Guidewire occlusion system utilizing repeatably inflatable gas-filled occlusive device

• US 6,932,828 B2
• Filed: 11/06/2001
• Issued: 08/23/2005
• Est. Priority Date: 11/06/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Bonnette, Michael J., Thor, Eric J.
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US10/012,903
• Publication Number:
  US 20030088263A1
• Time in Patent Office: 1,386 Days
• Field of Search: 606191-200, 606/168, 604 9601-103
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10186 One-way valves
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

A guidewire occlusion system for use in vascular procedures includes a repeatably inflatable gas-filled occlusive device proximate a distal end of a tubular guidewire assembly having an extended sealable section proximate a proximal end. A gas inflation/evacuation system is removably connectable to the proximal end of the guidewire assembly and includes an evacuation system to evacuate air from the guidewire and an inflation system for introducing a gas under pressure into the guidewire to inflate the occlusive balloon a plurality of times. A sealing system is also removably connectable to the proximal end of the guidewire assembly and selectively seals the extended sealable section at one of a plurality of separate locations along the extended sealable section to form an airtight seal of the tubular guidewire. Each time a deflation of the occlusive device is desired to reestablish blood flow to the vessel downstream of the occlusive device, the extended sealable section is opened distal to the location of the last seal to quickly deflate the occlusive device.

Claims

1. A guidewire occlusion system for use in vascular procedures comprising:

(a) a tubular guidewire assembly having an occlusive balloon proximate a distal end and an extended sealable section proximate a proximal end;

(b) a gas inflation/evacuation system removably connectible to the proximal end of the tubular guidewire assembly, including;

(1) means for evacuating the tubular guidewire assembly; and

,

(2) means for introducing a gas into the tubular guidewire assembly to inflate the occlusive balloon a plurality of times; and

,

(c) a sealing system removably connectible to the proximal end of the tubular guidewire assembly, including;

(1) means for selectively sealing the tubular guidewire assembly by forming successive permanent airtight seals at separate locations along the extended sealable section to retain the gas in the occlusive balloon a plurality of times, wherein the diameter of the extended sealable section when sealed is no greater than the diameter of any other portion of the tubular guidewire assembly so that the tubular guidewire assembly may be used as a guidewire to introduce a catheter over the guidewire while gas is retained in the occlusive balloon.

2. The system of claim 1 wherein the tubular guidewire assembly has an effective length of at least 40 cm and an outer diameter of less than 0.060 inch, wherein the extended sealable section has an effective length of at least 1 cm and an outer diameter of less than 0.050 inch, and wherein the occlusive balloon can be deflated in less than two minutes.

3. The system of claim 1 wherein the tubular guidewire assembly has an effective length of at least 100 cm and an outer diameter of less than 0.018 inch, wherein the extended sealable section has an effective length of at least 5 cm and an outer diameter of less than 0.012 inch, and wherein the occlusive balloon can be deflated in less than one minute.

4. The system of claim 1 wherein the extended sealable section comprises an extended crimpable section and the means for selectively sealing comprises a crimping mechanism which permanently deforms and crimps the extended crimpable section.

5. The system of claim 4 wherein the extended crimpable section is dimensioned and the crimping mechanism is arranged such that an effective outer diameter of the extended crimpable section at the location of a seal is no greater than the outer diameter of a main body portion of the tubular guidewire assembly when the extended crimpable section is crimped at the location of the seal.

6. The system of claim 1 wherein the occlusive balloon is capable of repeated inflation and deflation during a vascular procedure in between which the proximal end of the tubular guidewire assembly is free of mechanical connections and obstructions, thereby enabling the tubular guidewire assembly to function as a conventional guidewire for catheter exchanges.

7. The system of claim 1 further comprising means for selectively opening the extended sealable section distal to each successive permanent airtight seal to deflate the occlusive balloon.

8. The system of claim 1 wherein the gas is a biocompatible gas that will effectively go into solution in blood better than ambient air.

9. A guidewire occlusion system for use in vascular procedures comprising:

(a) a tubular guidewire assembly having an occlusive balloon proximate a distal end and an extended sealable section proximate a proximal end;

(b) a gas inflation/evacuation system removably connectible to the proximal end of the tubular guidewire assembly, including;

(1) an evacuation system that selectively evacuates the tubular guidewire assembly; and

,

(2) an inflation system that selectively introduces a gas into the tubular guidewire assembly to inflate the occlusive balloon a plurality of times; and

,

(c) a sealing system removably connectible to the proximal end of the tubular guidewire assembly that selectively seals the tubular guidewire assembly at one of a plurality of separate locations along the extended sealable section to form one of a plurality of successive permanent airtight seals of the tubular guidewire assembly along the extended sealable section to retain the gas in the occlusive balloon a plurality of times such that the occlusive balloon is capable of repeated inflation and deflation during a vascular procedure in between which the proximal end of the tubular guidewire assembly is free of mechanical connections and obstructions, thereby enabling the tubular guidewire assembly to function as a conventional guidewire for catheter exchanges.

10. The system of claim 9 wherein the tubular guidewire assembly has an effective length of at least 40 cm and an outer diameter of less than 0.060 inch, wherein the extended sealable section has an effective length of at least 1 cm and an outer diameter of less than 0.050 inch, and wherein the occlusive balloon can be deflated in less than two minutes.

11. The system of claim 9 wherein the tubular guidewire assembly has an effective length of at least 100 cm and an outer diameter of less than 0.018 inch, wherein the extended sealable section has an effective length of at least 5 cm and an outer diameter of less than 0.012 inch, and wherein the occlusive balloon can be deflated in less than one minute.

12. The system of claim 9 wherein the extended sealable section comprises a metallic tube and the sealing system comprises a crimping mechanism which permanently deforms and crimps a portion of the metallic tube closing the tube at the crimp.

13. The system of claim 12 wherein the metallic tube is dimensioned and the crimping mechanism is arranged such that an effective outer diameter of the metallic tube at the location of a seal is no greater than the outer diameter of a main body portion of the tubular guidewire assembly when the metallic tube is crimped at the location of the seal.

14. A guidewire occlusion system for use in vascular procedures comprising:

(a) a tubular guidewire assembly having an occlusive balloon along a distal end and an extended sealable section at a proximal end;

(b) a gas inflation system removably connectible to the proximal end of the tubular guidewire assembly capable of introducing a gas into the tubular guidewire assembly to inflate the occlusive balloon a plurality of times; and

,

(c) a sealing system removably connectible to the proximal end of the tubular guidewire assembly, including;

(1) means for selectively sealing the tubular guidewire assembly at one of a plurality of separate locations along the extended sealable section to form one of a plurality of successive permanent airtight seals of the tubular guidewire assembly along the extended sealable section; and

,

(2) means for severing the extended sealable section distal to each successive permanent airtight seal to release the gas from the occlusive balloon a plurality of times.

15. The system of claim 14 wherein the tubular guidewire assembly has an effective length of at least 100 cm and an outer diameter of less than 0.018 inch, wherein the extended sealable section has an effective length of at least 5 cm and an outer diameter of less than 0.012 inch, and wherein the occlusive balloon can be deflated in less than one minute.

16. The system of claim 14 wherein the means for selectively sealing comprises a crimping mechanism and the extended sealable section comprises an extended crimpable section.

17. The system of claim 16 wherein the extended crimpable section is dimensioned and the crimping mechanism is arranged such that an effective outer diameter of the extended crimpable section at the location of a seal is no greater than the outer diameter of a main body portion of the tubular guidewire assembly when the crimpable section is crimped at the location of the seal.

18. The system of claim 14 wherein the means for selectively sealing comprises a plugging mechanism that selectively inserts a plug of material into the proximal end of the extended sealable section while maintaining an airtight seal between the tubular guidewire assembly and the gas inflation system.

19. A guidewire occlusion system for use in vascular procedures comprising:

(a) a tubular guidewire assembly having an occlusive balloon proximate a distal end and an extended sealable section proximate a proximal end;

(b) an inflation system that selectively introduces a gas into the tubular guidewire assembly to inflate the occlusive balloon a plurality of times; and

,

(c) a sealing system removably connectible to the proximal end of the tubular guidewire assembly that selectively seals the extended sealable section at one of a plurality of separate locations along the extended sealable section to form one of a plurality of successive permanent airtight seals of the tubular guidewire assembly along the extended sealable section to retain the gas in the occlusive balloon a plurality of times such that the occlusive balloon is capable of repeated inflation and deflation during a vascular procedure in between which the proximal end of the tubular guidewire assembly is free of mechanical connections and obstructions, thereby enabling the tubular guidewire assembly to function as a conventional guidewire for catheter exchanges.

20. The system of claim 19 wherein the tubular guidewire assembly has an effective length of at least 100 cm and an outer diameter of less than 0.018 inch, wherein the extended sealable section has an effective length of at least 5 cm and an outer diameter of less than 0.012 inch, and wherein the occlusive balloon can be deflated in less than one minute.

21. The system of claim 19 wherein the sealing system comprises a crimping mechanism and the extended sealable section comprises an extended crimpable section.

22. The system of claim 21 wherein the extended crimpable section is dimensioned and the crimping mechanism is arranged such that an effective outer diameter of the extended crimpable section at the location of a seal is no greater than the outer diameter of a main body portion of the tubular guidewire assembly when the extended crimpable section is crimped at the location of the seal.

23. A method for repeatedly occluding a blood vessel during a vascular procedure comprising:

(a) guiding a tubular guidewire assembly having an occlusive balloon proximate the distal end into a blood vessel and positioning the occlusive balloon distal to a region of the blood vessel to be treated;

(b) evacuating the occlusive balloon through the tubular guidewire assembly;

(c) introducing a biocompatible gas under pressure into the tubular guidewire assembly to inflate the occlusive balloon;

(d) sealing a proximal portion of the tubular guidewire assembly;

(e) introducing a catheter over a proximal end of the tubular guidewire assembly and over the sealed proximal portion of the tubular guidewire assembly and advancing the catheter over the tubular guidewire assembly to the region of the blood vessel to be treated;

(f) performing a procedure using the catheter as part of the procedure;

(g) removing the sealed portion of the tubular guidewire assembly thereby deflating the occlusive balloon; and

,

(h) repeating at least steps (b)-(d) and (g) such that the occlusive balloon is inflated and deflated a plurality of times during the procedure.

24. The method of claim 23 wherein step (f) includes a step of aspirating at least a portion of the blood vessel prior to step (g).

25. The method of claim 23 wherein step (g) is performed within five minutes of step (c) and wherein step (g) is accomplished such that the occlusive balloon is substantially deflated and blood flow is reestablished in the blood vessel is less than two minutes.

26. The method of claim 25 wherein step (g) is accomplished such that the occlusive balloon is substantially deflated and blood flow is reestablished in the blood vessel in less than one minute.

27. A method for repeatedly occluding a blood vessel during a vascular procedure comprising:

(a) guiding a tubular guidewire assembly having an occlusive balloon proximate the distal end into a blood vessel and positioning the occlusive balloon distal to a region of the blood vessel to be treated;

(b) introducing a gas under pressure into the tubular guidewire assembly to inflate the occlusive balloon;

(c) sealing a proximal portion of the tubular guidewire assembly;

(d) introducing a catheter over a proximal end of the tubular guidewire assembly and over the sealed proximal portion of the tubular guidewire assembly and advancing the catheter over the tubular guidewire assembly to the region of the blood vessel to be treated;

(e) performing a procedure using the catheter as part of the procedure;

(f) removing the sealed portion of the tubular guidewire assembly thereby deflating the occlusive balloon; and

,

(g) repeating at least steps (b)-(c) and (f) such that the occlusive balloon is inflated and deflated a plurality of times during the procedure.

28. The method of claim 27 wherein step (e) includes a step of aspirating at least a portion of the blood vessel prior to step (f).

29. The method of claim 27 wherein step (f) is performed within five minutes of step (b) and wherein step (f) is accomplished such that the occlusive balloon is substantially deflated and blood flow is reestablished in the blood vessel in less than two minutes.

30. The method of claim 29 wherein step (f) is accomplished such that the occlusive balloon is substantially deflated and blood flow is reestablished in the blood vessel in less than one minute.

31. The method of claim 27 wherein the procedure of step (e) is a thrombectomy procedure including the introduction and evacuation of a fluid from the region of the blood vessel to be treated such that the occlusive balloon when inflated prevents passage of the fluid downstream of the occlusive balloon.

32. A guidewire occlusion system for use in vascular procedures comprising:

(a) a tubular guidewire assembly having an occlusive balloon proximate a distal end and an extended sealable section proximate a proximal end;

(b) a gas inflation/evacuation system removably connectible to the proximal end of the tubular guidewire assembly, including;

(1) means for evacuating the tubular guidewire assembly; and

,

(2) means for introducing a gas into the tubular guidewire assembly to inflate the occlusive balloon a plurality of times; and

,

(c) a sealing system removably connectible to the proximal end of the tubular guidewire assembly which includes means for selectively sealing the tubular guidewire assembly by forming successive permanent airtight seals at separate locations along the extended sealable section to retain the gas in the occlusive balloon a plurality of times, the means for selectively sealing including a mechanism selected from the group of mechanisms consisting of a crimping mechanism and a plugging mechanism.

33. The system of claim 32 wherein the means for selectively sealing comprises a plugging mechanism that selectively inserts a plug of material into the distal end of the extended sealable section while maintaining an airtight seal between the tubular guidewire assembly and the gas inflation/evacuation system.