Perfusion shunt device and method

• US 5,536,250 A
• Filed: 09/13/1994
• Issued: 07/16/1996
• Est. Priority Date: 04/01/1994
• Status: Expired due to Fees

• Current Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Original Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Inventors: Goeld, Paul M., Klein, Enrique J.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/305,250
• Time in Patent Office: 672 Days
• Field of Search: 604/96, 604/21, 604/53, 604/104, 604/97, 604/103, 604/52, 604/107, 604/49, 604/28, 604/266, 604/264, 604/101, 606/108, 606/192, 606/194, 623/1
• US Class Current: 604/103.01
• CPC Class Codes: A61M 2025/0025 having a collapsible lumen
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A perfusion shunt device is used in conjunction with balloon catheters to provide blood perfusion across an inflated balloon in a blood vessel. The perfusion shunt device comprises a flexible conduit structure having one or more blood perfusion paths formed from a proximal end to a distal end thereof. The flexible conduit structure is usually attached directly or indirectly to a proximal shaft structure. Discrete anchors or expansible sleeves or cages are provided for locating the conduit structure over the balloon on the catheter. The flexible conduit structure will not be directly attached to the balloon, but rather will be secured at locations distal to an proximal of the balloon. In this way, constriction and distortion of the conduit structure and/or balloon resulting from balloon expansion are minimized. The device may be loaded over a conventional angioplasty balloon catheter within or outside of the blood vessel being treated, either before or after an angioplasty procedure.

Claims

1. A perfusion shunt device comprising:

a flexible conduit structure having a proximal end, a distal end, and a blood perfusion path extending axially over at least a portion of the conduit structure;

a proximal shaft structure extending proximally from the conduit structure; and

means attached to the conduit structure for securing the conduit structure to a catheter at locations proximal of and distal to an expansible balloon on the catheter, wherein the flexible conduit structure is not directly secured over the balloon.

2. A device as in claim 1, wherein the blood perfusion path comprises at least one lumen extending through the conduit structure, wherein the lumen has a plurality of axially spaced-apart ports which permit blood perfusion into the out of the lumen.

3. A device as in claim 2, wherein the blood perfusion path comprises a pair of axial lumens, each of which has a plurality of axially spaced-apart ports.

4. A device as in claim 1, wherein the blood perfusion path comprises at least one axial channel formed in an exterior surface of the conduit structure.

5. A device as in claim 1, wherein the shaft structure comprises a rod attached directly to the proximal end of the flexible conduit structure.

6. A device as in claim 1, wherein the shaft structure comprises a tubular sleeve having a proximal end and a distal end.

7. A device as in claim 6, wherein a distal portion of the tubular sleeve is axially split to allow for radial expansion and comprises the balloon-securing means.

8. A device as in claim 1, wherein the balloon-attaching means comprises an anchor disposed near the distal end of the conduit structure, which anchor captures a distal end of an angioplasty balloon catheter.

9. A device as in claim 8, wherein the single anchor is a distal end piece having a receptacle open in a proximal direction for receiving the distal end of the angioplasty balloon catheter, wherein said receptacle is radially offset from the flexible conduit structure.

10. A device as in claim 8, wherein the conduit-securing means comprises at least one additional anchor disposed on the conduit structure, which additional anchor(s) capture the angioplasty balloon catheter proximally of the balloon.

11. A device as in claim 1, wherein the conduit-securing means comprises an expansible cage which receives the balloon and which is attached to the flexible conduit structure only at locations distal and proximal to a portion of the cage which receives the balloon.

12. A device as in claim 11, wherein the expansible cage comprises an axially split tube.

13. A device as in claim 11, wherein the expansible cage comprises an elastomeric tube.

14. A device as in claim 11, wherein the expansible cage comprises a mesh structure.

15. A device as in claim 11, wherein the expansible cage comprises a pouch composed of a non-compliant material.

16. A device as in claim 11, wherein a proximal extension of the expansible cage comprises the shaft.

17. A method for perfusing blood past a treatment site within a blood vessel, said method comprising:

providing a flexible conduit structure having a blood perfusion path extending axially over at least a portion thereof;

positioning the flexible conduit over an expansible balloon on a vascular catheter, wherein the conduit is attached to the catheter at locations distal of an proximal to the expansible balloon but is not directly attached to the balloon; and

expanding the balloon at the treatment site within the blood vessel, wherein blood flows through the perfusion path past the expanded balloon.

18. A method as in claim 17, wherein the flexible conduit is attached by a first anchor disposed at a distal end of the flexible conduit which is placed over a distal end of the balloon catheter and at least one additional anchor which is placed over a proximal portion of the catheter.

19. A method as in claim 17, wherein the flexible conduit is attached by an expansible cage which receives the expansible balloon and which is attached to the flexible conduit structure only at locations distal and proximal to a portion of the cage which receives the balloon.

20. A method as in claim 17, wherein flexible conduit is positioned over the expansible balloon while the vascular catheter is withdrawn from the blood vessel.

21. A method as in claim 17, wherein the flexible conduit is positioned over the expansible balloon while the vascular catheter is disposed within the blood vessel.