Introducer for therapy delivery elements

• US 7,792,591 B2
• Filed: 06/09/2006
• Issued: 09/07/2010
• Est. Priority Date: 06/09/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rooney, Ethan A., Stone, Richard T., Cross, Thomas E. Jr., King, Gary W.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Anderson; Michael J
• Application Number:
  US11/450,147
• Publication Number:
  US 20070118196A1
• Time in Patent Office: 1,551 Days
• Field of Search: 604/116, 604104-109, 604/96.01, 604/164.01, 604/523, 607/116, 606/192, 606/194, 606/200
• US Class Current: 607/116
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

The disclosure describes an introducer for facilitating implantation of therapy elements into a patient. The introducer has an elongated body that defines a lumen for advancement of a therapy element to an implant site, and includes a curved portion medially located between substantially straight proximal and distal portions. As an example, the shape of the introducer may allow a clinician to more easily, and without substantially damaging surrounding tissue, find the correct tissue depth and follow that tissue depth to the implant site. For example, the introducer may facilitate implantation of a therapy element within or between desired layers of tissue of the patient. In some embodiments, fluid may be injected through the introducer to create a space within the tissue to implant the therapy element. Fluid may also be evacuated through the introducer prior to implantation.

Claims

1. A device to facilitate implantation of a therapy element into a patient comprising an elongated body having a proximal end and a distal end for insertion into tissue of the patient,

wherein the elongated body defines a lumen sized for insertion of the therapy element from the proximal end to the distal end through the lumen,

wherein the elongated body comprises a substantially straight and substantially rigid proximal portion, a substantially straight and substantially rigid distal portion, and a curved portion located between the proximal portion and the distal portion, the curved portion less rigid than the proximal and distal portions, and

wherein a length of the distal portion as measured from the distal end to the curved portion is greater than or approximately equal to a length of the proximal portion as measured from the curved portion to the proximal end,

wherein the length of the distal portion is at least approximately twice the length of the proximal portion.

2. The device of claim 1, wherein the curved portion is located closer to the proximal end of the elongated body than the distal end of the elongated body.

3. The device of claim 1, wherein the curved portion defines an angle between a longitudinal axis of the proximal portion and a longitudinal axis of the distal portion, the angle within a range of approximately twenty degrees to approximately sixty degrees.

4. The device of claim 1, wherein the lumen is sized to receive at least one of an implantable medical device, an implantable medical lead, or a catheter.

21. The device of claim 1, further comprising a handle protruding from the proximal portion for the application of force in the direction of advancement of the distal portion within the patient.

24. The device of claim 1, wherein the elongated body defines a continuous and smooth external surface that extends over the substantially straight and substantially rigid proximal portion, the substantially straight and substantially rigid distal portion, and the curved portion located between the proximal portion and the distal portion.

5. A kit to facilitate implantation of therapy elements into a patient comprising:

a therapy element; and

an introducer comprising an elongated body having a proximal end and a distal end for insertion into tissue of the patient,

wherein the elongated body defines a lumen sized for advancement of the therapy element from the proximal end to the distal end through the lumen,

wherein the elongated body comprises a substantially straight and substantially rigid proximal portion, a substantially straight and substantially rigid distal portion, and a curved portion located between the proximal portion and the distal portion, the curved portion less rigid than the proximal and distal portions, and

wherein a length of the distal portion as measured from the distal end to the curved portion is greater than or approximately equal to a length of the proximal portion as measured from the curved portion to the proximal end,

wherein the length of the distal portion is at least approximately twice the length of the proximal portion.

6. The kit of claim 5, wherein the curved portion defines an angle between a longitudinal axis of the proximal portion and a longitudinal axis of the distal portion, the angle within a range of approximately twenty degrees to approximately sixty degrees.

7. The kit of claim 5, wherein the therapy element comprises at least one of an implantable medical device, an implantable medical lead, or a catheter.

8. The kit of claim 5, wherein the therapy element comprises an implantable medical device that includes a housing having one or more electrodes.

9. The kit of claim 5, further comprising a stylet sized to pass through the lumen from the proximal end of the elongated body to the distal end of the elongated body, wherein a distal end of the stylet is tapered to an edge for dissecting tissue when the introducer is inserted into the patient with the distal end of the stylet located within the lumen.

22. The kit of claim 5, further comprising a handle protruding from the proximal portion for the application of force in the direction of advancement of the distal portion within the patient.

23. The kit of claim 5, wherein the elongated body defines a continuous and smooth external surface that extends over the substantially straight and substantially rigid proximal portion, the substantially straight and substantially rigid distal portion, and the curved portion located between the proximal portion and the distal portion.

10. A kit to facilitate implantation of therapy elements into a patient comprising:

a therapy element;

an introducer comprising an elongated body having a proximal end and a distal end for insertion into tissue of the patient,

wherein the elongated body defines a lumen sized for advancement of the therapy element from the proximal end to the distal end through the lumen,

wherein the elongated body comprises a substantially straight and substantially rigid proximal portion, a substantially straight and substantially rigid distal portion, and a curved portion located between the proximal portion and the distal portion, the curved portion less rigid than the proximal and distal portions, and

wherein a length of the distal portion as measured from the distal end to the curved portion is greater than or approximately equal to a length of the portion as measured from the curved portion to the proximal end; and

a fluid source that delivers fluid proximate to the distal end of the elongated body through the lumen of the elongated body to create a space within tissue of the patient.

11. The kit of claim 10, further comprising a vacuum source that evacuates fluid from the space.

12. A method comprising:

inserting an introducer into a patient, the introducer comprising an elongated body having a proximal end and a distal end for insertion into tissue of the patient, the elongated body defining a lumen;

advancing the distal end of the elongated body through tissue of the patient to a position within the patient proximate to a therapy delivery site;

advancing a therapy element from the proximal end of the elongated body to the distal end of the elongated body through the lumen to implant the therapy element at the therapy delivery site,

wherein the elongated body comprises a substantially straight and substantially rigid proximal portion, a substantially straight and substantially rigid distal portion, and a curved portion located between the proximal portion and the distal portion, the curved portion less rigid than the proximal and distal portions, and

wherein a length of the distal portion as measured from the distal end to the curved portion is greater than or approximately equal to a length of the proximal portion as measured from the curved portion to the proximal end; and

introducing fluid into the implantation site through the lumen defined by the elongated body to create a space for implanting the therapy element.

13. The method of claim 12, wherein advancing the distal end of the elongated body comprising advancing the distal end substantially parallel to a surface of skin of the patient.

14. The method of claim 12, wherein inserting the introducer comprises inserting the introducer such that the distal end of the elongated body is substantially positioned between two layers of tissue of the patient, advancing the distal end comprises advancing the distal end substantially between the layers to a position proximate to a therapy delivery site and between the layers, and advancing the therapy element comprises advancing the therapy element to implant the therapy element substantially between the layers at the therapy delivery site.

15. The method of claim 14, wherein the layers comprise two of an intra-dermal, deep dermal, or subcutaneous tissue layer of the patient.

16. The method of claim 14,

wherein inserting the introducer comprises:

inserting a stylet through the lumen such that a distal end of the stylet is located at the distal end of the elongated body; and

inserting the introducer with the distal end of the stylet located at the distal end of the elongated body, wherein the distal end of the stylet is tapered to an edge, and

wherein advancing the distal end of the elongated body through tissue of the patient comprise dissecting the tissue between the layers with the edge of the introducer.

17. The method of claim 12, wherein introducing fluid to create a space comprises introducing fluid to separate layers of tissue of the patient.

18. The method of claim 17, wherein the layers comprise two of an intra-dermal, deep dermal, or subcutaneous tissue layer of the patient.

19. The method of claim 12, wherein introducing a therapy element comprises introducing at least one at least one of an implantable medical device, an implantable medical lead, or a catheter.

20. The method of claim 12, wherein introducing a therapy element comprises introducing an implantable medical device that includes a housing having one or more electrodes.