SHAPEABLE FOR STEERABLE GUIDE SHEATHS AND METHODS FOR MAKING AND USING THEM

• US 20080015625A1
• Filed: 05/09/2007
• Published: 01/17/2008
• Est. Priority Date: 10/04/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Acumen Medical, Inc. (Medtronic Plc)
• Inventors: Pulido, Alfonso, Leeflang, Stephen, Ventura, Christine
• Granted Patent: US 7,993,350 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 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

Apparatus and methods are provided for providing access to a body lumen, e.g., to deliver a pacing lead within a patient'"'"'s heart. 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. An elongate member extends from the distal end of the tubular member. An expandable sheath extends along at least a portion of the elongate 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 stylet or other shaped element is insertable into the elongate member for changing a shape of at least a distal tip of the elongate member, e.g., for accessing side branches extending from a body lumen, e.g., within a patient'"'"'s coronary venous system.

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 flexible distal tip;

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; and

a stylet insertable into and removable from the distal tip of the elongate member for changing a shape of the distal tip.

2. The apparatus of claim 1, wherein the stylet is insertable into and removable from the tubular member proximal end for inserting the stylet into and removing the stylet from the distal tip of the elongate member via the tubular member.

3. The apparatus of claim 2, wherein at least a distal portion of the stylet is malleable such that the stylet is shapeable by a user before insertion into the tubular member proximal end.

4. The apparatus of claim 3, wherein the elongate member distal tip is relatively flexible compared to the stylet such that the distal tip assumes a shape of the distal portion of the stylet when the distal portion is inserted into the distal tip.

5. The apparatus of claim 1, wherein the distal tip of the elongate member is biased to assume a first nonlinear shape, and wherein the stylet is biased to assume a second nonlinear shape for changing the first nonlinear shape when the stylet is inserted into the distal tip.

6. The apparatus of claim 5, wherein the distal tip is relatively flexible compared to the stylet such that the distal tip is biased to assume the second nonlinear shape when the stylet is inserted into the distal tip.

7. The apparatus of claim 5, wherein the distal tip is biased to assume a third nonlinear shape when the stylet is inserted into the distal tip that is based on the first and second nonlinear shapes.

8. The apparatus of claim 5, wherein the second nonlinear shape comprises an acute angled tip on the stylet.

9. The apparatus of claim 1, wherein a stop on at least one of the stylet and the distal tip prevents the stylet from extending beyond the distal tip of the elongate member.

10. The apparatus of claim 9, wherein the distal portion is biased to define an acute angle when advanced beyond the distal tip for accessing a side branch from a body lumen within which the elongate member is disposed.

11. The apparatus of claim 1, further comprising an actuator on the tubular member proximal end for moving the stylet between a proximal position and a distal position, the stylet being disposed within the distal tip at the distal position and removed from the distal tip in the proximal position.

12. The apparatus of claim 1, wherein the elongate member comprises a lumen extending to the distal tip, the stylet being insertable into the lumen for changing the shape of the distal tip.

13. The apparatus of claim 1, wherein the tubular member has a length sufficient to reach at least one of the vena cava, right atrium, and coronary sinus of a patient'"'"'s heart from a percutaneous entry location.

14. The apparatus of claim 1, wherein the elongate member extends beyond the distal end of the tubular member not more than about thirty centimeters (30 cm).

15. The apparatus of claim 1, wherein the elongate member extends beyond the distal end of the tubular member not more than about ten centimeters (10 cm).

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

17. 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.

18. 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.

19. 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, 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 first nonlinear shape;

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; and

an elongate element insertable into the distal portion of the elongate member for changing a shape of the distal portion.

20. The apparatus of claim 19, wherein the element comprises one or more lumens extending between proximal and distal ends thereof, and wherein the elongate element is insertable into the lumen for changing the shape of the distal portion.

21. The apparatus of claim 19, wherein the elongate element comprises a stylet biased to assume a second nonlinear shape different than the first nonlinear shape.

22. The apparatus of claim 19, wherein the elongate element comprises a stylet that is malleable to a desired shape before insertion into the distal portion.

23. A method for accessing a side branch of a body lumen using an apparatus including a tubular proximal portion and an expandable distal portion, the distal portion comprising an expandable sheath, the method comprising:

advancing the distal portion into a patient'"'"'s body to access a first location within a body lumen;

advancing a stylet into the distal portion to change a shape of the distal portion to a nonlinear shape;

accessing a branch extending from the first location using the distal portion in the nonlinear shape; and

advancing the distal portion into the branch to access a target location.

24. The method of claim 23, further comprising advancing an elongate instrument through the proximal portion and the expandable sheath to deliver the instrument to the target location.

25. The method of claim 24, further comprising removing the apparatus from the body lumen, while maintaining the instrument at the target location.

26. The method of claim 23, wherein the distal portion is biased to a first nonlinear shape, and wherein advancing the stylet causes the distal portion to change from the first nonlinear shape to another shape to access the branch.

27. The method of claim 23, wherein accessing the branch comprises manipulating the apparatus with the distal portion in the nonlinear shape to direct the distal portion and stylet into the branch, and advancing the distal portion over the stylet into the branch.

28. The method of claim 23, wherein the branch extends at an acute angle from the first location, and wherein the nonlinear shape of the distal portion defines an acute angle for accessing the branch.

29. The method of claim 23, wherein the first location comprises a vessel within a patient'"'"'s coronary venous system, and the target location is an implantation site.