Enhanced infusion-site pain-reduction for drug-delivery devices

• US 10,071,209 B2
• Filed: 03/11/2013
• Issued: 09/11/2018
• Est. Priority Date: 03/15/2012
• Status: Active Grant

• Current Assignee: United Therapeutics Corporation
• Original Assignee: SteadyMed Ltd. (United Therapeutics Corporation)
• Inventors: Solomon, Ian, Rand, Jacob, Rigby, Jonathan
• Primary Examiner(s): Bosques, Edelmira
• Assistant Examiner(s): Legette-Thompson, Tiffany
• Application Number:
  US14/384,131
• Publication Number:
  US 20150045718A1
• Time in Patent Office: 2,010 Days
• Field of Search: 604 20, 604112, 604506
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/422 Desensitising skin
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

The present invention provides an infusion-patch comprising; a cannula; a base; at least one adhesive region in said base suitable for skin attachment; at least one skin-access area within said base; and at least one conduit in fluid connection with said at least one skin access area, wherein said at least one conduit in fluid connection with said at least one skin access area facilitates the transfer of an anesthetic substance within at least a first anesthetic-reservoir which may be removably attached and in fluid connection with said at least one contact area, promoting delivery of said anesthetic substance to said at least one skin-access areas, and wherein said anesthetic substance delivered to said skin-access areas may be at least partially replenished without removing said infusion-patch.

Claims

1. An infusion-patch comprising:

a cannula;

a base;

at least one adhesive region in said base suitable for skin attachment;

at least one skin-access area within said base; and

at least one conduit in fluid connection with said at least one skin-access area,

wherein;

said at least one conduit in fluid connection with said at least one skin-access area facilitates the transfer of an anesthetic substance within a first anesthetic-reservoir which is removably attached from the infusion-patch and in fluid connection with said at least one skin-access area,

said at least one conduit providing fluid connection that allows transfer of said anesthetic substance from said first anesthetic-reservoir to said at least one skin-access area,

said cannula is not in fluid communication with said at least one conduit, and

said anesthetic substance delivered to said at least one skin-access area is at least partially replenished without removing said infusion-patch.

2. The infusion-patch of claim 1 further comprising an actuator and a drug-reservoir containing a drug to be delivered via said cannula, thereby constituting a patch-pump.

3. The infusion-patch of claim 1 where said cannula belongs to a group including rigid cannulas and flexible cannulas.

4. The infusion-patch of claim 1 where said first anesthetic-reservoir is integral to said infusion-patch and is compressed in order to propel the anesthetic substance through said at least one conduit.

5. The infusion-patch of claim 1, further comprising transcutaneous electrical nerve stimulation (TENS) electrodes for applying transcutaneous electrical nerve stimulation.

6. The infusion-patch of claim 1 where said anesthetic substance is in a form selected from the group consisting of including creams, liquids and foams.

7. The infusion-patch of claim 6, where said anesthetic substance comprises a compound selected from the group consisting of anesthetics, analgesics and anti-inflammatory substances.

8. The infusion-patch of claim 6, where said anesthetic substance is a toxin isolated from Clostridium botulinum.

9. The infusion-patch of claim 1 where said infusion-patch further comprises a connector in fluid connection with said cannula, wherein said first anesthetic-reservoir is external to said infusion-patch;

and is attachable to said connector.

10. The infusion-patch of claim 9, further comprising:

a second anesthetic-reservoir, wherein;

said second anesthetic-reservoir is external to said infusion-patch,

said second anesthetic-reservoir is attachable to said connector when first anesthetic-reservoir is detached from said connector.

11. The infusion-patch of claim 9, wherein the first anesthetic-reservoir is a tube.

12. A method of treating pulmonary arterial hypertension in a patient using the infusion-patch of claim 1 to deliver Treprostinil into a subcutaneous fat layer of the patient via said cannula of the infusion-patch and to deliver said anesthetic substance to a skin surface of the patient via said at least one skin-access area of the infusion-patch.

13. The method of claim 12, wherein said anesthetic substance is a neurotoxin.

14. The method of claim 12, wherein said anesthetic substance is a neurotoxin isolated from Clostridium botulinum.

15. The method of claim 12, wherein using the infusion-patch of claim 1 comprises squeezing the first anesthetic-reservoir to deliver said anesthetic substance to the skin surface.

16. The infusion-patch of claim 1, wherein:

said at least one skin-access area is a channel in the base.

17. The infusion-patch of claim 16, wherein:

the channel comprises apertures located along a length of said channel,

the apertures enable release of the anesthetic substance so that the anesthetic substance delivered to said channel is released externally from the base.

18. The infusion-patch of claim 17, wherein:

the apertures comprise an exit point, and

the exit point is configured to expel excess anesthetic substance from the base.

19. The infusion-patch of claim 18, wherein:

the exit point is configured to expel excess anesthetic substance in a direction different from a direction defined by a longitudinal axis along the cannula.

20. An infusion-patch comprising:

a cannula;

a base; and

a first anesthetic-reservoir containing an anesthetic substance,

wherein;

the base comprises an adhesive region suitable for attaching the infusion-patch to skin,

the base defines a channel,

the base defines an aperture along the length of the channel,

the first anesthetic-reservoir is in fluid communication with the channel and the aperture,

the cannula is not in fluid communication with the channel,

the aperture is a skin-access area where when the infusion-patch is attached to the skin and when anesthetic substance is disposed in skin-access area, the anesthetic substance is in contact with the skin,

the first anesthetic-reservoir is detachable from the base and replaceable by a second anesthetic-reservoir, and

the infusion-patch is configured such that anesthetic substance delivered to the channel is at least partially replenished without removing the infusion-patch from the skin.