Membrane shell of an implantable dosage system

• US 8,152,793 B2
• Filed: 04/23/2008
• Issued: 04/10/2012
• Est. Priority Date: 04/27/2007
• Status: Expired due to Fees

• Current Assignee: Bayer OY (Bayer Nordic SE)
• Original Assignee: Bayer OY (Bayer Nordic SE)
• Inventors: Keinänen, Antti, Koskinen, Jukka, Järvelä, Pentti
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Thomas, Jr., Bradley
• Application Number:
  US12/597,679
• Publication Number:
  US 20100062034A1
• Time in Patent Office: 1,448 Days
• Field of Search: 424/422, 424424-426, 604/131, 604/890.1, 604/891.1, 604/892.1, 604/93.01
• US Class Current: 604/891.1
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The membrane shell of an implantable dosage system according to the invention is particularly suitable for subcutaneous applications to release an active agent with steady amounts during a longer period of time. The membrane shell (3) according to the invention comprises a first half (1) and a second half (2), which both halves comprise a continuous closure edge (8, 9), and are adapted to be connected to each other through a closable joint. The closure edges (8, 9) of the halves comprise at least one groove (10) and/or at least one protrusion (11) as continuous or discontinuous, and the membrane shell (3) is adapted to be closed so that at least one protrusion (11) and/or at least one groove (10) of the second half becomes opposed to at least one groove (10) and/or at least one protrusion (11) of the first half through a snap-fit joint.

Claims

1. A membrane shell of an implantable dosage system incorporating an active agent, comprising:

a first half and

a second half, wherein both the first and second halves comprise an inner surface and an outer surface,

wherein the first and second halves are adapted to be connected to each other through a closable joint comprising a closure edge of the first half as continuous on the inner surface of the first half essentially at a perimeter of the first half and a closure edge of the second half as continuous on the inner surface of the second half essentially at a perimeter of the second half, and the closure edges of the first and second halves comprise at least one groove and/or at least one protrusion as continuous or discontinuous,

wherein the membrane shell is adapted to be closed so that at least one protrusion and/or at least one groove of the second half becomes opposed to at least one groove and/or at least one protrusion of the first half through a snap-fit joint,

wherein the active agent is released through the membrane shell when implanted in a patient, and

wherein the membrane shell is fabricated solely from a molded composition comprising modified PDMS (polydimethyl siloxane) either alone or in combination with PDMS so as to influence the release of the active agent.

2. The membrane shell according to claim 1, wherein the modified PDMS is trifluoropropyl-substituted siloxane or a siloxane carrying poly(alkyleneoxide) groups.

3. The membrane shell according to claim 1 or 2, wherein the closure edge of the first half comprises at least one continuous groove, and the closure edge of the second half comprises at least one continuous protrusion.

4. The membrane shell according to claim 1 or 2, wherein the first half and the second half are connected to each other through a membrane hinge.

8. An implant, comprising:

a membrane shell according to claim 1 or 2, and

at least one core containing an active agent, which core is adapted to be incorporated into at least one cavity inside the membrane shell.

9. The implant according to claim 8, wherein at least one ready shaped core is adapted to be placed in at least one cavity pit before closing the shell through a snap-fit joint.

10. The implant according to claim 8, wherein the implant comprises at least one injected core in at least one cavity inside the closed membrane shell.

5. The membrane shell according to 1 or 2, wherein the membrane shell comprises a cavity pit on the inner surface of the first half and/or of the second half, essentially in the middle of the membrane shell so that the cavity pits of the first half and of the second half are adapted to become opposed upon closing the membrane shell.

6. The membrane shell according to 1 or 2, wherein the membrane shell comprises two or more cavity pits on the inner surfaces of the first half and/or the second half.

7. The membrane shell according to claim 6, wherein the cavity pits of the first half and the second half are adapted to become opposed upon closing the membrane shell.

11. A membrane shell of an implantable dosage system incorporating an active agent, comprising:

a first half and

a second half, wherein both the first and second halves comprise an inner surface and an outer surface,

wherein the first and second halves are adapted to be connected to each other through a closable joint comprising a closure edge of the first half as continuous on the inner surface of the first half essentially at a perimeter of the first half and a closure edge of the second half as continuous on the inner surface of the second half essentially at a perimeter of the second half, and the closure edges of the first and second halves comprise at least one groove and/or at least one protrusion as continuous or discontinuous,

wherein the membrane shell is adapted to be closed so that at least one protrusion and/or at least one groove of the second half becomes opposed to at least one groove and/or at least one protrusion of the first half through a snap-fit joint,

wherein the active agent is released through the membrane shell when implanted in a patient, and

wherein the membrane shell is fabricated from modified PDMS (polydimethyl siloxane) either alone or in combination with PDMS so as to influence the release of the active agent.

12. The membrane shell according to claim 11, wherein the modified PDMS is trifluoropropyl-substituted siloxane or a siloxane carrying poly(alkyleneoxide) groups.

13. The membrane shell according to claim 11, wherein the closure edge of the first half comprises at least one continuous groove, and the closure edge of the second half comprises at least one continuous protrusion.

14. The membrane shell according to claim 11, wherein the first half and the second half are connected to each other through a membrane hinge.

15. An implant comprising:

a membrane shell, comprising

a first half and a second half, wherein both the first and second halves comprise an inner surface and an outer surface,

wherein the first and second halves are adapted to be connected to each other through a closable joint comprising a closure edge of the first half as continuous on the inner surface of the first half essentially at a perimeter of the first half and a closure edge of the second half as continuous on the inner surface of the second half essentially at a perimeter of the second half, and the closure edges of the first and second halves comprise at least one groove and/or at least one protrusion as continuous or discontinuous,

wherein the membrane shell is adapted to be closed so that at least one protrusion and/or at least one groove of the second half becomes opposed to at least one groove and/or at least one protrusion of the first half through a snap-fit joint,

wherein the membrane shell is fabricated solely from a molded composition comprising modified PDMS (polydimethyl siloxane) either alone or in combination with PDMS so as to influence the release of the active agent; and

at least one core containing an active ingredient, which core is incorporated into at least one cavity inside the membrane shell, wherein the active ingredient is released through the membrane shell when the implant is implanted in a patient.

16. The implant of claim 15, wherein the modified PDMS is trifluoropropyl-substituted siloxane or a siloxane carrying poly(alkyleneoxide) groups.