Method of promoting tissue adhesion

• US 20040034371A1
• Filed: 06/05/2003
• Published: 02/19/2004
• Est. Priority Date: 05/18/2001
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Lehman, Glen, Filipi, Charles J.
• Granted Patent: US 8,105,351 B2
• Time in Patent Office: Days
• US Class Current: 606/144
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00619 Welding
• CPC Class Codes: A61B 2018/1253 monopolar

Abstract

The present invention provides methods and devices for promoting tissue adhesion, which utilizes the healing process and scar tissue formation to bond two tissue surfaces together. A tissue injury is accomplished by destroying the mucosal layer of tissue. After the injury is initiated, the tissue is preferably held in close contact by a tissue apposition means such as a suture, staple or clip device placed adjacent to the treatment site. The tissue injury may be initiated by electrical/radiofrequency energy; chemical or mechanical means integrated with the tissue apposition device or delivered by a separate instrument such as an electrocautery catheter through an endoscope. As scar tissue created by the injury forms, the tissue surfaces become bonded together in a permanent union.

Claims

1. A method of promoting tissue adhesion between tissue surfaces comprising:

injuring an area of the each tissue surface to be joined to initiate an injury response in the tissue that will result in scar tissue formation;

securing the injured tissue surfaces in contact for at least the period encompassing the resulting scar tissue formation.

2. A method of promoting tissue adhesion as defined in claim 1 wherein the tissue surfaces are secured in contact by a suture placed adjacent the injured tissue area.

3. A method of promoting tissue adhesion as defined in claim 2 wherein the suture is secured by a knot.

4. A method of promoting tissue adhesion as defined in claim 2 wherein the suture is secured by a suture lock device.

5. A method of promoting tissue adhesion as defined in claim 1 wherein the tissue surfaces are secured by a staple placed adjacent to the injured tissue areas.

6. A method of promoting tissue adhesion as defined in claim 1 wherein the injury destroys the mucosal layer of the affected areas of tissue.

7. A method of promoting tissue adhesion as defined in claim 1 wherein the injury is created by electrical energy.

8. A method of promoting tissue adhesion as defined in claim 7 wherein the energy is radiofrequency energy.

9. A method of promoting tissue adhesion as defined in claim 7 wherein the radiofrequency energy is applied by an electrocautery catheter.

10. A method of promoting tissue adhesion as defined in claim 1 wherein the injury is created by a chemical substance.

11. A method of promoting tissue adhesion as defined in claim 10 wherein injury is created by application of sodium oleate.

12. A method of promoting tissue adhesion as defined in claim 7 wherein the injury created by the radiofrequency energy is supplemented by application of sodium oleate.

13. A method of promoting tissue adhesion as defined in claim 1 wherein the injury is created by mechanical means to abrade the tissue.

14. A method of promoting tissue adhesion as defined in claim 1 wherein the tissue surfaces comprise external tissue of the human body.

15. A method of promoting tissue adhesion as defined in claim 1 wherein the tissue surfaces comprises internal tissue of the human body.

16. A method of promoting tissue adhesion as defined in claim 15 wherein the injury is created between and on facing surfaces of tissue folds previously collected and through which a suture has been passed.

17. A method of promoting tissue adhesion as defined in claim 16 further comprising tightening the suture to draw the tissue folds and injured surfaces together after the injury has been created.

18. A method of promoting tissue adhesion as defined in claim 16 further comprising tightening the suture to draw the tissue folds together, inserting tissue injury means between the folds to create an injury area between the folds and on the facing surfaces of the folds.

19. A method of promoting tissue adhesion between surfaces of tissue comprising:

collecting a first tissue area into a first fold,

placing a tissue apposition means through the collected fold;

releasing the collected tissue;

collecting a second tissue area, adjacent to the first tissue area, into a second fold;

placing a tissue apposition means through the second fold;

creating a tissue injury between the first and second tissue folds;

tightening the tissue apposition means to draw the tissue folds, including the injured tissue area into contact with each other;

securing the tissue apposition means.

20. A method of promoting tissue adhesion as defined in claim 19 wherein the tissue is gastric tissue and the injury is applied to the mucosal layer of the gastric tissue.

21. A method of promoting tissue adhesion as defined in claim 20 wherein the method is performed endoscopically.

22. A method of promoting tissue adhesion between the surfaces of tissue comprising:

collecting a first tissue area into a fold;

placing a method in promoting tissue adhesion through the collected tissue first fold;

releasing the collected tissue;

collecting a second tissue area, adjacent to the first tissue area, into a second fold;

placing a tissue apposition means through the second fold;

tightening the tissue apposition means to draw the tissue folds together;

inserting a tissue injury means between the tissue folds;

creating a tissue injury between the tissue folds;

securing the tissue apposition means.

23. A method of promoting tissue adhesion as defined in claim 22 wherein the tissue is gastric tissue and the injury is applied to the mucosal layer of the gastric tissue.

24. A method of promoting tissue adhesion as defined in claim 23 wherein the method is performed endoscopically.

25. A method of promoting tissue adhesion surfaces of gastric tissue comprising:

providing a first endoscope having an endoscopic suturing device at its distal end;

providing a second endoscope;

providing an electrocautery catheter;

advancing the first endoscope through the esophagus of a patient to a location below the gastroesophageal junction, adjacent gastric tissue;

applying vacuum to the suturing device to capture a fold of tissue;

passing a tissue apposition means carrying needle through the tissue to apply tissue apposition means;

withdrawing the needle and releasing the fold of tissue from the suturing device;

moving the endoscopic suturing device to an adjacent area of gastric tissue;

applying vacuum to capture a fold of gastric tissue;

advancing a tissue apposition means carrying needle through the captured tissue;

withdrawing the needle and releasing the captured tissue;

withdrawing the first endoscope from the esophagus of the patient;

advancing the second endoscope through the esophagus of a patient to the location of the tissue apposition means;

advancing an electrocautery catheter through the working channel of the second endoscope so that it protrudes from the distal end of the endoscope;

applying radiofrequency energy to the gastric tissue surface between the tissue apposition means placed in the tissue to create a tissue injury area;

withdrawing the electrocautery catheter and second endoscope from the esophagus of the patient;

tightening the tissue apposition means to draw the folds of tissue together and place the tissue injury areas in contact;

securing the tissue apposition means to maintain the injured tissue area in contact.

26. A method of promoting tissue adhesion surfaces of gastric tissue comprising:

providing a first endoscope having an endoscopic suturing device at its distal end;

providing a second endoscope;

providing an electrocautery catheter;

advancing the first endoscope through the esophagus of a patient to a location below the gastroesophageal junction, adjacent gastric tissue;

applying vacuum to the suturing device to capture a fold of tissue;

passing a tissue apposition means carrying needle through the tissue to apply a tissue apposition means;

withdrawing the needle and releasing the fold of tissue from the suturing device;

moving the endoscopic suturing device to an adjacent area of gastric tissue;

applying vacuum to capture a fold of gastric tissue;

advancing a tissue apposition means carrying needle through the captured tissue;

withdrawing the needle and releasing the captured tissue;

withdrawing the first endoscope from the esophagus of the patient;

advancing the second endoscope through the esophagus of a patient to the location of the tissue apposition means;

advancing an electrocautery catheter through the working channel of the second endoscope so that it protrudes slightly from the distal end of the endoscope;

applying radiofrequency energy to the gastric tissue surface between the tissue apposition means placed in the tissue to create a tissue injury area;

withdrawing the electrocautery catheter and second endoscope from the esophagus of the patient;

tightening the tissue apposition means to draw the folds of tissue together and place the tissue injury areas in contact;

securing the tissue apposition means to maintain the injured tissue area in contact.

27. A tissue apposition device comprising:

a tissue securement device;

a cavity for capturing a fold of tissue; and

tissue abrasion means configured to produce an injury to tissue.

28. A tissue apposition device as defined in claim 27 wherein the tissue securement mechanism comprises a needle configured to deliver a suture.

29. A tissue apposition device as defined in claim 27 wherein the cavity captures tissue by application of vacuum.

30. A tissue apposition device as defined in claim 27 wherein the tissue abrasion means comprise one or more RF energy emitting plates.

31. A tissue apposition device as defined in claim 30 wherein the RF emitting plates are independently operable.

32. A tissue apposition device as defined in claim 27 wherein the tissue abrasion means is positioned within the cavity.

33. A method of joining tissue surfaces comprising:

providing a tissue apposition device having a tissue securement device, a cavity and tissue abrasion means;

placing the tissue apposition device adjacent a first portion of tissue to be joined;

capturing the first portion of tissue in the cavity;

advancing the tissue securement device through the captured tissue;

abrading the tissue of the tissue abrasion means on a surface that will be placed in contact with a second tissue portion to be joined to the first tissue portion;

releasing the tissue from the cavity;

moving the apposition device to a second tissue potion to be joined;

capturing the second tissue portion into the cavity;

advancing the tissue securement device through the second tissue portion;

operating the tissue abrasion means to abrade a surface of the second tissue portion that will be placed in contact with the abraded surface of the first tissue portion;

releasing the second tissue portion from the cavity;

tightening the tissue securement mechanism to draw the tissue portions together so that the abraded areas are placed in contact.