Medical wire introducer and balloon protective sheath

• US 5,997,562 A
• Filed: 03/24/1998
• Issued: 12/07/1999
• Est. Priority Date: 06/13/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Percusurge Inc. (Medtronic Plc)
• Inventors: Tomas, Andres D., Ha, Hung, Bagaoisan, Celso, Patel, Mukund, Zadno-Azizi, G. Reza
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US09/047,303
• Time in Patent Office: 623 Days
• Field of Search: 606/194, 606/180, 606/184, 606/108, 604/171, 604/158, 604/264, 604/280
• US Class Current: 606/194
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

The present invention provides a protective sheath assembly which combines the function of an introducer, the function of a protective sheath and the function of a sealing valve in an integrated assembly. The protective sheath assembly of the present invention preferably comprises a protective sheath, a strain-relief tubing, and a connecting member or a hub. These parts are mounted, removably or permanently, into an integral device. The protective sheath assembly can also be used in combination with an introducer such as a needle introducer. The protective sheath has a proximal end, a distal end, and an elongated hollow body defining a lumen along the longitudinal direction of the protective sheath. A hub is provided to secure the proximal end of the protective sheath to an introducer. The lumen of the protective sheath serves to accommodate and protect a balloon catheter, as well as seal around the catheter.

Claims

1. A protective sheath assembly that fits over a balloon catheter or a fixed-wire device catheter having a balloon and a soft tip attached thereto, used to protect the catheter when introduced into a blood vessel through a blood flow preventing valve, comprising:

a protective sheath having a proximal end, a distal end that covers the balloon and soft tip attached to the catheter when passing through the blood flow preventing valve, and an elongated body defining a lumen along a longitudinal axis of said protective sheath, said lumen having a proximal portion and a distal portion, wherein the cross-sectional diameter of the distal portion of the lumen is larger than the maximum diameter of the catheter so that said catheter can be moved through the lumen, and wherein at least a portion of the protective sheath remains in the blood flow preventing valve.

2. The protective sheath assembly of claim 1, wherein the balloon catheter being moved through the lumen is sealed against blood bleed by the proximal portion of the lumen containing the balloon and the soft tip.

3. The protective sheath assembly of claim 1, wherein the protective sheath assembly further comprises a strain-relief tubing enclosing the proximal portion the protective sheath.

4. The protective sheath assembly of claim 1, further comprising a hub, said hub being connected to the proximal end of the protective sheath.

5. The protective assembly of claim 1, wherein the distal end of the protective sheath has a flared inner surface.

6. The protective sheath assembly of claim 1, wherein the transition point between the narrower proximal portion and the broader distal end of the protective is smoothly tapered.

7. A protective sheath assembly for introducing a balloon catheter containing a balloon and a soft tip into a blood vessel, comprising:

a protective sheath having a proximal end, a distal end, and an elongated body defining a lumen along a longitudinal axis of said protective sheath, said lumen having a proximal portion and a distal portion;

a metallic hypotube having a diameter slightly larger than the diameter of the balloon catheter, said hypotube being inserted into the proximal portion of the protective sheath with part of the proximal portion not in touch with the hypotube, wherein the lumen and the hypotube encapsulate the balloon catheter so that the balloon catheter can be moved through the lumen and the hypotube while being sealed against blood bleed.

8. The protective sheath assembly of claim 7, wherein the inner diameter of the metallic hypotube is larger than the inner diameter of the part of the proximal portion of the protective sheath which is not in touch with the metallic hypotube.

9. The protective sheath assembly of claim 7, further comprising a hub connected to the proximal end of the protective sheath.

10. An introducer/protective sheath assembly for introducing a catheter with a balloon and a soft tip into a blood vessel system, comprising:

a protective sheath having a proximal end, a distal end with a flared inner surface and tapered outer surface, and an elongated hollow body defining a lumen along the longitudinal axis of said protective sheath, said lumen having a proximal portion and a distal portion, the proximal portion having an inner diameter smaller than that of the distal portion and slightly larger than the outer diameter of the catheter, so that the catheter can move within the lumen along the longitudinal axis of said protective sheath;

an introducer having a first end, a second end, and an elongated body defining a cavity along its longitudinal axis; and

a connecting member for securing the protective sheath to the introducer, said connecting member having a distal end with a first mechanism for receiving the proximal end of the protective sheath, a proximal end with a second mechanism for receiving the introducer, and a hole along the center line of the connecting member.

11. A method for maling a protective sheath assembly having an introducer, a protective sheath, and a connecting member wherein the protective sheath houses a balloon catheter, said method comprising the steps of:

extruding a plastic tubing of desired dimension;

inserting a mandrel of predetermined dimension into the plastic tubing;

exposing one end of the plastic tubing to a hot air;

heating and stretching the exposed end of the plastic tubing to a predetermined smaller diameter;

flaring the other end of the plastic tubing;

inserting the exposed end into a strain-relief tubing; and

connecting the exposed end and the strain-relief tubing to one side of a connecting member.

12. The method of claim 11, wherein said plastic tubing contains one or more stepped regions where the regions consist of variable diameters.

13. A method of using a protective sheath assembly for protecting a balloon catheter during angioplasty comprising the following steps:

inserting a guide catheter into a blood vessel of a patient;

connecting a Y-adaptor containing a hemostasis valve to the guide catheter;

inserting the balloon catheter into the protective sheath assembly having a proximal end and a distal end;

inserting the distal end of said protective sheath assembly into the Y-adaptor through the hemostasis valve; and

advancing said balloon catheter towards a treatment site.

14. The method of claim 13, further comprising placing an arterial protective sheath between the guide catheter and the Y-adaptor.

15. The method of claim 13, wherein the protective sheath assembly is removed either before of after the catheter is advanced towards the treatment site.

16. A sheath assembly for use in angioplasty that encloses and protects a catheter with a balloon and a soft tip, comprising:

a protective sheath having a proximal portion, a distal portion, an inner surface, and an outer surface, wherein the inner surface defines a lumen having a narrow proximal portion and a broad distal portion; and

a tubular sleeve, wherein the inner diameter of the tubular sleeve is slightly larger than the outer diameter of the proximal portion of the protective sheath, and wherein the tubular sleeve covers at least a portion of the proximal portion of the protective sheath.

17. The sheath assembly of claim 16 further comprising a hypotube, wherein the hypotube is positioned inside the proximal portion of the lumen.

18. The sheath assembly of claim 17, wherein the hypotube has an outer diameter slightly larger than the inner diameter of the proximal portion of the protective sheath.

19. The sheath assembly of claim 16, wherein the connecting member is a luer lock.

20. The sheath assembly of claim 16, wherein the proximal port of the connecting member is connected to an introducer.

21. The sheath assembly of claim 16, wherein the proximal portion of the lumen is broader than the distal portion of the lumen.