Patch, with system and apparatus for manufacture

• US 5,851,549 A
• Filed: 03/04/1996
• Issued: 12/22/1998
• Est. Priority Date: 05/25/1994
• Status: Expired due to Fees

• Current Assignee: Vyteris, Inc.
• Original Assignee: Becton, Dickinson & Co
• Inventors: Svec, James A.
• Primary Examiner(s): Schofer, Joseph L.
• Assistant Examiner(s): Shelborne, Kathryne E.
• Application Number:
  US08/549,747
• Time in Patent Office: 1,023 Days
• Field of Search: 424/448, 424/449, 156/252
• US Class Current: 424/448
• CPC Class Codes: A61F 2013/00906 for transcutaneous or transdermal drugs application
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: Y10T 156/1056 Perforating lamina

Abstract

A system of the present invention for applying a substance to an applied area includes a patch (11), as well as apparatus (12, 14, 16, 18 and 21) and methods for making the same. The patch includes backing material (52) and a tri-laminate (54), with a dose of medication sealed therebetween in reservoir (62). To facilitate and increase transdermal and/or topical application of the medication to the applied area, such as the skin of a user, the tri-laminate includes a layer material (68) having at least one opening therein (64), which permits the medication to flow through each opening without tearing or ripping the layer of material covering the reservoir.

Claims

1. A patch for applying a substance topically to an applied area, comprising:

a trilaminate material including;

a first material having a reservoir formed therein;

wherein said reservoir is defined by dimple formed in said first material with a cavity therein;

a dosage of medication contained in said reservoir; and

a second material including a diaphragm covering said reservoir with a plurality of slits in said diaphragm through which the medication may pass for application to the applied area.

2. The patch defined in claim 1, further comprising a porous material situated between the second material and said dose of medication.

3. The patch defined in claim 2, wherein said porous material includes a layer of non-woven material.

4. The patch defined in claim 3, wherein said second material further includes a layer of an adhesive material and a release liner covering said layer of adhesive material with said adhesive material sandwiched between said release liner and said diaphragm.

5. The patch defined in claim 1, wherein at least either said first material or said second material includes a heat seal coating.

6. The patch defined in claim 1, wherein said reservoir is defined by a dimple formed in said first material with a cavity therein.

18. The patch as recited in claim 1, wherein said medication in said reservoir is a transdermal medication.

7. A method of making a patch for topically applying a substance to an applied area of a patient comprising the steps of:

forming a reservoir in a backing material;

cutting a plurality of slits in a diaphragm portion of a tri-laminate material said diaphragm layer covering said reservoir;

placing a dose of medication on said tri-laminate material proximate said slits in said diaphragm;

sealing said backing material and said tri-laminate material together to form a continuous web; and

cutting a patch from said web.

8. The method of forming a patch defined in claim 7, further comprising the step of placing a porous material between said tri-laminate material and said backing material prior to placing said dose of medication on said tri-laminate material so that said porous material is situated between said dose of medication and said tri-laminate material.

9. The method of forming a patch defined in claim 8, wherein said step of placing said porous material includes feeding a layer of non-woven material.

10. The method of forming a patch defined in claim 7, wherein said step of sealing said backing material to said tri-laminate material incudes the step of forming a heat seal around a periphery of said reservoir.

11. The method of forming a patch defined in claim 7, wherein said step of cutting said patches from said continuous web includes die cutting.

12. The method of forming a patch defined in claim 7, further comprising the step of forming said reservoir in said backing material by applying a positive pressure to one side of said backing material.

19. A method in accordance with claim 7, wherein said medication is a transdermal medication.

13. A patch for applying a substance topically to an applied area, comprising:

a trilaminate material including a first material having a reservoir formed therein,

wherein said reservoir is defined by dimple formed in said first material with a cavity therein;

a dosage of medication contained in said reservoir; and

a second material including a diaphragm covering said reservoir with at least one slit formed in said diaphragm through which the medication may pass for application to the applied area,

wherein said second material further includes a layer of adhesive material and a release liner covering said layer of adhesive material, with said adhesive material sandwiched between said release liner and said diaphragm.

14. The patch defined in claim 13, further comprising a porous material situated between the second material and said dose of medication.

15. The patch defined in claim 14, wherein said porous material includes a layer of non-woven material.

16. The patch defined in claim 13, wherein said at least one opening includes a plurality of slits formed in the diaphragm.

17. The patch defined in claim 13, wherein at least either said first material or said second material includes a heat seal coating.

20. A patch as recited in claim 13, wherein said medication in said reservoir is a transdermal medication.