Devices for maintaining patency of surgically created channels in tissue

• US 8,308,682 B2
• Filed: 01/18/2006
• Issued: 11/13/2012
• Est. Priority Date: 07/18/2003
• Status: Active Grant

• Current Assignee: Broncus Medical Incorporated
• Original Assignee: Broncus Medical Incorporated
• Inventors: Kramer, Thomas A., Loomas, Bryan E., Willink, Christopher, Keast, Thomas, Roschak, Edmund J.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US11/335,263
• Publication Number:
  US 20060135984A1
• Time in Patent Office: 2,491 Days
• Field of Search: 604/104, 604/105, 604/106, 604/107, 604/96.01, 604/101.01, 606191-194, 623/1.1, 623/1.11
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Devices and methods for altering gaseous flow within a lung to improve the expiration cycle of an individual, particularly individuals having chronic obstructive pulmonary disease. The methods and devices create channels in lung tissue and maintain the patency of these surgically created channels in tissue. Maintaining the patency of the channels allows air to pass directly out of the lung tissue which facilitates the exchange of oxygen ultimately into the blood and/or decompresses hyper-inflated lungs.

Claims

1. A hole-making catheter for creating and dilating an opening within tissue, the catheter comprising;

an elongate shaft having a proximal portion and a distal portion, and at least one lumen extending through the proximal end;

a nondistensible balloon having an interior in fluid communication with the lumen, the nondistensible balloon located on the distal portion of the elongate shaft; and

an actuatable piercing member cooperatively affixed to the catheter and located at the distal portion of the elongate shaft, the piercing member being extendable distal to the distal portion of the elongate shaft to create an opening within tissue and wherein the piercing member is configured to be removed from the tissue opening prior to the distal portion of the elongate shaft entering the opening such that collateral damage to tissue is minimized when the elongate shaft is being advanced through tissue.

2. The catheter of claim 1, where the piercing member comprises a wire extending through the elongate shaft where the distal end of the wire is sufficiently sharp to pierce tissue.

3. The catheter of claim 1, further comprising a second lumen extending through the piercing member.

4. The catheter of claim 1, further comprising an elongate member adapted to the piercing member and slidably movable within the elongate shaft.

5. The catheter of claim 4, further comprising a PTFE coating around the elongate member.

6. The catheter of claim 4 further comprising a closed coiled spring around the elongate member.

7. The catheter of claim 4 further where the elongate member and the piercing member have a continuous lumen extending therethrough.

8. The hole-making catheter of claim 1, where the elongate shaft has sufficient flexibility to advance through a fully articulated bronchoscope.

9. The hole-making catheter of claim 1, where the balloon comprises a proximal balloon end, a distal balloon end, and a center balloon section, where upon inflation of the balloon, the proximal and distal balloon ends form a diameter greater than a diameter of the center balloon section.

10. The catheter of claim 1, further comprising a depth limiter stop located on the distal portion of the elongate shaft, proximal to the balloon and larger in working diameter than the uninflated balloon, which resists the maximum penetration of the catheter into tissue.

11. The catheter of claim 10, where the depth limiter stop is a tube.

12. The catheter of claim 11, where the tube extends to the proximal end of the elongate member.

13. The catheter of claim 10, where the depth limiter stop is a second balloon.

14. The catheter of claim 10, where the depth limiter stop is a folding basket.

15. The catheter of claim 10, where the depth limiter stop is formed into the elongate shaft.

16. The catheter of claim 1, further comprising a collar located on the distal portion of the piercing member, which limits the maximum extension and retraction of the piercing member.

17. The catheter of claim 1, wherein the piercing member is configured such that the opening remains open upon removal of the piercing member from the opening.

18. A hole-making catheter for creating and dilating an opening within tissue, the catheter comprising;

an elongate shaft having a proximal portion and a distal portion, and at least one lumen extending through the proximal end;

a nondistensible balloon having proximal end and a distal end and an interior in fluid communication with the lumen, the nondistensible balloon located on the distal portion of the elongate shaft, and

an actuatable piercing member cooperatively affixed to the catheter and located at the distal portion of the elongate shaft, the piercing member being slidable within the elongate shaft such that a distal end of the piercing member may extend distal to a distal end of the balloon to create an opening within tissue and, upon sliding of the piercing member, the distal end of the balloon may be distal to the distal end of the piercing member, wherein the piercing member is configured to be removed from the tissue opening prior to the distal portion of the elongate shaft entering the opening such that collateral damage to tissue is minimized when the elongate shaft is being advanced through tissue.

19. The hole-making catheter of claim 18, where the working diameter of the balloon is less than a diameter of the distal end of the elongate shaft.

20. The hole-making catheter of claim 18, where the balloon extends out of the distal end of the elongate shaft.

21. The hole-making catheter of claim 18 where the balloon is fixed relative to the elongate shaft.

22. The hole-making catheter of claim 18 where the balloon comprises tube within the balloon, where the piercing member is slidably located within the tube and the balloon may deflate onto the tube.

23. The hole-making catheter of claim 18 further comprising a second lumen extending through the piecing member.

24. A implant delivery system for deploying the implant within a wall of tissue, the system comprising;

an elongate shaft having a distal portion, a proximal end, a distal end, at least one lumen extending through the proximal end;

a nondistensible balloon member having an interior in fluid communication with the lumen, the nondistensible balloon member located on the distal portion of the elongate shaft;

an actuatable piercing member cooperatively affixed to the delivery system and distally located to the distal end of the elongate shaft within a second lumen, the solid piercing member being actuatable relative to the distal end of the elongate shaft and having a sharpened distal end adapted to penetrate tissue to create an opening within tissue and wherein the piercing member is configured to be removed from the tissue opening prior to the distal end of the elongate shaft entering the opening such that collateral damage to tissue is minimized when the elongate shaft is being advanced through tissue; and

an expandable implant located about the balloon member.

25. The implant delivery system of claim 24, where the piercing member is extendable and retractable.

26. The implant delivery system of claim 24, where the piercing member is formed from one wire extending into the proximal end of the elongate shaft.

27. The implant delivery system of claim 26, where the wire is constructed from nitinol.

28. The implant delivery system of claim 24, further comprising a second lumen continuous within the piercing member.

29. The catheter of claim 24, further comprising a PTFE coating around the piercing member.

30. The catheter of claim 24, further comprising a closed coiled spring around the pushing member.

31. The catheter of claim 24, further comprising a closed coil spring connected to the outside of the pushing member.

32. The implant delivery system of claim 24, where the elongate shaft and piercing member has sufficient flexibility to advance through a fully articulated bronchoscope.

33. The implant delivery system of claim 24, where the balloon member comprises a proximal balloon end, a distal balloon end, and a center balloon section, where upon inflation of the balloon, the proximal and distal balloon ends form a diameter greater than a diameter of the center balloon section.

34. The implant delivery system of claim 24, where the implant is a different color or texture from the balloon member thereby making the implant optically distinguishable from the balloon when viewed through an endoscope.

35. The implant delivery system of claim 34, where the implant is white.

36. The implant delivery system of claim 34, where the balloon member comprises a colored sheath over a balloon.

37. The implant delivery system of claim 36, where the sheath is blue.