Guidewire occlusion system utilizing repeatably inflatable gas-filled occlusive device

• US 20030088263A1
• Filed: 11/06/2001
• Published: 05/08/2003
• Est. Priority Date: 11/06/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Bonnette, Michael J., Thor, Eric J.
• Granted Patent: US 6,932,828 B2
• Time in Patent Office: Days
• 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 tubular guidewire assembly having an occlusive balloon proximate a distal end and an extended sealable section proximate a proximal end;

a gas inflation/evacuation system removably connectable to the proximal end of the guidewire assembly, including;

means for evacuating air from the guidewire assembly; and

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

a sealing system removably connectable to the proximal end of the guidewire assembly, including;

means for selectively sealing the extended sealable section at one of a plurality of separate locations along the extended sealable section to form one of a plurality of airtight seals of the tubular guidewire assembly along the extended sealable section.

2. The system of claim 1 wherein the gas inflation/evacuation system and the sealing system are arranged as parts of a handheld apparatus.

3. The system of claim 2 wherein the proximal end of the guidewire assembly is selectively insertable into a first aperture of the handheld apparatus and the gas inflation system is operably connected to a second aperture of the handheld apparatus, the handheld apparatus comprising an airtight passageway connecting the first aperture and the second aperture.

4. The system of claim 1 wherein the guidewire assembly has an effective length of at least 40 cm and an outer diameter of less than 0.060 inches, the extended sealable section has an effective length of at least 1 cm and an outer diameter of less than 0.050 inches and the occlusive device is deflated in less than two minutes.

5. The system of claim 1 wherein the guidewire assembly has an effective length of at least 100 cm and an outer diameter of less than 0.018 inches, the extended sealable section has an effective length of at least 5 cm and an outer diameter of less than 0.012 inches and the occlusive device is deflated in less than one minute.

6. The system of claim 1 wherein the means for sealing comprises a crimping mechanism and the sealable section comprises an extended crimpable section.

7. The system of claim 6 wherein the extended crimpable section is dimensioned and the crimping mechanism is arranged such that an effective outer diameter of the crimpable section at the location of a seal is no greater than the outer diameter of a main body of the guidewire assembly when the crimpable section is crimped at the location of the seal.

8. The system of claim 1 wherein the means for sealing comprises a plugging mechanism that selectively inserts a plug of material into the distal end of the sealable section while maintaining an airtight seal between the guidewire assembly and the inflation/evacuation system.

9. The system of claim 1 wherein the occlusive device is capable of repeated inflation and deflation during a vascular procedure in between which the proximal end of the guidewire assembly is free of mechanical connections and obstructions and functions as a conventional exchange guidewire.

10. The system of claim 1 further comprising:

means for selectively opening the extended sealable section distal to the location of the airtight seal to deflate the occlusive balloon.

11. The system of claim 1 further comprising:

sterile packaging containing the tubular guidewire, the gas inflation/evacuation system and the sealing system.

12. The system of claim 9 wherein the sterile packaging is packaged in a vessel filled with a biocompatible gas that is soluble in blood and has a driving gradient greater than air and any gas within the sterile packaging when packaged is only the biocompatible gas.

13. The system of claim 1 wherein the gas is a biocompatible gas that is soluble in blood and has a driving gradient greater than air.

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

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

a gas inflation/evacuation system removably connectable to the proximal end of the guidewire assembly, including;

an evacuation system that selectively evacuates air from the guidewire assembly; and

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

a sealing system removably connectable to the proximal end of the 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 airtight seals of the tubular guidewire assembly along the extended sealable section,

such that the occlusive device is capable of repeated inflation and deflation during a vascular procedure in between which the proximal end of the guidewire assembly is free of mechanical connections and obstructions and functions as a conventional exchange guidewire.

15. The system of claim 14 wherein the gas inflation/evacuation system and the sealing system are arranged as parts of a handheld apparatus and the proximal end of the guidewire assembly is selectively insertable into a first aperture of the handheld apparatus and the gas inflation system is operably connected to a second aperture of the handheld apparatus, the handheld apparatus comprising an airtight passageway connecting the first aperture and the second aperture.

16. The system of claim 14 wherein the guidewire assembly has an effective length of at least 40 cm and an outer diameter of less than 0.060 inches, the extended sealable section has an effective length of at least 1 cm and an outer diameter of less than 0.050 inches and the occlusive device is deflated in less than two minutes.

17. The system of claim 14 wherein the guidewire assembly has an effective length of at least 100 cm and an outer diameter of less than 0.018 inches, the extended sealable section has an effective length of at least 5 cm and an outer diameter of less than 0.012 inches and the occlusive device is deflated in less than one minute.

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

19. The system of claim 18 wherein the extended crimpable section is dimensioned and the crimping mechanism is arranged such that an effective outer diameter of the crimpable section at the location of a seal is no greater than the outer diameter of a main body of the guidewire assembly when the crimpable section is crimped at the location of the seal.

20. The system of claim 15 wherein the means for sealing comprises a plugging mechanism that selectively inserts a plug of material into the distal end of the sealable section while maintaining an airtight seal between the guidewire assembly and the inflation/evacuation system.

21. The system of claim 15 further comprising:

sterile packaging containing the tubular guidewire, the gas inflation/evacuation system and the sealing system.

22. The system of claim 21 wherein the sterile packaging is packaged in a vessel filled with a biocompatible gas that is soluble in blood and has a driving gradient greater than air and any gas within the sterile packaging when packaged is only the biocompatible gas.

23. The system of claim 15 wherein the gas is a biocompatible gas that is soluble in blood and has a driving gradient greater than air.

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

a tubular guidewire having an occlusive balloon proximate a distal end and a crimpable section proximate a proximal end;

a gas inflation/deflation system selectively operably connectable to and removable from the proximal end of the guidewire, including;

a hand-held structure having a first aperture and a second aperture with a lumen defined therebetween such that the proximal end of the guidewire is insertable into the first aperture,

a sealing mechanism housed within the handheld structure and positioned along at least a portion of the lumen to sealably engage the proximal end of the guidewire;

a crimping mechanism operably arranged to selectively crimp the guidewire at a point along the crimpable section when the proximal end of the guidewire is inserted in the first aperture of the hand-held structure;

a first syringe system;

a second syringe system containing a volume of a gas sufficient to inflate the occlusive balloon a plurality of times; and

conduits operably connecting the first syringe system and the second syringe system to the second aperture of the hand-held structure, the conduits including a valve arrangement that selectively connects only one of the evacuation system and the inflation system to the second aperture at a time.

25. The system of claim 24 wherein the second syringe system includes a plurality of individual syringes, each individual syringe containing a sufficient volume of gas to inflate the occlusive balloon one time.

26. The system of claim 24 wherein the conduit connecting to the first syringe system includes a one-way check valve only permitting evacuation and the conduit connecting to the second syringe system includes a one-way check valve only permitting inflation.

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

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

a gas inflation system removably connectable to the proximal end of the guidewire assembly capable of introducing a gas into the guidewire assembly to inflate the occlusive balloon a plurality of times; and

a sealing system removably connectable to the proximal end of the guidewire assembly, including;

means for selectively sealing the extended sealable section at one of a plurality of separate locations along the extended sealable section to form one of a plurality of airtight seals of the tubular guidewire assembly along the extended sealable section.

28. The system of claim 27 wherein the guidewire assembly has an effective length of at least 100 cm and an outer diameter of less than 0.018 inches, the extended sealable section has an effective length of at least 5 cm and an outer diameter of less than 0.012 inches and the occlusive device is deflated in less than one minute.

29. The system of claim 27 wherein the means for sealing comprises a crimping mechanism and the sealable section comprises an extended crimpable section.

30. The system of claim 29 wherein the extended crimpable section is dimensioned and the crimping mechanism is arranged such that an effective outer diameter of the crimpable section at the location of a seal is no greater than the outer diameter of a main body of the guidewire assembly when the crimpable section is crimped at the location of the seal.

31. The system of claim 27 wherein the means for sealing comprises a plugging mechanism that selectively inserts a plug of material into the distal end of the sealable section while maintaining an airtight seal between the guidewire assembly and the inflation/evacuation system.

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

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

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

a sealing system removably connectable to the proximal end of the 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 airtight seals of the tubular guidewire assembly along the extended sealable section,

such that the occlusive device is capable of repeated inflation and deflation during a vascular procedure in between which the proximal end of the guidewire assembly is free of mechanical connections and obstructions and functions as a conventional exchange guidewire.

33. The system of claim 32 wherein the guidewire assembly has an effective length of at least 100 cm and an outer diameter of less than 0.018 inches, the extended sealable section has an effective length of at least 5 cm and an outer diameter of less than 0.012 inches and the occlusive device is deflated in less than one minute.

34. The system of claim 32 wherein the means for sealing comprises a crimping mechanism and the sealable section comprises an extended crimpable section.

35. The system of claim 34 wherein the extended crimpable section is dimensioned and the crimping mechanism is arranged such that an effective outer diameter of the crimpable section at the location of a seal is no greater than the outer diameter of a main body of the guidewire assembly when the crimpable section is crimped at the location of the seal.

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

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

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

(b) evacuating air from the guidewire;

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

(d) sealing a proximal portion of the guidewire;

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

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

(g) opening the proximal portion of the guidewire to unseal the guidewire thereby deflating the occlusive balloon;

(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.

38. The method of claim 37 wherein step (f) includes a step of aspirating at least a portion of the blood vessel prior to step (g).

39. The method of claim 37 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 in less than two minutes.

40. The method of claim 39 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.

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

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

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

(c) sealing a proximal portion of the guidewire;

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

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

(f) opening the proximal portion of the guidewire to unseal the guidewire thereby deflating the occlusive balloon;

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

42. The method of claim 41 wherein step (f) includes a step of aspirating at least a portion of the blood vessel prior to step (g).

43. The method of claim 41 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 in less than two minutes.

44. The method of claim 43 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.

45. The method of claim 41 wherein the procedure of step (f) 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.