CA2189870A1 - Device for the release of an active agent - Google Patents

Device for the release of an active agent

Info

Publication number
CA2189870A1
CA2189870A1 CA002189870A CA2189870A CA2189870A1 CA 2189870 A1 CA2189870 A1 CA 2189870A1 CA 002189870 A CA002189870 A CA 002189870A CA 2189870 A CA2189870 A CA 2189870A CA 2189870 A1 CA2189870 A1 CA 2189870A1
Authority
CA
Canada
Prior art keywords
stem
active agent
fastening means
transverse part
polymer matrix
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA002189870A
Other languages
French (fr)
Inventor
Matti Lehtinen
Olli Puhakka
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Oy
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2189870A1 publication Critical patent/CA2189870A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • A61K9/0039Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/142Wirelike structures, e.g. loops, rings, spirals
    • A61F6/144Wirelike structures, e.g. loops, rings, spirals with T-configuration

Landscapes

  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Gynecology & Obstetrics (AREA)
  • Urology & Nephrology (AREA)
  • Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicinal Preparation (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

The invention relates to an intrauterine body (10) essentially in the shape of a T for releasing an active agent comprising an elongated stem (20). To one end (21) of the stem an elongated transverse part (40) is joined so that this and the stem (20) together form the body (10) essentially in the shape of a T. Accordingto the invention, the transverse part (40) comprises a polymer matrix reservoir (41) containing an active agent The stem (20) may be a polymer matrix reservoir containing an active agent or a part which contains no active agent.

Description

~ 21 89870 W096/0l092 r~llr- 5 DEVICE FOR TEIE RELEASE O~ AN ACTIVE AGENT
.
The invention relates to an intrauterine device substantially in the shape of a T for r~ ARin~ an active agent like a hormone.
A widely used intrauterine contraceptive is a T-shaped body 5 made of plastic r ~ in~ an elongated stem part one end of which i6 connected with a transverse part so that the stem and the transverse part together form a body substantially in the shape of a T. The stem is partly twisted by a copper wire which ig capable of rell~A1lin~
10 copper ions. The device is inserted into the uterus by a separate insertion device. Attached to the device is a thread which is so long that it extends outside the uterine cervix when the device is in inserted position.
T-shaped intrauterine devices releasing h~ -~ and other 15 active agents for contraception and treatment of hl ~ A 1 disorders are also known in literature. US patent 3,935,860 de6cribes a T-shaped body comprising a reservoir surrounded by a wall wherein the hormone is in~onm; 1r~ with the carrier. The wall is made of a substance which releases the 20 active agent at a controlled rate. The carrier which is solid or liquid contains the active agent which is progestational or estrogenic hormone.
US patent 4,014,988 describes also a T-shaped body which comprises a reservoir ~uLl~,ullded by a wall containing 25 progestational hormone int~ d with a carrier. The wall is made of a material which releases the hormone at a controlled rate.
US patents 4,264,575 - 4,264,578 describe intr~luterine devices in which the active agent is dispersed into a 30 silicon polymer which releases the agent at a controlled rate. The patent publications do not separately describe 21 8987~` ~
W0 96/01092 ~ r- S

any particular device conf igurations but it i8 mentioned that the device may have e.g. a shape of a T.
US patent 4 ,180, 064 di6closes various intrauterine devices, a T-shaped device among others, wherein the progestational 5 or estrogenic hormone is in~-~rmi Y~r~ with a hiori~r~ Ah polymer .
Common to the above T-shaped devices releasing hormone or other active agents is that both the stem and its transverse part together form one single piece. For this 10 reason the device is complicated to manufacture and it i8 expensive and insertion of the device into the uterus is problematic .
A commercially available levonorgestrel releasing contraceptive comprises a T-shaped device with a sheath-15 like polymer reservoir containing the hormonelevonoly~a Llcl, the reservoir being f itted around its vertical polyethylene stem. One way of fabric~ting it has been p--hl i ~h~ in the international patent application PCT/FI93/00296. One aspect associated with this solution is 20 that while the device is in inserted position in the uterus, release of the active agent takes place only in the lower part of the uterus. From the point of view of the results of treatment with active agents used for contraception as well as for other purposes, it is 25 advantageous that their release takes place as high in the uterus as possible. This result can be achieved if the reservoir containing the active agent is placed higher in the T-piece than in the known levonorgegtrel r~ i n~
contraceptive .
The purpose of this invention is to eliminate the above rlra~hal~k~ and to obtain a novel, essentially T-shaped intrauterine device containing an active agent which is the most effective po~ihle from the point of view of the 35 treatment and which is simple to manufacture and easy to _ _ _ _ _
2 1 89870 WO 96/01092 1 ~/r~

insert Lnto the uterus.
A so-c~lled bundle tie a fastening means widely used, for instance, in the f ield of packaging . It compri6es a strip of flexible material, e.g. plastic, with a ring formed at 5 its one end having grooves on its inner side. The other end of the strip is passed through the ring thus forming a loop. The strip is provided with ridges essentially over the entire length of the strip which fit into the grooves formed in the ring. The ridges and the grooves are so lO shaped that pulling of the strip to tighten up the loop is possible whereas pulling of the strip in opposite direction to loosen the loop is impossible.
Some of the solutions according to this invention are based on the utilization of the bundle tie technique.
lS The ob~ect of the invention is therefore an intrauterine device essentially in the shape of a T for releasing an active agent comprising an elongated stem, to one end of which an elongated transverse part is ~oined so that this and the stem together form the body essentially in the 20 shape of a T. The invention is characterized in that the transverse part comprises a polymer matrix reservoir containing the active agent and that the stem either comprises a polymer matrix reservoir containing the active agent or that it is a part which contains no active agent.
25 According to one: 'i t the stem is secured to the transverse part by tightening a fastening means at the end of the stem partly or wholly around the transverse part.
.

The reservoir containing the active agent may be surrounded by such a ~ e which is capable of releasing the active 30 agent at a predet~rm; nPd rate .
The active agent may be e . g . a hormone suitable f or the treatment of menopausal symptoms or contraception, WO96~01092 ~ /rl .

particularly estrogenic or progestational hormone.
The matrix reservoir containing the active agent and the surrounding ' n~ CAn be made of the same or different polymer or polymer mixture. It i9 essential that both the material of the matrix and the possible surrounding ',rAnP is made of a flexible polymer. Silicon polymers are particularly suitable for this purpose.
The invention is described in the following referring to the enclosed drawings in which lO Fig. l shows a plan view of the T-shaped body according to the invention in which the stem is secured to the transverse part by tightening the fastening means formed at the end of the stem around the transverse part 15 Fig. 2 shows a side view of the T-shaped body of Fig. l Fig . 3 shows the T-shaped body f itted into an insertion tube Fig. 4 shows a cross-sectional view of the stem which together with the fastening means together with the stem form a uniform piece Fig. 5 shows the stem of Fig. 4 according to a second embodiment ig. 6 shows the stem of Fig. 4 accor~lin~ to a third - i t 5 Fig. 7 shows the stem of Fig. 4 according to a fourth t Fig. 8 shows the stem of Fig. 4 according to a fifth ~mho~l i t ~ 2 ~ 8q87~
Wo 96101092 . ~I~rL _ v Fig. 9 shows the stem of Fig. 4 according to a sixth Fig. 10 shows the stem which is to be ~oined to the transverse part and in which the fastening means is a separate piece which can be secured to the stem Fig. 11 shows a T-shaped body where also the stem is a polymer matrix reservoir containing the active agent Fig. 12 shows a fastening means suitable for joining the stem of Fig. 11 and the transverse part together Fig. 13 shows the fastening means of Fig. 12 according to a second F.mhn~l i L
5 Fig. 14 shows a T-shaped body with two transverse parts ~oined to the stem Fig. 15 shows a stem suitable for ~oining two transverse parts .
Fig. 1 shows a T-shaped body 10 according to the invention 20 wherein the stem 20 is secured to a transverse psrt 40 by tightening the fastening means 22 formed at the end 21 of the stem around the transverse part 4 0 according to the so-called bundle tie technique. Securing to a ring 25 located at the end of the fastening means takes place in the way 25 which is illustrated more clearly e . g . in Figs . 4 and 5 . A
pull-out thread 50 is attached to the opposite end 23 of the stem 20. Fig. 2 shows the T-shaped body of Fig. 1 seen from the side. In this solution the transverse part 40 comprises both a polymer matrix reservoir 41, which 30 contains the active agent, and a covering membrane 42 2189a7 Wo 96/01092 r~

6urrounding the reservoir 41 which is capable of controlling the release rate of the active agent. The ends 43a, 43b (Fig. 1) of the transverse part 40 are preferably uncovered. IIence the release rate of the active agent nt 5 the ends is higher than from the area covered by the -- ^ 42 and this is an advantage from the point of view of the result of treatment.
Fig. 3 shows the T-shaped body seen from the front fitted into a cross-sectioned insertion tube 51. The size of the 10 ring 25 of the fastening means 22 most preferably matches with the outer diameter of the insertion tube 51. Figure shows that the diameter of the fastening means tapers upwards. This shape is particularly suitable from the point of view of the insertion. The transverse part 40 is made of 15 a very f lexible polymer material and as the insertion device is introduced through the uterine cervix, the wings 44a, 44b of the body 40 on both sides of the fastening means 22 readily bend downwards so that they follow the insertion tube as indicated by the dashed lines upon 20 penetrating the uterine cervix. The polymer material must be flexible enough so that the part 40 straightens again inside the uterus.
Fig. 4 shows as a cross-section the stem 20 of the T-shaped body of Figs. 1-3 and one ~mhofli- t of the fastening 25 element bent into a loop. The fastening means 22, which is of the same piece as the stem itself, comprises also the loop 25 iormed at its end. The fastening means 22 is provided, at least within the part to be secured, with ridges 27 which lock with the grooves 26 formed on the 30 inside of the ring 25. The ridges 27 and the grooves 26 are so shaped that tightening in the direction of the arrow is allowed but loosening in the opposite direction of the arrow is prevented. If desired, the stem 20 can be provided with ridges over the entire length in which case ad~ustment 35 pQ88i hil; ties are not limited .
, 2t 89~370 WO96101092 I~l/rL_~ /u In Fig. 5 the ridges 27 have been replaced by a single dovetail barb 27 ' which locks against the lower surface of the ring 25.
Fig. 6 shows a third r~mho~ t of the stem 20 and the 5 fastening means. Here also the fastening means is of the same piece as the stem itself and it comprises an annular ring 25 with a hole of exactly the right size to allow the spherical parts 28 fitted along the stem to be pulled through the hole by pulling hard enough in the direction of l O the arrow .
Fig. 7 shows a fourth ~ i t of the stem and the fastening means. The fastening means 22, which together ~~
with the stem constitute one piece, is a loop whose ends 20 and 30 can be locked to one another by means of a dovetail 15 barb 27 ~ formed at the end 29 and a groove 26 ' shaped at the end 3 0 .
Fig. 8 shows a fifth: ~)nll~ t of the stem and the fastening means. ~he end 29 of the fastening means 22 forming a loop is provided with ridges 27 and the loop can 20 be locked by pushing the end 29 with the ridges to a desired depth into the opposite end 30 which is provided with such grooves 26 the pull-out of the end 29 out of the end 30 is prevented.
In Fig. 9 the fastening means 22 forms an open loop whose 25 ends 29, 30 need not be interlocked. In the assembly of the -shaped body the transverse part is pressed down between the flexible ends 29, 30. Due to the tension of the ends 29, 30 of the loop, the transverse part is held fast in the grip of loop.
30 Fig. lO shows a stem in which the fastening means 22 is separate loop which can be locked to the stem 20. It has barbs at both ends 29, 30 and locking takes place as the ends are placed against one another and are pushed into the 2189~7 WO g6/01092 ~ llr~

groove 26 formed into the shaped end 21 of the stem.
Flg. 11 shows a T-shaped body in which also the stem 20 is a polymer matrix reservoir containing the active agent. The stem 20 and the transverse part 40 are attached to each S other with a separate fastening means 22 which is shown in more detail in Fiys. 12 and 13. The principle of operation of the fastening means of Fig. 12 .~ uAds to the loop shown in Fig. 9. The loop 22 in the vertical plane holds the transverse part of the T-shaped body and the open loop 10 33 in the horizontal plane holds the Qnd of the stem. Due to the tension of the ends 34, 35 of the loop 33, the end of the stem is held fast in the grip of the loop.
Fig. 13 shows a solution which is an alternative to that of Fig. 12. Also in this solution the loop 22 in the vertical 15 plane holds fast the transverse part of the T-shaped body and the loop 33 in the horizontal plane holds the end of the stem. The ends are interlocked acrr~r~lin~ to the principle of the solution of Fig. 7.
Fig. 14 shows a T-shaped body in which two transverse parts 20 40 and 40' are ~oined to the stem both of which comprise polymer matrix reservoirs containing the active agent.
Fig. 15 shows a stem 20 suitable for ~oining two transverse parts. The fastening means 22, which o ~ ,nds to that of Fig. 9, holds the upper transverse part 40 in place. The 25 lower f~stening means 22', which functions according to the same fastening principle as the upper fastening means 22, opens to one or the other side and fastening of the lower transverse part 40 ' takes place by pushing it into the loop 22 ' from the side .
30 In those solution where the device 10 comprises two separate polymer matrix reservoirs, either so that the device has two transverse parts 40, 40' or so that also the stem 20 forms a polymer matrix reservoir, the reservoirs .

WO 96tO1092 r~,l/rl . v can contain the 6ame or different active agents. For example, one reservoir may contain hormone and the other re6ervo~ r agent which prevents inf lammation .
It is obvious to a specialist in the field that different 5 : ' ' i ts of the invention can vary within the limits of the claims presented hereinafter.

Claims (5)

1. An intrauterine body (10) essentially in the shape of a T for releasing an active agent comprising an elongated stem (20), to one end (21) of which an elongated transverse part (40) is joined so that this and the stem (20) together form the body (10) essentially in the shape of a T, wherein the transverse part (40) comprises a polymer matrix reservoir (41) containing an active agent and the stem (20) either comprises a polymer matrix reservoir containing an active agent or that it is a part which contains no active agent, characterized in that - the stem (20), which is a part made of a suitable material, containing no active agent, is secured to the transverse part (40) by tightening a fastening means (22) at the end (21) of the stem partly or wholly around the transverse part (40), and (i) the stem (20) and the fastening means (22) form a uniform piece, or (ii) the fastening means (22) is a separate piece which can be secured to the stem (20); or - that the stem (20), which comprises a polymer matrix reservoir containing the active agent, is attached to the transverse part (40) by means of a separate fastening means (22).
A T-shaped body according to claim 1 characterized in that the stem (20) and the fastening means (22) form one piece and that the stem has also another fastening means (22') to which a second polymer matrix reservoir (41') containing the active agent is attached.
3. A T-shaped body according to claim 1 or 2 characterized in that the transverse part (40, 40') is a polymer matrix reservoir (41, 41') containing the active agent and that this is surrounded by a membrane (42, 42') which is capable of releasing the active agent at a predetermined rate.
4. A T-shaped body according to claim 1, 2 or 3 characterized in that the active agent is a hormone suitable for the treatment of menopausal symptoms or contraception.
5. A T-shaped body according to claim 4 characterized in that the hormone is estrogen or progestin.
CA002189870A 1994-07-05 1995-05-19 Device for the release of an active agent Abandoned CA2189870A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FI943201A FI97944C (en) 1994-07-05 1994-07-05 Active substance delivery device
FI943201 1994-07-05

Publications (1)

Publication Number Publication Date
CA2189870A1 true CA2189870A1 (en) 1996-01-18

Family

ID=8541056

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002189870A Abandoned CA2189870A1 (en) 1994-07-05 1995-05-19 Device for the release of an active agent

Country Status (10)

Country Link
EP (1) EP0768850A1 (en)
JP (1) JPH10510168A (en)
CN (1) CN1151686A (en)
AU (1) AU2448895A (en)
BR (1) BR9507667A (en)
CA (1) CA2189870A1 (en)
FI (1) FI97944C (en)
MX (1) MX9606579A (en)
WO (1) WO1996001092A1 (en)
ZA (1) ZA954368B (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999018884A1 (en) * 1997-10-10 1999-04-22 Duirs Nz Limited Drug delivery system
US6759393B1 (en) 1999-04-12 2004-07-06 Pfizer Inc. Growth hormone and growth hormone releasing hormone compositions
NZ509894A (en) * 2001-02-09 2002-11-26 Interag A "T" or "Y" shaped intravaginal device suitable for delivery of pharmaceuticals such as progesterone
BE1014635A3 (en) * 2002-02-12 2004-02-03 Wildemeersch Dirk
EP1400258A1 (en) * 2002-09-18 2004-03-24 Schering Oy Pharmaceutical composition delivery device and its manufacturing process
WO2004096151A2 (en) * 2003-04-29 2004-11-11 The General Hospital Corporation Methods and devices for the sustained release of multiple drugs
US7862552B2 (en) 2005-05-09 2011-01-04 Boston Scientific Scimed, Inc. Medical devices for treating urological and uterine conditions
EP2057972A1 (en) 2007-11-07 2009-05-13 N.V. Organon Intrauterine deposit
EP2140860A1 (en) 2008-07-03 2010-01-06 Bayer Schering Pharma Oy An improved method of contraception
US8568374B2 (en) 2009-05-04 2013-10-29 Merck Sharp & Dohme B.V. Intrauterine system
WO2012063262A2 (en) * 2010-11-08 2012-05-18 Hll Lifecare Limited A novel intrauterine device with controlled copper release
US9907691B2 (en) 2013-03-13 2018-03-06 Hologic, Inc. Intrauterine contraceptive devices
WO2015189853A1 (en) * 2014-06-13 2015-12-17 Meril Endo Surgery Private Limited An intrauterine device
CN105726103B (en) * 2016-02-05 2018-08-10 复旦大学附属肿瘤医院 A kind of uterine neck pore prevents adhesion device

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3845761A (en) * 1970-06-02 1974-11-05 Alza Corp Intrauterine contraceptive anti-fertility device for the management of reproduction
US4180064A (en) * 1972-12-27 1979-12-25 Alza Corporation System for delivering agent to environment of use over prolonged time
US4014988A (en) * 1975-10-31 1977-03-29 Alza Corporation Method for treating hypermenorrhea with uterine therapeutic system
GB2010676B (en) * 1977-12-27 1982-05-19 Alza Corp Diffusional drug delivery device with block copolymer as drug carrier
FI59719C (en) * 1978-06-29 1987-05-05 Medholding Oy Process for the preparation of interuterine contraceptives.
US4326511A (en) * 1979-10-05 1982-04-27 Zimerman Clota E Intrauterine contraceptive device
US4582052A (en) * 1982-03-23 1986-04-15 Repromed, Inc. Povidone-iodine dispensing fiber
WO1991007934A1 (en) * 1989-11-23 1991-06-13 Metallicom A.G. Process for the manufacture of a carrier or iud provided with a pulling element, and a carrier or iud provided with a pulling element

Also Published As

Publication number Publication date
FI943201A0 (en) 1994-07-05
MX9606579A (en) 1997-06-28
WO1996001092A1 (en) 1996-01-18
EP0768850A1 (en) 1997-04-23
FI97944B (en) 1996-12-13
FI97944C (en) 1997-03-25
ZA954368B (en) 1996-03-07
FI943201A (en) 1996-01-06
JPH10510168A (en) 1998-10-06
BR9507667A (en) 1997-10-07
CN1151686A (en) 1997-06-11
AU2448895A (en) 1996-01-25

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