Valve, catheter and method for preventing the introduction of air into the body of a patient

• US 4,784,644 A
• Filed: 05/15/1987
• Issued: 11/15/1988
• Est. Priority Date: 01/13/1986
• Status: Expired due to Fees

• Current Assignee: Interface Biomedical Laboratories Corp.
• Original Assignee: Interface Biomedical Laboratories Corp.
• Inventors: Miller, Lester F., Sawyer, Philip N., Fitzgerald, Joseph F.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/050,589
• Time in Patent Office: 550 Days
• Field of Search: 604/122, 604/247, 604/250, 137/846, 137/847, 137/849, 137/850, 137/493, 137/843, 137/852
• US Class Current: 604/122
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281
• CPC Class Codes: Y10T 137/7771 Bi-directional flow valves
• CPC Class Codes: Y10T 137/7879 Resilient material valve

Abstract

A method for preventing the introduction of air into the vascular system of a patient during intravenous or intra-arterial procedures, as well as for preventing the reflux of fluids into the body of a patient. Also, novel fluid directing means and catheters which include integral or attached fluid flow control means for use in this method.

Claims

1. Fluid flow control means comprising:

tubular means having open input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough;

obturating means located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means from the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed;

inlet and outlet connectors for insertion into said input and output bores, respectively of the tubular means for releasable attachment of the control means to fluid directing means; and

housing means enclosing said tubular means and obturating means, and maintaining said inlet and outlet connectors at a predetermined spaced distance.

4. The flow control means of claim 1 wherein said inlet and output connectors each include leur lock means to facilitate said releasable attachment.

5. The flow control means of claim 1 wherein the obturating means comprises disc means for maintaining said tubular means in a substantially flat configuration, and wherein the tubular means is a silicon tube.

2. Fluid flow control means comprising:

tubular means having open input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough; and

obturating means comprising disc means for maintaining said tubular means in a substantially flat configuration located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means from the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position hen said positive pressure is removed.

3. The flow control means of claim 2 wherein the tubular means is a silicon tube.

6. Fluid flow control means comprising:

tubular means having open input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough;

obturating means comprising disc means located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means beings forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means from the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed; and

concentric housing means for enclosing said tubular means and obturating means.

7. The flow control means of claim 6 wherein said tubular means input and output bores are each connected to leur lock means to facilitate releasable attachment to fluid directing means, and wherein the tubular means is a silicon tube.

8. Catheter means comprising an elongated body portion for insertion into a patient;

an integral hub portion adjacent to the body portion for introducing or removing fluids through the body portion; and

fluid flow control means comprising;

a tubular structure having input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough; and

obturating means located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means from the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed.

9. The catheter means of claim 8 wherein the fluid flow control means is integral with said body portion.

10. The catheter means of claim 8 wherein the fluid flow control means is integral with said hub portion.

11. The catheter means of claim 8 which further comprises means to maintain the fluid flow control means in an open position to facilitate the introduction of second catheter means, trocar means, needle means or fluid directing means.

12. The catheter means of claim 11 wherein a first hub portion allows the introduction of a fluid into the body of the catheter means and a second hub portion allows a fluid to be removed from the body of the catheter means;

the first hub portion including fluid flow control means which remains competent in response to fluid reflux or ambient air pressure but which opens in response to a positive fluid pressure above that of ambient air;

the second hub portion including fluid flow control means which remains competent in response to fluid reflux but which opens in response to fluid pressure in the catheter body.

13. The catheter means of claim 8 wherein the fluid flow control means is releasably secured to the hub portion.

14. The catheter means of claim 8 wherein two integral hub portions are provided and each hub includes fluid flow control means located adjacent thereto.

15. The catheter means of claim 14 wherein the end of the body portion opposite the hub portion includes a plurality of apertures to facilitate fluid collection or removal.

16. The catheter of claim 8 wherein the obturating means comprises disc means for maintaining said tubular means in a substantially flat configuration and wherein the tubular means is a silicon tube.

17. The catheter of claim 8 wherein the flow control means further comprises concentric housing means for enclosing said tubular means and obturating means.

18. A method for preventing the introduction of air on reflux of blood flow into the vascular system of a patient through catheter means during intravenous or intra-arterial procedures which comprises:

providing catheter means with fluid flow control means comprising;

tubular means having open input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough; and

obturating means located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means from the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed;

introducing the catheter means into the vascular system of the patient during intravenous or intra-arterial procedures; and

introducing a fluid into said patient through said fluid flow control means and catheter means by directing the fluid under a positive pressure into the bore of the input means of said fluid flow control means so that the fluid flow control means opens in response to said positive fluid pressure to allow flow therethrough, but remains competent in response to ambient air pressure in the bore of said input means to prevent the introduction of air into the vascular system of the patient.

19. A method for preventing the introduction of air or reflux or blood into the vascular system of a patient through catheter means during intravenous or intra-arterial procedures which comprises:

providing catheter means having fluid flow control means comprising;

tubular means having open input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough;

obturating means located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means beings forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means from the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed; and

concentric housing means for enclosing said tubular means and obturating means;

introducing the catheter means into the vascular system of the patient during intravenous or intra-arterial procedures; and

introducing a fluid into said patient through said fluid flow control means and catheter means by directing the fluid under a positive pressure into the bore of the input means of said fluid flow control means so that the fluid flow control means opens in response to said positive fluid pressure to allow flow therethrough, but remains competent in response to ambient air pressure in the bore of said input means to prevent the introduction of air into the vascular system of the patient.

20. A method for preventing the introduction of air or reflux or blood into the vascular system of a patient through catheter means during intravenous or intra-arterial procedures which comprises:

providing catheter means comprising;

an elongated body portion for insertion into the patient;

a hub portion adjacent to the body portion for introducing or removing fluids through the body portion; and

fluid flow control means comprising;

a tubular structure having input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough; and

obturating means located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means form the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed;

introducing the catheter means into the vascular system of the patient during intravenous or intra-arterial procedures; and

introducing as fluid into said patient through said fluid flow control means and catheter means by directing the fluid under a positive pressure into the bore of the input means of said fluid flow control means so that the fluid flow controls means opens in response to said positive fluid pressure to allow flow therethrough, but remains competent in response to ambient air pressure in the bore of said input means to prevent the introduction of air into the vascular system of the patient.

21. A method for preventing the reflux of fluids into an organ or the pleural cavity of a patient when fluid directing means is utilized for removal of such fluids, which comprises:

providing fluid directing means having fluid flow control means comprising;

tubular means having open input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough;

obturating means located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means form the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed; and

inlet and outlet connectors for insertion into said input and output bores, respectively, of the tubular means for releasable attachment of the control to means said fluid directing means;

introducing the fluid directing means into the organ or pleural cavity of a patient; and

removing fluids from said organ or plural cavity by directing said fluid under a positive pressure into the bore of the input means of said fluid flow control means to facilitate removal of said fluids by flow therethrough while preventing the reflux of fluid or the introduction of air into the organ or pleural cavity of the patient.

22. A method for preventing the reflux of fluids into an organ or the pleural cavity of a patient when fluid directing means is utilized for removal of such fluids, which comprises:

providing fluid directing having fluid flow control means comprising;

tubular means having open input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough; and

obturating means comprising disc means for maintaining said tubular means in a substantially flat configuration located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means from the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed;

introducing the fluid directing means into the organ or pleural cavity of a patient; and

removing fluids from said organ or pleural cavity by directing said fluid under a positive pressure into the bore of the input means of said fluid flow control means to facilitate removal of said fluids by flow therethrough while preventing the reflux of fluid or introduction of air into the organ or pleural cavity of the patient.

23. A method for preventing the reflux of fluids into an organ or the pleural cavity of a patient when catheter means is utilized for removal of such fluids, which comprises:

introducing into an organ or pleural cavity of a patient catheter means comprising;

an elongated body portion for insertion into the patient;

a hub portion adjacent to the body portion for introducing or removing fluids through the body portion; and

fluid flow control means comprising;

a tubular structure having input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough; and

obturating means comprising disc means for maintaining said tubular means in a substantially flat configuration located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means form the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel mean to said closed position when said positive pressure is removed; and

removing fluids from said organ or pleural cavity by directing said fluid under a positive pressure into the bore of the input means of said fluid flow control means to facilitate removal of said fluids by flow therethrough while preventing the reflux of fluid or introduction of air into the organ or pleural cavity of the patient.

24. A method for preventing the reflux of fluids into an organ or the pleural cavity of a patient when catheter means is utilized for removal of said fluids, which comprises:

introducing into an organ or pleural cavity of a patient catheter means comprising;

an elongated body portion for insertion into the patient;

a hub portion adjacent the body portion for introducing or removing fluids through the body portion; and

fluid flow control means comprising;

a tubular structure having input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough; and

obturating means comprising disc means for maintaining said tubular means in a substantially flat configuration located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means from the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed; and

removing fluids form said organ or pleural cavity by directing said fluid under a positive pressure into the bore of the input means of said fluid flow control means to facilitate removal of said fluids by flow therethrough while preventing the reflux of fluid or introduction of air into the organ or pleural cavity of the patient.

25. A method for preventing the reflux of fluids into an organ or the pleural cavity of a patient when catheter means are utilized for removal of such fluids, which comprises:

introducing into an organ or pleural cavity of a patient catheter means comprising;

an elongated body portion for insertion into the patient;

at least two hub portions adjacent the body portion for introducing or removing fluids through the body portion; and

fluid flow control means associated with each hub portion comprising;

tubular means having open input and output bores connected by channel means and operable between an open position to allow fluid flow therethrough and a closed position to prevent ambient pressure air from passing therethrough; and

obturating means located within said channel means for prestressing and maintaining a portion of said channel means in said closed position, said channel means being forceable to said open position in response to a positive fluid pressure in said input or output bore of said tubular means to allow fluid flow through said channel means from the bore containing the positive pressure to the other bore, said fluid flow control means capable of passing fluid in either direction depending upon which bore contains the positive pressure;

said obturating means returning said channel means to said closed position when said positive pressure is removed; and

removing fluids from said organ or pleural cavity by directing said fluid under a positive pressure into the bore of the input means of at least one of said fluid flow control means to facilitate removal of said fluids by flow therethrough while preventing the reflux of fluid or introduction into the organ or pleural cavity of the patient.