Protective intraluminal sheath

• US 5,647,857 A
• Filed: 03/16/1995
• Issued: 07/15/1997
• Est. Priority Date: 03/16/1995
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Inventors: Anderson, Scott C., Cannon, James M. Jr.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): Alexander, V.
• Application Number:
  US08/405,511
• Time in Patent Office: 852 Days
• Field of Search: 604/264, 604/280, 604/96, 604/160, 604/161, 604/286, 604/14, 604/15, 604/171, 606/108, 606/192, 606/194, 215/254, 229/238, 229/239, 229/309-314, 229/316, 229/926, 623/1
• US Class Current: 604/264
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths

Abstract

A sheath holds a device against a balloon catheter for delivery in the lumen of a patient. The device can be a stent and graft combination. The stent is kept properly centered over the balloon catheter by the sheath as the graft is placed in a blood vessel. The smooth outer surface of the sheath protects the vessel wall from the rough surface of the stent. A notch is formed in the end of the sheath where the free end of a strand of thread protrudes from the sheath. The sheath is removed from the graft by pulling on the free end of the strand otherwise located distally from the outer surface of the sheath. The strand cuts through and splits open the sheath as a result of the force applied on the free end of the strand. The other end of the strand is attached to a reinforced collar at the other end of the sheath. The strand does not cut through the collar. After reaching the collar, the proximal force applied on the strand now pulls the split sheath from the graft and stent combination without disturbing the placement of the stent over the balloon delivery catheter.

Claims

1. A retractable sheath for use with a catheter for delivering treatment to a body lumen of a patient, said sheath comprising:

a tubular sheath body for covering a treatment-delivering portion of the catheter and having an inner surface, an outer surface, a proximal end and a distal end;

a collar radially disposed about and attached to said proximal end of said sheath body;

a strand including a peelable portion having a first end and a free portion having a free end;

said peelable portion being embedded in said inner surface of said sheath body and extending axially from said collar to said distal end of said sheath body, said first end of said peelable portion being affixed to said collar and said free portion of said strand extending out of said distal end of said sheath body and resting alongside said outer surface of said sheath body further extending back towards said proximal end of said sheath body;

whereby the proximal application of a tearing force to said free end of said free portion of said strand causes said peelable portion to cut through said sheath body up to said collar, said collar being resistant to the tearing force applied.

2. A sheath according to claim 1, wherein said distal end of said sheath body includes a notch, to facilitate the tearing of said sheath body by said peelable portion of said strand upon proximal application of a tearing force.

3. A sheath according to claim 1, wherein said sheath body further includes a perforation extending axially from said distal end towards said proximal end, to encourage the propagation of said peelable portion of said strand through said sheath body upon proximal application of a tearing force.

4. A sheath according to claim 1, wherein said collar is formed from a first layer and a second layer of said proximal end of said sheath body, said first layer doubled over said second layer of said proximal end of said sheath body so that said collar is resistant to the tearing force of said strand.

5. A sheath according to claim 1, wherein said collar further comprises a coaxial tube.

6. A sheath according to claim 5, wherein said coaxial tube is provided with a cleft to form a split along said tube for facilitating the removal of said sheath from the catheter.

7. A displaceable sheath intended for use with a catheter for delivering treatment to a body lumen of a patient, said sheath comprising:

a hollow sheath body for covering a treatment-delivering portion of the catheter, said sheath body having an inner surface, an outer surface, an open proximal end, and a distal end having an aperture;

a collar radially disposed about and affixed to said open proximal end of said sheath body; and

a first strand including a first peelable portion with a first collar end and a first free portion adjacent said first peelable portion having a first free end, said first collar end of said first peelable portion being affixed to said collar and said first peelable portion extending from said collar along said inner surface of said sheath body and out of said aperture in said distal end of said sheath body, and said first free portion of said first strand extending back from said distal end of said sheath body back towards said open proximal end of said sheath body against said outer surface of said sheath body;

whereby the proximal application of a tearing force to said first free end of said first free portion of said first strand causes said first peelable portion to cut through said sheath body up to said collar, said collar being resistant to the tearing force applied.

8. A sheath according to claim 7, wherein said aperture in said distal end of said sheath body includes a notch, to facilitate the tearing of said sheath body by said first peelable portion of said first strand upon proximal application of a tearing force.

9. A sheath according to claim 7, wherein said sheath body further includes a perforation extending axially from said distal end towards said proximal end, to encourage the propagation of said first peelable portion of said first strand through said sheath body upon proximal application of a tearing force.

10. A sheath according to claim 7, wherein said collar is formed from a first layer and a second layer of said proximal end of said sheath body, said first layer doubled over said second layer of said proximal end of said sheath body so that said collar is resistant to the tearing force of said first strand.

11. A sheath according to claim 7, wherein said collar further comprises a coaxial tube.

12. A sheath according to claim 11, wherein said coaxial tube is provided with a cleft to form a split along said tube for facilitating the removal of said sheath from the catheter.

13. A sheath according to claim 7, further comprising a second strand including a second peelable portion with a second collar end and a second free portion adjacent said second peelable portion having a second free end, said second collar end of said second peelable portion being affixed to said collar and said second peelable portion extending from said collar along said inner surface of said sheath body and out of said aperture in said distal end of said sheath body, and said second free portion of said second strand extending back from said distal end of said sheath body back towards said open proximal end of said sheath body against said outer surface of said sheath body;

whereby the proximal application of a tearing force to said second free end of said second free portion of said second strand causes said second peelable portion to cut through said sheath body up to said collar, said collar being resistant to the tearing force applied.

14. A method of protecting a vessel wall from damage during the implantation of a medical device in a patient with a delivery catheter whereby the medical device is surrounded by a protective sheath, the sheath comprising a sheath body having an inner surface, an outer surface, a proximal end and a distal end, a collar affixed to said proximal end, a strand affixed to said collar, routed along the inner surface of the sheath body and having a free portion that extends out of the distal end of the sheath body and having a free end, said method comprising the steps of:

loading the medical device to be implanted on the delivery catheter;

surrounding the medical device with the sheath;

orienting the free portion of the strand so that it lies alongside the outer surface of the sheath body and extends towards the proximal end of the sheath body;

inserting the delivery catheter in the body lumen of a patient while preventing the free end from entering the lumen;

routing the catheter so that the device carried thereon and which is protected by the sheath is positioned at the site at which implantation is to occur;

pulling the free end of the strand proximally of the patient to cause the strand to slice through the sheath body up to the collar;

pulling further on the free end of the strand to apply a force to the collar, which collar is resistant to being cut by the strand, to cause the collar to travel proximally along the catheter and thus pull the severed sheath away from the medical device so that implantation then can be accomplished.

15. The method of claim 14, wherein the proximal end of the sheath body includes a notch, and the step of orienting the free portion of the strand further includes the step of orienting the free portion of the strand so that it rests in the notch.

16. The method of claim 14, wherein the collar comprises a portion of the proximal end of the sheath body that is doubled back on itself.

17. The method of claim 14, wherein the portion of the strand that is routed along the inner surface of the sheath body is embedded in the sheath body.

18. The method of claim 14, wherein the collar is a coaxial tube surrounding the delivery catheter.

19. The method of claim 14, wherein the medical device to be implanted is an intraluminal stent.

20. The method of claim 14, wherein the medical device to be implanted is a stent-and-graft combination.