Expandable percutaneous sheath

• US 20050125021A1
• Filed: 07/02/2004
• Published: 06/09/2005
• Est. Priority Date: 12/05/2003
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Bishop, Joseph, Kick, George F., Nance, Edward J., Lenker, Jay, Tchulluian, Onnik
• Granted Patent: US 7,780,692 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• 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: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 31/005 for contrast media

Abstract

Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross-sectional configuration by a tubular restraint. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as percutaneous nephrostomy or urinary bladder access.

Claims

1. A percutaneous access system for providing minimally invasive access, comprising:

an access sheath comprising an elongate tubular body that defines a lumen, at least a portion of the elongate tubular body being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile; and

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular structure in the first, folded, smaller cross-sectional profile;

wherein the elongate tubular body is sufficiently pliable to allow the passage of objects having a maximum cross-sectional dimension that is larger than an inner diameter of a circle corresponding to the cross-sectional area of the elongate tubular body in the second, greater cross-sectional profile.

2. The percutaneous access system of claim 1, wherein, when the objects having a maximum cross-sectional dimension larger than the inner diameter of the elongate tubular body are passed through the lumen, the elongate tubular body reconfigures to change the cross-sectional shape of the lumen.

3. The percutaneous access system of claim 2, wherein, when the elongate tubular body reconfigures the cross-sectional shape of the lumen, the cross-sectional dimensions of the lumen decrease in a first direction and increase in a second direction.

4. The percutaneous access system of claim 2, wherein the elongate tubular body includes at least one crease along which the elongate tubular body folds in the first, folded, smaller cross-sectional profile.

5. The percutaneous access system of claim 4, wherein the elongate tubular body reconfigures by bending along the at least one crease.

6. The percutaneous access system of claim 2, the elongate tubular body is elastic and the elongate tubular body reconfigures, at least in part, by elastic deformation to increase the cross sectional area of the lumen.

7. The percutaneous access system of claim 1, farther comprising an expandable device positioned within the elongate tubular body.

8. The percutaneous access system of claim 7, wherein the expandable device comprises an inflatable balloon.

9. A percutaneous access system for providing minimally invasive access, comprising:

an access sheath comprising an elongate tubular body having a proximal end and a distal end and defining a first axial lumen, at least a portion of the elongate tubular body being expandable from a first, smaller cross-sectional profile to a second, greater cross-sectional profile;

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular member in the first, smaller cross-sectional profile;

an extender comprising an elongate tubular structure, which defines a second axial lumen,

complementary structures in between the elongate tubular body and the extender that provide a releaseable connection between the elongate tubular body and the extender to place the first axial lumen in communication with the second axial lumen.

10. The percutaneous access system of claim 9, wherein the complementary retention structures comprise threads.

11. The percutaneous access system of claim 9, wherein the complementary retention structures comprise a quick release connector.

12. The percutaneous access system of claim 9, wherein the complementary retention structures comprise Luer lock.

13. A percutaneous access sheath assembly for providing minimally invasive access, comprising:

an access sheath comprising an elongate tubular member having a proximal end and a distal end and defining a working lumen, at least a portion of the elongate tubular member being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile;

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular member in the first, smaller cross-sectional profile; and

an extender comprising an inner tubular member and an outer tubular member that is positioned over the inner tubular member, the inner member and outer member moveable between a first position in which the inner member and outer member overlap such that the extender has a first, shorter axial length and a second position in which the overlap between the inner and outer members is reduced and the extender has a second, longer axial length.

14. The percutaneous access sheath assembly as in claim 13, further comprising complementary retention structures between the inner and outer tubular members, the complementary retention structures configured to resist axial movement between the inner and outer tubular members.

15. A percutaneous access system, for providing minimally invasive access, comprising:

an elongate tubular body that defines a lumen, at least a portion of the elongate tubular body being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile;

a releasable restraint carried by the access sheath to restrain at least a portion of the elongate tubular structure in the first, smaller cross-sectional profile;

an expandable member positioned within the elongate tubular body and configured to expand the elongate tubular body from the first, smaller cross-sectional profile to the second, greater cross-sectional profile; and

a stop configured to limit distal movement of the releasable restraint as the elongate tubular body expands.

16. The percutaneous access system as in claim 15, wherein the restraint includes a distal end that forms a distal face and the stop includes a proximal end that forms a proximal face that engages the distal face of the restraint to limit distal movement of the releasable restraint.

17. The percutaneous access system as in claim 15, wherein the stop is carried by the expandable member.

18. A percutaneous access assembly for providing minimally invasive access, comprising:

an elongate tubular body that defines a lumen, at least a portion of the elongate tubular structure being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile; and

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular body in the first, smaller cross-sectional profile;

wherein in the first, folded, smaller-cross-sectional profile the elongate tubular body forms at least two creased sections, the at least two creases sections being positioned on a perimeter of the tubular body and generally facing each other.

19. The percutaneous access assembly of claim 18, wherein the elongate tubular body has a distal end that forms a distal face which is beveled with respect to a longitudinal axis of the elongate tubular body, the distal face having a distal edge and a proximal edge.

20. The percutaneous access assembly of claim 18, wherein the at least two creased sections are positioned on a perimeter of the elongate tubular body on a side of the elongate tubular body generally opposite the proximal edge.

21. The percutaneous access assembly of claim 18, wherein the two creased sections overlap each other.

22. A percutaneous access sheath system for providing minimally invasive access, comprising:

an elongate tubular structure that defines a lumen, at least a portion of the elongate tubular structure being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile,

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular structure in the first, smaller cross-sectional profile; and

a guidewire positioned between the elongate tubular structure and the releasable jacket.

23. A method of providing percutaneous access, the method comprising:

inserting a guidewire into a patient,

percutaneously inserting an elongate tubular body having a first, smaller cross-sectional profile over the guidewire;

expanding, with an expandable member, the elongate tubular body from the first, smaller cross-sectional profile to a second, greater cross-sectional profile;

releasing the elongate tubular body from a constraining tubular jacket;

removing the expandable member from the elongate tubular body;

collapsing the elongate tubular body to a cross-sectional profile smaller than the second, greater cross-sectional profile; and

removing the elongate tubular body from the patient.

24. The method as in claim 23, wherein the step of collapsing the elongate tubular body comprises pulling the elongate tubular body in a radially inward direction.

25. The method as in claim 23, wherein the step of collapsing the elongate tubular body comprises inserting a collapsible device into the elongate tubular body and collapsing the collapsible device.

26. The method as in claim 25, further comprising engaging complementary retention structures between the collapsible device and the elongate tubular structure.

27. The method as in claim 25, wherein the step of collapsing the collapsible device comprises deflating a balloon.

28. The method as in claim 25, wherein the step of expanding the elongate tubular body from the first, smaller cross-sectional profile to a second, greater cross-sectional profile comprises expanding an expandable member positioned within the elongate tubular body.

29. The method as in claim 25, wherein the step of expanding the elongate tubular body from the first, smaller cross-sectional profile to a second, greater cross-sectional profile comprises expanding the collapsible member which is positioned within the elongate tubular body.

30. The method as in claim 23, wherein the step of releasing the elongate tubular body from a constraining tubular jacket is accomplished in response to the step of expanding, with an expandable member, the elongate tubular body from the first, smaller cross-sectional profile to a second, greater cross-sectional profile.

31. A percutaneous access sheath system for providing minimally invasive access, comprising:

an elongate tubular body that defines a lumen, at least a portion of the elongate tubular structure being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile,

a jacket removably carried by the access sheath to restrain at least a portion of the elongate tubular body in the first, smaller cross-sectional profile;

a collapsible member configured to be inserted into the elongate tubular body when the elongate tubular body is in the second, greater cross-sectional profile;

a first coupling structure on the collapsible member; and

a second complementarily coupling structure on the elongate tubular body for radially coupling the collapsible member to the elongate tubular body.

32. A percutaneous access system for providing minimally invasive access, comprising:

an access sheath comprising an elongate tubular body that defines a lumen, at least a portion of the elongate tubular body being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile; and

a restraint carried by the access sheath to restrain at least a portion of the elongate tubular structure in the first, folded, smaller cross-sectional profile;

wherein the elongate tubular body is sufficiently pliable that when the elongated tubular structure is in the second, greater cross-sectional area, the elongated tubular body may bend at least about 15 degrees with respect to a straight longitudinal axis extending through the lumen while maintaining at least about 50% of the cross-sectional area of the lumen in the second, greater cross-sectional profile.