U.S. patent application number 09/957451 was filed with the patent office on 2002-06-27 for methods and devices for folding and securing tissue.
Invention is credited to Geitz, Kurt A.E., Sakal, Robert, Schurr, Marc O..
Application Number | 20020082621 09/957451 |
Document ID | / |
Family ID | 22881036 |
Filed Date | 2002-06-27 |
United States Patent
Application |
20020082621 |
Kind Code |
A1 |
Schurr, Marc O. ; et
al. |
June 27, 2002 |
Methods and devices for folding and securing tissue
Abstract
The present invention relates to devices, and methods for using
the devices, to create and secure a tissue fold during an
endoluminal medical procedure. The devices and methods may be used
for folding and securing, for example, a fundus wall onto an
esophagus wall or esophageal tissue in the region of the lower
esophageal sphincter (LES) to reduce the diameter of the esophagus
opening in that region. One aspect of the invention includes
forming the tissue fold by closing a grasping arm that is pivotably
connected to an overtube that has been positioned at the juncture
of the fundus wall and esophagus wall. A further aspect of the
invention includes tissue clips configured to be inserted and
positioned through an endoluminal device.
Inventors: |
Schurr, Marc O.; (Tuebingen,
DE) ; Geitz, Kurt A.E.; (Sudbury, MA) ; Sakal,
Robert; (Bolton, MA) |
Correspondence
Address: |
Finnegan, Henderson, Farabow
Garrett & Dunner, L.L.P.
1300 I Street N.W.
Washington
DC
20005-3315
US
|
Family ID: |
22881036 |
Appl. No.: |
09/957451 |
Filed: |
September 21, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60234360 |
Sep 22, 2000 |
|
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 2017/0647 20130101;
A61B 2017/0641 20130101; A61B 17/122 20130101; A61B 17/00234
20130101; A61B 17/0643 20130101; A61B 17/1285 20130101; A61B
2017/081 20130101; A61B 17/0644 20130101; A61B 17/0682 20130101;
A61B 2017/00827 20130101; A61B 17/068 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 017/10 |
Claims
What is claimed:
1. A device for securing a fold of tissue in a medical procedure,
the device comprising: a first arm; and a second arm disposed
substantially opposite to the first arm and having an end connected
to an end of the first arm to define an opening to receive the fold
of tissue, wherein the first and second arms are configured to
secure to the tissue fold with the arms remaining exterior to an
outer surface of the tissue fold.
2. The device of claim 1, wherein the first and second arms are
configured to frictionally engage the outer surface of the tissue
fold.
3. The device of claim 1, wherein at least one of the first and
second arms includes a barb protruding from an inner surface of the
at least one of the first and second arms.
4. The device of claim 1, wherein at least one of the first and
second arms defines a fixation hole configured to receive an
anchoring member.
5. The device of claim 1, wherein a gripping tab is disposed on a
free end of at least one of the first and second arms.
6. The device of claim 1, wherein the first and second arms are
comprised of a bioabsorbable material.
7. The device of claim 1, wherein the first and second arms form a
substantially U-shaped configuration.
8. A method of securing a tissue fold in an endoluminal medical
procedure, the method comprising the steps of: inserting an
endoluminal device proximal to the tissue to be folded; folding
tissue to create a tissue fold; inserting a tissue clip through the
endoluminal device; positioning the tissue clip such that the
tissue fold is placed in an opening defined by the clip; and
engaging the fold with the tissue clip.
9. The method of claim 8, wherein the engaging step includes
pulling upward on the clip.
10. The method of claim 8, wherein the engaging step includes
frictionally engaging the clip with an outer surface of the tissue
fold.
11. The method of claim 8, wherein the clip has first and second
arms defining a substantially U-shaped configuration and the
engagement occurs between the arms and an outer surface of the
tissue fold.
12. The method of claim 8, wherein the engaging step includes at
least one barb disposed on the tissue clip engaging the tissue
fold.
13. The method of claim 8, wherein the tissue clip inserting step
includes gripping a gripping tab on a free end of the clip.
14. The method of claim 8, wherein the folding step includes
folding a fundus wall onto and an esophagus wall.
15. A working end of an endoluminal device for use in an
endoluminal medical procedure, the working end of the device
comprising: a plurality of interconnected members having an
expandable working surface area configured to engage with a portion
of the body to perform the medical procedure.
16. The device of claim 15, wherein the plurality of interconnected
members includes a plurality of hydraulically-actuated members.
17. The device of claim 16, wherein each of said plurality of
hydraulically-actuated members defines a lumen, each said lumen
being in fluid communication with each other.
18. The device of claim 17, wherein an area of the working surface
changes in accordance with an amount of a hydraulic fluid supplied
to the lumens.
19. The device of claim 17, wherein the hydraulically-actuated
members engage each other in an end-to-end configuration when the
lumens are filled with a hydraulic fluid.
20. The device of claim 17, wherein the hydraulically-actuated
members substantially overlap each other when a hydraulic fluid is
removed from the lumens.
21. The device of claim 18, wherein the hydraulically-actuated
members include tubes.
22. The device of claim 21, wherein the tubes telescope as the area
of the working surface is decreased.
23. The device of claim 15, wherein the interconnected members
pivot relative to the endoluminal device to fold tissue during a
fundoplication procedure.
24. A device for creating a tissue fold in an endoluminal medical
procedure, the device including: a tube defining a channel
extending in a longitudinal direction from a proximal end to a
distal end of the tube; and an expandable arm pivotably disposed on
the distal end of the tube, said arm configured to pivot between a
position substantially along the longitudinal direction and a
position angled to the longitudinal direction, the arm expandable
from a retracted configuration to an expanded configuration.
25. The device of claim 24, wherein the angled position is
substantially perpendicular to the longitudinal direction of the
tube.
26. The device of claim 24, wherein the arm is substantially flush
with the tube when it is in the position substantially along the
longitudinal direction of the tube.
27. The device of claim 24, further including an actuator extending
from the arm to the proximal end of the tube, wherein the actuator
pivots the arm.
28. The device of claim 27, wherein the actuator includes a
cable.
29. The device of claim 24, wherein the arm includes a
hydraulically-actuated member.
30. The device of claim 29, wherein the member includes a plurality
of hydraulically-actuated tubes.
31. The device of claim 30, wherein each of the plurality of tubes
defines a lumen for receiving a hydraulic fluid, the lumens being
in fluid communication with each other.
32. The device of claim 31, wherein the tube includes a passage in
fluid communication with the tube lumens.
33. The device of claim 30, wherein the tubes have an end-to-end
configuration when the arm is in the expanded configuration.
34. The device of claim 30, wherein the tubes are substantially
concentrically disposed when the arm is in the retracted
configuration.
35. A method for creating a tissue fold during an endoluminal
medical procedure, the method comprising the steps of: providing a
tube and an expandable arm pivotably connected to a distal end of
the tube; inserting the tube into the body while the expandable arm
is positioned along the tube and retracted; pivoting the arm away
from the tube; expanding the arm; positioning the arm adjacent the
tissue to be folded; and pivoting the arm toward the tube to fold
the tissue.
36. The method of claim 35, wherein the expanding step includes
expanding to an extent necessary to create a tissue fold of desired
depth.
37. The method of claim 35, wherein the arm is expanded by
hydraulic pressure.
38. The method of claim 35, wherein the arm includes a plurality of
tubes having lumens in fluid communication with each other for
receiving a hydraulic fluid, the arm expanding as the hydraulic
fluid fills the lumens.
39. The method of claim 35, wherein the second pivoting step
includes folding a fundus wall onto an esophagus wall.
40. The method of claim 35, further comprising the steps of:
inserting a tissue clip through the tube; positioning the tissue
clip such that the tissue fold is placed in an opening defined by
the clip; and engaging the fold with the tissue clip.
41. The method of claim 40, wherein the clip has first and second
arms defining a substantially U-shaped configuration and the
engagement occurs between the first and second arms and an outer
surface of the tissue fold.
42. The method of claim 41, wherein the engaging step includes
pulling upward on the clip.
43. The method of claim 42, wherein the engaging step includes
frictionally engaging the clip with an outer surface of the tissue
fold.
44. The method of claim 40, wherein the step of inserting the
tissue clip includes feeding the clip out of the tube through a
hole in a side of the tube over which the expandable arm is
positioned during insertion of the tube into the body.
45. The method of claim 42, wherein the first arm of the clip is
configured to be positioned between a first outer surface of the
tissue fold and an outer surface of the tube and the second arm is
configured to be positioned between a second outer surface of the
tissue fold and an inner surface of the expandable arm when the
clip is being pulled upward.
46. The method of claim 40, wherein the expandable arm is retracted
and the tube and expandable arm are removed from the body after the
tissue clip is engaged to secure the tissue fold.
47. A device for securing a tissue fold, comprising: a mounting
member having a peripheral surface, the mounting member including a
plurality of first engagement portions disposed about the
peripheral surface; and a plurality of tissue securing members
configured to engage the mounting member at the first engagement
portions and thereby secure a tissue fold.
48. The device of claim 47, wherein second engagement portions are
disposed on each of the plurality of tissue securing members.
49. The device of claim 48, wherein the first engagement portions
include one of engagement recesses and engagement members
configured to engage the engagement recesses, and the second
engagement portions include the other of the engagement recesses
and the engagement members configured to engage the engagement
recesses.
50. The device of claim 49, wherein the engagement recesses are
apertures extending through the mounting member.
51. The device of claim 47, wherein the mounting member and the
tissue securing members are configured to be inserted endoluminally
to secure the tissue fold.
52. The device of claim 47, wherein the mounting member is made of
relatively elastic material.
53. The device of claim 47, wherein the mounting member has a
substantially circular shape.
54. The device of claim 47, wherein the peripheral surface of the
mounting member defines an opening and the peripheral surface is
configured to frictionally engage an inner surface of an
esophagus.
55. The device of claim 47, wherein the mounting member and tissue
securing members are made of a bioabsorbable material.
56. The device of claim 49, wherein each tissue securing member
includes a first portion and a second portion connected to the
first portion, wherein one of the first and second portions engages
a first exterior surface of the tissue fold and the other of the
first and second portions engages a second exterior surface of the
tissue fold.
57. The device of claim 56, wherein each of the engagement members
includes a shaft portion and a head portion, the head portion
configured to pass through the engagement recess in a first
direction prior to engagement and to be restricted from passing
back through the engagement recess in a direction opposite to the
first direction after engagement.
58. The device of claim 49, wherein the engagement members are
configured to pierce tissue forming the tissue fold.
59. The device of claim 47, wherein the tissue securing members are
integral with the mounting member.
60. The device of claim 47, wherein the tissue securing members are
fixedly attached to the mounting member.
61. The device of claim 47, wherein the tissue securing members
include legs, each leg having one end attached to the mounting
member and a free end.
62. The device of claim 61, wherein an engagement member is
disposed proximate the free end of each leg, the engagement member
being configured to engage the first engagement portions.
63. The device of claim 62, wherein the engagement member is
rotatably mounted to the leg.
64. The device of claim 61, wherein each leg includes a hinge
portion substantially at a midpoint of the leg.
65. A method for securing a tissue fold, comprising: providing a
mounting member having a peripheral surface and a plurality of
first engagement portions disposed on the peripheral surface;
providing a plurality of tissue securing members adapted to engage
the mounting member at the first engagement portions; inserting the
mounting member and tissue securing members endoluminally and
proximal to the tissue fold to be secured; positioning the tissue
securing members on exterior surfaces of the tissue fold; and
engaging the tissue securing members with the first engagement
portions to secure the tissue securing members in place with
respect to the tissue fold and the mounting member.
66. The method of claim 65, wherein engaging the tissue securing
members includes engaging a second engagement portion disposed on
each of the tissue securing members with the first engagement
portions.
67. The method of claim 65, wherein the engaging step includes
piercing the tissue fold.
68. The method of claim 65, wherein the peripheral surface of the
mounting member defines an opening and installing the mounting
member includes frictionally engaging the peripheral surface of the
mounting member with an inner surface of the esophagus.
69. The method of claim 65, wherein the tissue securing members
include a first portion and a second portion connected to the first
portion, and positioning the tissue securing members on exterior
surfaces of the tissue fold includes positioning one of the first
and second portions on a first exterior surface of the fold and the
other of the first and second portions on a second exterior surface
of the fold.
70. A device for securing tissue, comprising: a tube defining a
lumen therein and an opening proximate a distal end of the tube,
said tube configured to accommodate suction through the lumen to
draw tissue to be secured into the opening; a holding member
disposed in said lumen and configured to hold a tissue clip for
securing the tissue; and an inner member disposed in said lumen and
configured to actuate relative to the tube between an open position
and a closed position to open and close the tube opening, wherein
the tissue clip is installed by the relative actuation.
71. The device of claim 70, wherein the inner member includes a
sleeve, at least a portion of which has a semi-circular shape.
72. The device of claim 70, wherein the tube is configured for
endoluminal insertion.
73. The device of claim 70, wherein the opening is in a side of the
tube.
74. The device of claim 70, wherein the inner member disposed in
said lumen includes a rotatable member, the rotatable member
rotating to install the tissue clip.
75. The device of claim 70, wherein the holding member includes a
first holding member disposed on the inner member.
76. The device of claim 75, wherein the holding member further
includes a second holding member disposed on the tube.
77. The stapling device of claim 76, wherein the first holding
member is configured to hold one of a female part and a male part
and the second holding member is configured to hold the other of
the female part and the male part, said female part and said male
part being configured to engage each other to form said tissue
clip.
78. The device of claim 77, wherein one of the first and second
holding members holding the female part includes an aperture
configured to align with an opening defined by the female part.
79. The device of claim 77, wherein the tube is configured to
rotate in a direction opposite to a rotation of the inner member
such that the first and second holding members move toward each
other during installation of the tissue clip.
80. The device of claim 77, wherein the first holding member and
the second holding member are positioned at opposite sides of said
tube opening when said inner member is in the open position.
81. The device of claim 77, wherein the second holding member
includes a small lip disposed on an inner surface of the tube.
82. The device of claim 77, wherein the first holding member
includes a small lip extending from an edge of the inner
member.
83. The device of claim 77, wherein said female part defines a
plurality of openings and the male part includes a plurality of
darts configured to engage with said plurality of openings.
84. The device of claim 77, wherein the female part and the male
part are made of a biocompatible material.
85. The device of claim 84, wherein the biocompatible material
include s a bioabsorbable material.
86. A method of securing tissue together, comprising: providing a
tube defining a lumen therein and an opening proximate a distal
lend of the tube; positioning said opening proximal to tissue to be
secured together; drawing tissue through said opening by the
application of suction through said lumen; and actuating an inner
member disposed in the lumen to install a tissue clip to secure the
tissue together.
87. The method of claim 86, wherein actuating the inner member
disposed in the lumen includes rotating the inner member relative
to the tube to install the tissue clip.
88. The method of claim 86, wherein said positioning includes
inserting the tube endoluminally.
89. The method of claim 86, wherein securing the tissue includes
securing esophageal tissue proximal the lower esophageal
sphincter.
90. The method of claim 89, wherein securing the tissue includes
reducing the diameter of the esophagus.
91. The method of claim 86, further comprising holding the tissue
clip in said lumen prior to installing the tissue clip.
92. The method of claim 91, wherein the tissue clip is held in the
lumen during the positioning and drawing steps.
93. The method of claim 92, wherein holding the tissue clip
includes holding one of a female part and a male part by a first
holding member on the tube and holding the other of the female part
and male part by a second holding member on the inner member.
94. The method of claim 93, wherein the actuating step includes
rotating the tube relative to the inner member to install the
tissue clip such that the first holding member moves toward the
second holding member.
95. The method of claim 87, wherein rotating the inner member
includes rotating the inner member through an open position and a
closed position to open and close the tube opening.
96. The method of claim 87, further comprising rotating the inner
member to an original position and the stopping the suction after
installation of the tissue clip.
97. The method of claim 96, further comprising rotating the tube
opening to a new position and repeating the drawing and actuating
steps at the new position.
98. A device for securing tissue in a medical procedure, the device
comprising: a cannula having a proximal end, a distal end, and a
longitudinal solt located adjacent the distal end; a suction device
for creating a vaccum through the cannula and to the slot, the
suction urging tissue into the slot; and a grasping element located
in the cannula and movable between a non-grasping position where
the element is outside a boundary of the slot to a grasping
position where the grasping element is within the boundary of the
slot.
99. The device of claim 98, wherein the grasping element is a wire
extending from the slot and through the cannula to a proximal end
portion of the device.
100. The device of claim 99, wherein the grasping element is a
grasping plate.
101. The device of claim 100, wherein the grasping plate is formed
in a C-shaped configuration.
102. A device for creating a tissue fold in an endoluminal medical
procedure, the device including: a tube defining a channel
extending in a longitudinal direction from a proximal end to a
distal end of the tube; and an arm pivotably disposed on the distal
end of the tube, said arm configured to pivot between a closed
position substantially along the longitudinal direction and a
position angled to the longitudinal direction.
103. The device of claim 102, wherein the angled position is
substantially perpendicular to the longitudinal direction of the
tube.
104. The device of claim 102, wherein the arm is substantially
flush with the tube when it is in the position substantially along
the longitudinal direction of the tube.
105. The device of claim 102, further including an actuator
extending from the arm to the proximal end of the tube, wherein the
actuator pivots the arm.
106. The device of claim 105, wherein the actuator includes a
cable.
107. The device of claim 102, wherein the arm comprises an opening
therethrough.
108. The device of claim 102, wherein the tube comprises a
longitudinally extending slot at a distal end of the tube.
109. The device of claim 108, wherein the slot is located adjacent
the arm when the arm is in the closed position.
110. The device of claim 102, wherein the tube includes a clear
section at a distal end of the tube.
111. A method for creating a tissue fold during an endoluminal
medical procedure, the method comprising the steps of: providing a
tube and an arm pivotably connected to a distal end of the tube;
inserting the tube into the body while the arm is positioned along
the tube; pivoting the arm away from the tube; positioning the arm
adjacent the tissue to be folded; and pivoting the arm toward the
tube to fold the tissue.
112. The method of claim 111, wherein the second pivoting step
includes folding a fundus wall onto an esophagus wall.
113. The method of claim 108, further comprising the steps of:
inserting a tissue clip through the tube; positioning the tissue
clip such that the tissue fold is placed in an opening defined by
the clip; and engaging the fold with the tissue clip.
114. The method of claim 113, wherein the clip has first and second
arms defining a substantially U-shaped configuration and the
engagement occurs between the first and second arms and an outer
surface of the tissue fold.
115. The method of claim 114, wherein the engaging step includes
pulling upward on the clip.
116. The method of claim 115, wherein the engaging step includes
frictionally engaging the clip with an outer surface of the tissue
fold.
117. The method of claim 113, wherein the step of inserting the
tissue clip includes feeding the clip out of the tube through a
slot in a side of the tube over which the arm is positioned during
insertion of the tube into the body.
118. The method of claim 115, wherein the first arm of the clip is
configured to be positioned between a first outer surface of the
tissue fold and an outer surface of the tube and the second arm is
configured to be positioned between a second outer surface of the
tissue fold and an inner surface of the arm when the clip is being
pulled upward.
119. The method of claim 113, wherein the tube and arm are removed
from the body after the tissue clip is engaged to secure the tissue
fold.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of provisional
application no. 60/234,360 filed on Sep. 22, 2000, the contents of
which are herein incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention pertains to devices, and methods for
using the devices, for folding tissue and securing a tissue fold
during an endoluminal medical procedure.
BACKGROUND OF THE INVENTION
[0003] 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).
[0004] 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 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 into the stomach. This
pressure essentially closes the esophagus so that contents of the
stomach cannot pass back into the esophagus. The LES opens in
response to swallowing and peristaltic motion in the esophagus,
allowing food to pass into the stomach. After opening, however, a
properly functioning LES should return to the resting, or closed
state. Transient relaxations of the LES do occur in healthy
individuals, typically resulting in occasional bouts of
heartburn.
[0005] The physical interaction occurring between the gastric
fundus and the esophagus also prevents gastroesophageal reflux. The
gastric fundus is a lobe of the stomach situated at the top of the
stomach proximal to the esophagus. In healthy individuals, the
fundus presses against the opening of the esophagus when the
stomach is full of food and/or gas. This effectively closes off the
esophageal opening to the stomach and helps to prevent acid reflux
back into the esophagus.
[0006] In individuals with GERD, the LES functions abnormally,
either due to an increase in transient LES relaxations, decrease in
length of the esophagus, decreased muscle tone of the LES 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, sand/or hiatal hernia. Avoiding these exacerbating
mechanisms helps curb the negative side effects associated with
GERD, but does not cure the disease completely.
[0007] 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
otherwise. Fundoplication involves bringing the fundus into closer
proximity to the esophagus to help close off the esophageal opening
into the stomach. In Nissen Fundoplication, a particular type of
the fundoplication procedure, the fundus is pulled up and around
the esophagus and then sutured to itself and the esophagus such
that it completely encircles the esophagus. Traditionally, this
procedure has been performed as an open surgery, but has recently
enjoyed success as a laparoscopic procedure, as discussed in
McKernan, J. B., Champion, J. K., "Laparoscopic antireflex
surgery," American Surgeon, Vol. 61, pp. 530-536, (1995).
[0008] As with any open surgery, complications can occur as a
result of infection, blood loss or from the use of anesthesia.
Further, the relatively large incisions necessary in the
performance of open surgery require extended recovery times for the
incision to heal. Though laparoscopic surgical procedures reduce
these negative effects by using relatively small devices at a
relatively small incision site in the abdominal wall, there still
exists an increased risk of infection due to the incision. 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.
[0009] Other surgical procedures specifically address the LES.
These procedures attempt to prevent reflux by thickening the LES
region and reducing the diameter of the esophageal opening to the
stomach, i.e., tighten the LES region. However, existing procedures
are lengthy and difficult to perform.
SUMMARY OF THE INVENTION
[0010] The advantages and purpose of the present 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 advantages and purpose of the invention will
be realized and attained by means of the elements and combinations
particularly pointed out in the appended claims.
[0011] The present invention includes devices, and related methods
for using the devices, to perform an endoluminal medical procedure.
In particular, the inventive devices, and the methods for using the
devices, may be employed for the treatment of GERD. The inventive
devices and methods allow the procedure to be completed rapidly and
repeatedly without compromising safety or increasing
invasiveness.
[0012] To attain the advantages and in accordance with the purpose
of the invention, as embodied and broadly described herein, the
invention includes a device for securing a fold of tissue in a
medical procedure. The device includes a first arm and a second arm
disposed substantially opposite to the first arm and having an end
connected to an end of the first arm. Thus connected, the arms
define an opening to receive the fold of tissue. The arms are
configured to secure to a tissue fold with the arms remaining
exterior to an outer surface of the tissue fold.
[0013] According to another aspect of the present invention, a
method for securing a tissue fold during an endoluminal medical
procedure includes inserting an endoluminal device proximal to the
tissue to be folded, folding tissue together to create a tissue
fold, and inserting a tissue clip through the endoluminal device.
The tissue clip is then positioned such that the fold is placed in
an opening defined by the clip, and engaged with the tissue
fold.
[0014] Yet another aspect of the present invention is a working end
of an endoluminal device for use in an endoluminal medical
procedure. The working end includes a plurality of interconnected
members having an expandable working surface area configured to
engage with a portion of the body to perform the medical
procedure.
[0015] According to another aspect of the present invention, there
exists a device for creating a tissue fold in an endoluminal
medical procedure. The device includes a tube defining a channel
extending in a longitudinal direction from a proximal end to a
distal end of the tube. An expandable arm is pivotably disposed on
the distal end of the tube. The arm is configured to pivot between
a position substantially along the longitudinal direction and a
position angled to the longitudinal direction. The arm is
expandable from a retracted configuration to an expanded
configuration.
[0016] According to a further aspect of the present invention, a
method for creating a tissue fold during an endoluminal procedure
includes providing a tube Wand an expandable arm pivotably
connected to a distal end of the tube, the tube and the arm are
configured to be inserted into the body to perform a medical
procedure. The method further includes inserting the tube in the
body while the expandable arm is positioned along the tube and
retracted. After insertion, the arm is pivoted away from the tube
and expanded. The arm is then positioned under the tissue to be
folded, and pivoted toward the tube to fold the tissue.
[0017] Another aspect according to an embodiment of the present
invention includes a device for securing a tissue fold. The device
includes a mounting member having a peripheral surface. The
mounting member includes a plurality of first engagement portions
disposed about the peripheral surface. The device further includes
a plurality of tissue securing members configured to engage the
mounting member at the first engagement portions.
[0018] Another aspect according to an embodiment of the present
invention includes a method for securing a tissue fold. The method
includes providing a mounting member having a peripheral surface
with a plurality of first engagement portions disposed about the
peripheral surface. A plurality of tissue securing members are also
provided and are adapted to engage the mounting member at the first
engagement portions. The method further includes installing the
mounting member and tissue securing members endoluminally and
proximal to the tissue fold. The tissue securing members are then
positioned on exterior surfaces of the tissue fold and engaged with
the first engagement portions to secure the tissue securing members
in place with respect to the tissue fold and the mounting
member.
[0019] Another aspect according to an embodiment of the present
invention includes a device for securing a fold of tissue. The
device includes a tube defining a lumen therein and an opening
proximate a distal end of the tube. The tube is configured to draw
suction through the lumen and accommodate tissue to be secured into
the opening. A holding member is disposed in the lumen and is
configured to hold a tissue clip that secures the tissue. A member
is disposed in the lumen and configured to actuate relative to the
tube between an open position and a closed position to open and
close the tube opening. The tissue clip is installed by the
relative actuation.
[0020] Yet another aspect of the invention includes a method for
securing a tissue. The method includes providing a tube defining a
lumen therein and an opening proximate a distal end of the tube.
The method further includes positioning the opening proximal to
tissue to be secured together and drawing tissue through the
opening by application of suction through the lumen. After the
tissue is drawn the opening, a member disposed within the lumen is
actuated to install a tissue clip to secure the tissue
together.
[0021] According to still yet another aspect of the present
invention a device for securing tissue in a medical procedure
includes a cannula having a proximal end, a distal end, and a
longitudinal window located adjacent the distal end, a suction
device for creating a vaccum through the cannula and to the window,
the suction urging tissue into the window, and a grasping element
located in the cannula and movable between a non-grasping position
where the element is outside a boundary of the window to a grasping
position where the grasping element is within the boundary of the
window.
[0022] Yet another aspect of the present invention includes a
method for treating gastro-esophageal reflux disease including the
steps of introducing a cannula into the stomach cavity, inserting a
suction-grasper device into a lumen of the cannula and securing
tissue in the suction-grasper device, urging the secured tissue
toward a distal end of the cannula, releasing the secured tissue so
that it can be grasped between the cannula and a grasping element
located at the distal end of the cannula, and fixedly attaching the
grasped tissue to a tissue wall of the patient.
[0023] 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
[0024] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate the preferred
embodiments of the invention and, together with the description,
serve to explain the principles of the invention. In the
drawings,
[0025] FIG. 1 is a cross-sectional view of the gastrointestinal
tract from a mid-point of the esophagus to a point near the
beginning of the duodenum;
[0026] FIGS. 2A-2C are a respective side view of an A-frame
grasper-overtube with the grasping arm in a closed position and a
front view and a side view of the A-frame grasper-overtube with the
grasping arm in an open position;
[0027] FIG. 2D is a top view of an A-frame grasper-overtube with
the grasping arm in an open position;
[0028] FIG. 3 is a cross-sectional view of a portion of the
esophagus and stomach with the A-frame grasper-overtube inserted to
perform a fundoplication procedure;
[0029] FIG. 4 is a cross-sectional view of a portion of the
esophagus and stomach with a side view of an A-frame
grasper-overtube actuated to fold the fundus wall onto the
esophagus wall during a fundoplication procedure;
[0030] FIG. 5 is a side view of an expandable grasping arm
according to an embodiment of the present invention, with the arm
disposed on the distal end of an A-frame grasper-overtube;
[0031] FIG. 6A is a planar view of a tissue clip according to an
embodiment of the present invention;
[0032] FIG. 6B is an enlarged view of the gripping tab of the
tissue clip of FIG. 6A;
[0033] FIG. 7 is a cross-sectional view of a portion of the
esophagus and stomach with a side view of an A-frame
grasper-overtube actuated to fold the fundus wall onto the
esophagus wall and a side view of a tissue clip according to an
embodiment of the present invention inserted through the
grasper-overtube to secure to the tissue fold created in the
fundoplication procedure;
[0034] FIG. 8 is a cross-sectional view of a portion of the
esophagus and stomach with two tissue clips shown securing the
fundus to the esophagus according to an embodiment of the present
invention;
[0035] FIG. 9 is a planar view of a mounting device according to an
embodiment of the present invention, with one of the legs of the
device engaged with an aperture of the ring;
[0036] FIG. 9A is a perspective view of an engagement recess that
can be used instead of an aperture to engage the legs and the ring
of the mounting device;
[0037] FIG. 10 is cross-sectional view of a portion of the
esophagus leading into the stomach with the mounting device of FIG.
9 shown in place with respect to a tissue fold created between the
fundus wall and the esophagus wall prior to folding the legs of the
mounting device and engaging the legs with the apertures;
[0038] FIG. 11 is a vertical cross-sectional view of a mounting
device of FIG. 9 installed to secure a tissue fold formed by the
fundus wall and esophagus wall;
[0039] FIG. 12 is a top view of a mounting device according to
another embodiment of the present invention;
[0040] FIG. 13 is a side cross-sectional view of the mounting
device of FIG. 12 taken through plane 13-13' with a tissue clip
shown for engagement with the ring;
[0041] FIG. 14 is a vertical cross-sectional view of the mounting
device of FIGS. 12 and 13 installed to secure a tissue fold formed
by the fundus wall and esophagus wall;
[0042] FIGS. 15A-15C are perspective open front, closed front, and
open side views of a suction stapler according to an embodiment of
the present invention;
[0043] FIG. 16 is an embodiment of respective male and female parts
of a tissue clip to be used with a suction stapler according to an
embodiment of the present invention;
[0044] FIG. 17 is a cross-sectional view taken through plane 17-17
in FIG. 15a showing details of the internal structure of the
suction stapler according to an embodiment of the present
invention;
[0045] FIG. 18 is a view of the suction stapler of FIG. 17 with the
male and female parts of the tissue clip inserted according to an
embodiment the present invention;
[0046] FIG. 19 is a vertical, cross-sectional view of the suction
stapler according to an embodiment of the present invention
inserted into the esophagus to suck the esophageal tissue into the
side wall opening of the device;
[0047] FIG. 20 is a cross-sectional view of the suction stapler and
inserted tissue clip according to an embodiment of the present
invention, with placement of the stapler relative to a portion of
esophageal tissue to be secured and suction being drawn through the
stapler;
[0048] FIG. 21 is a cross-sectional view of the suction stapler and
esophageal tissue shown in FIG. 20 with the tissue being sucked
into the opening in the suction stapler and arrows showing the
relative rotation of the inner sleeve and the outer tube to deploy
the male and female parts of the tissue clip according to an
embodiment of the present invention;
[0049] FIG. 22 is a cross-sectional view of the suction stapler and
secured esophageal tissue after the inner sleeve and outer tube
have been fully rotated to engage the male and female parts of the
tissue clip to secure the tissue fold according to an embodiment of
the present invention;
[0050] FIG. 23 is a cross-sectional view of a portion of the
esophageal wall with a tissue clip installed to secure the tissue
fold after having been deployed using the suction stapler according
to an embodiment of the present invention;
[0051] FIG. 24 is a vertical, cross-sectional view of a portion of
the esophagus and stomach showing the installation of the tissue
clip to secure the fold of esophageal tissue according to an
embodiment of the present invention;
[0052] FIG. 25 is a cross-sectional view of the entire
circumference of the esophagus showing tissue clips installed at
three spaced radial intervals around the esophagus according to an
embodiment of the present invention;
[0053] FIG. 26 is a perspective view of a suction-grasper device
according to the present invention;
[0054] FIG. 27 illustrates the operation of the suction-grasper
device after tissue has been located therein; and
[0055] FIG. 28 is a perspective view of an alternative embodiment
of a suction-grasper device according to the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0056] A newly developed form of fundoplication, referred to as
Endoscopic Fundoplication, is an endoluminal procedure in which the
fundus wall is folded back onto the esophagus wall. The tissue fold
formed between the esophagus and the fundus 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. Such a procedure has the
benefits of being less invasive, quicker, and less expensive as
compared to previous techniques.
[0057] A device currently employed in Endoscopic Fundoplication is
shown in FIGS. 2A-2C. This device, referred to as an A-frame
grasper-overtube 100, includes an overtube 110 with a
cable-actuated grasper 120 at a distal end of the device.
Cable-actuated grasper 120 includes a grasping arm 122 attached to
the distal end of overtube 110 by a pivot 112. Overtube 110
includes a lumen 130, preferably having a diameter capable of
accommodating a 6 mm-diameter articulating endoscope, as well as
other endoluminal devices. Overtube 110 is preferably made of metal
reinforced plastic and is flexible. At its distal end, near grasper
120, overtube 110 includes a large opening 105 disposed in a
sidewall of overtube 110. Opening 105 accommodates grasping arm 122
such that, in an insertion position of the A-frame grasper-overtube
100, grasping arm 122 essentially closes opening 105 and lies
substantially flush with the rest of the overtube sidewall that
defines opening 105. Grasping arm 122 also includes an elongated
slot or opening 127 extending substantially longitudinally in the
center of the arm and a plurality of protrusions 129 for assisting
in grasping the tissue.
[0058] The insertion or closed position is shown best in FIG. 2a.
Grasping arm 122 of A-Frame grasper-overtube 100 may be actuated or
opened by pulling a first cable 124 attached at the proximal end of
grasping arm 122 at or adjacent pivot 112 and running up through a
lumen 132 in overtube 110 to a proximal end of the device. The
pulling motion of first cable 124 causes grasping arm 122 to rotate
about pivot 112 to thereby form an increasing angle between
grasping arm 122 and overtube 110. FIG. 2C shows grasping arm 122
in an actuated or open position and forming approximately a 90
degree angle with overtube 110. A second cable 125 may also be
attached at the proximal end of grasping arm 122 and running up
through a lumen 134 in overtube 110 to a proximal end of the
device. Second cable 125 is actuatable to rotate grasping arm 122
from an open position to a closed position. Pulling of second cable
125 causes grasping arm 122 to rotate about pivot 112 in a
direction opposite that caused by pulling on first cable 124, and
thus reducing the angle formed between grasping arm 122 and
overtube 110 toward the completely retracted position shown in FIG.
2a. First and second cables 124, 125 may run through a combined or
separate channels 132,134 formed in overtube 110 and extending from
a proximal end to a distal end of the device. Alternatively, one
cable may extend from a proximal end of overtube 110, connect to
grasping arm 122, loop around pivot 112, and extend back to the
proximal end of overtube 110. In this arrangement, the cable would
have two proximal ends and pulling one end of the proximal ends of
the cable would cause retraction of the grasping arm 122, and
pulling the other proximal end of the cable would cause opening of
the grasping arm 122.
[0059] Distal end of overtube 110 may include a clear section
formed opposite opening 105. Clear section would allow for visual
confirmation of the location of tissue intended to be folded by
A-frame grasper-overtube 100. Such visual confirmation could be
achieved by way of, for example, an endoscope. Alternatively, the
whole overtube 110 may be fabricated of a clear material.
[0060] Using the grasper-overtube shown in FIGS. 2A-2C, Endoscopic
Fundoplication is performed in the following manner. In the
insertion position shown in FIG. 2A, grasper-overtube 100 is
inserted into the stomach through the esophagus. Insertion of
grasper-overtube 100 continues until the distal end of the
grasper-overtube 100 reaches a point within the stomach below the
fundus. Grasper-overtube 100 preferably is inserted with the
sidewall containing opening 105 facing toward the fundus. However,
it is contemplated that after insertion, grasper-overtube 100 can
be rotated about its longitudinal axis to the desired position. An
endoscope may be extended through lumen 130 in overtube 110 to
provide vision within the stomach after insertion of
grasper-overtube 100. Preferably, a 6 mm-diameter articulating
endoscope is used, however the size and type of endoscope can be
selected depending on the particularities associated with the
procedure being performed.
[0061] After inserting and positioning overtube 110 to the desired
location below the fundus, grasping arm 122 is actuated and pivots
downward to its open position approximately perpendicular to
overtube 110, as shown in FIG. 3. Grasper-overtube 100 is then
lifted upward toward the opening of the esophagus in the stomach.
Next, cable 124 is actuated to return grasping arm 122 to its
closed position. The arcing motion of grasping arm 122 as it
engages the wall of the fundus, causes the fundus to fold against
the side of the esophagus near its opening into the stomach, as
illustrated in FIG. 4. After the fundus wall has been folded back
onto the esophagus wall, it is secured into place and
grasper-overtube 100 is removed.
[0062] After the fold has been created, securing the fundus can be
accomplished using a variety of fastening mechanisms such as, for
example, sutures, clips, staples, or other suitable like
mechanisms. It is desirable that the fastening mechanisms selected
can be installed relatively quickly in a relatively non-invasive
manner, and can create a substantially uniform fold of tissue once
installed.
[0063] As with most endoluminal procedures, Endoscopic
Fundoplication is preferably completed as rapidly as possible
without compromising the safety or non-invasiveness of the
procedure. To maintain the procedure as relatively non-invasive,
any device used in the procedure should be small, yet preferably
have a working size adaptable to the particular circumstances that
may be present during any individual procedure, such as, the
particular size and anatomy of a patient. An additional goal of
Endoscopic Fundoplication involves the ability to implement the
procedure repeatedly.
[0064] Various aspects of this invention pertain generally to
devices to be used in conjunction, for example, with an A-frame
grasper-overtube to perform a Endoscopic Fundoplication procedure.
The inventive devices include improvements to the A-frame
grasper-overtube so that Endoscopic Fundoplication can be performed
repeatedly and more quickly, without degrading the safety or
non-invasiveness of the procedure. Moreover, the inventive devices
to be disclosed can be inserted into endoluminal devices having
limited lumen diameters and can be used in patients of varying
sizes and anatomies.
[0065] To accomplish these objectives, the present invention
includes a tissue clip device and an expandable grasping arm.
Preferably, both of the inventive devices are capable of being used
with the A-frame grasper-overtube described in connection with
FIGS. 2-4, though use of the devices other than with the
grasper-overtube are within the scope of this invention.
Additionally, the present invention includes respective methods for
using the tissue clip and the expandable grasping arm.
[0066] An embodiment of an expandable grasping arm according to the
present invention is shown in FIG. 5. Expandable grasping arm 200
is shown in conjunction with A-frame grasper-overtube 100. However,
the expandable grasping farm can be used with other devices as
well. The various structural features of A-frame grasper-overtube
100 of FIG. 5, with the exception of grasping arm 200 and the
structure required to operate the arm to be described, are the same
as those disclosed in the description of overtube 100 of FIG. 2,
and have the same Preference numerals to indicate identical
parts.
[0067] In the preferred embodiment shown, expandable grasping arm
200 includes hollow tubes 201-203, shown in FIG. 5. Tubes 201-203
engage each other in a telescoping relationship to extend and
retract grasping arm 200. A lumen (not shown) formed by tubes
201-203 receives a hydraulic fluid supplied by a syringe into a
proximal end of overtube 110. The fluid can be supplied by a
syringe or other suitable supplying device into a tube 204
extending through a lumen formed in overtube 110 that opens into
the lumen within tubes 201-203 of grasping arm 200. The increased
pressure in the tubes that results from the feeding of the
hydraulic fluid into the lumen of tubes 201-203 causes the tubes to
slide outward to extend the grasping arm 200. In a fully-expanded
configuration, tubes 201-203 essentially are disposed in an
end-to-end relationship. By removing the fluid pressure in tubes
201-204, grasping arm 200 can be retracted. In a fully-retracted
configuration, tubes 201-203 are disposed in a substantially
concentric relationship.
[0068] Although three tubes are shown in the embodiment of the
expandable grasping arm 200 shown in FIG. 5, it is considered
within the scope of the invention to provide more or less than
three tubes. Selection of the number of tubes depends on various
parameters of the procedure to be performed, such as, for example,
the length of the fold and the size of the lumen diameter of the
grasper-overtube. However, the overall length of the grasping arm
should not exceed that which is required to maintain the mechanical
advantage of the device when creating the fold of tissue.
[0069] The scope of the present invention includes a grasping arm
that includes other expandable structures. For example, rather than
providing a telescoping arrangement of tubes, a telescoping ladder
configuration may be provided. Such an embodiment would operate
similar to the embodiment of FIG. 5, however, instead of hydraulic
actuation, each arm segment could be coupled to an actuating wire
or wires to extend or retract the grasping arm.
[0070] The use of shape memory materials, inflatable members, and
folding members, as opposed to the hydraulic telescoping members,
in making the =;expandable grasping arm also is contemplated by the
present invention.
[0071] The following describes the use of the inventive expandable
grasping arm to create a tissue fold. As discussed with reference
to FIG. 3, the A-frame grasper-overtube is inserted into the body
to a point below the fundus. Expandable grasping arm 200 is
actuated in a manner similar to the grasping arm 122. That is, a
cable is actuated, causing pivot 112 to rotate expandable grasping
arm 200 in a downward direction until it is substantially
perpendicular with overtube 110. During this actuation step, tubes
201-203 are in their fully-retracted configuration. After pivotable
actuation of expandable grasping arm 200, grasping arm 200 is
extended by feeding a hydraulic fluid through the channel in the
overtube and the lumen formed by tubes 201-203. Expandable grasping
arm 200 can be extended to a length suitable for the patient's
anatomy and for the desired depth of folded tissue. Upon extending
grasping arm 200 to the proper length, the cable is actuated again
to rotate grasping arm 200 in an upward motion to create and hold
the fold formed by the fundus and esophagus walls in place. Once
the fold of tissue has been held in place with the use of the
expandable grasper, clips, staples, sutures, or other securing
mechanisms may be used to secure the fundus to the esophagus to
complete the fundoplication procedure. Tissue clips 300 disclosed
below can be used to secure the fundus to the esophagus in a
Endoscopic Fundoplication procedure. After the fold is secured,
expandable grasping arm 200 can be rotated downward to release the
fold of tissue and arm 200 can be retracted lengthwise by reversing
the feed of hydraulic fluid out of tubes 201-203 and overtube
110.
[0072] It will be apparent to those skilled in the art from
consideration of the specification and practice of the invention
disclosed herein that various modifications and variations can be
made in the expandable grasping arm of the present invention. For
example, the overall length of the grasper arm may vary according
to the configuration of the endoluminal device with which it is
employed.
[0073] An embodiment of a tissue clip 300 according to the present
invention is shown in FIG. 6A. Tissue clip 300 is configured to
secure the fundus wall to the outer wall of the esophagus proximal
to the opening of the esophagus into the stomach. Thus, tissue clip
300 may be used to complete a fundoplication procedure, and
specifically a Endoscopic Fundoplication procedure. Tissue clip 300
essentially includes two arms, 301 and 302, connected to each other
so as to have a substantially U-shaped configuration. Arms 301 and
302 preferably connect to one another such that when disposed to
secure the tissue fold in the fundoplication procedure, each arm
301 and 302 will frictionally engage with a surface of the fold.
This frictional engagement preferably establishes a compressive
force on the folded tissue to hold the tissue together.
[0074] Tissue clip 300, as shown in FIG. 6A, includes a gripping
tab 303 for grasping during installation of tissue clip 300.
Gripping tab 303 allows tissue clip 300 to be held by a deployment
device 310 (FIG. 7) having a distal end configured to mate with
gripping tab 303. When tissue clip 300 is positioned on the fold of
the tissue appropriately, deployment device 310 will release
gripping tab 303. Tissue clip 300 further includes reverse-angle
stabilizing barbs 304 disposed on opposing inner surfaces of the
clip. Barbs 304 help to prevent the clip from moving relative to
the tissue fold and assist in holding tissue clip 300 in place
should the frictional engagement between the clip and the fold be
overcome. Fixation holes 305 also may be disposed on each arm 301
and 302 of tissue clip 300 so that, if necessary, clip 300 may be
anchored to the tissue. Anchors may be provided in the form of
pins, bolts, sutures, staples, biodegradable rods or other suitable
anchoring devices. As shown, two barbs 304 are disposed on tissue
clip 300, with one barb on each inner surface of arms 301 and 302.
The barbs 304 are positioned directly opposite to one another.
However, it is contemplated that more than one barb can be disposed
on each inner surface of clip 300 and can be positioned such that
they are spaced vertically from one another. One having ordinary
skill in the art would recognize that the exact number and
placement of the barbs can vary according to factors such as, for
example, the thickness of the tissue to be secured, the exact
placement of the tissue clip, the clip material, the number of
total clips desired to secure the tissue, and other similar
factors.
[0075] In the embodiment of tissue clip 300 shown in FIG. 6A, arm
301 extends in a substantially vertical direction when the clip is
grabbed by gripping tab 303. Arm 302 connects to arm 301 at a
slight angle such that the opening formed between arms 301 and 302
is slightly tapered, with the widest portion of the taper occurring
at the proximal ends of the arms. One of arms 301 or 302 also may
have a slight crook 306 at its proximal end for the purpose of
providing a surface to push against to bring the arms closer
together during insertion. The crook 306 also may be used to permit
smooth, easy insertion of tissue fold into clip 300 by sliding the
fold along the inner surface of crook 306. Preferably, crook 306 is
disposed on the arm that does not include gripping tab 303.
[0076] Tissue clip 300 can be made of any suitable material that is
biocompatible, such as titanium, polyethylene, teflon or ABS.
Preferred materials include bioabsorbable materials, such as,
polylactic acid or polyglycolic acid. When a bioabsorbable material
is used to make tissue clip 300, it is contemplated that eventually
the tissue on the walls of the esophagus and the fundus will adhere
together such that external securing means, such as the clip, are
unnecessary. Thus, the bioabsorbable material should be selected
such that disintegration of the clip occurs after the tissue of the
fold has had an opportunity to fully adhere. A material to be
selected for clip 300 may be one that results in some frictional
engagement between the esophogeal and fundus tissue and the surface
of clip 300. For example, the surface of clip 300 can be textured
for the purpose of enhancing the frictional engagement.
[0077] In general, tissue clip 300 has dimensions that allow it to
be used with endoluminal devices and for the purposes of securing
the fold created during a fundoplication procedure. One form of
tissue clip 300 has dimensions that enable it to be inserted and
installed using an A-frame grasper-overtube 100. Thus, tissue clip
300 preferably has a length of approximately 4 centimeters, as
measured from the apex of the U to the ends of arms 301 and 302. An
opening 307 at the mouth of clip 300 preferably is approximately 6
millimeters measured between the inner surfaces of arms 301 and
302. Dimensioned in this way, tissue clip 300 will fit within lumen
130 of the A-frame grasper-overtube described in connection with
FIGS. 2-4. However, such dimensions are meant to be exemplary only
and the particular dimensions may vary according to the design of
the particular A-frame grasper-overtube used to perform the
procedure or to whether the clip is used in conjunction with other
delivery devices. The method of using tissue clip 300 to perform
Endoscopic Fundoplication will now be described, with reference to
FIG. 8. First, A-frame grasper-overtube 100 is implemented
according to the steps described in connection with FIGS. 2-4 such
that grasping arm 122 has been actuated to complete the folding of
the fundus wall onto the esophagus wall. Then, tissue clip 300 is
inserted through lumen 130. Any standard gripper may be used to
grasp tissue clip 300 by gripping tab 303 to insert the tissue clip
through lumen 130 of grasper-overtube 100. Tissue clip 300 is
lowered through opening 105 to a position below the fold of the
tissue, which continues to be held in place via grasping arm 122.
The dimensions of tissue clip 300 allow arms 301 and 302 to be
placed on opposite sides of the fold of tissue such that arm 301
rests within opening 105 and arm 302 rests within the opening of
grasping arm 122, as shown most clearly in FIG. 7 where tissue clip
300 has been engaged with the tissue fold created by
grasper-overtube 100. Once positioned such that the apex of the
tissue fold enters opening 307 of tissue clip 300, the clip, by way
of the gripper, is pulled upward in a firm motion to seat the fold
of tissue fully into the clip. Barbs 304 will engage outer surfaces
of the tissue fold to inhibit movement of tissue clip 300 is
relative to the tissue fold. If necessary, tissue clip 300 can be
anchored to the tissue using an anchoring member through fixation
hole 305.
[0078] After tissue clip 300 is secured in place to hold the fold
of tissue, cable 124 can be actuated to cause grasper arm 111 to
assume an open position to release the fold of tissue. A-frame
grasper-overtube 100 then can be removed from the area of the fold.
If more than one tissue clip is needed to complete the
fundoplication procedure, A-frame grasper-overtube 100 can be
rotated to a new position and the process described above for
folding and securing tissue can be repeated. Tissue clips may be
installed around the entire circumference of the esophageal opening
to hold the folded fundus into place. Thus, using the tissue clip
of the present invention, a fundoplication procedure such as
Endoscopic Fundoplication can be completed relatively quickly and
non-invasively. The securing of the fundus wall to the esophagus
wall can be completed entirely through the use of a single
endoluminal device, requiring only a single point of insertion on
the body. Additionally, the U-shaped configuration of tissue clip
300 results in a more uniform geometry associated with the fold
because the clips essentially provide a consistent template for the
depth of tissue that will be secured.
[0079] FIG. 8 shows an example of a completed Endoscopic
Fundoplication procedure with two tissue clips 300 used to secure
the fundus to the esophagus.
[0080] As a final step in the method of using tissue clip 300, a
sclerosing agent may be injected into the folds to promote the
natural adhesion of the fundus to the esophagus. If tissue clips
300 are made from a bioabsorbable material, they will eventually
disintegrate. Preferably, the bioabsorbable material chosen for
tissue clip 300 disintegrates over a time period longer than is
required for natural adhesion to occur.
[0081] It will be apparent to those skilled in the art from
consideration of the specification and practice of the invention
disclosed herein that various modifications and variations can be
made in the tissue clip of the present invention.
[0082] For example, the tissue clip may be provided in different
sizes, for example, small, medium, and large, for use with
children, average-sized, and larger patients, respectively.
[0083] Furthermore, the particular use of both the tissue clip and
the grasper arm in conjunction with the A-frame grasper-overtube
device and Endoscopic Fundoplication procedure are illustrative
only. It is considered to be within the scope of this invention to
use these devices with other endoluminal procedures, as well as for
purposes outside of the medical industry that may require insertion
and installation of fasteners or material grabbing devices through
small spaces.
[0084] An embodiment of a mounting device 410 according to the
present invention is shown in FIGS. 9-11. The mounting device
includes a ring 411 preferably having an outer peripheral surface
forming a substantially circular shape as shown. Ring 411 is
configured to be inserted into the esophagus during an endoluminal
procedure. To facilitate insertion through a narrow passage
associated with an endoluminal device or through the esophagus
itself, ring 411 preferably is made of a flexible or elastic
material, such as silicone and polyurethane. Furthermore, the
dimensions of ring 411 allow the ring to be inserted through a
narrow passage and placed within a base portion of the esophagus
near its opening into the stomach. For example, ring 411 may have a
diameter of approximately 18 mm. In particular, the outer
peripheral surface of ring 411 preferably establishes a frictional
fit with the inside of the esophagus without impeding the
esophageal passageway. Alternatively, ring 411 may be affixed to
the inside of the esophagus through sutures or other suitable
fixation means. Ring 411 should be positioned within the esophagus
such that the longitudinal axis of the ring and the esophagus are
substantially colinear. Using an elastic or flexible material for
ring 411 also allows the esophagus to close to prevent reflux.
[0085] Ring 411 further includes at least one engagement portion
disposed on the peripheral surface of the ring. In the embodiment
shown in FIG. 9, an aperture 413 extends through the peripheral
surface of the ring in a direction perpendicular to the ring's
longitudinal axis. Further shown in FIG. 9, ring 411 preferably
defines three apertures 413 evenly spaced around the circumference
of the ring. At locations around ring 411 corresponding to
apertures 413, legs 412 depend from ring 411. Legs 412 extend in a
direction essentially parallel to the longitudinal axis of ring
411. Legs 412 can depend either from a bottom of ring 411, as
shown, for example, in FIG. 9 or from a peripheral surface of the
ring.
[0086] Each leg 412 includes a grooved region 414 located
approximately midway along its length. Grooved region 414 forms a
hinge to allow legs 412 to fold easily around a tissue fold. At a
free end 415, each leg 412 includes an engagement member 416
configured to engage aperture 413. Engagement member 416 protrudes
from leg 412 in a direction perpendicular to the leg and away from
the longitudinal axis of ring 411. Although there are three
apertures and corresponding legs shown in FIG. 9, any number of
apertures and corresponding legs can be provided depending on the
desired fold configuration, the thickness of the fold, and other
similar factors.
[0087] Engagement member 416 and aperture 413 are configured such
that, prior to their engagement, engagement member 416 is capable
of insertion through aperture 413. After engagement member 416 has
been inserted into aperture 413, however, engagement member 416 is
restricted from passing back through aperture 413 in a direction
opposite to that of initial insertion. Thus, according to one
embodiment of the invention, engagement member 416 includes a shaft
portion 418 and a tapered head 420, with the widest portion of
tapered head 420 adjacent shaft 418. At its free end, tapered head
420 is configured to pierce the tissue fold to be secured. Shaft
418 has a length long enough to extend through a tissue fold.
During insertion, the free end of head 420 will pass through
aperture 413 first. Once the widest portion of head 420 has passed
through aperture 413, attempting to pass engagement member 416 back
through aperture 413 in a direction opposite to insertion will
cause the widest portion of head 420 to abut the inner surface of
ring 411. This restricts engagement member 416 from disengaging
aperture 413.
[0088] Aperture 413 preferably has the shape of a slotted hole or
an X, or other similar suitable configuration that allows passage
of head 420 during insertion but restricts passage after
insertion.
[0089] As shown in FIG. 9A, apertures 413, which extend entirely
through ring 411, can be replaced with engagement recesses 413'.
Each engagement recess 413' extends only partially through ring 411
and includes a widened opening 413'B within the depth of ring 411.
In this manner, tapered head 420 of engagement member 416 would be
inserted through recess opening 413'A in the direction toward the
widened opening 413'B, but would be prohibited from passing back
through in an opposite direction. That is, the wide portion of the
head 420 would abut against the interior surface between widened
opening 413'B and recess opening 413'A.
[0090] Furthermore, apertures 413 or recesses 413' could be
disposed on the tissue securing members, and engagement members 416
disposed on the ring. In this case, preferably ring 411 will
include a housing recess, or other protection mechanism, to protect
the esophagus from being damaged by the sharp portion of head 420
as ring 411 is inserted. In such an embodiment, an actuator could
place the engagement members into positions perpendicular to the
ring peripheral surface when the tissue is ready for securing.
[0091] In the embodiment shown in FIGS. 9-11, ring 411 and legs 412
form an integral device. The entire device can be formed as either
a single-molded piece or legs 412 can be fixedly attached to ring
411 using an adhesive or other suitable fastening means apparent to
one having ordinary skill in the art.
[0092] Ring 411 and legs 412 can be made of any suitable material
that is biocompatible, and at least for an initial time period
resistant to degradation from acids and other substances passing
through the esophagus. Preferably, a bioabsorbable material is used
so that the device will disintegrate after a certain time period
sufficient for the natural adhesion of the tissue of the tissue
fold to occur. Ring 411 may be made of a different material than
legs 412, for example, ring 411 may be formed of a flexible
material such as silicone or polyurethane, while legs 412 may be
formed of bioabsorbable material such as polyactic acid or
polyglycolic acid. In this way, ring 411 can have sufficient
flexibility to allow the esophagus to close, while legs 412 have
sufficient rigidity to secure the tissue fold. Further, ring 411
can be dimensioned to pass through the digestive tract so as not to
cause complications if ring 411 were to be separated from legs
412.
[0093] Installation of mounting device 410 during an endoluminal
procedure, such as, for example Endoscopic Fundoplication, will now
be described. With legs 412 in their extended position, mounting
device 410 is inserted through the esophagus. An endoluminal
device, such as, for example, a flexible tube carrying ring 411 on
its exterior, can be used to insert mounting device 10 into the
esophagus. During insertion, it is important that heads 420 of
engagement members 416 do not damage the esophagus. One way to
avoid such damage includes providing a shield on each head 420 to
protect any surface that would otherwise contact the sharpened free
end of head 420. As an alternative to providing a shield, each
engagement member 16 may be rotatably mounted on leg 412. Thus,
during insertion, engagement members 416 would lie substantially
along legs 412 in a direction parallel to the longitudinal axis of
ring 411. Legs 412 may include a recessed housing for receiving
engagement member 416. Once ring 411 is placed with respect to the
esophagus, engagement members 416 can be rotated to a position
perpendicular to legs 412. Other suitable mechanisms for preventing
damage to the esophagus from engagement members 416 during
insertion into the esophagus are within the scope of this
invention.
[0094] Referring to FIG. 10, mounting device 410 is then positioned
relative to the esophagus such that ring 411 engages the inner
surface of the esophagus hand free ends 415 of legs 412 are
disposed below the opening of the esophagus into the stomach.
Mounting device 410 should be positioned with respect to the
esophagus so that grooved portions 414 of legs 412 are slightly
lower than the seat of the tissue fold to be secured. Preferably, a
frictional fit occurs between ring 411 and the esophagus. However,
sutures or other suitable securing means may also be used to secure
ring 411 to the esophagus. A-Frame grasper-overtube 100 is also
illustrated in FIG. 10 with grasping arm 122 folding a section of
tissue. Extending through overtube 110 of A-Frame grasper-overtube
100 is a clip actuation mechanism 422 for folding legs 412 of
mounting device 410. Clip actuation mechanism 422 may be formed in
any conventional manner so long as it is capable of urging legs 412
to secure the tissue fold. For example, as illustrated in FIG. 10,
clip actuation mechanism 422 may include a pivoting member for
urging legs 412 into engagement with the folded tissue.
[0095] With a fold of tissue created between the fundus wall and
the esophagus wall, using a device such as the A-frame
grasper-overtube, or other suitable folding device, free end 415 is
then folded up such that the surface of leg 412 on which engagement
member 416 is disposed engages the exterior surface of the tissue
fold. Legs 412 can be folded by clip actuation 422 mechanism
extending through lumen 130 of A-frame grasper-overtube 100. The
clip actuation mechanism is actuated to force leg 412 to pivot
about grooved portions 414 and engage the folded tissue. Free end
415 is moved toward ring 411 with a force sufficient for head 420
to pierce the tissue fold and pass through aperture 413. Once head
420 passes through aperture 413, leg 412 secures the tissue fold in
place at that location. The engaged relationship between engagement
member 416 and aperture 413 also assists in holding ring 411 in
place with respect to the esophagus. Each of the legs 412 provided
on ring 411 will be folded in the same manner to secure a uniform
fold of tissue around the perimeter of the esophagus. Once mounting
device 410 has been secured to the tissue fold, the flexible
delivery tube or other delivery device can be removed from the
esophagus. As the delivery tube is removed, mounting device 410
will be released from the exterior of the flexible tube.
[0096] The final placement of mounting device 410 after completion
of the fundoplication procedure is shown in FIG. 11. Due to the
cross-sectional perspective, only two legs 412 are shown.
Preferably, legs 412 each have the same length such that, when
mounting device 410 is installed to secure the tissue fold, a
tissue fold having a uniform depth is created around the esophagus.
Furthermore, the mounting device causes alignment of the tissue
clips in a radial and vertical direction around the esophageal
opening into the stomach to avoid torsional stresses on the tissue
after securing the fold.
[0097] An alternative manner of placing mounting device 410 to
secure the tissue fold includes creating the fold of tissue during
the step of folding legs 412. This procedure includes inserting the
mounting device using the flexible tube as described above,
followed by inserting through the tube an actuatable grasping and
folding device, similar to the grasping arm of the A-frame
grasper-overtube. Once the actuatable grasping and folding device
has been inserted, it is positioned with respect to a leg 412 of
mounting device 410 and actuated such that free end 415 of leg 412
is rotated up toward ring 411. As leg 412 rotates toward ring 411,
tissue to be folded will be grabbed by the leg and brought toward
the esophagus to create the tissue fold. Legs 412 will then be
secured to hold the tissue fold by inserting engagement member 416
with aperture 413. To avoid damage to tissue by engagement member
416, as a result of folding leg 412, engagement member 416 could be
housed within leg 412 and deployable through a spring-activated
mechanism. Other suitable deploying or protection mechanisms could
also be used to prevent tissue from being damaged by engagement
member 416 during folding of leg 412 and are within the scope of
this invention. According to one embodiment of the present
invention, legs 412 may be formed with different lengths. The
shorter length legs may be used to secure a fold where the
curvature of the stomach near the esophagus is smaller.
[0098] Another embodiment of a mounting device according to the
present invention is shown in FIGS. 12-14. The mounting device
shown in these Figures essentially includes a ring 511 configured
to be used with tissue clips that are substantially similar to
tissue clip 300 described with reference to FIGS. 6 and 7. Tissue
clip 300 shown in FIGS. 6 and 7 is a particularly suitable
embodiment of a fastening mechanism for use in securing tissue
during Endoscopic Fundoplication.
[0099] FIGS. 12-14 show a ring 511 configured to be used with
tissue clips having substantially similar structure to tissue clips
300. In this embodiment, the tissue clip and ring 511 are not
manufactured to be an integral piece. Rather, tissue clips 300'
shown in FIGS. 12-14 are configured to detachably engage with ring
511 along its peripheral surface. Ring 511 includes apertures 513
spaced at various intervals around the peripheral surface of the
ring. Apertures 513 extend through ring 511 in a direction
perpendicular to the longitudinal axis of the ring. In the
embodiment shown, three apertures 513 are disposed substantially
evenly-spaced around ring 511. However, any number of apertures can
be provided depending on the desired fold configuration, the
thickness of the fold, and other similar factors.
[0100] Apertures 513 have a size and shape that allow them to
receive an engagement member 316 disposed on arm 301' of tissue
clip 300' to lock the clip into place on ring 511. Engagement
member 316 engages aperture 513 in a Manner similar to the way in
which engagement member 416 engages aperture 413, as described with
reference to the embodiment shown in 9-11. Once inserted through
aperture 513, a head portion 320 of engagement member 316 is
configured to pierce the tissue of the tissue fold being secured.
Positioning ring 511 within the esophagus, in a manner to be
described shortly, results in a vertical alignment of apertures 513
with respect to the esophagus. Thus, when engagement members 316
are locked through apertures 513 of ring 511 and into the tissue
fold to be secured, tissue clips 300' also will be aligned
vertically with respect to each other. Placement of tissue clips
300' utilizing ring 511 thus results in both radial and vertical
alignment in the esophagus, thereby creating a uniform tissue
fold.
[0101] Alternatively, apertures 513 could be replaced with
engagement recesses similar to engagement recesses 413' described
with reference to FIG. 9A. In such an embodiment, engagement
members 316 would not extend through ring 511 to pierce the tissue
of the tissue fold. Rather, the frictional fit between tissue clip
300' and the tissue to be secured, as well as the engagement
between barbs 304' and the tissue, would secure the tissue fold
with tissue clip 300'.
[0102] As described with reference to mounting device 410 in FIGS.
9-11, ring 511 and tissue clips 300' can be made of any suitable
material that is biocompatible. Preferably, a bioabsorbable
material is used so that the device will disintegrate after a
certain time period sufficient for the natural adhesion of the
tissue of the tissue fold to occur. Additionally, different
materials may be used for ring 511 and tissue clips 300', for
example, ring 511 may be formed of a flexible material such as
silicone or polyurethane, while clips 300' may be formed of
bioabsorbable material such as polyactic acid or polyglycolic acid.
In this way, ring 511 can have sufficient flexibility to allow the
esophagus to close, while clips 300' have sufficient rigidity to
secure the tissue fold.
[0103] The following describes the use of ring 511 and tissue clips
300' to perform a medical procedure, such as, for example,
Endoscopic Fundoplication. Initially an endoluminal device, such
as, for example, a flexible tube or an A-frame grasper overtube, is
inserted through the esophagus and into the stomach to provide
access to the fundus. Ring 511 is then inserted within the
endoluminal device using either an endoscopic gripper of the type
discussed with reference to gripping tab 303' on tissue clip 300'
or by placing ring 511 on the exterior of the flexible tube.
Preferably, ring 511 comprises a flexible material that enables it
to compress if it is necessary to insert the ring through the
endoluminal device. Thus, ring 511 can be made of an elastomeric
material that also is biocompatible, such as silicone or
polyurethane. When placed within the esophagus, ring 511 should be
configured to form a frictional fit between its peripheral surface
and the inner surface of the esophagus to prevent the ring from
sliding, yet should not interfere With the esophageal passage.
Aside from the frictional fit, however, the engagement of
engagement members 316 and the esophagus occurs through apertures
513 and assists in holding ring 511 in place. Additionally, sutures
or other suitable securing means can be implemented to secure ring
511 to the esophagus if necessary.
[0104] Engaging tissue clips 300' with ring 511 may occur either
before or after ring has been positioned within the esophagus.
Placing tissue clips 300' after ring 511 has been installed
preferably includes inserting the clips using A-frame
grasper-overtube 100 as described with reference to FIG. 6A,
although other endoluminal devices may be used as well. In this
manner, tissue clips 300' are pulled up to seat the tissue fold
between the two arms of the tissue clip in such a way so as to
align engagement member 316 with an aperture 513 on ring 511. Once
aligned, tissue clip 300' can be manipulated, via a gripper, to
force engagement member 316 through aperture 513 and into the
tissue fold. This process is repeated until all of the tissue clips
have been installed and engaged with the corresponding
apertures.
[0105] It is also contemplated that engagement member 316 could
pass through the entire thickness of the tissue fold to engage with
a fixation hole 305' on arm 302'. In this case, fixation hole 305'
and engagement member 316 also would be configured to restrict
passage of engagement member 316 through fixation hole 305' once
engagement member 316 has been inserted into fixation hole
105'.
[0106] Tissue clips 300' also may be attached to ring 511 before
ring is placed around the esophagus.
[0107] In using any of the embodiments of the mounting devices
according to the present invention, a sclerosing agent may be added
after installation of the devices to promote the natural adhesion
of the tissue forming the tissue fold. It is preferable to select
materials for the various parts of the mounting devices that
disintegrate after a time period long enough for the tissue of the
tissue fold to have adhered together.
[0108] It will be apparent to those skilled in the art from
consideration of the specification and practice of the invention
disclosed herein that various modifications and variations can be
made in the mounting devices of the present invention. For example,
the tissue clips, whether in the form of legs integral with the
ring or in the form of separate members, may be provided in
different sizes, for example, small, medium, and large, for use
with children, average-sized, and larger patients, respectively.
Additionally, the number of tissue clips and corresponding
apertures can be changed according to the dimensions of the fold to
be secured. Also, it is contemplated that the mounting devices
disclosed can be installed in an open or laparascopic procedure
rather than endoluminally installed.
[0109] Furthermore, the particular use of both the tissue clip and
the ring in conjunction with the A-frame grasper-overtube device
and Endoscopic Fundoplication procedure are illustrative only. It
is considered to be within the scope of this invention to use these
devices with other endoluminal procedures, as well as for purposes
outside of the medical industry that may require insertion,
alignment, and installation of fasteners or material manipulators
through small spaces.
[0110] Addressing another aspect of the present invention, a
technique for folding and thereby thickening esophageal tissue and
reducing the diameter of the esophageal opening in the region of
the LES to treat GERD is accomplished through another endoluminal
medical procedure. The endoluminal device used in this procedure is
configured for insertion through the esophagus to create a
generally longitudinal tissue fold and then securing the fold. As
with the procedures described above, this endoluminal procedure has
the benefits of being less invasive, quicker, and less expensive as
compared to previous techniques.
[0111] As with most endoluminal procedures, completion of the
folding and securing procedure preferably occurs as rapidly as
possible without compromising the safety or non-invasiveness of the
procedure. To maintain the procedure as relatively non-invasive, it
is preferable to provide a device that is relatively small in size,
yet has the capability to secure tissue in the esophagus in a
plurality of locations and with consistent results. In addition, a
catheter need only be inserted once and the device can easily be
removed, reloaded and reinserted to secure tissue around the
circumference of the esophagus.
[0112] To accomplish these objectives, a suction stapler configured
for endoluminal insertion is used to create and secure tissue
folds. The suction stapler, and method for its use, are
particularly suited for performing a medical procedure in which
tissue is folded and secured in the region of the LES. Using the
inventive device to secure the esophageal tissue allows the
procedure to be performed rapidly and relatively non-invasively,
and results in a substantially uniform tissue fold.
[0113] Although the inventive device and method will be discussed
mainly with reference to securing esophageal tissue in the region
of the LES, the device and method can be employed in conjunction
with other medical procedures that require creating and securing
tissue folds. Moreover, the device and method are applicable in
other settings, including industrial settings, that require the
securing of two surfaces together in an environment having limited
access to the two surfaces.
[0114] An embodiment of a suction stapler 610 according to the
present invention is shown in FIGS. 15A-15c. Suction stapler 610
includes an outer tube 611 defining a lumen 612. Toward its distal
end, outer tube 611 includes a sidewall opening 613 extending along
a portion of outer tube 611. Opening 613 has an axial length at
least as long as the length of a tissue clip to be described, such
as, for example, approximately 2 to 4 cm. Opening 613 has a width
sufficient to provide a suction force to draw a portion of
esophageal tissue therein, as will also be described, such as, for
example, approximately 7 mm. Outer tube 611 is hollow and sealed at
a distal end 616.
[0115] Within lumen 612 is a rotatable inner sleeve 615.
Innersleeve 615 is hollow and has a semi-circular configuration at
least along an axial length of its distal end corresponding to
opening 613. Otherwise, sleeve 615 can have a completely circular
or substantially circular cross-section. As shown most clearly in
FIGS. 15A and 15B, the semi-circular configuration allows inner
sleeve 615 to close and open opening 613 as the sleeve rotates
within outer tube 611.
[0116] At a proximal end (not shown) of the suction stapler, a
vacuum source connects to a fitting disposed on outer tube 611.
When initiated, the vacuum source creates a suction force at
sidewall opening 613 in tube 611. Also disposed at the proximal end
of outer tube 611 is an actuator for rotating outer tube 611 and
inner sleeve 615 relative to one another. Such an actuator can
either be manually or automatically controlled. Such vacuum
fittings and proximal actuators may be of any type known in the
art, such as, for example the vacuum fitting 625 and rotation
actuator 626 illustrated in FIG. 15A.
[0117] Outer tube 611 and inner sleeve 615 preferably are made of
metal or other suitable like material capable of withstanding the
suction force generated by the vacuum source, permitting relative
rotational motion, and sufficiently flexible to the extent through
the esophagus and, for example, through an endoscope. For example,
outer tub 611 and inner sleeve 615 may be formed of metal braid and
coil reinforced polymers such as nylon, polyamide, or nylon block
copolymers. The diameter of lumen 612 of outer tube 611 may be
approximately 10 mm.
[0118] FIG. 16 shows an embodiment of a tissue clip 616 that can be
deployed using suction stapler 610. In the embodiment shown, tissue
clip 616 includes a female part 617 and a male part 618. Female
part 617 extends lengthwise and defines a number of holes 619 that
correspond in number and position to darts 620 disposed on male
part 618. Darts 620 and holes 619 are configured so that darts 620
can be inserted in a first direction through holes 619 when female
part 617 and male part 618 are disengaged. Once darts 620 have been
inserted through holes 619, female part 617 and male part 618 are
in an engaged relationship and darts 620 cannot be pulled back
through holes 620 in a second direction opposite to the first
direction.
[0119] FIG. 16 shows female part 617 and male part 618 including
five holes and darts, respectively. However, any number, rows,
columns, or distribution of corresponding holes and darts may be
used depending on such factors as the amount of tissue to be
secured, the positioning of the clip, and other similar factors.
Tissue clip 616, including both female part 617 and male part 618,
preferably is made of a biocompatible material, and in particular
of a bioabsorbable material. Utilizing a bioabsorbable material
enables tissue clip 616 to disintegrate safely within the body
after the tissue surfaces being secured together by clip 616 have
had an opportunity to form a natural adhesion.
[0120] FIGS. 17 and 18 best show the general placement of female
part 617 and male part 618 in suction stapler 610 prior to their
deployment to secure tissue. The Figures show a cross-sectional
view of outer tube 611 and inner sleeve 615 in the region of
sidewall opening 613 and taken through plane 17-17 shown in FIGS.
15A-15c. As shown in these Figures, inner sleeve 615 includes a
first small lip or ledge 621 formed at the edge defining the
semi-circular opening and Configured to hold and push male part
618. Ledge 621 may include a protrusion or recess for securely
engaging a similarly sized recess or protrusion in male part 618.
Lip 621 is positioned proximate one edge of sidewall opening 613 of
outer tube 611 when inner sleeve 615 is rotated to completely open
opening 613. For holding female part 617 prior to installation of
tissue clip 616, outer tube 611 includes a second small lip or
ledge 622 positioned on its inner surface near an edge of opening
613. Thus, lip 622 is positioned opposite to the edge of opening
613 by which lip 621 is positioned when inner sleeve 615 is rotated
to the completely open position. Lip 622 defines an aperture 623
located substantially at a center thereof. Aperture 623 aligns with
holes 619 when lip 622 holds female part 617, as shown in FIG. 18.
Thus, aperture 623 accommodates the tip of dart 620 during the
insertion of dart 620 through hole 619 to engage female part 617
and male part 618. Although the Figures show female part 617 being
held by ledge 622 disposed on outer tube 611 and male part 618 by
lip 621 disposed on inner sleeve 615, female part 617 could be held
instead by inner sleeve 615 and male part 618 by outer tube 611.
Regardless of which element holds female part 617, an aperture
should be provided that aligns with holes 619. Lips 621 and 622
also limit the relative rotational displacement of tube 611 and
sleeve 615.
[0121] Installation of tissue clip 616 to secure a fold of
esophageal tissue during the medical procedure according to the
present invention will now be described with particular reference
to FIGS. 19-21 FIG. 19 shows suction stapler 610 inserted through a
patient's esophagus, with its distal end positioned proximal to the
opening of the esophagus into the stomach. As shown, sidewall
opening 613 is positioned close to the esophagus wall that includes
the tissue to be folded and secured. Suction stapler 610 can be
inserted either directly into the esophagus or through an
endoscope. If the stapler is inserted directly through the
esophagus, a viewing mechanism in the form of an optical fiber or
the like may be inserted through lumen 612 for initial positioning
of the stapler with respect to the esophagus wall. Once stapler 610
is positioned, the viewing mechanism can be removed.
[0122] Upon proper positioning of sidewall opening 613 with respect
to the esophagus, as shown in FIGS. 19 and 20, the vacuum source is
turned on to create suction through opening 613 and outer tube
lumen 612. The arrows in FIG. 20 illustrate the direction of the
suction force with respect to opening 613 and inner sleeve 615.
Upon proper positioning of stapler 610, the suction force acts on
the esophagus wall to suck esophageal tissue through opening 613
and into the hollow space defined by inner sleeve 615, as shown in
FIG. 20. The strength of the suction force should be sufficient to
suck the esophageal tissue into stapler 610, but should be gentle
enough to avoid tearing or otherwise damaging the tissue.
[0123] Once the desired tissue fold has been created within inner
sleeve 615, as shown in FIG. 21, installation of tissue clip 616 to
secure the fold proceeds in the following manner. First, actuation
of inner sleeve 615 and outer tube 611 occurs through the actuation
member disposed at the proximal end of suction stapler 610. The
actuation member causes inner sleeve 615 to rotate in one direction
and outer tube 611 to rotate in another, as shown by the arrows in
FIG. 21. That is, inner sleeve 615 rotates in a direction such that
female part 617 moves toward male part 618. Accordingly, outer tube
611 rotates in a direction opposite to inner sleeve 615 such that
male part 618 moves toward female part 617. It only may be
necessary to rotate one of the tube 611 and sleeve 615, rather than
both.
[0124] The relative rotation of inner sleeve 615 and outer tube 611
continues until darts 620 on male part 618 pierces and extends
through the tissue fold and is driven through apertures 619 in
female part 617. After such engagement of female part 617 and male
part 618, inner sleeve 615 and outer tube 611 are again
counter-rotated to return to their original positions. Upon the
return of inner sleeve 615 and outer tube 611 to their original
positions, the vacuum source is turned off and suction stapler 610
is removed from the esophagus. The force resulting from the
engagement of female part 617 and male part 618 overcomes the force
holding female part 617 and male part 618 to outer tube 611 and
inner sleeve 615, respectively. Thus, as shown in FIG. 23, tissue
clip 616 remains to secure the tissue fold after removal of suction
stapler 610. FIG. 25 shows a vertical cross-sectional view of the
esophagus with three tissue clips 616 in place to secure tissue
folds. If tissue clip 616 is made of bioabsorbable material, it
eventually disintegrates after a time period sufficient to allow
natural adhesion of the surfaces of the tissue fold.
[0125] If more tissue folds need securing, the suction is turned
off, suction stapler 610 is removed, reloaded with staples, and
reinserted into the esophagus. Suction stapler 610 can be
reinserted to a new position relative to the circumference of the
esophagus. When sidewall 613 has been placed in the new position,
the vacuum source is initiated and the stapling procedure repeated
as described above.
[0126] The suction stapler also may be modified to incorporate a
magazine:type loading of staples or other assembly of multiple
staple loads so that the suction stapler does not need to be
removed to initiate and secure more than one tissue fold around the
circumference of the esophagus. In this way, the suction stapler
can permit the installation of a plurality of tissue clips 616
around the circumference of the esophagus during a single insertion
of the device and perform the thickening and tightening technique
in a relatively quick and non-invasive manner. For instance, FIG.
25 shows the installation of three tissue clips to secure tissue
folds at evenly-spaced intervals around the esophagus. Of course,
any number of tissue folds at any desired spacing may be created as
required to achieve the desired increase in tissue thickening of
the esophageal region and reduction in diameter of the opening of
the esophagus.
[0127] Further, metal staples could be used in place of tissue
clips 616. In this embodiment, lip 621 would be replaced by a
staple pusher, and lip 622 would be replaced with a staple forming
anvil. Thus, rotation of outer tube 611 with respect to inner
sleeve 615 would cause a metal staple to be urged against the anvil
to deform the staple and secure the tissue fold. This embodiment
would not require the use of female part 617 as described
above.
[0128] It will be apparent to those skilled in the art from
consideration of the specification and practice of the invention
disclosed herein that various modifications and variations can be
made in the stapling device of the present invention. For example,
the tissue clip used in conjunction with the stapling device may be
provided in different sizes, such as, for example, small, medium,
and large, for use with children, average-sized, and larger
patients, respectively. However, it is important that the entire
device be configured to fit in the esophagus, or other part of the
body, depending on the particular endoluminal procedure being
performed. Additionally, as already mentioned the number of tissue
clips installed to secure tissue folds may be altered. Moreover,
other lumens may be provided in the tube so that additional devices
may be inserted into the esophagus and stomach to perform
additional operations.
[0129] The particular use of both the tissue clip and the stapling
device in conjunction with a LES folding and securing procedure is
illustrative only. It is considered to be within the scope of this
invention to use these devices with other endoluminal procedures,
as well as for purposes outside of the medical industry that may
require insertion and installation of fasteners through small
spaces.
[0130] In accordance with yet another aspect of the present
invention, a suction-grasper device, general indicated at 730 in
FIG. 26, is an endoscopic tool used to manipulate tissue.
Suction-grasper device 730 performs a portion of an endoluminal
GERD procedure, but has applications in many endoscopic,
laparoscopic or percutaneous procedures. Suction-grasper device 730
acts to grasp esophageal tissue and draw it into the lumen 733 of
cannula 732. In particular, suction grasper 730 is beneficial in
assisting in GERD procedures which are complicated by a herniated
esophageal tissue, where the tissue has bulged and protruded above
the diaphragm (a hiatal hania). In the instance of a hiatal hemia,
the tissue must be grasped and pulled downward toward the stomach.
Suction-grasper device 730 accomplishes this task by initially
grabbing the esophageal tissue by way of suction and then securing
the tissue to allow manipulation of the tissue that suction alone
could not achieve.
[0131] As illustrated in FIGS. 26 and 27, suction-grasper device
730 includes a flexible, possibly reinforced, polymer cannula 732
having a central lumen 733, a sealed distal end 734 and a
longitudinal window 736 cut or formed into distal end 734 of
cannula 732. Distal end 734 may include a housing or cap fixedly
attached to cannula 732. Window 736 may be about 4 cm long and
cover about 1/3 of the external circumference of suction-grasper
device 730. Suction applied to a proximal end (not shown) of
cannula 732 results in a vacuum created at the area of window
736.
[0132] According to one embodiment of the present invention,
grasping the tissue suctioned through window 736 into cannula 732
takes place with a grasping wire 738 which extends across the
length of window 736 and back to the proximal end of the cannula
732. Wire 738 is aligned such that in the free, non-tensioned
position, wire 738 does not impinge upon a open area of the window
736. However, once tensioned by an operator at the proximal end of
the instrument, wire 738 moves into an intermediate position
between the longitudinal edges 740, 742 of the window 736, thereby
securing or grasping the tissue.
[0133] Grasping wire 738 may be formed in cannula 732, or
integrated into the above mentioned housing or cap. Further,
grasping wire 738 can carry a serrated tube to assist in fixing the
tissue in window 736.
[0134] Suction-grasper device 730 acts in the following manner with
respect to endoluminal treatment of GERD. Suction-grasper device
730 is inserted into the esophagas with suction window 736 located
towards the esophageal tissue. When suction is applied to the
suction-grasper device 730, tissue is drawn toward window 736 of
suction-grasper 730. When the tissue is sufficiently positioned
within lumen 733 and window 736 of suction-grasper device 730,
tension is applied to the proximal end of grasping wire 738. Due
to, for example, an eccentric alignment of wire contact points
within cannula 732, tensioned wire 738 will be moved to within
window 736 and in contact with the tissue. As further force is
applied to wire 738, the tissue is securely grasped.
[0135] It is appreciated that there are various alternative
arrangements for securing the wire 738 so that tension from the
operator causes the wire to fix the tissue within window 736. For
Example, as shown in FIG. 28, grasping wire 738 may be wrapped
around a grasping plate 739 so that the pulling of grasping wire
738 causes the grasping plate to secure the tissue. In this
embodiment, grasping plate 739 may be formed in a generally
U-shaped or C-shaped configuration and tension of the grasping wire
738 would cause the open ends 744 and 746 of the grasping plate 739
to close and secure the tissue. Alternatively, grasping wire 738
could be coupled to cannula 732 above and below grasping plate 739
and wrapped around only one open end of grasping plate 739. In this
configuration, tension of grasping wire 738 would urge one open end
of grasping plate 739 toward the opposing open end and thus secure
the tissue.
[0136] Once the tissue is grasped, suction-grasper device 730 is
advanced proximally along the esophagus, to take up and straighten
out the loose tissue created by the hiatal hernia, and position the
tissue where desired. Advancing the tissue may take a bit of force,
thereby necessitating the use of grasping wire 738. Suction-grasper
device 730 may then release the tissue by releasing the grasping
wire and then cutting off the vacuum supply.
[0137] Grasping wire 738 has been found to be an extremely
effective mode of grabbing and positioning a length of tissue in
the procedure described above. The device allows a large amount of
longitudinal force to be applied to the esophageal tissue without
losing the secure grip of suction-grasper device 730.
[0138] There are other possible embodiments of components to grasp
the tissue within suction-grasper device 730, including (but not
limited to) a coaxial tube with a window, aligned with window 736,
such that upon tissue being located within both windows (by suction
or otherwise), rotation of the coaxial tube relative to window 736
would cause the edges of the coaxial tube to grasp the tissue
located between the coaxial tube and suction-grasper cannula 732.
Instead of a coaxial tube, a sliding flap may be included in
cannula 732 to fix tissue in window 736.
[0139] Distal end 734 of suction-grasper device 730 may include a
clear section of cannula 732 formed opposite window 736. Clear
section would allow for visual confirmation of tissue being sucked
through window 736 into cannula 732. Such visual confirmation could
be achieved by way of, for example, an endoscope. Alternatively,
the whole device may be fabricated of a clear material.
[0140] Suction-grasper device 730 is not restricted in use to the
treatment of GEM. Suction-grasper tool 730 is not absolutely
necessary to treat GERD, but is especially suited for assisting a
treatment of GERD that is complicated by a hiatal hernia. As noted
above, suction-grasper device 730 may be utilized in any
endoscopic, laparoscopic, endoluminal or percutaneous procedure
requiring tissue manipulation.
[0141] The invention described above, in its broader aspects, is
not limited to the specific details and illustrative examples shown
and described in the specification. It is intended that departures
may be made from such details without departing from the true
spirit or scope of the general inventive concept as defined by the
following claims and their equivalents.
* * * * *