Methods for preventing the introduction of air or fluid into the body of a patient

• US 4,722,725 A
• Filed: 05/11/1987
• Issued: 02/02/1988
• Est. Priority Date: 04/12/1983
• Status: Expired due to Fees

• Current Assignee: Interface Biomedical Laboratories Incorporated
• Original Assignee: Interface Biomedical Laboratories Incorporated
• Inventors: Fitzgerald, Joseph F., Sawyer, Philip N.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/053,495
• Time in Patent Office: 267 Days
• Field of Search: 604/122, 604/27, 604/28, 604/30, 604/43-45, 604/167-170, 604/247, 604/52, 604/53, 604/129
• US Class Current: 604/27
• CPC Class Codes: A61M 39/228 with a tubular diaphragm constrictable by radial fluid force
• 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

Abstract

Methods for preventing the introduction of air into the vascular system of a patient during intravenous or intraarterial procedures, as well as for preventing the reflex of fluids into the body of a patient. Also, novel fluid directing means and catheters which include integal or attached fluid flow control means for use in these methods.

Claims

1. A method for preventing the introduction of ambient air into the vascular system of a patient through catheter means introduced into said vascular system during intravenous or intra-arterial procedures which comprises:

5. The method of claim 1 wherein the fluid flow control means is integral with or attached to the catheter means.

6. The method of claim 1 which further comprises utilizing means to maintain the fluid flow control means in an open position to view blood reflux through the catheter means or to facilitate the introduction of obturating means.

10. The method of claim 6 which further comprises utilizing means to maintain the fluid flow device in an open position to temporarily view blood reflux through the catheter means or to facilitate the introduction of obturating means, trocar means, second catheter means, or fluid directing means into the first catheter means.

2. providing the catheter means with fluid flow control means comprising:

a tubular structure including input means and output means;

each provided with an open bore constituting a flow channel; and

further means located between the bores of said input and output means of said tubular structure and having an open and a closed position, said further means providing for a connecting channel between said bores when said further means is in the open position, said further means normally being prestressed to said closed position and being forcible to said open position in response to a positive fluid pressure in the bore of either of said input or output means, said further means being constructed and arranged so as to return to said closed position in response to a removal of positive fluid pressure from said bore containing same;

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

and

7. The method of claim 3 wherein the means to maintain the fluid flow control means in an open position further comprises a second fluid flow control means which remains competent in response to ambient air pressure but which opens in response to a positive fluid pressure above that of ambient air.

8. The method of claim 3 wherein the obturating means comprises second catheter means, trocar means, needle means, or fluid directing means.

11. The method of claim 7 wherein the means to maintain the fluid flow control means in an open position further comprises a second fluid flow control means which remains competent in response to blood reflux and ambient air pressure, but which opens in response to a positive fluid pressure above that of ambient air.

12. The method of claim 7 which further comprises connecting the maintaining means to exterior conduit means such that, in the event the exterior conduit means is disengaged from the patient, the maintaining means is also removed, thus returning the fluid flow control means to a closed position.

16. The catheter means of claim 12 wherein the fluid flow control means is releasably secured to the hub portion.

17. The catheter means of claim 12 wherein two integral hub portions are provided and each hub includes fluid flow control means located adjacent thereto.

20. The catheter means of claim 12 further comprising obturating means for rendering incompetent the fluid flow control means.

21. The catheter means of claim 17 wherein the obturating means is second catheter means, trocar means, needle means, or fluid directing means.

22. The catheter means of claim 17 wherein the obturating means is trocar means and the trocar means includes a fluid flow control means which remains competent in response to blood reflux or ambient air pressure but which opens in response to a positive fluid pressure above that of ambient air.

23. The catheter means of claim 17 wherein the obturating means is trocar means and the trocar means includes a fluid flow control means which remain competent in response to fluid reflux but which opens in response to fluid pressure in the patient.

24. The catheter means of claim 12 wherein the end of the body portion opposite the hub portion includes a plurality of apertures.

25. The catheter means of claim 12 wherein the fluid flow control means is located in the body portion.

26. The catheter means of claim 12 wherein the fluid flow control means is located adjacent to the hub portion.

29. The catheter means of claim 12 wherein said fluid flow control means further comprises a relatively rigid support tube having spaced ends and provided with a bore within which said tubular structure is partly accommodated, said tubular structure including end portions extending out of the support tube and being rolled over the support tube ends for engagement therewith.

30. The catheter means of claim 26 wherein saidf fluid flow control means further comprises a housing provided with first and second channels of different diameters in coaxial relation to define a shoulder therebetween, said support tube and tubular structure insertable into said first channel and trapping said support tube and tubular structure against said shoulder and a catheter accommodated in said second channel, said plug means and catheter providing passageways coupled through said tubular structure.

31. The catheter means of claim 24 wherein the fluid flow control means further comprises a relatively rigid support member having spaced ends and an internal bore within which said tubular structure is at least partly accommodated, said input and output bores of said tubular structure including end portions extending out of the support member and being rolled over the support member ends for engagement therewith.

33. The catheter means of claim 29 wherein said obturating means comprises clip means for retaining said channel means portion in a closed condition in the absence of positive fluid pressure.

34. The catheter menas of claim 25 wherein the fluid flow control means furhter comprises a relatively rigid support member having spaced ends and an internal bore within which said tubular structure is at least partly accommodated, said input and output bores of said tubular structure including end portions extending out of the support member and being rolled over the support member ends for engagement therewith.

35. The catheter means of claim 31 wherein the fluid flow control means further comprises:

a housing provided with first and second channels of different diameters in coaxial relation to define a shoulder therebetween;

said support member and channel means being accommodated in said first channel, and

plug means insertable into said first channel and trapping said support member and channels means against said shoulder.

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

9. A method for preventing the reflux of blood from the vascular system of a patient through catheter means introduced into said vascular system during intravenous or intra-arterial procedures which comprises:

providing the catheter means with fluid flow control means comprising;

a tubular structure including input means and output means, each provided with an open bore constituting a flow-channel; and

further means located between the bores of said input and output means of said tubular structure and having an open and a closed position, said further means providing for a connecting channel between said bores when said further means is in the open position, said further means normally being prestressed to said closed position and being forcible to said open position in response to a positive fluid pressure in the bore of either of said input or output means, said further means being constructed and arranged so as to return to said closed position in response to a removal of positive fluid pressure from said bore containing same;

introducing the catheter 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 above that of ambient air into the bore of the input means of said fluid flow control means so that the fluid flow control means remains competent in response to blood reflux in said output bore and ambient air pressure in said input bore but which opens in response to said positive fluid pressure to allow fluid flow therethrough, while also preventing the inntroduction of air into or the reflux of blood from the vascular system of the patient.

14. The method of claim 9 which further comprises periodically utilizing means to maintain the fluid flow device in an open position to facilitate faster removal of said fluid from the patient.

18. The catheter means of claim 14 wherein each fluid flow control means is releasably secured to its respective hub portion.

19. The catheter means of claim 14 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 body 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 patient.

13. A method for preventing the reflux of fluids into an organ or the pleural cavity of a patient through fluid directing means utilized for removal of said fluids from the patient which comprises:

providing the fluid directing means with fluid flow control means comprising;

a tubular structure including input means and output means, each provided with an open bore constituting a flow channel; and

further means located between the bores of said input and output means of said tubular structure and having an open and a closed position, said further means providing for a connecting channel between said bores when said further means is in the open position, said further means normally being prestressed to said closed position and being forcible to said open position in response to a positive fluid pressure in the bore of either of said input or output means, said further means being constructed and arranged so as to return to said closed position in response to a removal of positive fluid pressure from said bore containing same;

introducing the fluid directing means into the organ or pleural cavity of the patient for removal of fluids therefrom; and

removing fluid from said organ or pleural cavity of said patient through said fluid flow control means and fluid directing means by directing said fluid under a positive pressure ito the bore of the input means of said fluid flow control means so that the fluid flow control means remains competent in respnse to fluid reflux but which opens in response to said fluid pressure in the patient to facilitate the removal of said fluids by flow therethrough, while also preventing the introduction of air or the reflux of fluid into the organ or pleural cavity of the patient.

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

at least one integral hub portion adjacent to the body portion; and

at least one fluid flow control means located in the body or hub portion or adjacent to the hub portion, which means comprises;

a tubular structure including input means and output means, each provided with an open bore constituting a flow channel; and

further means located between the bores of said input and output means of said tubular structure and having an open and a closed position, said further means providing for a connecting channel between said bores when said further means is in the open position, said further means normally being prestressed to said closed position and being forcible to said open position in response to a positive fluid pressure in the bore of either of said input or output means, said further means being constructed and arranged so as to return to said closed position in response to a removal of positive fluid pressure from said bore containing same so that the fluid flow control means remains competent in response to ambient air pressure or fluid reflux but which opens in response to a positive fluid pressure above that of ambient air to allow fluid flow through said further means from the bore containing the positive pressure to the other bore, said flow control means capable of passing fluid in either direction depending upon which bore contains the positive fluid pressure.

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

an integral hub portion adjacent to the body portion for introducing fluids into the body portion; and

integral fluid flow control means located in the body portion; and

integral fluid flow control means located in the body portion adjacent the hub portion which comprises;

a tubular structure having input means and output means, each provided with an open bore, and channel means connecting said input and output bores and operating between open and closed positions; and

means for retaining a portion of the channel means in a prestressed condition to obturate said channel means so as to maintain the channel means in said closed position;

said channel means being forcible to said open position in response to a positive pressure above that of ambient air in one of said bores to facilitate flow therethrough;

said retaining means returning said channel means to said closesd position when said positive pressure is removed, so that the control means remains competent in response to blood reflux or ambient air pressure, but which opens in response to a positive fluid pressure above that of ambient air to allow fluid flow there said retaining 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 fluid pressure.

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

an integral hub portion adjacent to the body portion for removal of fluids from the patient through the body portion; and

integral fluid flow control means located in the body portion adjacent to the hub portion which comprises;

a tubular structure having input means and output means, each provided with an open bore, and channel means connecting said input and output bores and operating between open and closed positions; and

means for retaining a portion of the channel means in a prestressed condition to obturate said channel means so as to maintain the channel means in said closed position;

said channel means being forcible to said open position in response to a positive pressure above that of ambient air in one of said bores to facilitate flow therethrough;

said retaining means returning said channel means to said closed position when said positive pressure is removed, so that control means remains competent in response to fluid reflux but which opens in response to fluid pressure in the patient to allow fluid flow through said further means from the bore containing the positive pressure to the other bore, said flow control means capable of passing fluid in either direction depending upon which bore contains the positive fluid pressure.

32. The catheter means of claim 28 wherein the fluid flow control means further comprises:

a housing provided with first and second channels of different diameters in coaxial relation to define a shoulder therebetween;

said support member and channel means being accommodated in said first channel, and

plug means insertable into said first channel and trapping said support member and channel means against said shoulder.

36. The catheter means of claim 32 wherein said obturating means comprises clip means for retaining said channel means portion in a closed condition in the absense of positive fluid pressure.