US20110213385A1 - Delivery systems and methods for gastric reduction - Google Patents
Delivery systems and methods for gastric reduction Download PDFInfo
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- US20110213385A1 US20110213385A1 US13/108,270 US201113108270A US2011213385A1 US 20110213385 A1 US20110213385 A1 US 20110213385A1 US 201113108270 A US201113108270 A US 201113108270A US 2011213385 A1 US2011213385 A1 US 2011213385A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3478—Endoscopic needles, e.g. for infusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0404—Buttons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0417—T-fasteners
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0419—H-fasteners
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
- A61B2017/0458—Longitudinal through hole, e.g. suture blocked by a distal suture knot
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06066—Needles, e.g. needle tip configurations
- A61B2017/061—Needles, e.g. needle tip configurations hollow or tubular
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
- A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
- A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
- A61B2017/3488—Fixation to inner organ or inner body tissue
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.
Description
- 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.
- The present invention relates to methods and apparatus for reducing the effective cross-sectional area of a gastro-intestinal (“GI”) lumen.
- 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.
- 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.
- 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.
- 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.
- It also would be desirable to provide methods and apparatus for gastric reduction including various end effectors that facilitate gastric reduction.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
-
FIG. 1 is a schematic view of an illustrative delivery catheter for use with the gastric reduction methods of the present invention; -
FIG. 2 is a side-sectional view of the delivery catheter ofFIG. 1 , loaded with an anchor of the present invention, penetrating a GI tissue wall of a patient; -
FIG. 3 is a perspective view of the handle of the catheter ofFIGS. 1 and 2 ; -
FIGS. 4A and 4B are views of one preferred embodiment of an anchor of the present invention in the reduced delivery state; -
FIGS. 5A-5C are side views depicting transmural implantation of the anchor assembly ofFIGS. 4A-4B ; -
FIG. 6 is a perspective view of a fastener suitable for use with the anchors of the present invention; -
FIGS. 7A-7E are cross-sectional views depicting methods of using the gastric reduction system of the present invention; -
FIG. 8 is a side view of a delivery catheter having a slotted torqueable tube constructed in accordance with the present invention; -
FIGS. 9A-9D are side views of an obturator suitable for use with a delivery catheter of the present invention; -
FIG. 10 is a sectional view of an alternative obturator suitable for use with a delivery catheter of the present invention; -
FIGS. 11A and 11B are cross-sectional views of an ejection needle suitable for use with a delivery catheter of the present invention; -
FIG. 12 is a cross-sectional view depicting the use of a pliers assembly to crimp a fastener of the present invention; -
FIG. 13 is a cross-sectional view depicting the use of a scissors assembly to cut sutures of the present invention; -
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; -
FIGS. 15A and 15B are perspective and sectional views, respectively, of alternative delivery catheters of the present invention; -
FIG. 16 is a sectional view of an alternative stabilizing device of the present invention; -
FIGS. 17A and 17B are perspective views of an alternative stabilizing device of the present invention; -
FIGS. 18A-18C are perspective views of an alternative delivery catheter featuring a curved needle according to the present invention. - Overview of a Preferred Gastric Reduction System
- 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 comprisesanchor delivery catheter 11,anchor 22, and suture tensioning assembly 50. The structure and operation of each of these components are described separately below. - A. Delivery Catheter
- Referring now to
FIGS. 1 and 2 , an illustrative embodiment ofdelivery catheter 11 constructed in accordance with the principles of the present invention is described.Delivery catheter 11 compriseselongate torqueable tube 14 havinglumen 15 andneedle 16 disposed for translation withinlumen 15.Torqueable tube 14 preferably is formed of braided stainless steel wire havingTEFLON coating 17.Needle 16 includeslumen 18 and non-coringdistal tip 19 that facilitates penetration of tissuewall 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. - Push
rod 21 is disposed for translation withinlumen 18, and is configured to eject anchor 22 (seeFIG. 2 ) out ofdistal end 23 of the delivery catheter and through tissue wall W. Referring toFIG. 2 , one ormore sutures 43 are attached to anchor 22, and extend throughlumen 18 ofneedle 16 so that the proximal ends of thesutures 43 extend out of the mouth of the patient. - To facilitate penetration of
needle 16 into tissue wall W,delivery catheter 11 preferably includes a stabilization device in the form ofcoil 24 that may be engaged to tissue wall W to stabilizedistal end 23 ofdelivery catheter 11 against the tissue during actuation ofneedle 16.Coil 24 preferably is attached at one end todistal end 23 ofcatheter 11 and terminates at the other end in sharpenedtip 25. According to some embodiments,coil 24 and needle are coaxial such thatcoil 24 defines a central passage that permitsneedle 16 to be reciprocated therethrough. - Referring to
FIG. 3 , anillustrative handle 30 for controlling operation ofdelivery catheter 11 is described.Handle 30 comprisesproximal portion 31 anddistal portion 32.Distal portion 32 is coupled to elongatetube 14 so that rotation ofknob 35 rotatescoil 24 to engage wall W of the gastro-intestinal tissue, as illustrated inFIG. 2 .Handle 30 further comprisesslider buttons needle 16 and pushrod 21, respectively. - In operation, after
knob 35 has been rotated to engagecoil 24 to tissue wall W,slider button 36 is actuated to urgeneedle 16 distally to pass throughcoil 24 and penetrate wall W. Onceneedle tip 19 has penetrated the tissue wall,slider button 37 is actuatedurge push rod 21 distally, thus ejectinganchor 22 fromneedle 16 on the distal side of tissue wall W. After the anchor assembly has been deployed,slider buttons elongate tube 14.Knob 35 may then be rotated in the opposite direction to release its engagement with tissue wall W. - B. Anchor
- Referring now to
FIGS. 4A and 4B , a preferred embodiment ofanchor 22 constructed in accordance with the principles of the present invention is described.Anchor 22 comprises braidedsleeve 40 coupled toproximal bushing 41 anddistal bushing 42. One ormore sutures 43 are coupled todistal bushing 42 and extend throughbushing 41.Proximal bushing 41 may slide along the suture(s) relative to thedistal bushing 42, so that braided sleeve expands radially outward. Accordingly, afteranchor 22 is disposed through a tissue wall (as depicted inFIG. 2 ), application of tension to the sutures causes the anchor to transition from an elongate reduced delivery profile (FIG. 4 a) to an expanded, substantially disk-shaped deployed profile (FIG. 4B ). -
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. -
Anchor 22 may be made by thermo-forming two ends of a short length of braided sleeve to form proximal anddistal bushings 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. -
FIGS. 5A-5C depict deployment ofanchor 22 from the reduced delivery profile to the expanded deployed profile. InFIG. 5A ,anchor 22 has been forced through tissue wall W, illustratively the stomach wall, vianeedle lumen 18. Oncedelivery catheter 11 is withdrawn,anchor 22 is left disposed through tissue wall W withuntensioned 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. - In
FIG. 5B , sutures 43 are shown partially tensioned, so thatproximal 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 byneedle 16. When further tension is applied tosutures 43,distal bushing 42 is approximated towardproximal bushing 41, thereby causing braidedsleeve 40 to expand in the radially to the substantially disk-shaped profile shown inFIG. 5C . - Alternatively,
anchor 22 may be preformed to self-expand to disk-shaped profile to automatically upon ejection from lumen 18 ofneedle 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. - C. Suture Tensioning Assembly
- Referring now to
FIG. 6 ,illustrative suture fastener 54 constructed in accordance with the principles of the present invention is described.Fastener 54 comprisescollar 70 havingbody 71 andchannel 72 through which sutures 43 may freely translate prior to crimping. Oncefastener 54 is crimped, sutures 43 are restrained from further translation throughchannel 72, thus retaining a desired amount of tension onsutures 43. Optionally,body 71 may incorporate lining 74 to enhance friction betweenbody 71 andsuture 43, thereby reducing the risk of slippage. -
FIGS. 7A to 7E illustrate the steps of one procedure using gastric reduction system 10 to treat obesity. InFIG. 7A delivery catheter 11 ofFIGS. 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 ofFIG. 7A . -
FIG. 7B depicts a step in the which a pair ofanchors 22 have been positioned through opposing tissue walls W of the stomach so thatsutures 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 offastener 54. At this point,fastener 54 has not been crimped and may be freely translated alongsutures 43 using a push rod. More particularly, tension is maintained in the sutures whilepush rod 58 is used to urgefastener 54 through patient's mouth and esophagus E and into the stomach. -
FIG. 7D depicts a step in whichfastener 54 is moved to a position approximately midway between anchors 22. Pushrod 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 inFIG. 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. - At this step in the procedure,
fastener 54 is crimped to maintain the tension insutures 43. The excess length ofsutures 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. - 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.
- Alternative Delivery Catheter Embodiments Suitable for Use with the Gastric Reduction System
- As described above with respect to
FIG. 1 , thepreferred delivery catheter 11 includestorqueable tube 14 formed of braided stainless steel wire. Referring now toFIG. 8 ,alternative delivery catheter 75 instead comprisestorqueable 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, includingneedle 16 and pushrod 21, may be configured as described hereinabove for the embodiment ofFIG. 1 . - 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 oftorqueable 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. - Referring to
FIGS. 9A-9D , the anchors of the present invention may be delivered usingobturator 90 translatably disposed within a lumen ofdelivery catheter 91. InFIG. 9A ,obturator 90 preferably includeselongated shaft 92 having sharpeneddistal tip 93 to facilitate tissue penetration. InFIG. 9B ,anchor 22 is shown disposed in the reduced delivery profile aroundobturator shaft 92, withsuture 95 attached to the anchor atfixture point 96.Obturator 90 is disposed to reciprocate within the delivery catheter, so that the sharpened distal tip may be extended past thedistal tip 94. Becauseobturator 90 has sharpeneddistal tip 93, the anchor need not include a sharpened end suitable for penetration. - With respect to
FIG. 9B , to penetrate tissue wall W,obturator 90 is extended fromdelivery catheter 91 and until the distal tip of the obturator passes through the tissue wall along withanchor 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 tosuture 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. - Although
obturator 90 ofFIG. 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 aspush rod 21 ofFIG. 1 ) translatably disposed withindelivery catheter 91, and adjacent to the obturator shaft may be used to advance the anchors along the shaft. - Referring now to
FIG. 10 and in accordance with an alternative embodiment,obturator 90 includes blunt, spring-loadeddistal tip 100. When the obturator is pushed against a tissue wall,blunt tip 100 is depressed within longitudinally disposedcavity 101 containingcompression spring 102. Depressing the blunt distal tip also exposes the tissue to sharpenedobturator tip 104, which punctures the tissue wall. Once the sharpenedtip 104 penetrates the tissue wall,compression spring 102 ejects theblunt tip 100 fromcavity 101, thereby shielding surrounding tissue from sharpenedtip 104. - With respect to
FIGS. 11A and 11B , an alternative embodiment of an ejection needle suitable for use with the delivery catheter ofFIG. 1 and configured to house and deliver a plurality ofanchors 22 is described.Ejection needle 108 comprises non-coringdistal tip 109,ejection lumen 110 through which pushrod 111 is slidably disposed,anchor lumen 114 for storinganchors 22,first compression spring 115 disposed proximally with respect toanchor lumen 114 and spring-loadedshifting element 116 for shifting individual anchors from the anchor lumen to the ejection lumen. Shiftingelement 116 is coupled tosecond 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 ofcatheter 108. - When the trigger is actuated, the actuator cable is pulled proximally. This caused shifting
element 116 to overcome the force exerted bycompression spring 117 and move away fromejection lumen 110. Retraction of shiftingelement 116 againstcompression spring 117 permits anchor 22 a to slide distally out of lumen 114 (under the urging of compression spring 115), so thatanchor 22 a is disposed substantially directly beneath shiftingelement 116 in the path of push rod 111 (FIG. 11A ). When the trigger is released,compression spring 117 forces the shiftingelement 116 andanchor 22 atoward ejection lumen 110. Once the anchor is pushed intoejection lumen 110,push rod 111 is used to ejectanchor 22 a fromdistal tip 109. - With respect to
FIGS. 12-14 , various end effectors suitable for use with the delivery catheter ofFIG. 1 are described. Referring again toFIGS. 7A-7E , aftersutures 43 have been threaded throughfastener 54 and pushrod 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. -
FIG. 12 illustratespliers assembly 120, comprisingarms 121 arranged to articulate aboutpivot point 122, which may be used to crimpfastener 54 and thereby retain sutures 43.Pliers assembly 120 is used to grip and crimpfastener 54 by manipulating an actuator disposed generally at the proximal end ofcatheter 11. Afterpliers assembly 120 is used to crimpfastener 54, it is retracted andscissor assembly 125 is advanced throughcatheter 11. -
FIG. 13 depicts the use ofscissors assembly 125, comprising blades 126 arranged to articulate aboutpivot point 127, to cut unneeded lengths ofsutures 43 afterfastener 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 ofcatheter 11. Oncesutures 43 have been cut,scissor assembly 125 is retracted throughdelivery catheter 11. - 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 ofjaws 131 arranged to rotate aboutpivot point 132.FIG. 14A illustrates thatjaw assembly 130 may be articulated into position adjacent a tissue wall using an actuator disposed generally at the proximal end ofdelivery catheter 11. InFIG. 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 byneedle 16 and subsequent delivery ofanchor assembly 22 to the opposing side of the tissue wall. - Referring to
FIG. 15A ,delivery catheter 11 ofFIG. 1 may be configured so thatneedle 16 exits a lumen offset fromcoil screw 24. In operation,coil screw 24 is threaded into the tissue wall and retains the delivery catheter in engagement with the tissue wall whileneedle 16 is pushed through the tissue wall.Delivery catheter 11 may further compriseadditional 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. - With respect to
FIGS. 16 and 17 additional alternative embodiments ofstabilization devices 138 suitable for use with the delivery catheter of the present invention are described.Stabilization device 138 ofFIG. 16 comprisesshaft 140 disposed withinlumen 135 and includesresilient fingers 142 attached thereto. Whenshaft 140 is moved distally,fingers 142exit 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. -
Stabilization device 138 ofFIGS. 17A and 17B comprises a plurality of resilientcurved wires 144 disposed withinlumens 145 and spaced apart around the periphery oflumen 135.Curved wires 144 are connected to an actuator located generally at the proximal end of the delivery catheter. Actuation of the actuator causescurved wires 144 to be either extended from or retracted intolumens 145. - Illustratively,
curved wires 144 ofFIG. 17 extend radially outward when extended fromlumens 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. - (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 ofFIG. 18 comprisescoil screw 24 andcurved needle 150. In addition,endoscope 151 may be provided to visualize the site and aid in anchor delivery. Referring toFIG. 18A , oncecoil screw 24 has been screwed into tissue wall W,curved needle 150 is deployed throughcoil screw 24 such thatneedle 150 penetrates tissue wall W at first location W1. As theneedle 150 is deployed from the distal tip ofcatheter 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 ofcurved needle 150 through the coil screw causes the needle to penetrate the tissue wall (at W1) such thatdistal tip 152 of the needle moves from first side S1 of the tissue wall to second side S1 of the tissue wall. - Further deployment of
needle 150 through the coil screw causes the needle to penetrate the tissue wall for a second time (at W2) such thatdistal tip 152 moves from the second side of the tissue wall back to the first side of the tissue wall. Referring toFIG. 18B ,anchor assembly 22 is ejected through the needle afterdistal tip 152 penetrates the tissue wall for the second time. After ejectinganchor assembly 22, the needle is retracted. Referring toFIG. 18C , tensioning of thesuture 43 produces fold F in tissue wall W between first location W1 and second location W2. - 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.
Claims (17)
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.
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US8663236B2 (en) | 2005-04-26 | 2014-03-04 | Usgi Medical Inc. | Transgastric abdominal access |
US20060237023A1 (en) | 2005-04-26 | 2006-10-26 | Usgi Medical Inc. | Transgastric tubal ligation |
US9585651B2 (en) | 2005-05-26 | 2017-03-07 | Usgi Medical, Inc. | Methods and apparatus for securing and deploying tissue anchors |
US8628541B2 (en) | 2005-05-26 | 2014-01-14 | Usgi Medical, Inc. | Methods and apparatus for securing and deploying tissue anchors |
US8298291B2 (en) | 2005-05-26 | 2012-10-30 | Usgi Medical, Inc. | Methods and apparatus for securing and deploying tissue anchors |
US20070123840A1 (en) | 2005-10-18 | 2007-05-31 | Usgi Medical, Inc. | Instrument assisted abdominal access |
US20070142849A1 (en) | 2005-12-16 | 2007-06-21 | Usgi Medical, Inc. | Helical tissue manipulation instruments and methods of use |
-
2003
- 2003-07-01 US US10/612,109 patent/US7942898B2/en active Active
- 2003-12-22 WO PCT/US2003/040846 patent/WO2005011519A2/en active Application Filing
- 2003-12-22 AU AU2003297443A patent/AU2003297443A1/en not_active Abandoned
-
2011
- 2011-05-16 US US13/108,270 patent/US20110213385A1/en not_active Abandoned
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9011365B2 (en) | 2013-03-12 | 2015-04-21 | Medibotics Llc | Adjustable gastrointestinal bifurcation (AGB) for reduced absorption of unhealthy food |
US9067070B2 (en) | 2013-03-12 | 2015-06-30 | Medibotics Llc | Dysgeusia-inducing neurostimulation for modifying consumption of a selected nutrient type |
US9456916B2 (en) | 2013-03-12 | 2016-10-04 | Medibotics Llc | Device for selectively reducing absorption of unhealthy food |
CN109820623A (en) * | 2017-11-23 | 2019-05-31 | 上海微创医疗器械(集团)有限公司 | Medical device |
Also Published As
Publication number | Publication date |
---|---|
US20040122473A1 (en) | 2004-06-24 |
AU2003297443A1 (en) | 2005-02-15 |
WO2005011519A3 (en) | 2007-08-23 |
WO2005011519A2 (en) | 2005-02-10 |
US7942898B2 (en) | 2011-05-17 |
AU2003297443A8 (en) | 2005-02-15 |
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Legal Events
Date | Code | Title | Description |
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AS | Assignment |
Owner name: USGI MEDICAL, INC., CALIFORNIA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:EWERS, RICHARD C.;SAADAT, VAHID;CHEN, EUGENE;REEL/FRAME:026282/0669 Effective date: 20030715 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |