Methods and apparatus for treating body tissue sphincters and the like

• US 10,398,440 B2
• Filed: 07/29/2014
• Issued: 09/03/2019
• Est. Priority Date: 04/26/2002
• Status: Active Grant

• Current Assignee: Torax Medical, Inc. (Johnson & Johnson)
• Original Assignee: Torax Medical, Inc. (Johnson & Johnson)
• Inventors: Kugler, Chad J., Grudem, Jr., Jerome K., Berg, Todd A., Swanson, William J.
• Primary Examiner(s): Simpson, Sarah A
• Application Number:
  US14/445,723
• Publication Number:
  US 20140336696A1
• Time in Patent Office: 1,862 Days
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/12018 Elastic band ligators
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 5/005 Gastric bands
• CPC Class Codes: A61F 5/0069 in the wall of the stomach

Abstract

A plurality of structures that resiliently attract one another are provided for implanting in a patient around a body tissue structure of the patient. For example, the body tissue structure may be the esophagus, and the plurality of structures may be implanted in an annulus around the outside of the esophagus, the annulus being substantially coaxial with the esophagus. The attraction may be between annularly adjacent ones of the structures in the annulus, and it may be provided, for example, by magnets or springs. The array of structures is preferably self-limiting with respect to the smallest area that it can encompass, and this smallest area is preferably large enough to prevent the apparatus from applying excessive pressure to tissue passing through that area.

Claims

1. A surgical method of treating a patient'"'"'s internal body tissue structure, the method comprising:

(a) sizing a site on an internal tissue structure; and

(b) surgically implanting a sized apparatus comprising a plurality of magnetic bodies in an array to annularly surround the site on the tissue structure such that the apparatus applies resilient pressure to the tissue structure and such that each of the magnetic bodies contacts the tissue structure, the apparatus being self-limiting with respect to a smallest area that the apparatus encompasses, the smallest area being a non-zero area, wherein each magnetic body is magnetically attracted to an adjacent magnetic body, wherein each magnetic body comprises a magnet and a biocompatible housing assembly, wherein the biocompatible housing assembly defines a first cavity and a second cavity, wherein the first cavity comprises a biocompatible surface that extends from a first open end into a second open end of the biocompatible housing assembly, wherein the first cavity is isolated from the second cavity, wherein the second cavity houses the magnet, each magnetic body in the array having a structural link housed within the first cavity, wherein the structural link connects each magnetic body to a next adjacent magnetic body in the array, each of the structural links allowing the magnetic bodies it connects to move apart from one another in a direction that is annular of the array, and each of the structural links including a stop that is trapped but movable inside one of the magnetic bodies it connects for stopping such movement apart of the magnetic bodies it connects when spacing between those magnetic bodies reaches a maximum spacing, each structural link being unconnected to any annularly adjacent structural link except by the magnetic body between that structural link and the annularly adjacent structural link, wherein each structural link is bent laterally along its length.

2. The method defined in claim 1 wherein the implanting comprises:

(i) delivering the apparatus into the patient'"'"'s body in a substantially linear form,

(ii) wrapping the apparatus around the tissue structure, and

(iii) attaching ends of the apparatus to one another.

3. A surgical method of treating a patient'"'"'s internal body tissue structure, the method comprising:

(a) sizing a site on an internal tissue structure; and

(b) surgically implanting a sized apparatus including a plurality of magnetic bodies in an array to annularly surround the tissue structure for applying resilient pressure to the tissue structure and such that each of the magnetic bodies contacts the tissue structure, the apparatus being self-limiting with respect to a largest area that the apparatus encompasses, wherein each magnetic body is magnetically attracted to an adjacent magnetic body, wherein each magnetic body comprises a biocompatible housing assembly and a magnet, wherein the biocompatible housing assembly defines a first cavity and a second cavity, wherein the first cavity and the second cavity are isolated from each other, wherein the second cavity houses the magnet, wherein each magnetic body in the array comprises a structural link slidably housed within the first cavity and connected to a next adjacent magnetic body in the array, each of the structural links allowing the magnetic bodies it connects to move apart from one another in a direction that is annular of the array, and each of the structural links including a stop that is trapped but movable inside one of the magnetic bodies it connects for stopping such movement apart of the magnetic bodies it connects when spacing between those magnetic bodies reaches a maximum spacing, each structural link being unconnected to any annularly adjacent structural link except by the magnetic body between that structural link and the annularly adjacent structural link, wherein each structural link is bent laterally along its length.

4. A surgical method of treating a patient'"'"'s internal body tissue structure, the method comprising:

(a) sizing a site on an internal tissue structure; and

(b) surgically implanting a sized annularly continuous apparatus including a plurality of magnetic bodies in an array to annularly surround the tissue structure for applying resilient pressure to the tissue structure and such that each of the magnetic bodies contacts the tissue structure, the apparatus being self-limiting with respect to a smallest area that the apparatus encompasses, the smallest area being a non-zero area, wherein each magnetic body is magnetically attracted to an adjacent magnetic body, wherein each magnetic body comprises a biocompatible housing, wherein the biocompatible housing comprises a first mating component and a second mating component configured to couple with each other to define a magnetic housing, wherein the first mating component comprises a hollow post defining a through hole, wherein the through hole is isolated from the magnetic housing, wherein each magnetic body in the array comprises a structural link slidably housed within the hollow post, wherein the structural link connects to a next adjacent magnetic body in the array, each of the structural links allowing the magnetic bodies it connects to move apart from one another in a direction that is annular of the array, and each of the structural links including a stop that is trapped but movable inside one of the magnetic bodies it connects for stopping such movement apart of the magnetic bodies it connects when spacing between those magnetic bodies reaches a maximum spacing, each structural link being unconnected to any annularly adjacent structural link except by the magnetic body between that structural link and the annularly adjacent structural link, wherein each structural link is bent laterally along its length.

5. A surgical method of treating a patient'"'"'s internal body tissue structure, the method comprising:

(a) sizing a site on an internal tissue structure; and

(b) surgically implanting a sized apparatus comprising a plurality of magnetic bodies in an array to annularly surround the tissue structure such that each of the magnetic bodies contacts the tissue structure for applying resilient pressure to the tissue structure while allowing the tissue structure to resiliently change the radius of curvature of the tissue structure, the apparatus being self-limiting with respect to a smallest area that the apparatus encompasses, the smallest area being a non-zero area, wherein each magnetic body is magnetically attracted to an adjacent magnetic body, wherein each magnetic body comprises a magnet and a biocompatible housing assembly, wherein the biocompatible housing assembly defines a first cavity and a second cavity, wherein the first cavity comprises a biocompatible surface that extends from a first open end into a second open end of the biocompatible housing assembly, wherein the first cavity is isolated from the second cavity, wherein the second cavity houses the magnet, each magnetic body in the array having a structural link housed within the first cavity, wherein the structural link connects each magnetic body to a next adjacent magnetic body in the array, each of the structural links allowing the magnetic bodies it connects to move apart from one another in a direction that is annular of the array, and each of the structural links including a stop that is trapped but movable inside one of the magnetic bodies it connects for stopping such movement apart of the magnetic bodies it connects when spacing between those magnetic bodies reaches a maximum spacing, each structural link being unconnected to any annularly adjacent structural link except by the magnetic body between that structural link and the annularly adjacent structural link, wherein each structural link is bent laterally along its length.

6. A surgical method of treating a patient'"'"'s internal body tissue structure, the method comprising:

(a) sizing a site on an internal body tissue structure;

(b) surgically implanting a sized prosthesis comprising a plurality of magnetic bodies in an array into the patient'"'"'s body in a discontinuous form;

(c) disposing the prosthesis around the site on the tissue structure such that the array of magnetic bodies annularly surround the tissue structure so that each of the magnetic bodies contacts the tissue structure; and

(d) converting the prosthesis to a continuous form around the site on the tissue structure, wherein each magnetic body is magnetically attracted to an adjacent magnetic body, wherein each magnetic body comprises a biocompatible housing assembly and a magnet, wherein the biocompatible housing assembly defines a first cavity and a second cavity, wherein the first cavity and the second cavity are isolated from each other, wherein the second cavity houses the magnet, wherein each magnetic body in the array comprises a structural link connecting it to a next adjacent magnetic body in the array, each of the structural links allowing the magnetic bodies it connects to move apart from one another in a direction that is annular of the array, and each of the structural links including a stop that is trapped but movable inside one of the magnetic bodies it connects for stopping such movement apart of the magnetic bodies it connects when spacing between those magnetic bodies reaches a maximum spacing, each structural link being unconnected to any annularly adjacent structural link except by the magnetic body between that structural link and the annularly adjacent structural link, wherein each structural link is bent laterally along its length.

7. A surgical method of treating an internal body passage, the method comprising:

(a) sizing a site on an internal body passage, the body passage having an outside with a wall;

(b) surgically implanting and disposing a sized band comprising a plurality of magnetic bodies in an array at the site annularly around the outside of the body passage, the band being configured to provide radial support to the body passage; and

(c) securing at least a portion of the band to the wall of the body passage such that each of the magnetic bodies contacts the body passage, wherein each magnetic body is magnetically attracted to an adjacent magnetic body, wherein each magnetic body comprises a biocompatible housing and a magnet, wherein the biocompatible housing comprises a first mating component and a second mating component configured to couple with each other to define a magnetic housing, wherein the first mating component comprises a hollow post defining a through hole, wherein the through hole is isolated from the magnetic housing, wherein each magnetic body in the array comprises a structural link connecting it to a next adjacent magnetic body in the array, each of the structural links allowing the magnetic bodies it connects to move apart from one another in a direction that is annular of the array, and each of the structural links including a stop that is trapped but movable inside one of the magnetic bodies it connects for stopping such movement apart of the magnetic bodies it connects when spacing between those magnetic bodies reaches a maximum spacing, each structural link being unconnected to any annularly adjacent structural link except by the magnetic body between that structural link and the annularly adjacent structural link, wherein each structural link is bent laterally along its length.

8. The method defined in claim 7 wherein the body passage is an esophagus.

9. The method defined in claim 7 wherein the securing comprises:

suturing at least a portion of the band to the wall of the body passage.

10. The method defined in claim 7 wherein the band is configured to allow expansion of the body passage.

11. A method of treating an internal body passage, the method comprising:

(a) sizing a site on an internal body passage having an outside; and

(b) surgically implanting and disposing a sized band comprising a plurality of magnetic bodies in an array at the site annularly around the outside of the body passage such that each of the magnetic bodies contacts the outside of the body passage, the band being configured to provide inwardly directed radial support to the body passage, wherein the band is configured to allow expansion of the body passage, wherein each magnetic body is magnetically attracted to an adjacent magnetic body, wherein each magnetic body comprises a magnet and a biocompatible housing assembly, wherein the biocompatible housing assembly defines a first cavity and a second cavity, wherein the first cavity comprises a biocompatible surface that extends from a first open end into a second open end of the biocompatible housing assembly, wherein the first cavity is isolated from the second cavity, wherein the second cavity houses the magnet, wherein each magnetic body in the array comprises a structural link connecting it to a next adjacent magnetic body in the array, each of the structural links allowing the magnetic bodies it connects to move apart from one another in a direction that is annular of the array, and each of the structural links including a stop that is trapped but movable inside one of the magnetic bodies it connects for stopping such movement apart of the magnetic bodies it connects when spacing between those magnetic bodies reaches a maximum spacing, each structural link being unconnected to any annularly adjacent structural link except by the magnetic body between that structural link and the annularly adjacent structural link, wherein each structural link is bent laterally along its length.

12. The method defined in claim 11 further comprising:

securing at least a portion of the band to a wall of the body passage.

13. The method defined in claim 12 wherein the securing comprises:

suturing at least a portion of the band to the wall of the body passage.

14. The method defined in claim 11 wherein the body passage is an esophagus.