PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD AND INTERNAL BLOOD CONTROL SEPTUM

• US 20140364809A1
• Filed: 06/04/2014
• Published: 12/11/2014
• Est. Priority Date: 06/07/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Isaacson, S. Ray, Harding, Weston F., Ma, Yiping, Shevgoor, Siddarth K., Bornhoft, Stephen T.
• Granted Patent: US 10,500,376 B2
• Time in Patent Office: Days
• US Class Current: 604/164.08
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/0015 Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0618 having means for protecting only the distal tip of the needle, e.g. a needle guard
• CPC Class Codes: A61M 25/0625 with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: A61M 39/00 Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use for respiratory devices, e.g. tracheal tubes A61M16/00; artificial heart valves A61F2/24
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3275 being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An extravascular system is provided which includes a catheter adapter having a blood control septum configured to control flow of a fluid through the catheter adapter, the catheter adapter further having a catheter configured for intravenous insertion. The extravascular system further includes a septum activator slidably inserted within the catheter adapter and configured for advancement through the blood control septum to provide a fluid pathway through the blood control septum. Further still, the extravascular system includes an external safety mechanism comprising a needle hub and a needle shield interconnected via a tether, wherein the needle shield includes a safety clip that is configured to retain a sharpened end of the introducer needle within the needle shield. Some implementations further comprise an access port forming a portion of the catheter adapter and providing selective access to the lumen of the catheter adapter.

Claims

1. An extravascular system for accessing the vasculature of a patient, comprising:

a catheter adapter having a distal end supporting a catheter, and further comprising a proximal opening, the catheter adapter having a lumen;

an access port coupled to an outer surface of the catheter adapter and having an inner lumen that is in fluid communication with the lumen of the catheter adapter;

a blood control septum disposed within the lumen of the catheter adapter and dividing the lumen into a proximal fluid chamber and a distal fluid chamber;

a defeatable barrier disposed within the lumen of the catheter adapter and forming a sealed interface with the inner lumen of the access port;

a septum activator slidably positioned within the proximal fluid chamber, the septum activator having a base and a probe end; and

an external safety mechanism removably coupled to the proximal opening of the catheter adapter and comprising a safety clip configured to secure a sharpened tip of an introducer needle.

2. The system of claim 1, wherein the introducer needle further comprises a base supported by a needle hub and a body extending between the base and the sharpened tip of the introducer needle, the body of the introducer needle inserted through the external safety mechanism, the lumen of the catheter adapter, and the catheter such that the sharpened tip of the introducer needle is positioned external to a tip of the catheter, and the needle hub is adjacent the external safety mechanism prior to insertion of the catheter into the vasculature of the patient.

3. The system of claim 2, further comprising a tether having a first end coupled to the needle hub and a second end coupled to the external safety mechanism.

4. The system of claim 2, wherein the external safety mechanism is a needle shield.

5. The system of claim 2, wherein the body of the introducer needle passes through the external safety mechanism to hold the safety clip in a first position prior to insertion of the catheter into the vasculature of the patient.

6. The system of claim 5, wherein following insertion of the catheter into the vasculature of the patient, the introducer needle is withdrawn from the lumen of the catheter adapter and through a pathway of the external safety mechanism to bypass the safety clip, thereby releasing the safety clip from the first position to a second position, wherein the second position blocks the pathway of the external safety mechanism to prevent the sharpened tip from passing therethrough.

8. The system of claim 6, wherein the tether prevents removal of the sharpened tip from the external safety mechanism.

7. The system of 6, wherein the tether comprises a length that is less than a distance between the sharpened tip and the base of the introducer needle.

9. A method for manufacturing an extravascular system for accessing the vasculature of a patient, the method comprising steps for:

providing a catheter adapter having a distal end supporting a catheter, the catheter adapter further comprising a proximal opening and a lumen interposed between the proximal opening and the catheter;

coupling an access port to an outer surface of the catheter adapter, the access port having an inner lumen in fluid communication with the lumen of the catheter adapter;

disposing a blood control septum within the lumen of the catheter adapter and dividing the lumen into a proximal fluid chamber and a distal fluid chamber;

disposing a defeatable barrier within the lumen of the catheter adapter and forming a sealed interface with the inner lumen of the access port;

slidably inserting a septum activator within the proximal fluid chamber, the septum activator having a base and a probe end; and

coupling an external safety mechanism to the proximal opening of the catheter adapter, the external safety mechanism having a safety clip configured to secure a sharpened tip of an introducer needle.

10. The method of claim 9, further comprising a step for providing a needle hub for supporting a base end of the introducer needle, the introducer needle further comprising a body extending between the base and the sharpened tip.

11. The method of claim 10, further comprising a step for threadedly inserting the body of the introducer needle through the external safety mechanism, the lumen of the catheter adapter, and the catheter such that the sharpened tip of the introducer needle is positioned external to a tip of the catheter, and the needle hub is adjacent the external safety mechanism.

12. The method of claim 10, further comprising a step for providing a tether having a first end coupled to the needle hub and a second end coupled to the external safety mechanism.

13. The method of claim 10, wherein the external safety mechanism is a needle shield.

14. The method of claim 10, further comprising a step for positioning the body of the introducer needle in the external safety mechanism such that the safety clip is held in a first position by the body of the introducer needle.

15. The method of claim 14, wherein following insertion of the catheter into the vasculature of the patient, the introducer needle is withdrawn from the lumen of the catheter adapter and through a pathway of the external safety mechanism to bypass the safety clip, thereby releasing the safety clip from the first position to a second position, wherein the second position blocks the pathway of the external safety mechanism to prevent the sharpened tip from passing therethrough.

16. The method of claim 15, further comprising a step for selecting a length of the tether that is less than a distance between the sharpened tip and the base of the introducer needle.

17. The method of claim 15, wherein the tether prevents removal of the sharpened tip from the external safety mechanism.

18. The method of claim 9, wherein the sealed interface between the inner lumen and the access port is defeated by either injecting a fluid into the access port or by inserting a secondary infusion device into the access port to manually contact and displace the defeatable barrier.

19. An extravascular system for accessing the vasculature of a patient, comprising:

a catheter adapter having a distal end supporting a catheter, and further comprising a proximal opening, the catheter adapter having a lumen;

an access port coupled to an outer surface of the catheter adapter and having an inner lumen that is in fluid communication with the lumen of the catheter adapter;

a blood control septum disposed within the lumen of the catheter adapter and dividing the lumen into a proximal fluid chamber and a distal fluid chamber;

a defeatable barrier disposed within the lumen of the catheter adapter and forming a sealed interface with the inner lumen of the access port;

a septum activator slidably positioned within the proximal fluid chamber, the septum activator having a base and a probe end;

an external safety mechanism removably coupled to the proximal opening of the catheter adapter and comprising a safety clip configured to secure a sharpened tip of an introducer needle, the introducer needle further comprising a base supported by a needle hub and having a body extending between the base and the sharpened tip, the body of the introducer needle being inserted through the external safety mechanism, the lumen of the catheter adapter and the catheter such that the sharpened tip of the introducer needle is positioned external to a tip of the catheter prior to insertion of the catheter into the vasculature of the patient; and

a pawl forming a portion of the safety clip and positioned within a proximal rim of the catheter adapter to maintain an interlocked connection between the external safety mechanism and the catheter adapter, wherein upon removal of the introducer needle from the external safety mechanism the safety clip is released and the pawl is disengaged from the proximal rim, thereby disconnecting the external safety mechanism from the catheter adapter.

20. The system of claim 19, further comprising:

a needle hub coupled to the base of the introducer needle; and

a tether having a first end coupled to the needle hub and a second end coupled to the external safety mechanism, wherein the tether comprises a length that is less than a distance between the base and the sharpened tip of the introducer needle.