Safety catheter system and method

• US 20040127854A1
• Filed: 12/30/2002
• Published: 07/01/2004
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Cardinal Health 303 Incorporated (Cardinal Health, Inc.)
• Inventors: Shute, Matthew R., Leinsing, Karl R.
• Granted Patent: US 7,125,396 B2
• Time in Patent Office: Days
• US Class Current: 604/167.03
• CPC Class Codes: A61M 2039/262 having a fluid space within the valve remaining the same upon connection and disconnection, i.e. neutral-drawback valve
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

Abstract

A catheter integral with a valved needle-free connector provides a safety catheter device configured to receive a blunt cannula and sharp needle forming an insertion mechanism. The sharp needle is mounted within a needle tube and a control handle is used to slide the sharp needle out of and into the protective needle tube. When the insertion mechanism is mounted to the connector and the control handle is used to slide the sharp needle out of the tube, a blunt cannula first moves into contact with and enters the bore of the valve mechanism of the connector opening it and protecting it from damage that may be caused by the sharp needle. The sharp needle is then extended through the connector and extends out the distal end of the catheter so that a venipuncture procedure may be performed to properly locate the catheter in the patient'"'"'s circulatory system. Once located, the needle may be retracted into the insertion mechanism, the insertion mechanism disconnected from the connector, and discarded.

Claims

1. A safety catheter system that provides access to a biological site, the system comprising:

a catheter defining a lumen and having a first end for insertion into the biological site and a second end; and

a connector for controlling the flow of fluid through the lumen of the catheter, the connector having an internal fluid passageway by which fluid may flow through the connector, the connector comprising;

a housing having a first port and a second port, the first port being adapted to receive a blunt cannula and the second port being connected to the second end of the catheter; and

a movable element positioned within the housing, the movable element having a first position in the housing at which the movable element blocks fluid flow through the housing and a second position at a different location within the housing at which the movable element permits fluid flow through the housing.

2. The safety catheter system of claim 1 wherein the movable element comprises a head defining a naturally open bore forming a part of the fluid passageway through the connector, the head being configured such that when the movable element is in the second position, the bore opens thereby permitting fluid flow through the connector, the head being further configured such that when the moveable element is in the first position the bore moves to a closed configuration preventing fluid flow.

3. The safety catheter system of claim 2 further comprising an insertion mechanism comprising:

a blunt cannula adapted for insertion through the first port of the housing and into contact with the head of the movable element to move the movable element to the second position at which the bore opens, the blunt cannula also adapted to slide within the open bore of the head of the movable element; and

a needle having a sharp tip, the needle slidably engaged with the blunt cannula and adapted to extend through the blunt cannula after the blunt cannula has slid within the bore of the movable element, the needle also adapted to slide through the catheter until the sharp tip projects beyond the first end of the catheter so that the sharp tip may penetrate the biological site to locate the catheter in the biological site;

wherein the blunt cannula protects the movable element from possible damage by the sharp needle.

4. The safety catheter system of claim 3 wherein:

the housing has an increased inner diameter at the second position of the movable element;

the head being configured such that when the movable element is in the second position at the increased inner diameter of the housing, the bore is permitted to assume its naturally open configuration thereby permitting fluid flow through the connector,

5. The safety catheter system of claim 3 wherein:

the insertion mechanism further comprises a control handle coupled to the sharp needle such that movement of the control handle causes movement of the sharp needle; and

movement of the control handle also causes movement of the blunt cannula to extend from the insertion mechanism into the connector by a predetermined length.

6. The safety catheter system of claim 5 wherein:

the insertion mechanism further comprises a locking device configured to lock the blunt cannula in a predetermined position so that it may be neither extended farther from the insertion mechanism nor retracted into the insertion mechanism.

7. The safety catheter system of claim 5 wherein the insertion mechanism further comprises:

a sharp needle protection device located so as to provide a physical barrier at the sharp tip of the needle to protect users of the insertion mechanism from being punctured by the sharp tip;

wherein the control handle also is configured to engage the protection device with the sharp needle to provide the barrier when moved to a needle protection position.

8. The safety catheter system of claim 7 wherein the insertion mechanism further comprises a control handle locking device configured to permanently retain the control handle at the needle protection position once the control handle has been there moved.

9. The safety catheter system of claim 1 further comprising an insertion mechanism comprising:

a needle having a sharp tip adapted to extend through the connector and catheter until the sharp tip projects beyond the first end of the catheter so that the sharp tip may penetrate the biological site and the catheter may be located as desired in the biological site; and

a blunt cannula adapted for insertion through the first port of the housing and into contact with the movable element to move the movable element to the second position to permit fluid flow through the connector, at which position the blunt cannula protects the movable element from the sharp needle.

10. The safety catheter system of claim 9 wherein the housing comprises threads located adjacent the first port and the insertion mechanism also comprises threads such that the housing and the insertion mechanism may be threadably engaged.

11. The safety catheter system of claim 9 further comprising a needle tube surrounding the needle, the needle having a sharp tip, the tube comprising a control handle, the tube configured such that when the control handle is in a retracted position, the sharp tip of the needle is covered by the tube to protect a user of the insertion device from being punctured by the sharp tip, and configured such that when the control handle is in an extended position, the sharp tip of the needle is outside the tube so that the needle may be extended into the catheter.

12. The safety catheter system of claim 11 wherein the outer tube comprises a limiting device configured to limit the travel of the blunt cannula, and is further configured to provide a restraint against the sharp tip of the needle projecting beyond an end of the blunt cannula before the blunt cannula reaches the limit of travel.

13. The safety catheter system of claim 12 wherein the outer tube further comprises a locking mechanism to retain the sharp needle in a retracted position within the tube after use at which position, the sharp tip of the needle is covered.

14. The safety catheter system of claim 9 wherein the first port of the housing comprises a female Luer adapter for receiving standard male Luer connector tips for fluid communication.

15. A safety catheter system that provides access to a biological site, the system comprising:

a catheter defining a lumen and having a first end for insertion into the biological site and a second end;

a connector for controlling the flow of fluid through the lumen of the catheter, the connector having an internal fluid passageway by which fluid may flow through the connector, the internal fluid passageway being in fluid communication with the lumen of the catheter, the connector comprising;

a housing having a first port and a second port, the first port being adapted to receive a male Luer connector, and the second port being connected to the second end of the catheter; and

a movable element positioned within the housing, the movable element having a lumen forming a part of the fluid passageway of the connector and a septum, the movable element having a first position in the housing at which the septum is closed and blocks fluid flow through the passageway and a second position at a different location within the housing at which the septum is open and permits fluid flow through the passageway;

an insertion mechanism comprising;

a blunt cannula adapted for insertion through the first port of the housing and into contact with the movable element to move the movable element to the second position at which position the septum opens, the blunt cannula also configured to slide within the opening of the septum of the movable element; and

a needle having a sharp tip slidably engaged with the blunt cannula and adapted to extend through the blunt cannula after the blunt cannula has slid within the septum of the movable element, and to slide through the catheter until the sharp tip projects beyond the first end of the catheter so that the sharp tip may penetrate the biological site to properly locate the catheter in the biological site;

wherein the blunt cannula protects the movable element from possible damage by the sharp needle.

16. The safety catheter system of claim 15 wherein the movable element comprises a head defining a naturally open bore forming a part of the fluid passageway through the connector, the head being configured such that when the movable element is in the second position, the bore opens thereby permitting fluid flow through the connector, the head being further configured such that when the moveable element is in the first position the bore moves to a closed configuration preventing fluid flow.

17. The safety catheter system of claim 16 wherein the housing comprises threads located adjacent the first port and the insertion mechanism further comprises threads adapted to engage the threads of the housing adjacent the first port in a threaded relationship.

18. The safety catheter system of claim 16 further comprising an outer tube surrounding the needle, the needle having a sharp tip, the tube comprising a control handle, the tube configured such that when the control handle is in a retracted position, the sharp tip of the needle is covered by the tube to protect a user of the insertion mechanism from being punctured by the sharp tip, and configured such that when the control handle is in an extended position, the sharp tip of the needle is outside the tube so that the needle may be extended into the catheter.

19. The safety catheter system of claim 18 wherein the outer tube comprises a limiting device adapted to limit the sliding travel of the blunt cannula, and is further adapted to provide a restraint against the sharp needle tip projecting beyond an end of the blunt cannula before the blunt cannula reaches the limit of sliding travel.

20. The safety catheter system of claim 19 wherein the outer tube further comprises a locking device to retain the blunt cannula in an extended position from the tube during use at which position the sharp tip of the needle may be extended beyond the blunt cannula.

21. The safety catheter system of claim 20 wherein the outer tube further comprises a locking device to retain the needle in a retracted position within the tube after use at which position, the sharp tip of the needle is covered.

22. A method for providing access to a biological site through placement of a catheter in the site, the method comprising:

moving a blunt cannula into a first port of a connector into contact with a movable element of the connector to move the movable element into a housing of the connector to a position where the movable element opens to permit flow of fluid through the connector, the blunt cannula also moving into the opening of the movable element to provide protection to the movable element;

sliding a needle having a sharp tip through the blunt cannula and through a catheter connected to the connector so that the sharp tip of the needle extends beyond the catheter a sufficient length that enables an operator to access a biological site with the sharp needle and catheter;

retracting the sharp needle from the catheter and the blunt cannula;

removing the blunt cannula from the connector; and

moving the movable element of the connector to a closed position at which the movable element prevents flow of fluid through the catheter.

23. The method of claim 22 further comprising the step of protecting the sharp tip of the needle with a physical barrier whereby the possibilities of a operator being punctured with the sharp tip are reduced.

24. The method of claim 22 wherein the step of moving a blunt cannula into a first port of a connector into contact with a movable element comprises:

moving the movable element into a second position within a housing of the connector at which position a bore through the movable element resumes its naturally open shape providing a fluid flow passageway through the connector; and

moving the blunt cannula into the bore of the movable element to provide protection to the movable element.

25. The method of claim 24 further comprising the steps of:

limiting the movement of the blunt cannula to a position within the connector to entering the open bore; and

restraining the sharp needle tip from projecting beyond an end of the blunt cannula before the blunt cannula reaches the limit of its movement.

26. The method of claim 22 further comprising the steps of:

threadably connecting an insertion mechanism to the connector, the insertion mechanism containing the blunt cannula and the sharp needle; and

unthreading the insertion device from the connector after the biological site has been accessed whereby the insertion device containing the sharp needle may be discarded.

27. The method of claim 26 further comprising the steps of:

controlling the position of the sharp needle in the insertion mechanism with a control handle, wherein moving the control handle to a retracted position causes the sharp needle to be moved to a retracted position within the insertion mechanism so that the insertion mechanism covers the sharp tip of the needle; and

moving the control handle to an extended position causes the sharp needle to be extended from the insertion mechanism so that the sharp needle may be extended through the catheter and used to access the biological site.

28. The method of claim 27 further comprising the step of locking the sharp needle in a retracted position within the insertion mechanism after its use in accessing the biological site at which position the sharp tip of the needle is protected.