U.S. patent application number 10/783717 was filed with the patent office on 2005-08-25 for tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same.
Invention is credited to Adams, John M., Alferness, Clifton A., Baker, Steve G., Carter, Brett J., Kraemer, Stefan J. M..
Application Number | 20050187565 10/783717 |
Document ID | / |
Family ID | 34861313 |
Filed Date | 2005-08-25 |
United States Patent
Application |
20050187565 |
Kind Code |
A1 |
Baker, Steve G. ; et
al. |
August 25, 2005 |
Tissue fixation devices and a transoral endoscopic gastroesophageal
flap valve restoration device and assembly using same
Abstract
Tissue fasteners carried on a tissue piercing deployment wire
fasten tissue layers of a mammalian body together. The fasteners
include a first member, a second member, and a connecting member
extending between the first and second members. The first and
second members are substantially parallel to each other. The
fasteners may be deployed in limited spaces and in various
applications including the restoration of a gastroesophageal flap
valve.
Inventors: |
Baker, Steve G.; (Redmond,
WA) ; Carter, Brett J.; (Monroe, WA) ;
Kraemer, Stefan J. M.; (Seattle, WA) ; Alferness,
Clifton A.; (Redmond, WA) ; Adams, John M.;
(Sammamish, WA) |
Correspondence
Address: |
GRAYBEAL, JACKSON, HALEY LLP
155 - 108TH AVENUE NE
SUITE 350
BELLEVUE
WA
98004-5901
US
|
Family ID: |
34861313 |
Appl. No.: |
10/783717 |
Filed: |
February 20, 2004 |
Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 17/0469 20130101;
A61B 2017/0419 20130101; A61B 2017/00827 20130101; A61B 17/064
20130101; A61B 2017/0414 20130101; A61B 17/0401 20130101; A61B
17/068 20130101; A61B 2017/0409 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 017/08 |
Claims
1. A fastener for use in a mammalian body, comprising: a first
member; a second member, the first and second members having first
and second ends; and a connecting member fixed to each of the first
and second members intermediate the first and second ends and
extending between the first and second members, the first and
second members being separated by the connecting member, and one of
the first and second members having a longitudinal axis and a
through channel along the axis arranged to be slidingly received on
a tissue piercing deployment wire.
2. The fastener of claim 1 wherein one end of the one of the first
and second members further includes a pointed tip.
3. The fastener of claim 2 wherein the connecting member is
flexible permitting another one of the first and second members to
be next to the one of the first and second members when the one of
the first and second members is on the tissue piercing deployment
wire.
4. The fastener of claim 2 wherein the pointed tip is conical.
5. The fastener of claim 2 wherein the pointed tip comprises a
sectioned portion.
6. The fastener of claim 2 wherein the pointed tip is a dilation
tip.
7. The fastener of claim 1 wherein the through channel comprises a
through bore.
8. The fastener of claim 1 wherein both the first and second
members include a longitudinal axis and a through channel along
each respective axis.
9. The fastener of claim 8 wherein one end of both the first and
second members includes a pointed tip.
10. The fastener of claim 9 wherein the pointed tips point in
opposite directions.
11. The fastener of claim 8 wherein the through channels are
through bores.
12. The fastener of claim 8 wherein the through channels are
arranged to be slidingly received by the tissue piercing deployment
wire and wherein the connecting member is flexible permitting the
first and second members to be in line with each other on the
tissue piercing deployment wire.
13. The fastener of claim 1 wherein the fastener is at least
partially radio opaque.
14. The fastener of claim 1 wherein the length of the connecting
member between the first and second members is adjustable.
15. The fastener of claim 1 wherein the connecting member is formed
of elastic material.
16. The fastener of claim 1 wherein the first member, the second
member, and the connecting member are all formed of plastic
material.
17. The fastener of claim 16 wherein the first member, the second
member, and the connecting member are all formed in one piece.
18. The fastener of claim 17 wherein one end of the one of the
first and second members further includes a pointed tip.
19. The fastener of claim 18 wherein the pointed tip comprises a
truncated cone.
20. The fastener of claim 18 wherein the through channel comprises
a through bore.
21. The fastener of claim 17 wherein both the first and second
members include a longitudinal axis and a through channel along
each respective axis.
22. The fastener of claim 21 wherein one end of both the first and
second members includes a pointed tip.
23. The fastener of claim 22 wherein the pointed tips point in
opposite directions.
24. The fastener of claim 16 wherein the connecting member is
formed of plastic elastic material.
25. The fastener of claim 16 wherein the connecting member is
formed of a plastic, permanently deformable material.
26. The fastener of claim 16 wherein the plastic material includes
a color pigment contrasting with body tissue color to enable
visualization of the fastener with an endoscope.
27. The fastener of claim 17 wherein the connecting member has a
vertical dimension and a horizontal dimension transverse to the
vertical dimension, and wherein the horizontal dimension is
substantially less than the vertical dimension rendering the
connecting member readily bendable in a horizontal plane.
28. The fastener of claim 17 wherein at least one of the first and
second members includes a plurality of longitudinally spaced
vertical slots rendering the at least one of the first and second
members flexible in a direction opposite the slots but stiff in a
direction of the slots.
29. The fastener of claim 1 further comprising a plurality of
connecting members extending between the first and second
members.
30. The fastener of claim 1 wherein the first and second members
and the connecting member are formed of different materials.
31. The fastener of claim 1 wherein the first and second members
and the connecting member have different textures.
32. The fastener of claim 1 wherein the first member, the second
member, and the connecting member are integrally formed from a same
tubular member stock.
33. The fastener of claim 32 wherein both the first and second
members include a through channel for being slidingly received in
line on the tissue piercing deployment wire.
34. The fastener of claim 32 wherein the fastener is formed of
metal.
35. The fastener of claim 33 wherein the fastener is formed of a
shape memory material and wherein the first and second members are
self-deployable.
36. The fastener of claim 35 wherein the fastener is formed of
nitinol.
37. The fastener of claim 33 wherein at least one of the first and
second members is self-deployable while on the tissue piercing
deployment wire.
38. The fastener of claim 33 wherein at least one of the first and
second members is self-deployable upon removal from the tissue
piercing deployment wire.
39. The fastener of claim 38 wherein the at least one of the first
and second members includes a restrictor that provides a controlled
resistance to movement between the fastener and the tissue piercing
deployment wire.
40. The fastener of claim 39 wherein the restrictor comprises a
crimp.
41. The fastener of claim 32 wherein the connecting member
comprises a strip of the tubular member formed by a pair of
longitudinal substantially parallel, substantially coextensive cuts
within the tubular member and the first and second members are
formed by a substantially transverse circumferential cut between
the substantially parallel coextensive cuts.
42. The fastener of claim 41 wherein the tubular member has first
and second opposed ends and wherein the substantially parallel
substantially coextensive cuts begin spaced from the first end and
terminate spaced from the second ends, and wherein the first and
second members are tubular member sections between the
circumferential cut and the tubular member first and second
ends.
43. The fastener of claim 42 further comprising an elongated notch
extending from one of the ends of the tubular member, substantially
diametrically opposite and juxtaposed to a portion of the
connecting member strip.
44. The fastener of claim 1 wherein the fastener is formed of a
shape memory material.
45. The fastener of claim 44 wherein the metal material is a shape
memory material.
46. The fastener of claim 45 wherein the shape memory material is
Nitinol.
47. A fastener assembly for use in a mammalian body, comprising: a
fastener including a first member, a second member, wherein the
first and second members have first and second ends, and a
connecting member fixed to each of the first and second members
intermediate the first and second ends and extending between the
first and second members, wherein the first and second members are
separated by the connecting member, and wherein one of the first
and second members has a longitudinal axis and a through channel
along the axis; a deployment wire that slidingly receives the
through channel of the one of the first and second members and
pierces into the tissue; and a pusher that pushes the one of first
and second members into the tissue while on the deployment
wire.
48. The assembly of claim 47 wherein the pusher is also arranged to
be slidingly received on the deployment wire.
49. The assembly of claim 47 wherein the connecting member of the
fastener is flexible, and wherein the assembly further comprises a
guide tube extending over the deployment wire and the fastener, the
other one of the first and second members being disposed next to
the one of the first and second members within the guide tube.
50. The assembly of claim 47 wherein the first and second members
are arranged to be side by side when the one of the first and
second members is slidingly received on the deployment wire.
51. The assembly of claim 47 wherein one end of the one of the
first and second members of the fastener further includes a pointed
tip.
52. The assembly of claim 51 wherein the pointed tip comprises a
truncated cone.
53. The assembly of claim 51 wherein the pointed tip comprises a
sectioned portion.
54. The assembly of claim 47 wherein the through channel of the
fastener comprises a through bore.
55. The assembly of claim 47 wherein both the first and second
members include a longitudinal axis and a through channel along
each respective axis.
56. The assembly of claim 55 wherein one end of both the first and
second members includes a pointed tip.
57. The assembly of claim 56 wherein the pointed tips point in
opposite directions.
58. The assembly of claim 55 wherein the through channels are
through bores.
59. The assembly of claim 55 wherein the through channels of the
first and second members are arranged to be slidingly received by
the tissue piercing deployment wire and wherein the connecting
member is flexible permitting the first and second members to be in
line with each other on the tissue piercing deployment wire.
60. The assembly of claim 59 further comprising a guide tube
extending over the deployment wire and the fastener.
61. The assembly of claim 47 wherein the first member, the second
member, and the connecting member of the fastener are all formed of
plastic material.
62. The assembly of claim 61 wherein the first member, the second
member, and the connecting member of the fastener are all formed in
one piece.
63. The assembly of claim 47 wherein the first member, the second
member, and the connecting member of the fastener comprises
separate pieces.
64. The assembly of claim 47 wherein one end of the one of the
first and second members of the fastener further includes a
dilation tip.
65. The assembly of claim 64 wherein the dilation tip is a pointed
tip.
66. The assembly of claim 65 wherein the pointed tip of the
fastener is conical.
67. The assembly of claim 47 wherein the through channel of the
fastener comprises a through bore.
68. The assembly of claim 47 wherein both the first and second
members of the fastener include a longitudinal axis and a through
channel along each respective axis.
69. The assembly of claim 68 wherein one end of both the first and
second members of the fastener includes a dilation tip.
70. The assembly of claim 69 wherein the dilation tips point in
opposite directions.
71. The assembly of claim 47 wherein the connecting member of the
fastener is formed of plastic elastic material.
72. The assembly of claim 71 wherein the connecting member of the
fastener is formed of one of polyurethane, themoplastic elastomer,
and polypropylene.
73. The assembly of claim 47 wherein the connecting member of the
fastener is formed of a plastic, permanently deformable
material.
74. The assembly of claim 73 wherein the connecting member is
formed of one of polypropylene and polyethylene.
75. The assembly of claim 61 wherein the plastic material includes
a color pigment contrasting with body tissue color to enable
visualization of the fastener with an endoscope.
76. The assembly of claim 47 wherein the connecting member of the
fastener has a vertical dimension and a horizontal dimension
transverse to the vertical dimension, and wherein the horizontal
dimension is substantially less than the vertical dimension
rendering the connecting member readily bendable in a horizontal
plane.
77. The assembly of claim 47 wherein at least one of the first and
second members of the fastener includes a plurality of
longitudinally spaced vertical slots rendering the at least one of
the first and second members flexible in a direction opposite the
slots but stiff in a direction of the slots.
78. The assembly of claim 47 wherein the first member, the second
member, and the connecting member of the fastener are integrally
formed from a same tubular member stock.
79. The assembly of claim 78 wherein both the first and second
members of the fastener include a through channel for being
slidingly received in line on the tissue piercing deployment
wire.
80. The assembly of claim 47 wherein the fastener is formed of
metal.
81. The assembly of claim 47 wherein the fastener is formed of a
shape memory material and wherein the first and second members are
self-deployable.
82. The assembly of claim 81 wherein the fastener is formed of
Nitinol.
83. The assembly of claim 79 wherein at least one of the first and
second members of the fastener is self-deployable while on the
tissue piercing deployment wire.
84. The assembly of claim 79 wherein at least one of the first and
second members of the fastener is self-deployable upon removal from
the tissue piercing deployment wire.
85. The assembly of claim 84 wherein the at least one of the first
and second members of the fastener is distal to another one of the
first and second members and wherein the another one of the first
and second members includes a crimp that provides a controlled
resistance to movement on the tissue piercing deployment wire.
86. The assembly of claim 78 wherein the connecting member
comprises a strip of the tubular member formed by a pair of
longitudinal substantially parallel substantially coextensive cuts
within the tubular member and the first and second members are
formed by a substantially transverse circumferential cut between
the substantially parallel coextensive cuts.
87. The assembly of claim 86 wherein the tubular member has first
and second exposed ends and wherein the substantially parallels
substantially coextensive cuts begin spaced from the first end and
terminate spaced from the second end, and wherein the first and
second members are tubular member sections between the
circumferential cut and the tubular member first and second
ends.
88. The assembly of claim 87 wherein the tubular member includes an
elongated notch extending from one of the ends of the tubular
member, substantially diametrically opposite and juxtaposed to a
portion of the connecting member strip.
89. The assembly of claim 47 wherein the fastener is formed of a
shape memory material.
90. The assembly of claim 89 wherein the shape memory material is
Nitinol.
91. The assembly of claim 87 wherein both the first and second
tubular members are arranged to be slidingly received on the
deployment wire.
92. The assembly of claim 91 further comprising a guide tube
extending over the deployment wire and fastener.
93. The assembly of claim 92 wherein the fastener is formed of a
shape memory material.
94. The assembly of claim 93 wherein the shape memory material is
Nitinol.
95. The assembly of claim 47 further comprising a guide tube
extending over the deployment wire and fastener and wherein the
guide tube includes a distal notch permitting a proximal one of the
first and second members to deploy before the guide tube proximally
clears the proximal member.
96. The assembly of claim 95 wherein the proximal one of the first
and second members is deployable while on the deployment wire.
97. The assembly of claim 47 wherein the deployment wire includes a
bent tip.
98. The assembly of claim 47 further comprising a plurality of the
fasteners slidingly received on the deployment wire.
99. A tissue fixation assembly comprising: a fastener, and a pair
of hingedly coupled first and second arms for receiving the tissue
therebetween, the first arm including a fastener director that
directs the fastener into the tissue and the second arm including
an opening permitting the fastener to be driven through the tissue
while being held between the first and second arms.
100. The assembly of claim 99 wherein the second arm is a frame
structure.
101. The assembly of claim 99 further comprising a tissue gripper
that grips the tissue and pulls the tissue into and between the
first and second arms.
102. The assembly of claim 99 wherein the first arm has a tissue
engaging surface and wherein the fastener director includes a
channel communicating with the tissue engaging surface through
which the fastener passes into the tissue.
103. The assembly of claim 102 wherein the fastener director
includes a plurality of the channels to direct a like plurality of
fasteners into the tissue.
104. The assembly of claim 102 further comprising a fastener
deployment wire extending through the channel and that guides the
fastener through the channel and into the tissue.
105. The assembly of claim 104 wherein the fastener comprises a
first member, a second member, the first and second members having
first and second ends, and a connecting member fixed to each of the
first and second members intermediate the first and second ends and
extending between the first and second members, the first and
second members being substantially parallel to each other and
separated by the connecting member when the fastener is deployed,
and one of the first and second members having a longitudinal axis
and a through channel along the axis arranged to be slidingly
received on the fastener deployment wire.
106. A transoral gastroesophageal flap valve restoration device
comprising: a longitudinal member, a portion of which is arranged
for transoral placement into a stomach; a fastener; and a tissue
shaper carried on the longitudinal member that shapes stomach
tissue into a shape, the tissue shaper comprising a pair of
hingedly coupled first and second arms for receiving the stomach
tissue therebetween, the first arm including a fastener director
that directs the fastener into the stomach tissue and the second
arm including an opening permitting the fastener to be driven
through the stomach tissue while being held between the first and
second arms.
107. The device of claim 106 wherein the second arm of the tissue
shaper is a frame structure.
108. The device of claim 106 wherein the tissue shaper further
comprises a tissue gripper that grips the stomach tissue and pulls
the stomach tissue into and between the first and second arms.
109. The device of claim 106 wherein the first arm of the tissue
shaper has a tissue engaging surface and wherein the fastener
director includes a channel communicating with the tissue engaging
surface through which the fastener passes into the stomach
tissue.
110. The device of claim 109 wherein the fastener director includes
a plurality of the channels to direct a like plurality of fasteners
into the stomach tissue.
111. The device of claim 109 further comprising a fastener
deployment wire extending through the channel and that guides the
fastener through the channel and into the stomach tissue.
112. The device of claim 111 wherein the fastener comprises a first
member, a second member, the first and second members having first
and second ends, and a connecting member fixed to each of the first
and second members intermediate the first and second ends and
extending between the first and second members, the first and
second members being substantially parallel to each other and
separated by the connecting member when the fastener is deployed,
and one of the first and second members having a longitudinal axis
and a through channel along the axis arranged to be slidingly
received on the fastener deployment wire.
113. A tissue fixation assembly comprising: a fastener; a pair of
hingedly coupled first and second arms for receiving the tissue
therebetween, the first arm including a fastener director that
directs the fastener into the tissue and the second arm including
an opening permitting the fastener to be driven through the tissue
while being held between the first and second arms; and a tissue
gripper including a helical coil that grips the tissue and pulls
the tissue into and between the first and second arms, wherein the
fastener comprises a first member, a second member, the first and
second members having first and second ends, and a connecting
member fixed to each of the first and second members intermediate
the first and second ends and extending between the first and
second members, the first and second members being substantially
parallel to each other and separated by the connecting member when
the fastener is deployed, and one of the first and second members
having a longitudinal axis and a through channel along the axis
arranged to be slidingly received on a fastener deployment
wire.
114. A transoral gastroesophageal flap valve restoration device
comprising: a longitudinal member, a portion of which is arranged
for transoral placement into a stomach; a fastener; a tissue shaper
carried on the longitudinal member that shapes stomach tissue into
a shape, the tissue shaper comprising a pair of hingedly coupled
first and second arms for receiving the stomach tissue
therebetween, the first arm including a fastener director that
directs the fastener into the stomach tissue and the second arm
including an opening permitting the fastener to be driven through
the stomach tissue while being held between the first and second
arms; and a tissue gripper including a helical coil that grips the
stomach tissue and pulls the stomach tissue into and between the
first and second arms, wherein the fastener comprises a first
member, a second member, the first and second members having first
and second ends, and a connecting member fixed to each of the first
and second members intermediate the first and second ends and
extending between the first and second members, the first and
second members being substantially parallel to each other and
separated by the connecting member when the fastener is deployed,
and one of the first and second members having a longitudial axis
and a through channel along the axis arranged to be slidingly
received on a fastener deployment wire.
Description
FIELD OF THE INVENTION
[0001] The present invention generally relates to tissue fixation
devices, and more particularly to devices for treating
gastroesophageal reflux disease using the same. The present
invention more particularly relates to such tissue fixation devices
which may be used in surgical environments and which are
self-deploying.
BACKGROUND
[0002] Gastroesophageal reflux disease (GERD) is a chronic
condition caused by the failure of the anti-reflux barrier located
at the gastroesophageal junction to keep the contents of the
stomach from splashing into the esophagus. The splashing is known
as gastroesophageal reflux. The stomach acid is designed to digest
meat, and will digest esophageal tissue when persistently splashed
into the esophagus.
[0003] A principal reason for regurgitation associated with GERD is
the mechanical failure of a deteriorated gastroesophageal flap to
close and seal against high pressure in the stomach. Due to reasons
including lifestyle, a Grade I normal gastroesophageal flap may
deteriorate into a malfunctioning Grade III or absent valve Grade
IV gastroesophageal flap. With a deteriorated gastroesophageal
flap, the stomach contents are more likely to be regurgitated into
the esophagus, the mouth, and even the lungs. The regurgitation is
referred to as "heartburn" because the most common symptom is a
burning discomfort in the chest under the breastbone. Burning
discomfort in the chest and regurgitation (burping up) of
sour-tasting gastric juice into the mouth are classic symptoms of
gastroesophageal reflux disease (GERD). When stomach acid is
regurgitated into the esophagus, it is usually cleared quickly by
esophageal contractions. Heartburn (backwashing of stomach acid and
bile onto the esophagus) results when stomach acid is frequently
regurgitated into the esophagus and the esophageal wall is
inflamed.
[0004] Complications develop for some people who have GERD.
Esophagitis (inflammation of the esophagus) with erosions and
ulcerations (breaks in the lining of the esophagus) can occur from
repeated and prolonged acid exposure. If these breaks are deep,
bleeding or scarring of the esophagus with formation of a stricture
(narrowing of the esophagus) can occur. If the esophagus narrows
significantly, then food sticks in the esophagus and the symptom is
known as dysphagia. GERD has been shown to be one of the most
important risk factors for the development of esophageal
adenocarcinoma. In a subset of people who have severe GERD, if acid
exposure continues, the injured squamous lining is replaced by a
precancerous lining (called Barrett's Esophagus) in which a
cancerous esophageal adenocarcinoma can develop.
[0005] Other complications of GERD may not appear to be related to
esophageal disease at all. Some people with GERD may develop
recurrent pneumonia (lung infection), asthma (wheezing), or a
chronic cough from acid backing up into the esophagus and all the
way up through the upper esophageal sphincter into the lungs. In
many instances, this occurs at night, while the person is in a
supine position and sleeping. Occasionally, a person with severe
GERD will be awakened from sleep with a choking sensation.
Hoarseness can also occur due to acid reaching the vocal cords,
causing a chronic inflammation or injury.
[0006] GERD never improves without intervention. Life style changes
combined with both medical and surgical treatments exist for GERD.
Medical therapies include antacids and proton pump inhibitors.
However, the medical therapies only mask the reflux. Patients still
get reflux and perhaps emphysema because of particles refluxed into
the lungs. Barrett's esophagus results in about 10% of the GERD
cases. The esophageal epithelium changes into tissue that tends to
become cancerous from repeated acid washing despite the
medication.
[0007] Several open laparotomy and laproscopic surgical procedures
are available for treating GERD. One surgical approach is the
Nissen fundoplication. The Nissen approach typically involves a
360-degree wrap of the fundus around the gastroesophageal junction.
The procedure has a high incidence of postoperative complications.
The Nissen approach creates a 360-degree moveable flap without a
fixed portion. Hence, Nissen does not restore the normal movable
flap. The patient cannot burp because the fundus was used to make
the repair, and may frequently experience dysphagia. Another
surgical approach to treating GERD is the Belsey Mark IV (Belsey)
fundoplication. The Belsey procedure involves creating a valve by
suturing a portion of the stomach to an anterior surface of the
esophagus. It reduces some of the postoperative complications
encountered with the Nissen fundoplication, but still does not
restore the normal movable flap. None of these procedures fully
restores the normal anatomical anatomy or produces a normally
functioning gastroesophageal junction. Another surgical approach is
the Hill repair. In the Hill repair, the gastroesophageal junction
is anchored to the posterior abdominal areas, and a 180-degree
valve is created by a system of sutures. The Hill procedure
restores the moveable flap, the cardiac notch and the Angle of His.
However, all of these surgical procedures are very invasive,
regardless of whether done as a laproscopic or an open
procedure.
[0008] New, less surgically invasive approaches to treating GERD
involve transoral endoscopic procedures. One procedure contemplates
a machine device with robotic arms that is inserted transorally
into the stomach. While observing through an endoscope, an
endoscopist guides the machine within the stomach to engage a
portion of the fundus with a corkscrew-like device on one arm. The
arm then pulls on the engaged portion to create a fold of tissue or
radial plication at the gastroesophageal junction. Another arm of
the machine pinches the excess tissue together and fastens the
excess tissue with one pre-tied implant. This procedure does not
restore normal anatomy. The fold created does not have anything in
common with a valve. In fact, the direction of the radial fold
prevents the fold or plication from acting as a flap of a
valve.
[0009] Another transoral procedure contemplates making a fold of
fundus tissue near the deteriorated gastroesophageal flap to
recreate the lower esophageal sphincter (LES). The procedure
requires placing multiple U-shaped tissue clips around the folded
fundus to hold it in shape and in place.
[0010] This and the previously discussed procedure are both highly
dependent on the skill, experience, aggressiveness, and courage of
the endoscopist. In addition, these and other procedures may
involve esophageal tissue in the repair. Esophageal tissue is
fragile and weak. Involvement of esophageal tissue in the repair of
a gastroesophageal flap valve poses unnecessary risks to the
patient.
[0011] A new and improved apparatus and method for restoration of a
gastroesophageal flap valve is fully disclosed in copending U.S.
application Ser. No. 10/150,740, filed May 17, 2002, for TRANSORAL
ENDOSCOPIC GASTROESOPHAGEAL FLAP VALVE RESTORATION DEVICE,
ASSEMBLY, SYSTEM AND METHOD, is assigned to the assignee of this
invention, and is incorporated herein by reference. That apparatus
and method provides a transoral endoscopic gastroesophageal flap
valve restoration. A longitudinal member arranged for transoral
placement into a stomach carries a tissue shaper that
non-invasively grips and shapes stomach tissue. A tissue fixation
device is then deployed to maintain the shaped stomach tissue in a
shape approximating a gastroesophageal flap.
[0012] Whenever tissue is to be maintained in a shape as, for
example, in the improved assembly last mentioned above, it is
necessary to fasten at least two layers of tissue together. In
applications such as gastroesophageal flap valve restoration, there
is very limited room to maneuver a fastener deployment device. For
example, this and other medical fastening applications provide
confined working channels and spaces and often must be fed through
an endoscope to permit visualization or other small lumen guide
catheters to the place where the fasteners are to be deployed. To
make matters worse, multiple fasteners may also be required. Hence,
with current fasteners and deployment arrangements, it is often
difficult to direct a single fastener to its intended location, let
alone a number of such fasteners.
[0013] Once the fastening site is located, the fasteners employed
must be truly able to securely maintain the tissue. Also, quite
obviously, the fasteners are preferably deployable in the tissue in
a manner which does not unduly traumatize the tissue.
SUMMARY
[0014] The present invention provides a fastener for use in a
mammalian body, comprising a first member, a second member, the
first and second members having first and second ends, and a
connecting member fixed to each of the first and second members
intermediate the first and second ends and extending between the
first and second members. The first and second members are
separated by the connecting member, and one of the first and second
members has a longitudinal axis and a through channel along the
axis arranged to be slidingly received on a tissue piercing
deployment wire.
[0015] The connecting member may be flexible permitting another one
of the first and second members to be next to the one of the first
and second members when the one of the first and second members is
on the tissue piercing deployment wire.
[0016] One end of the one of the first and second members may
include a pointed tip. The pointed tip may be conical or comprise a
tapered sectioned portion.
[0017] Both the first and second members may include a longitudinal
axis and a through channel along each respective axis. One end of
both the first and second members may include a pointed tip. The
pointed tips may point in opposite directions.
[0018] The through channels are arranged to be slidingly received
by the tissue piercing deployment wire. The connecting member may
be flexible permitting the first and second members to be in line
with each other on the tissue piercing deployment wire.
[0019] The first member, second member, and the connecting member
may all be formed of plastic material and in one piece or multiple
pieces.
[0020] The connecting member of the fastener may be formed of
plastic elastic material. Alternatively, the connecting member may
be formed of a plastic, permanently deformable material. The
plastic material may include a color pigment contrasting with body
tissue color to enable visualization of the fastener with an
endoscope.
[0021] The connecting member has a vertical dimension and a
horizontal dimension transverse to the vertical dimension, and the
horizontal dimension may be substantially less than the vertical
dimension rendering the connecting member readily bendable in a
horizontal plane. At least one of the first and second members may
include a plurality of longitudinally spaced vertical slots
rendering the at least one of the first and second members flexible
in a direction opposite the slots but stiff in a direction of the
slots. The device may comprise a plurality of the connecting
members.
[0022] The fastener may alternatively be formed of metal and
particularly a shape memory material. The first and second members
may then be self-deployable. One of the first and second members
may be self-deployable while on the tissue piercing deployment
wire.
[0023] At least one of the first and second members may be
self-deployable upon removal from the tissue piercing deployment
wire. The at least one of the first and second members is
preferably distal to another one of the first and second members
and the another one of the first and second members may include a
crimp that provides a controlled resistance to movement on the
tissue piercing deployment wire.
[0024] The first member, the second member, and the connecting
member may be integrally formed from a same tubular member stock.
The connecting member may comprise a strip of the tubular member
formed by a pair of longitudinal substantially parallel,
substantially coextensive cuts within the tubular member and the
first and second members may be formed by a substantially
transverse circumferential cut between the substantially parallel
coextensive cuts.
[0025] The tubular member may have first and second opposed ends
and the substantially parallel substantially coextensive cuts may
begin spaced from the first end and terminate spaced from the
second end. The first and second members may then be tubular member
sections between the circumferential cut and the tubular member
first and second ends. An elongated notch may extend from one of
the ends of the tubular member, substantially diametrically
opposite and juxtaposed to a portion of the connecting member
strip.
[0026] The invention further provides a fastener assembly for use
in a mammalian body. The assembly includes a fastener including a
first member, a second member, the first and second members having
first and second ends, and a connecting member fixed to each of the
first and second members intermediate the first and second ends and
extending between the first and second members. The first and
second members are separated by the connecting member, and one of
the first and second members may have a longitudinal axis and a
through channel along the axis. The assembly further includes a
deployment wire that slidingly receives the through channel of the
one of the first and second members and pierces into the tissue,
and a pusher that pushes the one of first and second members into
the tissue while on the deployment wire.
[0027] The pusher is preferably also arranged to be slidingly
received on the deployment wire. The connecting member of the
fastener may be flexible, and the assembly may further comprise a
guide tube extending over the deployment wire and the fastener. The
other one of the first and second members may be disposed next to
the one of the first and second members within the guide tube.
[0028] One end of the one of the first and second members of the
fastener may further include a pointed tip. The pointed tip may
comprise a truncated cone. Alternatively, the pointed tip may
comprise a sectioned portion. Either one or both of the first and
second members may include a longitudinal axis and a through
channel along each respective axis. The through channels of the
first and second members may be arranged to be slidingly received
by the tissue piercing deployment wire and the connecting member is
preferably flexible permitting the first and second members to be
in line with each other on the tissue piercing deployment wire. The
guide tube may then extend over the deployment wire and the
fastener.
[0029] The invention still further provides a tissue fixation
assembly. The assembly includes a fastener and a pair of hingedly
coupled first and second arms for receiving the tissue
therebetween. The first arm includes a fastener director that
directs the fastener into the tissue and the second arm includes an
opening permitting the fastener to be driven through the tissue
while being held between the first and second arms. The second arm
is preferably a frame structure.
[0030] The assembly may further comprise a tissue gripper that
grips the tissue and pulls the tissue into and between the first
and second arms. The first arm may have a tissue engaging surface
and the fastener director may include a channel communicating with
the tissue engaging surface through which the fastener passes into
the tissue.
[0031] The fastener director may include a plurality of the
channels to direct a like plurality of fasteners into the tissue.
The assembly may further comprise a fastener deployment wire that
guides the fastener through one of the channels and into the
tissue.
[0032] The fastener of the assembly may comprise a first member, a
second member, the first and second members having first and second
ends, and a connecting member fixed to each of the first and second
members intermediate the first and second ends and extending
between the first and second members. The first and second members
are separated by the connecting member when the fastener is
deployed. One of the first and second members preferably has a
longitudinal axis and a through channel along the axis arranged to
be slidingly received on the fastener deployment wire.
[0033] The invention still further provides a transoral
gastroesophageal flap valve restoration device. The device includes
a longitudinal member, a portion of which is arranged for transoral
placement into a stomach, a fastener, and a tissue shaper carried
on the longitudinal member. The tissue shaper shapes stomach tissue
into a shape and includes a pair of hingedly coupled first and
second arms for receiving the stomach tissue therebetween, the
first arm including a fastener director that directs the fastener
into the stomach tissue and the second arm including an opening
permitting the fastener to be driven through the stomach tissue
while being held between the first and second arms.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] The features of the present invention which are believed to
be novel are set forth with particularity in the appended claims.
The invention, together with further objects and advantages
thereof, may best be understood by making reference to the
following description taken in conjunction with the accompanying
drawings, in the several figures of which like referenced numerals
identify like elements, and wherein:
[0035] FIG. 1 is a front cross-sectional view of the
esophageal-gastro-intestinal tract from a lower portion of the
esophagus to the duodenum;
[0036] FIG. 2 is a front cross-sectional view of the
esophageal-gastro-intestinal tract illustrating a Grade I normal
appearance movable flap of the gastroesophageal flap valve (in
dashed lines) and a Grade III reflux appearance gastroesophageal
flap of the gastroesophageal flap valve (in solid lines);
[0037] FIG. 3 is a perspective view of a fastener according to an
embodiment of the invention;
[0038] FIG. 4 is a perspective view of another fastener according
to an embodiment of the invention;
[0039] FIG. 5 is a perspective view with portions cut away of a
fastener assembly according to an embodiment of the invention in an
early stage of deploying a fastener embodiment of the
invention;
[0040] FIG. 6 is a perspective view of the assembly of FIG. 5 shown
with the fastener being driven in the tissue layers to be
fastened;
[0041] FIG. 7 is a perspective view of the assembly of FIG. 5 shown
with the fastener extending through the tissue layers to be
fastened;
[0042] FIG. 8 is a perspective view of the assembly of FIG. 5 shown
with the fastener initially deployed;
[0043] FIG. 9 is a perspective view showing the fastener of the
assembly of FIG. 5 fully deployed and securely fastening a pair of
tissue layers together;
[0044] FIG. 10 is a perspective view with portions cut away of
another fastener deployment assembly according to an embodiment of
the invention in an early stage of deploying another fastener
embodiment of the invention;
[0045] FIG. 11 is a perspective view with portions cut away of
another fastener deployment assembly according to an embodiment of
the invention in an early stage of deploying another fastener
embodiment of the invention;
[0046] FIG. 12 is a perspective view showing the fastener of the
assembly of FIG. 11 fully deployed and securely fastening a pair of
tissue layers together;
[0047] FIG. 13A is a perspective view, to an enlarged scale, of the
fastener of FIG. 13;
[0048] FIG. 14 is a perspective view of the assembly of FIG. 13
shown with the fastener being driven in the tissue layers to be
fastened;
[0049] FIG. 15 is a perspective view of the assembly of FIG. 13
shown with the fastener extending through the tissue layers to be
fastened and partially deployed;
[0050] FIG. 16 is a perspective view of the assembly of FIG. 13
shown with the fastener initially fully deployed;
[0051] FIG. 17 is a perspective view showing the fastener of the
assembly of FIG. 13 fully deployed and securely fastening a pair of
tissue layers together;
[0052] FIG. 18 is a perspective view with portions cut away of
another fastener deployment assembly according to an embodiment of
the invention in an early stage of deploying the fastener of FIG.
13;
[0053] FIG. 19 is a perspective view of the assembly of FIG. 18
shown with the deployment wire driven through the tissue layers to
be fastened;
[0054] FIG. 20 is a perspective view of the assembly of FIG. 18
shown as in FIG. 19 but with the proximal end of the fastener being
released into a deployed configuration before the fastener is
driven into the tissue layers to be fastened;
[0055] FIG. 21 is a perspective view of the assembly of FIG. 18
shown with the fastener extending through the tissue layers to be
fastened;
[0056] FIG. 22 is a perspective view of the assembly of FIG. 18
shown with the fastener initially deployed;
[0057] FIG. 23 is a perspective view showing the fastener of the
assembly of FIG. 18 fully deployed and securely fastening a pair of
tissue layers together;
[0058] FIG. 24 is a perspective view of the fastener of FIG. 13
showing the fastener embedded within a layer of tissue;
[0059] FIG. 25 is a perspective view with portions cut away of a
fastener assembly according to an embodiment of the invention in an
early stage of deploying a still further fastener embodiment of the
invention;
[0060] FIG. 26 is a side view, partly in cross-section of another
fastener embodiment of the invention which provides resistance to
relative movement between the fastener and a deployment wire;
[0061] FIG. 27 is a perspective side view, partly in phantom of a
gastroesophageal flap valve restoration device embodying the
present invention shown in an initial state before use;
[0062] FIG. 28 is another perspective side view, partly in phantom
of the gastroesophageal flap valve restoration device of FIG. 27
embodying the present invention shown in an intermediate state
during use;
[0063] FIG. 29 is a side view, partly in cross-section of the
gastroesophageal flap valve restoration device of FIG. 27 shown
forming a gastroesophageal flap valve from stomach tissue prior to
delivery of a fastener to maintain the flap valve.
[0064] FIG. 30 is a perspective view of another fastener embodiment
of the present invention;
[0065] FIG. 31 is a top plan view of the fastener of FIG. 30;
[0066] FIG. 32 is a perspective view of still another fastener
embodiment of the present invention, and;
[0067] FIG. 33 is a top plan view of the fastener of FIG. 32.
DETAILED DESCRIPTION
[0068] FIG. 1 is a front cross-sectional view of the
esophageal-gastro-intestinal tract 40 from a lower portion of the
esophagus 41 to the duodenum 42. The stomach 43 is characterized by
the greater curvature 44 on the anatomical left side and the lesser
curvature 45 on the anatomical right side. The tissue of the outer
surfaces of those curvatures is referred to in the art as serosa
tissue. As will be seen subsequently, the nature of the serosa
tissue is used to advantage for its ability to bond to like serosa
tissue. The fundus 46 of the greater curvature 44 forms the
superior portion of the stomach 43, and traps gas and air bubbles
for burping. The esophageal tract 41 enters the stomach 43 at an
esophageal orifice below the superior portion of the fundus 46,
forming a cardiac notch 47 and an acute angle with respect to the
fundus 46 known as the Angle of His 57. The lower esophageal
sphincter (LES) 48 is a discriminating sphincter able to
distinguish between burping gas, liquids, and solids, and works in
conjunction with the fundus 46 to burp. The gastroesophageal flap
valve (GEFV) 49 includes a moveable portion and an opposing more
stationary portion. The moveable portion of the GEFV 49 is an
approximately 180 degree, semicircular, gastroesophageal flap 50
(alternatively referred to as a "normal moveable flap" or "moveable
flap") formed of tissue at the intersection between the esophagus
41 and the stomach 43. The opposing more stationary portion of the
GEFV 49 comprises a portion of the lesser curvature 45 of the
stomach 43 adjacent to its junction with the esophagus 41. The
gastroesophageal flap 50 of the GEFV 49 principally comprises
tissue adjacent to the fundus 46 portion of the stomach 43, is
about 4 to 5 cm long (51) at it longest portion, and the length may
taper at its anterior and posterior ends. The gastroesophageal flap
50 is partially held against the lesser curvature 45 portion of the
stomach 43 by the pressure differential between the stomach 43 and
the thorax, and partially by the resiliency and the anatomical
structure of the GEFV 49, thus providing the valving function. The
GEFV 49 is similar to a flutter valve, with the gastroesophageal
flap 50 being flexible and closeable against the other more
stationary side.
[0069] The esophageal tract is controlled by an upper esophageal
sphincter (UES) in the neck near the mouth for swallowing, and by
the LES 48 and the GEFV 49 at the stomach. The normal anti-reflux
barrier is primarily formed by the LES 48 and the GEFV 49 acting in
concert to allow food and liquid to enter the stomach, and to
considerably resist reflux of stomach contents into the esophagus
41 past the gastroesophageal tissue junction 52. Tissue aboral of
the gastroesophageal tissue junction 52 is generally considered
part of the stomach because the tissue protected from stomach acid
by its own protective mechanisms. Tissue oral of the
gastroesophageal junction 52 is generally considered part of the
esophagus and it is not protected from injury by prolonged exposure
to stomach acid. At the gastroesophageal junction 52, the juncture
of the stomach and esophageal tissues form a zigzag line, which is
sometimes referred to as the "Z-line." For the purposes of these
specifications, including the claims, "stomach" means the tissue
aboral of the gastroesophageal junction 52.
[0070] FIG. 2 is a front cross-sectional view of an
esophageal-gastro-intestinal tract illustrating a Grade I normal
appearance movable flap 50 of the GEFV 49 (shown in dashed lines)
and a deteriorated Grade III gastroesophageal flap 55 of the GEFV
49 (shown in solid lines). As previously mentioned, a principal
reason for regurgitation associated with GERD is the mechanical
failure of the deteriorated (or reflux appearance) gastroesophageal
flap 55 of the GEFV 49 to close and seal against the higher
pressure in the stomach. Due to reasons including lifestyle, a
Grade I normal gastroesophageal flap 50 of the GEFV 49 may
deteriorate into a Grade III deteriorated gastroesophageal flap 55.
The anatomical results of the deterioration include moving a
portion of the esophagus 41 that includes the gastroesophageal
junction 52 and LES 48 toward the mouth, straightening of the
cardiac notch 47, and increasing the Angle of His 57. This
effectively reshapes the anatomy aboral of the gastroesophageal
junction 52 and forms a flattened fundus 56. The deteriorated
gastroesophageal flap 55 illustrates a gastroesophageal flap valve
49 and cardiac notch 47 that have both significantly degraded. Dr.
Hill and colleagues developed a grading system to describe the
appearance of the GEFV and the likelihood that a patient will
experience chronic acid reflux. L. D. Hill, et al., The
gastroesophageal flap valve: in vitro and in vivo observations,
Gastrointestinal Endoscopy 1996:44:541-547. Under Dr. Hill's
grading system, the normal movable flap 50 of the GEFV 49
illustrates a Grade I flap valve that is the least likely to
experience reflux. The deteriorated gastroesophageal flap 55 of the
GEFV 49 illustrates a Grade III (almost Grade IV) flap valve. A
Grade IV flap valve is the most likely to experience reflux. Grades
II and III reflect intermediate grades of deterioration and, as in
the case of III, a high likelihood of experiencing reflux. With the
deteriorated GEFV represented by deteriorated gastroesophageal flap
55 and the fundus 46 moved inferior, the stomach contents are
presented a funnel-like opening directing the contents into the
esophagus 41 and the greatest likelihood of experiencing reflux.
Disclosed subsequently is a device for restoring the normal
gastroesophageal flap valve anatomy, which device is one embodiment
of the present invention.
[0071] Referring now to FIG. 3, it is a perspective view of a
fastener 100 according to an embodiment of the invention. The
fastener 100 generally includes a first member 102, a second member
104, and a connecting member 106. As may be noted in FIG. 3, the
first member 102 and second member 104 are substantially parallel
and substantially perpendicular to the connecting member 106 which
connects the first member 102 to the second member 104.
[0072] The first and second members 102 and 104 are generally
cylindrical. Each has a longitudinal axis 108 and 110 and a through
channel 112 and 114 along the longitudinal axes 108 and 110. The
through channels 112 and 114 are formed by through bores which are
dimensioned to be slidingly received on a tissue piercing
deployment wire to be described hereinafter.
[0073] The first member 102 also includes a first end 116 and a
second end 118. Similarly, the second member 114 includes a first
end 120 and a second end 122. The first ends 116 and 120 form
pointed dilation tips 124 and 126, respectively. The dilation tips
124 and 126 are conical and more particularly take the shape of
truncated cones. The pointed tips 129 and 126 are pointed in
opposite directions.
[0074] The first and second members 102 and 104 and the connecting
106 may be formed of different materials and have different
textures. These materials may include, for example, plastic
materials such as polypropylene, polyethylene, polyglycolic acid,
polyurethane, or a thermoplastic elastomer. As may be further noted
in FIG. 3, the connecting member 106 has a vertical dimension 128
and a horizontal dimension 130 which is transverse to the vertical
dimension. The horizontal dimension is substantially less than the
vertical dimension to render the connecting member 106 readily
bendable in a horizontal plane. The connecting member is further
rendered bendable by the nature of the plastic material from which
the fastener 100 is formed. The connecting member may be formed
from either an elastic plastic or a permanently deformable plastic.
An elastic material would prevent compression necrosis in some
applications.
[0075] Referring now to FIG. 4, it illustrates another fastener 140
embodying the present invention. As with the fastener 100 of FIG.
3, the fastener 140 includes a first member 142, a second member
144, and a connecting member 146. The fastener 140 may be formed in
one piece and a plastic material similar to the fastener 100 of
FIG. 3. The fasteners 100 and 140 may be formed of a plastic
material which includes a color pigment, for example pthalocyanine
blue, for contrasting with the color of body tissue to enable
visualization of the fastener with an endoscope during the
deployment of the fasteners. In addition, as may be seen in FIG. 4,
the fastener 140 is impregnated with radio opaque material 148 so
as to render the fastener 140 at least partially viewable under
fluoroscopy. The radio opaque particles may be, for example, barium
sulfate, bismuth subcarbonate, tungsten powder or tantalum
powder.
[0076] In addition to the foregoing, the second member 144 of the
fastener 140 includes a plurality of longitudinally spaced vertical
slots 150. This renders the second member 144 flexible in a
direction opposite the slots but stiff in a direction of the slots.
Hence, the second member 144 is resistant to bending in a first
direction indicated by arrow 152 while being substantially less
resistant to bending in a direction indicated by arrow 154. The
reduced resistance to bending in the direction 154 of the second
member 144 of the fastener 140 may be utilized to advantage in the
deployment of the fastener 140.
[0077] Referring now to FIG. 5, it is a perspective view with
portions cut away of a fastener assembly embodying the present
invention. The tissue layer portions above the fastener 162 have
been shown cut away in FIGS. 5-9 to enable the deployment procedure
to be seen more clearly. The assembly 160 generally includes a
fastener 162, a deployment wire 164, a pusher 166, and a guide tube
168.
[0078] The fastener 162 takes the form of a further fastener
embodiment of the present invention and includes a first member
172, a second member 174, and a connecting member 176. The fastener
162 differs from the fasteners 100 and 140 of FIGS. 3 and 4,
respectively, in that the second member 174 is of solid
construction and does not include a longitudinal through channel or
a pointed tip. However, the first member 172 includes a through
channel as previously described and a pointed tip 178.
[0079] The first member 172 of the fastener 162 is slidingly
received on the deployment wire 164. The deployment wire 164 has a
pointed tip 178 for piercing the tissue layers 180 and 182 to be
fastened together. As will be seen hereinafter, and in accordance
with further aspects of the present invention, the tissue layers
180 and 182 may be folded stomach tissue which are to be fastened
and maintained together to form and maintain a gastroesophageal
flap valve.
[0080] As will be noted in FIG. 5, the tissue piercing wire 164,
fastener 162, and the pusher 166 are all within the guide tube 168.
The guide tube 168 may take the form of a catheter, for
example.
[0081] As will be further noted in FIG. 5, the second member 174 is
disposed along side the first member 172. This is rendered possible
by the flexibility of the connecting member 176. Preferably, the
first member, connecting member, and second member are arranged so
that the connecting member 176 lies to the side of the first member
172 and the second member 174.
[0082] With the first member 172 of the fastener 162 slidingly
received on the tissue piercing wire 164 and with the pusher 166
just touching the first member 172 on the tissue piercing wire 164,
the tip 178 of the tissue piercing wire 164 pierces the tissue
layers 180 and 182. The subassembly of the tissue piercing wire
164, fastener 162, and pusher 166 may be guided to its intended
location relative to the tissue layers 180 and 182 by the guide
tube 168. As will be seen hereinafter, this subassembly may be
alternatively guided by guide channels arranged to accommodate the
tissue piercing wire 164, fastener 162, pusher 166, and the guide
tube 168.
[0083] Once the tissue piercing wire 164 has pierced the tissue
layers 180 and 182 to be fastened together, the pusher 166 may be
utilized to push the first member 172 of the fastener 162 through
the tissue layers 180 and 182 on the tissue piercing wire 164. This
is illustrated in FIG. 6. As the pusher 166 pushes the first member
172 through the tissue layers 180 and 182, the connecting member
176 follows along beside and immediately adjacent to the first
member 172 of the fastener 162 and the pusher 166. As may be seen
in FIG. 7, the pusher 166 continues to push the first member 172 of
the fastener 162 through the tissue layers 180 and 182 on the
tissue piercing wire 164 until the end 173 of the first member 172
engaging the pusher 166 clears the second tissue layer 182. It may
also be noted that at this time, the second member 174 of the
fastener 162 has engaged the surface 181 of tissue layer 180.
[0084] Referring now to FIG. 8, it will be seen that once the end
173 of the first member 172 has cleared the tissue layer 182, the
tissue piercing wire 164 is then retracted within the pusher 166 to
release the first member 172. The first member 172 being thus
released from the tissue piercing wire 164 will return to its
original configuration substantially parallel to the second member
174 and substantially perpendicular to the connecting member 176.
When the first member 172 is deployed as shown in FIG. 8, the
tissue piercing wire 164 and pusher 166 may be withdrawn.
[0085] FIG. 9 illustrates the fastener 162 in its deployed
position. It will be noted that the tissue layers 180 and 182 are
fastened together between the first member 172 of the fastener 162
and the second member 174 of the fastener 162. The connecting
member 176 extends through the tissue layers 180 and 182.
[0086] FIG. 10 is a perspective view with portions cut away of
another fastener and fastener assembly embodying the present
invention in an early stage of deploying the fastener. The fastener
190 of FIG. 10 includes a first member 192, a second member 194,
and a connecting member 196. The fastener 190 is similar to the
fastener 100 of FIG. 3 in that both the first member 192 and second
member 194 includes a through bore. This permits the first member
192 and second member 194 to be slidingly received in line with
each other on the tissue piercing wire 164. With both the first
member 192 and second member 194 being disposed on the tissue
piercing wire 164, the second member 194 will not be deployed until
after the tissue piercing wire 164 is retracted from the second
member 194. As a result, the second member of the fastener 162
illustrated in FIGS. 5-9 will deploy before the second member 194
of fastener 190. However, the arrangement illustrated in FIG. 10
may be advantageous where space is at a premium and the guide tube
168 has a reduced diameter. The deployment of the fastener 190 by
the tissue piercing wire 164, the pusher 166, and the guide tube
168 is otherwise similar to the deployment procedure described
above with respect to FIGS. 5-9.
[0087] FIG. 11 shows another fastener 200 embodying the present
invention. The fastener 200 is illustrated in an initial stage of
deployment by the tissue piercing deployment wire 164, the pusher
166, and the guide tube 168 to fasten tissue layers 180 and 182
together. FIG. 12 shows the fastener 200 after deployment fastening
tissue layers 180 and 182 together. The fastener 200 may be
deployed as previously described in connection with FIGS. 5-9.
[0088] The fastener 200 includes a first member 202, a second
member 204, and a connecting member 206. The connecting member 206
takes the form of a beaded chain and the second member is
bifurcated at 208 to permit the second member 204 to be positioned
between any pair of beads of the connecting member 204. This
renders the length of the connecting member 206 between the first
and second members 202 and 204 adjustable to accommodate tissue
layers of various densities and thicknesses.
[0089] FIG. 13 shows another fastener 210 embodying the present
invention. The fastener 210 is illustrated in an initial stage of
deployment by the tissue piercing deployment wire 164, the pusher
166, and the guide tube 168 to fasten tissue layers 180 and 182
together. FIG. 13A shows the fastener 210 in greater detail.
[0090] The fastener includes a first member 212, a second member
214, and a connecting member 216. The first member 212, second
member 214, and connecting member 216 are integrally formed from a
same tubular member stock of material. The fastener 212 may be
formed of plastic or metal, such as stainless steel or nitinol. As
will be seen hereinafter, it is preferred that the fastener 212,
and all other fasteners embodying the present invention be formed
of a material which is capable of returning to a desired shape or
assuming a desired shape after being bent. Many plastics and metals
are capable of providing this function to render the first member
212 and second member 214 self-deployable for fastening the tissue
layers 180 and 182.
[0091] As may be best seen in FIG. 13A, the connecting member 216
is formed of a strip of a tubular member formed by a pair of
longitudinal substantially parallel, substantially co-extensive
cuts within the tubular body of the fastener 210. One such cut 218
is illustrated in the drawing, and the other such cut is formed
along the opposite side of the tubular body. The first member 212
and second member 214 are formed by a substantially transverse
circumferential cut 220 between the substantially parallel
co-extensive cuts 218. The substantially parallel substantially
co-extensive cuts 218 begin spaced from a first end 222 of the
fastener 210 and terminates spaced from a second end 224 of a
second end. The first member 212 and second member 214 are thus
tubular member sections between the circumferential cut 220 and the
tubular member first end 222 and second end 224. The fastener 210
still further includes an elongated notch 226 extending from the
second end 224 of the fastener 210 and extends towards the second
end 222 substantially diametrically opposite and juxtaposed to a
portion of the connecting member 216. The notch 226 terminates
proximal to the transverse circumferential cut 220.
[0092] The foregoing results in fastener 210 including a through
channel 228 within the first member 212 and a through channel 230
within the second member 214 to permit the fastener 210 to be
slidingly received on the tissue piercing wire 164 as illustrated
in FIG. 13. In addition, the fastener 210 at the first end 222
includes a pointed tip 232 which is formed by a sectioned portion
of the tubular stock of the fastener 210.
[0093] As may be best seen in FIG. 13, when the fastener 210 is to
be deployed, it is placed on the tissue piercing wire 164 with the
first member 212 and second member 214 in line with one another.
The tissue piercing wire 164 and fastener 210 are guided to their
proper position adjacent tissue layer 180. Next, the tissue
piercing wire 164 is advanced to pierce tissue layers 180 and 182
as illustrated in FIG. 13.
[0094] Next, as seen in FIG. 14, the pusher 166 is utilized to push
the fastener 212 through the tissue layers 180 and 182 on the
tissue piercing wire 164. As depicted in FIG. 14, the end of the
first member 212 has just cleared the surface 181 of tissue layer
180.
[0095] Referring now to FIG. 15, when the pusher 166 pushes the
fastener so that the first member 212 is through the tissue layer
182, the first member 212 is free to deflect to a preformed
configuration with respect to connecting member 216. The first
member 212 deflects as shown in FIG. 15 after the tissue piercing
wire 164 is partially withdrawn as illustrated in FIG. 15. At this
point, the second member 214 remains on the tissue piercing wire
164 and has not deflected to its preshaped configuration.
[0096] As may be best seen in FIG. 16, a pusher 166 and most
importantly the guide tube 168 are retracted to free the second
member 214 to deflect to its preformed configuration. By virtue of
the notch 226, the second member 214 is free to deflect as
illustrated while on the tissue piercing wire 164. As illustrated
in FIG. 16, the fastener 210 is in its deployed configuration. The
first member 212 self-deployed with the partial retraction of the
tissue piercing wire 164 and the second member 214 self-deployed
with a retraction of the guide tube 168. With the fastener 210 thus
deployed, the tissue piercing wire 164, pusher 166, and guide tube
168 may be fully retracted. This is illustrated in FIG. 17. As may
be best seen in FIG. 17, the fastener 210 is deployed with the
first member 212 and second member 214 in contact with opposite
sides of tissues 180 and 182 and with the connecting member 216
extending between the first member 212 and second member 214
through the tissue layers 180 and 182. The shape memory material of
the fastener 210 also permits the connecting member 216 to be
provided with a preshaped arcuate configuration as shown to cause
the connecting members 212 and 214 to securely fasten and pinch the
tissue layers 180 and 182 together.
[0097] FIGS. 18-22 show another tissue fastening assembly 240
embodying the present invention. The assembly 240 includes the
fastener 210 previously described with reference to FIG. 13A and
the tissue fastening assembly of FIGS. 13-16.
[0098] In addition to the fastener 210, the assembly 240 includes
the tissue piercing wire 164, the pusher 166, and a guide tube 368.
The guide tube 368 is similar to the guide tube 168 previously
described. However, a guide tube 368 includes a slot 370 at its
distal end 372. The slot 372, as will be seen subsequently, permits
the second member 214 to assume its deployed configuration before
the first member 212 assumes its deployed configuration. FIG. 18
illustrates the assembly 240 in an early stage of deploying the
fastener 210. FIG. 19 shows the assembly 240 wherein the tissue
piercing wire 164 has been advanced to pierce the tissue layers 180
and 182 while the guide tube 368, the pusher 166, and the fastener
210 are held stationary. With the tissue piercing wire 164 piercing
the tissue layers 180 and 182, the guide tube 368 may be partially
retracted so that the notch 370 is adjacent the second member 214.
By virtue of the notch 226, the second member 214 is permitted to
assume its deployed configuration through the slot 370.
[0099] FIG. 20 illustrates the second member 214 of the fastener
210 in its deployed configuration within the slot 370. As will be
noted in FIG. 20, the connecting member 216 is permitted to assume
its preshaped configuration and the second member 214 is permitted
to slide along the tissue piercing wire 164 within the notch 226.
With the second member 214 in its deployed configuration, the
pusher 166 may now push the first member 212 through the tissue
layers 180 and 182 on the tissue piercing wire 164.
[0100] FIG. 21 illustrates the fastener 210 with the first member
212 pierced through the tissue layers 180 and 182 and the second
member 214 in its deployed configuration. The second member 214 is
now against surface 181 of tissue layer 180.
[0101] With the second member 214 first deployed, as may be seen in
FIG. 22, the tissue piercing wire 164 may be partially retracted to
free the first member 212 and to permit the first member 212 to
assume its deployed configuration. At this point, the second member
214 is still on the tissue piercing wire 164.
[0102] Now that both of the first and second members 212 and 214
respectively are deployed, the tissue piercing wire 164, pusher
160, and guide tube 368 may be fully retracted to leave the
fastener 210 in its deployed configuration.
[0103] FIG. 23 illustrates the fastener 210 in its deployed
configuration after the tissue piercing wire 164, pusher 166, and
guide tube 368 are fully retracted. Again, the tissue layers 180
and 182 are securely fastened together by the fastener 210 as
previously described.
[0104] FIG. 24 is a perspective view of the fastener 210 imbedded
within a tissue layer 184 which is adjacent the tissue layer 180.
Here it will be seen that the first member 212 of the fastener 210
is fully imbedded within the tissue layer 184. The fastener 210 may
be deployed as illustrated in FIG. 24 by any one of the methods
previously described with respect to FIGS. 13-16 and FIGS. 18-22.
Once the tissue piercing wire 164 is withdrawn to free the second
member 212, the second member 212 will become imbedded within the
tissue 184. This illustrates the flexibility provided by the
fasteners of the present invention for use with varying types of
tissue.
[0105] FIG. 25 is a perspective view with portions cut away of a
further fastener 310 embodying the present invention in association
with the tissue piercing wire 164, the pusher 166, and the guide
tube 168 for fastening tissue layers 180 and 182 together. The
fastener 310 includes a first member 312, a second member 314, and
a connecting member 316. The fastener 310 is essentially identical
to the fastener 210 previously described except that its notch 326
extends the entire longitudinal length of the second member 314. As
a result, the second member 314 may assume its deployed
configuration off of the tissue piercing wire 164. In other words,
when the second member 314 deploys, it will be, by virtue of the
continuous notch 326, free of the tissue piercing wire 164. As a
result, the tissue piercing wire 164 need not be fully retracted to
free the second member 314 from the tissue piercing wire 164 after
it has been deployed.
[0106] FIG. 26 is a side view, partly in cross-section, of another
fastener embodiment 410 of the invention. The fastener 410 includes
a first member 412, a second member 414, and a connecting member
which cannot be seen in the figure. One of the first and second
members 412 and 414 includes a restrictor or crimp 418. Here it may
be seen that the second member 414 includes the crimp 418. The
depth of the crimp 418 is controlled to exert a controlled amount
of pressure against the tissue piercing wire 164. The controlled
pressure by the crimp 418 on the tissue piercing wire 164 provides
controlled resistance to movement between the fastener 410 and the
tissue piercing wire 164. This may provide a more "in control" feel
between the fastener 410 and tissue piercing wire 164 during the
deployment of the fastener 410. It may also be noted in FIG. 26
that the deployment wire 164 has a bent or curved tip 165. The bent
tip 165 renders the development wire 164 steerable to aid in
guiding the fastener to its intended location within the body.
[0107] Referring now to FIGS. 27-29, they illustrate a tissue
fixation assembly 500 which may utilize the fasteners and fastener
deployment assemblies previously described and embodying the
present invention to advantage. Although the fasteners and
deployment assemblies previously described and embodying the
present invention may be used in numerous applications, the
assembly 500 of FIGS. 27-29 is particularly configured as a
transoral gastroesophageal flap valve restoration device for
restoring a gastroesophageal flap valve.
[0108] With initial reference to FIG. 27, the device of FIG. 27
generally includes a longitudinal member 502 and a tissue shaper
504 carried at the distal end of the longitudinal member 502. The
tissue shaper 504 and longitudinal member 502 are dimensioned for
passing through the esophagus for transoral placement into a
stomach.
[0109] The tissue shaper 504 includes a first arm 506 and a second
arm 508. The first arm 506 and second arm 508 are hingedly coupled
together at a hinge point 510.
[0110] The first arm includes a fastener director 512. As will be
seen hereinafter, stomach tissue layers to be fastened together may
be shaped by the tissue shaper 504 by the first arm 506 and second
arm 508 confining the stomach tissue layers therebetween. The first
arm 506 has a tissue engaging surface 514. The first arm further
includes a plurality of fastener directing channels 516. The
fastener directly channels 516 communicate with the tissue engaging
surface 514. Each of the fastener directing channels 516 serves to
direct a fastener into the tissue layers to be fastened together.
Accordingly, the fastener directing channels 516 are configured and
dimensioned for receiving a tissue fastener such as, for example,
any one of the fasteners previously described herein and embodying
the present invention.
[0111] The second arm 508 is a frame structure 518. The frame
structure 518 defines an opening 520 to permit the fasteners to be
driven through the tissue layers while being held between the first
arm 506 and second arm 518.
[0112] The tissue shaper 504 further includes a tissue gripper 522.
The tissue gripper 522 takes the form of a helical coil that grips
the stomach tissue. As will be seen hereinafter, the tissue gripper
is arranged to pull the stomach tissue into and between the first
and second arms 506 and 508.
[0113] Referring now to FIG. 28, it illustrates the configuration
of the device 50 when shaping stomach tissue into a
gastroesophageal flap valve. Here it may be seen that the second
arm 508 has been pivoted relative to the first arm 506. This
permits stomach tissue pulled between the arms 506 and 508 to be
shaped as a gastroesophageal flap. FIG. 29 shows this in greater
detail. Here it may be seen that the tissue gripper 522 has gripped
stomach tissue 581 to form tissue layers 580 and 582 in the shape
approximating a gastroesophageal flap. With the stomach tissue 581
drawn into and between the first arm 506 and second arm 508 with
the tissue engaging the tissue engaging surface 514, fasteners may
now be directed through the channels 516 and deployed for fastening
stomach tissue layers 580 and 582 together. A plurality of channels
516 are provided to enable a plurality of fasteners to be
deployed.
[0114] In deploying the fasteners, the fastener directing channels
516 may serve as guide tubes for guiding tissue piercing wires and
pushers as previously described for deploying the fasteners.
Alternatively, fastener guide tubes taking the form, for example,
of guide tube 168 previously described, may also be utilized and
directed by the channels 516 in the deployment of the
fasteners.
[0115] Once the tissue layers 580 and 582 are fastened together,
they will be maintained in the folded configuration to approximate
a gastroesophageal flap valve. The helical coil 522 may then be
rotated to disengage from the tissue and the first and second arms
506 and 508 may be pivoted back to an in line configuration for
retraction from the stomach and esophagus to complete the
gastroesophageal flap valve restoration procedure.
[0116] Because in this embodiment, the contacting tissue layers
held by the fastener are both serosa tissue, the tissue layers will
eventually grow together. Hence, the fasteners of the present
invention may be formed of reabsorbable material which, after
sufficient time to permit fusion of the tissue layers, will be
absorbed by the body.
[0117] Referring now to FIGS. 30 and 31, they illustrate still
another fastener 600 according to an embodiment of the invention.
The fastener 600 generally includes a first member 602, a second
member 604, and a connecting member structure 606. As may be noted
in FIGS. 30 and 31 the connecting member structure includes a
plurality of connecting members 608 and 610. The connecting members
608 and 610 connect the first member 602 to the second member
604.
[0118] The first member 602 is cylindrical and the second member
604 is a cylindrical half-section. Each has a longitudinal through
channel 612 and 614. The through channel 614 is a through bore
which is dimensioned to be a slidingly received on a tissue
piercing deployment wire. The channel 614 is dimensioned to be
optionally carried on the deployment wire prior to deployment.
[0119] The first member 602 also includes a conical pointed tip
614.
[0120] The fastener 600 may be formed of any of the plastic or
metal material previously described. As may be further noted in
FIGS. 30 and 31 the connecting members 600 and 610 are relatively
thin to render the connecting member structure 606 readily bendable
for ease of deployment. The connecting member structure is further
rendered bendable of course by the nature of the plastic or metal
material from which the fastener 600 is formed.
[0121] Referring now to FIGS. 32 and 33, they illustrate another
fastener 700 embodying the present invention. As with the previous
fastener, the fastener 700 includes a cylindrical first member 702,
cylindrical half-section 704 and a connecting member structure 706.
The connecting member structure 706 includes connecting members 708
and 710. Here however, the pointed tip 714 takes the form of a
tapered section of the first member 702.
[0122] As in the previous embodiment the first member 702 of the
fastener 700 may be slidingly received on a deployment wire. The
deployment wire may be received by a bore 712. The fasteners 600
and 700 may be deployed as previously described.
[0123] While particular embodiments of the present invention have
been shown and described, modifications may be made, and it is
therefore intended in the appended claims to cover all such changes
and modifications which fall within the true spirit and scope of
the invention.
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