Methods and systems for reducing tissue adhesion

• US 5,984,942 A
• Filed: 04/02/1997
• Issued: 11/16/1999
• Est. Priority Date: 04/02/1997
• Status: Expired due to Term

• Current Assignee: FemRx, Inc. (Johnson & Johnson)
• Original Assignee: FemRx, Inc. (Johnson & Johnson)
• Inventors: Savage, George M., Kresch, Arnold J., Alden, Donald L.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/832,014
• Time in Patent Office: 958 Days
• Field of Search: 604/96-101, 606/191, 606/194, 606/195, 606/192, 606/198, 606/190, 600/207
• US Class Current: 606/190
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The invention provides systems and methods for interfering with the adhesion formation process. In some embodiments, the present invention makes use of intermittent blunt dissection of fibrin bridging adjacent tissues prior to the formation of adhesions. Dissection is generally provided by pulsing a balloon implanted between the tissues. Optionally, the balloon will comprise an elastic structure to disrupt the formation of fibrin between the balloon and the surrounding tissues. Alternatively, the balloon may be at least partially covered by a bio-active anti-adhesion material. In some embodiments, the anti-adhesion material forms an envelope which is left between the tissues when the balloon is removed.

Claims

1. A method for interfering with formation of adhesions between two tissues, the tissues having nominal positions adjacent to each other within a patient body, the method comprising:

inflating a balloon to separate the tissues;

deflating the balloon to allow the tissues to return toward their nominal positions; and

intermittently repeating the inflating and deflating steps during an adhesion prophylactic period.

2. A method as claimed in claim 1, wherein the deflating steps are repeated soon after the preceding inflating steps so that the balloon is deflated for more time than it is inflated.

3. A method as claimed in claim 1, wherein the inflating steps repeatedly disrupt fibrin which bridges the tissues.

4. A method as claimed in claim 3, wherein a time interval between sequential inflating steps is less than a time for formation of adhesion tissues bridging the tissues along the fibrin.

5. A method as claimed in claim 3, wherein the deflating step allows at least a portion of the separated tissues to substantially return to their nominal positions.

6. A method as claimed in claim 5, wherein a tissue separation region extends substantially beyond the balloon when the balloon is inflated.

7. A method as claimed in claim 1, further comprising positioning the balloon between the tissues adjacent an internal surgical site, closing the surgical site over the positioned balloon, and removing the balloon from the surgical site after the adhesion prophylactic period.

8. A method as claimed in claim 1 wherein the inflating step comprises actuating a subcutaneous pump which has been introduced through skin of the patient body.

9. A method as claimed in claim 1, further comprising covering at least a portion of the balloon with a bio-active anti-adhesion material.

10. A method for controlling tissue scar formation, the method comprising:

inserting a balloon system into a patient body, wherein a bio-active anti-adhesion material is disposed between at least a portion of the balloon system and surrounding tissues;

inflating the balloon within the patient body;

deflating the balloon; and

removing the balloon from the patient body.

11. A method as claimed in claim 10, wherein the anti-adhesion material is bio-absorbable, and wherein at least a portion of the anti-adhesion material remains within the body after the balloon is removed.

12. A method as claimed in claim 11, further comprising covering the balloon with an envelope formed of the anti-adhesion material, wherein the removing step comprises extracting the balloon from the envelope so that the anti-adhesion material remains in the body.

13. A method as claimed in claim 10, further comprising intermittently repeating the inflating and deflating steps during an adhesion prophylactic period.

14. A method as claimed in claim 10, wherein the balloon is continuously inflated to maintain mechanical separation of the tissues for an adhesion prophylactic period.

15. A system for controlling the formation of adhesions between nominally adjacent tissues, the system comprising:

an implantable elastomeric balloon;

a pressurization system in fluid communication with the balloon for repeatedly inflating and deflating the balloon so that the balloon intermittently separates the normally adjacent tissues.

16. A system as claimed in claim 15, wherein the pressurization system comprises a pump which is adapted to be implanted subcutaneously.

17. A system as claimed in claim 16, wherein the pump is actuatable through the skin when implanted.

18. A system as claimed in claim 15, wherein the balloon comprises an elastic material to dislodge fibrin forming on an outer surface of the balloon.

19. A system as claimed in claim 15, wherein the balloon comprises a substantially non-distensible inner body and a distensible toroid disposed circumferentially around the inner body, and wherein the toroid is inflatable from a small thickness to a large thickness to bluntly dissect adjacent tissues radially beyond the inner body.

20. A system as claimed in claim 15, further comprising an anti-adhesion material covering at least a portion of the balloon.

21. A system for controlling the formation of adhesions between nominally adjacent tissues within a patient body, the system comprising:

a balloon which is implantable within the patient body, the balloon being inflatable to separate the nominally adjacent tissues;

a pressurization system in fluid communication with the balloon for inflating the balloon; and

a bio-active anti-adhesion material covering at least a portion of the balloon.

22. A system as claimed in claim 21, where the anti-adhesion material comprises a bio-absorbable envelope which removably covers the balloon.

23. A system for controlling the formation of adhesions between nominally adjacent tissues, the system comprising:

an implantable balloon; and

a pressurization system in fluid communication with the balloon for repeatedly inflating and deflating the balloon so that the balloon intermittently separates the normally adjacent tissues, wherein the pressurization system comprises a pump which is adapted to be implanted subcutaneously.

24. A system as claimed in claim 23, wherein the pump is actuatable through the skin when implanted.

25. A system for controlling the formation of adhesions between nominally adjacent tissues, the system comprising:

an implantable balloon;

wherein the balloon comprises a substantially non-distensible inner body and a distensible toroid disposed circumferentially around the inner body, and wherein the toroid is inflatable from a small thickness to a large thickness to bluntly dissect adjacent tissues radially beyond the inner body; and

a pressurization system in fluid communication with the balloon for repeatedly inflating and deflating the balloon so that the balloon intermittently separates the normally adjacent tissues.