Placement of chronic micro-catheter device and method

• US 20030187459A1
• Filed: 03/26/2002
• Published: 10/02/2003
• Est. Priority Date: 03/26/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Image Guided Neurologics, Inc. (Medtronic Plc)
• Inventors: Parmer, Kari, Solar, Matthew S., Lee, David, Murdock, Frank
• Granted Patent: US 7,588,581 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

A device and method of placement of a chronic micro-catheter is shown that allows effective guiding of micro-catheters through a host catheter that is later removable while leaving the micro-catheter implanted in place within the patient. The novel configuration allows the micro-catheter to be completely radially enclosed during insertion, and still allows the host catheter to be removed, leaving the micro-catheter behind. Additionally, the configuration allows several micro-catheters to be placed at any number of depths and orientations while still using a minimally invasive host catheter.

Claims

1. A guide device, having a guide axis, comprising:

a sheath that defines a radially enclosed longitudinal cavity in a first state, and is adapted to be split substantially along a longitudinal wall and radially removed from the guide axis in a second state; and

a mandrel that, when inserted into the sheath in its first state, defines a substantially continuous longitudinal guide region bounded on a first longitudinal portion by the mandrel, and on a second longitudinal portion by the sheath.

2. The guide device of claim 1, wherein the mandrel defines a plurality of substantially continuous longitudinal guide regions, each guide region bounded on a first longitudinal portion by the semi-rigid mandrel, and on a second longitudinal portion by the sheath.

3. The guide device of claim 2, wherein the mandrel includes:

an axial portion; and

a plurality of dividing members extending radially from the axial portion that defines the first longitudinal portion of each guide region.

4. The guide device of claim 3, wherein the axial portion is coaxial with the mandrel and the sheath when the mandrel is inserted in the sheath in its first state.

5. The guide device of claim 1, wherein the mandrel further includes a shield portion, such that when the mandrel is fully inserted in the sheath, the shield portion substantially shields a distal opening in the sheath in its first state.

6. The guide device of claim 5, wherein the shield portion includes a curved end portion.

7. The guide device of claim 5, further including a ramp located at a distal end of the guide region, behind the curved end portion, the ramp directing the distal end of the guide region at least partially radially outward from the guide axis.

8. The guide device of claim 7, wherein a shape of the ramp and a shape of the curved end portion are changeable between a first state and a second state.

9. A guide device, having a guide axis, comprising:

a sheath that defines a radially enclosed longitudinal cavity in a first state, and is adapted to be split substantially along a longitudinal wall and radially removed from the guide axis in a second state;

a first mandrel that, when inserted in the sheath in its first state, provides structural support to the sheath during insertion, the first mandrel having a blunt distal end portion that substantially shields a distal opening in the sheath in its first state; and

a second mandrel that is adapted to be inserted in the sheath in place of the first mandrel such that the second mandrel defines a substantially continuous longitudinal guide region bounded on a first longitudinal portion by the mandrel, and on a second longitudinal portion by the sheath.

10. The guide device of claim 9, wherein the second mandrel includes:

an axial portion; and

a plurality of dividing members extending radially from the axial portion that defines the first longitudinal portion of a plurality of guide regions.

11. The guide device of claim 10, wherein the axial portion is coaxial with the second mandrel and the sheath when the second mandrel is inserted in the sheath in its first state.

12. A method of insertion of a medical device comprising:

inserting a guide device into a patient to a target location;

inserting a primary medical device into the guide device to the target location;

removing the guide device from the patient without moving the primary medical device; and

wherein the guide device is radially removed from the primary medical device.

13. The method of claim 12, wherein inserting the guide device includes inserting a blunt tipped guide device, wherein the blunt tip is substantially solid.

14. The method of claim 12, wherein inserting the guide device includes:

inserting a mandrel into a sheath; and

inserting the sheath and mandrel into the patient.

15. The method of claim 14, wherein inserting the primary medical device into the guide device includes inserting the primary medical device into a substantially continuous longitudinal guide region defined on a first longitudinal portion by the semi-rigid mandrel, and on a second longitudinal portion by the sheath.

16. The method of claim 15, wherein removing the guide device from the patient includes:

removing the mandrel from the sheath wherein the first longitudinal portion of the longitudinal guide region is radially removed from a side of the primary medical device as it exits the patient; and

removing the sheath from the patient by peeling the sheath apart radially from the side portion of the primary medical device as the sheath exits the patient.

17. The method of claim 15, wherein inserting the primary medical device into the substantially continuous longitudinal guide region includes inserting the primary medical device into one of a plurality of continuous longitudinal guide regions, each of the plurality of continuous guide regions being defined on a first longitudinal portion by the semi-rigid mandrel, and on a second longitudinal portion by the sheath.

18. A method of manufacturing a guide device comprising:

forming a sheath that defines a radially enclosed longitudinal cavity in a first state;

forming a weakened portion of a longitudinal wall of the sheath such that the sheath is adapted to be split substantially along the weakened portion of the longitudinal wall and radially removed from the guide axis in a second state;

forming a mandrel that fits within the longitudinal cavity of the sheath; and

forming a surface on the mandrel such that when inserted into the sheath in its first state, the mandrel defines a substantially continuous longitudinal guide region bounded on a first longitudinal portion by the surface, and on a second longitudinal portion by the sheath.

19. The method of claim 18, wherein forming a surface on the mandrel includes forming a plurality of surfaces on the mandrel that define a plurality of substantially continuous longitudinal guide regions, each guide region bounded on a first longitudinal portion by the plurality of surfaces, and on a second longitudinal portion by the sheath.

20. The method of claim 18, further including forming a shield portion on a distal end of the mandrel, such that when the mandrel is fully inserted in the sheath, the shield portion substantially shields a distal opening in the sheath in its first state.

21. The method of claim 20, further including forming a ramp located at a distal end of the guide region, behind the shield portion, the ramp directing the distal end of the guide region at least partially radially outward from the guide axis.

22. The guide device of claim 21, wherein forming the ramp located at the distal end of the guide region, behind the shield portion includes forming a ramp and shield portion that are changeable between a first state and a second state.

23. An insertion system comprising:

a guide device, having a guide axis, comprising;

a sheath that defines a radially enclosed longitudinal cavity in a first state, and is adapted to be split substantially along a longitudinal wall and radially removed from the guide axis in a second state;

a mandrel that, when inserted into the sheath in its first state, defines a substantially continuous longitudinal guide region bounded on a first longitudinal portion by the mandrel, and on a second longitudinal portion by the sheath; and

a primary medical device capable of insertion through the guide region.

24. The insertion system of claim 23, wherein the primary medical device includes and electrode.

25. The insertion system of claim 23, wherein the primary device includes a drug delivery device.