US20130123811A1 - Medical device fixation tool and method of fixation of a medical device - Google Patents

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present invention is a division of U.S. patent application Ser. No. 12/541,567, filed on Aug. 14, 2009, which claims priority from U.S. provisional patent application Ser. No. 61/107,511, filed on Oct. 22, 2008, and U.S. patent application Ser. No. 12/541,567 is a continuation-in-part of International Patent Cooperation Treaty Application No. PCT/US08/53962, filed on Feb. 14, 2008, which claims priority from U.S. provisional patent application Ser. No. 60/901,457, filed on Feb. 14, 2007, and U.S. provisional patent application Ser. No. 60/921,930, filed on Apr. 5, 2007, the disclosures of which are hereby incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTION
• The present invention is directed to a medical device fixation tool and a method of fixation of a medical device and, in particular, to a technique to fix a medical device within a hollow organ or cavity through a natural orifice.
• 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 into 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• FIG. 1 is a perspective view of a medical device fixation tool juxtaposed with a medical device;
• FIG. 2 is a side elevation view of a medical device fixation tool and medical device inFIG. 1;
• 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;
• FIG. 4 is a perspective view of the distal portion of the medical device fixation tool inFIG. 3;
• FIG. 5 is an enlarged perspective view of a medical device fixation tool inFIG. 3 illustrating aiming of the needle driver;
• FIG. 6 is a side elevation of a medical device fixation tool with the support distally extended;
• FIG. 7 is the same view asFIG. 6 with the support in a partially deployed position;
• FIG. 8 is the same view asFIG. 7 with the needle guide being aimed;
• FIG. 9 is the same view asFIG. 8 with the support fully deployed in a use position;
• FIG. 10 is the same view asFIG. 9 with the needle deployment tube in a use position;
• FIG. 11 is the same view asFIG. 10 with the needle deployed;
• FIG. 12 is the same view asFIG. 11 with the needle guide in a partially retracted position and the needle remaining deployed;
• FIG. 13 is the same view asFIG. 12 with the support distally retracted;
• FIG. 14 is a side elevation of an embodiment of a tether clamp device connected to a tether;
• FIG. 15 is an enlarged elevation of an alternative embodiment of the tether clamp device;
• FIG. 16 is an elevation of a tether clamp;
• FIG. 17 is the same view asFIG. 16 illustrated with a tether;
• FIG. 18 is a perspective view of an alternative embodiment of a medical device fixation tool juxtaposed with a medical device;
• FIGS. 19 and 20 are perspective views of a medical device fixation tool and actuator inFIG. 18 in a deployment position;
• FIG. 21 is the same view asFIG. 19 with the support in the use position;
• FIG. 22 is a similar view toFIG. 19 illustrating the needle driver being deployed;
• FIG. 23 is a perspective view illustrating the support juxtaposed with a cardiac member body;
• FIG. 24 illustrates tether needles penetrating a cardiac member body;
• FIG. 25 illustrates accommodation of the tether needles by the support as the needles penetrate a cardiac member;
• FIG. 26 is a perspective view of another alternative embodiment of a medical device fixation tool;
• FIG. 27 is an enlarged view of a portion of the medical device fixation tool ofFIG. 26;
• FIG. 28 is a side elevation of another alternative embodiment of a medical device fixation tool;
• FIG. 29 is an illustration of the medical device fixation tool ofFIG. 28 in use;
• FIG. 30 is a side elevation of another alternative embodiment of a medical device fixation tool;
• FIG. 31 is another side elevation of the medical device fixation tool ofFIG. 30 taken from a different direction;
• FIG. 32 is a side elevation of another alternative embodiment of a medical device fixation tool;
• FIG. 33 is a side elevation of another alternative embodiment of a medical device fixation tool in use;
• FIG. 34 is an enlarged elevation of the medical device fixation tool ofFIG. 33;
• FIG. 35 is a perspective view of another alternative embodiment of a medical device fixation tool in a deployment position;
• FIG. 36 is a bottom plane view of the medical device fixation tool inFIG. 35;
• FIG. 37 is the same view asFIG. 35 showing the medical device fixation tool in a use position;
• FIG. 38 is a perspective view of an actuator assembly;
• FIG. 39 is a perspective view of a plunger; and
• FIGS. 40-43 are exploded perspective views of the plunger illustrated inFIG. 39 in various stages of assembly.
DESCRIPTION OF THE PREFERRED EMBODIMENT
• Referring now specifically to the drawings and the illustrative embodiments depicted therein, a medical device fixation tool, such as atether application apparatus10 includes aneedle driver assembly18 and ashaft30 used to position at least a portion ofneedle driver assembly18 within a hollow organ or cavity16 (FIGS. 1 though15). Thetether application apparatus10 may further include asupport90 to offer resistance to distal movement resulting from forces arising whenneedle24 penetrates a material, such as mammalian tissue or a wall of amedical device12.
• Tether application apparatus10 is adapted to aid installation of amedical device12, such as a bariatric device of the type disclosed in commonly assigned International Patent Application Publication No. WO 2008/101048 A2 and patent application Ser. Nos. 60/901,457 filed Feb. 14, 2007; 60/921,930, filed Apr. 5, 2007 and Ser. No. 12/539,112 filed Aug. 11, 2009 entitled BARIATRIC DEVICE AND METHOD, the disclosures of which are hereby incorporated herein by reference in their entirety.Shaft30 may be deployed endoluminally through a natural orifice, such as the esophagus via an overtube. Thesupport90 is then deployed in a manner described in detail below.Needle driver18 is actuated to driveneedles24 connected with thetether filament62 through a first portion ofmedical device12, 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 amedical device12. Thesupport90 is then retracted and the tether application apparatus is withdrawn.
• Referring now toFIGS. 3 through 5,support90 is pivotally mounted to a distal end ofshaft30 with a pivot32.Support90 is moveable between a use position illustrated inFIG. 3 and a deployment position illustrated inFIG. 6 by a pull wire34 that is reeved about a pulley36. A spring (not shown) biases support90 to the extended position inFIG. 6, and pull wire34 moves support90 to the position inFIG. 3.
• Needle driver18 may include aneedle housing22, aneedle guide20 that can be aimed, and aneedle pusher assembly26 that is moveable withinneedle guide20 to drive the needle.Needle guide20 includes a tube21 that moves with respect tohousing22 and a yoke27 that receives a distal end of tube21 and pivots with respect toshaft30.Needle guide20 is capable of being aimed by the physician from outside the patient. This may be accomplished in the illustrated embodiment by a pivot yoke27 pivoting with respect toshaft30, as best seen inFIG. 5.Needle pusher assembly26 slides in tube21 as tube21 is paid out throughpusher housing22 and receives aneedle24.Connector material60, such asneedle24 operatively connected with atether62 is delivered bypusher assembly26.Needle pusher assembly26 is capable of applying a sufficient force onneedle24 to penetrate through one or more walls ofmedical device12.Tether62 extends through a cavity inshaft30 to the proximal end ofshaft30. Alternatively,tether62 can run alongside shaft30 external of the patient.
• Yoke27 allows needle tube21 to be adjusted to lie substantially along the face ofshaft30 in a deployment position, thereby easing deployment of the medical device fixation tool in a hollow organ orcavity16. Needle tube21 may also be adjusted to displace from such deployment position to a use position by distally displacing a greater length of needle tube21 out ofpusher housing22, one illustration of which appears inFIG. 3. In this use position,needle guide20 may be further adjusted to allowneedle pusher26 to substantially alignneedle24 with a desired location onmedical device12 whensupport90 is in a use position. Accordingly,pusher assembly26 may deliverconnector material60 through material lying betweensupport90 andshaft30, such as mammalian tissue and a wall ofmedical device12.
• Referring now toFIG. 4,support90 may have afirst portion94 and asecond portion96. Thefirst portion94 includes pivot32 attaching toshaft30, allowingsupport90 to rotate about the pivot into a range of positions with respect toshaft30. For endoluminal deployment of the medical device fixation tool, thesupport90 may be pivoted distally into substantial alignment with the shaft (as illustrated inFIG. 6). Alternatively,support90 may be pivoted proximally into substantial alignment with the shaft for deployment.Second portion96 may further include a void92, which may be an aperture, hole, divot, or other void suitable for receivingneedle24 with the rest ofsecond portion96 surroundingvoid92 supporting a portion ofmedical device12. In an alternative embodiment (not shown),support90 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 ofsupport90 to allow the needle to fully pass through pierced material.
• Operation of medicaldevice fixation tool10 can be understood by reference toFIGS. 6 through 13. Referring now toFIG. 6, medicaldevice fixation tool10 is shown in a deployment position capable of endoluminal deployment in a hollow organ orcavity16.Support90 is pivoted distally into substantial alignment withshaft30, andneedle guide20 is adjusted to lie substantially along the face ofshaft30.Needle pusher assembly26 and needle24 (not shown inFIG. 6) are in the deployment position. A needle control handle40 is shown with a graspinghandle42, aneedle guide46 in the deployment position, and a two-partneedle deployment actuator48 in the retracted position. A support control handle50 includes asupport actuator56 in the retracted position. The proximal end oftether62 is shown protruding from the proximal terminus ofshaft30. After a physician has satisfactorily positionedshaft30, such as through an overtube positioned in the hollow organ orcavity16, 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 asshaft30, as best seen inFIG. 1.
• Referring now toFIG. 7,support90 is pivoted into a partially deployed position by rotatingsupport actuator56 on support control handle50. The physician may use graspinghandle52 to aid in manipulation of support control handle50.Actuator56 may be connected to a lead screw (not shown) that converts rotational motion to linear motion of pull wire34, which is connected between the lead screw andsupport90. It will, however, be apparent to the skilled artisan that other ways to accomplish the actuation ofsupport90 are possible.
• Referring now toFIG. 8,needle guide20 is moved to a use position by elongating needle tube21 frompusher housing22. This may be accomplished by slidingneedle guide actuator48 on needle control handle40.Needle guide20 is adjusted to be substantially aligned with the desired path ofneedle pusher assembly26 and, hence, to aim delivery ofneedle24.
• Referring now toFIG. 9,support90 is pivoted into a use position by further rotatingactuator56 oncontrol handle50, as described above. The use position is the position wheresecond portion96 is able to support any portion ofmedical device12 to be transversed byneedle24 against distal movement in the direction of needle travel. In this position,needle24 is substantially aligned withcentral void92, so thatneedle24 may pass into or throughcentral void92.
• Referring now toFIG. 10,needle pusher assembly26 is deployed by distal sliding ofsecond actuator48 on needle control handle40.Needle pusher assembly26 is configured to supportneedle24 in a manner that provides a smooth transition between the outer surface ofneedle deployment tube29 and needle24 (FIG. 14).Needle24 may, in turn, be connected to a distal portion oftether62, which may travel alongshaft30 to a proximal portion in the vicinity of needle control handle50, thereby allowing the operator to accesstether62 after it is connected.Needle deployment filament31 is positioned within deployment tube29 (FIG. 14) and is also movable byneedle deployment actuator48. In particular, a first portion48aofneedle deployment actuator48 moves needledeployment tube29 and a second portion48bofneedle deployment actuator48 moves needledeployment filament31. When both portions48aand48bare moved together, as illustrated inFIG. 10,needle deployment tube29 andneedle deployment filament31 move distally together. The physician may use graspinghandle42 to aid in manipulation ofneedle deployment actuator48. Although linear actuation withneedle deployment actuator48 is disclosed herein, it will be apparent to the skilled artisan that other ways to accomplish the actuation ofneedle deployment tube29 are possible.
• Referring now toFIG. 11, withneedle deployment tube29 andneedle deployment filament31 in use positions,needle24 is deployed by being dislodged fromneedle deployment tube29 by proximal sliding of portion48bofsecond actuator48 on needle control handle40 relative to portion48a. This causesneedle control filament31 to move relative toneedle deployment tube29, thus freeingneedle24 from the needle deployment tube. In the illustrated embodiment, this is accomplished byneedle control filament31 retracting proximally with respect toneedle deployment tube29. However, medicaldevice fixation tool10 could be configured forneedle control filament31 to extend relative toneedle deployment tube29 to deploy the needle. As seen inFIG. 12, movement of actuator portion48awill retractneedle deployment tube29 such thatneedle pusher assembly26 is now fully retracted reversing the motion shown inFIG. 10 and described above.
• Referring now toFIG. 13,support90 can be pivoted to the deployment position substantially aligned withshaft30 in preparation for removal of the medical device fixation tool from hollow organ orcavity16. Such pivoting is accomplished by rotation ofactuator56 on support control handle50, in reverse of actions shown inFIGS. 7 and9 and described above. Central void92 insecond portion96 ofsupport90 clearsconnector material60 andneedle24, if it is present.Needle guide20 may then be adjusted to a deployment position usingfirst actuator46 on needle control handle40, and the medical device fixation tool can be removed from hollow organ orcavity16.
• Referring now toFIG. 14, one embodiment ofconnector material60 is illustrated.Connector material60 includesneedle24 that is integral with a “T”clamp device66, so that after deployment the tip ofneedle24 forms a portion of the top of the “T”.Tether62 forms the trunk of the “T” and is connected to theneedle24, such as by crimping the needle. Thus, afterneedle pusher assembly26 has drivenneedle24 through mammalian tissue,medical device12, or other material,needle24 will rotate and holdtether62 against a distal surface of such material.
• Referring now toFIG. 15, another embodiment is shown of the connector material. In this embodiment, aneedle124 is connected toneedle deployment tube29, so thatneedle124 is manipulable by manipulatingneedle deployment tube29 and will withdraw after deployment. A “T”clamp device166 is contained within ahollow cavity37 ofneedle124 in alignment withneedle deployment filament31. When ready for deployment,needle deployment filament31 ejects “T”clamp device166 fromhollow cavity37, enabling “T”clamp device166 to unfold and anchor against a distal surface of pierced material.Needle124 anddeployment tube29 may be commonly made from a laterally flexible yet longitudinally non-compressible material, such as a Nitinol tube that is ground to a beveled point.Tether62 forms the trunk of the “T” and passes through pierced material, enabling connections or other manipulations from the proximal portion oftether62. Alternatively,tether62 may pass through the barrel ofdeployment tube29 to a proximal terminal portion thereof.
• The embodiment illustrated inFIG. 15 allows the physician to retractneedle124 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.
• Referring now toFIGS. 16 and 17, the proximal end oftether62 may be clamped using a clamp device in the form of abutton64 in the form of adisk70 containing a plurality, such as three (3), of through-openings68.Disk70 may be made of a suitable material, such as polycarbonate, or the like. As illustrated inFIG. 17,button64 is attached to the proximal end of thetether62 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 device12, or other material and snugged up to a desired tension of thetether62, 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 device12, or other material. A roughened portion72 of the surface74 ofdisk70 may be provided to help lock the tether to resist movement ofbutton64. Also, an elongated extension of surface74 (not shown) may be provided on either side of opening68 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 thebutton64 within the esophageal member using a knot pusher.
• In an alternative embodiment, pivot32 can be made adjustable alongshaft30. This allows the amount of tissue captured betweensupport90 andshaft30 to be varied. Also, although the fixation tool is illustrated as a 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.
• Referring now toFIGS. 18 and 20, an alternative embodiment oftether application apparatus110 may include ashaft130 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 apparatus110 may include anactuator140 proximal ofshaft130.Actuator140 remains external the patient during a medical procedure, such as a bariatric device deployment procedure.Shaft130 may be covered by asheath114.Actuator140 may include agrasping handle142, asupport positioning actuator156, aneedle guide actuator146, and aneedle firing actuator148, although certain of these actuators may be combined for ease of use.
• FIGS. 19 and 20 illustratetether application apparatus110 withsupport190 in a deployment position in which it is capable of traversing a patient's esophagus through an overtube. Oncesupport190 is positioned within the stomach, operation ofsupport actuator156 causes support190 to pivot to a use position, as illustrated inFIG. 21. In the illustrative embodiment, this is accomplished by rotating cardiamember support actuator156. However, other mechanical actuating techniques may be used. Once the support is deployed, proximal movement of graspinghandle142 will causesupport190 to provide distal support to the cardia.
• Referring now toFIGS. 22 and 23, once thetether application apparatus110 is oriented properly, a physician operates theneedle guide actuator146 in order to distally move needle guides120. If abariatric device112 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 actuator146 is shown as a slide actuator, but other forms of actuator may be utilized.
• Once thesupport190 is properly supporting the cardia, and the cardiac member if it is present, and the needle guides120 are properly positioned, a physician operatesneedle firing actuator148. This causes needle(s)124 at the distal portion of the tether(s) to move distally into registration withsupport190. 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,support190 includes afirst portion194 andsecond portion196.First portion194 includes a pivot attaching toshaft130, allowingsupport190 to rotate about the pivot into a range of positions with respect toshaft130.Second portion196 may further include avoid192, which may be an aperture, hole, divot, or other void suitable for receivingneedle124 orneedle pusher120 while preventing material from passing intovoid192. In an alternative embodiment (not shown),support190 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 ofsupport190 to allow the needles to fully pass through the cardiac member.
• Referring now toFIGS. 24 and 25, once theneedles124 are properly fired, the operator can remove the tether application apparatus. This may be accomplished by distal movement of the tether application apparatus untilsupport190 is clear of protruding needles124.Support actuator156 can then be operated in order to fold thesupport190 againstshaft130 to traverse the esophagus.
• Although illustrated for use in deployment ofbariatric devices12 and112,tether application apparatuses10 and110 and/orclamp devices64 and66 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.
• Referring now toFIGS. 26 and 27, an alternativetether application apparatus270 includes ahead272 having awindow274 that fires the needle through the tissue. Ahollow shaft276 draws a vacuum atwindow274 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 atube278.Shaft276 may be made flexible to fit the anatomy of the patient, if required.
• Referring now toFIGS. 28 and 29, another alternativetether application apparatus280 includes atether tube282 that passes aneedle284, and attached tether, retroflex from the cardia through the GE junction and into the lower esophagus. It is illustrated as including a slidingneedle guide286 to facilitate passage of the device through the esophagus.
• Referring now toFIGS. 30 and 31, yet another alternativetether application apparatus290 is used to pass aneedle292 of atether294 through the esophagus and into the cardia. Acardia support296 is pivoted at298 to ashaft300. Acable302 is operated by an actuator (not shown) to pivot thecardia support296 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 atube304. Aslot306 incardia support296 facilitates passage ofneedle292 while allowing the cardia to be supported.
• Referring now toFIG. 32, another alternativetether application apparatus310 includes ashaft312 and a spiral formedneedle driver314.Needle driver314 is used to pass aneedle316 having an attachedtether318 through the lower esophagus and the cardia by twistingshaft312 and advancingneedle driver314.
• Referring now toFIGS. 33 and 34, another alternativetether application apparatus320 drives the needle in a retroflex manner from the cardia to the GE junction, then into the esophagus. The device includes aflexible neck322 that is mounted distally on ashaft324 and supports aneedle driver326.Neck322 can be straightened for insertion of the device through the patient's esophagus and formed to the shape illustrated inFIG. 34 by the operation of an actuator (not shown).Needle driver326 drives aneedle328 with attachedtether330 through the cardia, past the GE junction and through the esophageal wall.
• Another alternative embodiment of a medicaldevice fixation tool400 includes a needle driver, such as aneedle pusher assembly420, and a shaft402 (FIGS. 35-37).Shaft402 has a size and configuration to positionneedle driver420 within a hollow organ or cavity through a natural orifice. For example,shaft402 has a length and diameter that is capable of passing through an over-tube positioned in the esophagus and to positionneedle pusher assembly420 in the GE region of the recipient of a medical device such as a bariatric device of the type described in International Patent Application Publication No. WO 2008/101048 A2 entitled BARIATRIC DEVICE AND METHOD.Needle pusher assembly420 is capable of transmitting sufficient force to penetrate the walls of the esophageal and cardiac members of the bariatric device and the intervening tissue.
• Shaft402 has aflexible portion404 and a morerigid end portion406.Flexible portion404 can adapt to various shapes, such as curved paths, to thereby facilitate movement oftool400 through an over-tube in the natural orifice, such as the esophagus of the recipient of the medical device including natural curvature of the esophagus.Tool400 includes asupport408 that is pivotally mounted toshaft402 atend portion406.Support408 is pivotal between the deployment position, illustrated inFIG. 35, in which it is generally in line withshaft402 and a use position, illustrated inFIG. 37, capable of providing support to the medical device as it is penetrated by the needle pusher assembly.Support408 has afirst portion410 that is pivotally mounted toshaft402 by apivot416.Support408 further includes a second,outer portion412 that defines an opening or void414 that allowsneedle pusher assembly420 to pass. Asemi-flexible join418 may be provided betweenportions410 and412 to facilitate flexing ofsupport408 as it passes through the over-tube during deployment, but allows only limited flexing so thatouter portion412 is sufficiently rigid during use. Asupport adjustment wire432 passes through a flexible portion ofshaft404, though opening427 and attaches to support408 in order to adjust the position of the support relative toshaft402. Withsupport408 biased to an extended position in line with the shaft, such as illustrated inFIG. 35, by a torsion spring, or the like, a pulling force applied towire432 will pivotsupport408 to the use position, illustrated inFIG. 37.Wire432 may be actuated by a wire adjustment member444 (FIG. 38) or other such actuator as would be apparent to the skilled artisan.
• Once the medical device is fixed,support adjustment wire432 can be relaxed to allowsupport408 to move to its deployment position in line withshaft404 for removal from the recipient. Other techniques may be used to assist in maintaining the alignment ofsupport408 withshaft402 during deployment of the fixation tool. For example, a small opening could be formed at the distal tip ofsupport408 and passed over a guide wire that has previously been inserted in the recipient, such as through an over-tube in the natural orifice. The guide wire can be used both to guide medicaldevice fixation tool400 through the natural orifice as well as to resistsupport408 from moving out of line withshaft402. Also,support408 may be latched into a position in line withshaft408, using known techniques, during deployment through the over-tube and released to move into its use position once the fixation tool is in position.
• Needle pusher assembly420 includes a needle guide in the form of aneedle housing426 that is pivotally mounted distally to endportion406 ofshaft402 by a pivotally mountedyoke422. As best seen inFIG. 36,yoke422 is pivotally mounted in anopening427 ofend portion406 by apivot424.Needle pusher assembly420 further includes a needle pusher assembly in the form of aneedle assembly428 that is axially moveable withinhousing426 between a retracted position illustrated inFIG. 35 and an extended position illustrated inFIG. 37. In the illustrated embodiment,needle assembly428 is made from a laterally flexible yet longitudinally non-compressible material, such as a Nitinol tube that is ground to abevel point429 in a similar fashion as the combination of needle224 and deployment tube229 previously described.Needle assembly428 is hollow having an axial through-passage that houses a T-fastener (not shown, similar tofastener166 previously described),adjacent point429, a tether (not shown, similar totether62 previously described), extending from the T-fastener and a needle control filament430 (FIG. 39) that extends out the proximal end ofneedle assembly428.Needle control filament430 is axially moveable by an actuator (not shown) to dislodge the T-fastener distally from the needle assembly after the needle assembly has penetrated the medical device, such as the cardiac member of the bariatric device.Needle housing426 may be made as a hollow flexible cable, such as from a polymeric tube, such as a polymide tube, with a wire wound around the tube to provide stiffness and abrasion resistance.
• Medicaldevice fixation tool400 includes an aimingdevice433 for aiming the needle pusher driver relative toshaft402. In the illustrative embodiment, aimingdevice433 is made up of awire434 that is looped aroundneedle housing426 and extends thoughshaft402 to a proximal actuator, such as a wire adjustment member444 (FIG. 38).Yoke422 may be spring biased, such as by a torsion spring, or the like, into an orientation (not illustrated) withneedle housing426 close toflexible portion404. This maintains a small diameter fortool400 to pass through the natural orifice during deployment. Whenadjustment member444 retractswire434, the force onneedle housing426 overcomes the biasing force onyoke422 and pivots the housing to a use position, such as that illustrated inFIGS. 35-37. This aims the needle pusher driver in the direction ofvoid414. It also allows the physician to steerneedle assembly428 relative to the medical device, as necessary, to properly position the tether. An alternative embodiment ofyoke422 may include a cam surface (not shown) withneedle aiming wire434 passing over the cam surface proximally to its attachment toneedle housing426. This would create a lever effect to thereby increase the amount of torque that could be applied bywire434 toyoke422 for a given amount of force applied to the wire, as would be apparent to the skilled artisan. Also, other forms of an aimingdevice433, such as a worm gear operated by a rotary shaft, or the like, would be apparent to the skilled artisan.
• In the illustrated embodiment,flexible portion404 is made from a flexible polymer tube, such as of the type available from Kientec Systems, Inc. or MicroLumen.Wires432 and434 may be routed through channels or tubes formed, such as from Nitinol tubes withinshaft402 or along the shaft. For particular applications, such as a reusable medical device fixation tool, an outer cover may be applied toflexible portion404 to add durability and to increase smoothness. It should be apparent to the skilled artisan that the medical device fixation tool described herein can be made as a single-use device. The medicaldevice fixation tool400 can also be combined with the medical device to provide a combination fixation tool andmedical device450 in order to both deploy and fix the medical device within a body cavity through a natural orifice. In the case of abariatric device12, the cardiac member12acould be compressed in proper orientation with respect to support408 with the esophageal member12baroundshaft402. Cardiac member12acan be held in a compressed state with a wire orother filament452 wound around the cardiac member12a. Esophageal member12bcan be held in a compressed state with a wire orother filament454 wound around esophageal member12b. Once the combination fixation tool andbariatric device450 is properly positioned within the recipient, thefilaments452 and454 holding the bariatric device members12a,12bin their compressed states and can be pulled in order to release the members12a,12bto expand to their deployed state. Because thefixation tool400 is already aligned with the bariatric device, thesupport408 can be actuated to its use position and theneedle guide426 actuated to its aimed position to apply the tether(s). However, the medical device could be deployed separately from the fixation tool, if desired.
• While various actuators may be used to operateneedle pusher assembly420,support adjustment wire432, andneedle aiming wire434, medicaldevice fixation tool400 may include anactuator assembly440 that is illustrated inFIGS. 38-43.Actuator assembly440 may include aneedle deployment actuator442 that is attached to a base441 affixed proximally toshaft402.Needle deployment actuator442 includes anextension448 of base441and aplunger445 that is moveable with respect toextension448.Needle deployment actuator442 may be configured to limit movement ofneedle assembly428. This reduces the likelihood ofneedle assembly428 inadvertently rupturingneedle housing426 by being retracted too far into the housing.
• Referring to drawingFIGS. 38-43,needle deployment actuator442 includes aplunger445 having abarrel446 that moves linearly with respect toextension448. One end ofbarrel446 graspsneedle assembly428 via aclamp450 and aknurled nut452 that tightensclamp450 toneedle assembly428 whennut452 engages mating threads on anadapter454 that threads intobarrel446. The other end ofbarrel446 is restrained for limited motion with respect toextension448. This is accomplished by a threadedstop456 that holds anotherknurled nut458 for limited sliding motion with respect toextension448.Knurled nut458 threads intobarrel446. In addition to limiting movement ofplunger445, and, hence,needle assembly428, the components of theneedle deployment actuator442 can be disassembled to allow for cleaning and sterilization as needed.
• Actuator assembly440 may further include separatewire adjustment members444 for longitudinally displacingwires432 and434, although only onewire adjustment member444 is illustrated.Member444 includes aclasp460 that grasps a proximal end of awire432,434 and arotary knob462 attached to clasp460.Knob462 is threadably engaged with a threadedtube464 that extends frombase441. Asknob462 is rotated, the large threads between the knob andtube464 provide fine movement of therespective wires430,432.
• 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 (20)

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

1. A method of fixing a bariatric device against distal migration, said bariatric device having an esophageal member with an esophageal wall that is configured to the shape and size of a portion of the esophagus and a cardiac member having a cardiac wall that is configured to generally conform to the shape and size of a portion of the cardiac portion of the stomach, said method comprising:

positioning the bariatric device with the esophageal member at the abdominal portion of the esophagus and the cardiac member at the cardiac portion of the stomach;

passing a tether through the esophageal wall of the esophageal member, through a wall of the esophagus, through a wall of the stomach and through the cardiac wall of the cardiac member, one end portion of the tether restrained at the esophageal wall and an opposite end portion of the tether restrained at the cardiac wall.

2. The method as claimed inclaim 1 wherein said passing a tether includes passing a needle assembly through the esophageal wall of the esophagus member, through the wall of the esophagus, through the wall of the stomach and through the cardiac wall of the cardiac member, said tether connected with said needle assembly.

3. The method as claimed inclaim 2 wherein said needle assembly includes a tubular member having a sharpened end portion at a distal end thereof and a T-shaped device in a cavity in said needle assembly, said tether attached to said T-shaped device, said tether restrained at the cardiac wall with said T-shaped device.

4. The method as claimed inclaim 3 wherein said tubular member is hollow and including fastener deployment filament passing through said tubular member to deploy said T-shaped device from said needle assembly.

5. The method as claimed inclaim 2 including positioning a support at said cardiac wall and supporting said cardiac wall and said esophageal wall with said support while passing said needle assembly through the esophageal wall of the esophagus member, through the wall of the esophagus, through the wall of the stomach and through the cardiac wall of the cardiac member.

6. The method as claimed inclaim 5 wherein said positioning a support comprises passing a shaft with said support attached thereto through the esophagus and into the stomach.

7. The method as claimed inclaim 6 including a needle guide attached to said shaft and wherein said passing a needle assembly includes guiding said needle assembly in said needle guide.

8. The method as claimed inclaim 6 including aligning said support with said shaft to pass said support though the esophagus and into the stomach and deploying said support at an angle to said shaft when said support is in the stomach.

9. The method as claimed inclaim 1 wherein the bariatric device includes a connector connecting said esophageal member and said cardiac member, said method further including positioning said connector at the esophageal-gastric junction.

10. The method as claimed inclaim 9 including positioning said connector opposite the angle of His and passing said tether at the angle of His.

11. The method as claimed inclaim 9 including connecting said connector with said esophageal member and said cardiac member external the recipient of the bariatric device and passing said tether in situ.

12. The method as claimed inclaim 1 wherein said passing a tether includes passing a plurality of tethers, each through the esophageal wall of the esophageal member, through a wall of the esophagus, through a wall of the stomach and through the cardiac wall of the cardiac member.

13. A method of fixing a bariatric device against distal migration, said bariatric device having an esophageal member with an esophageal wall that is configured to the shape and size of a portion of the esophagus, a cardiac member with a cardiac wall that is configured to generally conform to the shape and size of a portion of the cardiac portion of the stomach and a connector connecting said esophageal member and said cardiac member, said method comprising:

positioning the bariatric device with the esophageal member at the abdominal portion of the esophagus, the cardiac member at the cardiac portion of the stomach and the connector passing through the esophageal-gastric junction;

positioning a support at said cardiac wall, wherein said support is positioned at a distal end portion of a shaft, wherein said positioning said support includes passing said shaft through the esophagus and into the stomach;

passing a needle assembly with a tether attached thereto through the esophageal wall of the esophagus member, through a wall of the esophagus, through a wall of the stomach and through the cardiac wall of the cardiac member with said support providing resistance to movement of said esophageal member and said cardiac member as said needle assembly penetrates said esophageal member and said cardiac member; and

terminating said tether at said esophageal wall and said cardiac wall.

14. The method as claimed inclaim 13 wherein said needle assembly includes a tubular member having a sharpened end portion at a distal end thereof and a T-shaped device in a cavity in said needle assembly, said tether attached to said T-shaped device, wherein said terminating said tether includes positioning with said T-shaped device against said cardiac wall.

15. The method as claimed inclaim 14 wherein said tubular member is hollow and including fastener deployment filament passing through said tubular member to deploy said T-shaped device from said needle assembly.

16. The method as claimed inclaim 15 including aligning said support with said shaft to pass said support though the esophagus and into the stomach and deploying said support at an angle to said shaft when said support is in the stomach.

17. The method as claimed inclaim 13 including aligning said support with said shaft to pass said support though the esophagus and into the stomach and deploying said support at an angle to said shaft when said support is in the stomach.

18. The method as claimed inclaim 13 including positioning said connector opposite the angle of His and passing said tether at the angle of His.

19. The method as claimed inclaim 13 including passing a plurality of tethers, each through the esophageal wall of the esophageal member, through a wall of the esophagus, through a wall of the stomach and through the cardiac wall of the cardiac member.

20. The method as claimed inclaim 13 including a needle guide attached to said shaft and wherein said passing a needle assembly includes guiding said needle assembly in said needle guide.

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