Gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device

• US 20070060881A1
• Filed: 09/01/2005
• Published: 03/15/2007
• Est. Priority Date: 09/01/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Prather, Richard, Bonnette, Michael, Thor, Eric
• Granted Patent: US 7,615,031 B2
• Time in Patent Office: Days
• US Class Current: 604/97.10
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation

Abstract

A gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device for use in thrombectomy or other vascular procedures includes a multiple element valved guidewire assembly having an occlusive balloon removably and sealingly connectible to an included manifold assembly where a guidewire tube defines a lumen for inflation or deflation of the occlusive balloon. A first syringe for evacuating the lumen and a second syringe for introducing a biocompatible gas into the lumen to inflate the occlusive balloon that is in fluid communication with the lumen a plurality of times are included. A sealing valve arrangement selectively seals the proximal portion of the guidewire tube to control inflated or deflated states of the occlusive balloon.

Claims

1. A gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device, the system comprising:

a. a multiple element valved guidewire assembly having an occlusive balloon;

b. a manifold assembly removably connectible to the multiple element valved guidewire assembly having an occlusive balloon;

c. an evacuation syringe operable in cooperation with the manifold assembly for selectively withdrawing a biocompatible gas from the multiple element valved guidewire assembly so as to selectively evacuate the occlusive balloon a plurality of times; and

,

d. an inflation syringe operable in cooperation with the manifold assembly for selectively introducing a biocompatible gas under pressure into the multiple element valved guidewire assembly so as to selectively inflate the occlusive balloon a plurality of times.

2. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 1, wherein the multiple element valved guidewire assembly having an occlusive balloon includes:

i. a flexible guidewire tube of braided polyimide, the flexible guidewire tube having a lumen, a wall, a proximal end, and a distal end;

ii. an occlusive balloon located at the distal end of guidewire tube;

iii. a plurality of inflation orifices extending through the wall of the flexible guidewire tube and communicating between the lumen and the occlusive balloon;

iv. a flexible tip located distal to the occlusive balloon; and

,

v. a seal of flexible compliant material located and fixed internally within the proximal end of the guidewire tube with a seal opening.

3. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 1, wherein the multiple element valved guidewire assembly further includes:

i. a sealing rod of flexible material with a round cross section, the sealing rod being sealingly slideable within the seal opening; and

,

ii. a flexible support extension having a round cross section less than the seal opening wherein the seal opening of the seal, the sealing rod, and the flexible support extension together defining a valve of the multiple element valved guidewire assembly.

4. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 1, wherein the manifold assembly removably accommodates and attaches to and cooperates with the multiple element valved guidewire assembly.

5. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 1, wherein the manifold assembly cooperates with the evacuation syringe and the inflation syringe.

6. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 1, wherein the manifold assembly includes a manifold of tubular configuration including:

i. a manifold body;

ii. a proximal hemostatic valve;

iii. a distal hemostatic valve opposing the proximal hemostatic valve; and

,

iv. an inflation/evacuation branch having an inflation/evacuation hemostatic valve.

7. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 6, wherein the manifold assembly further includes a pressure monitor.

8. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 1, wherein the evacuation syringe includes a plunger, a check valve, a connector and a needle.

9. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 8, wherein the needle of the evacuation syringe is blunt.

10. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 1, wherein the inflation syringe includes a plunger, a check valve, and a needle.

11. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 10, wherein the needle of the evacuation syringe is blunt.

12. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 6, wherein the manifold assemble has a longitudinally oriented main passageway extending between the proximal and distal hemostatic valves.

13. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 12, wherein the proximal and distal hemostatic valves each include a hemostatic nut, threadably connectible to the manifold body and snappingly engageable to the manifold body.

14. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 13, wherein the proximal and distal hemostatic valves are each self-sealing hemostatic valves, each being compressible and sealingly expandable.

15. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 14, wherein the proximal and distal hemostatic valves are formed of silicone material.

16. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 15, wherein the proximal and distal hemostatic valves are symmetrically fashioned and include mirror-like planar and circular-shaped faces having opposing radiused recessed surfaces increasingly thinner in a direction toward the center.

17. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 16, wherein the proximal and distal hemostatic valves each have a plurality of slits.

18. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 17, wherein the plurality of slits of the proximal and distal hemostatic valves extend outwardly in radial fashion from the center of the hemostatic valve thereby creating boundaries and defining lobes.

19. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 18, wherein the proximal and distal hemostatic valves have plural lobes defined by boundaries corresponding to slits, such that adjacent lobes have mutual contact along a slit and thereby effect a seal from side-to-side, thereby effecting a self-sealing hemostatic valve relationship to be formed on the manifold.

20. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 19, wherein the proximal and distal hemostatic valves each have three slits.

21. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 20, wherein the proximal and distal hemostatic valves are each self-sealing hemostatic valves, which can be modified in sealing properties by the hemostatic nut associated therewith.

22. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 3, wherein the lumen of the guidewire tube may be sealed at the valve by sealingly sliding the sealing rod into the seal opening.

23. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 3, wherein the lumen of the guidewire tube may be unsealed at the valve by unsealingly sliding the sealing rod from the seal opening and thereby allowing passage to form between the seal opening and the flexible support extension.

24. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 3, wherein urging the sealing rod proximally from the seal opening opens the valve and urging the sealing rod distally into the seal opening closes the valve.

25. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 24, wherein the occlusive balloon may be inflated or deflated when the valve is open and is maintained when the valve is closed.

26. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 2, wherein the balloon is formed of a material selected from polymer or rubber.

27. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 26, wherein the balloon has been prestretched to render expansion relatively linear with pressure.

28. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 27, wherein the balloon is expanded with gas pressure.

29. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 28, wherein the distal end of the multiple element valved guidewire is visible under fluoroscopy.

30. The gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive device of claim 29, wherein the balloon is two-layer balloon with a fluoroscopy visible liquid employed between layers of the two-layer balloon.

31. A method of vascular intervention comprising the steps of:

a. providing a gas inflation/evacuation system with a multiple element valved guidewire assembly having an occlusive balloon, the system including;

(1) a manifold assembly removably connectible to a multiple element valved guidewire assembly having an occlusive balloon;

(2) syringe means operated in cooperation with the manifold assembly for selectively evacuating the multiple element valved guidewire assembly; and

,

(3) syringe means operated in cooperation with the manifold assembly for introducing a biocompatible gas under pressure into the multiple element valved guidewire assembly to selectively inflate the occlusive balloon a plurality of times; and

,

b. inserting the guidewire assembly into the manifold assembly and maneuvering the guidewire assembly within the vasculature so as to position the occlusive balloon at a desired location in the vasculature and so as to position a controllable valve for inflational and deflational control of the occlusive balloon.

32. The method of claim 31, further comprising the step of separating the guidewire assembly from the manifold assembly, thereby providing a “

stand-alone”

guidewire within the vasculature.

33. The method of claim 31, further comprising the step of inflating the balloon.

34. The method of claim 31, further comprising the step of deflating the balloon.

35. The method of claim 32, further comprising the step of closing the controllable valve prior the step of separating, thereby maintaining inflational and deflational control of the balloon.

36. The method of claim 35, further comprising the steps of:

a. reinserting the previously separated guidewire assembly in the manifold assembly;

b. opening the controllable valve; and

,

c. deflating the balloon.

37. The method of claim 36, further comprising the steps of:

a. moving the deflated balloon of the guidewire assembly to another desired position within the vasculature; and

,

b. reinflating the balloon to occlude the vasculature at the another desired location.

38. The method of claim 37, further comprising the steps of:

a. closing the controllable valve; and

,

b. separating the guidewire assembly from the manifold assembly to provide a “

stand-alone”

guidewire in the another desired position within the vasculature.

39. The method of claim 38, further comprising the steps of:

a. reinserting the guidewire assembly in the manifold assembly;

b. opening the controllable valve and deflating the balloon; and

,

c. withdrawing the guidewire assembly with deflated balloon from the vasculature.

40. The method of claim 31, further comprising the step of observing the balloon location by fluoroscopy.

41. The method of claim 33, wherein the balloon is inflated with a biocompatible gas.

42. The method of claim 33, wherein the biocompatible gas is selected from CO2 and helium.

43. The method of claim 31, wherein the balloon is prestretched.

44. The method of claim 31, wherein the controllable valve is opened by urging a sealing rod proximally and closed by urging a sealing rod distally.

45. A system for vasculature intervention comprising:

a. a multiple element valved guidewire assembly having an occlusive device; and

,

b. a manifold assembly removably connectible to the multiple element valved guidewire assembly.

46. The system of claim 45, wherein the multiple element valved guidewire assembly has a distal end and a proximal end, and includes:

i. a braided polyimide guidewire tube, the braided polyimide guidewire tube defining a lumen;

ii. an occlusive device, the occlusive device situated adjacent the distal end of the guidewire;

iii. at least one occlusive device actuator means communicating between the lumen and the occlusive device;

iv. a flexible distally located tip; and

,

v. a proximal end including an internally located lock means of the at least one occlusive device actuator means.

47. The system of claim 46, wherein the occlusive device is an occlusive balloon, the occlusive device actuator means is an inflation orifice, and the lock means is a linearly actuated control valve.

48. The system of claim 47, wherein the linearly actuated control valve includes a one-piece flexible sealing rod having a reduced radius support extension extending therefrom, the rod being slidingly accommodated by a braided polyimide guidewire tube.

49. The system of claim 48, wherein the rod stiffens the guidewire tube, thereby adding “

pushability”

to facilitate positioning of the occlusive balloon in the vasculature.

50. The system of claim 45, wherein the occlusive device is a balloon and the manifold includes means for providing inflation and evacuation of the balloon.

51. The system of claim 50, wherein the means for inflation and evacuation include syringes.

52. The system of claim 51, wherein the syringes are connected to the manifold by threadable connections or by needles passing flexible resilient valves.