INTERSPINOUS PROCESS SPACER DIAGNOSTIC PARALLEL BALLOON CATHETER AND METHODS OF USE

• US 20110213301A1
• Filed: 02/26/2010
• Published: 09/01/2011
• Est. Priority Date: 02/26/2010
• Status: Active Grant

• Current Assignee: Medtronic Europe SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Auyoung, Bryan J.
• Granted Patent: US 8,147,526 B2
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril

Abstract

An interspinous process spacer diagnostic parallel balloon catheter and method. The balloon catheter has a plurality of main expandable members disposed one inside another, a distal expandable member and a proximal expandable member that all can be expanded from a collapsed configuration to an expanded configuration and then collapsed again to a collapsed configuration. The device can be used to determine whether a particular patient is a candidate for implantation of an interspinous process spacer to treat the symptoms of lumbar spinal stenosis and the size of such a spacer if indicated.

Claims

1. An interspinous process spacer diagnostic parallel balloon catheter, comprising:

an elongate member;

a first main expandable member connected to a distal portion of the elongate member;

a second main expandable member disposed inside the first main expandable member and connected to a distal portion of the elongate member;

a distal expandable member connected to a distal portion of the elongate member adjacent to a distal end of the first main expandable member;

a proximal expandable member connected to a distal portion of the elongate member adjacent to a proximal end of the first main expandable member; and

a plurality of lumens disposed in the elongate member in communication with one or more of the first main expandable member, the second main expandable member, the distal expandable member and the proximal expandable member.

2. The catheter of claim 1 wherein the first main expandable member and the second main expandable member are formed from a relatively non-compliant material.

3. The catheter of claim 1 wherein the distal expandable member and the proximal expandable member are formed from a relatively compliant material.

4. The catheter of claim 2 wherein the distal expandable member and the proximal expandable member are formed from a relatively compliant material.

5. The catheter of claim 4 wherein either the first main expandable material, the second main expandable member or both are formed from a three layer material having a middle layer, an inner layer and an outer layer.

6. The catheter of claim 5 wherein the middle layer is a relatively non-compliant material.

7. The catheter of claim 6 wherein the inner layer and the outer layer are a relatively compliant material.

8. The catheter of claim 1 wherein the lumens are coaxial.

9. The catheter of claim 1 wherein the elongate member defines at least two lumens extending therein wherein one lumen is in fluid communication with the distal expandable member and the proximal expandable member and one lumen is in fluid communication with either the first main expandable member, the second main expandable member or both.

10. The catheter of claim 9 wherein the two lumens extend coaxially in the elongate member.

11. The catheter of claim 1 wherein the elongate member defines one lumen extending therein wherein the one lumen is in fluid communication with the distal expandable member, the first main expandable member, the second main expandable member and the proximal expandable member.

12. The catheter of claim 11 wherein the lumen extends coaxially in the elongate member.

13. The catheter of claim 1 wherein the elongate member defines at least three lumens extending therein wherein one lumen is in fluid communication with the distal expandable member, one lumen is in fluid communication with the first main expandable member, the second main expandable member or both and one lumen is in fluid communication with the proximal expandable member.

14. A diagnostic method, comprising:

inserting a device having a first expandable member and a second expandable member wherein the first expandable member is disposed in the second expandable member, into the patient;

expanding the first expandable member to a first expanded diameter;

identifying whether the patient experiences pain relief, when the first expandable member is expanded to the first diameter;

collapsing the first expandable member;

removing the first expandable member and the second expandable member; and

implanting an interspinous process spacer into the patient.

15. The method of claim 14 further comprising expanding the second expandable member to a second expanded diameter after identifying whether the patient experiences pain relief when the first expandable member is expanded to the first diameter.

16. The method of claim 15 further comprising rupturing the first expandable member during the expansion of the second expandable member.

17. The method of claim 15 wherein the first expandable member is collapsed prior to expanding the second expandable member.

18. The method of claim 14 wherein the device includes a third expandable member disposed about the second expandable member and further comprising expanding the third expandable member to a third expanded diameter after identifying whether the patient experiences pain relief when the second expandable member is expanded to the second diameter.

19. The method of claim 18 wherein the first expandable member and the second expandable member are collapsed prior to expanding the third expandable member.

20. The method of claim 18 wherein the first expandable member and the second expandable member are ruptured during the expansion of the third expandable member.

21. A diagnostic method using a device having an elongate member, a first main expandable member connected to a distal portion of the elongate member, a second main expandable member disposed in the first expandable member, a distal expandable member connected to a distal portion of the elongate member adjacent to a distal end of the first main expandable member, and a proximal expandable member connected to a distal portion of the elongate member adjacent to a proximal end of the first main expandable member;

comprising;

inserting the distal portion of the balloon catheter into the patient;

expanding one of the distal expandable member or the proximal expandable member;

determining whether the distal portion of the balloon catheter is properly located;

deflating one of the distal expandable member or the proximal expandable member;

repositioning the distal portion of the balloon catheter;

inflating the proximal expandable member and the distal expandable member;

inflating the second main expandable member;

identifying whether the patient experiences pain relief when the second main expandable member is expanded with the first volume of fluid;

collapsing the second main expandable member, the proximal expandable member and the distal expandable member; and

removing the balloon catheter from the patient.

22. The method of claim 21 further comprising implanting an interspinous process spacer into the patient based on the diameter of the first expandable member or the second expandable member.

23. The method of claim 21 further comprising inflating the first expandable member and identifying whether the patient experiences pain relief when the first main expandable member is expanded with a second volume of fluid.

24. The method of claim 23 wherein the second expandable member is collapsed prior to inflating the first expandable member.

25. The method of claim 23 wherein the second expandable member is ruptured during inflation of the first expandable member.