Expandable sheath tubing

• US 7,963,952 B2
• Filed: 08/19/2004
• Issued: 06/21/2011
• Est. Priority Date: 08/19/2003
• Status: Active Grant

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Inventors: Wright, John A. Jr., Core, Lee A., Kolber, Andrea B., Peavey, Todd A.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): HOLLOWAY, IAN KNOBEL
• Application Number:
  US10/921,484
• Publication Number:
  US 20050080430A1
• Time in Patent Office: 2,497 Days
• Field of Search: 493/918, 534/69, 604/14, 604/90, 604/104, 604/164.03, 604/264, D24/112, D24/118
• US Class Current: 604/264
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2090/08021 of the patient or his organs
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 : with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 : Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An expandable catheter accommodates a medical device that is being removed from a body with a larger diameter than the catheter. The same catheter may be used to reposition a device within the body to an alternative delivery site. A catheter or sheath may be used to deliver a medical device, surgical instrument, or biological sample.

Claims

1. A catheter sheath for retrieving an object in a body, comprising:

an expandable distal end, the expandable distal end being a tube including a first layer and a second layer, wherein the first layer is bonded to the second layer, the second layer is positioned outside of the first layer, the first layer comprises a slit that extends from the distal edge of the first layer, a portion of the slit is not parallel to the longitudinal axis of the tube, and the outer surface of the first layer does not contact the inner surface of the first layer, wherein the second layer extends beyond the distal edge of the first layer to create an overhang;

a proximal end including a port for the passage of objects into the catheter sheath; and

a tubular percutaneous delivery component located between the proximal and distal ends that creates an uninterrupted conduit between the expandable distal end and the proximal end.

2. The catheter sheath according to claim 1, wherein the slit spirals around the distal end at least one-eighth of a turn.

3. The catheter sheath according to claim 1, wherein the slit is of zig-zag form.

4. The catheter sheath according to claim 1, wherein

the first layer is an inner layer including at least two slits, in which the at least two slits are generally longitudinally oriented, and a portion of at least one of the at least two slits is not parallel to the longitudinal axis of the tube, and

the second layer is an outer layer that does not have slits.

5. The catheter sheath according to claim 4, wherein the outer layer is elastomeric.

6. The catheter sheath according to claim 4, wherein the outer layer comprises at least one material selected from the group consisting of silicone, polyurethane, and polyether-amide block copolymer.

7. The catheter sheath according to claim 4, wherein the outer layer is elastomeric and has a thickness in the range of about 0.002 to about 0.008 inches.

8. The catheter sheath according to claim 4, wherein the at least two slits are of a zig-zag cut that forms teeth and the teeth are triangular shaped.

9. The catheter sheath according to claim 4, wherein the at least two slits are of a zig-zag cut that forms teeth and the teeth are semi-circular shaped.

10. The catheter sheath according to claim 4, wherein the outer layer is elastomeric and insures during expansion of the expandable distal end that the teeth remain at least partially interlocked.

18. The catheter sheath according to claim 1, wherein the distal end has at least a first inner layer and a second outer layer, the second layer is made of a material that is less stiff than the material used to make the first layer, the second layer extending past the first layer at the distal end.

20. The catheter sheath according to claim 4, wherein the outer layer is elastomeric, wherein the at least two slits are of a zig-zag cut that forms teeth, and wherein the teeth separate and do not remain at least partially interlocked.

11. A catheter sheath for delivery and retrieval of objects during medical procedures, comprising:

a percutaneous shaft component; and

an expandable distal end of at least one layer attached to the end of the percutaneous shaft component, including and elastomeric outer cover and a braided layer constructed of braided material that expands axially when a portion of the expandable distal end is contracted longitudinally, wherein the elastomeric outer cover is positioned over the portion of the braided material that receives the object to be retrieved and extends beyond a distal edge of the braided layer to create an overhang.

12. The catheter sheath according to claim 11, wherein the expandable distal end includes a slit layer inside the braided layer, the slit layer including at least two slits, the at least two slits being generally longitudinally oriented.

13. The catheter sheath according to claim 11, further comprising:

a control element that controls the diameter of the expandable distal end by adapting the longitudinal contraction of said portion.

14. A method of recovery of an object in a biological vas, comprising:

introducing of a percutaneous catheter sheath, the catheter sheath including a proximal end, an expandable distal end, and a tubular percutaneous component,

the proximal end including a port for the passage of objects in the catheter sheath,

the tubular percutaneous component located between the proximal and distal ends that creates an uninterrupted conduit between the expandable distal end and the proximal end, and

the expandable distal end being a tube including a first layer and a second layer wherein the first layer is bonded to the second layer, the second layer is positioned outside of the first layer, the first layer comprises a slit that extends from the distal edge of the first layer, a portion of the slit is not parallel to the longitudinal axis of the tube, and the outer surface of the first layer does not contact the inner surface of the first layer, wherein the second layer extends beyond the distal edge of the first layer to create an overhang; and

recovering the object in the biological vas at least partially into the expandable distal end while causing the expandable distal end to partially expand.

15. The method of recovery according to claim 14, further comprising:

redeploying the object in the biological vas after recovering the object at least partially into the expandable distal end.

16. The method of recovery according to claim 14, wherein

the first layer is an inner layer including at least two slits, in which the at least two slits are generally longitudinally oriented and a portion of at least one of the at least two slits is not parallel to the longitudinal axis of the tube,

and the second layer is an outer layer that is an elastomeric material that does not have slits,

the method further comprising:

ensuring that the teeth remain at least partially interlocked during expansion of the expandable distal end during manipulation of the object in the biological vas.

17. The method of recovery according to claim 16, further comprising:

redeploying the object in the biological vas after recovering the object at least partially into the expandable distal end.

19. The catheter sheath according to claim 17, wherein the second layer extends past the first layer by a distance of 0.005 to 0.5 inches.

21. A catheter sheath for retrieving an object in a body, comprising:

an expandable distal end, the expandable distal end being a tube including a first layer and a second layer, wherein the first layer is bonded to the second layer, the second layer is positioned outside of the first layer, and the first layer comprises at least two slits that extend from the distal edge of the first layer, wherein the second layer extends beyond the distal edge of the first layer to create an overhang;

a proximal end including a port for the passage of objects into the catheter sheath; and

a tubular percutaneous delivery component located between the proximal and distal ends that creates an uninterrupted conduit between the expandable distal end and the proximal end.

22. The catheter sheath according to claim 21, wherein the at least two slits spiral around the distal end at least one-eighth of a turn.

23. The catheter sheath according to claim 21, wherein the at least two slits are generally longitudinally oriented and a portion of at least one of the at least two slits is not parallel to the longitudinal axis of the tube, and the second layer is an outer layer that does not have slits.

24. The catheter sheath according to claim 23, wherein the outer layer is elastomeric.

25. The catheter sheath according to claim 23, wherein the outer layer comprises at least one material selected from the group consisting of silicone, polyurethane, and polyetheramide block copolymer.

26. The catheter sheath according to claim 23, wherein the outer layer is elastomeric and has a thickness in the range of about 0.002 to about 0.008 inches.