U.S. patent application number 13/108270 was filed with the patent office on 2011-09-01 for delivery systems and methods for gastric reduction.
This patent application is currently assigned to USGI MEDICAL, INC.. Invention is credited to Eugene CHEN, Richard C. EWERS, Vahid SAADAT.
Application Number | 20110213385 13/108270 |
Document ID | / |
Family ID | 34115684 |
Filed Date | 2011-09-01 |
United States Patent
Application |
20110213385 |
Kind Code |
A1 |
EWERS; Richard C. ; et
al. |
September 1, 2011 |
DELIVERY SYSTEMS AND METHODS FOR GASTRIC REDUCTION
Abstract
A delivery catheter for a gastric reduction system includes an
elongate torqueable tube, a needle translatably disposed within the
torqueable tube, an anchor translatably disposed within the needle
and a stabilization device for holding a distal tip of the
torqueable tube against a tissue wall.
Inventors: |
EWERS; Richard C.;
(Fullerton, CA) ; SAADAT; Vahid; (Atherton,
CA) ; CHEN; Eugene; (Carlsbad, CA) |
Assignee: |
USGI MEDICAL, INC.
San Clemente
CA
|
Family ID: |
34115684 |
Appl. No.: |
13/108270 |
Filed: |
May 16, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10612109 |
Jul 1, 2003 |
7942898 |
|
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13108270 |
|
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60433065 |
Dec 11, 2002 |
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Current U.S.
Class: |
606/145 ;
606/139 |
Current CPC
Class: |
A61B 17/00234 20130101;
A61B 17/0487 20130101; A61B 2017/0458 20130101; A61B 2017/061
20130101; A61B 2017/0419 20130101; A61B 17/3478 20130101; A61B
17/3468 20130101; A61B 2017/0496 20130101; A61B 17/0401 20130101;
A61B 2017/3488 20130101; A61B 17/0644 20130101; A61B 2017/0464
20130101; A61B 2017/0404 20130101; A61B 2017/0417 20130101 |
Class at
Publication: |
606/145 ;
606/139 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A delivery catheter comprising: an elongate torqueable tube
having a back end and a front end; a needle translatably disposed
within the tube, with the needle having a penetrating tip; at least
one anchor translatably disposed within the needle, and moveable
out of the penetrating tip of the needle; and a coil on a front end
of a shaft that is translatably disposed within a lumen in said
tube, said coil being extendible out of the front end of the
tube.
2. The delivery catheter of claim 1, wherein the tube is formed of
a braided wire.
3. The delivery catheter of claim 1, wherein the tube contains a
plurality of slots disposed substantially perpendicular to a
longitudinal axis of the tube.
4. The delivery catheter of claim 3, wherein the slots are formed
in a sinusoidal pattern.
5. The delivery catheter of claim 3, wherein the slot density is
increased near a distal end of the tube.
6. The delivery catheter of claim 1, wherein the coil includes a
sharpened distal tip to facilitate tissue penetration.
7. The delivery catheter of claim 1, wherein the coil comprises a
plurality of coils that form a central opening for the passage of
the needle.
8. The delivery catheter of claim 1, wherein the coil and needle
are substantially coaxial.
9. The delivery catheter of claim 1, further comprising a push rod
translatably disposed within the needle and adapted to push the
anchor out of a distal end of the needle.
10. A catheter comprising: a tube having a front end and a back
end; a needle within the tube and having a tip extendible out of
the front end of the tube; at least one anchor positioned within
the needle and moveable out of the needle during a surgical
procedure; a suture connected to one or more of the anchors, and
with the suture extending within the needle towards the back end of
the needle; and a coil on a front end of a shaft that is
translatably disposed within a lumen in said tube, said coil being
extendible out of the front end of the tube.
11. The catheter of claim 10 wherein the tube is torqueable and is
formed of braided wire.
12. The catheter of claim 10 wherein the tube contains a plurality
of slots extending substantially perpendicular to a longitudinal
axis of the tube, to increase the flexibility of the tube.
13. The catheter of claim 10, wherein said coil has a sharp
tip.
14. The catheter of claim 13 with the needle having a penetrating
tip adjacent to the front end of the tube.
15. The catheter of claim 13 with the needle positioned to extend
out of the front end of the tube and through the coil.
16. The catheter of claim 10 further comprising a push rod
longitudinally moveable within the needle for pushing one or more
anchors out of the tip of the needle.
17. A catheter comprising: a torqueable tube having a front end and
a back end; a handle attached adjacent to the back end of the tube;
a hollow needle within the tube and having a piercing tip
extendible out of the front end of the tube; one or more anchors
within the needle, with the anchor moveable out of the piercing tip
of the needle; an anchor ejector within the needle; a suture
connected to the anchor and leading out towards the handle; a
needle control on the handle linked to the needle, for moving the
needle within the tube; an anchor ejector control on the handle
linked to the anchor ejector; and a coil on a front end of a shaft
that is translatably disposed within a lumen in said tube, said
coil being extendible out of the front end of the tube.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/612,109, filed on Jul. 1, 2003 which claims
benefit of priority to U.S. Provisional Patent Application No.
60/433,065 filed Dec. 11, 2002, 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 postoperative 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 and apparatus
for gastric reduction including various end effectors that
facilitate gastric reduction.
[0008] It further would be desirable to provide methods and
apparatus for gastric reduction using a delivery catheter having an
obturator that facilitates delivery of biocompatible anchors.
[0009] It further would be desirable to provide methods and
apparatus for gastric reduction using a delivery catheter having an
ejection needle capable of housing and placing a plurality of
anchors sequentially.
SUMMARY OF THE INVENTION
[0010] In view of the foregoing, it is an object of the present
invention to provide methods and apparatus for gastric reduction
having various end effectors that facilitate gastric reduction.
[0011] It is another object of the present invention to provide
methods and apparatus for gastric reduction using anchors that can
be reconfigured from a reduced delivery profile to an expanded
deployed profile.
[0012] It is an additional object of this invention to provide
methods and apparatus for gastric reduction using a delivery
catheter having an obturator that facilitates delivery of
biocompatible anchors.
[0013] It is a further object of the present invention to provide
methods and apparatus for gastric reduction using a delivery
catheter having an ejection needle capable of housing and placing a
plurality of anchors sequentially.
[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.
[0015] One aspect of the present invention involves using a
delivery catheter to narrow a cross-sectional area of a
gastro-intestinal lumen. The delivery catheter comprises an
elongate torqueable tube, a needle translatably disposed within the
torqueable tube and an anchor translatably disposed within the
needle. The delivery catheter may include a stabilization device
such as a coil screw to facilitate anchor delivery. According to
some embodiments, the coil screw is fixedly attached to a distal
end of the torqueable tube and the individual coils form a central
opening for the passage of the needle. In another embodiment, the
coil screw is translatably disposed within a delivery catheter
lumen.
[0016] In a further embodiment, the stabilization device comprises
a shaft coupled to a plurality of resilient fingers and disposed
within a delivery catheter lumen. The resilient fingers are adapted
to automatically expand into a deployed configuration upon exiting
the delivery catheter. Alternatively, the stabilization device
comprises a plurality of resilient wires disposed within lumens
spaced apart around the periphery of the torqueable tube. The
resilient wires preferably are curved such that they extend
radially outward from the distal tip of the torqueable tube when in
a deployed configuration.
[0017] In still further embodiments, the needle is curved such that
initial deployment of the needle through the coil screw causes the
needle to penetrate the tissue wall such that a distal tip of the
needle moves from a first side of the tissue wall to a second side
of the tissue wall. Further deployment of the needle through the
coil screw causes the needle to penetrate the tissue wall for a
second time such that the distal tip of the needle moves from the
second side of the tissue wall back to the first side of the tissue
wall. The anchor then is ejected through the needle after the
distal tip of the needle penetrates the tissue wall for the second
time.
[0018] According to another aspect of the present invention, the
delivery catheter includes an obturator comprising an elongate
shaft translatably disposed within the torqueable tube.
Advantageously, a plurality of anchors may be disposed about the
shaft of the obturator. The obturator includes a sharpened distal
tip adapted to be extended beyond the distal end of the torqueable
tube to facilitate the penetration of tissue wall. Alternatively,
the obturator may have a blunt, spring-loaded tip extending
distally from a sharpened distal tip so that the blunt,
spring-loaded tip extends beyond the sharpened distal tip after the
tip penetrates within a cavity.
[0019] According to a further aspect of the present invention, the
delivery catheter comprises an ejection needle having an actuator
cable, a first lumen housing a plurality of anchors, a second lumen
and a spring-loaded shifting element for shifting the anchors from
the first lumen to the second lumen. Pulling the actuator cable in
a proximal direction causes an anchor to be shifted from the first
lumen to the second lumen. The delivery catheter further comprises
a push rod for ejecting the anchor from the ejection lumen.
BRIEF DESCRIPTION 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] FIG. 8 is a side view of a delivery catheter having a
slotted torqueable tube constructed in accordance with the present
invention;
[0029] FIGS. 9A-9D are side views of an obturator suitable for use
with a delivery catheter of the present invention;
[0030] FIG. 10 is a sectional view of an alternative obturator
suitable for use with a delivery catheter of the present
invention;
[0031] FIGS. 11A and 11B are cross-sectional views of an ejection
needle suitable for use with a delivery catheter of the present
invention;
[0032] FIG. 12 is a cross-sectional view depicting the use of a
pliers assembly to crimp a fastener of the present invention;
[0033] FIG. 13 is a cross-sectional view depicting the use of a
scissors assembly to cut sutures of the present invention;
[0034] FIGS. 14A and 14B are cross-sectional views depicting the
use of a jaw assembly to create a tissue fold in accordance with
the principles of the present invention;
[0035] FIGS. 15A and 15B are perspective and sectional views,
respectively, of alternative delivery catheters of the present
invention;
[0036] FIG. 16 is a sectional view of an alternative stabilizing
device of the present invention;
[0037] FIGS. 17A and 17B are perspective views of an alternative
stabilizing device of the present invention;
[0038] FIGS. 18A-18C are perspective views of an alternative
delivery catheter featuring a curved needle according to the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0039] Overview of a Preferred Gastric Reduction System
[0040] 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 suture tensioning assembly 50. The
structure and operation of each of these components are described
separately below.
[0041] A. Delivery Catheter
[0042] 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.
[0043] 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. Referring to
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.
[0044] 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.
[0045] 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 gastro-intestinal
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.
[0046] 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.
[0047] B. Anchor
[0048] 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).
[0049] 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.
[0050] 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.
[0051] 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.
[0052] 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.
[0053] 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.
[0054] C. Suture Tensioning Assembly
[0055] 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.
[0056] 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.
[0057] 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.
[0058] 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.
[0059] 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.
[0060] 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.
[0061] Alternative Delivery Catheter Embodiments Suitable for Use
with the Gastric Reduction System
[0062] As described above with respect to FIG. 1, the preferred
delivery catheter 11 includes torqueable tube 14 formed of braided
stainless steel wire. Referring now to FIG. 8, alternative delivery
catheter 75 instead comprises torqueable tube 76 having a plurality
of through-wall slots 77 formed therein to enhance flexibility of
the tube, yet maintain torqueability. Other components of the
delivery catheter, including needle 16 and push rod 21, may be
configured as described hereinabove for the embodiment of FIG.
1.
[0063] Preferably, torqueable tube 76 is made from stainless steel
with a laser-cut slot pattern. The slot pattern may be a sinusoidal
repeating pattern of slots perpendicular to the longitudinal axis
of torqueable tube 76. Alternatively, the slot density may be
increased near the distal end of torqueable tube to provide a
flexible distal tip capable of retroflexing, yet maintain a high
degree of torqueability.
[0064] Referring to FIGS. 9A-9D, the anchors of the present
invention may be delivered using obturator 90 translatably disposed
within a lumen of delivery catheter 91. In FIG. 9A, obturator 90
preferably includes elongated shaft 92 having sharpened distal tip
93 to facilitate tissue penetration. In FIG. 9B, anchor 22 is shown
disposed in the reduced delivery profile around obturator shaft 92,
with suture 95 attached to the anchor at fixture point 96.
Obturator 90 is disposed to reciprocate within the delivery
catheter, so that the sharpened distal tip may be extended past the
distal tip 94. Because obturator 90 has sharpened distal tip 93,
the anchor need not include a sharpened end suitable for
penetration.
[0065] With respect to FIG. 9B, to penetrate tissue wall W,
obturator 90 is extended from delivery catheter 91 and until the
distal tip of the obturator passes through the tissue wall along
with anchor 22. Once the obturator and anchor have passed through
tissue wall W, the obturator is retracted (FIG. 9D). At this point,
anchor 22 either self-expands to the expanded deployed profile or
is induced to expand by applying tension to suture 95. Contact
between the expanded anchor and the tissue wall prevents the anchor
from being retracted along with the obturator. Tension applied to
suture 95 to approximate tissue further reinforces the expanded
profile by pulling the bushings together.
[0066] Although obturator 90 of FIG. 9 accepts only a single
anchor, it will be apparent to one of skill in the art of
instrument design that obturator 90 may be configured to accept a
plurality of anchors without departing from the scope of the
present invention. A push rod (such as push rod 21 of FIG. 1)
translatably disposed within delivery catheter 91, and adjacent to
the obturator shaft may be used to advance the anchors along the
shaft.
[0067] Referring now to FIG. 10 and in accordance with an
alternative embodiment, obturator 90 includes blunt, spring-loaded
distal tip 100. When the obturator is pushed against a tissue wall,
blunt tip 100 is depressed within longitudinally disposed cavity
101 containing compression spring 102. Depressing the blunt distal
tip also exposes the tissue to sharpened obturator tip 104, which
punctures the tissue wall. Once the sharpened tip 104 penetrates
the tissue wall, compression spring 102 ejects the blunt tip 100
from cavity 101, thereby shielding surrounding tissue from
sharpened tip 104.
[0068] With respect to FIGS. 11A and 11B, an alternative embodiment
of an ejection needle suitable for use with the delivery catheter
of FIG. 1 and configured to house and deliver a plurality of
anchors 22 is described. Ejection needle 108 comprises non-coring
distal tip 109, ejection lumen 110 through which push rod 111 is
slidably disposed, anchor lumen 114 for storing anchors 22, first
compression spring 115 disposed proximally with respect to anchor
lumen 114 and spring-loaded shifting element 116 for shifting
individual anchors from the anchor lumen to the ejection lumen.
Shifting element 116 is coupled to second compression spring 117
that biases the shifting element toward the ejection lumen. In
addition, actuator cable 118 extends from the shifting element to a
trigger located at the proximal end of catheter 108.
[0069] When the trigger is actuated, the actuator cable is pulled
proximally. This caused shifting element 116 to overcome the force
exerted by compression spring 117 and move away from ejection lumen
110. Retraction of shifting element 116 against compression spring
117 permits anchor 22a to slide distally out of lumen 114 (under
the urging of compression spring 115), so that anchor 22a is
disposed substantially directly beneath shifting element 116 in the
path of push rod 111 (FIG. 11A). When the trigger is released,
compression spring 117 forces the shifting element 116 and anchor
22a toward ejection lumen 110. Once the anchor is pushed into
ejection lumen 110, push rod 111 is used to eject anchor 22a from
distal tip 109.
[0070] With respect to FIGS. 12-14, various end effectors suitable
for use with the delivery catheter of FIG. 1 are described.
Referring again to FIGS. 7A-7E, after sutures 43 have been threaded
through fastener 54 and push rod 58 has been used to approximate
the tissue walls, fastener 54 is crimped to hold the approximated
tissue walls in place. Sutures 43 then are cut.
[0071] FIG. 12 illustrates pliers assembly 120, comprising arms 121
arranged to articulate about pivot point 122, which may be used to
crimp fastener 54 and thereby retain sutures 43. Pliers assembly
120 is used to grip and crimp fastener 54 by manipulating an
actuator disposed generally at the proximal end of catheter 11.
After pliers assembly 120 is used to crimp fastener 54, it is
retracted and scissor assembly 125 is advanced through catheter
11.
[0072] FIG. 13 depicts the use of scissors assembly 125, comprising
blades 126 arranged to articulate about pivot point 127, to cut
unneeded lengths of sutures 43 after fastener 54 has been crimped.
Scissor assembly 125 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, scissor
assembly 125 is retracted through delivery catheter 11.
[0073] Referring now to FIGS. 14A and 14B, jaw assembly 130 is
described for use in creating a tissue fold or to grab and hold
tissue wall W during anchor delivery. Jaw assembly 130 comprises
pair of jaws 131 arranged to rotate about pivot point 132. FIG. 14A
illustrates that jaw assembly 130 may be articulated into position
adjacent a tissue wall using an actuator disposed generally at the
proximal end of delivery catheter 11. In FIG. 14B, jaw assembly 130
is depicted grabbing tissue wall W to create fold F in the tissue
wall. Advantageously, creation of fold F facilitates the
penetration of tissue wall by needle 16 and subsequent delivery of
anchor assembly 22 to the opposing side of the tissue wall.
[0074] Referring to FIG. 15A, delivery catheter 11 of FIG. 1 may be
configured so that needle 16 exits a lumen offset from coil screw
24. In operation, coil screw 24 is threaded into the tissue wall
and retains the delivery catheter in engagement with the tissue
wall while needle 16 is pushed through the tissue wall. Delivery
catheter 11 may further comprise additional lumen 135 dimensioned
for the passage of an endoscope, per se known in the art.
Alternatively, coil screw 24 may be translatably disposed within
lumen 135 (FIG. 15B), rather than mounted to a distal end of the
delivery catheter.
[0075] With respect to FIGS. 16 and 17 additional alternative
embodiments of stabilization devices 138 suitable for use with the
delivery catheter of the present invention are described.
Stabilization device 138 of FIG. 16 comprises shaft 140 disposed
within lumen 135 and includes resilient fingers 142 attached
thereto. When shaft 140 is moved distally, fingers 142 exit lumen
135 and self-expand to a deployed configuration. Fingers 142 then
may be manipulated to create a tissue fold by grasping and pulling
a tissue wall using an actuator disposed generally at the proximal
end of the delivery catheter.
[0076] Stabilization device 138 of FIGS. 17A and 17B comprises a
plurality of resilient curved wires 144 disposed within lumens 145
and spaced apart around the periphery of lumen 135. Curved wires
144 are connected to an actuator located generally at the proximal
end of the delivery catheter. Actuation of the actuator causes
curved wires 144 to be either extended from or retracted into
lumens 145.
[0077] Illustratively, curved wires 144 of FIG. 17 extend radially
outward when extended from lumens 145. Alternatively, curved wires
144 could extend radially inward at an oblique angle, so as to
assume a partial corkscrew shape. During use, stabilization device
138 (including curved wires 144) is brought into contact with a
tissue wall. Then, the wires are extended until they pierce and
stabilize the tissue wall for anchor delivery.
[0078] (start here) With respect to FIGS. 18A-18C, another
alternative embodiment of a delivery catheter constructed in
accordance with the principles of the present invention is
described. Delivery catheter 11 of FIG. 18 comprises coil screw 24
and curved needle 150. In addition, endoscope 151 may be provided
to visualize the site and aid in anchor delivery. Referring to FIG.
18A, once coil screw 24 has been screwed into tissue wall W, curved
needle 150 is deployed through coil screw 24 such that needle 150
penetrates tissue wall W at first location W1. As the needle 150 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 curved needle 150 through the coil screw
causes the needle to penetrate the tissue wall (at W1) such that
distal tip 152 of the needle moves from first side S1 of the tissue
wall to second side S1 of the tissue wall.
[0079] Further deployment of needle 150 through the coil screw
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. 18B, anchor assembly 22 is ejected through the needle after
distal tip 152 penetrates the tissue wall for the second time.
After ejecting anchor assembly 22, the needle is retracted.
Referring to FIG. 18C, tensioning of the suture 43 produces fold F
in tissue wall W between first location W1 and second location
W2.
[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.
* * * * *