Safety catheter system and method

• US 8,029,472 B2
• Filed: 10/23/2006
• Issued: 10/04/2011
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Inventors: Shute, Matthew R., Leinsing, Karl R.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US11/585,434
• Publication Number:
  US 20070100284A1
• Time in Patent Office: 1,807 Days
• Field of Search: 604/164.01, 604/164.02, 60416701-16704, 60416706-17002
• US Class Current: 604/164.01
• 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• CPC Class Codes: A61M 25/0631 having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle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;

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 fluid passageway being in fluid communication with the lumen of the catheter, the connector comprising a housing and a movable element positioned within the housing;

the 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, the movable element having a lumen forming a part of the fluid passageway of the connector and a septum adapted to move along a minor axis of the septum from a first position at which position the septum is disposed within a first section of the housing at which section the septum is closed and blocks fluid flow through the fluid passageway to a second position at which position the septum is disposed within a second section of the housing at which section the septum is open and permits fluid flow through the fluid passageway when the first port receives the male Luer connector; and

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 through the septum when the septum is open; 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 through 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.

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 septum forming a part of the head, 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 1 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.

4. The safety catheter system of claim 1 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.

5. The safety catheter system of claim 4 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.

6. The safety catheter system of claim 5 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.

7. The safety catheter system of claim 6 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.

8. The safety catheter system of claim 1 wherein the septum defines a naturally open bore forming a part of the fluid passageway through the connector, the septum being configured such that when the septum is in the first section of the housing, the bore opens thereby permitting fluid flow through the connector, the septum being further configured such that when the septum is in the second section of the housing the bore moves to a closed configuration preventing fluid flow.

9. 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 septum forming a part of the head, the head being configured such that when the septum is in the first section of the housing, the bore opens thereby permitting fluid flow through the connector, the head being further configured such that when the septum is in the second section of the housing the bore moves to a closed configuration preventing fluid flow.

10. The safety catheter system of claim 1 wherein the septum is in contact with the housing when it is disposed within the first section of the housing, and the septum is not in contact with the housing when it is disposed within the second section of the housing.

11. The safety catheter system of claim 1 wherein the second section of the housing has a larger internal diameter than the first section of the housing.

12. The safety catheter system of claim 1 wherein the first port of the housing comprises a female luer adapter.

13. 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 fluid passageway being in fluid communication with the lumen of the catheter, the connector comprising a housing and a movable element positioned within the housing;

the housing having a first port and a second port, the first port being adapted to be connected to a medical connector, and the second port being connected to the second end of the catheter, the movable element having a lumen forming a part of the fluid passageway of the connector and a valve mechanism adapted to move from a first position at which position the valve mechanism is disposed within a first section of the housing at which section the valve mechanism is closed and blocks fluid flow through the fluid passageway to a second position at which position the valve mechanism is disposed within a second section of the housing at which section the valve mechanism is open and permits fluid flow through the fluid passageway; and

an insertion mechanism comprising;

a blunt cannula adapted to be connected to the first port of the housing and into contact with the movable element to move the valve mechanism to the second position at which position the valve mechanism opens, the blunt cannula also configured to slide through the valve mechanism when the valve mechanism is open; 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 through the valve mechanism 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 valve mechanism from possible damage by the sharp needle.

14. The safety catheter system of claim 13 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.

15. The safety catheter system of claim 13 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.

16. The safety catheter system of claim 15 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.

17. The safety catheter system of claim 16 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.

18. The safety catheter system of claim 17 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.

19. The safety catheter system of claim 13 wherein the valve mechanism defines a naturally open bore forming a part of the fluid passageway through the connector, the valve mechanism being configured such that when the valve mechanism is in the first section of the housing the bore is squeezed to a closed configuration preventing fluid flow, the valve mechanism being further configured such that when the valve mechanism is in the second section of the housing, the bore resumes a naturally open shape thereby permitting fluid flow through the connector.

20. The safety catheter system of claim 13 wherein the movable element comprises a piston head section defining a naturally open bore forming a part of the fluid passageway through the connector, the valve mechanism forming a part of the piston head section, the piston head section being further configured such that when the valve mechanism is in the first section of the housing the bore is squeezed to a closed configuration preventing fluid flow, the piston head section being further configured such that when the valve mechanism is in the second section of the housing, the bore resumes a naturally open shape thereby permitting fluid flow through the connector.

21. The safety catheter system of claim 13 wherein the valve mechanism is in contact with the housing when it is disposed within the first section of the housing, and the valve mechanism is not in contact with the housing when it is disposed within the second section of the housing.

22. The safety catheter system of claim 13 wherein the second section of the housing has a larger internal diameter than the first section of the housing.