|Numéro de publication||US3892238 A|
|Type de publication||Octroi|
|Date de publication||1 juil. 1975|
|Date de dépôt||14 janv. 1974|
|Date de priorité||16 sept. 1971|
|Numéro de publication||US 3892238 A, US 3892238A, US-A-3892238, US3892238 A, US3892238A|
|Inventeurs||Banford John A, Mauer Russell E, Moyer Ronald H|
|Cessionnaire d'origine||Abbott Lab|
|Exporter la citation||BiBTeX, EndNote, RefMan|
|Citations de brevets (14), Référencé par (18), Classifications (13)|
|Liens externes: USPTO, Cession USPTO, Espacenet|
United States Patent [191 Banford et 31.
1 1 July 1, 1975 1 1 DRUG SUPPORTING ANCHOR  Assignee: Abbott Laboratories, North Chicago, 111.
 Filed: Jan. 14, 1974  Appl. No.: 433,062
Related US. Application Data  Continuation of Ser. No. 181,007, Sept. 16, 1971,
 US. Cl 128/260; 128/130  Int. Cl A6lm 31/00; A6lf 5/46  Field of Search 128/127, 130, 131, 260,
128/285, 266, 269, 270, 271, 263, 128, 272; 30/351; 24/73 B, 123 B, 123 F, 129 B 3,492,755 2/1970 Sundblad 43/43.]3
3,545,439 12/1970 Duncan 1281260 3,561,438 2/1971 Canel 3,572,341 3/1971 Glassman 128/285 3,598,115 8/1971 Horne, Jr 128/130 3,625,214 12/1971 Higuchi 128/260 FOREIGN PATENTS OR APPLICATIONS 834,446 5/1960 United Kingdom 24/129 B Primary Examiner-Richard A. Gaudet Assistant Examiner.l. C. McGowan Attorney, Agent, or FirmSherman & Shalloway [5 7 ABSTRACT A drug supporting anchor for insertion and retention in body cavities including an elongated member having a drug support surface with a spiral configuration for supporting a drug to be administered, and the combination of a drug supporting anchor as described above with a drug supported thereon in either strip form or as a uniform layer. A method for inserting a flexible spiral anchor having a drug supported thereon in a body cavity including stretching the anchor to reduce the diameter thereof, inserting the anchor in the body cavity and releasing the stretched anchor to permit the anchor to return to the original diameter after insertion.
17 Claims, 17 Drawing Figures DRUG SU PPORTING ANCHOR This is a continuation of application Ser. No. 181,007, filed Sept. 16, 1971, now abandoned.
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention pertains to pharmaceutical an chors for insertion in body cavities and, more particularly, to such anchors for intravaginal insertion.
2. Dicussion of the Prior Art It is desirable to treat mammals with the use of slow release drugs inserted in a body cavity; however, such treatment has presented a problem in the past due to the difficulty of proper insertion of the drug, the retention of the drug in proper position within the body cavity and removal of any device utilized to support the drugs within the body cavity.
Slow release drugs are particularly useful for insertion in the vagina of mammals, particularly for purposes of artificial insemination. That is, the drug may be, for example, a hormone utilized to control the heat cycle of a mammal whereby insertion of the slow release hormone stops the normal physiological heat cycle; and, when the hormone is removed from the mammal. physiological heat cycling will be initiated. Accordingly, the use of such hormone facilitates artificial insemination in that a group of mammals may be artificially inseminated at the same time.
In order to permit the application of such drugs in an effective manner, the drug must be inserted in the mammal in such a manner as to reduce pain and injury therefrom at a minimum. Furthermore, the drug must be maintained within the body cavity in such a manner that it cannot be expelled either at the mammals volition or during normal physical activities and physiological body functions, as is the case when sponges are utilized to support such drugs, and the device utilized to support the drug must be easily removed.
SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a drug supporting anchor for insertion and retention in body cavities to facilitate release of a drug carried thereby.
The present invention is generally characterized in a drug supporting anchor for insertion and retention in body cavities including an elongated member for supporting a drug to be administered, the elongated member having a drug support surface with a spiral configuration.
Another object of the present invention is to utilize a drug strip spirally wound around an elongated member for insertion in body cavities in order to administer slow release drugs.
A further object of the present invention is to provide an elongated drug supporting member for insertion and retention in body cavities with a spiral configuration.
The present invention has another object in that a drug supporting anchor is made of a flexible material with a helical configuration to permit the diameter of the anchor to be reduced by longitudinal stretching to facilitate insertion of the anchor in a body cavity.
Another object of the present invention is to provide a method of inserting a spiral drug supporting anchor in a body cavity by reducing the diameter ofthe anchor during insertion.
Yet another object of the present invention is to utilize an anchor having a hollow spiral configuration with spaced coils to support a slow release drug for insertion in a body cavity.
A further object of the present invention is to utilize the combination of a spiral drug supporting anchor having apertures therein and a strip of drug material having protrusions extending therefrom adapted to be inserted in the apertures in the anchor in order to facilitate the administering of a slow release drug in a body cavity.
The present invention has another object in that the quantity or dosage of a drug to be administered in a body cavity is provided with an enlarged surface area by use of an anchor having a spiral configuration.
Some of the advantages of the present invention over the prior art are that the drug support anchor of the present invention locks into the tissue within a body cavity to prevent expelling thereof, the drug support anchor is flexible to facilitate insertion into and removal from a body cavity, and an enlarged surface area for drug material is provided to increase the dosage or quantity of drug which is capable of being released.
Other objects and advantages of the present invention will become apparent from the following description of the preferred embodiments taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a broken elevation of a drug supporting anchor constructed in accordance with the present invention.
FIG. 2 is a broken elevation of a strip of drug material to be carried by the anchor of FIG. 1.
FIG. 3 is a broken elevation of the anchor of FIG. 1 combined with the strip of drug material of FIG. 2.
FIG. 4 is a broken elevation of another embodiment of a combination of a drug supporting anchor and a strip of drug material of the present invention.
FIG. 5 is a broken elevation of the combination of FIG. 4 after spiral cutting.
FIG. 6 is a broken elevation of a further embodiment of a combination of a drug supporting anchor and a strip of drug material of the present invention.
FIG. 7 is a broken elevation of the combination of FIG. 6 after spiral twisting.
FIG. 8 is a broken elevation of a partially cut drug supporting anchor according to another embodiment of the present invention.
FIG. 9 is a side elevation illustrating the coating of the anchor of FIG. 8 with a drug material.
FIGS. 10, 11 and 12 are elevations of modifications of the drug supporting anchor of the present invention.
FIG. 13 is an elevation of a flexible drug supporting anchor according to the present invention.
FIG. 14 is a perspective view of the anchor of FIG. 13 mounted on an insertion rod.
FIG. 15 is a side elevation of another embodiment of a drug supporting anchor according to the present invention.
FIG. 16 is a perspective view of the anchor of FIG. 15 mounted on an insertion rod.
FIG. 17 is a perspective view of the anchor of FIG. 15 after insertion in a body cavity.
DESCRIPTION OF THE PREFERRED EMBODIMENTS A drug supporting anchor 20 according to the present invention is illustrated in FIG. 1 and is composed ofa strip of material 22 provided with a spiral or helical configuration to define an elongated, hollow spiral member 24 having spaced adjacent coils. Strip 22 has a longitudinal channel 26 formed therein, and a plurality of spaced apertures 28 are centered in channel 26. Anchor 20 may, for example, be formed of a strip of plastic approximately 4mm. thick which is longitudinally cut to form channel 26 and punched or bored to provide apertures 28 at 5cm. centers starting approximately 1cm. from each end of the strip. The length and width of the strip will be determined by the surface area required for the drug to be administered and the shape and size of the body cavity into which the anchor is to be inserted. The grooved and punched strip is then wrapped around a cylindrical mandrel to provide the hollow spiral configuration. The diameter of the spiral member 24 is determined in accordance with the shape and size of the body cavity into which the anchor is to be inserted, and the pitch of the spiral configuration is determined by the surface area required for the drug to be administered. Of course, the anchor 20 could be formed in one or more steps by any conventional method such as injection molding or extrusion.
A strip 30 of slow release drug material is illustrated in FIG. 2 and is formed with a width and length corresponding to the width of channel 26 and the length of strip 22 of anchor 20, respectively. A plurality of button-like protrusions or knobs 32 extend from strip 30 and are spaced according to the spacing between apertures 28 in anchor 20. Strip 30 may be composed of any pharmaceutical or drug desired to be administered and compatible slow release carrier. For example, when the anchors are designed for intravaginal placement, the drugs may include digitoxin, triiodothyronine, isoproterenol, atropine, histamine, nitrogen mustard, vitamin B pyrimethamine, hormonal substances, i.e., estrogenic substances, progestation substances, androgenic substances, e.g., estradiol, progesterone, androstenedione, testosterone, cortisol, medroxyprogesterone acetate, melengestrol acetate, chlormadinone, and the like as long as such drugs have the property of being capable of passage through the carrier. The carrier may be any slow or controlled release, drug-permeable polymeric material, such as organopolysiloxane of the linear type converted to rubber by heat curing and known as dimethylpolysiloxane. Such drugs and slow release carriers of the silicone rubber type are more fully described in US. Pat. No. 3,545,439, the disclosure of which is incorporated herein by reference.
The strip of drug material 30 is assembled with the anchor 20 as illustrated in FIG. 3 such that the strip of drug material is received within channel 26 with protrusions 32 extending through apertures 28. By providing the protrusions 32 with a knob-like or bulbous configuration, the strip of drug material 30 can be mounted on the anchor 20 with a snap-type action; and the strip of drug material will be firmly held such that the drug material is not susceptible to being inadvertently detached from the anchor during insertion of the combination anchor and drug material in a body cavity. Of course, the strip of drug material 30 may be secured to the strip 22 prior to spiraling thereof to form member 24, and any mating configuration may be utilized to fasten the drug strip with the anchor. For instance, the drug strip can be provided with spaced apertures while the anchor has mating protrusions extending therefrom to be received in the apertures.
Another embodiment of the present invention is illustrated in FIG. 4 wherein a relatively large diameter rod 34 has a strip of drug material 36 similar to drug material 30 wrapped therearound to provide a spaced spiral configuration. The drug material may be secured to rod 34 in any suitable manner such as by attachment means at the ends of the rod and strip of drug material to provide a hook-and-eye or similar type fastening, or by means of a compatible adhesive or cement. Once the strip of drug material 36 is properly positioned on the rod 34 the rod is spirally cut to provide a spiral groove 38 as illustrated in FIG. 5 to form a helical land corresponding to the spacing between coils of the spiraled drug strip 36 defining a support surface for the drug strip. After cutting the combination anchor and drug strip will have a deep spiral configuration to thereby facilitate insertion and removal of the combination anchor and drug strip and to provide a large surface area for drug material.
A further embodiment of the present invention is illustrated in FIGS. 6 and 7 wherein an anchor for the drug material is formed of a solid, cylindrical, small diameter rod 40, and a strip of drug material 42 similar to drug strip 30 is wrapped tightly around rod 40 with no gaps therebetween. The strip of drug material 42 may be secured to the rod 40 in any suitable manner as mentioned above with respect to the embodiment of FIG. 4, and the combination anchor and drug strip is then twisted or spiraled around a suitable cylinder or other forming mandrel to provide the spiral configuration illustrated in FIG. 7.
An anchor 44 is illustrated in FIG. 8 and is formed from a hollow cylindrical tube 46 of high density polyethylene which is spirally cut to form an elongated helical member 48. The anchor 44 may be formed by placing a pre-cut spiral metal sleeve around tube 46 such that tube 46 may be cut in the same spiral form as the metal sleeve in a stencil-like fashion.
In order to coat the anchor 44 illustrated in FIG. 8 with a suitable slow release drug material, the drug and an appropriate slow release compound such as silicone adhesive rubber as described above with respect to the drug strip of FIG. 2, are dissolved in a solvent such as cyclohexane. The cyclohexane solvent sufficiently dilutes the slow release compound to form a solution 50 which is supported in a container 52, and anchor 44 is dipped into the solution such that the drug and slow release compound adhere to the helical member 48 on both the outer and inner surfaces thereof. After the anchor 44 is removed from the container 52, the solvent evaporates to leave remaining anchor 44 coated with the silicone rubber impregnated slow release drug material in a helical configuration.
Other embodiments of anchors according to the present invention are illustrated in FIGS. 10, 11 and I2, and all of these anchors may be coated with a slow release drug material in the same manner as above described with respect to anchor 44 as shown in FIG. 9.
An anchor 54 is illustrated in FIG. 10 and has a hollow, elongated helical member 56 with flat outer and inner drug supporting surfaces 58 and suitably respectively. Anchor 54 is desirably made of a plastic material such as a transparent acrylic resin and may be suitaably formed by molding or extrusion processes as well as by winding or twisting around a forming mandred.
An anchor 62, shown in FIG. II, has a hollow, elongated member 64; however, member 64 differs from the elongated member 56 of anchor 54 in that member 64 has a double helical configuration. That is, body member 64 includes a pair of spaced strips 66 and 68 joined at ends 70 and 72 and having outer and inner drug supporting surfaces 74, 76, 78 and 80, respectively. In other words, anchor 60 differs from anchor 54 primarily in that the flat strip forming the elongated member of anchor 54 is slotted in anchor 60.
The anchor 82 illustrated in FIG. 12 differs from anchors 54 and 60 in that anchor 82 is formed of a tube of material which is twisted about a mandrel to provide a helical configuration similar to rod 40 in the embodiment of FIGS. 6 and 7.
An especially advantageous embodiment of the present invention is illustrated in FIGS. 13 and 14. An anchor 84 has the same configuration as anchor 54; however, anchor 84 is made of a flexible material and has a proximal end 86 with an aperture 88 therein and a distal end 90 shaped to receive the flat end of a movable arm 92 of an insertion rod 94. Insertion rod 94 includes a stationary sleeve 96 which slidably carries movable arm 92 and pin 98 extending therefrom and adapted to be received in aperture 88 in proximal end 86 of anchor 84. Anchor 84 may be coated with a slow release drug material by dipping as described with respect to FIG. 1 or a strip of slow release drug material may be secured to anchor 84 in the manner described relative to FIGS. I through 7.
A method for inserting anchor 84 in a body cavity such as the vagina includes the step of disposing anchor 84 over insertion rod 94 with pin 98 engaging aperture 88. Arm 92 is then moved out of sleeve 94 to engage distal end 90; and, thereafter, as arm 92 is moved further out of sleeve 96, anchor 84 is stretched as shown in FIG. I4 such that the diameter of anchor 84 is reduced. The anchor and drug material carried thereby are then inserted in the vagina with a twisting or screwing motion to facilitate insertion; and once the anchor is properly inserted, proximal end 86 is disengaged from pin 98 such that the insertion rod may be removed leaving the anchor in the vagina. Any suitable means may be utilized to effectively reduce the diameter of the anchor by stretching; and, similarly, the means illustrated for detachably securing the anchor to the movable and stationary portions of the insertion rod are of an exemplary nature and other suitable means may be utilized therefor. The shape of distal end 90, however, is particularly advantageous in that it provides firm engagement of the end of movable arm 92 while not requiring specific detachment for removal of the insertion rod.
In order to remove anchor 84 or any of the other anchors of the present invention, the lips of the vulva are opened and the anchor is withdrawn such as by pulling a previously attached string which is left hanging outside of the body cavity after insertion.
Another embodiment of a drug supporting anchor 100 in accordance with the present invention is illustrated in FIGS. 15, I6, and 17 with a precursor strip 102 illustrated in FIG. 15. Strip I02 has an elongated flat configuration with parallel side edges 104 and 106 of equal length terminating at end portions I08 and 110. Ends 108 and H0 have the general configuration of isosceles triangles and are oriented on opposite sides of the strip. End portions I08 and H0 have inclined edges I12 and 114 making apex angles 116 and 118 with side edges I04 and 106 of 45, respectively. Near the tip of apexes I16 and 118 are disposed apertures 120 and 122, respectively, which are utilized in deforming strip 102 as will be described hereinafter. Strip 102 is made of a flexible, resilient material which will spring back to its original configuration after deformation.
Anchor may be coated with a slow release drug material by dipping or may carry a strip of slow release drug material as described above. In any case, anchor 100 initially has the flat, linear configuration illustrated in FIG. 15 and will, accordingly, try to return to the flat, linear configuration after being deformed into a helical configuration.
In order to insert the drug supporting anchor 100, the strip 102 is wound around an insertion rod 124 having a pin 126 extending from a distal end thereof and a pin 128 extending from a proximal end which has a handle 130 extending therefrom and mechanically linked with pins 126 and 128 such that the pins may be withdrawn into insertion rod 124. To facilitate winding of strip 102 around insertion rod 124 as illustrated in FIG. 16, the aperture in end portion 108 may be positioned to receive pin 126, and the insertion rod is rotated about its longitudinal axis while end portion 110 is held stationary. Once the proper number of coils have been fon'ned in the strip, pin 128 is inserted in aperture 122 to hold the strip 102 in a tightly coiled deformed configuration.
The drug supporting anchor 100 is inserted in the vagina or other body cavity by grasping the handle and inserting the combination anchor and insertion rod. Once the drug supporting anchor I00 is properly positioned within the vagina, the anchor is released by withdrawing pins 126 and 128 such that the strip 102 tries to return to its initial flat, linear configuration; however, the walls 10 of the vagina will prevent return to the initial configuration as illustrated in FIG. 17. Thus, drug supporting anchor 100 will be retained in the vagina with a helical configuration having a diameter greater than the diameter during insertion, and the spaced coils will lock into the tissue to resist expelling of the anchor. The 45 incline at the end portions 108 and 110 allow appreciably better retention in the vagina than anchors with substantially rounded ends; that is, apexes 116 and 118 increase the locking action with the tissue.
A string 132 is tied to anchor 100 through aperture 122, as illustrated in FIG. 17, such that the anchor may be easily removed from the vagina by pulling string I32 which hangs outside the vagina. Strip 102 returns to its initial flat, linear configuration as the anchor is removed from the vagina to facilitate such removal.
The anchors illustrated in FIGS. 1, 5, 7, 8, 10 through I3 and 15 may be constructed of compatible nonabsorbable plastic or metal materials. Examples of such materials include transparent acrylic resins such as those known commercially as Plexiglas and Lucite, high or low density polyolefins such as polyethylene, polypropylene, copolymers of ethylene and propylene, linear polyamides (nylons), polystyrene, polycarbonate and metals such as stainless steel or high carbon steel. Flat strips of high carbon and stainless steel have inherently a spring or flexibility and are. accordingly, extremely advantageous for use with the embodiments of FIGS. 13 and 15.
As previously mentioned, the drug material is combined with a slow release compound such as dimethylpolysiloxane or a block copolymer of dimethylopolysiloxane and polycarbonate. and the slow release drug material for any of the above described an chors may be applied thereto either as a strip of drug material or by dipping as illustrated in FIG. 9.
The spaced helical configuration of the anchors of the present invention provides an increased surface area for drug material and excellent retention within the vagina since the spacing between adjacent coils permits the anchor to lock into the tissue thereby requiring twisting for removal. The flexible anchor of the embodiments of FIGS. 3 and are particularly advantageous due to the reduced diameter caused by stretching which facilitates both insertion and removal and the embodiment of FIG. 15 is further advantageous due to ease of manufacture. low cost and increased retention characteristics.
Inasmuch as the present invention is subject to many variations and changes in detail, all matter described above or shown in the accompanying drawings is intended to be interpreted as illustrative and not in a limiting sense.
What is claimed is:
l. A drug supporting anchor for insertion and retention in body cavities comprising an elongated member defined by a plurality of spaced helices having flat peripheral outer surfaces defining a helical drug support and formed of a flat strip of flexible material, said elongated member having at its distal end means for engaging the end of an insertion means and at its proximal end means for attachment with said insertion means whereby said elongated member can be stretched to reduce the diameter thereof.
2. The drug supporting anchor as recited in claim 1 wherein said flexible material is metal.
3. A drug supporting anchor for insertion and retention in body cavities comprising an elongated member defined by a plurality of spaced helices having flat peripheral outer surfaces defining a helical drug support surface and formed of a flat strip of flexible material, said elongated member including a slow release drug supported on said helical drug support surface.
4. The combination as recited in claim 3 wherein said elongated member is solid with raised helical lands defining a helical drug support surface, and said drug strip is supported on said drug support surface.
5. The combination as recited in claim 3 wherein said elongated member carries attachment means and said drug strip carries engaging means having a configuration to mate with said attachment means, said engaging means being engaged with said attachment means to secure said drug strip to said elongated member.
6. The combination as recited in claim 5 wherein said attachment means includes a plurality of apertures spaced along said elongated member and said engaging means includes a plurality of protrusions extending from said drug strip and received in said apertures.
7. The combination as recited in claim 6 wherein said elongated member is formed of a flat strip of material having a helical configuration and an outer surface defining a drug support surface, and said drug strip is aligned with said drug support surface.
8. The combination as recited in claim 7 wherein said flat strip of material has a channel recessed in said outer surface and said apertures are centered in said channel.
9. A combination for insertion and retention in body cavities for administering drugs comprising an elongated member having a spiral configuration, said elongated member being formed of a flat strip of flexible material in the form of a helical strip having a flat outer surface defining a drug support surface. a layer of slow release drug material supported on said drug support surface, a proximal end and a distal end of said strip of flexible material carrying means for engaging the end of an insertion means and said proximal end of said strip of flexible material carrying means for attachment with the insertion means whereby said elongated member may be stretched to reduce the diameter thereof.
10. The combination as recited in claim 9 wherein said elongated member is formed of a strip of material having flat inner and outer surfaces to define said drug support surface.
11. In combination, an insertion rod having a distal end and a proximal end. an anchor for supporting a drug including an elongate strip of flexible. resilient material spirally wound around said insertion rod to form a plurality of spaced coils having flat peripheral drug supporting surfaces, said strip of material engaging said distal and proximal ends to have a spiral configuration. and a slow release drug material carried on said flat peripheral drug supporting surfaces.
12. The invention as recited in claim 11 wherein said strip of material is metal and has a flat linear initial configuration whereby said strip expands when released from said insertion rod.
13. The invention as recited in claim 12 wherein said insertion rod has a first pin extending from said distal end and a second pin extending from said proximal end. and said strip has apertures in opposite ends thereof removably engaging said first and second pins.
14. The invention as recited in claim 13 wherein said opposite ends of said strip have a generally triangular configuration.
15. The invention as recited in claim 14 wherein said strip has parallel side edges and said ends have inclined edges making angles of 45 with said side edges.
16. The drug supporting anchor recited in claim 3 wherein said slow release drug is diposed in a coating on said helical drug support surface.
17. The drug supporting anchor recited in claim 3 wherein. said elongated member has apertures at its distal and proximal ends for attachment of said elongated member to an insertion means.
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|Classification aux États-Unis||128/839, 128/833, 424/430, 600/35|
|Classification internationale||A61M31/00, A61D7/00, A61K9/00|
|Classification coopérative||A61K9/0036, A61D7/00, A61M31/002|
|Classification européenne||A61D7/00, A61K9/00M8B, A61M31/00D|