Method and apparatus for delivering a therapeutic substance through an injection port

• US 20110022006A1
• Filed: 09/30/2010
• Published: 01/27/2011
• Est. Priority Date: 12/08/2006
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Walters, Michael R., Thomas, Bradley S., Stanton, Katherine
• Granted Patent: US 9,180,257 B2
• Time in Patent Office: Days
• US Class Current: 604/272
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2048 Connecting means
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2039/027 having a particular valve, seal or septum septum A61M2039/0036
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2039/0285 with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
• CPC Class Codes: A61M 2039/0288 protectors, caps or covers therefor
• CPC Class Codes: A61M 2039/0294 having a specific shape matching the shape of a tool to be inserted therein, e.g. for easy introduction, for sealing purposes, guide
• 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 5/001 Apparatus specially adapted for cleaning or sterilising syringes or needles
• 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 5/3134 characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3287 Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

Adapters for utilizing a syringe or pen injector with a subcutaneous injection port to deliver a therapeutic substance through the injection port and methods of using the adapters are provided. A syringe adapter has a body having a first end and a second end. The first end of the body is configured to receive and engage the end of a syringe so that the cannula of the syringe is held at a fixed position with the respect to the adapter. The second end of the adapter configured to mate with a mating portion of the injection port. When the second end of the adapter engages the mating portion of the injection port, the adapter assures that the cannula of the syringe is properly aligned with the subcutaneous injection port and assures that the cannula penetrates the injection port to the proper depth. Adapters for use with pen style delivery systems are also disclosed. Additionally, an adapter to facilitate loading a syringe with a therapeutic substance from a vial is disclosed.

Claims

1. An adapter for utilizing a pen delivery system with an injection port, comprising:

an outer shield having a first end and a second end, the first end of the outer shield being configured to mate with a pen delivery system, the second end of the outer shield being configured to mate with an injection port; and

a pen needle disposed in the outer shield.

2. An adapter according to claim 1, further comprising a sterility cap adapted to be placed over the second end of the outer shield to form a sterile barrier.

3. An adapter according to claim 2, wherein the sterility cap is welded to the outer shield.

4. An adapter according to claim 2, wherein a plurality of longitudinally extending ribs are disposed on the sterility cap to facilitate removal of the sterility cap from the adapter.

5. An adapter according to claim 2, wherein a plurality of wings are disposed on the sterility cap to facilitate removal of the sterility cap from the adapter.

6. An adapter according to claim 2, wherein a removable protective barrier is disposed at the first end of the outer shield, the removable protective barrier being removed prior to engagement with the pen delivery system.

7. An adapter according to claim 6, wherein the removable protective barrier is a paper or foil sterility barrier.

8. An adapter according to claim 1, wherein a plurality of annular rings are disposed on an inner surface of the sterility cap to provide a sterile barrier.

9. An adapter for utilizing a pen delivery system with an injection port, comprising:

first, second, and third legs that are connected together to form a triangular shaped body;

first and second recesses formed in the first and second legs of the adapter to accommodate a pen needle assembly;

extending struts on the first and second legs that are arranged in a geometric pattern that corresponds to the shape of corresponding features on an injection port.

10. An adapter according to claim 9, wherein a first living hinge is formed between the first and second legs.

11. An adapter according to claim 10, wherein a second living hinge is formed between the second and third legs.

12. An adapter according to claim 9, wherein the first leg has a tab and the third leg has a corresponding slot, the tab being received by the slot to secure the first leg to the third leg.

13. A vial adapter for use with an injection port adapter, comprising:

a disc with a bottom surface and a top surface;

a plurality of flexible fingers extending from the bottom surface of the disc, the plurality of flexible fingers having a retention flange formed on an inner surface of the fingers, wherein the flexible fingers are configured to fit over the neck of vial, and the flexible fingers allow the retention flange to pass over a crimp ring on the neck of a vial;

a cylinder extending from the top surface of the disc, the cylinder having an outside diameter that corresponds to the inner diameter of an injection port adapter;

a septum covering an opening at the top of the cylinder to form a cavity within the cylinder; and

a cannula that extends through the disc into the cavity in the cylinder.

14. A vial adapter according to claim 13, wherein the septum is flush with a free end of the cylinder.