Shunt valve system

• US 5,304,114 A
• Filed: 05/15/1991
• Issued: 04/19/1994
• Est. Priority Date: 05/15/1991
• Status: Expired due to Fees

• Current Assignee: Sherwood Services AG
• Original Assignee: Eric R. Cosman, Michael A. Arnold
• Inventors: Arnold, Michael A., Cosman, Eric R.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US07/700,689
• Time in Patent Office: 1,070 Days
• Field of Search: 604/8, 604/9, 604/10, 604/175, 604/185, 137/510
• US Class Current: 604/8
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

This invention relates to a CSF shunting system that can be used in the human body for the control of hydrocephalus or excess cerebrospinal fluid (CSF) in the ventricles of the brain. The invention relates to the configuration of a fluid pressure controlling diaphragm which has a substantially planar, non-arched, or slightly convex occluding surface that contacts as its valve mechanism a non-planar opposing surface. The diaphragm element can be made out of silicone rubber or some other flexible material, and the opposing surface can be made from a dissimilar material from the diaphragm element to prevent sticking. The invention also relates to the configuration of this substantially flat diaphragm element, its central stem, and its mounting in a frame so as to facilitate pre-loads, calibrations, and optical, as well as mechanical, tests for quality assurance. The invention further relates to a confirmation of this pressure control invention in a larger shunt body geometry, which provides for modular, distal, and occlusion elements, and articulating shape to better fit the contour of a patient'"'"'s skull.

Claims

1. A shunt valve for the shunting and pressure regulation of cerebrospinal fluid from the ventricles of the brain, said shunt valve comprising:

A. a proximal end portion and a distal end portion;

B. a proximal body at the proximal end portion adapted for connection to a proximal catheter, said proximal body having a proximal port;

C. a distal body at said distal end portion of said shunt valve device adapted for connection to a distal catheter, said distal body having a distal port;

D. a flexible housing having;

(i) a proximal section located over said proximal port and cooperatively configured relative to said proximal port so that deflection of said proximal section will occlude said proximal port

(ii) a distal section located over said distal port and cooperatively configured relative to said distal port so that deflection of said distal section will occlude said distal port and,

(iii) a flexible middle section positioned between said proximal section and said distal section to form a chamber;

said flexible housing, said distal body, and said proximal body being cooperatively configured and so adapted to form a fluid channel between said proximal end portion and said distal end portion, and so that said proximal port will occlude said fluid channel when said flexible housing proximal section is deflected, and so that said distal port will occlude said fluid channel when said flexible housing distal section is deflected;

whereby the overall shape of said shunt valve can change upon implantation of the shunt valve to conform to the contours of the body in which it is implanted; and

,

E. a pressure control element having;

(i) a substantially planar diaphragm which deflects with change in fluid pressure of fluid in said fluid channel across said substantially planar diaphragm; and

,

(ii) an opposing occluding element with a non-planar occluding surface in the regions where said opposing occluding element contacts said substantially planar diaphragm for a pre-determined pressure relationship of said fluid on opposing sides of said substantially planar diaphragm.

2. A shunt valve for the shunting and pressure regulation of cerebrospinal fluid from the ventricles of the brain, said shunt valve comprising:

A. a proximal end portion and a distal end portion;

B. a proximal body at the proximal end portion adapted for connection to a proximal catheter, said proximal body having a proximal port;

C. a distal body at said distal end portion of said shunt valve device adapted for connection to a distal catheter, said distal body having a distal port;

D. a flexible housing having;

(i) a proximal section located over said proximal port and cooperatively configured relative to said proximal port so that deflection of said proximal section will occlude said proximal port

(ii) a distal section located over said distal port and cooperatively configured relative to said distal port so that deflection of said distal section will occlude said distal port and,

(iii) a flexible middle section positioned between said proximal section and said distal section to form a chamber;

said flexible housing, said distal body, and said proximal body being cooperatively configured and so adapted to form a fluid channel between said proximal end portion and said distal end portion, and so that said proximal port will occlude said fluid channel when said flexible housing proximal section is deflected, and so that said distal port will occlude said fluid channel when said flexible housing distal section is deflected;

whereby the overall shape of said shunt valve can change upon implantation of the shunt valve to conform to the contours of the body in which it is implanted; and

,

E. a pressure control element having;

(i) a non-arch-shaped diaphragm which moves with change of fluid pressure on opposing sides; and

,

(ii) an opposing, occluding element with a non-planar and in part concave occluding surface in the region which opposes said non-arch-shaped diaphragm so that when said non-arch-shaped diaphragm contacts said opposing occluding element, it will stop the flow of fluid past said non-arched-shaped diaphragm, and said opposing occluding element will not contact said non-arched-shaped element diaphragm over said concave surface.

3. The shunt valve of claim 2 wherein said in part concave occluding surface is a curvelinear surface of revolution.

4. The shunt valve of claim 2 wherein said in part concave occluding surface is a conical surface of revolution.

5. The shunt valve of claim 2 wherein said in part concave occluding surface is a beveled surface.

6. A shunt valve for the shunting and pressure regulation of cerebrospinal fluid from the ventricles of the brain, said shunt valve comprising:

A. a proximal end portion and a distal end portion;

B. a proximal body at the proximal end portion adapted for connection to a proximal catheter, said proximal body having a proximal port;

C. a distal body at said distal end portion of said shunt valve device adapted for connection to a distal catheter, said distal body having a distal port;

D. a housing having;

(i) a proximal section located over said proximal port and cooperatively configured relative to said proximal port so that deflection of said proximal section will occlude said proximal port

(ii) a distal section located over said distal port and cooperatively configured relative to said distal port so that deflection of said distal section will occlude said distal port and,

(iii) a middle section positioned between said proximal section and said distal section to form a chamber;

said housing, said distal body, and said proximal body being cooperatively configured and so adapted to form a fluid channel between said proximal end portion and said distal end portion, and so that said proximal port will occlude said fluid channel when said housing proximal section is deflected, and so that said distal port will occlude said fluid channel when said housing distal section is deflected;

E. a pressure control element having;

(i) a substantially planar diaphragm which deflects with change in fluid pressure of fluid in said fluid channel across said substantially planar diaphragm; and

,

(ii) an opposing occluding element with a non-planar occluding surface in the regions where said opposing occluding element contacts said substantially planar diaphragm for a pre-determined pressure relationship of said fluid on opposing sides of said substantially planar diaphragm.

7. A shunt valve for the shunting and pressure regulation of cerebrospinal fluid from the ventricles of the brain, said shunt valve comprising:

A. a proximal end portion and a distal end portion;

B. a proximal body at the proximal end portion adapted for connection to a proximal catheter, said proximal body having a proximal port;

C. a distal body at said distal end portion of said shunt valve device adapted for connection to a distal catheter, said distal body having a distal port;

D. a housing having;

(i) a proximal section located over said proximal port and cooperatively configured relative to said proximal port so that deflection of said proximal section will occlude said proximal port

(ii) a distal section located over said distal port and cooperatively configured relative to said distal port so that deflection of said distal section will occlude said distal port and,

(iii) a middle section positioned between said proximal section and said distal section to form a chamber;

said housing, said distal body, and said proximal body being cooperatively configured and so adapted to form a fluid channel between said proximal end portion and said distal end portion, and so that said proximal port will occlude said fluid channel when said housing proximal section is deflected, and so that said distal port will occlude said fluid channel when said housing distal section is deflected;

E. a pressure control element having;

(i) a non-arch-shaped diaphragm which moves with change of fluid pressure on opposing sides; and

,

(ii) an opposing, occluding element with a non-planar and in part concave occluding surface in the region which opposes said non-arch-shaped diaphragm so that when said non-arch-shaped diaphragm contacts said opposing occluding element, it will stop the flow of fluid past said non-arched-shaped diaphragm, and said opposing occluding element will not contact said non-arched-shaped element diaphragm over said concave surface.

8. The shunt valve of claim 7 wherein said in part concave occluding surface is a curvelinear surface of revolution.

9. The shunt valve of claim 7 wherein said in part concave occluding surface is a conical surface of revolution.

10. The shunt valve of claim 7 wherein said in part concave occluding surface is a beveled surface.