NEUROLOGICAL APPARATUS COMPRISING A PERCUTANEOUS ACCESS DEVICE

• US 20100042070A1
• Filed: 11/21/2007
• Published: 02/18/2010
• Est. Priority Date: 11/23/2006
• Status: Active Grant

• Current Assignee: Renishaw PLC
• Original Assignee: Renishaw PLC
• Inventors: Fielder, Paul David, Gill, Steven Streatfield
• Granted Patent: US 8,974,422 B2
• Time in Patent Office: Days
• US Class Current: 604/513
• CPC Class Codes: A61M 2039/025 through bones or teeth, e.g. through the skull
• CPC Class Codes: A61M 2039/0264 with multiple inlets or multiple outlets
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2039/0282 with implanted tubes connected to the port
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 2039/0291 method or device for implanting it in the body
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

Apparatus for delivering therapeutic agents to the central nervous system of a subject is described. The apparatus comprises at least one intracranial catheter and a percutaneous access device. The percutaneous access device comprises a body having at least one extracorporeal surface and at least one subcutaneous surface, the body defining at least one port for connection to an implanted intracranial catheter. The port is accessible from the extracorporeal surface of the device, but is provided with a seal such as a rubber bung between the lumen of the port and the extracorporeal surface. The percutaneous access device may have more than two ports and/or a flange. A method of implanting the percutaneous access device is also described.

Claims

1. Apparatus for delivering a therapeutic agent to the central nervous system, comprising at least one intracranial catheter and a percutaneous access device, the percutaneous access device comprising a body having at least one extracorporeal surface and at least one subcutaneous surface, the body defining at least one port for connection to an implanted intracranial catheter, the port being accessible from the extracorporeal surface of the device, but being provided with a seal between the lumen of the port and the extracorporeal surface.

2. An apparatus according to claim 1, wherein the percutaneous access device comprises more than two ports.

3. An apparatus according to claim 1, wherein the percutaneous access device comprises a flange extending from the body.

4. An apparatus according to claim 3, wherein the flange is curved but has a peripheral edge region that, when the percutaneous access device is implanted, is substantially parallel to the surface of the skin.

5. An apparatus according to claim 3, wherein the flange comprises an aperture through which tubing can pass.

6. An apparatus according to claim 3, wherein the flange comprises perforated material.

7. An apparatus according to claim 1, wherein a portion of the percutaneous access device is made from and/or coated with a material that encourages tissue ingrowth.

8. An apparatus according to claim 1, wherein the seal of the percutaneous access device is in the form of a bung.

9. An apparatus according to claim 1, wherein the seal of the percutaneous access device comprises an antibacterial or antimicrobial material.

10. An apparatus according to claim 1, wherein the extracorporeal surface of the percutaneous access device comprises an aperture to allow access to the port.

11. An apparatus according to claim 1, comprising at least one cap attachable to the extracorporeal surface of the percutaneous access device.

12. An apparatus according to claim 11, comprising a post operative cap to stabilise the percutaneous access device during the post-implantation healing process.

13. An apparatus according to claim 11, comprising a cap that can be locked to the percutaneous access device.

14. An apparatus according to claim 11, wherein the at least one cap has an antimicrobial lining.

15. An apparatus according to claim 1, wherein the one or more intracranial catheters are attached to the one or more ports of the percutaneous access device via a length of tubing.

16. An apparatus according to claim 1, comprising a delivery unit, the delivery unit comprising at least one conduit for delivering a fluid agent, the conduit being provided with a male connection portion for insertion into the port of the percutaneous access device such that the conduit and port are in fluid communication.

17. An apparatus according to claim 16, wherein the delivery unit comprises more than two conduits and the percutaneous access device comprises more than two ports.

18. An apparatus according to claim 16, wherein the delivery unit and percutaneous access device are arranged so that they fit together in only one way thereby ensuring the same conduits are connected to the same ports.

19. An apparatus according to claim 18, wherein the percutaneous access device is provided with a guide member and the delivery unit with a corresponding recess.

20. An apparatus according to claim 16, comprising a locking member to lock the delivery unit to the percutaneous access device.

21. A percutaneous access device for use with more than two intracranial catheters, the percutaneous access device comprising a body having at least one extracorporeal surface and at least one subcutaneous surface, the body defining more than two ports for connection to the more than two intracranial catheters, the more than two ports being accessible from the extracorporeal surface of the device, but being provided with a seal between the lumen of each port and the extracorporeal surface.

22. A percutaneous access device for use with an implanted catheter, the percutaneous access device comprising a body having at least one extracorporeal surface and at least one subcutaneous surface, the body defining at least one port for connection to an implanted device, the port being accessible from the extracorporeal surface of the device, but being provided with a seal between the lumen of the port and the extracorporeal surface, wherein a flange extends outwardly from the body of the percutaneous access device, the flange being curved but having a peripheral edge region that, when the percutaneous access device is implanted, lies substantially parallel to the surface of the skin.

23. A percutaneous access device according to claim 22 wherein, when implanted, the peripheral edge region of the flange is seated on the hypodermis.

24. A method of implanting a percutaneous access device, the percutaneous access device comprising an extracorporeal portion and a subcutaneous portion, the method comprising the steps, in any suitable order, of;

(a) making a first incision in the skin of a subject of a size that enables the whole of the percutaneous access device to be passed therethrough,

(b) making a second incision in the skin of the subject of a size that allows only the extracorporeal portion to pass therethrough,

(c) forming, via the first incision, a subcutaneous pocket under the second incision that is of sufficient size to receive the percutaneous access device, and

(d) passing the percutaneous access device through the first incision into the pocket and locating the percutaneous access device within the pocket such that the extracorporeal portion passes through the second incision.

25. A method according to claim 24, wherein the subcutaneous portion of the percutaneous access device comprises a flange extending from a body.

26. A method of delivering therapeutic agents to the central nervous system, comprising the steps, in any suitable order, of;

(i) implanting one or more catheters for fluid delivery to the nervous system of a subject,

(ii) implanting a percutaneous access device in the subject, the percutaneous access device comprising a port in fluid communication with the one or more catheters, the port also being accessible from an extracorporeal surface of the percutaneous access device, and

(iii) using at least one external pump to deliver a therapeutic agent to the one or more catheters via the percutaneous access device.

27. A method according to claim 26, wherein step (iii) is performed periodically, the external pump being disconnected from the percutaneous access device when the delivery of therapeutic agents is not required.

28. A method according to claim 26, wherein step (i) comprises implanting a plurality of catheters and step (iii) comprises delivering a therapeutic agent to each catheter wherein the delivery to each catheter is performed using at least one of different infusion rates and different infusion durations.