Catheter anchor system and method

• US 20050101915A1
• Filed: 12/20/2004
• Published: 05/12/2005
• Est. Priority Date: 04/23/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Morris, Mary M., Lahtinen, Stuart, Frion, Duane Gerald, Hankner, Douglas, Novotny, Jeff M.
• Granted Patent: US 7,270,650 B2
• Time in Patent Office: Days
• US Class Current: 604/174
• CPC Class Codes: A61M 2005/1416 placed on the body of the patient
• CPC Class Codes: A61M 2025/0213 where the catheter is attached by means specifically adapted to a part of the human body
• CPC Class Codes: A61M 2025/024 having a clip or clamp system
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/0286 anchored in the skin by suture or other skin penetrating devices
• CPC Class Codes: A61M 2039/025 through bones or teeth, e.g. through the skull
• CPC Class Codes: A61M 2210/0687 Skull, cranium
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 5/1418 Clips, separators or the like for supporting tubes or leads
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

A catheter system and method for intracranial infusion of therapeutic substances to a patient. An anchor formed of generally flexible, elastomeric material is used to mount the catheter to the outer surface of the skull of the patient. The anchor has a through hole for receiving the catheter, a channel, extending substantially from the through hole, into which a portion of the catheter may be inserted to retain the portion substantially parallel to the surface of the skull, and at least one flange for engaging the outer surface of the skull. An anchor clip may be provided to engage the anchor adjacent the through hole to further stabilize the catheter.

Claims

1. An anchor system for an elongate catheter used in intracranial delivery of therapeutic substances to a patient, the anchor system comprising:

an anchor for mounting the catheter to the outer surface of the skull of the patient, the anchor including;

a body formed of generally flexible, elastomeric material, the body having;

a through hole for receiving the catheter,

a channel, extending substantially from the through hole, into which a portion of the catheter may be inserted to retain the portion substantially parallel to the surface of the skull; and

at least one flange for engaging the outer surface of the skull; and

at least one substantially rigid standoff mounted in the flange, the standoff including an opening; and

a bone screw extending through the opening of the standoff for fastening the anchor to a surface of the skull.

2. The anchor system of claim 1 wherein the flange includes opposite major surfaces, and the standoff is exposed through the opposite major surfaces.

3. The anchor system of claim 2 wherein the standoff is substantially annular and has an undercut or circumferential channel helping to retain the standoff in the flange.

4. The anchor system of claim 3 in which:

the at least one flange comprises two flanges extending in opposite directions from the channel;

the at least one substantially rigid standoff comprising at least one standoff mounted in each flange; and

the channel is substantially perpendicular to the through hole.

5. The anchor system of claim 4 in which the anchor is adapted to flex and comply with adjacent tissue, and the standoffs are insert molded in the flanges of the anchor.

6. The anchor system of claim 5 in which the generally flexible, elastomeric material comprises silicone, and the standoffs are formed of titanium or titanium alloy.

7. The anchor system of claim 4 in which the body is generally elongate and coaxial with the channel, the body extending in a direction generally perpendicular to the through hole and openings of the standoffs, the flanges extending substantially in opposite directions substantially perpendicular to the body.

8. A catheter system for intracranial delivery of therapeutic substances to a patient, the system comprising:

an elongate catheter having a lumen and at least one drug delivery orifice in fluid communication with the lumen;

the anchor system of claim 1.

9. The catheter system of claim 8 in which the catheter is formed of silicone or polyurethane.

10. A system for intracranial delivery of therapeutic substances to a patient, the system comprising:

the catheter system of claim 9;

and

an implantable therapeutic substance infusion device, the catheter being directly or indirectly connected with the implantable therapeutic substance infusion device for infusion of therapeutic substance from the implantable therapeutic substance infusion device through the lumen and orifice(s) of the catheter.

11. A catheter system for intracranial delivery of therapeutic substances to a patient, the system comprising:

an elongate catheter having a lumen and at least one drug delivery orifice in fluid communication with the lumen;

an anchor for mounting the catheter to the outer surface of the skull of the patient, the anchor including;

a body formed of generally flexible, elastomeric material, the body having;

a through hole for receiving the catheter,

a channel, extending substantially from the through hole, into which a portion of the catheter may be inserted to retain the portion substantially parallel to the surface of the skull; and

at least one flange for engaging the outer surface of the skull; and

at least one substantially rigid standoff mounted in the flange, the standoff being substantially annular and having an opening for receiving a fastener to fasten the anchor to the skull, and an undercut or circumferential channel helping to retain the standoff in the flange.

12. The catheter system of claim 11 in which:

the at least one flange comprises two flanges extending in opposite directions from the channel;

the at least one substantially rigid standoff comprising at least one standoff mounted in each flange; and

the channel is substantially perpendicular to the through hole.

13. The catheter system of claim 12 wherein the flange includes opposite major surfaces, and the standoff is exposed through the opposite major surfaces.

14. The catheter system of claim 13 in which the anchor is adapted to flex and comply with adjacent tissue, and the standoffs are insert molded in the flanges of the anchor.

15. The catheter system of claim 14 in which the generally flexible, elastomeric material comprises silicone or polyurethane, and the standoffs are formed of titanium or titanium alloy.

16. The catheter system of claim 13 in which the body is generally elongate and coaxial with the channel, the body extending in a direction generally perpendicular to the through hole and openings of the standoffs, the flanges extending substantially in opposite directions substantially perpendicular to the body.

17. A system for intracranial delivery of therapeutic substances to a patient, the system comprising:

the catheter system of claim 11;

and

an implantable therapeutic substance infusion device, the catheter being directly or indirectly connected with the implantable therapeutic substance infusion device for infusion of therapeutic substance from the implantable therapeutic substance infusion device through the lumen and orifice(s) of the catheter.

18. A method of use of the catheter system of claim 11, the method comprising:

inserting the catheter into the parenchyma or a ventricle;

mounting the anchor on the catheter and the skull of a patient to retain the catheter in position, including fastening a bone screw through the opening of the standoff into the skull; and

infusing a therapeutic agent into the parenchyma or a ventricle for treatment of brain tissue.

19. The method of claim 18 in which the step of mounting the anchor on the catheter and the skull of a patient to retain the catheter in position includes:

inserting the catheter into the through hole of the anchor;

sliding the anchor along the catheter into engagement with the skull;

inserting a fastener through the opening of each standoff to fasten the anchor to the skull; and

placing the catheter in the channel.

20. The method of claim 19 in which the step of mounting the anchor on the catheter and the skull of a patient to retain the catheter in position further includes:

suturing the catheter in the channel.