Gas inflation/evacuation system and sealing system for guidewire assembly having occlusive device

• US 6,942,678 B2
• Filed: 11/06/2001
• Issued: 09/13/2005
• 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: Jenson, Mark L., Bonnette, Michael J., Thor, Eric J.
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US10/007,788
• Publication Number:
  US 20030088194A1
• Time in Patent Office: 1,407 Days
• Field of Search: 606191-200, 606/108, 606/159, 604 9601-103, 604/167.01, 604/167.02, 600/585
• US Class Current: 606/191
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 Valves
• 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 gas inflation/evacuation system and sealing system for use with occlusive devices such as occlusive balloons in vascular procedures. The gas inflation/evacuation system is removably connectible to a proximal portion of a guidewire assembly and includes an evacuation system to evacuate the guidewire assembly and an inflation system for introducing a biocompatible gas under pressure into the guidewire assembly to inflate an occlusive device a plurality of times. A sealing system is also removably connectible to the proximal portion of the guidewire assembly and selectively seals an extended sealable section at the proximal portion of the guidewire assembly at one of a plurality of separate locations to form an airtight seal of the guidewire assembly. Each time a deflation of the occlusive device is desired in order to reestablish blood flow to the vessel downstream of the occlusive device, the extended sealable section at the proximal portion of the guidewire assembly preferably is cut distal to the location of the last seal to quickly deflate the occlusive device.

Claims

1. A gas inflation/evacuation system and sealing system removably connectible to a proximal portion of a guidewire assembly which has an occlusive balloon at a distal portion thereof, comprising:

means for evacuating the guidewire assembly;

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

,

means for selectively sealing the guidewire assembly by forming successive permanent airtight seals at separate locations along the proximal portion of the guidewire assembly to retain the biocompatible 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.

2. The gas inflation/evacuation system and sealing system of claim 1, wherein the means for evacuating, the means for introducing a biocompatible gas, and the means for selectively sealing constitute a handheld apparatus.

3. The gas inflation/evacuation system and sealing system of claim 2, wherein the means for selectively sealing includes a first aperture into which the proximal portion of the guidewire assembly is selectively insertable, a second aperture to which the means for evacuating and the means for introducing a biocompatible gas are operably connected, and an airtight passageway connecting the first aperture and the second aperture.

4. The gas inflation/evacuation system and sealing system of claim 1, wherein the mechanism is a crimping mechanism.

5. The gas inflation/evacuation system and sealing system of claim 4, wherein the crimping mechanism comprises:

a first roller and a second roller proximately spaced from the first roller for traversal of the proximal portion of the guidewire assembly, the first roller being connected to a handle with a pivotable cam arrangement such that force on the handle causes the first roller to proportionately approach the second roller, a first threshold force on the handle causing sealing of the proximal portion of the guidewire assembly and a second threshold force on the handle causing severing of the proximal portion of the guidewire assembly.

6. The gas inflation/evacuation system and sealing system of claim 5, wherein the handle is spring biased for an automatic return to an open starting position upon the cessation of a force.

7. The gas inflation/evacuation system and sealing system of claim 1, wherein the mechanism is a plugging mechanism that selectively inserts a plug of material into the proximal portion of the guidewire assembly while maintaining an airtight seal between the guidewire assembly and the means for evacuating and the means for introducing a biocompatible gas.

8. The gas inflation/evacuation system and sealing system of claim 1, wherein the means for evacuating, the means for introducing a biocompatible gas, and the means for selectively sealing are contained in a sterile packaging filled with a biocompatible gas and wherein all gas within the sterile packaging is selected from the group consisting of carbon dioxide, oxygen, and nitrous oxide.

25. The gas inflation/evacuation system and sealing system of claim 1, wherein the means for evacuating comprises at least one syringe and the means for introducing a biocompatible gas comprises at least one syringe.

26. The gas inflation/evacuation system and sealing system of claim 1, further comprising means for severing the proximal portion of the guidewire assembly distal to each successive permanent airtight seal to reopen the proximal portion of the guidewire assembly to release the biocompatible gas from the occlusive balloon.

9. A gas inflation/evacuation system and sealing system removably connectible to a proximal portion of a guidewire assembly which has an occlusive balloon at a distal portion thereof, comprising:

a first syringe that selectively evacuates the guidewire assembly;

a second syringe that selectively introduces a biocompatible gas into the guidewire assembly to inflate the occlusive balloon at the distal portion of the guidewire assembly a plurality of times;

a sealing assembly removably connectible to the proximal portion of the guidewire assembly, the sealing assembly including a mechanism that selectively seals the proximal portion of the guidewire assembly at one of a plurality of separate locations to form one of a plurality of successive permanent airtight seals of the guidewire assembly; and

,

a valve arrangement that selectively opens and closes communication between the sealing assembly and the first syringe and between the sealing assembly and the second syringe.

10. The gas inflation/evacuation system and sealing system of claim 9, wherein the first syringe, the second syringe, and the sealing assembly form a handheld apparatus and wherein the sealing assembly includes a first aperture into which the proximal portion of the guidewire assembly is selectively insertable, a second aperture to which the first and second syringes are operably connected, and an airtight passageway connecting the first aperture and the second aperture.

11. The gas inflation/evacuation system and sealing system of claim 9, wherein the mechanism is a crimping mechanism which permanently deforms and crimps the proximal portion of the guidewire assembly.

12. The gas inflation/evacuation system and sealing system of claim 11, wherein the crimping mechanism comprises:

a first roller and a second roller proximately spaced from the first roller for traversal of the proximal portion of the guidewire assembly, the first roller being connected to a handle with a pivotable cam arrangement such that force on the handle causes the first roller to proportionately approach the second roller, a first threshold force on the handle causing sealing of the proximal portion of the guidewire assembly and a second threshold force on the handle causing severing of the proximal portion of the guidewire assembly.

13. The gas inflation/evacuation system and sealing system of claim 12, wherein the handle is spring biased for an automatic return to an open starting position upon cessation of a force.

14. The gas inflation/evacuation system and sealing system of claim 9, wherein the mechanism is a plugging mechanism that selectively inserts a plug of material into the proximal portion of the guidewire assembly while maintaining an airtight seal between the guidewire assembly and the first and second syringes.

15. The gas inflation/evacuation system and sealing system of claim 9, wherein the first and second syringes, the sealing assembly, and the valve arrangement are contained in a sterile packaging filled with a biocompatible gas and wherein all gas within the sterile packaging is selected from the group consisting of carbon dioxide, oxygen, and nitrous oxide.

27. The gas inflation/evacuation system and sealing system of claim 9, further comprising a severing mechanism for removing the portion of the proximal portion of guidewire assembly containing a permanent airtight seal.

16. A gas inflation/evacuation system and sealing system selectively operably connectable to and removable from a proximal portion of a guidewire assembly which has an occlusive balloon at a distal portion thereof, comprising:

a handheld unit including a crimping mechanism having a first aperture and a sealing mechanism having a second aperture, there being a passageway extending from the first aperture to the second aperture for receiving the proximal portion of the guidewire assembly;

a first syringe system that selectively evacuates the guidewire assembly;

a second syringe system containing a volume of a biocompatible gas sufficient to inflate the occlusive balloon at the distal portion of the guidewire assembly a plurality of times; and

,

conduits operably connecting the first syringe system and the second syringe system to the second aperture of the handheld unit, the conduits including a valve arrangement that selectively connects only one of the first syringe system and the second syringe system to the second aperture at a time.

17. The gas inflation/evacuation system and sealing system of claim 16, wherein the second syringe system includes a plurality of individual syringes, each individual syringe containing a sufficient volume of biocompatible gas to inflate the occlusive balloon one time.

18. The gas inflation/evacuation system and sealing system of claim 16, wherein the crimping mechanism comprises:

a first roller and a second roller proximately spaced from the first roller for traversal of the proximal portion of the guidewire assembly, the first roller being connected to a handle with a pivotable cam arrangement such that force on the handle causes the first roller to proportionately approach the second roller, a first threshold force on the handle causing sealing of the proximal portion of the guidewire assembly and a second threshold force on the handle causing severing of the proximal portion of the guidewire assembly.

19. The gas inflation/evacuation system and sealing system of claim 18, wherein the handle is spring biased for an automatic return to an open starting position upon cessation of a force.

20. A gas inflation/evacuation system and sealing system removably connectible to a proximal portion of a guidewire assembly which has an occlusive balloon at a distal portion thereof, comprising:

a handheld unit including a crimping mechanism having a first aperture and a sealing mechanism having a second aperture, there being a passageway extending from the first aperture to the second aperture for receiving the proximal portion of the guidewire assembly;

an evacuating syringe that selectively evacuates the guidewire assembly; and

,

a plurality of inflation syringes, each inflation syringe containing a volume of a biocompatible gas sufficient to inflate the occlusive balloon at the distal portion of the guidewire assembly a single time.

21. The gas inflation/evacuation system and sealing system of claim 20, further comprising:

conduits operably connecting the evacuation syringe and the plurality of inflation syringes to the second aperture of the handheld unit, the conduits including a valve arrangement that selectively connects only the evacuation syringe or the plurality of inflation syringes to the second aperture at one time.

22. The gas inflation/evacuation system and sealing system of claim 20, wherein the handheld unit, the evacuation syringe, and the plurality of inflation syringes are contained in a sterile packaging filled with a biocompatible gas and wherein all gas within the sterile packaging is selected from the group consisting of carbon dioxide, oxygen, and nitrous oxide.

23. A gas inflation/evacuation system and sealing system removably connectible to a proximal portion of a guidewire assembly which has an occlusive balloon at a distal portion thereof, comprising:

a first syringe system that selectively evacuates the guidewire assembly;

a second syringe system that selectively introduces a biocompatible gas into the guidewire assembly to inflate the occlusive balloon at the distal portion of the guidewire assembly a plurality of times; and

a plugging mechanism removably connectible to the proximal portion of the guidewire assembly that selectively seals the proximal portion of the guidewire assembly at one of a plurality of separate locations to form one of a plurality of successive permanent airtight seals of the guidewire assembly, including;

a first aperture and a second aperture in fluid communication, the first aperture being capable of receiving therethrough the proximal portion of the guidewire assembly, and the second aperture being removably attachable to a conduit;

an operational O-ring in coaxial alignment with the first aperture for operational engagement of the proximal portion of the guidewire assembly at a location proximal of the first aperture;

a sealant O-ring in coaxial alignment with the first aperture and proximally spaced from the operational O-ring such that further insertion of the proximal portion of the guidewire assembly through the first aperture and past the operational O-ring will bring the proximal portion of the guidewire assembly into engagement with the sealant O-ring; and

,

a sealant confinement layer for receiving the proximal portion of the guidewire assembly some distance past the sealant O-ring, the sealant confinement layer confining sealant material such that insertion of the proximal portion of the guidewire assembly through the sealant confinement layer and into the sealant material forces the sealant material into the proximal portion of the guidewire assembly.

24. The gas inflation/evacuation system and sealing system of claim 23, wherein the sealant material is selected from the group consisting of wax, plastic, polymer, and metal.