Medicament delivery device and a method of medicament delivery

Abstract

A medicament delivery device and method of delivery 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.

1 - 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 device as claimed in  claim 25 , wherein the means to provide controlled delivery of the medicament is provided in or on the body of the implant.  
     
     
         27 . The device as claimed in  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 device as claimed in  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 device as claimed in  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 device as claimed in  claim 25 , wherein the first end of the body has a semi-sharp point.  
     
     
         31 . The device as claimed in  claim 25 , wherein the device is absorbable.  
     
     
         32 . The device as claimed in  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 device as claimed in  claim 25 , wherein the second end comprises retrieval means.  
     
     
         34 . The device as claimed in  claim 33 , wherein the retrieval means is an elongate flexible member.  
     
     
         35 . The device as claimed in  claim 25  which has an axial length from 5 mm to 45 mm.  
     
     
         36 . The device as claimed in  claim 25  which has a diameter of from 0.5 mm to 4 mm.  
     
     
         37 . The device as claimed in  claim 25  comprising at least one medicament.  
     
     
         38 . The device as claimed in  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 device as claimed in  claim 37 , wherein the device comprises a medicament for oestrogen dependent proliferative disorders of the pelvis for example endometriosis or fibroids.  
     
     
         40 . The device as claimed in  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 device as claimed in  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, 2 years, 3 years, 4 years or 5 years.  
     
     
         42 . A kit for implanting a device as claimed in  claim 25  comprising: 
 a device as claimed in  claim 25;  and    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 step of: 
 inserting an implantable medicament delivery device, said device comprising means capable of providing controlled delivery of a medicament over a period of time, into the myometrium.    
     
     
         44 . The method as claimed in  claim 43  comprising the steps of: 
 providing an implantable medicament delivery device;    introducing the medicament delivery device into a myometrium of a uterine body through serosa surrounding the myometrium during open or laproscopic surgery.    
     
     
         45 . The method as claimed in  claim 43 , wherein the myometrium is the smooth muscle myometrial tissue of the cervix.  
     
     
         46 . The method as claimed in  claim 45  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.    
     
     
         47 . The method as claimed in  claim 46 , wherein the medicament implantable device is introduced into the body using an insertion tool.  
     
     
         48 . The method as claimed in  claim 43  comprising inserting the device as claimed in claim  4  into the myometrium to provide long term local delivery of medicaments to the vaginal cavity and epithelium and thereby into the pelvic region and organs thereof including to the bladder, peritoneum, vulva, vagina, ovaries, fallopian tubes and/or the uterus and/or then into the bloodstream.  
     
     
         49 . The method as claimed in  claim 43  comprising inserting the device as claimed in claim  2  into the myometrium to provide long term local delivery of medicaments to the myometrium and thereby into the pelvic region and organs thereof including to the bladder, peritoneum, vulva, vagina, ovaries, fallopian tubes and/or the uterus and/or then into the bloodstream.