Medicament delivery device and a method of medicament delivery

• US 8,709,471 B2
• Filed: 10/06/2008
• Issued: 04/29/2014
• Est. Priority Date: 03/27/2003
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): BARHAM, BETHANY P
• Application Number:
  US12/246,263
• Publication Number:
  US 20090123522A1
• Time in Patent Office: 2,031 Days
• Field of Search: None
• US Class Current: 424/430
• 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. An implantable medicament delivery device insertable into a female to provide controlled delivery of a medicament over a period of time, said device comprising:

a pharmaceutical carrier including a medicament for controlled delivery of the medicament, and

an elongate body having an outer surface, a first insertion end including a tissue penetrating tip for penetration of myometrium of the cervix, 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 is configured for manipulation and surveillance of the implant.

2. The implantable device of claim 1, wherein the pharmaceutical carrier is provided in or on the elongate body of the implant.

3. The implantable device of claim 1, wherein the pharmaceutical carrier is provided in or on the head portion of the implant.

4. The implantable device of claim 1, wherein the first insertion end of the body comprises a semi-sharp point.

5. The implantable device of claim 1, wherein the device is absorbable.

6. The implantable device of claim 1, 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.

7. The implantable device of claim 1, wherein a second end of the implantable medicament delivery device is an elongate flexible member.

8. The implantable device of claim 1, having an axial length from 5 mm to 45 mm.

9. The implantable device of claim 1, having a diameter of from 0.5 mm to 4 mm.

10. The implantable device of claim 1, wherein the at least one medicament is selected from the group consisting of anti-infectives, antimicrobials, prebiotics, probiotics, acidifiers, antivirals, antibiotics, anti-allergenics, anti-inflammatories, anti-fungals, anticholinesterases, nutritional agents, cardiovascular agents, anti-hypertensive agents, and chemotherapeutic agents.

11. The implantable device of claim 1, wherein the at least one medicament is for treating oestrogen dependent proliferative disorders of the pelvis.

12. The implantable device of claim 1, wherein the medicament is at least one member selected from the group consisting of progestins, GnRH agonists/antagonists, NSAIDs, COX-II inhibitors, combined oral contraceptives, Danazol, smooth muscle relaxants and aromatase inhibitors.

13. The implantable device of claim 1, wherein the elongate body includes structures adapted for retention of the implantable device in the myometrium.

14. The implantable medicament delivery device of claim 1, 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.

15. A method for introducing an implantable medicament delivery device into a 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 of the cervix; and

implanting at least a portion of the medicament delivery device into the myometrium.

16. The method of claim 15, wherein a body of the medicament delivery device is implanted into the myometrium such that 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.

17. The method of claim 15, wherein when the device is implanted into myometrial tissue a head portion of the medicament delivery device protrudes from the myometrial tissue into the vagina and targets the medicament to the tissues of the vagina.

18. The method of claim 15, further comprising retrieving the implantable medicament delivery device from the body of the female mammal.

19. An implantable delivery device system for providing controlled delivery of a medicament to the uterine wall, said device comprising:

a device body including a first end and a second, opposite end, the first end having a first diameter and including a sharp tip for penetrating tissue, the second end having a second diameter and including a head portion, the second diameter being larger than the first diameter;

a drug coating disposed over at least a portion of the device body, wherein the drug coating provides controlled delivery of the drug over a duration of time;

an insertion tool comprising an elongate shaft between a proximal end and a distal end, the proximal end including a handle, the distal end being couplable to the head of the device body during an implantation procedure.