ACCESS DEVICE FOR BODY TISSUE AND METHOD OF USING SAME

• US 20090043314A1
• Filed: 07/15/2008
• Published: 02/12/2009
• Est. Priority Date: 07/16/2007
• Status: Abandoned Application

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Sevensson, Lars G., Lytle, Bruce
• Application Number:
  US12/173,688
• Publication Number:
  US 20090043314A1
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3486 Balloon

Abstract

A body tissue has oppositely disposed first and second tissue sides with an aperture extending therebetween. An apparatus for selectively permitting access through the body tissue includes a proximal balloon adapted for placement adjacent the first tissue side. A distal balloon is adapted for placement adjacent the second tissue side. An expandable support member is adapted to extend through the aperture and defines a support member lumen providing fluid communication between the first and second tissue sides. The expandable support member is attached to the proximal and distal balloons and has at least one of an inner support member lining and an outer support member cover. A support member valve is located within the support member lumen and selectively permits access through the aperture between the first and second tissue sides. A closure device is provided for permanently occluding the support member lumen.

Claims

1. An apparatus for selectively permitting access through a body tissue, the body tissue having oppositely disposed first and second tissue sides with an aperture extending therebetween, the apparatus comprising:

a proximal balloon adapted for placement adjacent the first tissue side;

a distal balloon adapted for placement adjacent the second tissue side;

an expandable support member adapted to extend through the aperture and defining a support member lumen providing fluid communication between the first and second tissue sides, the expandable support member being attached to the proximal and distal balloons and having at least one of an inner support member lining and an outer support member cover;

a support member valve located within the support member lumen and selectively permitting access through the aperture between the first and second tissue sides; and

a closure device for permanently occluding the support member lumen.

2. The apparatus of claim 1, wherein each of the proximal and distal balloons is selectively inflatable between a first, collapsed condition and a second, expanded condition, and the expandable support member is placed within the aperture with the distal balloon in the collapsed condition.

3. The apparatus of claim 2, wherein at least one of the proximal and distal balloons is adapted for permanent affixation in the expanded condition.

4. The apparatus of claim 3, wherein the permanent affixation is at least partially provided to the at least one of the proximal and distal balloons through at least one of:

a change in pH concentration, a change in ionic concentration, an organic solvent, permeation of a secondary material capable of precipitation, exposure to heat energy, exposure to light energy, exposure to laser energy, exposure to cooling energy, exposure to a gas, exposure to a liquid, exposure to pressure, the passage of time, and a mechanical retention structure.

5. The apparatus of claim 1, wherein the support member valve is a unidirectional support member valve.

6. The apparatus of claim 1, wherein the proximal and distal balloons are formed integrally.

7. The apparatus of claim 1, wherein at least one of the proximal and distal balloons exerts a compressive force upon the body tissue.

8. The apparatus of claim 1, wherein at least one of the proximal and distal balloons includes a semi-rigid structure.

9. The apparatus of claim 1, wherein the proximal balloon has a proximal inner cavity, the distal balloon has a distal inner cavity, and the proximal and distal inner cavities are in fluid communication.

10. The apparatus of claim 1, wherein the expandable support member defines at least two support member lumens.

11. The apparatus of claim 1, including a releasable coupling to selectively attach the apparatus to an implantation device.

12. The apparatus of claim 1, wherein at least a portion of the apparatus is formed from a material operative to encourage biological ingrowth of the body tissue to the material.

13. The apparatus of claim 1, wherein at least a portion of the apparatus is adapted to elute a therapeutic agent.

14. The apparatus of claim 1, including an adhesive portion adapted to adhere at least a portion of the apparatus to the body tissue.

15. The apparatus of claim 1, wherein the body tissue is at least one of a cardiac tissue, a peritoneal tissue, a pleural tissue, and a skin tissue.

16. The apparatus of claim 1, wherein the aperture is artificially formed in the body tissue.

17. The apparatus of claim 1, wherein at least one of the inner support member lining and the outer support member cover is at least partially formed of a tissue selected from the group comprising:

peritoneal tissue, pericardial tissue, pleural tissue, fascia tissue, and artificial tissue.

18. The apparatus of claim 1, wherein the expandable support member includes an outer support member wall, and the outer support member wall includes a padded portion adapted to contact at least a portion of the aperture.

19. The apparatus of claim 1, wherein the expandable support member is a rigid expandable support member.

20. An access device for a body tissue, the body tissue having oppositely disposed first and second tissue sides with an aperture extending therebetween, the access device comprising:

means for defining a lumen through the aperture;

means for padding the means for defining, the means for padding being at least partially located in contact with both the means for defining and the aperture;

means for retaining the means for defining within the aperture, the means for retaining being inflatable;

means for selectively permitting fluid communication through the lumen between the first and second tissue sides; and

means for permanently occluding the lumen.

21. The access device of claim 20, wherein the means for retaining is selectively inflatable between a first, collapsed condition and a second, expanded condition, the access device including means for inflating the means for retaining into the expanded condition.

22. The access device of claim 20, including means for eluting a therapeutic agent.

23. The access device of claim 20, wherein the means for selectively permitting fluid communication is means for selectively permitting unidirectional fluid communication through the lumen from the first tissue side toward the second tissue side.

24. A method of performing a surgical procedure through a body tissue, the body tissue having oppositely disposed first and second tissue sides with an aperture extending therebetween, the method comprising the steps of:

providing an expandable support member, having a support member lumen, with at least one of an outer support member cover and an inner support member lining;

extending the expandable support member through the aperture;

providing fluid communication between the first and second tissue sides through the support member lumen;

inflating a proximal balloon adjacent the first tissue side, the proximal balloon being attached to a first end of the expandable support member;

inflating a distal balloon adjacent the second tissue side, the distal balloon being attached to a second end of the expandable support member spaced apart from the first end;

selectively permitting fluid communication through the support member lumen;

extending at least one surgical tool through the support member lumen to conduct the surgical procedure through the aperture;

removing the at least one surgical tool from the support member lumen; and

permanently occluding the support member lumen.

25. The method of claim 24, including the step of contacting at least a portion of the aperture with a padded portion of the expandable support member.

26. The method of claim 24, including the step of preventing fluid flow through the lumen from the second tissue side to the first tissue side.

27. The method of claim 24, including the step of permanently retaining at least one of the proximal and distal balloons in an inflated condition.