U.S. patent application number 13/108331 was filed with the patent office on 2012-03-22 for methods for reduction of gastric lumen.
This patent application is currently assigned to USGI Medical, Inc.. Invention is credited to Rodney BRENNEMAN, Eugene CHEN, Richard C. EWERS, Saadat VAHID.
Application Number | 20120071900 13/108331 |
Document ID | / |
Family ID | 32871809 |
Filed Date | 2012-03-22 |
United States Patent
Application |
20120071900 |
Kind Code |
A1 |
VAHID; Saadat ; et
al. |
March 22, 2012 |
METHODS FOR REDUCTION OF GASTRIC LUMEN
Abstract
A method of reducing the cross-sectional area of a
gastrointestinal lumen is provided wherein a delivery catheter
having a needle, one or more anchors disposed within the needle and
a suture coupled to each anchor is advanced into the
gastrointestinal lumen, the needle extended through the tissue
wall, and an anchor ejected from a distal tip of the needle through
the tissue wall. The needle is then repositioned against an
opposing tissue wall, another anchor deployed from the needle
through the opposing tissue wall, and the tissue walls approximated
by applying tension to the sutures.
Inventors: |
VAHID; Saadat; (Atherton,
CA) ; EWERS; Richard C.; (Fullerton, CA) ;
CHEN; Eugene; (Carlsbad, CA) ; BRENNEMAN; Rodney;
(San Juan Capistrano, CA) |
Assignee: |
USGI Medical, Inc.
San Clemente
CA
|
Family ID: |
32871809 |
Appl. No.: |
13/108331 |
Filed: |
May 16, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10612491 |
Jul 1, 2003 |
7942884 |
|
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13108331 |
|
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60433065 |
Dec 11, 2002 |
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Current U.S.
Class: |
606/144 |
Current CPC
Class: |
A61B 17/00234 20130101;
A61B 17/0401 20130101; A61B 2017/0404 20130101; A61B 2017/0458
20130101; A61B 17/3468 20130101; A61B 2017/061 20130101; A61B
2017/0419 20130101; A61B 17/0487 20130101; A61B 17/3478 20130101;
A61B 2017/0496 20130101; A61B 2017/0461 20130101; A61B 17/0644
20130101; A61B 2017/0456 20130101; A61B 2017/0454 20130101; A61B
2017/3445 20130101; A61B 2017/0417 20130101; A61B 2017/3488
20130101; A61B 2017/0464 20130101; A61B 2017/0451 20130101 |
Class at
Publication: |
606/144 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A method comprising: providing a delivery catheter including a
piercing element at a distal end of the catheter, one or more
anchors within the catheter and a suture coupled to the anchors,
with at least one of the anchors comprising a sleeve of braided
material and an eyelet for coupling the anchor to the suture;
advancing the delivery catheter to a target tissue within the body
of a patient; advancing the piercing element through a first tissue
wall, and then through a second tissue wall; ejecting a first
anchor from the piercing element on a first side of the first
tissue wall, and ejecting a second anchor from the piercing element
on a second side of the second tissue wall; and advancing a
fastener over the suture whereby a tension is applied to the
suture, the fastener comprising a collar having a central channel
through which the suture extends; such that the first and second
anchors and the suture hold the first tissue wall adjacent to the
second tissue wall.
2. The method of claim 1, further comprising: providing a
stabilization device at or near a distal end of the delivery
catheter; and engaging the stabilization device to the first tissue
wall before advancing the catheter through the first tissue
wall.
3. The method of claim 2, wherein the stabilization device
comprises a tissue holding element.
4. The method of claim 1, further comprising: providing an imaging
element in the vicinity of the distal end of the delivery catheter;
and using the imaging element to provide visual guidance.
5. A method for creating a tissue fold, comprising: providing a
delivery catheter having a translatable needle and an anchor
disposed within the needle and a suture coupled to the anchor, the
anchor comprising a sleeve of braided material and an eyelet for
coupling the anchor to a suture; engaging and pulling a tissue wall
within the body of a patient to create a tissue fold; extending the
needle through the tissue fold; ejecting the anchor from the
needle; withdrawing the needle from the tissue fold whereby the
suture is extended through the tissue fold; translating a fastener
over the suture; and maintaining the tissue fold via the anchor and
the suture.
6. The method of claim 5, further comprising: providing a second
anchor including a suture coupled thereto; and creating a second
tissue fold on an opposing tissue wall.
7. A method comprising: moving a catheter into a patient; holding a
first portion of tissue within the patient; extending a piercing
element from the catheter through the first portion of tissue;
moving a first anchor out from the piercing element, on a first
side of the first portion of tissue; withdrawing the piercing
element from the first portion of tissue; moving a second anchor
out from the piercing element, on a second side of the first
portion of tissue, with at least one of the first anchor and the
second anchor comprising a sleeve of braided material and an eyelet
for coupling the anchor to a connection element; holding the first
portion of tissue via a connection element connecting the first and
second anchors; and advancing a fastener over said connection
element to apply a tension force on said connection element.
8. A method of creating a tissue fold comprising: moving a catheter
to a surgical site of a patient; engaging and pulling a tissue wall
to form a tissue fold; pushing a piercing element extending out of
the catheter through the tissue fold; ejecting a first anchor from
the piercing element; withdrawing the piercing element from the
tissue fold; ejecting a second anchor from the piercing element,
said second anchor being connected to said first anchor by a
suture, with at least one of the first anchor and the second anchor
comprising a sleeve of braided material and an eyelet for coupling
the anchor to the suture; and advancing a fastener over said suture
to apply a tension force on said suture; with the anchors and the
suture maintaining the tissue fold.
9. The method of claim 8 wherein bringing the first and second
tissue walls adjacent results in reducing the cross sectional area
of an opening in the patient.
10. The method of claim 8 wherein bringing the first and second
tissue walls adjacent results in reducing the volume of an organ of
the patient.
11. The method of claim 8, further comprising: providing an imaging
element in the vicinity of the distal end of the catheter; and
using the imaging element to provide visual guidance during the
step of pushing a piercing element extending out of the catheter
through the tissue fold.
12. The method of claim 8, wherein ejecting a first anchor from the
piercing element comprises translating a push rod disposed in the
piercing element.
13. The method of claim 8, wherein pushing a piercing element
extending out of the catheter through the tissue fold further
comprises translating the piercing element distally through the
catheter.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/612,491, filed on Jul. 1, 2003, which
claims benefit of priority to U.S. Provisional Patent Application
No. 60/433,065 filed Dec. 11, 2002, the content of both of which
are incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to methods and apparatus for
reducing the effective cross-sectional area of a gastro-intestinal
("GI") lumen.
BACKGROUND OF THE INVENTION
[0003] Morbid obesity is a serious medical condition pervasive in
the United States and other countries. Its complications include
hypertension, diabetes, coronary artery disease, stroke, congestive
heart failure, multiple orthopedic problems and pulmonary
insufficiency with markedly decreased life expectancy.
[0004] Several surgical techniques have been developed to treat
morbid obesity, e.g., bypassing an absorptive surface of the small
intestine, or reducing the stomach size. These procedures are
difficult to perform in morbidly obese patients because it is often
difficult to gain access to the digestive organs. In particular,
the layers of fat encountered in morbidly obese patients make
difficult direct exposure of the digestive organs with a wound
retractor, and standard laparoscopic trocars may be of inadequate
length.
[0005] In addition, previously known open surgical procedures may
present numerous life-threatening post-operative complications, and
may cause a typical diarrhea, electrolytic imbalance, unpredictable
weight loss and reflux of nutritious chyme proximal to the site of
the anastamosis. Further, the sutures or staples that are often
used in these surgical procedures may require extensive training by
the clinician to achieve competent use, and may concentrate
significant force over a small surface area of the tissue, thereby
potentially causing the suture or staple to tear through the
tissue.
[0006] In view of the aforementioned limitations, it would be
desirable to provide methods and apparatus for achieving gastric
reduction by reconfiguring the GI lumen of a patient.
[0007] It also would be desirable to provide methods for delivering
anchors for use in a gastric reduction system for reducing the
cross-sectional area of a gastrointestinal lumen.
[0008] It further would be desirable to provide methods for
reducing the cross-sectional area of a gastrointestinal lumen by
approximating opposing tissue walls of the gastrointestinal
lumen.
[0009] It further would be desirable to provide methods and
apparatus for creating gastrointestinal tissue folds to facilitate
tissue approximation within a gastrointestinal lumen.
SUMMARY OF THE INVENTION
[0010] In view of the foregoing, it is an object of the present
invention to provide methods and apparatus for achieving gastric
reduction by approximating tissue to reconfigure the GI lumen of a
patient.
[0011] It is another object of the present invention to provide
methods for delivering anchors for use in a gastric reduction
system for reducing the cross-sectional area of a gastrointestinal
lumen.
[0012] It is an additional object of this invention to provide
methods for reducing the cross-sectional area of a gastrointestinal
lumen by approximating opposing tissue walls of the
gastrointestinal lumen.
[0013] It is a further object of the present invention to provide
methods and apparatus for creating gastrointestinal tissue folds to
facilitate tissue approximation within a gastrointestinal
lumen.
[0014] These and other aspects of the present invention are
accomplished by providing a gastric reduction system including
methods and apparatus for delivering a plurality of anchors on
opposing sides of a gastro-intestinal lumen and then moving the
anchors to approximate the opposing walls of the lumen. In
accordance with the principles of the present invention, the
anchors may have any of a variety of configurations employing
radially expanding sleeves or struts.
[0015] One aspect of the present invention involves a method of
delivering an anchor for use in a gastric reduction system for
reducing the cross-sectional area of a gastrointestinal lumen. A
preliminary step involves providing a delivery catheter including a
needle translatably disposed therein, a stabilization device
attached to a distal end of the delivery catheter and one or more
anchors disposed within the needle. Subsequent steps include
advancing the delivery into the gastrointestinal lumen, attaching
the stabilization device to a tissue wall of the gastrointestinal
lumen, pushing the needle through the tissue wall and ejecting an
anchor from a distal tip of the needle. The method may further
include the steps of providing an endoscope translatably disposed
within the delivery catheter to provide visual guidance during
anchor delivery.
[0016] Another aspect of the present invention involves a method of
reducing the cross-sectional area of a gastrointestinal lumen. A
preliminary step involves providing a delivery catheter including a
needle translatably disposed therein, one or more anchors disposed
within the needle and a suture coupled to each anchor. Subsequent
steps include advancing the delivery catheter into the
gastrointestinal lumen, pushing the needle through the tissue wall,
ejecting an anchor from a distal tip of the needle through the
tissue wall, pushing the needle through an opposing tissue wall,
ejecting an anchor from a distal tip of the needle through the
opposing tissue wall and approximating the tissue walls by applying
tension to the sutures.
[0017] The method may further include the steps of providing a
stabilization device disposed from a distal end of the delivery
catheter and engaging the stabilization device to the tissue wall
before pushing the needle through the tissue wall. According to
some embodiments, the stabilization device comprises a coil that is
screwed into the tissue wall to stabilize the tissue during anchor
delivery. Additionally, the step of approximating the tissue walls
may include the steps of providing a fastener for maintaining
tension in the sutures, threading the sutures through the fastener
and crimping the fastener to maintain the tension in the sutures.
The method may further include the step of cutting unneeded lengths
of the sutures.
[0018] A further aspect of the present invention involves a method
of creating a gastrointestinal tissue fold including the
preliminary step of providing a delivery catheter including a
translatable curved needle, an anchor disposed within the needle
and a suture coupled to the anchor. Subsequent steps involve
pushing the needle through the tissue wall at a first location such
that the needle curves around and punctures the tissue wall at a
second location, ejecting the anchor from the curved needle and
tensioning the suture to create the tissue fold. The method may
also include the steps of providing a second anchor including a
suture coupled thereto, creating a second tissue fold on an
opposing tissue wall and approximating the tissue folds by applying
tension to the sutures.
[0019] An additional aspect of the present invention involves a
method of creating a gastrointestinal tissue fold including the
preliminary step of providing a delivery catheter including a
translatable needle, a jaw assembly, an anchor disposed within the
needle and a suture coupled to the anchor. Subsequent steps involve
grabbing and pulling a tissue wall of the gastrointestinal lumen
using the jaw assembly to create a tissue fold, pushing the needle
through the tissue fold, ejecting the anchor from the needle and
maintaining the tissue fold by applying tension to the suture.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0020] The above and other objects and advantages of the present
invention will be apparent upon consideration of the following
detailed description, taken in conjunction with the accompanying
drawings, in which like reference characters refer to like parts
throughout, and in which:
[0021] FIG. 1 is a schematic view of an illustrative delivery
catheter for use with the gastric reduction methods of the present
invention;
[0022] FIG. 2 is a side-sectional view of the delivery catheter of
FIG. 1, loaded with an anchor of the present invention, penetrating
a GI tissue wall of a patient;
[0023] FIG. 3 is a perspective view of the handle of the catheter
of FIGS. 1 and 2;
[0024] FIGS. 4A and 4B are views of one preferred embodiment of an
anchor of the present invention in the reduced delivery state;
[0025] FIGS. 5A-5C are side views depicting transmural implantation
of the anchor assembly of FIGS. 4A-4B;
[0026] FIG. 6 is a perspective view of a fastener suitable for use
with the anchors of the present invention;
[0027] FIGS. 7A-7E are cross-sectional views depicting methods of
using the gastric reduction system of the present invention;
[0028] FIGS. 8A-8H are cross-sectional views depicting a preferred
method of using the gastric reduction system of the present
invention;
[0029] FIGS. 9A-9C are perspective views of an alternative delivery
catheter featuring a curved needle according to the present
invention;
[0030] FIGS. 10A-10D are cross-sectional views depicting another
method of forming a gastrointestinal fold according to the present
invention;
[0031] FIGS. 11-14 are side-sectional views of alternative methods
of the present invention for approximating gastrointestinal
tissue;
[0032] FIG. 15 is a side-sectional view of teethed suture suitable
for use with the fastener of FIG. 6;
[0033] FIG. 16 is a cross-sectional view of an alternative fastener
of the present invention;
[0034] FIGS. 17A and 17E are, respectively, perspective and
cross-sectional views of further alternative fasteners constructed
in accordance with the principles of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0035] Overview of a Preferred Gastric Reduction System
[0036] Referring to FIGS. 1-7, illustrative components of gastric
reduction apparatus 10 in accordance with the principles of the
present invention are described. As explained in detail
hereinafter, apparatus 10 enables a clinician to treat obesity by
approximating the walls of a gastro-intestinal lumen to narrow the
lumen, thus reducing the area for absorption in the stomach or
intestines. Gastric reduction system 10 comprises anchor delivery
catheter 11, anchor 22, and optionally, suture tensioning assembly
50. The structure and operation of each of these components are
described separately below.
[0037] A. Delivery Catheter
[0038] Referring now to FIGS. 1 and 2, an illustrative embodiment
of delivery catheter 11 constructed in accordance with the
principles of the present invention is described. Delivery catheter
11 comprises elongate torqueable tube 14 having lumen 15 and needle
16 disposed for translation within lumen 15. Torqueable tube 14
preferably is formed of braided stainless steel wire having TEFLON
coating 17. Needle 16 includes lumen 18 and non-coring distal tip
19 that facilitates penetration of tissue wall W. Needle 16
preferably is configured to penetrate tissue wall W so that the
tissue anchor, described below, may employ a substantially
atraumatic distal tip.
[0039] Push rod 21 is disposed for translation within lumen 18, and
is configured to eject anchor 22 (see FIG. 2) out of distal end 23
of the delivery catheter and through tissue wall W. As shown in
FIG. 2, one or more sutures 43 are attached to anchor 22, and
extend through lumen 18 of needle 16 so that the proximal ends of
the sutures 43 extend out of the mouth of the patient.
[0040] To facilitate penetration of needle 16 into tissue wall W,
delivery catheter 11 preferably includes a stabilization device in
the form of coil 24 that may be engaged to tissue wall W to
stabilize distal end 23 of delivery catheter 11 against the tissue
during actuation of needle 16. Coil 24 preferably is attached at
one end to distal end 23 of catheter 11 and terminates at the other
end in sharpened tip 25. According to some embodiments, coil 24 and
needle are coaxial such that coil 24 defines a central passage that
permits needle 16 to be reciprocated therethrough.
[0041] Referring to FIG. 3, an illustrative handle 30 for
controlling operation of delivery catheter 11 is described. Handle
30 comprises proximal portion 31 and distal portion 32. Distal
portion 32 is coupled to elongate tube 14 so that rotation of knob
35 rotates coil 24 to engage wall W of the gastrointestinal tissue,
as illustrated in FIG. 2. Handle 30 further comprises slider
buttons 36 and 37 for imparting translational movement to needle 16
and push rod 21, respectively.
[0042] In operation, after knob 35 has been rotated to engage coil
24 to tissue wall W, slider button 36 is actuated to urge needle 16
distally to pass through coil 24 and penetrate wall W. Once needle
tip 19 has penetrated the tissue wall, slider button 37 is actuated
urge push rod 21 distally, thus ejecting anchor 22 from needle 16
on the distal side of tissue wall W. After the anchor assembly has
been deployed, slider buttons 36 and 37 are retracted in the
proximal direction to retract the needle and push rod back within
elongate tube 14. Knob 35 may then be rotated in the opposite
direction to release its engagement with tissue wall W.
[0043] B. Anchor
[0044] Referring now to FIGS. 4A and 4B, a preferred embodiment of
anchor 22 constructed in accordance with the principles of the
present invention is described. Anchor 22 comprises braided sleeve
40 coupled to proximal bushing 41 and distal bushing 42. One or
more sutures 43 are coupled to distal bushing 42 and extend through
bushing 41. Proximal bushing 41 may slide along the suture(s)
relative to the distal bushing 42, so that braided sleeve expands
radially outward. Accordingly, after anchor 22 is disposed through
a tissue wall (as depicted in FIG. 2), application of tension to
the sutures causes the anchor to transition from an elongate
reduced delivery profile (FIG. 4a) to an expanded, substantially
disk-shaped deployed profile (FIG. 4B).
[0045] Braided sleeve 40 preferably comprises a highly porous,
compliant and high strength material composed of numerous
individual monofilament elements. Suitable materials for the
monofilament elements include polyester, nylon, TEFLON,
polypropylene and combinations thereof. Braided sleeve 40 also may
be formed from a shape memory metal, such as a Nickel-Titanium
alloy. In addition, the porous braid structure may promote an
easily and uniformly absorbable structure for use in applications
in which anchor 22 is not intended for permanent implantation.
Conversely, the porous braid structure may promote tissue growth to
enhance anchoring in applications in which anchor 22 is designed
for permanent implantation.
[0046] Anchor 22 may be made by thermo-forming two ends of a short
length of braided sleeve to form proximal and distal bushings 41
and 42. Alternatively, separate bushings may be glued, over-molded,
soldered or welded onto the ends of a length of braided sleeve.
Suture(s) 43 may be attached to distal bushing 42 at a fixture
point comprising, for example, one or more holes 46 formed in the
distal bushing. Alternatively, the sutures may be attached using an
eyelet, adhesive or other suitable fastener.
[0047] FIGS. 5A-5C depict deployment of anchor 22 from the reduced
delivery profile to the expanded deployed profile. In FIG. 5A,
anchor 22 has been forced through tissue wall W, illustratively the
stomach wall, via needle lumen 18. Once delivery catheter 11 is
withdrawn, anchor 22 is left disposed through tissue wall W with
untensioned sutures 43 extending into the patient's stomach S.
Sutures 43 pass through the esophagus and extend from the patient's
mouth where they may be manipulated by the clinician.
[0048] In FIG. 5B, sutures 43 are shown partially tensioned, so
that proximal bushing 41 engages the distal surface of tissue wall
W. Because the stomach wall comprises a tough, resilient material,
contact between the expanded braided sleeve and distal surface of
the tissue wall causes the braided sleeve to partially expand,
rather than slip back into the stomach via the track left by needle
16. When further tension is applied to sutures 43, distal bushing
42 is approximated toward proximal bushing 41, thereby causing
braided sleeve 40 to expand in the radially to the substantially
disk-shaped profile shown in FIG. 5C.
[0049] Alternatively, anchor 22 may be preformed to self-expand to
disk-shaped profile to automatically upon ejection from lumen 18 of
needle 16. Such a preset shape may be accomplished by coupling the
anchor to a fixture (e.g., a mandrel) and heat setting the braided
sleeve in the disk-shaped profile. For example, the bushings may be
approximated and then retained in close proximity by a fixture, or
the shape may be imposed by compressing the braid in a disk-shaped
mold. The formed anchor and fixture then may be placed into an oven
for a predetermined amount of time, and quenched or slowly cooled
to room temperature.
[0050] C. Suture Tensioning Assembly
[0051] Referring now to FIG. 6, illustrative suture fastener 54
constructed in accordance with the principles of the present
invention is described. Fastener 54 comprises collar 70 having body
71 and channel 72 through which sutures 43 may freely translate
prior to crimping. Once fastener 54 is crimped, sutures 43 are
restrained from further translation through channel 72, thus
retaining a desired amount of tension on sutures 43. Optionally,
body 71 may incorporate lining 74 to enhance friction between body
71 and suture 43, thereby reducing the risk of slippage.
[0052] FIGS. 7A to 7E illustrate the steps of one procedure using
gastric reduction system 10 to treat obesity. In FIG. 7A delivery
catheter 11 of FIGS. 1-3 is inserted through a patient's mouth,
esophagus E and stomach S. FIGS. 7B-7E depict cross-sectional views
of the stomach taken along plane P of FIG. 7A.
[0053] FIG. 7B depicts a step in the which a pair of anchors 22
have been positioned through opposing tissue walls W of the stomach
so that sutures 43 pass from each anchor through esophagus E and
extend out of the patient's mouth. FIG. 7C depicts a step in which
sutures 43 have been threaded through the channel of fastener 54.
At this point, fastener 54 has not been crimped and may be freely
translated along sutures 43 using a push rod. More particularly,
tension is maintained in the sutures while push rod 58 is used to
urge fastener 54 through patient's mouth and esophagus E and into
the stomach.
[0054] FIG. 7D depicts a step in which fastener 54 is moved to a
position approximately midway between anchors 22. Push rod 58 then
is used to hold the fastener in place while additional tension is
applied to the sutures, thereby causing opposing walls W of the
stomach to bow inward toward one another. As depicted in FIG. 7E,
the application of additional tension pulls the opposing tissue
walls into proximity with each other, thereby narrowing the
cross-sectional area of stomach S.
[0055] At this step in the procedure, fastener 54 is crimped to
maintain the tension in sutures 43. The excess length of sutures 43
is cut and removed via the patient's mouth. Advantageously,
narrowing of stomach S limits the amount of food the patient
consumes by providing a feeling of satiety after only a small
amount of food is ingested.
[0056] Alternatively or in addition, sutures 43 may comprise
self-tightening materials that shrink over time, or materials such
as nickel titanium or electroactive polymers that are pre-stretched
so that the subsequent application of heat or electricity causes
the sutures to shorten. By way of example, if pre-stretched nickel
titanium or electroactive polymeric sutures are used, heat from a
radiofrequency device or hot water may be used after the procedure
to induce the sutures to tighten. Tension may be controlled by the
ability of the sutures to tighten to a specific load. Tension also
may be maintained by tying a knot or fusing the sutures to each
other via application of heat.
[0057] Method of Stomach Reduction Using the Gastric Reduction
System
[0058] FIGS. 8A to 8E are cross-sectional views of a patient's
stomach S that illustrate a preferred method of using gastric
reduction system 10. FIG. 8A depicts a step in which guide catheter
60 is advanced through esophagus E and disposed in a proximal
portion of stomach S. Next, endoscope 62 is advanced through the
guide catheter and delivery catheter is positioned within stomach S
under the visual guidance provided by endoscope 62.
[0059] Referring again to FIGS. 1-3, delivery catheter 11 includes
needle 16 translatably disposed within lumen 15, one or more
anchors 22 translatably disposed within needle 16, coil 24 for
stabilizing the distal end 23 of delivery catheter 11 against
tissue wall W during anchor delivery, push rod 21 configured to
eject anchor 22 out of distal end 23 of the delivery catheter and
through tissue wall W, and one or more sutures 43 are attached to
anchor 22.
[0060] FIG. 8B depicts a step in which coil 24 is screwed into
tissue wall W at a first location W1. Coil 24 is used to stabilize
the delivery catheter during anchor delivery. Referring again to
FIG. 2, after coil is screwed into the tissue wall, needle 16 is
translated distally within delivery catheter 11 such that distal
tip 19 travels through tissue wall W. In the next step, push rod 21
is used to eject anchor 22 from distal tip 19 and through tissue
wall W. Then, coil 24 is screwed into tissue wall W at a second
location W2 and the above-described anchor delivery steps are
repeated. Referring to FIG. 8C, after anchor delivery, a suture 43
extends from each anchor 22, through delivery catheter 11, and out
of the mouth of the patient.
[0061] FIG. 8D depicts a step in which sutures 43 have been
threaded through the channel of fastener 54. At this point,
fastener 54 has not been crimped such that sutures 43 may be freely
translated within the fastener channel using push rod 58. Tension
is maintained in the sutures while push rod 58 is used to urge
fastener 54 through esophagus E and into the stomach S.
[0062] FIG. 8E depicts a step in which fastener 54 is moved to a
position approximately midway between anchors 22. Push rod 58 then
is used to hold the fastener in place while additional tension is
applied to the sutures, thereby causing opposing walls W of the
stomach to bow inward toward one another. FIG. 8F depicts a step in
which the application of additional tension to sutures 43 pulls the
opposing tissue walls into proximity with each other, thereby
narrowing the cross-sectional area of stomach S.
[0063] FIG. 8G depicts a step in which a pliers assembly 66 is used
to crimp fastener 54 and thereby retain sutures 43 under tension.
Pliers assembly 66 comprises arms 68 arranged to articulate about
pivot point 70. Pliers assembly 66 is used to grip and crimp
fastener 54 by manipulating an actuator disposed generally at the
proximal end of catheter 11. After crimping fastener 54, pliers
assembly 66 is retracted and scissor assembly 72 is advanced
through catheter 11.
[0064] FIG. 8H depicts a step in which scissors assembly 72 is used
to cut unneeded lengths of sutures 43 after fastener 54 has been
crimped. Scissors assembly 72 comprises blades 74 arranged to
articulate about pivot point 76. Scissor assembly 72 is manipulated
into cutting position and used to cut the sutures using an actuator
disposed generally at the proximal end of catheter 11. Once sutures
43 have been cut, the excess length of sutures 43 is removed
through the patient's mouth and scissor assembly 72 is retracted
through delivery catheter 11. Advantageously, narrowing of stomach
S limits the amount of food the patient consumes by providing a
feeling of satiety after only a small amount of food is
ingested.
[0065] Referring to FIGS. 9A-9C, a method of creating a
gastrointestinal tissue fold will now be described. The initial
step involves providing delivery catheter 11 comprising coil screw
24 and a translatable curved needle 80. In addition, endoscope 82
may be provided to visualize the site and aid in anchor delivery.
Referring to FIG. 9A, once coil screw 24 has been screwed into
tissue wall W, curved needle 80 is deployed through coil screw 24
such that needle 80 penetrates tissue wall W at first location W1.
As needle 80 is deployed from the distal tip of catheter 11, it
curves outwardly such that full deployment results in the needle
curving around and penetrating tissue wall W at second location W2.
In other words, initial deployment of needle 80 through coil screw
24 causes the needle to penetrate tissue wall (at W1) such that
distal tip 84 of the needle moves from first side S1 of the tissue
wall to second side S1 of the tissue wall.
[0066] Further deployment of needle 80 through coil screw 24 causes
the needle to penetrate the tissue wall for a second time (at W2)
such that distal tip 152 moves from the second side of the tissue
wall back to the first side of the tissue wall. Referring to FIG.
9B, anchor assembly 22 is ejected through the needle after distal
tip 84 penetrates the tissue wall for the second time. After
ejecting anchor assembly 22, the needle is retracted. Referring to
FIG. 9C, tensioning of the suture 43 produces fold F in tissue wall
W between first location W1 and second location W2.
[0067] Referring now to FIGS. 10A-10D, an alternative method of
creating a gastrointestinal tissue fold will now be described. The
initial step involves providing a delivery catheter 11 comprising
translatable needle 16 and deployable jaw assembly 90. Delivery
catheter 11 also may include an endoscope to visualize the site and
aid in anchor delivery.
[0068] Jaw assembly 90 comprises pair of jaws 92 arranged to rotate
about pivot point 94. FIG. 10A depicts a step in which jaw assembly
90 is deployed and articulated into a position adjacent tissue wall
W using an actuator disposed generally at the proximal end of
delivery catheter 11. FIG. 10B depicts a step in which jaw assembly
90 is used to grab and pull tissue wall W to create fold F. The
creation of fold F facilitates the penetration of tissue wall W by
needle 16 and subsequent delivery of anchor assembly 22.
[0069] FIG. 10C depicts a step in which needle 16 is deployed and
articulated such that the needle tip penetrates through fold F
created using jaw assembly 90. After the needle tip passes through
fold F, anchor assembly 22 is ejected. FIG. 10D depicts a step in
which jaw assembly 90 and needle 16 are retracted into delivery
catheter 11. Suture 43 extends from anchor 22 through tissue fold F
and into delivery catheter 11; the tissue fold is maintained by
applying tension to suture 43. The foregoing steps to create a
gastrointestinal tissue fold may be repeated to create additional
tissue folds. These tissue folds may be approximated by applying
tension to the sutures and then tying the sutures together or,
alternatively, using a fastener 54 such as described with respect
to FIG. 6.
[0070] The anchors of the present invention may be ejected through
a tissue wall or a tissue fold. By applying tension to the sutures,
the tissue walls or tissue folds engaging the anchors are pulled
into proximity with each other.
[0071] FIGS. 11-14 depict various methods of approximating
gastrointestinal tissue walls w and/or tissue folds F. More
particularly, FIG. 11 depicts the approximation of a pair of tissue
walls W. After anchors 22 have been delivered (e.g., as disclosed
with respect to FIGS. 1-3) and walls W are approximated and
fastener 43 then is crimped to hold the walls in the approximated
position. FIG. 12 depicts the approximation of a pair of folds F1,
F2 that are disposed on opposing tissue walls. After anchors 22
have been delivered (e.g., as disclosed with respect to FIG. 9A-9C
or 10A-10D) and folds F1, F2 are approximated, fastener 43 is
crimped to hold the folds in the approximated position.
[0072] FIG. 13 depicts the approximation of a pair of folds F1, F2
that are disposed adjacent to each other on tissue wall. Anchors 22
again may be delivered as disclosed with respect to FIG. 9A-9C or
10A-10D. However, the approximation of adjacent folds F1, F2
creates a third fold F3 disposed generally between folds F1, F2 and
oriented in a substantially opposite direction. The combination of
folds F1, F2, F3 form a W-shape, as depicted in FIG. 13. After
approximation, fastener 43 is crimped to hold the folds in the
approximated position. FIG. 14 depicts the approximation of fold F
and tissue wall W. Anchor 22a can be delivered as disclosed with
respect to FIGS. 1-3 and anchor 22b may be delivered as disclosed
with respect to FIG. 9A-9C or 10A-10D. After anchor delivery, fold
F and tissue wall W are approximated and fastener 54 is crimped to
hold the fold and tissue wall in the approximated position.
[0073] Referring to FIG. 15, teethed suture 100 configured for use
with fastener 54 (as described with respect to FIG. 6) will now be
described. As depicted in FIG. 15, a pair of anchors 22 including
teethed sutures 100 have been delivered through opposing tissue
walls W of a gastrointestinal lumen. Each teethed suture 100
comprises a polymeric or metal strand having teeth 102 partially
disposed along the length of teethed suture 100. Teethed sutures
100 are configured to be inserted simultaneously through fastener
channel 72 in a first direction such that they may not be pulled
back through channel 72 in the opposite direction. Accordingly,
teethed sutures 100 may be inserted through the channel, but teeth
102 do not allow the teethed sutures to be pulled back through
channel 72 because the teeth engage the fastener lip along the
outer periphery of channel 72.
[0074] FIG. 15 depicts adjustable clip 110 suitable for use as a
suture fastener in lieu of fastener 54 (as described with respect
to FIG. 6). Adjustable clip 110 comprises housing 112 and
engagement piece 114 translatably disposed within housing 112.
Housing 112 has bore 116, which is disposed orthogonal to the
direction of translation of engagement piece 114, and has a
cross-sectional area that accommodates unrestricted movement of
sutures 43 therebetween. Engagement piece 114 has bore 118 disposed
substantially parallel to bore 116 with a cross-sectional area that
also accommodates unrestricted movement of sutures 43
therebetween.
[0075] Adjustable clip 110 further comprises spring 120 disposed
between housing 112 and engagement piece 114 to bias engagement
piece 114 so that the bores 116, 118 are misaligned absent an
external force that counters the force of spring 120. When the
bores 116, 118 are misaligned, sutures 43 are constrained from
freely translating therebetween. However, when an external force is
applied to counter the biasing force of spring 120, engagement
piece 114 translates within housing 112 until engagement piece 144
contacts ledge 122. At this point, bores 116, 118 are aligned such
that sutures 43 may freely translate therebetween, thus permitting
the suture tension to be adjusted. Advantageously, this permits the
overall reduction in the cross-section area of the gastrointestinal
lumen to be readily adjusted.
[0076] FIG. 17A depicts alternative fastener 130 that may be used
to maintain the tension in one or more sutures 43 after tissue
approximation. Fastener 130 includes housing 131 and channel 132
within which suture 43 may pass freely. One end of channel 132
includes sharpened edge or blade 134 which may be positioned at
least partially around the perimeter of channel 132 such that
crimping fastener 130 causes blade 134 to extend into channel 132
and sever sutures 43 that extend beyond blade 134.
[0077] Although fastener 130 may be configured to allow sutures 43
to pass freely therebetween, fastener 130 is preferably designed to
permit unidirectional travel of sutures 43 through the fastener.
This allows sutures 43 to be tightened through the anchors but
prevents sutures 43 from slipping back and releasing the tension
within the anchors. FIGS. 17B-17E show various alternative designs
which allow for unidirectional tensioning of sutures 43. More
particularly, FIG. 17B shows a cross-sectional side view of one
variation of fastener 130 in which tension is maintained within
sutures 43 via ratchet 138. As fastener 130 is passed over sutures
43 through channel 132, ratchet 138 allows sutures 43 to pass
freely yet remains in contact due to the biasing force of spring
element 140. However, when sutures 43 slip in the opposite
direction, ratchet 138 rotates about pivot 142 and is stopped by
stop 144. The edge of ratchet 138 engages sutures 43 to stop
movement of sutures 43 in the reverse direction. After sutures 43
have been tightened, fastener 130 may be crimped so that blade 134
is urged against sutures 43 and severs them from the deployed
anchors.
[0078] FIG. 17C depicts another alternative fastener 130, wherein
ratchet 138 is formed integrally with fastener 130 and coarse
suture 43a is employed to present a roughened surface for ratchet
138. As suture 43a is passed through the fastener channel, the
angle of ratchet 138 allows for the unidirectional travel of suture
43a from right to left. If pulled in the opposite direction,
ratchet 138 engages the roughened surface and prevents movement of
suture 43a in the reverse direction. After suture 43a has been
desirably tensioned, fastener 130 may be crimped to sever suture
43a with blade 134.
[0079] FIG. 17D depicts a further alternative fastener 130, wherein
ratchet 138 is rotatable about pivot 142 while remaining in contact
with suture 43 due to the biasing force of spring element 140. The
rotation of ratchet 138 is limited by stop 144, which enables
ratchet 138 to press suture 43 against housing 131, thereby
stopping the movement of fastener 130 relative to suture 43. FIG.
17E depicts yet another alternative fastener 130 that utilizes
roughened or beaded suture 43b. Suture 43b preferably defines a
plurality of beads or knots 150 periodically along its length.
Ratchet 138 is configured such that it may open in one direction,
thereby allowing the passage of suture 43b, yet movement of suture
43b in the opposite direction forces ratchet 152 to close due to
biasing spring element 154. Ratchet 152 is preferably configured
such that suture 43b may pass through in the reverse direction, but
because of beads or knots 150, further slippage of suture 43b is
prevented.
[0080] Although preferred illustrative embodiments of the present
invention are described above, it will be evident to one skilled in
the art that various changes and modifications may be made without
departing from the invention. It is intended in the appended claims
to cover all such changes and modifications that fall within the
true spirit and scope of the invention.
* * * * *