Device for subcutaneous medication delivery

• US 5,545,143 A
• Filed: 01/07/1994
• Issued: 08/13/1996
• Est. Priority Date: 01/21/1993
• Status: Expired due to Term

• Current Assignee: Magnolia Medical, LLC (Medtronic Plc)
• Original Assignee: T S I Medical
• Inventors: Fischell, David R.
• Primary Examiner(s): WEISS, JOHN
• Application Number:
  US08/173,983
• Time in Patent Office: 949 Days
• Field of Search: 604/164, 604/167, 604/180, 604/264, 604/282, 604/280, 604/272
• 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. A device for delivery of medication from an external source through a patient'"'"'s skin comprising:

a needle assembly consisting of a needle having proximal and distal sections, the proximal section having proximal and distal ends and further having a greater outside diameter as compared to the distal section thus forming an exterior shoulder at the junction of the distal section with the distal end of the proximal section, the needle assembly also having a handle fixedly attached onto the needle'"'"'s proximal section; and

,

an injection port assembly consisting of a main body having a bottom surface and a top surface and an outer perimeter situated at the intersection of the top and bottom surfaces and a flexible cannula that protrudes in a generally downward direction from the main body, the flexible cannula having an interior shoulder which is adapted to mate with the exterior shoulder of the needle so that the cannula resists bucking when the needle and cannula are pushed together through the patient'"'"'s skin.

2. The device of claim 1 further comprising a self-sealing septum that is mounted into the main body.

3. The device of claim 1 where the main body is molded in one piece.

4. The device of claim 1 further comprising an adhesive coating on the bottom surface of the main body.

5. The device of claim 1 further comprising a tubular needle guard which is placed over the needle and cannula, the needle guard having a closed distal end and also having a proximal end which is removably attached to the bottom surface of the main body.

6. The device of claim 1 wherein an adhesive tape is mounted on the top surface of the main body, the tape extending beyond the outer perimeter of the main body.

7. The device of claim 1 wherein the main body has a concave upper surface so as to maximize the flexibility of the main body near its outer perimeter so that the outer perimeter readily adapts its shape to the changing shape of the skin to which the main body can be adhesively attached.

8. The device of claim 1 wherein the cannula has at least one side port through which the medication can exit.

9. The device of claim 1 wherein the needle has a solid core.

10. The device of claim 1 wherein the needle has a central lumen.

11. The device of claim 1 wherein the needle has a solid distal section and a hollow proximal section.

12. The device of claim 1 wherein the length of a flexible cannula is between 0.2 and 0.8 cm.

13. The device of claim 1 wherein the length of the flexible cannula is greater than 0.8 cm.

14. The device of claim 1 wherein the flexible cannula is formed from a separate piece of flexible plastic.

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

a needle assembly consisting of a needle having proximal and distal sections and a handle fixedly attached onto the needle'"'"'s proximal section, the proximal section of the needle being a hollow tube with a side entry port and the needle having an exit port at the needle'"'"'s proximal end; and

,

an injection port assembly consisting of a main body having an entry lumen which has a distal end and an exit lumen, the side entry port of the needle being joined to and in fluid communication with the distal end of the entry lumen thus allowing medication to flow through the needle'"'"'s side entry port so that the device can be primed through the needle either prior to or after insertion of the needle through the patient'"'"'s skin.

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

a needle assembly consisting of a needle having proximal and distal sections and a handle fixedly attached onto the needle'"'"'s proximal section;

a needle guard that is placed over the distal section of the needle, the needle guard being adapted for removal prior to insertion of the needle through the patient'"'"'s skin; and

,

an injection port assembly consisting of a main body having a bottom surface and a top surface and having an entry lumen and an exit lumen which lumens are in fluid communication with each other after the needle assembly is withdrawn out of the main body, the exit lumen being formed within a flexible cannula that protrudes in a generally downward direction from the bottom surface of the main body, the bottom surface also having a groove into which the needle guard is removably inserted.

17. The device of claim 16 wherein the groove is of a generally circular shape to accept one end of a generally tubular needle guard.

18. The device of claim 16 wherein the needle guard is removably held onto a generally cylindrical structure formed as part of the main body from which cylindrical structure the cannula extends in a generally downward direction.

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

a needle assembly consisting of a needle having proximal and distal sections and a handle fixedly attached onto the needle'"'"'s proximal section;

an injection port assembly consisting of a main body having a bottom surface and a top surface and an entry lumen and an exit lumen which lumens are in fluid communication with each other after the needle assembly is withdrawn from the main body, the exit lumen being formed within a flexible cannula that protrudes in a generally downward direction from the bottom surface of the main body

a needle guard having a proximal portion and a distal portion and a proximal end that is removably attached to the main body, the needle guard being adapted to cover the needle'"'"'s distal section prior to insertion of the needle through the patient'"'"'s skin, the needle guard having a closed distal end forming an enclosed chamber within the needle guard when the needle guard is attached to the main body, the needle guard also having an antibiotic ointment placed within the enclosed chamber.

20. The device of claim 19 wherein the antibiotic substance is a broad spectrum antibiotic ointment.

21. The device of claim 19 wherein the antibiotic substance is placed within a proximal portion of the needle guard to essentially cover only the puncture wound in the skin after the cannula is subcutaneously inserted.

22. The device of claim 19 wherein the antibiotic substance is placed inside a distal portion of the needle guard so as to coat the needle and the cannula when they are subcutaneously inserted through the skin so as to provide lubrication and an antibiotic coating to both the needle and the cannula.

23. The device of claim 19 wherein the volume of the antibiotic substance and the volume of a groove formed into the bottom of the main body are adapted for each other such that most of the excess antibiotic substance enters the groove after the cannula is fully inserted and only a minimum volume of antibiotic substance becomes situated on the bottom surface of the main body.

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

a needle assembly consisting of a needle having proximal and distal sections and a handle fixedly attached onto the needle'"'"'s proximal section; and

,

an injection port assembly consisting of a main body having top and bottom surfaces and having an entry lumen which has a distal end and an exit lumen which has a proximal end, the exit lumen being formed within a flexible cannula that protrudes in a generally downward direction from the bottom surface of the main body, the injection port assembly also including a self-sealing septum through which the needle is placed, the septum having a bottom surface which is situated at the luminal intersection so that when the needle is removed from the septum, the entry and exit lumens are joined and in fluid communication with each other so as to provide a continuous flow path through the luminal intersection.

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

a needle assembly consisting of a needle having proximal and distal sections and a handle fixedly attached onto the needle'"'"'s proximal section; and

,

an injection port assembly consisting of a main body having top and bottom surfaces and having an exit lumen which has a proximal end, the exit lumen being formed within a flexible cannula that protrudes in a generally downward direction from the bottom surface of the main body, the injection port assembly also including a bacterial filter and a single septum, the septum and the main body forming an injection chamber therebetween, the injection chamber being separated from the proximal end of the exit lumen by the bacterial filter, the single septum being adapted to first allow penetration by the needle of the needle assembly and then being further adapted to allow penetration by a hypodermic syringe injection needle after the needle assembly is removed from the septum, the septum having an outer surface that has an indication means to indicate correct placement of the hypodermic syringe injection needle so that medication injected from the syringe enters the injection chamber before passing through the bacterial filter into the exit lumen.