Neurological apparatus comprising a percutaneous access device

• US 8,974,422 B2
• Filed: 11/21/2007
• Issued: 03/10/2015
• Est. Priority Date: 11/23/2006
• Status: Active Grant

• Current Assignee: Renishaw PLC
• Original Assignee: Renishaw PLC
• Inventors: Gill, Steven Streatfield, Fielder, Paul David
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US12/312,584
• Publication Number:
  US 20100042070A1
• Time in Patent Office: 2,666 Days
• Field of Search: 604/175, 604/288.01, 604/288.02, 604/513
• US Class Current: 604/175
• 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 two intracranial catheters;

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 two ports for connection to said intracranial catheters, each 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, each port separately passing through the body such that each intracranial catheter is separately accessible from the extracorporeal surface of the device, the at least one subcutaneous surface comprising a portion that encourages skin to form a tight junction with the percutaneous access device,

wherein each of the intracranial catheters is connected to a respective one of the ports of the percutaneous access device by a respective passage, each passage comprising a tube extending from within multilumen tubing and exiting the percutaneous access device in the same direction.

2. An apparatus according to claim 1, wherein the body defines 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 the portion that encourages skin to form a tight junction with 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 at least one aperture to allow access to the ports.

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

12. An apparatus according to claim 11, wherein the at least one cap comprises a post operative cap to stabilise the percutaneous access device during a post-implantation healing process.

13. An apparatus according to claim 11, further comprising a lock structure that locks the at least one cap 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, further 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 one of the ports of the percutaneous access device such that the conduit and port are in fluid communication.

16. An apparatus according to claim 15, wherein the delivery unit comprises more than two conduits and the body of the percutaneous access device defines more than two ports.

17. 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 that each conduit is connected to the correct port.

18. An apparatus according to claim 17, wherein the percutaneous access device is provided with a guide member, and the delivery unit is provided with a corresponding recess into which the guide member inserts.

19. An apparatus according to claim 15, further comprising a locking member that locks the delivery unit to the percutaneous access device.

20. An apparatus according to claim 1, wherein the passages have lengths that enable the percutaneous access device to be offset from positions at which the at least two intracranial catheters enter a patient'"'"'s cranium.

23. A method of delivering therapeutic agents to the central nervous system using the apparatus of claim 1, comprising the steps, in any suitable order, of;

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

(ii) implanting the percutaneous access device in the subject, the port being 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 intracranial catheters via the percutaneous access device.

24. A method according to claim 23, 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.

25. A method according to claim 23, 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.

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, each port separately passing through the body such that each intracranial catheter is separately accessible from the extracorporeal surface of the device, the at least one subcutaneous surface comprising a portion that encourages skin to form a tight junction with the percutaneous access device, wherein each of the intracranial catheters is connected to a respective one of the ports of the percutaneous access device by a respective passage, each passage comprising a tube extending from within multilumen tubing and exiting the percutaneous access device in the same direction.

22. A percutaneous access device according to claim 21, wherein the passages have lengths that enable the percutaneous access device to be offset from positions at which the intracranial catheters enter a patient'"'"'s cranium.