Guide-wire mounted balloon modulation device and methods of use

• US 6,902,535 B2
• Filed: 08/26/2002
• Issued: 06/07/2005
• Est. Priority Date: 08/26/2002
• Status: Expired due to Term

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kansey Nash Corporation
• Inventors: Sauro, Dennis M., Eberhart, Mark, Nash, John E., Fisher, William T.
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US10/227,996
• Publication Number:
  US 20040039305A1
• Time in Patent Office: 1,016 Days
• Field of Search: 600433-435, 600/585, 604/96.01, 604/98.01, 604 9701- 9703, 604 9901- 9904, 604/101.01, 604/104, 604/264, 604/523, 606191-200
• US Class Current: 600/585
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

An apparatus for modulating the pressure of a fluid such as a gas within the expandable portion of a guide wire catheter. A preferred embodiment apparatus features a mechanism for controllably gripping and releasing the open, proximal end of a tubular guide wire, a mechanism for introducing a fluid to a desired pressure and volume into the expandable portion of the tubular guide wire through the open end, and, while maintaining the pressure and volume of fluid in the tubular guide wire, a mechanism for introducing a sealing member into the open end of the tubular guide wire to seal the fluid in the tubular guide wire. In a particularly preferred embodiment, the apparatus also features a deflation tool for piercing the seal and letting the fluid out. Using this apparatus, the tubular guide wire can be re-sealed and re-opened as necessary.

Claims

1. An apparatus for modulating the pressure of a fluid within an expandable portion of a tubular guide wire or catheter, the apparatus comprising an inflation tool comprising:

means for controllably gripping an open, proximal end of a tubular guide wire or catheter, the gripping means comprising a deformable member and a deforming mechanism, the deforming mechanism comprising a lever mechanism arranged to controllably act upon the deformable member to cause gripping of the tubular guide wire or catheter by the deformable member;

means for introducing a fluid into said expandable portion of said tubular guide wire or catheter through said open, proximal end, thereby inflating said expandable portion of said tubular guide wire or catheter to a desired extent; and

means for introducing a sealing member into said open proximal end of said tubular guide wire or catheter to seal said fluid in said tubular guide wire or catheter.

2. The apparatus of claim 1, further comprising a means for re-opening said proximal end of said tubular guide wire or catheter.

3. The apparatus of claim 2, wherein said means for re-opening said proximal end of said tubular guide wire or catheter comprises a deflation tool comprising a needle for piercing said sealing member.

4. The apparatus of claim 3, wherein said deflation tool further comprises a handle having a bore that is open on at least one end, and wherein said needle is mounted in said bore coaxially with a centerline of said bore.

5. The apparatus of claim 4, further comprising a lead-in taper to said bore, and a spring coiled around said needle to help support said needle.

6. The apparatus of claim 4, wherein said needle arranged in said bore creates a channel between said needle and an inner wall of said handle, said channel having a spring arranged therein such that said spring maintains concentricity of said needle in said bore.

7. The apparatus of claim 1, wherein said sealing member comprises wax.

8. The apparatus of claim 1, wherein said means for introducing said sealing member comprises a rod mounted in said apparatus, said rod being capable of moving axially and radially.

9. The apparatus of claim 8, wherein said sealing member is housed in a bore in a flat surface of said rod that is to contact said open end of said tubular guide wire or catheter, said bore being offset from a longitudinal axis of said rod.

10. The apparatus of claim 9, wherein said open, proximal end of said tubular guide wire or catheter is urged against said flat surface.

11. The apparatus of claim 10, wherein said introducing means for said sealing member is arranged to rotate said rod until said bore containing said sealing member comes into alignment with said proximal end of said tubular guide wire or catheter, and press said rod axially toward said tubular guide wire or catheter, such that said proximal end of said tubular guide wire or catheter is sealed.

12. The apparatus of claim 9, wherein said flat surface is striated to permit fluid to enter said tubular guide wire or catheter through said proximal end when said tubular guide wire or catheter is in contact with said flat surface of said rod.

13. The apparatus of claim 1, wherein the lever mechanism is arranged such that said lever mechanism in a first position allows the slidable entry of said tubular guide wire or catheter into said gripping means.

14. The apparatus of claim 1, wherein the lever mechanism is arranged such that said lever mechanism in a second position causes said gripping of said tubular guide wire or catheter.

15. The apparatus of claim 1, wherein said inflation tool further comprises a pierceable diaphragm to capture a charge of said fluid.

16. A valve mechanism for modulating pressure in a balloon or expandable member on or about a catheter or guide wire, the valve mechanism comprising:

a) an inflation tool, the inflation tool comprising

a gripping means, the gripping means comprising a deformable member and a deforming mechanism comprising a lever mechanism arranged to controllably deform the deformable member, thereby controllably gripping said catheter or guide wire;

an inflating means, the inflating means comprising a charge of fluid, and a means of modulating the pressure of the charge of fluid, and a pierceable diaphragm to prevent premature leakage of the charge of fluid;

a sealing means;

the sealing means comprising a material suitable for sealing and maintaining pressure in the guide wire or catheter, and an insertion rod, the insertion rod facilitating the insertion of the suitable material into a guide wire or catheter and;

b) a deflation tool, the deflation tool comprising a needle and a handle, the needle upon application penetrating the suitable material to allow pressure relief of the balloon or expandable member, the handle arranged to manipulate the needle.

17. A valve mechanism for modulating pressure in a balloon or expandable member on or about a catheter or guide wire, the valve mechanism comprising:

a) an inflation tool, the inflation tool comprising

a gripping means, the gripping means comprising a deformable member and a deforming mechanism, the deforming mechanism acting upon the deformable member to cause gripping of the guide wire or catheter by the deformable member;

an inflating means, the inflating means comprising a charge of fluid, and a means of modulating the pressure of the charge of fluid, and a pierceable diaphragm to prevent premature leakage of the charge of fluid;

a sealing means;

the sealing means comprising a deformable material, an insertion rod and an arm, wherein the deformable material is suitable for sealing and maintaining pressure in the guide wire or catheter, wherein the insertion rod facilitates the insertion of the deformable material into a guide wire or catheter, the insertion rod having a striated face that contacts said proximal end of the guide wire or catheter, and wherein the arm actuates said insertion rod; and

b) a deflation tool, the deflation tool comprising a needle, the needle upon application penetrating the deformable material to allow pressure relief of the balloon or expandable member, and a handle, the handle arranged to manipulate the needle.

18. The valve mechanism of claim 17, wherein said arm is arranged to rotate said insertion rod, such that upon rotation of said insertion rod, said deformable material enters alignment with said catheter or guide wire, thereupon said deformable material is driven into said catheter or guidewire, creating a seal.