Medicament Delivery Device and a Method of Medicament Delivery

• US 20090123522A1
• Filed: 10/06/2008
• Published: 05/14/2009
• Est. Priority Date: 03/27/2003
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Granted Patent: US 8,709,471 B2
• Time in Patent Office: Days
• US Class Current: 424/432
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 6/02 for use by males A61F6/20 takes precedence
• CPC Class Codes: A61F 6/06 for use by females A61F6/20 takes precedence
• CPC Class Codes: A61F 6/142 Wirelike structures, e.g. loops, rings, spirals
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61K 9/0039 Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/028 Other inorganic materials not covered by A61L31/022 - A61L31/026
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/043 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 31/007 Injectors for solid bodies, e.g. suppositories
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics

Abstract

A medicament delivery device and method of delivering a medicament is provided wherein the device is insertable into the uterine myometrium for the delivery of medicaments to the pelvic area and organs thereof, for example, the bladder, peritoneum, the vulva, vagina, fallopian tubes, ovaries, and uterus, and then to the bloodstream.

Claims

1-24. -24. (canceled)

25. An implantable medicament delivery device insertable into the female uterine myometrium to provide controlled delivery of a medicament over a period of time said device comprising means for providing controlled delivery of a medicament, an elongate body having an outer surface, a first end, and a second end wherein the second end includes a head portion wherein the head portion is a lateral extension from the longitudinal axis of the elongate body and the head portion allows manipulation and surveillance of the implant.

26. The implantable device of claim 25, wherein the means to provide controlled delivery of the medicament is provided in or on the body of the implant.

27. The implantable device of claim 26, wherein, in use, when inserted in the myometrium, the body of the medicament delivery device is surrounded by smooth muscle and soft tissue of the myometrium and the medicament passes through the smooth muscle and soft tissue and targets the pelvic region and organs thereof.

28. The implantable device of claim 25, wherein the means to provide controlled delivery of a medicament is provided in or on the head portion of the implant.

29. The implantable device of claim 28, wherein, in use, when the device is inserted into myometrial tissue, the head portion protrudes from the myometrial tissue into the vagina and targets the medicament to the tissues of the vagina.

30. The implantable device of claim 25, wherein the first end of the body has a semi-sharp point.

31. The implantable device of claim 25, wherein the device is absorbable.

32. The implantable device of claim 25, wherein the head portion is a substantially flat plate which extends in all radial directions from the second end of the body of the device.

33. The implantable device of claim 25, wherein the second end comprises retrieval means.

34. The implantable device of claim 33, wherein the retrieval means is an elongate flexible member.

35. The implantable device of claim 25, which has an axial length from 5 mm to 45 mm.

36. The implantable device of claim 25 which has a diameter of from 0.5 mm to 4 mm.

37. The implantable device of claim 25, comprising at least one medicament.

38. The implantable device of claim 37, wherein the least one medicament is selected from anti-infectives, antimicrobials, prebiotics, probiotics, acidifiers, antivirals, antibiotics, anti-allergenics, anti-inflammatories, anti-fungals, anti-cholinesterases, nutritional agents, cardiovascular agents, anti-hypertensive agents, and chemotherapeutic agents.

39. The implantable device of claim 37, wherein the device comprises a medicament for oestrogen dependent proliferative disorders of the pelvis for example endometriosis or fibroids.

40. The implantable device of claim 37, wherein said the medicament is at least one member chosen from the group including progestins, GnRH agonists/antagonists, NSAIDs, COX-II inhibitors, combined oral contraceptives, Danazol, smooth muscle relaxants or aromatase inhibitors.

41. The implantable device of claim 25, wherein, in use, the cumulative release of medicament is in an amount selected from 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or 99% relative to the total amount of medicament in the device after implantation for a period of 1 day, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 6 months, 1 year, years, 3 years, 4 years or 5 years.

42. The implantable medicament delivery device of claim 25, wherein said device is provided in a kit for introducing said medicament delivery device into a mammal, the kit also comprising an insertion tool comprising an elongate shaft, said shaft having a handle means at a first end thereof and device mounting means at a second opposite end wherein the medicament delivery device is mountable on the device mounting means of the insertion tool.

43. A method for introducing a medicament into the body of a female mammal, comprising the steps of:

providing an implantable medicament delivery device, said device capable of providing controlled delivery of a medicament over a period of time into a myometrium; and

introducing the medicament delivery device into the myometrium of a uterine body through serosa surrounding the myometrium during open or laparoscopic surgery.

44. A method for introducing a medicament into the body of a female mammal, comprising the steps of:

providing an implantable medicament delivery device;

introducing the medicament delivery device into the body via the vagina;

penetrating the myometrium via the uterine cervix; and

inserting the medicament delivery device into the myometrium.