Devices and methods for installation and removal of a needle tip of a needle

• US 10,512,734 B2
• Filed: 04/03/2015
• Issued: 12/24/2019
• Est. Priority Date: 04/03/2014
• Status: Active Grant

• Current Assignee: Versago Vascular Access, Inc.
• Original Assignee: Versago Vascular Access, Inc.
• Inventors: Tallarida, Steven J., Rodgers, Richard P., Butziger, John M.
• Primary Examiner(s): Vu, Quynh-Nhu H.
• Application Number:
  US15/301,498
• Publication Number:
  US 20170173273A1
• Time in Patent Office: 1,726 Days
• Field of Search: 604506
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61M 2005/14284 with needle insertion means
• CPC Class Codes: A61M 2209/04 Tools for specific apparatus
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/329 characterised by features of the needle shaft
• CPC Class Codes: A61M 5/343 Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub A61M5/322 takes precedence
• CPC Class Codes: A61M 5/346 friction fit A61M5/344 takes precedence

Abstract

The present disclosure provides medical devices, particularly medical grade needles with removable tips, as well as methods of needle tip installation and removal, and devices therefor. Needle tip installation and removal devices may include needle tip installation and removal tools and kits, including hand held and manipulated tools that facilitate the installation and removal of needle tips, particularly on vascular access port needles. Such installation and removal devices may provide more expedient hook up of the access port for the therapy. Also, the installation and removal of the needle tips may be conducted in a more sterile manner.

Claims

1. A medical device comprising:

at least one needle tip having a pointed closed end configured to penetrate tissue, the needle tip configured to be installed on a hollow needle shaft having a fluid flow passage within the needle shaft, and the needle tip configured to be removed from the needle shaft;

the needle tip configured to close the fluid flow passage within the needle shaft when the needle tip is installed on the needle shaft; and

at least one tool configured to install the at least one needle tip on the needle shaft, the tool comprising a tool body having a proximal end and a distal end, and a needle tip holder located at the distal end of the tool, the needle tip holder comprising a needle tip receptacle configured to receive the needle tip, including the pointed closed end, therein, and configured to hold the needle tip during an installation of the needle tip on the needle shaft.

2. The medical device of claim 1 wherein:

the at least one needle tip and the at least on tool are components of a sterilized medical device kit.

3. The medical device of claim 1 wherein:

the at least one need tip is securable to the needle shaft by a positive mechanical engagement connection.

4. The medical device of claim 3 wherein:

the positive mechanical engagement connection comprises a threaded connection.

5. The medical device of claim 4 wherein:

the at least one needle tip comprises a needle shaft receptacle to receive a portion of the needle shaft;

the needle shaft receptacle includes needle shaft receptacle threads;

the needle shaft includes needle shaft threads; and

the at least one needle tip is securable to the needle shaft by threaded engagement of the needle shaft receptacle threads of the needle tip with the needle shaft threads of the needle shaft.

6. The medical device of claim 1 wherein:

the needle tip receptacle comprises a mating portion configured to mate with a mating portion of the needle tip.

7. The medical device of claim 6 wherein:

the mating portion of the needle tip receptacle is configured to mate with the mating portion of the needle tip such that, when the tool is rotated about a longitudinal axis of rotation, both the needle tip receptacle and the needle tip rotate about the longitudinal axis of rotation.

8. The medical device of claim 6 wherein:

the mating portion of the needle tip receptacle has a polygonal shape; and

the mating portion of the needle tip has a polygonal shape which fits inside the polygonal shape of the needle tip receptacle.

9. The medical device of claim 1 wherein:

the needle tip receptacle of the needle tip holder is configured to hold the needle tip during the installation of the needle tip on the needle shaft.

10. The medical device of claim 9 wherein:

the needle tip receptacle is configured to hold the needle tip during the installation of the needle tip on the needle shaft with a positive mechanical engagement connection formed with the needle tip.

11. The medical device of claim 10 wherein:

the at least one needle tip includes needle tip threads;

the needle tip receptacle includes needle tip receptacle threads; and

the positive mechanical engagement is formed by threaded engagement of the needle tip threads with the needle tip receptacle threads.

12. The medical device of claim 10 wherein:

the at least one needle tip includes at least one needle tip ridge and/or at least one needle tip groove;

the needle tip receptacle includes at least one needle tip receptacle ridge and/or at least one needle tip receptacle groove; and

the positive mechanical engagement is formed by positive mechanical engagement of the at least one needle tip ridge with the at least one needle tip receptacle groove and/or engagement of the at least one needle tip groove with the at least one needle tip receptacle ridge.

13. The medical device of claim 10 wherein:

the positive mechanical engagement is formed by a portion of the at least one needle tip which overlaps a portion of the needle tip receptacle in a plane transverse to a longitudinal axis of the tool.

14. The medical device of claim 9 wherein:

the needle tip receptacle is configured to hold the needle tip during the installation of the needle tip on the needle shaft with a friction fit connection formed with the needle tip.

15. The medical device of claim 14 wherein:

the needle tip receptacle includes an elastically deformable member; and

the friction fit connection is formed by elastic deformation of the elastically deformable member when the needle tip is in the needle tip receptacle.

16. The medical device of claim 9 wherein:

the needle tip receptacle is configured to hold the needle tip during the installation of the needle tip on the needle shaft with a magnetic force applied to the needle tip.

17. The medical device of claim 16 wherein:

the needle tip receptacle includes a magnet; and

the needle tip comprises a magnetic material.

18. The medical device of claim 9 wherein:

the needle tip receptacle is configured to hold the needle tip during the installation of the needle tip on the needle shaft with a vacuum force applied to the needle tip.

19. The medical device of claim 18 wherein:

the needle tip receptacle is in fluid communication with a vacuum passage through which a vacuum is drawn with a vacuum generating device.

20. The medical device of claim 1 wherein:

the needle tip is configured to close the fluid flow passage within the needle shaft when the needle tip is installed on the needle shaft to ingress of fluid into the fluid flow passage.

21. The medical device of claim 1 wherein:

the fluid flow passage within the needle shaft is provided by a lumen of the needle shaft.

22. The medical device of claim 21 wherein:

the needle tip is configured to close the lumen of the needle shaft when the needle tip is installed on the needle shaft to ingress of fluid into the lumen.