Disposable transducer manifold

• US 4,960,127 A
• Filed: 01/23/1989
• Issued: 10/02/1990
• Est. Priority Date: 01/23/1989
• Status: Expired due to Term

• Current Assignee: LON Research Incorporated 700 Bevier RD Sanford FL
• Original Assignee: LON Research Incorporated
• Inventors: Basta, Michael, Noce, Louis O.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Lacyk, J. P.
• Application Number:
  US07/299,500
• Time in Patent Office: 617 Days
• Field of Search: 128/672-675, 128/748, 73/706, 73/708, 73/715, 73/756
• US Class Current: 600/488
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: G01L 19/0023 for flowthrough systems having a flexible pressure transmitting element
• CPC Class Codes: G01L 19/147 Details about the mounting of the sensor to support or covering means

Abstract

A disposable transducer manifold assembly is provided which includes a tubular manifold formed within a frame and having an inlet and provided with at least one sensing port. The sensing port is enclosed by a chamber defined by a housing integrally formed within said frame. A pressure sensing transducer in the form of a microchip sensor is located within said housing such that a sensing surface is adapted for direct exposure to fluid in said tubular manifold through said sensing port. Electrical cable connection means are provided which extend outwardly from the housing for electrically connecting the pressure sensing transducer to a monitor.

Claims

1. A disposable transducer manifold assembly for fluid pressure monitoring comprising:

an elongated manifold frame;

a hollow, elongated tubular manifold formed within and at least coextensive with said frame and having an inlet end for receiving fluid directly from a patient, an outlet end for returning said fluid to the patient and a substantially axial passageway extending between said inlet and outlet ends;

at least one valve port and at least one sensing port provided in the tubular manifold intermediate said inlet and outlet ends, and opening into said passageway;

a pressure sensing transducer mounted within a housing at least partially molded into said manifold frame adjacent said sensing port, a sensing surface of said transducer adapted for direct exposure to fluid flowing through said passageway across said sensing port; and

electrical connector means extending from said pressure sensing transducer to a monitor.

2. A disposable transducer manifold assembly according to claim 1 wherein said pressure sensing transducer comprises a microchip surrounded by a gel exposed directly to said fluid.

3. A disposable transducer manifold assembly according to claim 1 wherein said pressure sensing transducer comprises a microchip exposed indirectly to said fluid via a diaphragm.

4. A disposable transducer manifold assembly according to claim 2 wherein said gel is formed with a concave sensing surface.

5. A disposable transducer manifold assembly according to claim 1 wherein said pressure sensing transducer comprises a microchip surrounded by a gel composition, said gel composition providing a sensing surface, and wherein sealing means are provided which surround said sensing surface and said sensing port, to prevent leakage of fluid from said assembly through said sensing port.

6. A disposable transducer manifold assembly according to claim 1 wherein said manifold frame is provided with a plurality of sensing ports.

7. A disposable transducer manifold assembly according to claim 1 wherein said tubular manifold is closable at an end opposite said one end.

8. A disposable transducer manifold assembly according to claim 1 wherein said sensing port comprises an aperture in said tubular manifold and wherein said transducer lies adjacent said aperture and is surrounded by sealing means which prevents leakage of fluid from said sensing port.

9. A disposable transducer manifold assembly according to claim 1 wherein said housing includes an integrally molded shroud portion formed in said manifold frame, and wherein said electrical connector means extend from said transducer and are partially enclosed by said shroud portion.

10. A disposable transducer manifold assembly comprising:

an elongated frame;

an elongated tubular manifold formed within said frame and having an inlet end and an outlet end, said tubular manifold defining an axial fluid passageway between said inlet and outlet ends, said tubular manifold provided with and at least one sensing port and at least one valve port in communication with said passageway;

a pressure sensing transducer located directly over said at least one sensing port, said sensing transducer enclosed within an integral housing portion of said frame, said pressure sensing transducer comprising

a microchip sensor encased within a gel composition which provides a sensing surface, said sensing surface adapted for direct contact with fluid flowing over said sensing port in said axial fluid passageway of said tubular manifold.

11. Hemodynamic pressure sensing apparatus comprising:

a hollow, elongated tubular manifold integrally molded within a frame and defining an axial fluid passageway, said tubular manifold having an inlet at one end thereof;

at least one sensing port and at least one valve port open to said fluid passageway formed within said tubular manifold;

a housing portion integrally formed with said tubular manifold and surrounding said sensing port;

a cap portion fixed to said housing portion to form a chamber;

a pressure sensing transducer mounted within said chamber such that a pressure sensing surface lies adjacent and in communication with, said sensing port;

resilient sealing means interposed between said housing portion and said pressure sensing transducer and surrounding said sensing port to prevent leakage of fluid from said tubular manifold; and

electrical leads extending from said sensing transducer, through said housing portion.

12. Hemodynamic pressure sensing apparatus according to claim 11 wherein said sealing means comprises an O-ring.

13. Hemodynamic pressure sensing apparatus according to claim 12 wherein said housing portion is formed with an outwardly extending shroud for partially enclosing said electrical leads.

14. Hemodynamic pressure sensing apparatus according to claim 11 wherein said pressure sensing transducer comprises a microchip which includes a temperature compensation and recalibration circuit.

15. Hemodynamic pressure sensing apparatus according to claim 11 wherein said tubular manifold, said frame, said housing portion and said cap portion are comprises of plastic.

16. A process for continuous monitoring of blood pressure in a patient comprising the steps of:

(a) providing a frame having a tubular manifold integrally formed therein and extending axially between opposite ends of said frame, said tubular manifold having an inlet end, an outlet end, at least one sensing aperture and at least one valve port located intermediate said inlet and outlet ends;

(b) permanently securing a pressure sensing transducer within a housing portion of said manifold frame such that a pressure sensing surface of said transducer is aligned with said sensing port and thus exposed directly to blood flowing through said manifold by means of said at least one sensing aperture;

(c) sealing said pressure sensing surface relative to said tubular manifold about said aperture; and

(d) providing electrical cable means for connection between said manifold and a monitor device.

17. A process according to claim 16 wherein the tubular manifold is mountable directly on the patient and the inlet is connected to a catheter supplying blood from said patient to the manifold.

18. A process according to claim 16 wherein said pressure sensing transducer comprises a microchip sensor.

19. A process according to claim 18 wherein said pressure sensing transducer includes a gel composition encasing said microchip, said gel forming said sensing surface.

20. A process according to claim 16 wherein said sealing step includes providing an O-ring between said pressure sensing surface and said manifold in surrounding relationship to said at least one sensing aperture.

21. A disposable transducer manifold assembly comprising:

an elongated rectangular frame having a pair of side walls, a pair of end walls;

a tubular manifold integrally formed with said frame and extending between said end walls, said tubular manifold having an inlet and an outlet at each of said end walls, respectively;

a plurality of laterally spaced reinforcing webs extending between said side walls and said tubular manifold;

a housing portion integrally formed in said frame within at least one of said reinforcing webs, said housing portion including an interior chamber;

at least one sensing port provided in said tubular manifold opening into said interior chamber of said housing portion;

a transducer mounted within said interior chamber with a sensing surface located adjacent said sensing port; and

at least one valve port formed in said tubular manifold and including a valve located within said valve port and operable to control flow of liquid through said tubular manifold

22. A disposable transducer manifold assembly according to claim 21 wherein said valve comprises a three-way petcock.

23. A disposable transducer manifold assembly according to claim 21 wherein three sensing ports are provided in said tubular manifold, each of said ports having a three-way valve associated therewith.

24. A disposable transducer manifold assembly according to claim 21 and including an electrical connector and associated cable extending from said transducer.

25. A disposable transducer manifold assembly according to claim 21 wherein said frame, said tubular manifold, said reinforcing webs and said housing portion are constructed of transparent plastic material.