Expandable guide sheath with steerable backbone and methods for making and using them

• US 20060217755A1
• Filed: 02/03/2006
• Published: 09/28/2006
• Est. Priority Date: 10/04/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Mourlas, Nicholas J., Leeflang, Stephen A., Ventura, Christine P., Eversull, Christian S.
• Granted Patent: US 7,875,049 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• 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 25/0662 Guide tubes

Abstract

Apparatus and methods are provided for providing access to a body lumen. The apparatus includes a tubular member including a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending therebetween. A pushable stiffening member extends from the distal end of the tubular member. An expandable sheath extends along at least a portion of the stiffening member, the sheath being expandable from a contracted condition to facilitate insertion into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen. A distal portion of the sheath is steerable, e.g., using a pull wire disposed within a lumen of the sheath or within the stiffening member. In addition or alternatively, the stiffening member may be biased to a predetermined shape to facilitate introduction.

Claims

1. An apparatus for providing access to a body lumen, comprising:

a tubular member comprising a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending between the proximal and distal ends;

an elongate member extending from the distal end of the tubular member, the elongate member terminating in a steerable distal tip; and

an expandable sheath extending along at least a portion of the elongate member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the elongate member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen.

2. The apparatus of claim 1, wherein the sheath comprises a lubricious material.

3. The apparatus of claim 1, wherein the sheath is attached to the elongate member at one or more locations between the distal end of the tubular member and the distal tip of the elongate member.

4. The apparatus of claim 1, wherein the sheath comprises a distal end having an opening such that an instrument inserted into the tubular member lumen may be advanced through the tubular member and sheath and extend from the opening into a body lumen.

5. The apparatus of claim 1, wherein the elongate member has sufficient column strength that the distal tip may be advanced through a body lumen by pushing the proximal end of the tubular member without substantial risk of the elongate member kinking or buckling.

6. The apparatus of claim 1, further comprising a steering element coupled to the distal tip for causing the distal tip to bend when the steering element is actuated.

7. The apparatus of claim 6, wherein the steering element comprises a pull wire extending from the distal tip to the proximal end of the tubular member.

8. The apparatus of claim 6, further comprising a steering lumen extending along one of the elongate member and the expandable sheath, the steering element extending through the steering lumen.

9. An apparatus for providing access to a body lumen, comprising:

a tubular member comprising a proximal end, a distal end sized for insertion into a body lumen, and a lumen extending between the proximal and distal ends;

an elongate member extending from the distal end of the tubular member, the elongate member terminating in a distal tip, the elongate member comprising a distal portion biased to assume a predetermined nonlinear shape; and

an expandable sheath extending along at least a portion of the elongate member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the elongate member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen communicating with the tubular member lumen.

10. The apparatus of claim 9, wherein the sheath comprises a lubricious material.

11. The apparatus of claim 9, wherein the sheath comprises a distal end having an opening such that an instrument inserted into the tubular member lumen may be advanced through the tubular member and sheath and extend from the opening into a body lumen.

12. The apparatus of claim 9, wherein the elongate member has sufficient column strength that the distal tip may be advanced through a body lumen by pushing the proximal end of the tubular member without substantial risk of the elongate member kinking or buckling.

13. The apparatus of claim 9, wherein the distal portion is biased to a curved shape.

14. The apparatus of claim 9, wherein the distal portion is biased to a shape including multiple curves in one or more planes.

15. The apparatus of claim 9, further comprising a steering element coupled to the distal tip for causing the distal tip to bend when the steering element is actuated.

16. The apparatus of claim 9, further comprising a steering element coupled to the distal portion for causing the distal portion to bend when the steering element is actuated.

17. A method for accessing a body lumen or cavity using an apparatus including a tubular proximal portion and an expandable distal portion having a size smaller than the proximal portion, the method comprising:

advancing the distal portion into a patient'"'"'s body with an expandable sheath thereon in a contracted condition, the proximal portion reaching a first location when the distal portion extends into a body cavity; and

manipulating the distal portion within the body cavity to access a body lumen;

advancing the distal portion into the body lumen to access a target location; and

advancing an elongate instrument through the proximal portion and the expandable sheath to deliver the instrument to the target location.

18. The method of claim 17, further comprising removing the apparatus from the body lumen, while maintaining the instrument at the target location.

19. The method of claim 17, wherein manipulating the distal portion comprises actuating a steering element to change a shape of the distal portion.

20. The method of claim 17, wherein the distal portion is biased to a predetermined nonlinear shape, and wherein manipulating the distal portion comprises positioning the distal portion such that the nonlinear shape causes the distal portion to access the body lumen.