Fluid-connection mechanism and methods for patch-pumps

• US 10,335,542 B2
• Filed: 05/25/2017
• Issued: 07/02/2019
• Est. Priority Date: 03/19/2012
• Status: Active Grant

• Current Assignee: United Therapeutics Corporation
• Original Assignee: SteadyMed Ltd. (United Therapeutics Corporation)
• Inventors: Rotem, Nir
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Legette-Thompson, Tiffany
• Application Number:
  US15/605,420
• Publication Number:
  US 20170304532A1
• Time in Patent Office: 768 Days
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• 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 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

Embodiments may include a method of delivering a drug. The method may include removing or releasing a structure from a patch-pump assembly. The patch-pump assembly may include a sealed prefilled drug-reservoir, a fluid passageway, a cannula-containing assembly, and a penetrator. The method may also include penetrating the sealed prefilled drug-reservoir containing the drug to establish fluid communication between the sealed prefilled drug-reservoir and a fluid passageway by removing or releasing the structure. The method may further include flowing the drug from the prefilled drug-reservoir to the fluid passageway. In addition, the method may include flowing the drug from the fluid passageway to a cannula-containing assembly. Furthermore, the method may include delivering the drug subcutaneously to a subject using the cannula-containing assembly.

Claims

1. A method of delivering a drug, the method comprising:

removing a pin from a patch-pump assembly to automatically cause a penetrator to penetrate a seal of a prefilled drug-reservoir, the patch-pump assembly comprising the penetrator, the prefilled drug-reservoir, a fluid-passageway, a cannula-containing assembly, and a spring-based mechanism;

flowing the drug from the prefilled drug-reservoir to the fluid-passageway;

establishing fluid communication between the fluid-passageway and the cannula-containing assembly using the spring-based mechanism;

flowing the drug from the fluid-passageway to the cannula-containing assembly; and

delivering the drug subcutaneously to a subject using the cannula-containing assembly.

2. The method of claim 1, wherein establishing fluid communication between the fluid-passageway and the cannula-containing assembly comprises the spring-based mechanism propelling the cannula-containing assembly.

3. The method of claim 1, further comprising:

propelling the cannula-containing assembly toward proximally located skin of the subject.

4. The method of claim 1, wherein removing the pin from the patch-pump assembly initiates the spring-based mechanism to propel the penetrator to establish fluid communication between the prefilled drug-reservoir and the fluid-passageway.

5. The method of claim 1, wherein establishing fluid communication between the fluid-passageway and the cannula-containing assembly comprises aligning an access port of the cannula-containing assembly to the fluid-passageway.

6. The method of claim 1, further comprising:

compressing the prefilled drug-reservoir after penetration of the prefilled drug-reservoir.

7. The method of claim 1, wherein the spring-based mechanism is in a compressed state before removing the pin.

8. A method of delivering a drug to a subject, the method comprising using a selectively activatable patch-pump assembly to deliver the drug to the subject, the selectively activatable patch-pump assembly comprising:

a sealed prefilled drug-reservoir containing the drug;

a fluid-passageway in connection therewith, wherein the fluid-passageway is free of the drug;

a selectively activatable penetrator which penetrates said sealed prefilled drug-reservoir and facilitates drug access to said fluid-passageway; and

a selectively activatable, associated, cannula-containing assembly for delivering a drug subcutaneously to a subject, in fluid connection with said fluid-passageway;

a first spring-based mechanism,

wherein a selective activation-step initiates penetration of said sealed prefilled drug-reservoir;

a structure preventing the inadvertent activation of said selectively activatable patch-pump assembly, the structure configured such that;

removing or releasing the structure from said selectively activatable patch-pump assembly is the selective activation-step, and

removing or releasing the structure from said selectively activatable patch-pump assembly automatically causes the first spring-based mechanism to propel said selectively activatable penetrator through said fluid-passageway to penetrate said sealed prefilled drug-reservoir, establishing fluid communication between said sealed prefilled drug-reservoir and said fluid-passageway;

wherein said sealed prefilled drug-reservoir is stationary relative to a central longitudinal axis defined by the cannula-containing assembly during initiation of penetration and during penetration of the sealed prefilled drug-reservoir by the selectively activatable penetrator.