Device for subcutaneous medication delivery

• US 6,017,328 A
• Filed: 08/12/1996
• Issued: 01/25/2000
• Est. Priority Date: 01/21/1993
• Status: Expired due to Fees

• Current Assignee: Magnolia Medical, LLC (Medtronic Plc)
• Original Assignee: Magnolia Medical, LLC (Medtronic Plc)
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/695,596
• Time in Patent Office: 1,261 Days
• Field of Search: 604/164, 604/167, 604/180, 604/264, 604/282, 604/280, 604/272, 604/523, 604/500, 604/502, 604/506, 604/513
• US Class Current: 604/180
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• 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 5/3202 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

Abstract

The present invention is an injection port assembly for subcutaneous delivery of medication. A single molded body has a soft cannula extending downward from a generally flat bottom surface and a self-sealing septum mounted at the center of a top surface which is generally of a concave shape sloping downward towards its outer perimeter at which point the single body is very thin. The single body also has a tubular extension which is directed outward parallel to the skin'"'"'s surface. A metal needle which penetrates through the septum and through the lumen of the soft cannula is used for inserting the cannula through the skin. Once the soft cannula is placed subcutaneously, the needle is removed and an adhesive tape is placed over the single body and onto the skin beyond the body'"'"'s outer perimeter. By having a distal section of the needle which is smaller in diameter as compared to most of the needle'"'"'s length, and by having the soft cannula fit tightly onto the needle, most of the cannula'"'"'s length will be in tension during insertion thereby preventing an accordion-like compressional failure of the cannula. A quick-release connector on the proximal end of the tubular extension or mounted directly on the injection port assembly allows the tubing connecting the injection port assembly to a portable medication pump to be disconnected when the patient showers or performs some similar activity.

Claims

1. An injection port for delivery of medication from an external source through a patient'"'"'s skin comprising:

a generally flat, disk shaped main body formed from a single molded elastomer including a septum formed integral at the center of the main body; and

,

a cannula section formed from a single molded elastomer of a harder durometer as compared to the elastomer of the main body, the cannula section being joined with a pressure tight seal to the main body, the cannula section further having a flexible elongated cannula that protrudes in a generally downward direction from the main body.

2. The device of claim 1 wherein the septum that is formed integral with the main body has a slit to facilitate the passage of a plastic needle.

3. The device of claim 2 wherein guide ridges are situated around the septum to facilitate the placement of a plastic needle through the slit in the septum.

4. The device of claim 1 wherein the cannula section has two through holes each hole having an engagement means for engaging a releasable connector engagement means.

5. The device of claim 1 wherein both the upper and lower surfaces of the main body are generally of a concave shape.

6. The device of claim 1 wherein a pressure sensitive adhesive is applied to the bottom surface of the main body.

7. A device for delivery of medication from an external source through a patient'"'"'s skin comprising:

an injection port assembly having top and bottom surfaces, a main body, an adhesive section and an elongated cannula with a central lumen that protrudes from the bottom surface of the injection port assembly in a direction that is generally perpendicular to the bottom surface of the injection port assembly, the lumen having proximal and distal ends, the lumen'"'"'s proximal end being situated just below a septum that is formed integral with and at the center of the main body, the injection port assembly further including two holes each including an engaging means for attachment to a fluid connector engaging means.

8. The device of claim 7 wherein the fluid connector has three prongs, the central prong having a passageway for medication and the outer two prongs having said fluid connector engaging means for releasable attachment to the cannula section engaging means.

9. The device of claim 8 wherein the central prong terminates in the plastic needle having a tapered distal end that is adapted to pass through a slit in the septum formed at the center of the main body, the plastic needle having a central lumen which is in fluid communication with the proximal end of cannula lumen after the plastic needle is inserted through the septum of the main body.

10. A device for delivery of medication from an external source through a patient'"'"'s skin comprising:

an injection port assembly having top and bottom surfaces, a main body, an adhesive section and an elongated cannula with a central lumen that protrudes from the bottom surface of the injection port assembly in a direction that is generally perpendicular to the bottom surface of the injection port assembly; and

a needle assembly including a housing and a slideable metal needle that can be advanced into and through the cannula for subcutaneous insertion of the cannula, the slideable metal needle having a sharpened needle point at its distal end that is adapted to be withdrawn into the housing so that the sharpened needle point becomes completely shielded by the housing.

11. A device for delivery of medication from an external source through a patient'"'"'s skin, comprising:

an injection port assembly having a top surface, a bottom surface, a main body and an elongated cannula that protrudes in a direction that is generally perpendicular to the bottom surface of the injection port assembly, the injection port assembly also having fluid connection means located within the main body of the injection port assembly; and

a connector and tubing assembly consisting of an elongated tube having a first end and a second end and having a first fluid connector located at the first end and a second fluid connector at the second end, the first fluid connector being adapted to be removably connected through the top surface of the injection port assembly and into the fluid connection means located within the main body of the injection port assembly.

12. The injection port assembly of claim 11 wherein an adhesive assembly consisting of an adhesive sheet that is covered by at least one removable plastic sheet is placed at the bottom surface of the injection port assembly.

13. The injection port assembly of claim 11 wherein the second fluid connector is adapted to join to an external source of medication.

14. The injection port assembly of claim 13 wherein the external source of medication is a portable insulin pump.