In situ stent forming catheter

• US 5,792,106 A
• Filed: 01/21/1997
• Issued: 08/11/1998
• Est. Priority Date: 12/02/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Mische, Hans A.
• Primary Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/785,799
• Time in Patent Office: 567 Days
• Field of Search: 604/890.1, 604/891.1, 604/8, 604/96, 604/101, 604/265, 604/266, 604/21, 623/1, 623/12, 623/66, 623/13, 606/191, 606/192, 606/194, 606/198
• US Class Current: 604/103.01
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/945 hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A curable fluid material is caused to flow out of the balloon in a balloon catheter, through perforations therein, to form a stent in situ in the PTCA procedure.

Claims

1. A device consisting of:

a. an elongated tubular member having a proximal end and a distal end;

b. a guide wire lumen disposed within the tubular member;

c. an inflatable balloon member located at the distal end of the tubular member and extending distally therefrom, said balloon member having a proximal end and a distal end, said balloon member being made of a flexible material and further comprising;

i. at least two spaced ridge seals formed upon at least partial inflation of said balloon member, said ridge seals in combination with a portion of the balloon member therebetween defining an isolation zone therebetween and exterior of the balloon member, said ridge seals for being positioned in use against a vessel wall such that in situ said isolation zone further defines a stent forming chamber; and

ii. infusion ports in fluid communication with the tubular member, said infusion ports being located at the portion of the balloon member between the two ridge seals, the guide wire lumen further extending through said balloon member, said guide wire lumen in combination with the distal end of the balloon member defining a distal balloon seal; and

d. a fluid injection port in combination with curable, fluid stent forming material, said fluid injection port being in fluid communication with the tubular member at the proximal end of the tubular member for delivery of the stent forming material, said infusion ports being small enough to allow the balloon member to inflate yet large enough at increased inflation pressure to allow the stent forming material to exit the balloon member through the infusion ports directly into the isolation zone, whereby the stent forming material is delivered through the fluid injection port, the tubular member and the infusion ports directly into the isolation zone to form a stent in situ in the stent forming chamber.

2. The device of claim 1 wherein the stent forming material comprises a cyanoacrylate.

3. The device of claim 2 wherein the formed stent further includes at least one drug.

4. The device of claim 1 wherein the stent forming material further includes at least one drug.

5. The device of claim 4 or 3 wherein the drug is released over time in an area to be treated.

6. The device of claim 1 further comprising a guide wire tip located at and extending distally from the distal end of the tubular member.

7. The device of claim 1 wherein the guide wire lumen is disposed substantially coaxially within the tubular member.

8. The device of claim 6, 7 or 1 wherein the isolation zone is substantially cylindrical.

9. The device of claim 1 wherein the formed stent is temporary.

10. The device of claim 1 wherein the formed stent is permanent.

11. The device of claim 1 wherein the formed stent is biodegradable.

12. The device of claim 1 wherein the infusion ports remain closed until the balloon is inflated to at least a predetermined pressure.

13. The device of claim 1 wherein the viscosity of the stent forming material, is such that it only travels through the infusion ports when the balloon is inflated to at least a predetermined pressure.

14. An in situ stent forming system comprising:

a. a device consisting of;

i. an elongated tubular member having a proximal end and a distal end;

ii. a guide wire lumen disposed within the tubular member;

iii. an inflatable balloon member located at the distal end of the tubular member and extending distally therefrom, said balloon member having proximal and distal ends, being made of a flexible material and further comprising;

a) at least two spaced ridge seals formed upon at least partial inflation of said balloon member, said ridge seals defining an isolation zone therebetween exterior of the balloon member, said ridge seals being positioned in use against a vessel wall such that in situ said isolation zone further defines a stent forming chamber; and

b) infusion ports in fluid communication with the tubular member, said infusion ports being located at an area of the balloon member between the two ridge seals, the guide wire lumen of the tubular member further extending through said balloon member, said guide wire lumen in combination with the distal end of the balloon member defining a distal balloon seal; and

iv. a fluid injection port in fluid communication with the tubular member at the proximal end of the tubular member; and

b. a source of curable fluid stent forming material connected to the fluid injection port, said infusion ports being small enough to allow the balloon member to inflate yet large enough at increased inflation pressure to allow the stent forming material to exit the balloon member directly into the isolation zone, whereby a curable fluid stent forming material is delivered through the fluid injection port, the tubular member and the infusion ports directly into the isolation zone to form a stent in situ in the stent forming chamber.

15. The device of claim 14 further comprising a guide wire tip located at and extending distally from the distal end of the tubular member.

16. The device of claim 14 wherein the guide wire lumen is disposed substantially coaxially within the tubular member.

17. The device of claim 14, 15 or 16 wherein the isolation zone is substantially cylindrical.