SUBCUTANEOUS AND INTRADERMAL PATCH INFUSERS

• US 20140194854A1
• Filed: 08/23/2012
• Published: 07/10/2014
• Est. Priority Date: 08/29/2011
• Status: Abandoned Application

• Current Assignee: Sid Technologies LLC
• Original Assignee: Sid Technologies LLC
• Inventors: Tsals, Izrail
• Application Number:
  US14/240,902
• Publication Number:
  US 20140194854A1
• Time in Patent Office: Days
• US Class Current: 604/513
• CPC Class Codes: A61M 2005/14256 with means for preventing access to the needle after use
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

The device infuses a compound subcutaneously or intradermally over an extended period of time. The delivery is from a conventional prefilled syringe with a staked cannula with the device adhered to the injection site and the syringe positioned substantially parallel to the injection site. The cannula is formed by a mechanism integral to the device to provide the cannula distal section substantially perpendicular to the syringe axis. The compound delivery is based on springs or other mechanisms. The approach offers a low cost mechanical system for the infusion of high volume, viscous compounds. The activation of the patch infuser required a few simple steps by the user. A single lever is used to trigger all device functions.

Claims

1. A disposable infuser device for rapid subcutaneous or intradermal delivery of a drug or other medical compositions to a living being, said infuser device comprising:

a housing comprising a prefilled syringe having a cannula coupled thereto, said prefilled syringe comprising the drug or other medical composition and including a displaceable stopper for driving the drug or other medical compositions from said syringe and through said cannula and wherein said prefilled syringe comprises a syringe axis that is parallel to the skin of the living being when said infuser device is coupled thereto;

an infuser base to which said housing is coupled, said infuser base configured to releasably secure to the skin of the living being;

a cannula bending mechanism associated with said housing that, when activated, bends said cannula to be substantially perpendicular to said syringe axis while penetrating the skin of the living being;

a cannula insertion mechanism associated with said lever, said housing and said base that when activated, inserts said cannula through the skin into the underlying tissue;

a drug delivery mechanism associated with said housing and said lever that drives said displaceable stopper to deliver the drug or other medical compositions through said cannula once said cannula has penetrated the skin of the living being; and

a lever that is manually displaceable by a user of said disposable infuser device, said lever activating said cannula bending mechanism, said cannula insertion mechanism, and said stopper driving mechanism via a single activation of said lever.

2. The disposable infuser device of claim 1 wherein said cannula bending mechanism comprises first and second mandrels that are operatively connected for bending said cannula substantially perpendicular to said syringe axis.

3. The disposable infuser device of claim 2 wherein said cannula bending mechanism comprises first and second mandrels that are operatively rotatatable for bending said cannula substantially perpendicular to said syringe axis.

4. The disposable infuser device of claim 2 wherein said cannula bending mechanism comprises first and second mandrels and wherein said mandrels displace linearly for bending said cannula substantially perpendicular to said syringe axis.

5. The disposable infuser device of claim 1 wherein said drug delivery mechanism comprises constant force springs that are operatively connected to a displaceable rod that is coupled to said displaceable stopper.

6. The disposable infuser device of claim 1 wherein said drug delivery mechanism comprises compression springs that are operatively connected to a displaceable rod that is coupled to said displaceable stopper.

7. The disposable infuser device of claim 3 wherein said first mandrel comprises said lever.

8. The disposable infuser device of claim 1 further comprising an observation window that permits a user to view contents of said syringe.

9. The disposable infuser device of claim 1 further comprising an adhesive on said infuser base that releasably secures said device to the skin of the living being.

10. The disposable infuser device of claim 1 wherein said housing and said infuser base are pivotally connected.

11. The disposable infuser device of claim 10 wherein said cannula is confined between said housing and said infuser base when said drug delivery is completed and said device is removed from the skin of the living being.

12. The disposable infuser device of claim 1 wherein said housing comprises adjustable retainers to accommodate glass syringes having different length tolerances while minimizing any change in a length of said cannula that penetrates the skin.

13. The disposable infuser device of claim 1 wherein said syringe is a molded polymer syringe which minimizes any variation in a length of cannula after bending.

14. The disposable infuser device of claim 1 wherein the cannula projects past the base 0.5 to 3.5 mm to infuse the compound primarily intradermally.

15. The disposable infuser device of claim 1 wherein the cannula projects past the base over 3.5 mm to infuse the compound primarily subcutaneously.

16. A method of subcutaneously or intradermally infusing a drug or other medical compounds into the skin of a living being, said method comprising:

securing a syringe, prefilled with the drug or other medical compounds, within a housing of a device that includes a base which can be releasably secured to the skin of the living being and wherein the syringe comprises a cannula and wherein the syringe and cannula are oriented parallel to the skin;

manipulating a lever associated with said housing that bends the cannula perpendicular to the skin, causes the cannula to penetrate the skin therethrough and triggers the infusion of the drug or other medical compounds from the prefilled syringe, through the cannula and the skin of the living being by continued motion of said lever.

17. The method of claim 16 wherein said step of manipulating a lever comprises a pair of counter-rotating mandrels that bend said cannula perpendicularly for insertion into the skin.

18. The method of claim 16 wherein said step of manipulating a lever comprises a pair of mandrels which displace linearly towards the cannula and bend said cannula perpendicularly for insertion into the skin.

19. The method of claim 16 wherein said step of manipulating a lever comprises deactivation of housing to base interlock and insertion of the cannula through the skin.

20. The method of claim 16 wherein said step of manipulating a lever releases a spring drive retainer that permits constant force springs within said housing to drive a displaceable stopper within said prefilled syringe for delivering the drug or other medical compounds through said bent cannula.

21. The method of claim 16 wherein said step of manipulating a lever releases a compression spring that drives a displaceable stopper within said prefilled syringe for delivering the drug or other medical compounds through said bent cannula.

22. The method of claim 16 wherein said step of securing a syringe comprises pivotally coupling said housing and said base and wherein said method further comprises confining said bent cannula between said housing and said base when said drug delivery is completed and said device is removed from the skin of the living being.

23. The method of claim 16 wherein said step of securing a syringe comprises removing a cannula cover before manipulating said lever.

24. The method of claim 16 further comprising the step of visually confirming the contents of said syringe, before drug delivery, and prior to removing said device from the skin.

25. The method of claim 16 wherein said base comprises an adhesive covered by a liner sheet and wherein said step of securing a syringe comprises removing said liner and applying said adhesive against the skin of the living being.

26. The method of claim 16 wherein said housing comprises syringe retainers that are adjustable and wherein said step of securing a syringe comprises adjusting said retainers to accommodate glass syringes of different length tolerances while minimizing any change in a length of said cannula that penetrates the skin.

27. The method of claim 16 wherein said step of securing a syringe comprises securing a molded polymer syringe within said housing for minimizing any variation in a length of said cannula after bending.

28. The method of claim 16 wherein said step of causing said cannula to penetrate the skin infuses the drug or other medical compound primarily intradermally when said cannula penetrates the skin between 1 to 3.5 mm from a base portion of said housing.

29. The method of claim 16 wherein said step of causing said cannula to penetrate the skin infuses the drug or other medical compound primarily subcutaneously when said cannula penetrates the skin over 3.5 mm from a base portion of said housing.