Intravenous catheter insertion and blood sample devices and method of use

• US 10,525,236 B2
• Filed: 05/30/2017
• Issued: 01/07/2020
• Est. Priority Date: 05/07/2007
• Status: Active Grant

• Current Assignee: Vascular Pathways, Inc. (Becton, Dickinson & Co)
• Original Assignee: Vascular Pathways, Inc. (Becton, Dickinson & Co)
• Inventors: Belson, Amir
• Primary Examiner(s): Hindenburg, Max F
• Application Number:
  US15/608,802
• Publication Number:
  US 20170259036A1
• Time in Patent Office: 952 Days
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150656 semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61B 5/15074 Needle sets comprising wings, e.g. butterfly type, for ease of handling
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/1535 comprising means for indicating vein or arterial entry A61B5/1545 takes precedence
• CPC Class Codes: A61B 5/1545 comprising means for indicating vein or arterial entry
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• 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 25/09 Guide wires
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

A catheter insertion device includes a housing, a needle, a catheter, and a guide wire. The needle has a proximal end positioned in the housing and a distal end extending beyond a distal end of the housing in a first position. The catheter is positioned coaxially over the needle, and may include a flexible tube and a catheter hub on a proximal end of the flexible tube. A proximal portion of the flexible tube and the catheter hub may be positioned in the housing. The guidewire may have a proximal end positioned in the housing and a distal end positioned in a lumen of the needle. The catheter insertion device also may include a handle coupled to the catheter, wherein movement of the handle relative to the housing moves the catheter hub from a position in the housing to a position outside of the housing.

Claims

1. An apparatus for drawing blood, comprising:

a housing having an interior volume;

a seal partitioning the interior volume of the housing into a distal interior volume portion and a proximal interior volume portion;

a blood draw port in fluid communication with the distal interior volume portion;

a needle extending through the seal, the needle having a proximal end positioned in the proximal interior volume portion and a distal end extending beyond a distal end of the housing in a first position; and

a guidewire having a proximal end positioned in the proximal interior volume portion and a distal end positioned in a lumen of the needle.

2. The apparatus for drawing blood according to claim 1, further comprising a flexible tube positioned coaxially over the needle in the distal interior volume portion.

3. The apparatus for drawing blood according to claim 2, wherein the flexible tube is part of an intravenous catheter including a catheter hub.

4. The apparatus for drawing blood according to claim 1, wherein a longitudinal length of the proximal interior volume portion is at least as long as a length of the needle to allow movement of the needle from the first position to a second position in which the distal end of the needle is positioned in the proximal interior volume portion.

5. The apparatus for drawing blood according to claim 1, further comprising a flexible tube positioned coaxially over the housing along the distal interior volume portion, the flexible tube having a proximal end in contact with the housing as a distal end is inserted into a blood vessel.

6. The apparatus for drawing blood according to claim 1, wherein the distal end of the needle extends from 1 mm to 10 mm beyond the distal end of the housing.

7. The apparatus for drawing blood according to claim 1, further comprising:

a slot in the housing;

a handle coupled to the guidewire through the slot, wherein movement of the handle along the slot moves the guidewire relative to the needle.

8. The apparatus for drawing blood according to claim 1, further comprising a mechanism in the housing coupled to the needle and the guidewire to retract the needle and the guidewire into the proximal interior volume portion proximal to the seal.

9. The apparatus for drawing blood according to claim 8, wherein the mechanism comprises a biasing element held in a compressed state by a release lever.

10. The apparatus for drawing blood according to claim 9, wherein when the biasing element is released, the needle and the guidewire are moved toward a proximal end of the housing such that the distal end of the needle is positioned in the proximal interior volume portion and the distal end of the guidewire is visible in a view window.

11. The apparatus for drawing blood according to claim 1, wherein the blood draw port includes a hollow member configured to penetrate a seal on a blood draw container.

12. The apparatus for drawing blood according to claim 1, wherein the blood draw port comprises a fitting having a lumen in communication with the distal interior volume portion.

13. The apparatus for drawing blood according to claim 1, wherein the distal end of the guide wire comprises a coiled tip.

14. A method for drawing blood from a patient, comprising:

obtaining an apparatus for drawing blood according to claim 2;

inserting the distal end of the needle into a blood vessel of the patient;

advancing the guidewire though the lumen of the needle and into the blood vessel;

advancing the flexible tube over the guidewire in the blood vessel;

moving the distal end of the needle into the proximal interior volume portion; and

withdrawing a blood sample from the flexible tube through the blood draw port.

15. The method of withdrawing blood from a patient according to claim 14, further comprising moving the guidewire into the housing to a position where the distal end of the guidewire is visible to a user.

16. The method of withdrawing blood from a patient according to claim 14, wherein moving the distal end of the needle into the proximal interior volume portion is performed manually by a user.

17. The method of withdrawing blood from a patient according to claim 14, wherein moving the distal end of the needle into the proximal interior volume portion is performed by releasing a biasing element.

18. The method of withdrawing blood from a patient according to claim 14, further comprising withdrawing the flexible tube from the blood vessel following the withdrawing step.

19. The method of withdrawing blood from a patient according to claim 14, further comprising disconnecting the flexible tube from the housing following the withdrawing step while maintaining the flexible tube in the blood vessel.

20. The method of withdrawing blood from a patient according to claim 19, further comprising securing the flexible tube to the patient while maintaining the flexible tube in the blood vessel.