIG. 8K, the
fastening member 611 is formed of a stent-like braided
configuration. The middle portion of the configuration is crimped
by a plurality of rings or is wrapped with a coil and constitutes
the connecting member. In an expanded state, rings are removed or a
coil is partially unwrapped at the distal end portion, or the
distal end is not otherwise crimped like the connecting member
portion, to form a fastening member 611 shown in the figure. FIGS.
8Q and 8R illustrate stent type fasteners 660, 670 respectively
having a dogbone or flare shape at each end. These fasteners are
deployed in a constricted manner and expanded or allowed to expand
into a fastener comprised of a singular structure. The fasteners of
FIGS. 8K, 8Q, and 8R may be constructed in any manner similar to
fabricating stents as is known in the art, including but not
limited to knitting, weaving, twisting, laser-cut tubes, welded
wires and molding.
[0057] In still another embodiment shown in FIG. 8L, the fastening
member 612 is formed of a bar or a plate, fixedly attached the
connecting member by a cotterpin 612a or a stopper. In still
another embodiment shown in FIG. 8M, the fastening member 613 is
formed by attaching a rivot to the connecting member 651. In this
case, the connecting member 651 includes an engagement member 653
protruding outwardly at its distal end, which engages the rivot to
form the fastening member 613. In still another embodiment shown in
FIG. 8N, the fastening member 614 is a clip having two or more legs
614b. The clip is expandable in a transverse direction, as
indicated by arrows in the figure, thereby enhancing the tissue
connection. Preferably, one or more bands or O-rings 614a are
attached to limit the expansion to a desired extent and to abut the
tissue layers. It should also be recognized that a plate or other
flat surface 614c may be attached to, or otherwise be integral
with, the expanded clip at its distal end, as shown in FIG. 8P.
[0058] In still another embodiment shown in FIG. 8O, the fastening
member 616 forms a staple-like configuration. Similar to the
embodiments shown in FIGS. 3-5, the wire 616a preferably forms a
substantially straight wire in a contracted state and, in an
expanded state, shown in the figure, the wire 616a expands
outwardly or inwardly to form the staple-like configuration.
Alternatively, an anvil can be placed behind tissue layers to bend
the wires 616a and form the staple-like configuration. It should be
recognized that more than two wires can be provided. Any other
suitable designs providing the similar function may be utilized. In
addition, the fastener may include any combination of fastening
members and connecting posts.
[0059] In an embodiment, as shown in FIG. 8E, a tissue fastener 605
also may include a hollow bore 630 passing through the tissue
fastener to inject a therapeutic chemical agent or an adhesion
promoting substance. The tissue fastener is provided with an
injection port 670 to permit introduction of the therapeutic
substances or the adhesion promoting substance. The hollow bore 630
may be provided with a one-way valve (e.g., check valve) 672 to
prevent a backflow. Fastener 605 may also comprise a weep hole 660
or other means along post 662 to allow delivery of the chemical
agent or adhesion promoting means between the tissue layers.
[0060] FIGS. 10A through 10OO show various other exemplary
fastening members according to various embodiments of the present
invention. These various embodiments, in addition to certain others
described throughout this specification, adjust to varying tissue
thickness so that sufficient tension, and in many embodiments
substantially constant tension, is placed on the tissue to hold the
tissue layers together. In many of the disclosed embodiments, such
adjustment is performed by adjusting the length of the connecting
member between the fastening members and/or by providing a means,
in many cases associated with a fastener member, for providing a
substantially constant tension on the tissue layers. Most of the
embodiments shown in FIGS. 10A-10OO include a pair of opposed
fastener members connected by a connecting member. It is to be
understood that fastener members and connecting members of any
embodiment may be used in combination with fastener members and
connecting members of other embodiments, as desired.
[0061] FIG. 10A shows a "T"-shaped tissue fastener 720 having a
first fastening member 721, a connecting member 722, and a second
fastening member 723. Member 721 may comprise any suitable
biocompatible elongate member, such as a portion of hypodermic
tubing. Connecting member 722 may comprise suture material, wire,
or any other like biocompatible material that fixedly connects to
member 721, preferably in a fashion that permits member 721 to
articulate with respect to connecting member 722 for ease of
delivery and to the extent needed while implanted. Member 723 may
comprise any bead or ball-shaped structure that permits connection
to connecting member 722. Member 723 may include a slot therein
permitting member 722 to slide through so that the length of member
722 between members 721,723 may be adjusted depending on the
thickness of the connected tissue layers. For example, member 723
may be similar to a fishing weight having a slit therein to hold
member 722. As an alternative and as shown in FIG. 10A', member 723
may be a torsion spring 723' having a pair of arms. When the arms
are forced open in the direction of the arrows, connecting member
722 loosens from within spring 723' and spring 723' can slide
relative to member 722 and be cinched against the tissue layers or
an additional member 721. When the arms are released, spring 723'
secures member 722 in position.
[0062] FIGS. 10B and 10B' show a tissue fastener 730 having first
fastening member 721, connecting member 722, and a second fastening
member 731 having a means for providing a substantially constant
force on the tissue layers. In this case, the means includes a
flexible bellows-like structure. The bellows of member 731 permit
adjustment in the length of connecting member 722 between members
721 and 731. FIG. 10B shows the bellows of member 731 in an
expanded, relaxed state. The bellows are contracted during delivery
through the esophagus and to the tissue layers. Then, as shown in
FIG. 10B', when fastener 730 is applied to tissue layers 735, the
bellows will expand to place a sufficient force against the tissue
layers to hold together those layers. In addition, through the use
of the bellow-like structure, a substantially constant force is
applied to the tissue layers, reducing tissue irritation or
loosening of the tissue fastener.
[0063] FIGS. 10C, 10D, and 101 show variations on means to maintain
constant force on the tissue layers. In FIG. 10C, tissue fastener
740 includes a second fastener member 741 having a spring 742
between two plate-like structures 743, such as disks or buttons. In
FIG. 10D, tissue fastener 743 includes a second fastener member 751
having a balloon 752 between the two structures 743. In FIG. 10I,
tissue fastener 800 includes a second fastener member 801 having a
spring 802. One end of spring 802 connects to structure 743 and the
other end of spring 802 is free and places a substantially constant
force against the tissue layers. Any suitable, biocompatible,
compressible structure may take the place of spring 742, balloon
752, or spring 802.
[0064] FIG. 10E shows a "double-T" shaped tissue fastener 760 that
is essentially of one-piece construction. Fastener 760 has two
opposing fastener members 762, each taking the form of either
member 721, member 743, or others described throughout this
specification. Members 762 are connected by an elastic connecting
member 761 that permits an adjustable length of member 761 between
members 762. Member 761 may be made of a elastic, biocompatible
material, similar to a rubber-band.
[0065] FIG. 10H shows a similar arrangement as FIG. 10E. Fastener
790 includes opposing fastener members 762 interconnected by a
bungee cord-like member 792. Member 792 may be pulled tightly
(elongated) between members 762 during delivery to the tissue
layers and then released so that member 792 shortens and grows in
diameter. The growth in diameter may permit an interference fit
between member 792 and a hole, notch, slit, or other opening within
one or both of the members 762, so that member 792 secures to
members 762.
[0066] In addition to certain embodiments already described, other
embodiments include structure associated with one or both fastener
members to permit adjustment of the length of the connecting member
between the fastener members. For example, FIG. 10F shows a
fastener 770 having first and second fastener members 771, 772 and
a connecting member 773. Member 773 includes a plurality of beads,
balls, or similar enlarged structures 774 spaced along the length
of member 773. As an alternative, the connecting member may include
a plurality of notches spaced along the length of the member. The
structures may be evenly or unevenly spaced as desired. The
structures 774 may be used in combination with a frangible member
772 having a hole that permits structures 774 to travel through the
hole to shorten the length of member 773 between members 771, 772.
To place more a desired force on the tissue layers, additional
structures 774 may be pulled through the hole in member 772. Member
772 may be constructed to include a notch therein to accommodate a
structure 774. The through hole in member 772 may be constructed to
permit passage of structures 774 in only one direction, i.e. away
from member 771 to shorten the length of member 773 between members
771, 772. In addition, member 771 may have a similar construction
as member 772 to permit passage of structures 774 therethrough.
Excess connecting member 773 may be removed by any suitable
method.
[0067] FIG. 10G shows a fastener 780 having a fastener member 781
with a ratchet-like mechanism to permit passage of connecting
member 782 therethrough in one direction (shown by arrow). Thus,
member 781 can move in the direction opposite the arrow to tighten
fastener 780 on the tissue layers, with the ratchet-like mechanism
preventing loosening of member 782 relative to member 781.
Similarly, FIG. 10J shows a fastener 810 having a fastener member
811 with teeth 812 to capture connecting member 813 and prevent
loosening. Teeth 812 may be angled in the direction of the applied
force to more strongly grasp member 813.
[0068] FIG. 10K shows a fastener 820 having a fastener member 821
with a biased locking mechanism 822. The lock 822 includes a ball
bearing 823 or like structure contained within a through hole or
passage of member 821, and a spring 824 biasing bearing 823 into
the passage. Bearing 823 will lock connecting member 825 within the
passage when member 825 is not being adjusted in length between the
fastener members.
[0069] Alternative locking mechanisms are shown in FIGS. 10M and
10N. FIG. 10M shows a locking mechanism 840 that includes a pair of
eccentric wheels 841 that rotate to lock connecting member 842 in
position after member 842 is adjusted in length between fastener
members, similar to eccentric wheel locking mechanisms used on
sailboats. Mechanism 840 may be located within one or both fastener
members of a fastener. FIG. 10N shows a similar arrangement, having
a locking mechanism 850 with eccentric wedges used to lock
connecting member 852 in position.
[0070] FIG. 10L shows a fastener 830 having a first fastening
member 831, a connecting member 832, and a second connecting member
833. Member 833 has a two-piece construction that includes a disk
834 that snaps or otherwise fixedly attaches to a complementary
dish-shaped head 835. After connecting member 832 is pulled through
a passage in head 835 to adjust the length of member 832 between
fastener member 831 and head 835, disk 834 is forced into and
attached to head 835, securing member 832 in position.
[0071] FIGS. 100 and 10P show front views of exemplary fastener
members 860 and 870 respectively. Member 860 includes a
wedge-shaped opening 861 therein that accepts a connecting member.
Member 871 has a wedge-shaped notch 871 in its side also for
accommodating a connecting member. After being pulled taut within
tissue and between fastener members, a connecting member may be
pulled in the direction of the point of the wedge opening 861 or
notch 871 to lock the connecting member in place.
[0072] FIG. 10Q shows a fastener 880 having a fastener member 881
having slots around its perimeter that accept connecting member
882. Member 881 may be twisted, as shown by the arrow, so that
member 882 wraps around member 881 to adjust the length of member
881 between fastener members 881, 883. When the desired length is
achieved, member 882 can lock in a notch or like structure on
member 881.
[0073] FIGS. 10T and 10U show fasteners 910 and 920 respectively.
Fastener 910 includes two dome-shaped fastening members 911 that
fully invert in the deployed position (bottom of FIG. 10T) to exert
additional force against the tissue layers. Similarly, fastener 920
includes two dome-shaped fastening members 921 that invert in their
centers when in the deployed position (bottom of FIG. 10T) to exert
additional force against the tissue layers.
[0074] FIG. 10V shows a fastener member 930 shaped in a figure
eight and having two openings. A connecting member 931 may be
adjusted in length between fastening members by winding member 931
around and through the openings, similar to a rappel loop. A small
notch in member 930 may hold member 931 once member 930 has been
drawn to the desired tension.
[0075] FIG. 10W shows a fastener 940 that includes a loop 941 and a
connection member 942. Loop 941 may comprise a cable, wire, or
other suitable biocompatible material. Loop 941 extends through the
tissue layers twice and joins at its ends at connection member 942,
which may be located on either side of the tissue layers, through
any suitable means. Loop 941 may be tightened and excess loop
portions may be excised by cutting or any other suitable method.
This embodiment results in a relatively small footprint at the
tissue layers.
[0076] FIG. 10X shows a fastener member 951 that is a spring clip.
Once connecting member 952 is adjusted to the desired tension,
spring clip 951 may be inserted over a needle 953 through which
connecting member 952 extends (see top portion of FIG. 10X). Spring
clip 951 is extended past the distal end of needle 953 to grasp
connecting member 952 adjacent tissue layers 954(see bottom portion
of FIG. 10X).
[0077] The right-hand side of FIG. 10Y shows a deployed fastener
960 that includes a collet 961 and a C-spring 962. The left-hand
side of FIG. 10Y shows collett 961 and C-spring 962 in undeployed
positions, i.e. in an open mode. Much like open drill bit chuck,
collett 961 can fit over any size connecting member 963. Once
collet 961 is in position over connecting member 963 and C-spring
962, or an O-ring or other like structure, is slipped over collet
961, collet 961 closes on member 963. This embodiment permits
fastener adjustments.
[0078] FIG. 10Z shows a fastener member 971 in both an open
position (left-hand side) and a closed position (right-hand side).
Member 971 includes a cap 973 with teeth to grip a connector member
972. Cap 973 is held to the remainder of member 971 by a hinge,
such as a living hinge. Pulling member 972 opens cap 973 enough to
let the connector member 972 adjust. Cap 973 snaps back down to
secure member 972. The exit of connecting member 972 from cap 973
could be at a slot or notch at an edge of cap 973.
[0079] As shown in the variations of FIGS. 10DD and 10EE (showing
end views of alternative fasteners 971 with caps 973' and 973''
respectively), the exit of connecting member 972 from cap 973',
973'' could be at a through hole 974 offcenter from the fastener
hole 975 (FIG. 10DD) or a slot 976 in cap 973 offset from fastener
hole 975 (FIG. 10EE). In these alternative embodiments, pulling
member 972 to adjust its length will open the cap 973', 973''
slightly.
[0080] FIG. 10AA shows a fastener 980 in the undeployed (left-hand
side) and deployed (right-hand side) states. Fastener 980 includes
fastener members 981 connected by a connecting member 982. Members
981 have an inward wedge shape that will displace some force to
friction along an axis of the connecting member 982. The wedge
increases surface area contact of the fastener member 981 with the
tissue layers and therefore friction between the layers and the
member 981. The wedge portion may include a fabric surface to
increase friction. The area of the fabric may be made larger than
the surface area of the wedge so that the fabric may bunch up to
further increase surface area and friction. A fabric surface or
covering may be placed over any suitable fastener member described
herein.
[0081] FIG. 10BB shows a fastener 990 having a fastener member 991
and a connecting member 992 attached at its ends to fastening
members 993. Member 991 may be a pledget or any other suitable
member described herein or known in the art. Members 993 may be
similar to member 921 described above in connection with FIG. 10A.
In FIG. 10BB, member 992 extends through the tissue layers and
member 991 in two places. After deployment of fastener 990, the
portion of member 992 extending through member 991 may be twisted
(as shown by the arrow) to place desired tension against the tissue
layers. Connecting member 992 may be similar to member 722 of FIG.
10A and may be a polymer suture so that ultrasonic or other energy
may be used to fuse the twisted portion together by melting.
[0082] As a variation of the embodiment of FIG. 10BB, FIG. 10CC
shows a fastener 990' having a suture-like member 992 that extends
through member 991 and is formed into a z-like pattern 994 on a
surface of member 991 away from the tissue. Member 992 tightens
between members 991 and 993 as member 992 is pulled in the
direction of the arrows. As a further variation of the embodiment
shown in FIG. 10BB, FIG. 10S shows a fastener 900 similar to
fastener 990 except that fastener 900 has a one-piece second
fastener member 902.
[0083] FIGS. 10FF, 10GG, and 10HH show variations of "r-shaped
fastener embodiments. Fastener 1000 includes fastener members 1002
each in the shape of an "H" connected by connecting member 1001.
Fastener 1010 includes "T" shaped fastener members 1011 connected
by a connecting member that splits into three portions 1012a,
1012b, and 1012c. Fastener 1020 is much like fastener 1010 and
includes "T" shaped fastener members 1021 connected by a connecting
member that splits into four portions 1022a, 1022b, 1022c, and
1022d. As with all of the embodiments described herein, any
combination of fasteners and connecting members from FIGS.
10FF-10HH may be used to form a suitable fastener.
[0084] FIG. 10II shows various embodiments of fasteners 1030, 1040,
1050 that include wire frames as fastener members. The wire frames
may be configured in any suitable shape, including triangular,
round, and irregular, as shown. It is preferable that the wire
frame be collapsible into a flattened shape for ease of delivery
and then expand upon deployment.
[0085] FIG. 10JJ shows embodiments of fasteners 1055, 1056 having
fastener members 1057, 1058 in kite-like configurations. The
fastener members 1057, 1058 may include a combination of wire
material on the external perimeter portions and suture material as
the spokes 1059 extending form the connecting members to the wire
perimeter. The fastener members may be configured in any suitable
shape, including square, diamond, etc., and, as in the FIG. 10II
embodiments, collapse into a flattened shape for delivery and
expand upon deployment.
[0086] FIG. 10KK shows a fastener 1060 made of a combination of
suture material 1061 connecting a pair of hypotubes 1062. the
suture material connects to a connecting member 1063 at an
approximate midpoint of the fastener 1060. The suture material in
the embodiments of FIGS. 10JJ and 10KK, and any other embodiments
disclosed herein, may be elastic, fuzzy (like dental floss), and/or
swell upon deployment.
[0087] FIGS. 10LL-10OO show various embodiments of fasteners
designed to have an increased footprint on the tissue layers. When
each of these embodiments is used in a fundoplication procedure, a
button is placed on the esophageal side of the tissue layers and a
mating cup is placed on the stomach side. These arrangements spread
force on the tissue layers beyond the button and prevent
pull-through in the esophagus. For example, Figure LL shows a
button-shaped fastener member 1072 adjacent esophageal tissue 1074
and a mating cup fastener member 1071 adjacent stomach tissue 1075.
A connecting member 1073 extends between button 1072 and cup 1071.
FIGS. 10MM-10OO show other shaped buttons and mating cups. FIG.
10MM shows fastener 1080 with a convex cup 1082 connected by a
connecting member 1083 to a concave mating cup 1081. FIG. 10NN
shows fastener 1090 with a wedge-shaped cup 1092 connected by a
connecting member 1093 to a corresponding mating cup 1081. FIG.
10OO shows fastener 1100 with a convex cup 1102 connected by a
connecting member 1103 to a concave mating cup 1101 surrounded by a
flattened area 1104 that further increases the footprint on the
tissue layers. Convex, wedge, and other like-shaped buttons
increase tissue contact area relative to a flat button arrangement.
Other shaped buttons and mating cups may be used.
[0088] FIG. 10PP shows a fastener 1110 in a delivered state (top)
and a deployed state (bottom). Fastener 1100 is a tube or rod that
includes a plurality of slits at ends 1111. Upon deployment at the
desired site, the slits at the ends permit the ends to attain a
fastener member arrangement having a plurality of arms 1112. Such
deployment may be attained through a shape memory material, a
deployment mechanism that separates the slits to form arms 1112, or
any other suitable method. FIG. 10QQ shows a variation of the
fastener embodiment shown in FIG. 10PP. Fastener 1120 includes a
pointed, slotted end 1121 that, when deployed, shapes into arms
1122. The pointed end may permit puncturing through the tissue
layers. The pointed tip may remain, may be removed through any
mechanical, thermal or other suitable method, or may be made of a
absorbable material.
[0089] FIG. 10RR shows a fastener 1130 that includes a connecting
member 1132 with expandable fastener members 1131 at each end. The
top portion of FIG. 10RR shows the delivered state in which members
1131 remain in a collapsed configuration, and the bottom view shows
members 1131 in a deployed configuration. Members 1131 may be
balloons and may be expanded by fluid actuation or any other
suitable method. Like fastener 1120, fastener 1130 may be modified
to include a pointed tip.
[0090] FIG. 10SS shows fasteners 1140 and 1150 having fastener
members 1141, 1151 respectively that include non-straight connector
pathways. Such pathways create an interference between the
connecting member 1142, 1152 and the member 1141, 1151 to aid in
securing them together. In the embodiments shown, member 1141
includes a wavy, or serpentine, pathway for member 1142, and member
1151 includes a pathway with a bend. Other non-straight pathways
may be used.
[0091] FIG. 10R shows a fastener 890 having a plurality of
connecting members 891 across the tissue layers to spread the force
applied to the tissue surfaces. The connecting members 891 may be
unconnected at their ends, or may be connected at their ends to be
a single member wrapped around the fastener members 892,893.
[0092] In further embodiments, friction between the connector
member and the fastener members may be increased by a rough surface
on the connector member (by for example braiding, knots, fibers),
an elastic connecting member, a coated connecting member, or a
fabric covered connecting member. In addition, the through hole of
the fastener member(s) may include gripping teeth arranged at an
angle to prevent reverse movement of the connecting member.
Embodiments as appropriate throughout this specification also may
include a quick-setting, water tolerant adhesive or glue, such as
cyanoacrylate, may be used to pack the passage or hole within a
fastening member.
[0093] FIGS. 9A through 9J show various other exemplary connecting
members according to other embodiments of the present invention. As
shown in the figures, a connecting member can be formed of a
telescopic bar 701, a collapsible bellows 702, a cylindrical bar
with a ball-socket arrangement 703, a stent-like braided
configuration 704, a spiral-shaped spring 705, a webbed spiral
spring 706, a crimped structure 707, ratchet 708, elastic member
710, or webbed member 712. In particular, at least the connecting
members 701, 702, 705, 706, 710, and 712 shown in FIGS. 9A, 9B, 9E,
9F, 9I, and 9J are configured to be expandable/contractible so as
to provide compressive forces to enhance fastening. In an
embodiment shown in FIG. 9E, the connecting member 705 is formed of
a spiral-shaped spring. As shown in FIG. 9F, the spiral-shaped
spring may be covered with a conforming material 706a, such as, for
example, polyurethane, silicone, polytetrafluoroethylene, webbed
material or other suitable material. In another embodiment shown in
FIG. 9G, the connecting member 707 is configured to be coupled to a
fastening member 618. Preferably, a pledget 717 or a ring is
utilized to couple between the connecting member 707 and the
fastening member 618 to allow moveability of the fastening member
618 along the connecting member 707. In yet another embodiment
shown in FIG. 9H, the connecting member 708 includes at least one
skirt-like or frustoconical-shaped ratchet 708a which permits
movement only in one direction. FIG. 9I illustrates a post
embodiment wherein the post comprises an elastic material. The
embodiment of FIG. 9J illustrates a post 712 comprising a webbed
material, for example, a knit or woven material. Any other suitable
designs providing the similar function may be utilized.
[0094] A connecting member 701-712 is preferably strong enough to
maintain its integrity and utility even under stressful events,
such as running, swimming, sneezing, coughing, vomiting, or the
like. These connecting members 701-712 can provide compressive
forces to enhance the fastening of the tissues. In addition, these
connecting members 701-712 provide enhanced flexibility for
traversing through a tortuous path within a body.
[0095] Many of the disclosed tissue fasteners, especially those
that expand from a contracted, delivered state to an expanded,
deployed state, may be made of a shape memory material, such as,
for example, nickel titanium alloy (e.g., Nitinol) or a polymer. By
utilizing a shape memory material, the fastening member is able to
transform from its delivered state to its deployed, functional
state automatically upon deployment. Alternatively, the
reconfiguration can be obtained by utilizing a material that is
reactive to a predetermined condition, e.g., temperature, pH,
electrical current, and/or a number of other internal and external
stimuli or by its material properties such as elasticity. The
expandability of the distal and proximal fastening members can also
be obtained by utilizing any suitable mechanical means, such as,
for example, a manually actuated expander.
[0096] The disclosed tissue fasteners are preferably composed of a
biocompatible and biocompliant material, i.e. similar to the
compliance of the tissue being connected. The fasteners also may be
coated with thrombogenic agents and therapeutics to prevent tissue
inflammation. Examples of materials for a tissue fastener,
including its coating or covering, include silicone-based polymers,
nylon-based polymers, hydrid Teflon-textile based polymers,
polypropylene, polyethlylene, or growth factors. Polymer coating
materials further include polycarboxylic acids, cellulosic polymers
(e.g., cellulose acetate and cellulose nitrate), gelatin,
polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone,
polyanhydrides (e.g., maleic anhydride polymers), polyamides,
polyvinyl alcohols, copolymers of vinyl monomers (e.g., EVA),
polyvinyl ethers, polyvinyl aromatics, polyethylene oxides,
glycosaminoglycans, polysaccharides, polyesters (polyethylene
terephthalate), polyacrylamides, polyethers, polyether sulfone,
polycarbonate, polyalkylenes, halogenated polyalkylenes (e.g.,
polytetrafluoroethylene), polyurethanes, polyorthoesters, proteins,
glycoproteins, recombinant proteins, polypeptides, silicones,
siloxane polymers, polylactic acid, polyglycolic acid,
polycaprolactone, polyhydroxybutyrate valerate and blends and
copolymers thereof, coatings from polymer dispersions such as
polyurethane dispersions (e.g., BAYHDROL.RTM.), fibrin, collagen
and its derivatives, polysaccharides (e.g., celluloses, starches,
dextrans, alginates and derivatives), hyaluronic acid, and squalene
emulsions. Other preferred materials include polyacrylic acid
(e.g., HYDROPLUS.RTM.), described in U.S. Pat. No. 5,091,205, the
disclosure of which is hereby incorporated by reference, and a
copolymer of polylactic acid and polycaprolactone. In a preferred
embodiment, the fastener comprises a bioabsorbable material. A
preferred coating would be one which would minimize tissue
inflammation around the fastener.
[0097] The disclosed tissue fastener can be made of biodegradable,
bioresorbable, and/or bioabsorbable material. The clamping force
created by the fastener will induce adhesion formation between the
tissue layers. This can occur in a controlled fashion by carefully
selecting a material with a predetermined degradation rate. The
bioabsorbable material may be formed of cross-linked polymer
networks that can be manufactured to be responsive to body
temperature, light, pH, and/or a number of other external/internal
stimuli.
[0098] Deployment of a tissue fastener is discussed below with
reference to an exemplary endoluminal deployment system, shown in
FIGS. 11A-C. For illustration purpose, the tissue fastener 1 shown
in FIG. 2 is used to illustrate various deployment stages of a
tissue fastener, according to an embodiment of the present
invention. The deployment system, however, may be used with various
other embodiments of tissue fasteners described above. The
deployment system 50 includes a flexible overtube 52 configured to
accommodate a tissue fastener 1 in a delivered state, and a
coupling mechanism 53 for grasping and moving the tissue fastener 1
along the lumen of the overtube 52. The deployment system 50 may
also be configured to accommodate multiple tissue fasteners that
are stacked axially. The coupling mechanism may be a mechanical
grasper 53 that is remotely operable by suitable actuation means at
the proximal end (not shown) of the overtube 52. The system 50 also
includes a pusher 54 for guiding the tissue fastener along the
overtube 52. The pusher 54 may include a hollow lumen through which
a cable for operating the grasper 53 passes. The overtube 52
includes a lumen 56 preferably having a diameter capable of
accommodating the tissue fastener 1. In at least one embodiment,
the overtube 52 may be incorporated into a conventionally known
endoluminal fundoplication device, described in U.S. Pat. No.
6,086,600, the disclosure of which is hereby incorporated by
reference. A device as taught in that patent may be used to fold
the esophageal and fundus walls together, with overtube 52 then
used to apply one or more fasteners. The overtube 52 is preferably
made of polymer, polymer reinforced with metal, or metal hypotube.
The overtube is preferably low in profile and flexible enough to
traverse the cricopharyngeal area transorally.
[0099] FIGS. 18A and 18B show an exemplary embodiment of deployment
system 50, wherein a grasper 53 is fixedly connected to a distal
end of a pusher 54. Grasper 53 includes a pair of arms 53' each
terminating in bent hooks 53''. Arms 53' are elastic and biased in
the open position shown in FIG. 18B. During delivery of a tissue
fastener, arms 53' are contracted within overtube 52, ands hooks
53'' mate with a head 11' of fastener member 11 to hold the
fastener to be deployed. When the fastener is deployed and pusher
54 is moved distally so that grasper arms 53' move past the end of
overtube 52, arms 53' bias to the open position and release member
11. Other suitable coupling methods and devices known in the art
for mechanically or otherwise coupling a tissue fastener to a
delivery mechanism may be used, such as for example, graspers, pull
wires, hooks, elastic couplings, springs, cups, and hypotubes.
[0100] In another method of detaching a tissue fastener, such as a
fastener made of a single wire or any other suitable fastener
described in this disclosure, the fastener may be attached to an
external mechanism, such as a wire, that runs outside the body. The
external wire then may carry the electrical current to electrically
detach the fastener when installation of the tissue fastener is
complete. Technology known as a Gugliemi Detachable Coil (GDC) or
GDC coil detachment, such as that described in U.S. Pat. No.
5,423,829, incorporated by reference herein, may be used in
connection with this embodiment.
[0101] Referring back to the embodiment shown in FIG. 11B, the
tissue fastener 1 is contained within the flexible overtube 52 and
endoluminally delivered to a desired site in a body to protect the
body lumen from possible damage caused by the sharp edge 15 of the
tissue fastener 1. As shown in FIG. 11B, once the distal end
opening 55 of the overtube 52 is placed at the desired site, the
tissue fastener 1 is advanced toward the tissue surface, such that
the sharp edge 15 of the tissue fastener 1 makes contact with the
tissues to be perforated. It should be understood that the tissue
fastener may be configured to perforate through the tissue layers,
or may be configured to pass through an opening already made by
other perforating instruments or the overtube 52. For example, the
overtube may include a sheath covering it to puncture through
tissue. Once the tissue fastener 1 passes through tissue layers,
the distal fastener member 13 is further advanced out of the
overtube 52, and the anchor legs 23 are expanded outwardly to form
an umbrella-shaped fastening member 13, as shown in FIG. 11C, to
hold the tissue layers together.
[0102] FIGS. 12A through 16 show implantation of a tissue fastener
1 in a fundoplication procedure, using the endoluminal deployment
system shown in FIGS. 11A-11C. The deployment includes performing
the delivery and placement of the tissue fastener 1 in essentially
one step. As shown in FIG. 12A, the deployment system 50 containing
the tissue fastener 1 is transorally inserted into the lower
esophagus 3 and positioned adjacent to a desired location near the
distal end of the esophagus 3 for the fundoplication procedure.
[0103] Preferably, prior to the insertion of the endoluminal
deployment system into the esophagus 3, the fundus wall 6 is lifted
and folded toward the esophageal wall 4 as shown in FIG. 12A. Any
suitable mechanism for lifting the fundus wall 6 toward the
esophageal wall 4 may be used for this purpose. An example of such
a suitable device is shown and described in U.S. Pat. No.
6,086,600, the entire disclosure of which is incorporated by
reference herein. It should also be understood that the lifting
device may be formed in combination with the endoluminal deployment
system 50.
[0104] After the distal end opening 55 of the overtube 52
positioned proximate a desired perforation site of the esophageal
wall 4, the tissue fastener 1 is advanced toward the esophageal
wall surface, such that the sharp edge 15 of the tissue fastener
makes contact with the surface, as illustrated in FIG. 12B Tissue
fastener 1 preferably extends out of the overtube 52 only enough so
that the edge 15 extends from the opening 55, yet a portion of legs
23 remain in the overtube 52 so that the distal fastening member 13
remains in a contracted state. As discussed above, the tissue
fastener 1 may be configured to cut through the esophageal wall 4
and the fundus wall 6, or may be configured to penetrate through an
opening already made by other instrument or the overtube 52. As
shown in FIG. 13, the overtube 52 with the sharp edge 15 of the
tissue fastener 1 protruded out of the overtube 52 is advanced
through the esophageal wall 4 and the fundus wall 6.
[0105] Once the tissue fastener 1 passes through the layers of
esophageal and fundus walls 4, 6, the distal fastening member 13 of
the tissue fastener 1 is further advanced out of the overtube 52
causing the anchor legs 23 of the distal fastening member 13 to
expand outwardly to form an umbrella-shaped fastening member 13, as
shown in FIG. 14. After the distal fastening member 13 is securely
placed against the inside fundus wall 6, the overtube 52 is
withdrawn and releases the tissue fastener 1 to completely expose
the proximal fastening member 11 of the tissue fastener 1. The
anchor legs 21 of the proximal fastening member 11 expand outwardly
to form the fastening member 11. FIG. 15 is a perspective view of
the proximal fastening member 11 of the tissue fastener 1, viewing
from inside the esophagus, after the deployment is complete. The
distal fastening member 13, i.e., the gastric side, should be
robust and resistant to low stomach pH, and the proximal fastening
member 11, i.e., esophageal side, should be low in profile to
prevent possible lumen occlusion.
[0106] FIG. 16 is a cross-section view of the esophageal wall 4 and
the fundus wall 6, with a tissue fastener in place, after the
fundoplication procedure is complete. The expanded distal and
proximal fastener members 13, 11 of the tissue fastener 1 hold and
maintain the esophageal and fundus walls 4, 6 together in place to
create the fundoplication. The tissue fastener 1 should be strong
enough to hold the esophagus and fundus together with a force of
approximately 6 lbs without damage to the esophageal wall 4 or
fundus wall 6. Furthermore, the tissue fastener 1 should be
sufficiently strong enough to maintain its integrity and utility
even under stressful events, such as running, swimming, sneezing,
coughing, vomiting, or the like. Depending on the type of tissue
fasteners used and the desired fastening strength, more than one
tissue fastener may be installed. In that instance, a deployment
system capable of loading multiple tissue fasteners can be
used.
[0107] The invention is not limited to the exemplary embodiment
used to illustrate the deployment of the tissue fastener 1. Other
various tissue fasteners encompassed in this disclosure can be used
with the deployment systems and methods described above. Moreover,
the disclosed tissue fasteners of the present invention can be used
with any other deployment mechanisms conventionally known in the
art. In particular, for the tissue fasteners 301, 401 that do not
encompass sharp cutting edges, an opening through the esophageal
wall 4 and the fundus wall 6 can be made by other piercing
instruments, or the endoluminal deployment system 70 having a
cutting edge 40 on its distal tip, as shown in FIGS. 17A and
17B.
[0108] FIGS. 17A and 17B illustrate endoluminal deployment systems
70 used for the disclosed tissue fasteners, according to still
other embodiments of the present invention. Similar to the
deployment system 50 shown in FIGS. 10A-C, the deployment system 70
shown in FIGS. 17A and 17B includes a flexible overtube 71 having
either a straight or curved distal portion and configured to
accommodate a tissue fastener 70 in a contracted state. Fastener 70
is represented with fastening head 74 and connector 72, but this
illustration is not intended to limit the possible embodiments. In
this embodiment, overtube 71 is represented as a needle. Overtube
71 may be of any size necessary to deploy fastener 71 while working
within the confines of anatomical space and instrument space needed
to fold and retain the fundus against the esophageal wall. The
overtube 71 includes an opening 45 at its distal tip, through which
a tissue fastener passes. The opening 45 is defined by a slanted
edge to form a sharp cutting edge 40. During deployment, the sharp
cutting edge 40 forms an opening through the tissue layers prior to
the deployment of a tissue fastener. The fastener 70 is deployed by
releasing a fastening head on one side of the tissue layers
undergoing attachment and withdrawing overtube 71 from the tissues
to release a second fastening head on the opposite tissue layer
side.
[0109] Other devices and methods for delivery and deployment of
tissue fasteners disclosed herein may be used. Suitable, exemplary
methods and devices are disclosed in U.S. application Ser. No.
______, of Robert Devries et al., filed on the same day as this
disclosure, and entitled "Devices and Methods for Fastening Tissue
Layers." The complete disclosure of that application is
incorporated by reference herein.
[0110] In addition, although the present invention is depicted in
this disclosure as being used in the treatment of GERD, e.g., a
fundoplication procedure, it is to be understood that the tissue
fastener and related deployment methods and systems of the present
invention can be used to treat any of a number of different disease
conditions, and can be used for fastening any desired body
tissues.
[0111] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims.
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