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05/01/08 | 1 views | #20080103441 | Prev - Next | USPTO Class 604 | About this Page  604 rss/xml feed  monitor keywords

Inside out t-fastener system

USPTO Application #: 20080103441
Title: Inside out t-fastener system
Abstract: A medical device for providing wall apposition of two bodily walls in accordance with the teachings of the present invention. The medical device is used at a previously formed puncture site having perforations formed in the walls. By way of example, the two walls are described herein as the abdominal and gastric walls, although it will be recognized that any two bodily walls may be fastened together utilizing the medical device and the methods described herein. It will also be understood that the procedures described herein may be performed using image guidance such as fluoroscopy, although the device and method may readily be performed without such assistance. (end of abstract)
Agent: Brinks Hofer Gilson & Lione/chicago/cook - Chicago, IL, US
Inventor: Jeffry S. Melsheimer
USPTO Applicaton #: 20080103441 - Class: 604 9601 (USPTO)

The Patent Description & Claims data below is from USPTO Patent Application 20080103441.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001]This application claims the benefit of U.S. Provisional Application Ser. No. 60/854,592 filed on Oct. 26, 2006, entitled "INSIDE OUT T-FASTENER", the entire contents of which are incorporated herein by reference.

FIELD OF THE INVENTION

[0002]The present invention relates generally to medical devices and procedures for wall apposition utilizing tissue fasteners such as "T-fasteners" or "T-anchors", and more particularly relates to percutaneous image-guided placement of such fasteners and gastrostomy tubes.

BACKGROUND OF THE INVENTION

[0003]The percutaneous image-guided placement of gastrostomy tubes is generally considered safer than endoscopic or surgical placement, but is usually limited to smaller diameter gastrostomy tubes and/or the use of T-fasteners so as not to push the gastric wall away from the abdominal wall. It has been found that one difficulty in using T-fasteners in this manner is that the fasteners sometimes go into the abdominal wall at unfavorable angles, or with unfavorable spacing, such that their efficacy is compromised or an excessive number of T-fasteners are necessary to place the tube.

BRIEF SUMMARY OF THE INVENTION

[0004]A medical device and method is provided for obtaining wall apposition of two bodily walls which reliably and accurately places fasteners at favorable angles, and in a controllable pattern that minimizes the number of fasteners required. The medical device generally includes an access cannula, a guide tube, and a flexible puncturing device. The guide tube is sized to be slidably received by the access cannula and is operable between a first linear configuration and a second non-linear configuration. The flexible puncturing device is sized to be slidably received by the guide tube. The method for providing apposition of two bodily walls utilizes this medical device and generally comprises the steps of forming a puncture site through the two walls, inserting the access cannula into the puncture site, passing the guide tube through the outer cannula, positioning a distal end of the guide tube proximate one of the walls, passing the flexible puncturing device through the guide tube and puncturing the two walls, connecting a fastener to the puncture device, retracting the puncture device to draw the fastener through the two walls, and securing the fastener to maintain apposition of the two walls.

[0005]According to more detailed aspects, the guide tube retroflexes in the second configuration for engagement of one of the bodily walls. A distal end of the guide tube in the second configuration is thus laterally spaced from the access cannula and is generally rotated about 180 degrees relative to its position in the first configuration. The guide tube is preferably formed of a shape memory material, and may either be biased towards the second non-linear configuration, or may be temperature dependent. In the latter case, the transition temperature is at about body temperature. In the former case, the access cannula is rigid and is used to straighten the guide tube into the first linear configuration. A distal end of the guide tube preferably includes an inflatable balloon for engagement of one of the bodily walls.

[0006]According to other additional features of the present invention, the positioning of the guide tube includes advancing and retracting the guide tube to engage one of the walls at a desired location. After placement of one fastener, the guide tube may be advanced to disengage the bodily wall, rotated (about an axis of the access cannula), and then retracted to position a distal end of the guide tube at a location spaced from the previously placed fastener. The steps may be repeated with a plurality of fasteners, resulting in a generally circular configuration of fasteners around the primary puncture site. One of many possible uses of the medical device and method is to obtain wall apposition of the abdominal and gastric walls, wherein the primary puncture site is used for placement of a gastrostomy tube.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007]The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention. In the drawings:

[0008]FIG. 1A is a cross-sectional view of a medical device constructed in accordance with the teachings of the present invention;

[0009]FIGS. 1B and 1C illustrate deployment of the medical device in FIG. 1A;

[0010]FIG. 2 is a cross-sectional view of the medical device depicted in FIG. 1A, showing its guide tube in a second configuration;

[0011]FIG. 3A is a cross-sectional view taken about the line 3-3 in FIG. 2, while FIG. 3B and FIG. 3C are cross-sectional views similar to FIG. 3A but showing alternate embodiments of the medical device constructed in accordance with the teachings of the present invention;

[0012]FIGS. 4-6 illustrate the placement of a fastener utilizing the medical device depicted in FIG. 1A;

[0013]FIG. 7 is cross-sectional view illustrating the placement of an additional fastener; and

[0014]FIG. 8 is a plan view schematically illustrating the placement of several fasteners utilizing the medical device and method of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0015]Turning now to the figures, FIGS. 1A-1C and 2 depict an embodiment of a medical device 30 for providing wall apposition of two bodily walls 10, 12 in accordance with the teachings of the present invention. The medical device 30 is used at a previously formed puncture site 14 having perforations 16, 18 formed in the walls, 10, 12, respectively. By way of example, the two walls 10, 12 are described herein as the abdominal and gastric walls, although it will be recognized that any two bodily walls may be fastened together utilizing the medical device 30 and the methods described herein. It will also be understood that the procedures described herein may be performed using image guidance such as fluoroscopy, although the device and method may readily be performed without such assistance.

[0016]To form the puncture site 14, a puncture device such a needle or a trocar is utilized to initially pass through the abdominal and gastric walls, 10, 12, and then deliver a wire guide 20 therethrough, although any known or future cutting means may be utilized. Various dilators (not shown) may be used to enlarge the initial openings to a size sufficient to receive the medical device 30. For example, an initial 16 gauge puncture needle may be utilized, which is then enlarged with dilators to approximately 20 french, for receiving the medical device 30.

[0017]The medical device 30 generally includes an access cannula 32, a guide tube 38 and a flexible puncturing device 48 (FIG. 4). The access cannula 32 and guide tube 38 may be placed over the wire guide 20, and the wire guide 20 is then removed. A loading dilator may be used during the initial access to take up the space between guide tube 38 and the wire guide 20 (or between guide tube 38 and puncture needle). The access cannula 32 defines an interior lumen 34 for receiving the guide tube 38, and may also include a handle 36 at its proximal end for providing easy manipulation thereof. The access cannula 32 is preferably formed of a rigid and dimensionally stable material, such as stainless steel or another metal, although this is not a necessary requirement and the access cannula can be flexible.

[0018]Once the access cannula 32 and guide tube 38 are positioned within the puncture site 14, the guide tube 38 may then be advanced relative to the access cannula 32, as shown in FIG. 2. The guide tube 38 also defines an interior lumen 40 and includes a handle 42 at its proximal end to facilitate manipulation and translation of the guide tube 38 relative to the access cannula 32. The handle 42 includes threaded connector 45 for attachment various instruments or devices such as the aforementioned dilator. The guide tube 38 is operable between a first linear configuration as depicted in FIG. 1A and a second non-linear configuration such as depicted in FIG. 2. In one preferred construction, the guide tube 38 is formed (at least in part) of a shape memory material such as nitinol or other similar alloys. As such, the guide tube 38 will be temperature dependent and is designed to transition between the first and second configurations at about body temperature. For example, the guide tube 38 is introduced into the patient at a temperature below body temperature and is a first entry. As the guide tube 38 is warmed to body temperature, it then assumes the second configuration.

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