MEDICAL DEVICE FIXATION TOOL AND METHOD OF FIXATION OF A MEDICAL DEVICE
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.
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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 INVENTIONThe 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 INVENTIONThe 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.
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 (
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 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. 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.
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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
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
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Operation of medical device fixation tool 10 can be understood by reference to
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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 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.
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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 into 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 into 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.
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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.
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Another alternative embodiment of a medical device fixation tool 400 includes a needle driver, such as a needle pusher assembly 420, and a shaft 402 (
Shaft 402 has a flexible portion 404 and a more rigid end portion 406. Flexible portion 404 can adapt to various shapes, such as curved paths, to thereby facilitate movement of tool 400 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. Tool 400 includes a support 408 that is pivotally mounted to shaft 402 at end portion 406. Support 408 is pivotal between the deployment position, illustrated in
Once the medical device is fixed, support adjustment wire 432 can be relaxed to allow support 408 to move to its deployment position in line with shaft 404 for removal from the recipient. Other techniques may be used to assist in maintaining the alignment of support 408 with shaft 402 during deployment of the fixation tool. For example, a small opening could be formed at the distal tip of support 408 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 medical device fixation tool 400 through the natural orifice as well as to resist support 408 from moving out of line with shaft 402. Also, support 408 may be latched into a position in line with shaft 408, 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 assembly 420 includes a needle guide in the form of a needle housing 426 that is pivotally mounted distally to end portion 406 of shaft 402 by a pivotally mounted yoke 422. As best seen in
Medical device fixation tool 400 includes an aiming device 433 for aiming the needle pusher driver relative to shaft 402. In the illustrative embodiment, aiming device 433 is made up of a wire 434 that is looped around needle housing 426 and extends though shaft 402 to a proximal actuator, such as a wire adjustment member 444 (
In the illustrated embodiment, flexible portion 404 is made from a flexible polymer tube, such as of the type available from Kientec Systems, Inc. or MicroLumen. Wires 432 and 434 may be routed through channels or tubes formed, such as from Nitinol tubes within shaft 402 or along the shaft. For particular applications, such as a reusable medical device fixation tool, an outer cover may be applied to flexible portion 404 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 medical device fixation tool 400 can also be combined with the medical device to provide a combination fixation tool and medical device 450 in order to both deploy and fix the medical device within a body cavity through a natural orifice. In the case of a bariatric device 12, the cardiac member 12a could be compressed in proper orientation with respect to support 408 with the esophageal member 12b around shaft 402. Cardiac member 12a can be held in a compressed state with a wire or other filament 452 wound around the cardiac member 12a. Esophageal member 12b can be held in a compressed state with a wire or other filament 454 wound around esophageal member 12b. Once the combination fixation tool and bariatric device 450 is properly positioned within the recipient, the filaments 452 and 454 holding the bariatric device members 12a, 12b in their compressed states and can be pulled in order to release the members 12a, 12b to expand to their deployed state. Because the fixation tool 400 is already aligned with the bariatric device, the support 408 can be actuated to its use position and the needle guide 426 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 operate needle pusher assembly 420, support adjustment wire 432, and needle aiming wire 434, medical device fixation tool 400 may include an actuator assembly 440 that is illustrated in
Referring to drawing
Actuator assembly 440 may further include separate wire adjustment members 444 for longitudinally displacing wires 432 and 434, although only one wire adjustment member 444 is illustrated. Member 444 includes a clasp 460 that grasps a proximal end of a wire 432, 434 and a rotary knob 462 attached to clasp 460. Knob 462 is threadably engaged with a threaded tube 464 that extends from base 441. As knob 462 is rotated, the large threads between the knob and tube 464 provide fine movement of the respective wires 430, 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
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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 9 including positioning said connector opposite the angle of His and passing said tether at the angle of His.
11. The method as claimed in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 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 in claim 13 including positioning said connector opposite the angle of His and passing said tether at the angle of His.
19. The method as claimed in claim 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 in claim 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.
International Classification: A61B 17/04 (20060101);