Flexible introducer

• US 20080132933A1
• Filed: 11/30/2006
• Published: 06/05/2008
• Est. Priority Date: 11/30/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Granted Patent: US 10,856,904 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An introducer for facilitating implantation of a therapy element into a patient defines a lumen configured to receive the therapy element. At least a portion of the introducer is configured to preferentially flex in at least a first direction over at least a second direction. That is, at least a portion of the introducer is predisposed to bend in a particular direction. In some embodiments, the introducer may also resist bending in one or more directions.

Claims

1. An apparatus to facilitate implantation of a therapy element into tissue of a patient, the apparatus comprising:

an elongated body; and

an inner lumen defined by the elongated body and configured to receive the therapy element,

wherein at least a portion of the elongated body is configured to preferentially flex in at least a first direction over at least a second direction.

2. The apparatus of claim 1, wherein the portion of the elongated body is configured to flex in the first direction to define a substantially curvilinear shape.

3. The apparatus of claim 1, wherein the portion of the elongated body is configured to flex in the first direction to substantially conform to a transverse contour of a neck of the patient.

4. The apparatus of claim 1, wherein when the portion of the elongated body is in substantially non-flexed state, the portion of the elongated body is substantially axially aligned with a proximal end and a distal end of the elongated body.

5. The apparatus of claim 1, wherein the portion of the elongated body comprises one or more grooves.

6. The apparatus of claim 5, wherein the one or more grooves extends at least partially around an outer perimeter of the portion of the elongated body.

7. The apparatus of claim 5, wherein the one or more grooves comprises a first groove, a second groove, and a third groove, the first, second, and third grooves being unevenly spaced with respect to each other.

8. The apparatus of claim 5, wherein the grooves extend substantially perpendicular to a longitudinal axis of elongated member.

9. The apparatus of claim 1, wherein a cross-sectional shape of at least the portion of the elongated body comprises a major axis and a minor axis, the portion of the elongated body being configured to flex along the major axis.

10. The apparatus of claim 1, wherein the portion of the elongated body comprises an inner wall that comprises a first section having a first thickness and a second section having a second thickness that is greater than the first thickness.

11. The apparatus of claim 1, wherein the elongated body comprises a proximal section and a distal section, at least one of the proximal or distal sections being inflexible, and the portion of the elongated body being located between the proximal section and the distal section.

12. The apparatus of claim 1, further comprising one or more markers disposed on the elongated body to indicate the first direction.

13. The apparatus of claim 1, further comprising one or more markers disposed on the elongated body to indicate a location of a distal end of the elongated body relative to skin of the patient.

14. The apparatus of claim 1, wherein the elongated body comprises:

a dilator comprising the portion of the elongated body; and

a dilator sheath defining the inner lumen, and the inner lumen being configured to receive the dilator.

15. The apparatus of claim 14, wherein the dilator sheath comprises a flexible material.

16. The apparatus of claim 1, wherein the portion of the elongated body is a first flexible portion and the elongated body further comprises a second flexible portion.

17. The apparatus of claim 16, wherein the second flexible portion is configured to preferentially flex in the second direction.

18. The apparatus of claim 16, wherein the second flexible portion is configured to preferentially flex in the first direction.

19. The apparatus of claim 1, wherein the therapy element comprises at least one of a lead body including one or more electrodes or a fluid delivery conduit.

20. The apparatus of claim 1, wherein the elongated body has a length in a range of approximately two centimeters to approximately forty centimeters.

21. The apparatus of claim 20, wherein the elongated body has a length in a range of approximately nine centimeters to approximately twenty centimeters.

22. The apparatus of claim 1, wherein the inner lumen has a diameter in a range of approximately one millimeter to approximately ten millimeters.

23. The apparatus of claim 1, wherein the elongated body comprises a biocompatible material.

24. A kit to facilitate implantation of a therapy element into a patient comprising:

a dilator; and

a sheath defining an inner lumen configured to interchangeably receive the dilator and the therapy element,

wherein at least one of the dilator or the sheath comprises a flexible portion configured to flex in a first direction and resist flexing in a second direction.

25. The kit of claim 24, wherein the flexible portion is configured to flex in the first direction to substantially conform to a transverse contour of a neck of the patient.

26. The kit of claim 24, wherein the flexible portion comprises one or more grooves.

27. The kit of claim 24, wherein a cross-sectional shape of the flexible portion comprises a major axis and a minor axis, the flexible portion being configured to flex along the major axis.

28. The kit of claim 24, wherein the flexible portion comprises an inner wall comprising a first section having a first thickness and a second section having a second thickness that is greater than the first thickness.

29. A method comprising:

inserting an introducer into a patient, the introducer comprising a lumen configured to receive a therapy element, wherein at least a portion of the introducer is configured to preferentially flex in at least a first direction over at least a second direction;

advancing the introducer to a target tissue site within the patient; and

manipulating the portion of the introducer to flex in the first direction.

30. The method of claim 29, further comprising introducing the therapy element into the lumen of the introducer.

31. The method of claim 29, wherein the introducer comprises a dilator comprising the portion and a dilator sheath defining the inner lumen, and the inner lumen being configured to receive the dilator, and the method further comprising at least partially withdrawing the dilator from the sheath prior to manipulating the portion of dilator.

32. The method of claim 29, wherein manipulating the portion of the introducer comprises manipulating the portion to substantially define a curvilinear shape.

33. The method of claim 29, wherein the portion of the introducer comprises one or more grooves, and manipulating the portion to flex in the first direction comprises flexing the portion substantially toward the grooves.

34. The method of claim 29, wherein a cross-sectional shape of the portion of the introducer comprises a major axis and a minor axis, and manipulating the portion to flex in the first direction comprises flexing the portion substantially along the major axis.

35. The method of claim 29, further comprising rotating the introducer such that the portion flexes substantially away from skin of the patient.

36. The method of claim 29, wherein the therapy element comprises at least one of a lead body comprising one or more electrodes or a fluid delivery conduit.

37. The method of claim 29, wherein the target tissue site is proximate to a peripheral nerve of the patient.