WO2008101078A2

WO2008101078A2 - Medical device fixation tool and method of fixation of a medical device

Info

Publication number: WO2008101078A2
Application number: PCT/US2008/053962
Authority: WO
Inventors: Randal S. Baker; James A. Foote; Frederick J. Walburn; Peter M. Wilson; Adam I. Lehman
Original assignee: Bfkw, Llc
Priority date: 2007-02-14
Filing date: 2008-02-14
Publication date: 2008-08-21
Also published as: EP2117443A2; WO2008101078A3

Abstract

A device fixation tool and method of fixation of a medical device within a hollow organ or cavity through a natural orifice includes providing a needle driver and a shaft. The needle driver is adapted for use with at least one needle. At least a portion of the needle driver is positioned with the shaft at a hollow organ or cavity through the natural orifice. Sufficient force is transmitted with the needle driver to the at least one needle to penetrate mammalian tissue and a portion of the medical device. The portion of the medical device may have a greater puncture resistance than the mammalian tissue.

Description

MEDICAL DEVICE FIXATION TOOL AND METHOD

OF FIXATION OF A MEDICAL DEVICE CROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present invention claims priority from U.S. Application No. 60/901,457, entitled

BARIATRIC DEVICE AND METHOD, filed February 14, 2007 and U.S. Application No. 60/921,930, filed April 5, 2007, entitled BARIATRIC DEVICE AND METHOD, the disclosures of which are hereby incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

[0002] The present invention is directed to a medical device fixation tool and a method of fixation of a medical device and in particular a technique to fix a medical device within a hollow organ or cavity through a natural orifice.

[0003] In the course of treating patients for a variety of different maladies and diseases, it sometimes becomes necessary to fix medical devices within the body. As with any procedure, it is desirable to minimize the invasiveness of surgery by avoiding, whenever possible, incisions in to the skin or exposure of internal organs. Such minimization not only reduces the patient's recovery time and the substantial costs associated with extended hospital stays, but also greatly diminishes the possibility of complications, such as infection or rejection by the body of a foreign element.

SUMMARY OF THE INVENTION

[0004] The present invention provides a medical tool and method for use within the body that can be performed through a natural orifice. This can be accomplished in a minimally invasive manner.

[0005] A medical tool and method of fixation for use within a hollow organ or cavity through a natural orifice according to an aspect of the invention includes providing a needle driver and a shaft. The needle driver is adapted for use with at least one needle. At least a portion of the needle driver is positioned with the shaft at a hollow organ or cavity through the natural orifice. Sufficient force is transmitted with the needle driver to the at least one needle to penetrate mammalian tissue.

[0006] Sufficient force may be transmitted with the needle driver to also penetrate a portion of a medical device to fix the medical device within the hollow organ or cavity. The portion of the medical device may have a greater puncture resistance than the mammalian tissue.

[0007] A support may be provided to resist distal movement of the portion of the medical device in response to the force of penetrating that portion of the medical device. The shaft may position the support at a side of the portion of the medical device opposite from said needle driver. The support may further define a first portion and a second portion, the first portion being adjacent the shaft and the second portion defining a central void. The second portion may be moveable from a deployment position to a use position, wherein said central void is substantially aligned with the needle driver in the use position. The second portion may be substantially aligned with said shaft in the deployment position. In the deployment position the support may extend from the shaft or be substantially aligned with the shaft. The support may be pivotally supported at the shaft. A support actuator may be provided to move the support between the use and deployment positions. The actuator may be at an end portion of the shaft opposite the support.

[0008] The needle driver may be aimable relative to the shaft. The needle driver may include a needle guide and a needle pusher assembly that is moveable along the needle guide. The needle guide may be aimable relative to the shaft. The needle guide may further include a pusher housing affixed to the shaft, a rotatable yoke fixed to the shaft and a pusher tube. The pusher tube may be slideable proximally in the pusher housing and terminated distally at the rotatable yoke. In this manner, the needle guide may be aimable by adjusting a portion of the pusher tube extending from the pusher housing. The needle guide may be moveable between a deployment position and a use position. The needle guide may be substantially parallel to the shaft in the deployment position and at an angle to the shaft in the use position.

[0009] The needle pusher assembly may include a needle deployment tube and a needle deployment filament that is moveable within the needle deployment tube. The needle deployment tube and the needle deployment filament may move together to drive the needle and move relative to each other to deploy the driven needle. A needle may be combined with the needle pusher assembly. The needle may deploy a fastener attached to a tether. A needle driver actuator may be provided to actuate the needle driver to drive a needle through the portion of the medical device. The needle driver actuator may be at an end portion of the shaft opposite the support.

[0010] The portion of the needle driver positioned with the shaft at a hollow organ or cavity through the natural orifice may include at lease one opening defined at a distal end of the shaft. The needle driver may include an elongated member having a distal needle that is adapted to enter the at least one opening to penetrate the portion of the medical device. The at least one opening may include a plurality of openings being at different angles relative to the shaft. In this manner, the needle driver may be aimable by entering a selected one of said openings. [0011] The needle driver may transmit sufficient force to the at least one needle to penetrate at least two portions of the medical device. Each of said portions of the medical device may have a greater puncture resistance than mammalian tissue. [0012] The medical device fixation tool may be used to fix medical devices such as esophageal stents, bariatric devices, anti-reflux devices, nasal gastric tubes, intestinal sleeves, and the like. [0013] These and other objects, advantages and features of this invention will become apparent upon review of the following specification in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a perspective view of a medical device fixation tool juxtaposed with a medical device; [0015] FIG. 2 is a side elevation view of a medical device fixation tool and medical device in

FIG. 1; [0016] FIG. 3 is a side elevation of a distal portion of the medical device fixation tool illustrating the relationship between the needles and needle driver and the support; [0017] FIG. 4 is a perspective view of the distal portion of the medical device fixation tool in

FIG. 3; [0018] FIG. 5 is an enlarged perspective view of medical device fixation tool in FIG. 3 illustrating aiming of the needle driver; [0019] FIG. 6 is a side elevation of a medical device fixation tool with the support distally retracted;

[0020] FIG. 7 is the same view as FIG. 6 with the support in a partially deployed position;

[0021] FIG. 8 is the same view as FIG. 7 with the needle guide being aimed;

[0022] FIG. 9 is the same view as FIG. 8 with the support in a use position;

[0023] FIG. 10 is the same view as FIG. 9 with the needle deployment tube in a use position;

[0024] FIG. 11 is the same view as FIG. 10 with the needle deployed;

[0025] FIG. 12 is the same view as FIG. 11 with the needle guide in a partially retracted position and the needle remaining deployed;

[0026] FIG. 13 is the same view as FIG. 12 with the support distally retracted;

[0027] FIG. 14 is a side elevation of an embodiment of a tether clamp device connected to a tether; [0028] FIG. 15 is an enlarged elevation of an alternative embodiment of the tether clamp device; [0029] FIG. 16 is an elevation of a tether clamp; [0030] FIG. 17 is the same view as FIG. 16 illustrated with a tether;

[0031] FIG. 18 is a perspective view of an alternative embodiment of a medical device fixation tool juxtaposed with a medical device; [0032] FIGS. 19 and 20 are perspective views of a medical device fixation tool and actuator in FIG. 18 in a deployment position;

[0033] FIGS. 21 is the same view as FIGS. 19 with the support in the use position;

[0034] FIGS. 22 is a similar view to FIGS. 19 illustrating the needle driver being deployed;

[0035] FIG. 23 is a perspective view illustrating the support juxtaposed with a cardiac member body;

[0036] FIG. 24 illustrates tether needles penetrating a cardiac member body;

[0037] FIG. 25 illustrates accommodation of the tether needles by the support as the needles penetrate a cardiac member; [0038] FIG. 26 is a perspective view of another alternative embodiment of a medical device fixation tool; [0039] FIG. 27 is an enlarged view of a portion of the medical device fixation tool of FIG.

26; [0040] FIG. 28 is a side elevation of another alternative embodiment of a medical device fixation tool;

[0041] FIG. 29 is an illustration of the medical device fixation tool of FIG. 28 in use;

[0042] FIG. 30 is a side elevation of another alternative embodiment of a medical device fixation tool; [0043] FIG. 31 is another side elevation of the medical device fixation tool of FIG. 30 taken from a different direction; [0044] FIG. 32 is a side elevation of another alternative embodiment of a medical device fixation tool; [0045] FIG. 33 is a side elevation of another alternative embodiment of a medical device fixation tool in use; and [0046] FIG. 34 is an enlarged elevation of the medical device fixation tool of FIG. 33.

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0047] Referring now specifically to the drawings and the illustrative embodiments depicted therein, a medical device fixation tool, such as a tether application apparatus 10 includes a needle driver assembly 18 and a shaft 30 used to position at least a portion of needle driver assembly 18 within a hollow organ or cavity 16 (FIGS. 1 though 15). The tether application apparatus 10 may further include a support 90 to offer resistance to distal movement resulting from forces arising when needle 24 penetrates a material such as mammalian tissue or a wall of a medical device 12.

[0048] Tether application apparatus 10 is adapted to aid installation of a medical device 12, such as a bariatric device of the type disclosed in commonly assigned International patent application No. PCT/US2008/53912 filed on Feb. 14, 2008 and patent application Ser. Nos. 60/901,457 filed Feb. 14, 2007 and 60/921,930, filed Apr. 5, 2007 entitled BARIATRIC DEVICE AND METHOD, the disclosures of which are hereby incorporated herein by reference in their entirety. Shaft 30 may be deployed endoluminally through a natural orifice such as the esophagus via an overtube. The support 90 is then deployed in a manner described in detail below. Needle driver 18 is actuated to drive needles 24 connected with the tether filament 62 through a first portion of medical device 12, and mammalian tissue such as the wall of the patient's esophagus, the wall of the patient's stomach at the cardia, and a second portion of a medical device 12. The support 90 is then retracted and the tether application apparatus is withdrawn.

[0049] Referring now to FIGS. 3 through 5, support 90 is pivotally mounted to a distal end of shaft 30 with a pivot 32. Support 90 is moveable between a use position illustrated in FIG. 3 and a deployment position illustrated in FIG. 6 by a pull wire 34 that is reeved about a pulley 36. A spring (not shown) biases support 90 to the extended position in FIG. 6 and pull wire 34 moves support 90 to the position in FIG. 3.

[0050] Needle driver 18 may include a needle housing 22, a needle guide 20 that can be aimed, and a needle pusher assembly 26 that is moveable within needle guide 20 to drive the needle. Needle guide 20 includes a tube 21 that moves with respect to housing 22 and a yoke 27 that receives a distal end of tube 21 and pivots with respect to shaft 30. Needle guide 20 is capable of being aimed by the physician from outside the patient. This may be accomplished in the illustrated embodiment by a pivot yoke 27 pivoting with respect to shaft 30 as best seen in FIG. 5. Needle pusher 26 slides in tube 21 as tube 21 is paid out through pusher housing 22 and receives a needle 24. Connector material 60, such as needle 24 operatively connected with a tether 62 is delivered by pusher assembly 26. Needle pusher assembly 26 is capable of applying a sufficient force on needle 24 to penetrate through one or more walls of medical device 12. Tether 62 extends through a cavity in shaft 30 to the proximal end of shaft 30. Alternatively, tether 62 can run along side shaft 30 external of the patient.

[0051] Yoke 27 allows needle tube 21 to be adjusted to lie substantially along the face of shaft 30 in a deployment position, thereby easing deployment of the medical device fixation tool in a hollow organ or cavity 16. Needle tube 21 may also be adjusted to displace from such deployment position to a use position by distally displacing a greater length of needle tube 21 out of pusher housing 22, one illustration of which appears in FIG. 3. In this use position, needle guide 20 may be further adjusted to allow needle pusher 26 to substantially align needle 24 with a desired location on medical device 12 when support 90 is in a use position. Accordingly, pusher assembly 26 may deliver connector material 60 through material lying between support 90 and shaft 30, such as mammalian tissue and a wall of medical device 12.

[0052] Referring now to FIG. 4, support 90 may have a first portion 94 and a second portion

96. The first portion 94 includes pivot 32 attaching to shaft 30, allowing support 90 to rotate about the pivot in to a range of positions with respect to shaft 30. For endoluminal deployment of the medical device fixation tool, the support 90 may be pivoted distally in to substantial alignment with the shaft (as illustrated in FIG. 6). Alternatively, support 90 may be pivoted proximally in to substantial alignment with the shaft for deployment. Second portion 96 may further include a void 92, which may be an aperture, hole, divot, or other void suitable for receiving needle 24 with the rest of second portion 96 surrounding void 92 supporting a portion of medical device 12. In an alternative embodiment (not shown), support 90 may have a surface that is penetrable by needle(s) 24. Thus, as a needle passes through the cardiac member, it also penetrates the proximal surface of support 90 to allow the needle to fully pass through pierced material.

[0053] Operation of medical device fixation tool 10 can be understood by reference to FIGS.

6 through 13. Referring now to FIG. 6, medical device fixation tool 10 is shown in a deployment position capable of endoluminal deployment in a hollow organ or cavity 16. Support 90 is pivoted distally in to substantial alignment with shaft 30, and needle guide 20 is adjusted to lie substantially along the face of shaft 30. Needle pusher assembly 26 and needle 24 (not shown in FIG. 6) are in the deployment position. A needle control handle 40 is shown with a grasping handle 42, a needle guide 46 in the deployment position, and a two- part needle deployment actuator 48 in the retracted position. A support control handle 50 includes a support actuator 56 in the retracted position. The proximal end of tether 62 is shown protruding from the proximal terminus of shaft 30. After a physician has satisfactorily positioned shaft 30, such as through an overtube positioned in the hollow organ or cavity 16, deployment of the medical device fixation tool may begin. Deployment may be visualized fluoroscopically or by an endoscope E that can be inserted in the same overtube as shaft 30, as best seen in FIG. 1. [0054] Referring now to FIG. 7, support 90 is pivoted in to a partially deployed position by rotating support actuator 56 on support control handle 50. The physician may use grasping handle 52 to aid in manipulation of support control handle 50. Actuator 56 may be connected to a lead screw (not shown) that converts rotational motion to linear motion of pull wire 34, which is connected between the lead screw and support 90. It will, however, be apparent to the skilled artisan that other ways to accomplish the actuation of support 90 are possible.

[0055] Referring now to FIG. 8, needle guide 20 is moved to a use position by elongating needle tube 21 from pusher housing 22. This may be accomplished by sliding needle guide actuator 46 on needle control handle 40. Needle guide 20 is adjusted to be substantially aligned with the desired path of needle pusher assembly 26 and hence to aim delivery of needle 24.

[0056] Referring now to FIG. 9, support 90 is pivoted in to a use position by further rotating actuator 56 on control handle 50, as described above. The use position is the position where second portion 96 is able to support any portion of medical device 12 to be transversed by needle 24 against distal movement in the direction of needle travel. In this position, needle 24 is substantially aligned with central void 92, so that needle 24 may pass in to or through central void 92.

[0057] Referring now to FIG. 10, needle pusher assembly 26 is deployed by distal sliding of second actuator 48 on needle control handle 40. Needle pusher assembly 26 is configured to support needle 24 in a manner that provides a smooth transition between the outer surface of needle displacement tube 29 and needle 24 (FIG. 14). Needle 24 may in turn be connected to a distal portion of tether 62, which may travel along shaft 30 to a proximal portion in the vicinity of needle control handle 50, thereby allowing the operator to access tether 62 after it is connected. Needle deployment filament 31 is positioned within deployment tube 29 (FIG. 14) and is also movable by needle deployment handle 48. In particular, a first portion 48a of needle deployment actuator 48 moves needle deployment tube 29 and a second portion 48b of needle deployment actuator 48 moves needle deployment filament 31. When both portions 48a and 48b are moved together, as illustrated in FIG. 10, needle deployment tube 29 and needle deployment filament 31 move distally together. The physician may use grasping handle 42 to aid in manipulation of needle deployment actuator 48. Although linear actuation with needle deployment actuator 48 is disclosed herein, it will be apparent to the skilled artisan that other ways to accomplish the actuation of needle deployment tube 29 are possible. [0058] Referring now to FIG. 11, with needle deployment tube 29 and needle deployment filament 31 in use positions, needle 24 is deployed by being dislodged from needle deployment tube 29 by proximal sliding of portion 48b of second actuator 48 on needle control handle 40 relative to portion 48a. This causes needle control filament 31 to move relative to needle deployment tube 29 thus freeing needle 24 from the needle deployment tube. In the illustrated embodiment, this is accomplished by needle control filament 31 retracting proximally with respect to needle deployment tube 29. However, medical device fixation tool 10 could be configured for needle control filament 31 to extend relative to needle deployment tube 29 to deploy the needle. As seen in FIG. 12, movement of actuator portion 48a will retract needle deployment tube 29 such that needle pusher 26 is now fully retracted reversing the motion shown in FIG. 10 and described above.

[0059] Referring now to FIG. 13, support 90 can be pivoted to the deployment position substantially aligned with shaft 30 in preparation for removal of the medical device fixation tool from hollow organ or cavity 16. Such pivoting is accomplished by rotation of actuator 56 on support control handle 50, in reverse of actions shown in FIGS. 7 and 9 and described above. Central void 92 in second portion 96 of support 90 clears connector material 60 and needle 24, if it is present. Needle guide 20 may then be adjusted to a deployment position using first actuator 46 on needle control handle 40, and the medical device fixation tool can be removed from hollow organ or cavity 16.

[0060] Referring now to FIG. 14, one embodiment of connector material 60 is illustrated.

Connector material 60 includes needle 24 that is integral with a "T" clamp device 66, so that after deployment the tip of needle 24 forms a portion of the top of the "T". Tether 62 forms the trunk of the "T" and is connected to the needle 24 such as by crimping the needle. Thus, after needle pusher assembly 26 has driven needle 24 through mammalian tissue, medical device 12, or other material, needle 24 will rotate and hold tether 62 against a distal surface of such material.

[0061] Referring now to FIG. 15, another embodiment is shown of the connector material. In this embodiment, a needle 124 is connected to needle deployment tube 29, so that needle 124 is manipulable by manipulating needle deployment tube 29 and will withdraw after deployment. A "T" clamp device 166 is contained within a hollow cavity 37 of needle 124 in alignment with needle deployment filament 31. When ready for deployment, needle deployment filament 31 ejects "T" clamp device 166 from hollow cavity 37, enabling "T" clamp device 66 to unfold and anchor against a distal surface of pierced material. Tether 62 forms the trunk of the "T" and passes through pierced material, enabling connections or other manipulations from the proximal portion of tether 62.

[0062] This embodiment allows the physician to retract needle 124 even after it has transversed the portion of the medical device, such as the cardiac portion in the case of a bariatric device. In this manner, should the physician not be pleased with the location of the penetration, the physician can retract the needle and reposition it. Once the physician is satisfied with the location, the T-clamp can then be deployed.

[0063] Referring now to FIGS. 16 and 17, the proximal end of tether 62 may be clamped using a clamp device in the form of a button 64 in the form of a disk 70 containing a plurality, such as three (3), of through-openings 68. Disk 70 may be made of a suitable material, such as polycarbonate, or the like. As illustrated in FIG. 17, button 64 is attached to the proximal end of the tether 62 by passing an end of the tether under a loop formed by the tether thereby forming a one-way clamp that operates similarly to a slipknot. This allows the tether clamp to be propelled along the tether from external the patient to a position engaging the proximal surface of mammalian tissue, medical device 12, or other material and snugged up to a desired tension of the tether 62, using a conventional knot pusher, or the like. Although the tether clamp can move relatively freely in one direction for deployment, it resists movement in the other direction, thereby firmly engaging the proximal surface of mammalian tissue, medical device 12, or other material. A roughened portion 72 of the surface 74 of disk 70 may be provided to help lock the tether to resist movement of button 64. Also, an elongated extension of surface 74 (not shown) may be provided on either side of opening 68 to trap or pinch a portion of the tether. For additional stability, the physician may choose to tie a slipknot to the ends, if more than one tether is used, and slide the slipknot against the button 64 within the esophageal member using a knot pusher.

[0064] In an alternative embodiment, pivot 32 can be made adjustable along shaft 30. This allows the amount of tissue captured between support 90 and shaft 30 to be varied. Also, although the fixation tool is illustrated as unitary assembly, a separate needle pusher, or needle driver, may be provided. This would allow the shaft and support, including associated actuator, to be provided as a separate support unit that can be separately positioned in the hollow organ or cavity. The support unit may include a plurality of openings that are adapted to receive the separate needle pusher. The openings are oriented to provide the physician the ability to aim the needle driver differently based upon which opening is engaged by the needle driver. The needle driver may be an integral unit made, by way of example, from hypodermic tubing which is commercially available. The separate needle driver may be deployed in a working channel of an endoscope.

[0065] Referring now to FIGS. 18 and 20, an alternative embodiment of tether application apparatus 110 may include a shaft 130 that is of a cross-sectional configuration and length that is adapted to extend through an overtube transorally to a patient's stomach. Tether application apparatus 110 may include an actuator 140 proximal of shaft 130. Actuator 140 remains external the patient during a medical procedure such as a bariatric device deployment procedure. Shaft 130 may be covered by a sheath 114. Actuator 140 may include a grasping handle 142, a support positioning actuator 156, a needle guide actuator 146, and a needle firing actuator 148, although certain of these actuators may be combined for ease of use.

[0066] FIGS. 19 and 20 illustrate tether application apparatus 110 with support 190 in a deployment position in which it is capable of traversing a patient's esophagus through an overtube. Once support 190 is positioned within the stomach, operation of support actuator 156 causes support 190 to pivot to a use position, as illustrated in FIG. 21. In the illustrative embodiment, this is accomplished by rotating cardia member support actuator 156. However, other mechanical actuating techniques may be used. Once the support is deployed, proximal movement of grasping handle 142 will cause support 190 to provide distal support to the cardia.

[0067] Referring now to FIGS. 22 and 23, once the tether application apparatus 110 is oriented properly, a physician operates the needle guide actuator 146 in order to distally move needle guides 120. If a bariatric device 112 is previously deployed, the physician concurrently aligns the needle guides with the desired position on the esophageal member of such device, which may be marked on the inner wall of the esophageal member in order to assist the physician. In the illustrated embodiment, needle guide actuator 146 is shown as a slide actuator, but other forms of actuator may be utilized.

[0068] Once the support 190 is properly supporting the cardia, and the cardiac member if it is present, and the needle guides 120 are properly positioned, a physician operates needle firing actuator 148. This causes needle(s) 124 at the distal portion of the tether(s) to move distally into registration with support 190. This assists deployment of the tether(s) without imparting a significant torque, or rotational movement, between an esophageal member and a cardiac member. In the illustrative embodiment, support 190 includes a first portion 194 and second portion 196. First portion 194 includes a pivot attaching to shaft 130, allowing support 190 to rotate about the pivot in to a range of positions with respect to shaft 130. Second portion 196 may further include a void 192, which may be an aperture, hole, divot, or other void suitable for receiving needle 124 or needle pusher 120 while preventing material from passing in to void 192. In an alternative embodiment (not shown), support 190 may have a surface that is penetrable by needle(s) 124. Thus, as the needles pass through the cardiac member, they also penetrate the proximal surface of support 190 to allow the needles to fully pass through the cardiac member.

[0069] Referring now to FIGS. 24 and 25, once the needles 124 are properly fired, the operator can remove the tether application apparatus. This may be accomplished by distal movement of the tether application apparatus until support 190 is clear of protruding needles 124. Support actuator 156 can then be operated in order to fold the support 190 against shaft 130 to traverse the esophagus.

[0070] Although illustrated for use in deployment of bariatric devices 12 and 112, tether application apparatuses 10 and 110 and/or clamp devices 64 and 66 may find applications for fixation of other medical devices including esophageal stents, anti-reflux devices, nasal gastric tubes, intestinal sleeves, and the like. They may also find other applications including closure of fistulas, tightening of anastomosis, closure of leaks, tightening of a gastric pouch and closure of a gastrotomy. Other applications will be apparent to the skilled artisan.

[0071] Referring now to FIGS. 26 and 27, an alternative tether application apparatus 270 includes a head 272 having a window 274 that fires the needle through the tissue. A hollow shaft 276 draws a vacuum at window 274 in order to pull the tissue at the GE junction into the window prior to firing the tether needles. The needle and tether are fired from a tube 278. Shaft 276 may be made flexible to fit the anatomy of the patient, if required.

[0072] Referring now to FIGS. 28 and 29, another alternative tether application apparatus

280 includes a tether tube 282 that passes a needle 284, and attached tether, retroflex from the cardia through the GE junction and into the lower esophagus. It is illustrated as including a sliding needle guide 286 to facilitate passage of the device through the esophagus.

[0073] Referring now to FIGS. 30 and 31, yet another alternative tether application apparatus

290 is used to pass a needle 292 of a tether 294 through the esophagus and into the cardia. A cardia support 296 is pivoted at 298 to a shaft 300. A cable 302 is operated by an actuator (not shown) to pivot the cardia support 296 between a deployment position, for passage through the esophagus, and a use position as illustrated for supporting the cardia. The tether needle is fired through a tube 304. A slot 306 in cardia support 296 facilitates passage of needle 292 while allowing the cardia to be supported.

[0074] Referring now to FIG. 32, another alternative tether application apparatus 310 includes a shaft 312 and a spiral formed needle driver 314. Needle driver 314 is used to pass a needle 316 having an attached tether 318 through the lower esophagus and the cardia by twisting shaft 312 and advancing needle driver 314.

[0075] Referring now to FIGS. 33 and 34, another alternative tether application apparatus

320 drives the needle in a retroflex manner from the cardia to the GE junction, then into the esophagus. The device includes a flexible neck 322 that is mounted distally on a shaft 324 and supports a needle driver 326. Neck 322 can be straightened for insertion of the device through the patient's esophagus and formed to the shape illustrated in FIG. 34 by the operation of an actuator (not shown). Needle driver 326 drives a needle 328 with attached tether 330 through the cardia, past the GE junction and through the esophageal wall.

[0076] Although various embodiments are illustrated herein, it should be understood that the features disclosed in each embodiment may be combined as would be apparent to the skilled artisan. Changes and modifications in the specifically described embodiments can be carried out without departing from the principles of the invention which is intended to be limited only by the scope of the appended claims, as interpreted according to the principles of patent law including the doctrine of equivalents.

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A medical device fixation tool that is adapted to fix a medical device within a hollow organ or cavity through a natural orifice, said medical device fixation tool comprising: a needle driver, said needle driver adapted to receive at least one needle; and a shaft, said shaft adapted to position at least a portion of said needle driver at the hollow organ or cavity through the natural orifice; wherein said needle driver is adapted to transmit sufficient force to the at least one needle to penetrate a portion of the medical device, wherein the portion of the medical device has a greater puncture resistance than mammalian tissue.

2. The medical device fixation tool as claimed in claim 1, further including a support, wherein said support is adapted to resist distal movement of the portion of the medical device in response to the force of penetrating that portion of the medical device.

3. The medical device fixation tool as claimed in claim 2 wherein said shaft is adapted to position said support at a side of the portion of the medical device opposite from said needle driver.

4. The medical device fixation tool as claimed in claim 3 wherein said support further defines a first portion and a second portion, said first portion being adjacent said shaft, said second portion defining a central void, wherein said second portion is moveable from a deployment position to a use position, wherein said central void is substantially aligned with said needle driver in said use position.

5. The medical device fixation tool as claimed in claim 4 wherein said second portion is substantially aligned with said shaft in said deployment position.

6. The medical device fixation tool as claimed in claims 4 or 5, further comprising a support actuator, said support actuator adapted to move said support between said use and deployment positions, said actuator being at an end portion of said shaft opposite said support.

7. The medical device fixation tool as claimed in any of claims 2 through 6, wherein said support is pivotally supported at said shaft.

8. The medical device fixation tool as claimed in claims 5 through 7, wherein said support is adapted to extend from said shaft to substantially align with said shaft hi said deployment position.

9. The medical device fixation tool as claimed in claims 5 through 7, wherein said support is adapted to fold against said shaft to substantially align with said shaft.

10. The medical device fixation tool as claimed in any of the preceding claims wherein said needle driver is aimable relative to said shaft.

11. The medical device fixation tool as claimed in claim 10 wherein said needle driver comprises a needle guide and a needle pusher assembly moveable along said needle guide and wherein said needle guide is aimable relative to said shaft.

12. The medical device fixation tool as claimed in claim 11 wherein said needle guide comprises a pusher housing affixed to said shaft, a rotatable yoke fixed to said shaft and a pusher tube, said pusher tube slideable proximally in said pusher housing and terminated distally at said rotatable yoke wherein said needle guide is aimable by adjusting a portion of said pusher tube extending from said pusher housing.

13. The medical device fixation tool as claimed in claim 12 wherein said needle guide is moveable between a deployment position and a use position, wherein said needle guide is substantially parallel to said shaft said shaft in said deployment position and is at an angle to said shaft in said use position.

14. The medical device fixation tool as claimed in any of claims 11 though 13 wherein said needle pusher assembly comprises a needle deployment tube and a needle deployment filament that is moveable within said needle deployment tube, wherein said needle deployment tube and said needle deployment filament are adapted to move together to drive the needle and are adapted to move relative to each other to deploy the driven needle.

15. The medical device fixation tool as claimed in any of claims 11 through 14 including a needle combined with said needle pusher assembly.

16. The medical device fixation tool as claimed in claim 15 wherein said needle is adapted to deploy a fastener attached to a tether.

17. The medical device fixation tool as claimed in any of claims 10 through 16 including a needle driver actuator, said needle driver actuator adapted to actuate said needle driver to drive a needle through the portion of the medical device, said needle driver actuator being at an end portion of said shaft opposite said support.

18. The medical device fixation tool as claimed in claim 1 wherein said portion of said needle driver comprises at lease one opening defined at a distal end of said shaft and wherein said needle driver further includes an elongated member having a distal needle that is adapted to enter said at least one opening to penetrate the portion of the medical device.

19. The medical device fixation tool as claimed in claim 18 wherein said at least one opening comprises a plurality of openings, said plurality of openings being at different angles relative to said shaft wherein said needle driver is aimable by entering a selected one of said openings.

20. The medical device fixation tool as claimed in any of the preceding claims wherein said needle driver is adapted to transmit sufficient force to the at least one needle to penetrate at least two portions of the medical device, wherein each of said portions of the medical device has a greater puncture resistance than mammalian tissue.

21. A method of fixation of a medical device within a hollow organ or cavity through a natural orifice, comprising: providing a needle driver, said needle driver being adapted for use with at least one needle; and providing a shaft, positioning at least a portion of said needle driver with said shaft at a hollow organ or cavity through the natural orifice; and transmitting sufficient force with said needle driver to the at least one needle to penetrate mammalian tissue and a portion of the medical device, wherein the portion of the medical device has a greater puncture resistance than the mammalian tissue.

22. The method of fixation as claimed in Claim 21, further including providing a support and resisting distal movement with said support of the portion of the medical device in response to the force of penetrating that portion of the medical device.

23. The method of fixation as claimed in claim 22 including positioning said support with said shaft at a side of the portion of the medical device opposite from said needle driver.

24. The method of fixation as claimed in claim 23 wherein said support further defining a first portion and a second portion, said first portion being adjacent said shaft, said second portion defining a central void, wherein said second portion is moveable from a deployment position to a use position, wherein said central void is substantially aligned with said needle driver in said use position.

25. The method of fixation as claimed in claim 24 including substantially aligning said second portion with said shaft in said deployment position.

26. The method of fixation as claimed in claims 24 or 25, including providing a support actuator and moving said support with said support actuator between said use and deployment positions, said actuator being at an end portion of said shaft opposite said support.

27. The method of fixation as claimed in any of claims 22 through 26, wherein said support is pivotally supported at said shaft.

28. The method of fixation as claimed in claims 25 through 27, wherein said support is adapted to extend from said shaft to substantially align with said shaft in said deployment position.

29. The method of fixation as claimed in claims 25 through 27, wherein said support is adapted to fold against said shaft to substantially align with said shaft.

30. The method of fixation as claimed in any of claims 21 through 29 including aiming said needle driver relative to said shaft.

31. The method of fixation as claimed in claim 30 wherein said needle driver comprises a needle guide and a needle pusher assembly moveable along said needle guide and wherein said aiming includes aiming said needle guide relative to said shaft.

32. The method of fixation as claimed in claim 31 wherein said needle guide comprises a pusher housing affixed to said shaft, a rotatable yoke fixed to said shaft and a pusher tube, said pusher tube slideable proximally in said pusher housing and terminated distally at said rotatable yoke wherein said aiming said needle guide includes adjusting a portion of said pusher tube extending from said pusher housing.

33. The method of fixation as claimed in claim 32 wherein said needle guide is moveable between a deployment position and a use position, including moving said needle guide to substantially parallel to said shaft said shaft in said deployment position and at an angle to said shaft in said use position.

34. The method of fixation as claimed in any of claims 31 though 33 wherein said needle pusher assembly comprises a needle deployment tube and a needle deployment filament that is moveable within said needle deployment tube, including moving said needle deployment tube and said needle deployment filament together to drive the needle and moving said needle deployment tube and said needle deployment filament relative to each other to deploy the driven needle.

35. The method of fixation as claimed in any of claims 31 through 34 including providing a needle combined with said needle pusher assembly.

36. The method of fixation as claimed in claim 35 including deploying with said needle a fastener attached to a tether.

37. The method of fixation as claimed in any of claims 30 through 36 including providing a needle driver actuator and actuating said needle driver with said needle driver actuator to drive a needle through the portion of the medical device, said needle driver actuator being at an end portion of said shaft opposite said support.

38. The method of fixation as claimed in claim 21 wherein said portion of said needle driver comprises at least one opening defined at a distal end of said shaft and wherein said needle driver further includes an elongated member having a distal needle, and further including entering said at least one opening with said elongated member to penetrate the portion of the medical device.

39. The method of fixation as claimed in claim 38 wherein said at least one opening comprises a plurality of openings, said plurality of openings being at different angles relative to said shaft and further including aiming said needle driver by entering a selected one of said openings.

40. The method of fixation as claimed in any of claims 21 through 39 including transmitting sufficient force with said needle driver to the at least one needle to penetrate at least two portions of the medical device, wherein each of said portions of the medical device has a greater puncture resistance than mammalian tissue.

41. The method of fixation as claimed in any of claims 21 through 40, used to fix one chosen from: (i) an esophageal stent; (ii) a bariatric device; (iii) an anti-refiux device; (iv) a nasal gastric tube; and (v) an intestinal sleeve.