MODULAR SPINAL FLUID FLOW REGULATION DEVICE AND METHOD

• US 20100076366A1
• Filed: 09/18/2009
• Published: 03/25/2010
• Est. Priority Date: 09/19/2008
• Status: Abandoned Application

• Current Assignee: Polaris Biotechnology, Inc.
• Original Assignee: Polaris Biotechnology, Inc.
• Inventors: Henderson, Fraser Cummins SR., Newman, John W.
• Application Number:
  US12/562,926
• Publication Number:
  US 20100076366A1
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

A shunt system for telemetrically measuring, regulating and/or adjusting cerebrospinal fluid flow rate, intercranial pressure, intraspinal pressure and/or intraventricular pressure and a method for use. The shunt system includes a shunt assembly, a first catheter and a second catheter that may be implanted using a novel introducer assembly. In addition to regulating fluid pressure and flow rate, the shunt system may also be used to deliver therapeutic compositions.

Claims

1. A shunt system comprising:

a first catheter comprising;

a first tube body; and

a sensor positioned on the first tube body; and

a shunt assembly configured to be surgically implanted in a bodily cavity and removably attached to the first catheter, wherein the shunt assembly comprises;

a reservoir;

a valve assembly that controls fluid flow through the shunt assembly; and

a first controller operatively associated with the valve assembly and sensor; and

a second catheter removably attached to the shunt assembly comprising a second tube body.

2. The shunt system of claim 1, wherein an exterior surface of the first tube body or second tube body has a textured region selected from the group consisting of:

protuberances, ribs, nubs, teeth, barbs, and combinations thereof.

3. The shunt system of claim 1, further comprising a wire embedded within, attached to or positioned along the first tube body connecting the valve assembly and controller.

4. The shunt system of claim 1, wherein a portion of the first tube body comprises a tubular elbow bent at a prefabricated angle.

5. The shunt system of claim 4, wherein said angle is about 45 degrees to about 120 degrees.

6. The shunt system of claim 1, wherein the shunt assembly further comprises a shunt inlet and a shunt outlet, wherein a surface of the shunt inlet or shunt outlet comprises a plurality of protuberances suitable to facilitate attachment to the first proximal end or the second proximal end.

7. The shunt system of claim 1, wherein said shunt assembly further comprising a supplemental valve that partitions the reservoir into a shunt inlet chamber and shunt outlet chamber.

8. The shunt system of claim 1, wherein the valve assembly comprises a pump capable of driving fluid through the shunt outlet.

9. The shunt system of claim 8, wherein the valve assembly is configured as a piezoelectric micropump.

10. The shunt system of claim 1, wherein said shunt assembly further comprises:

a first signal conditioner; and

a first transponder operatively associated with the first signal conditioner and sensor,

wherein the first transponder is capable of transmitting a signal encoding pressure or flow rate measurements obtained from the sensor; and

wherein the shunt system further comprises a reader assembly positioned outside of the bodily cavity, wherein the reader assembly comprises;

a second signal conditioner;

a remote second transponder operatively associated with the second signal conditioner and

capable of receiving the transmitted signal encoding pressure or flow rate measurements obtained from the sensor; and

a second controller operatively associated with the second transponder.

11. The shunt system of claim 10, wherein the first transponder and the second transponders are each configured as a magnetic induction coil.

12. The shunt system of claim 11, wherein the shunt assembly further comprises a rechargeable battery and wherein the battery may be remotely charged using the magnetic induction coil of the reader assembly.

13. The shunt system of claim 1, wherein the first catheter, shunt assembly or second catheter is constructed from a radiopaque and biocompatible material.

14. A shunt system comprising:

a shunt assembly configured to be surgically implanted in a bodily cavity, wherein the shunt assembly comprises;

a valve assembly that controls fluid flow through the shunt assembly, wherein said

valve assembly comprises a pump capable of forcing fluid out of the shunt assembly;

a first controller operatively associated with the valve assembly;

a sensor capable of measuring pressure or flow rate, wherein the sensor is operatively associated with the controller;

a first signal conditioner operatively associated with the controller; and

a first transponder operatively associated with the first signal conditioner and capable of receiving a signal; and

a reader assembly positioned outside the bodily cavity, wherein the reader assembly comprises;

a second signal conditioner;

a second transponder unit operatively associated with the second signal conditioner and capable of transmitting the signal; and

a second controller operatively associated with the second signal conditioner.

15. The shunt system of claim 14, wherein the first transponder and the second transponders are each configured as a magnetic induction coil.

16. The shunt system of claim 14, wherein the shunt assembly further comprises a rechargeable battery and wherein the battery may be remotely charged using the magnetic induction coils of the reader assembly.

17. The shunt system of claim 14, wherein the valve assembly is a piezoelectric micropump.

18. The shunt system of claim 14, further comprising a supplemental valve that partitions the reservoir into a shunt inlet chamber and shunt outlet chamber.

19. An introducer system comprising:

an introducer adapted to introduce a medical device into a body, wherein the introducer comprises;

a handle;

a sleeve attached to a distal end of the handle, wherein the sleeve comprises;

an introducer channel for receiving the medical instrument; and

a recess positioned on an exterior surface of the sleeve, wherein the recess is substantially parallel to the introducer channel and configured to guide surgical incisions.

20. The introducer system of claim 19, further comprising

a needle removably positioned within the introducer channel, wherein the needle comprises a needle channel;

and

a stylet removably received within the needle channel, wherein the stylet comprises a sensor for detecting an electrical potential of a tissue surrounding the sensor.