CA2250113A1 - Vaginal insert and device for treating urogenital disorders - Google Patents
Vaginal insert and device for treating urogenital disorders Download PDFInfo
- Publication number
- CA2250113A1 CA2250113A1 CA002250113A CA2250113A CA2250113A1 CA 2250113 A1 CA2250113 A1 CA 2250113A1 CA 002250113 A CA002250113 A CA 002250113A CA 2250113 A CA2250113 A CA 2250113A CA 2250113 A1 CA2250113 A1 CA 2250113A1
- Authority
- CA
- Canada
- Prior art keywords
- agent
- projecting
- vaginal insert
- electrode
- urogenital tract
- 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.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0521—Genital electrodes
- A61N1/0524—Vaginal electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/325—Applying electric currents by contact electrodes alternating or intermittent currents for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
- A61N1/303—Constructional details
- A61N1/306—Arrangements where at least part of the apparatus is introduced into the body
Abstract
A vaginal insert (36) and method for delivering an agent to a urogenital tract in a patient, the patient having a vagina, the vagina having anterior and posterior walls. The vaginal insert comprises a main portion (38) and first and second portions (48, 58) operably connected to the main portion. The first and second portions each have an end (50, 60) projecting outward from the main portion, at least one of the projecting ends has means (54, 62) for containing the gent. The projecting ends of the first and second portions are configured to engage the anterior vaginal wall while the main portion engages the posterior vaginal wall, thereby positioning the projecting end of the first portion proximal to one side of the urogential tract and positioning the projecting end of the second portion proximal to an opposite side of the urogenital tract.
Description
CA 022~0113 1998-09-29 W O 97t36641 PCTnUS97/04599 VAGINAL INSERT AND DEVICE FOR TREATING UROGENITAL DISORDERS
Tecbni~lField S
The present invention relates to the tre~tmçnt of urogenital disorders and more particularly to a vaginal insert and method for delivering an agent to a urogenital tract.
~~- ~ rO ~
Urinary incontinence is an involuntary discharge of urine from the bladder. Inconlh~ellce can be caused by a variety of factors including pregnancy, estrogen deficiency, general w~kPning of the spectral pelvic floor muscles, surgery along the urinary tract, infection, and other maladies localized in the urinary tract. In 15 addition to incontinence, women can experience chronic pain and infections along the urinary tract. These conditions are widespread and affect millions of people.
There are several types of incontinpnrp7 including stress h~col~ ence, urge incontinPnre7 and total incontinence. Stress hlco..~ P~-ce occurs when a person's body is under physical stress. People suffering from this type of 20 incontinence might experience urine discharge during physically stressful events.
Examples of stressful events include coughing, l~llghing, and rigorous exercise.Urge incontinence is ch~r~rteri7P,d as an urgent desire to urinate and results in total discharge of the bladder. During urge incontinPnce, the detrusor muscle contracts or spasms ina~opl;ately as the bladder fills. Such a contraction 25 can occur suddenly, without warning, and is frequently accompanied by a strong desire to void the bladder. Unstable bladder activity caused by urge incontinence is a common type of incontinence in females. This type of inc-~ntinPnre can occur at any time, but frequently occurs when a person has a sudden change in their physical position. Total incontinPnl e is characterized by a total lack of control over urine 30 discharge and is frequently caused by complete failure of the sphincter muscles.
For practical purposes, tre~ttnent~ for an unstable bladder are divided A_ into simple and complex therapy. Simply therapy includes behavioral modification and drug therapy, while complex therapy encomp~P~s electrical stimul~tion and - radical surgery, which is performed either to denervate the bladder or to ~ugment its 35 c~acily.
When treating detrusor instability, the use of thc,d~ulic agents such as drugs le~ese~ a ph~rm~cologic attempt to interfere with bladder smooth musclecontraction. Various agents may work at several dirrel~lll points in the physiologic , . _ , , . . . ~ .
CA 022~0113 1998-09-29 W O 97136641 PCT~US97/04599 pathway leading to detrusor contraction. Possible sites of action include modnl~ting control mech~ni~m~ in the central nervous system, blocking the activity of acetylcholine (which is the majom~culoLl~lsmitter in the bladder), directly relaxing bladder smooth muscle, or regulating other substances believed to have a mod-ll~ting 5 effect on bladder contractile function. Agents that are useful in treating detrusor instability may be broken down into at least six categories: anticholinergic drugs, ~nti~p~modic or spasmolytic drugs, tricyclic antideplG~sa~ , calcium channel blockers, prost~gl~n-lin synthetase inhibitors, and estrogens.
Because the main neu~olecc~lor involved in bladder contraction is 10 acetylcholine, most agents used in treating detrusor instability/hy~cllcflexia are drugs having significant anticholinergic plop~llies, even if these ~ p~.lies are not the main mech~ni~m of action when the drugs are categorized pharmacologically.
The plot~lyl,;cal anticholinergic drug is atropine, a powerfill belladonna alkaloid that exerts its effects through colllpe~ e ~ntiml~sc~rinic activity at parasympathetic 15 neuroreceptor junctions. These effects are felt in many organ systems, including the bladder.
Because these rcccl~tols are found in many parts of the body, the use of any anticholinergic drug will produce effects on many physiologic parameters,not just those related to bladder function. Atropine is far more potent than any of the 20 drugs used in the tre~tment of detrusor over activity. However, there has been little progress in developing anticholinergic drugs that act specifically on the bladder. As a result, the side effect p~tt~ of these other drugs will follow roughly the same dose-response pattern as atropine.
The most common side effects that may be experienced include a dry 25 mouth due to ~u~plession of salivary and oropharyngeal secretions, occasionaldrow~hless, conslipation due to decreased gastroint~tin~l motility, increased heart rate due to vagal blockade, and transient blurring of vision due to blockade of the sphin- tPr of the iris and the ciliary muscle of the lens of the eye. Delivering agents to treat disorders other than detrusor instability can also cause serious side effects or 30 harm to the patient.
Therefore, there is a need in the art for methods and a~pald~lses for treating various maladies that effect the urinary tract. There is also a need for methods and a~p~dluses for delivering an agent to tissue proximal to the urinarytract while ...illi,.,i~i,lg exposure ofthe agent to other tissue.
Summary One embodiment of the present invention is directed to a vaginal insert for delivering an agent to a urogenital tract in a patient, the patient having a CA 022~0ll3 l998-09-29 W O 97t36641 PCTrUS97/04599 vagina, the vagina having anterior and posterior walls. The vaginal insert has a main portion and first and second portions operably conn~cted to the main portion. The first and second portions each have an end projecting outward from the main portion, at least one of the projecting ends is configured to contain the agent. The projecting ends of the first and second portions are configured to engage the anterior vaginal wall while the main portion engages the posterior vaginal wall, thereby positioning the projecting end of the first portion proximal to one side of the urogenital tract and positioning the projecting end of the second portion proximal to an opposite side of the urogenital tract.
The present invention is also directed to a method of delivering an agent to a urogenital tract within a patient, the patient having a vagina, the vagina having an anterior wall and a posterior wall. The method compri~es the steps of inserting a vaginal insert into the vagina, the vaginal insert having a first and second projecting portions, the first proiecting portions co..~ g an agent; positioning the first projecting portion on one side of the urogenital tract and the second portion on an o~posile side of the urogenital tract; and transporting the agent from the first projecting portion to the urogenital tract.
De ~ ;ytion of the L~raw~
Figure 1 shows a vertical cross-section of the female genital and urinary anatomy.
Figure 2 shows a horizontal cross-section taken along line 2-2 of the female genital and urinary anatomy shown in Figure 1.
Figure 3 shows a perspective view of a vaginal insert used to deliver an agent to the urogenital tract.
Figure 4 shows a partial cross-section of the device shown in Figure 3, the partial cross-section taken along line 4-4.
Figure 5 shows an ~ltern~tive embodiment of the vaginal insert used to deliver an agent to the urogenital tract.
Figure 6 shows a partial cross-section of the device shown in Figure 5, the partial cross-section taken along line 6-6.
- Figure 7 shows a cross-section of an ~lt~ tive embodiment of the vaginal insert used to deliver an agent to the urogenital tract.
Figure 8 shows a cross-section of another alternative embodiment of the device used to deliver an agent to the urogenital tract.
Figure 9 shows a cross-section of an alternative embodiment of a vaginal insert useful for delivering an agent to the urogenital tract.
Figure 10 shows an al~ ive embodiment of a vaginal insert useful for delivering an agent to the urogenital tract.
Figure 1 lA shows a cross-section of the device shown in Figure 10, the cross-section taken along line 11-11.
Figure 1 lB shows a cross-section of an alternative embodiment of the device shown in Figure 10, the cross-section taken along line 11-11.
Figure 12 shows an exploded view of an al~ ive embodiment of the vaginal insert useful for delivering an agent to the urogenital tract.
Figure 13 shows a cross-section of the vaginal insert shown in Figure 12, the cross-section taken along line 13-13.
!)QtailQ~ Descr~ption The invention initially will be described in general terms in conjunction with a brief description of the female anatomy. The various vaginal inserts and methods then will be described in detail with reference to the drawings, wherein like reference numbers l.~resclll like parts and assemblies throughout the several views. Reference to the plefell~d embodiment does not limit the scope ofthe invention, which is limited only by the scope of the claims ~tt~rh~d hereto.Referring to Figure 1, the female body defines a urethra 20, which provides a discharge lumen that is in fluid c~ ication with a bladder 22. The urethra 20 meets the bladder 22 at the bladder neck 24. The urethra 20, bladder 22, and bladder neck 24 are individual parts of the urinary tract. Additionally, a vagina 26 is located directly behind the urethra 20 and leads to the cervix 28 and the uterus 30. The vagina has anterior and posterior walls 32 and 34 respectively. Only a thin layer of tissue is located between the urethra 20 and the anterior vaginal wall 32.
The present invention generally relates to an a~p~lus and method of inserting an agent into the vagina 26 and transporting that agent from the vagina 26, through the anterior vaginal wall 32, and to the tissue surrounding the urinary tract.
The target tissue surrounding the urinary tract can be the bladder 22, the neck 24 of the bladder 22, or the urethra 20. The techniques for transporting the agent from the vagina 26 to the tissue surrounding the urinary tract can involve passive or active delivery. Although the following description ~ c~ses delivering the agent to theurinary tract, the present invention can be used to deliver the agent to any tissue within the urogenital tract.
Fx~mples of passive delivery include natural absorption. Examples of active delivery include iontophoresis; phonophoresis; and magnetophoresis, which involves magnetic activation of the agent.
CA 022~0113 1998-09-29 W O 97/36641 rcTrusg7/04599 Additionally, the invention can be used to deliver agents for treating a variety of maladies such as incontin~r~ce; muscle spasms that have undesirable results such as involuntary bladder contractions; urethral syndrome; h~ Li~ial cystitis; and general m~l~flies such as pain, infections, and ~ e~eecl tissue. Various 5 agents can be used to treat these maladies including, but not limited to, anticholinergic drugs such as atropine and dil,opall, a-adrenergic agents, antispasmodic or spasmolytic drugs, tricyclic antidepress~nt~, calcium channel blockers, prost~gl~ntlin synt~t~ce inhibitors, estrogens, and other agents that act on skeletomuscles .
The present invention has many advantages. One advantage is that the agent is delivered directly to the tissue surrounding the urinary tract. Exposure of the agent to other parts of the body, including the reproductive organs, is ~imini~h~d As a result, the risk of side effects is minimi7e(1 This advantage is very important when delivering toxic drugs or hormones that can cause cancer, especially when delivery occurs on a periodic or frequent basis.
~inimi7ing the amount of agent that is delivered outside of the urinary tract also reduces waste. Thus, a smaller dose of the agent can be used with the present invention while increasing its effectiveness. In other words, the agent that is delivered into the patient will be used much more efficiently.
Figures 3 and 4 illustrate a vaginal insert, generally shown as 36, that has a main body or portion 38. The main body 38 is elongated and defines a main lumen 40. Additionally, the main body 38 is bent at an intermediate section 46.
A first member or portion 48 is operably connected to and projects outward from the main body 38. The first projecting member 48 has a projecting end 50 and defines a first branch lumen 52 that is in fluid communication with a first balloon 54. The first balloon 54 is operably connected to the projecting end 50 and is formed from a porous membrane 56.
A second projecting member or portion 58 is substantially similar to the first member 48. Specifically, the second member 58 is operably connected tothe main body 38, has a projecting end 60, and defines a second branch lumen (not shown). Additionally, a second balloon 62 is formed from a porous membrane 64 and is operably conn~cte~ to the projecting end 60. The second balloon 62 is in fluid communication with the second branch lumen.
~ First and second projecting members 48 and 58 are positioned so that 35 they form a gap or opening 65 therebetween. The gap 65 is sized to receive the bladder neck 24 when the first and second projecting members 48 and 58 engage the anterior vaginal wall 32. Additionally, the first and second projecting members 48 CA 022~0113 1998-09-29 WO 97/36641 PCTrUS97/04599 and 58 are positioned so that when they engage the anterior vaginal wall 32, theintennefli~te section 46 of the main body 38 engages the posterior vaginal wall 34.
A first electrode 66 iS positioned within the first balloon 54. The first electrode 66 is connected to a first lead 68 that extends through the first branch lumen 52 and the main lumen 40. The first lead 68 iS then connected to a power source 70. In one embodiment, a second electrode 72 iS remotely located and is connected to the power supply 70 by a second lead 74. In this configuration, thesecond electrode 72 is a patch-type electrode that can be placed against the patient's skin. A third electrode (not shown) is substantially similar to the first electrode 66 and is located within the second balloon 62. A third lead (not shown) connects the third electrode to the first lead 68 so that the first 66 and third electrodes have the same polarity.
The power supply 70 can be a simple DC power source that provides a direct current between the first and third electrodes and the second electrode.
Alternatively, the power supply 70 can provide a current having a predet~rmined type of ~v~ro,.n. Additionally, the power supply can provide an electric current at inte"~ le~lt intervals.
In use, the vaginal insert 36 iS placed within the vagina 26 and oriented so that the first and second balloons 54 and 62 engage and press into the anterior vaginal wall 20 SO that the bladder neck 24 iS positioned within the gap 65.
In this position, the intP.rmediate section engages the posterior vaginal wall 34 providing frictional engagement to secure the vaginal insert 36 in a stationary position. One skilled in the art will realize that the first and second balloons 54 and 62 can be positioned along other portions of the urinary tract such as the urethra 20.
After the vaginal insert 36 is secured in position, a fluid cont~ining an agent is injected into the main lumen 40 so that the fluid flows through the first 52 and second branch lumens and inflates the first and second balloons 54 and 62. The second electrode 72 is placed against the patient's body at a position such as the patient's abdomen or thigh. The power supply 70 iS then activated, which causes a current to flow between the first 66 and third electrodes and the second electrode 72.
Electrons that form the current will flow from the first 66 and third electrodes, through the anterior vaginal wall 32, through the tissue proximate to the bladder neck 24, and to the second electrode 72. The electrons carry the agent from the first and second balloons 54 and 62 to the tissue proximate to the bladder neck 24.
One skilled in the art will realize that the vaginal insert 36 shown in Figure 3 can have many alternative embodiments. For example, the first and second balloons 54 and 62 can be replaced with hollow spheres (not shown) that define aplurality of delivery ports. In this embodiment, the spheres may be covered with a CA 022~0113 1998-09-29 W O 97/36641 PCTnUS97/04~99 porous membrane (not shown) to diffuse the current and prevent a hot spot at tissue that is ~ G~nt to the delivery ports.
In another alternative embodiment, the first and second balloons 54 and 62 can be replaced with solid spheres (not shown) that have surface mounted 5 electrodes (not shown) and are covered with a m~teri~l (not shown) that can beimpregn~tecl with and release the agent. The material might be configured to n~hlr~lly release the agent or to release the agent only if subjected to some type of active delivery merll~ni~m such as iontophoresis or phonopholesis. Examples of suitable materials include a polymer matrix such as a hydrogel, a foam such as an 10 open cell foam or a hydrophilic foam, and or any other m~tçri~l that can contain and release the agent.
In yet another alternative embodiment, the main body 38 defines first and second main lumens (not shown). The first main lumen is in fluid communication with the first balloon 54 via the first branch lumen 52. The second 15 main lumen is in fluid communication with the second balloon 62 via the second branch lumen (not shown). In this embodiment, the first electrode 66 is positioned in the first balloon 54 and the second electrode 70 positioned in the second balloon 62. The first lead 68 extends through the first branch lumen 52 and the first main lumen. The second lead 74 extends through the second branch lumen and the second20 main lumen. Finally, the first and second leads 68 and 74 are c~nn~cte~l to the power supply 70 in a manner that creates a bipolar electrode configuration.
An advantage of this design is that two agents can be simlllt~neously delivered. The first fluid having an agent and charged ions of one polarity are injected into the first balloon 54 and a second fluid cont~ining an agent and ions of 25 an opposite polarity are injected into the second balloon 62. As a result, two dirr~nt agents can be simultaneously delivered, which can minimi7e the overall length of time required to deliver the prescribed dose of agents.
Additionally, the same agent can be delivered from both the first and second balloons 54 and 62 using a bipolar configuration. Delivery in this manner is 30 accomplished by linking the agent that is injected into the first balloon 54 to ions having one polarity and the agent that is injected into the second balloon 62 to ions having an opposite polarity. An advantage of this type of delivery is that the current density can be decreased, while still delivering the agent in an acceptable amount of time. Reducing the current density will help to alleviate the discomfort experienced 35 by the patient. An alt~ tive advantage is that delivery can be performed twice as fast, thereby minimi7inE the length of time the patient is in ~ comfort Figure 5 illustrates an ~ltçrn~tive vaginal insert, generally shown as 76, in which a first member or portion 78 is operably connected to the main portion CA 022~0ll3 l998-09-29 38, has a projecting end 80, and has a curved segment 82 that is shaped to conform to the bladder neck 24. The curved segment 82 can have a C-shaped configuration.Additionally, the first projecting member 78 defines a first branch lurnen 84 that is in fluid col.llllullication with the main lumen 40. Delivery ports 86 are defined in 5 the curved segment 82 and are in fluid communication with the first branch lumen 84.
The second projecting member 88iS subst~nti~lly similar to the first projecting member 78 and has a projecting end 90, a curved segment 92, a second branch lumen (not shown) that is in fluid communication with the main lumen 40, 10 and delivery ports 94 that are in fluid con~lunication with the second branch lumen.
Additionally, the second projecting member 88 has a flexible segm~nt 97 that allows the first and second projecting members 78 and 88 to move between an openstate and a closed state.
When in a closed state, the projecting ends 80 and 90 of the first and 15 second projecting members 78 and 88 are adjacent to one another. In the closed state, the curved segment~ 82 and 92 form a gap or opening 96 that is sized to allow the bladder neck and pro~ l,al tissue to pass tht;l~ ough. When in the open state, the opening 96is configured to receive the bladder neck 24 and proximal tissue.
Referring to Figure 6, a first electrode 98is positioned in the first 20 branch lumen 84 and is conn~cted to the first lead 68 that extends through the main lumen 40. The second electrode 72iS remotely located and conn~cte~l to the second lead 74. A third electrode (not shown) is positioned in the second branch lumen and is also connected to the first lead 68. The power supply 70iS connected to the first and second leads 68 and 74so that the polarity of the first 98 and third electrodes is opposite to the polarity of the second electrode 72.
In use, the vaginal insert 76iS inserted into the vagina 26so that the first and second projecting members 78 and 88 are in the open state and engage the anterior vaginal wall 32, thereby projecting along opposite sides of the bladder neck 24. The first and second projecting members 78 and 88 are then shifted to the closed state so that the delivery ports 86 and 94 subsl~llially circumscribe the bladder neck 24. Fluid is then injected through the main luInen 40so that it seeps through the delivery ports 86 and 94. Simultaneously, current is passed between the first 98 and third electrodes and the second electrode 72. The iontophoretic current helps tooll the fluid through the tissue ofthe anterior vaginal wall 32 and to the tissue proximal to the bladder neck 24. If the vaginal insert 76 has a bipolar configuration, fluids Co~ g agents with oppositely charged ions can be injected into the first 84 and second branch lurnens, respectively.
CA 022~0113 1998-09-29 Similar to the embodiment shown in Figure 3, one skilled in the art will realize that the vaginal insert 76 also can be configured to have a bipolarconfiguration in which the first electrode 98 having one polarity is positioned in the first branch lumen and the second electrode 72 having an opposite polarity is S positioned in the second branch lumen. The main body 38 has first and second main lumens (not shown). The first lead 68 extends through the first main lumen and the second lead 74 extends through the second main lumen.
Additionally, the first and second projecting members 78 and 88 can be covered with a polymer matrix to help diffuse the current density and prevent hot spots at tissue ~ cent to the delivery ports 86 and 94. One skilled in the art will also realize that the first and second projecting m~mhers 78 and 88 can be formed from a solid m~teri~l; can have surface mounted electrodes; and can be coated with a material such as polymer matrix, hydrogel, or foam that is hn~le~ l with an agent. ~ltern~tively, the first and second projecting members 78 and 88 can be formed from the agent-ret~ining material itsel~
Figure 7 illustrates yet another ~lt~rn~tive embodiment. In this embollim~nt a vaginal insert, generally shown as 100, has a U-shape and defines a main portion 102 that is central between first and second portions 104 and 106. First and second portions 104 and 106 have a circumference that is smaller than the circumference of the main portion 102. Additionally, a first electrode 108 is wound around the first portion 104 and a second electrode 110 is wound around the second portion 106. The first and second electrodes 108 and 110 are connected to a power supply 112 via first and second leads 114 and 116.
The first portion 104 and first electrode 108 are covered by a first cap 118 formed from an absorbent material such as a polymer matrix, a hydrogel, or afoam. Any of these sub~L~ces can be h~le~ ted with an agent. The second portion 106 and second electrode 110 are similarly covered with an absorbent material that can be impregn~ted with an agent.
One skilled in the art will realize that the power supply 112 can have several possible configurations. In one configuration, the power supply 112 can be a battery that provides a simple direct current. In this situation, the patient would activate the power supply 112 before the vaginal insert 100 is placed in the vagina 26. In an ~ e embodiment, the power supply 70 contains an inductive coil, similar to that of a l-~-sru-l--er. In this embodiment, the vaginal insert 100 is positioned within the vagina 26 and the patient or caregiver can place a magnetic source against the body and proximal to the power supply 70. The m~gn~tic sourcewill generate a field that induces an electrical current in the m~,~n~tic coil.
CA 022~0113 1998-09-29 In yet another embodiment the inductive circuit is a resonant circuit that is tuned to a frequency in the radio frequency (RF) range (i.e., greater than about 9 KHz). In this embodiment, the resident circuit in~ ces an electrical current when subject to a m~gnetic field that is oscillating at the resident frequency. One skilled 5 in the art will realize that the power supply 112 can include an AC/DC converter so that a direct current is passed between the first and second electrodes 108 and 110.
Alternatively, the power supply 112 can include additional ChCUiLI~ to generate a current having a particular waveform. An advantage of using a resonant circuit is that i~llelrelcllce from stray m~gn~tjc fields is minimi7P.~l In use, the first cap 118 is hll~le~ l with an agent having a pre-determined polarity. Additionally, the second cap 120 can be hllple~,llated with an agent having an opposite polarity. The vaginal insert 100 is positioned within the vagina 26 so that the first and second portions 104 and 106 engage the anterior vaginal wall 32 and are positioned along opposite sides of the urinary tract. The main portion then engages the posterior vaginal wall 34, thereby securing the vaginal insert 100 in a stationary position. One skilled in the art will realize that the vaginal insert 100 can be positioned p,o~illlal to any portion of the urinary tract such as the bladder neck 24 or the urethra 20. The electric current then passes between the first and second electrodes 108 and 110 and transports the agent from the first and second caps 118 and 120 to tissue proximal to the urinary tract that is located and between the first and second portion 104 and 106.
Figure 8 illu~ es another alternative embodiment that has a configuration s~lbst~nti~lly similar to the vaginal insert 100 and uses magnetophoresis to transport the agent. In particular, the vaginal insert, generally shown as 122, has a main portion 124, a first portion 126, and a second portion 128.
First and second caps 130 and 132 formed of an agent-ret~ining material such as a polymer matrix cover the first and second portions 126 and 128, respectively. The first and second caps 130 and 132 are impregnated with m~gn~tic particles in addition to an agent. In use, the vaginal insert 122 is positioned in the vagina 26 so that a portion of the urinary tract is positioned between the first and second portion 126 and 128. A user can then place a magnetic source against their body. The magnetic source generates a field that causes the magnetic particles to vibrate. This vibrating action drives the agent from the caps 130 and 132, through the anterior vaginal wall 32, and into tissue proximal to the pa ient's urinary tract.
Referring to Figure 9, another vaginal insert, generally shown as 134, has a base member 136 having a delivery portion 138 and a handle portion 140. The delivery portion 138 defines a chamber 142 and plurality of ports 144. A first electrode 146 is wound around the delivery portion 138. A first lead 149 extends CA 022~0113 1998-09-29 from the first electrode 146 and through the handle portion 140 so that it may be connected to the power source 70.
A membrane 148 is operably connected to the base member 136 and defines a reservoir lS0. The membrane 148 has a porous section for eng~ging the anterior vaginal wall 32. The ports 144 provide fluid communication between the chamber 142 and the reservoir 150. Additionally, the porous section of the membrane 148 can be located in only that portion of the membrane 148 that is placed against the anterior vaginal wall 32, thereby minimi7in~ the amount of tissue outside of the urinary tract that is exposed to the agent. However, one skilled in this art will realize that the entire m~mhr~n~ 148 could be porous.
The handle portion 140 defines a supply port 152 that is covered by a septum 154, which seals if punctured by a needle. The supply port 152 provides apassage for supplying fluid into the chamber 142 and the reservoir 150. A secondelectrode 156 is a patchtype electrode and configured to be placed against the patient's body. The second electrode 156 has a second lead 158 for connecting to the power source 70.
In use, a patient or caregiver will inject a fluid co~ g an agent through the supply port 152 and fill the reservoir 150 and chamber 142. The fluid is supplied in an amount that fills the reservoir l S0 with a ~l~s~u~e that p~ the membrane 148 to remain pliable. The vaginal insert 134 is then placed in the vagina 26 so that the pores in the membrane 148 engage the anterior vaginal wall 32. The second electrode 156 is then placed against the patient's body at a position such as the patient's abdomen or thigh. The power supply 70 is activated so that an iontophoretic current passes between the first and second electrodes 146 and 156 and transports the agent from the reservoir l S0 to tissues surrounding the urinary tract.
An advantage of vaginal insert 134 is that upon insertion, the vaginal walls will exert pres:iule against the membrane 148 and cause the fluid and agent to pass through the pores and through the anterior vaginal wall 32 where the agent can be absorbed by tissue surrounding the urinary tract.
Figures 10 and 11 A illustrate another vaginal insert, generally shown as 160, having a base member 162 and a first electrode 164 mounted on a surface 166 of the base member 162. The first electrode 164 is connectçd to the power source 70 via a first lead 167. A second, patch-type electrode 168 is configured to ~ be placed against the skin and is attached to the power source 70 via a lead 170. An agent-ret~ining member 172 is operably connectçd to the base member 162 and has an outer surface 174. The base m~mber 162 and agent-retaining member 172 are curved, thereby defining a channel 176 that is sized to engage the anterior vaginal wall 32 and receive tissue proxirnal the urethra 20. In this configuration, the agent-CA 022~0113 1998-09-29 lGl~ini~-g member 172 can be formed from a material such as polymer matrix, hydrogel, or hydrophilic foam that can be impregnated with the agent. The agent-re~ining member 172 is hllple~ ated with an agent.
In use, the vaginal insert 160 is placed in the vagina 26 so that the S curved outer surface 174 engages the anterior vaginal wall 32 and the channel 176 receives the tissue surrounding the urethra 20. The second electrode 168 is thenplaced against the patient's abdomen or thigh and the power source 70 is activated.
The iontophoretic current passes bc;lw~xll the first and second e}ectrodes 164 and 168 and transports the agent from the agent-ret~ining member 172 to the tissue proximal to the urethra 20.
In an alternative embodiment illustrated in Figure 1 lB, the base member 162 can define a chamber 163 and a plurality of delivery ports 165. The delivery ports provide fluid col-~ ication between the charnber 163 and the surface of base member 162. An electrode 169 is positioned within the chamber 163. The electrode is operably comlecled to the first lead 167. The base member 162 also defines a hole (not shown) that is covered by a septum (not shown). In order to fill the charnber, the user can simply inject the agent or a solution cont~ining the agent through the septum.
This alternative embodiment may contain the agent-retaining member 172. If the agent-~ g member 172 is used, it may contain a second theldpeulic agent or a penetration enh~n~er. Alternatively, the agent-ret~ining member could be loaded only with water in order to provide a path for the iontophoretic current that passes between the electrodes 169 and 168. One skilled in the art will realize that the alternative embodiment shown in Figure 1 lB is used in a sllhst~ti~lly similar manner to the embodiment shown in Figure 11 A.
Referring to Figures 12 and 13, another vaginal insert, generally shown as 178, has a base member 180 on which a first electrode 182 is mounted.
The first electrode 182 is co~ e~l~d to a power source 70 via a first lead 184. A
second, patch-type electrode 186 is configured to be placed against the patient's body at a point such as the abdomen or thigh. The second electrode 186 is then is connected to the power source 70 via a second lead 188. A cotton-fiber matrix 190 is mounted on the base member. The cotton-fiber matrix is absorbent and swells when it becomes wetted. One skilled in the art will realize that other materials that can be in.pl~e~ rd with an agent and that swells when wetted can be ~ubsliLu~ed for the cotton-fiber matrix 190.
The base member 180 and cotton-fiber matrix 190 are sized to fit within a tubular tampon-like applicator 192 when the cotton-fiber matrix 190 is not CA 022~0113 1998-09-29 W O 97/36641 PCTrUS97/04599 wetted. The tampon-like applicator 192 has a leading end 194 that is open and a trailing end 196 that is open.
In use, a user will position the base unit 180 and unwetted cotton-fiber matrix 190 in the tampon-like applicator 192 so that the first lead 184 extends S through the trailing end 196. The cotton-fiber matrix 190 is then wetted with a fluid that contains an agent. The user uses the tampon-like applicator 192 to insert the base member 180 and cotton-fiber matrix 190 combination into the vagina 26 much like a tampon. During this process, the cotton-fiber matrix 190 exr~n-l~ as it is pushed out of the leading end 194 of the tampon-like applicator 192. After the tampon-like applicator 192 is removed from the vagina 26, the swelled cotton-fiber matrix 190 will conform to the con~oul~ of the interior vaginal wall. The secondelectrode 186 is placed against the patient's body at a point such as the abdomen or thigh. When an electric current passes between the first and second electrodes 182 and 186, the agent will be t,a~s~nJ~led from the cotton-fiber matrix 190 to tissue surrounding the urinary tract, including the urethra 20.
One skilled in the art will realize that any of the embodiments described above can use ~ltern~tive methods to lla~ls~oll the agent. ~or example, the active ~ ll meçh~ni~m can be phonophoresis in which the electrodes are be replaced with an ultrasonic tr~n~d~lcers. Phonophoresis uses ultrasonic waves totransport the agent from the vaginal insert to the target tissue that is proximal to the urinary tract. Another alternative transport mech~ni~m is magnetophoresis. a magnetophoresis transport mech~ni~m has both an agent and magnetic particles impregnated in an agent-ret~ining m~teri~l that forms part of the vaginal insert. The magnetic particles will vibrate when subjected to an oscillating m~gn~ tic field, thereby driving the agent toward the target tissue. Additionally, all of the embo~iment~ described above can be used with passive delivery, in which case electrodes, ultrasonic trAn~lucers, and magnetic particles are not nece~ry. One skilled in the art will also realize that any agent-ret~ining m~t~ri~l may be substituted for a polymer matrix, hydrogel, or foam.
Although the description of vaginal inserts and methods has been quite specific, it is contemplated that various modifications could be made.
Accordingly, it is intentletl that the scope and spirit of the present invention can be dictated by the appended claims, rather than by the foregoing description.
.
Tecbni~lField S
The present invention relates to the tre~tmçnt of urogenital disorders and more particularly to a vaginal insert and method for delivering an agent to a urogenital tract.
~~- ~ rO ~
Urinary incontinence is an involuntary discharge of urine from the bladder. Inconlh~ellce can be caused by a variety of factors including pregnancy, estrogen deficiency, general w~kPning of the spectral pelvic floor muscles, surgery along the urinary tract, infection, and other maladies localized in the urinary tract. In 15 addition to incontinence, women can experience chronic pain and infections along the urinary tract. These conditions are widespread and affect millions of people.
There are several types of incontinpnrp7 including stress h~col~ ence, urge incontinPnre7 and total incontinence. Stress hlco..~ P~-ce occurs when a person's body is under physical stress. People suffering from this type of 20 incontinence might experience urine discharge during physically stressful events.
Examples of stressful events include coughing, l~llghing, and rigorous exercise.Urge incontinence is ch~r~rteri7P,d as an urgent desire to urinate and results in total discharge of the bladder. During urge incontinPnce, the detrusor muscle contracts or spasms ina~opl;ately as the bladder fills. Such a contraction 25 can occur suddenly, without warning, and is frequently accompanied by a strong desire to void the bladder. Unstable bladder activity caused by urge incontinence is a common type of incontinence in females. This type of inc-~ntinPnre can occur at any time, but frequently occurs when a person has a sudden change in their physical position. Total incontinPnl e is characterized by a total lack of control over urine 30 discharge and is frequently caused by complete failure of the sphincter muscles.
For practical purposes, tre~ttnent~ for an unstable bladder are divided A_ into simple and complex therapy. Simply therapy includes behavioral modification and drug therapy, while complex therapy encomp~P~s electrical stimul~tion and - radical surgery, which is performed either to denervate the bladder or to ~ugment its 35 c~acily.
When treating detrusor instability, the use of thc,d~ulic agents such as drugs le~ese~ a ph~rm~cologic attempt to interfere with bladder smooth musclecontraction. Various agents may work at several dirrel~lll points in the physiologic , . _ , , . . . ~ .
CA 022~0113 1998-09-29 W O 97136641 PCT~US97/04599 pathway leading to detrusor contraction. Possible sites of action include modnl~ting control mech~ni~m~ in the central nervous system, blocking the activity of acetylcholine (which is the majom~culoLl~lsmitter in the bladder), directly relaxing bladder smooth muscle, or regulating other substances believed to have a mod-ll~ting 5 effect on bladder contractile function. Agents that are useful in treating detrusor instability may be broken down into at least six categories: anticholinergic drugs, ~nti~p~modic or spasmolytic drugs, tricyclic antideplG~sa~ , calcium channel blockers, prost~gl~n-lin synthetase inhibitors, and estrogens.
Because the main neu~olecc~lor involved in bladder contraction is 10 acetylcholine, most agents used in treating detrusor instability/hy~cllcflexia are drugs having significant anticholinergic plop~llies, even if these ~ p~.lies are not the main mech~ni~m of action when the drugs are categorized pharmacologically.
The plot~lyl,;cal anticholinergic drug is atropine, a powerfill belladonna alkaloid that exerts its effects through colllpe~ e ~ntiml~sc~rinic activity at parasympathetic 15 neuroreceptor junctions. These effects are felt in many organ systems, including the bladder.
Because these rcccl~tols are found in many parts of the body, the use of any anticholinergic drug will produce effects on many physiologic parameters,not just those related to bladder function. Atropine is far more potent than any of the 20 drugs used in the tre~tment of detrusor over activity. However, there has been little progress in developing anticholinergic drugs that act specifically on the bladder. As a result, the side effect p~tt~ of these other drugs will follow roughly the same dose-response pattern as atropine.
The most common side effects that may be experienced include a dry 25 mouth due to ~u~plession of salivary and oropharyngeal secretions, occasionaldrow~hless, conslipation due to decreased gastroint~tin~l motility, increased heart rate due to vagal blockade, and transient blurring of vision due to blockade of the sphin- tPr of the iris and the ciliary muscle of the lens of the eye. Delivering agents to treat disorders other than detrusor instability can also cause serious side effects or 30 harm to the patient.
Therefore, there is a need in the art for methods and a~pald~lses for treating various maladies that effect the urinary tract. There is also a need for methods and a~p~dluses for delivering an agent to tissue proximal to the urinarytract while ...illi,.,i~i,lg exposure ofthe agent to other tissue.
Summary One embodiment of the present invention is directed to a vaginal insert for delivering an agent to a urogenital tract in a patient, the patient having a CA 022~0ll3 l998-09-29 W O 97t36641 PCTrUS97/04599 vagina, the vagina having anterior and posterior walls. The vaginal insert has a main portion and first and second portions operably conn~cted to the main portion. The first and second portions each have an end projecting outward from the main portion, at least one of the projecting ends is configured to contain the agent. The projecting ends of the first and second portions are configured to engage the anterior vaginal wall while the main portion engages the posterior vaginal wall, thereby positioning the projecting end of the first portion proximal to one side of the urogenital tract and positioning the projecting end of the second portion proximal to an opposite side of the urogenital tract.
The present invention is also directed to a method of delivering an agent to a urogenital tract within a patient, the patient having a vagina, the vagina having an anterior wall and a posterior wall. The method compri~es the steps of inserting a vaginal insert into the vagina, the vaginal insert having a first and second projecting portions, the first proiecting portions co..~ g an agent; positioning the first projecting portion on one side of the urogenital tract and the second portion on an o~posile side of the urogenital tract; and transporting the agent from the first projecting portion to the urogenital tract.
De ~ ;ytion of the L~raw~
Figure 1 shows a vertical cross-section of the female genital and urinary anatomy.
Figure 2 shows a horizontal cross-section taken along line 2-2 of the female genital and urinary anatomy shown in Figure 1.
Figure 3 shows a perspective view of a vaginal insert used to deliver an agent to the urogenital tract.
Figure 4 shows a partial cross-section of the device shown in Figure 3, the partial cross-section taken along line 4-4.
Figure 5 shows an ~ltern~tive embodiment of the vaginal insert used to deliver an agent to the urogenital tract.
Figure 6 shows a partial cross-section of the device shown in Figure 5, the partial cross-section taken along line 6-6.
- Figure 7 shows a cross-section of an ~lt~ tive embodiment of the vaginal insert used to deliver an agent to the urogenital tract.
Figure 8 shows a cross-section of another alternative embodiment of the device used to deliver an agent to the urogenital tract.
Figure 9 shows a cross-section of an alternative embodiment of a vaginal insert useful for delivering an agent to the urogenital tract.
Figure 10 shows an al~ ive embodiment of a vaginal insert useful for delivering an agent to the urogenital tract.
Figure 1 lA shows a cross-section of the device shown in Figure 10, the cross-section taken along line 11-11.
Figure 1 lB shows a cross-section of an alternative embodiment of the device shown in Figure 10, the cross-section taken along line 11-11.
Figure 12 shows an exploded view of an al~ ive embodiment of the vaginal insert useful for delivering an agent to the urogenital tract.
Figure 13 shows a cross-section of the vaginal insert shown in Figure 12, the cross-section taken along line 13-13.
!)QtailQ~ Descr~ption The invention initially will be described in general terms in conjunction with a brief description of the female anatomy. The various vaginal inserts and methods then will be described in detail with reference to the drawings, wherein like reference numbers l.~resclll like parts and assemblies throughout the several views. Reference to the plefell~d embodiment does not limit the scope ofthe invention, which is limited only by the scope of the claims ~tt~rh~d hereto.Referring to Figure 1, the female body defines a urethra 20, which provides a discharge lumen that is in fluid c~ ication with a bladder 22. The urethra 20 meets the bladder 22 at the bladder neck 24. The urethra 20, bladder 22, and bladder neck 24 are individual parts of the urinary tract. Additionally, a vagina 26 is located directly behind the urethra 20 and leads to the cervix 28 and the uterus 30. The vagina has anterior and posterior walls 32 and 34 respectively. Only a thin layer of tissue is located between the urethra 20 and the anterior vaginal wall 32.
The present invention generally relates to an a~p~lus and method of inserting an agent into the vagina 26 and transporting that agent from the vagina 26, through the anterior vaginal wall 32, and to the tissue surrounding the urinary tract.
The target tissue surrounding the urinary tract can be the bladder 22, the neck 24 of the bladder 22, or the urethra 20. The techniques for transporting the agent from the vagina 26 to the tissue surrounding the urinary tract can involve passive or active delivery. Although the following description ~ c~ses delivering the agent to theurinary tract, the present invention can be used to deliver the agent to any tissue within the urogenital tract.
Fx~mples of passive delivery include natural absorption. Examples of active delivery include iontophoresis; phonophoresis; and magnetophoresis, which involves magnetic activation of the agent.
CA 022~0113 1998-09-29 W O 97/36641 rcTrusg7/04599 Additionally, the invention can be used to deliver agents for treating a variety of maladies such as incontin~r~ce; muscle spasms that have undesirable results such as involuntary bladder contractions; urethral syndrome; h~ Li~ial cystitis; and general m~l~flies such as pain, infections, and ~ e~eecl tissue. Various 5 agents can be used to treat these maladies including, but not limited to, anticholinergic drugs such as atropine and dil,opall, a-adrenergic agents, antispasmodic or spasmolytic drugs, tricyclic antidepress~nt~, calcium channel blockers, prost~gl~ntlin synt~t~ce inhibitors, estrogens, and other agents that act on skeletomuscles .
The present invention has many advantages. One advantage is that the agent is delivered directly to the tissue surrounding the urinary tract. Exposure of the agent to other parts of the body, including the reproductive organs, is ~imini~h~d As a result, the risk of side effects is minimi7e(1 This advantage is very important when delivering toxic drugs or hormones that can cause cancer, especially when delivery occurs on a periodic or frequent basis.
~inimi7ing the amount of agent that is delivered outside of the urinary tract also reduces waste. Thus, a smaller dose of the agent can be used with the present invention while increasing its effectiveness. In other words, the agent that is delivered into the patient will be used much more efficiently.
Figures 3 and 4 illustrate a vaginal insert, generally shown as 36, that has a main body or portion 38. The main body 38 is elongated and defines a main lumen 40. Additionally, the main body 38 is bent at an intermediate section 46.
A first member or portion 48 is operably connected to and projects outward from the main body 38. The first projecting member 48 has a projecting end 50 and defines a first branch lumen 52 that is in fluid communication with a first balloon 54. The first balloon 54 is operably connected to the projecting end 50 and is formed from a porous membrane 56.
A second projecting member or portion 58 is substantially similar to the first member 48. Specifically, the second member 58 is operably connected tothe main body 38, has a projecting end 60, and defines a second branch lumen (not shown). Additionally, a second balloon 62 is formed from a porous membrane 64 and is operably conn~cte~ to the projecting end 60. The second balloon 62 is in fluid communication with the second branch lumen.
~ First and second projecting members 48 and 58 are positioned so that 35 they form a gap or opening 65 therebetween. The gap 65 is sized to receive the bladder neck 24 when the first and second projecting members 48 and 58 engage the anterior vaginal wall 32. Additionally, the first and second projecting members 48 CA 022~0113 1998-09-29 WO 97/36641 PCTrUS97/04599 and 58 are positioned so that when they engage the anterior vaginal wall 32, theintennefli~te section 46 of the main body 38 engages the posterior vaginal wall 34.
A first electrode 66 iS positioned within the first balloon 54. The first electrode 66 is connected to a first lead 68 that extends through the first branch lumen 52 and the main lumen 40. The first lead 68 iS then connected to a power source 70. In one embodiment, a second electrode 72 iS remotely located and is connected to the power supply 70 by a second lead 74. In this configuration, thesecond electrode 72 is a patch-type electrode that can be placed against the patient's skin. A third electrode (not shown) is substantially similar to the first electrode 66 and is located within the second balloon 62. A third lead (not shown) connects the third electrode to the first lead 68 so that the first 66 and third electrodes have the same polarity.
The power supply 70 can be a simple DC power source that provides a direct current between the first and third electrodes and the second electrode.
Alternatively, the power supply 70 can provide a current having a predet~rmined type of ~v~ro,.n. Additionally, the power supply can provide an electric current at inte"~ le~lt intervals.
In use, the vaginal insert 36 iS placed within the vagina 26 and oriented so that the first and second balloons 54 and 62 engage and press into the anterior vaginal wall 20 SO that the bladder neck 24 iS positioned within the gap 65.
In this position, the intP.rmediate section engages the posterior vaginal wall 34 providing frictional engagement to secure the vaginal insert 36 in a stationary position. One skilled in the art will realize that the first and second balloons 54 and 62 can be positioned along other portions of the urinary tract such as the urethra 20.
After the vaginal insert 36 is secured in position, a fluid cont~ining an agent is injected into the main lumen 40 so that the fluid flows through the first 52 and second branch lumens and inflates the first and second balloons 54 and 62. The second electrode 72 is placed against the patient's body at a position such as the patient's abdomen or thigh. The power supply 70 iS then activated, which causes a current to flow between the first 66 and third electrodes and the second electrode 72.
Electrons that form the current will flow from the first 66 and third electrodes, through the anterior vaginal wall 32, through the tissue proximate to the bladder neck 24, and to the second electrode 72. The electrons carry the agent from the first and second balloons 54 and 62 to the tissue proximate to the bladder neck 24.
One skilled in the art will realize that the vaginal insert 36 shown in Figure 3 can have many alternative embodiments. For example, the first and second balloons 54 and 62 can be replaced with hollow spheres (not shown) that define aplurality of delivery ports. In this embodiment, the spheres may be covered with a CA 022~0113 1998-09-29 W O 97/36641 PCTnUS97/04~99 porous membrane (not shown) to diffuse the current and prevent a hot spot at tissue that is ~ G~nt to the delivery ports.
In another alternative embodiment, the first and second balloons 54 and 62 can be replaced with solid spheres (not shown) that have surface mounted 5 electrodes (not shown) and are covered with a m~teri~l (not shown) that can beimpregn~tecl with and release the agent. The material might be configured to n~hlr~lly release the agent or to release the agent only if subjected to some type of active delivery merll~ni~m such as iontophoresis or phonopholesis. Examples of suitable materials include a polymer matrix such as a hydrogel, a foam such as an 10 open cell foam or a hydrophilic foam, and or any other m~tçri~l that can contain and release the agent.
In yet another alternative embodiment, the main body 38 defines first and second main lumens (not shown). The first main lumen is in fluid communication with the first balloon 54 via the first branch lumen 52. The second 15 main lumen is in fluid communication with the second balloon 62 via the second branch lumen (not shown). In this embodiment, the first electrode 66 is positioned in the first balloon 54 and the second electrode 70 positioned in the second balloon 62. The first lead 68 extends through the first branch lumen 52 and the first main lumen. The second lead 74 extends through the second branch lumen and the second20 main lumen. Finally, the first and second leads 68 and 74 are c~nn~cte~l to the power supply 70 in a manner that creates a bipolar electrode configuration.
An advantage of this design is that two agents can be simlllt~neously delivered. The first fluid having an agent and charged ions of one polarity are injected into the first balloon 54 and a second fluid cont~ining an agent and ions of 25 an opposite polarity are injected into the second balloon 62. As a result, two dirr~nt agents can be simultaneously delivered, which can minimi7e the overall length of time required to deliver the prescribed dose of agents.
Additionally, the same agent can be delivered from both the first and second balloons 54 and 62 using a bipolar configuration. Delivery in this manner is 30 accomplished by linking the agent that is injected into the first balloon 54 to ions having one polarity and the agent that is injected into the second balloon 62 to ions having an opposite polarity. An advantage of this type of delivery is that the current density can be decreased, while still delivering the agent in an acceptable amount of time. Reducing the current density will help to alleviate the discomfort experienced 35 by the patient. An alt~ tive advantage is that delivery can be performed twice as fast, thereby minimi7inE the length of time the patient is in ~ comfort Figure 5 illustrates an ~ltçrn~tive vaginal insert, generally shown as 76, in which a first member or portion 78 is operably connected to the main portion CA 022~0ll3 l998-09-29 38, has a projecting end 80, and has a curved segment 82 that is shaped to conform to the bladder neck 24. The curved segment 82 can have a C-shaped configuration.Additionally, the first projecting member 78 defines a first branch lurnen 84 that is in fluid col.llllullication with the main lumen 40. Delivery ports 86 are defined in 5 the curved segment 82 and are in fluid communication with the first branch lumen 84.
The second projecting member 88iS subst~nti~lly similar to the first projecting member 78 and has a projecting end 90, a curved segment 92, a second branch lumen (not shown) that is in fluid communication with the main lumen 40, 10 and delivery ports 94 that are in fluid con~lunication with the second branch lumen.
Additionally, the second projecting member 88 has a flexible segm~nt 97 that allows the first and second projecting members 78 and 88 to move between an openstate and a closed state.
When in a closed state, the projecting ends 80 and 90 of the first and 15 second projecting members 78 and 88 are adjacent to one another. In the closed state, the curved segment~ 82 and 92 form a gap or opening 96 that is sized to allow the bladder neck and pro~ l,al tissue to pass tht;l~ ough. When in the open state, the opening 96is configured to receive the bladder neck 24 and proximal tissue.
Referring to Figure 6, a first electrode 98is positioned in the first 20 branch lumen 84 and is conn~cted to the first lead 68 that extends through the main lumen 40. The second electrode 72iS remotely located and conn~cte~l to the second lead 74. A third electrode (not shown) is positioned in the second branch lumen and is also connected to the first lead 68. The power supply 70iS connected to the first and second leads 68 and 74so that the polarity of the first 98 and third electrodes is opposite to the polarity of the second electrode 72.
In use, the vaginal insert 76iS inserted into the vagina 26so that the first and second projecting members 78 and 88 are in the open state and engage the anterior vaginal wall 32, thereby projecting along opposite sides of the bladder neck 24. The first and second projecting members 78 and 88 are then shifted to the closed state so that the delivery ports 86 and 94 subsl~llially circumscribe the bladder neck 24. Fluid is then injected through the main luInen 40so that it seeps through the delivery ports 86 and 94. Simultaneously, current is passed between the first 98 and third electrodes and the second electrode 72. The iontophoretic current helps tooll the fluid through the tissue ofthe anterior vaginal wall 32 and to the tissue proximal to the bladder neck 24. If the vaginal insert 76 has a bipolar configuration, fluids Co~ g agents with oppositely charged ions can be injected into the first 84 and second branch lurnens, respectively.
CA 022~0113 1998-09-29 Similar to the embodiment shown in Figure 3, one skilled in the art will realize that the vaginal insert 76 also can be configured to have a bipolarconfiguration in which the first electrode 98 having one polarity is positioned in the first branch lumen and the second electrode 72 having an opposite polarity is S positioned in the second branch lumen. The main body 38 has first and second main lumens (not shown). The first lead 68 extends through the first main lumen and the second lead 74 extends through the second main lumen.
Additionally, the first and second projecting members 78 and 88 can be covered with a polymer matrix to help diffuse the current density and prevent hot spots at tissue ~ cent to the delivery ports 86 and 94. One skilled in the art will also realize that the first and second projecting m~mhers 78 and 88 can be formed from a solid m~teri~l; can have surface mounted electrodes; and can be coated with a material such as polymer matrix, hydrogel, or foam that is hn~le~ l with an agent. ~ltern~tively, the first and second projecting members 78 and 88 can be formed from the agent-ret~ining material itsel~
Figure 7 illustrates yet another ~lt~rn~tive embodiment. In this embollim~nt a vaginal insert, generally shown as 100, has a U-shape and defines a main portion 102 that is central between first and second portions 104 and 106. First and second portions 104 and 106 have a circumference that is smaller than the circumference of the main portion 102. Additionally, a first electrode 108 is wound around the first portion 104 and a second electrode 110 is wound around the second portion 106. The first and second electrodes 108 and 110 are connected to a power supply 112 via first and second leads 114 and 116.
The first portion 104 and first electrode 108 are covered by a first cap 118 formed from an absorbent material such as a polymer matrix, a hydrogel, or afoam. Any of these sub~L~ces can be h~le~ ted with an agent. The second portion 106 and second electrode 110 are similarly covered with an absorbent material that can be impregn~ted with an agent.
One skilled in the art will realize that the power supply 112 can have several possible configurations. In one configuration, the power supply 112 can be a battery that provides a simple direct current. In this situation, the patient would activate the power supply 112 before the vaginal insert 100 is placed in the vagina 26. In an ~ e embodiment, the power supply 70 contains an inductive coil, similar to that of a l-~-sru-l--er. In this embodiment, the vaginal insert 100 is positioned within the vagina 26 and the patient or caregiver can place a magnetic source against the body and proximal to the power supply 70. The m~gn~tic sourcewill generate a field that induces an electrical current in the m~,~n~tic coil.
CA 022~0113 1998-09-29 In yet another embodiment the inductive circuit is a resonant circuit that is tuned to a frequency in the radio frequency (RF) range (i.e., greater than about 9 KHz). In this embodiment, the resident circuit in~ ces an electrical current when subject to a m~gnetic field that is oscillating at the resident frequency. One skilled 5 in the art will realize that the power supply 112 can include an AC/DC converter so that a direct current is passed between the first and second electrodes 108 and 110.
Alternatively, the power supply 112 can include additional ChCUiLI~ to generate a current having a particular waveform. An advantage of using a resonant circuit is that i~llelrelcllce from stray m~gn~tjc fields is minimi7P.~l In use, the first cap 118 is hll~le~ l with an agent having a pre-determined polarity. Additionally, the second cap 120 can be hllple~,llated with an agent having an opposite polarity. The vaginal insert 100 is positioned within the vagina 26 so that the first and second portions 104 and 106 engage the anterior vaginal wall 32 and are positioned along opposite sides of the urinary tract. The main portion then engages the posterior vaginal wall 34, thereby securing the vaginal insert 100 in a stationary position. One skilled in the art will realize that the vaginal insert 100 can be positioned p,o~illlal to any portion of the urinary tract such as the bladder neck 24 or the urethra 20. The electric current then passes between the first and second electrodes 108 and 110 and transports the agent from the first and second caps 118 and 120 to tissue proximal to the urinary tract that is located and between the first and second portion 104 and 106.
Figure 8 illu~ es another alternative embodiment that has a configuration s~lbst~nti~lly similar to the vaginal insert 100 and uses magnetophoresis to transport the agent. In particular, the vaginal insert, generally shown as 122, has a main portion 124, a first portion 126, and a second portion 128.
First and second caps 130 and 132 formed of an agent-ret~ining material such as a polymer matrix cover the first and second portions 126 and 128, respectively. The first and second caps 130 and 132 are impregnated with m~gn~tic particles in addition to an agent. In use, the vaginal insert 122 is positioned in the vagina 26 so that a portion of the urinary tract is positioned between the first and second portion 126 and 128. A user can then place a magnetic source against their body. The magnetic source generates a field that causes the magnetic particles to vibrate. This vibrating action drives the agent from the caps 130 and 132, through the anterior vaginal wall 32, and into tissue proximal to the pa ient's urinary tract.
Referring to Figure 9, another vaginal insert, generally shown as 134, has a base member 136 having a delivery portion 138 and a handle portion 140. The delivery portion 138 defines a chamber 142 and plurality of ports 144. A first electrode 146 is wound around the delivery portion 138. A first lead 149 extends CA 022~0113 1998-09-29 from the first electrode 146 and through the handle portion 140 so that it may be connected to the power source 70.
A membrane 148 is operably connected to the base member 136 and defines a reservoir lS0. The membrane 148 has a porous section for eng~ging the anterior vaginal wall 32. The ports 144 provide fluid communication between the chamber 142 and the reservoir 150. Additionally, the porous section of the membrane 148 can be located in only that portion of the membrane 148 that is placed against the anterior vaginal wall 32, thereby minimi7in~ the amount of tissue outside of the urinary tract that is exposed to the agent. However, one skilled in this art will realize that the entire m~mhr~n~ 148 could be porous.
The handle portion 140 defines a supply port 152 that is covered by a septum 154, which seals if punctured by a needle. The supply port 152 provides apassage for supplying fluid into the chamber 142 and the reservoir 150. A secondelectrode 156 is a patchtype electrode and configured to be placed against the patient's body. The second electrode 156 has a second lead 158 for connecting to the power source 70.
In use, a patient or caregiver will inject a fluid co~ g an agent through the supply port 152 and fill the reservoir 150 and chamber 142. The fluid is supplied in an amount that fills the reservoir l S0 with a ~l~s~u~e that p~ the membrane 148 to remain pliable. The vaginal insert 134 is then placed in the vagina 26 so that the pores in the membrane 148 engage the anterior vaginal wall 32. The second electrode 156 is then placed against the patient's body at a position such as the patient's abdomen or thigh. The power supply 70 is activated so that an iontophoretic current passes between the first and second electrodes 146 and 156 and transports the agent from the reservoir l S0 to tissues surrounding the urinary tract.
An advantage of vaginal insert 134 is that upon insertion, the vaginal walls will exert pres:iule against the membrane 148 and cause the fluid and agent to pass through the pores and through the anterior vaginal wall 32 where the agent can be absorbed by tissue surrounding the urinary tract.
Figures 10 and 11 A illustrate another vaginal insert, generally shown as 160, having a base member 162 and a first electrode 164 mounted on a surface 166 of the base member 162. The first electrode 164 is connectçd to the power source 70 via a first lead 167. A second, patch-type electrode 168 is configured to ~ be placed against the skin and is attached to the power source 70 via a lead 170. An agent-ret~ining member 172 is operably connectçd to the base member 162 and has an outer surface 174. The base m~mber 162 and agent-retaining member 172 are curved, thereby defining a channel 176 that is sized to engage the anterior vaginal wall 32 and receive tissue proxirnal the urethra 20. In this configuration, the agent-CA 022~0113 1998-09-29 lGl~ini~-g member 172 can be formed from a material such as polymer matrix, hydrogel, or hydrophilic foam that can be impregnated with the agent. The agent-re~ining member 172 is hllple~ ated with an agent.
In use, the vaginal insert 160 is placed in the vagina 26 so that the S curved outer surface 174 engages the anterior vaginal wall 32 and the channel 176 receives the tissue surrounding the urethra 20. The second electrode 168 is thenplaced against the patient's abdomen or thigh and the power source 70 is activated.
The iontophoretic current passes bc;lw~xll the first and second e}ectrodes 164 and 168 and transports the agent from the agent-ret~ining member 172 to the tissue proximal to the urethra 20.
In an alternative embodiment illustrated in Figure 1 lB, the base member 162 can define a chamber 163 and a plurality of delivery ports 165. The delivery ports provide fluid col-~ ication between the charnber 163 and the surface of base member 162. An electrode 169 is positioned within the chamber 163. The electrode is operably comlecled to the first lead 167. The base member 162 also defines a hole (not shown) that is covered by a septum (not shown). In order to fill the charnber, the user can simply inject the agent or a solution cont~ining the agent through the septum.
This alternative embodiment may contain the agent-retaining member 172. If the agent-~ g member 172 is used, it may contain a second theldpeulic agent or a penetration enh~n~er. Alternatively, the agent-ret~ining member could be loaded only with water in order to provide a path for the iontophoretic current that passes between the electrodes 169 and 168. One skilled in the art will realize that the alternative embodiment shown in Figure 1 lB is used in a sllhst~ti~lly similar manner to the embodiment shown in Figure 11 A.
Referring to Figures 12 and 13, another vaginal insert, generally shown as 178, has a base member 180 on which a first electrode 182 is mounted.
The first electrode 182 is co~ e~l~d to a power source 70 via a first lead 184. A
second, patch-type electrode 186 is configured to be placed against the patient's body at a point such as the abdomen or thigh. The second electrode 186 is then is connected to the power source 70 via a second lead 188. A cotton-fiber matrix 190 is mounted on the base member. The cotton-fiber matrix is absorbent and swells when it becomes wetted. One skilled in the art will realize that other materials that can be in.pl~e~ rd with an agent and that swells when wetted can be ~ubsliLu~ed for the cotton-fiber matrix 190.
The base member 180 and cotton-fiber matrix 190 are sized to fit within a tubular tampon-like applicator 192 when the cotton-fiber matrix 190 is not CA 022~0113 1998-09-29 W O 97/36641 PCTrUS97/04599 wetted. The tampon-like applicator 192 has a leading end 194 that is open and a trailing end 196 that is open.
In use, a user will position the base unit 180 and unwetted cotton-fiber matrix 190 in the tampon-like applicator 192 so that the first lead 184 extends S through the trailing end 196. The cotton-fiber matrix 190 is then wetted with a fluid that contains an agent. The user uses the tampon-like applicator 192 to insert the base member 180 and cotton-fiber matrix 190 combination into the vagina 26 much like a tampon. During this process, the cotton-fiber matrix 190 exr~n-l~ as it is pushed out of the leading end 194 of the tampon-like applicator 192. After the tampon-like applicator 192 is removed from the vagina 26, the swelled cotton-fiber matrix 190 will conform to the con~oul~ of the interior vaginal wall. The secondelectrode 186 is placed against the patient's body at a point such as the abdomen or thigh. When an electric current passes between the first and second electrodes 182 and 186, the agent will be t,a~s~nJ~led from the cotton-fiber matrix 190 to tissue surrounding the urinary tract, including the urethra 20.
One skilled in the art will realize that any of the embodiments described above can use ~ltern~tive methods to lla~ls~oll the agent. ~or example, the active ~ ll meçh~ni~m can be phonophoresis in which the electrodes are be replaced with an ultrasonic tr~n~d~lcers. Phonophoresis uses ultrasonic waves totransport the agent from the vaginal insert to the target tissue that is proximal to the urinary tract. Another alternative transport mech~ni~m is magnetophoresis. a magnetophoresis transport mech~ni~m has both an agent and magnetic particles impregnated in an agent-ret~ining m~teri~l that forms part of the vaginal insert. The magnetic particles will vibrate when subjected to an oscillating m~gn~ tic field, thereby driving the agent toward the target tissue. Additionally, all of the embo~iment~ described above can be used with passive delivery, in which case electrodes, ultrasonic trAn~lucers, and magnetic particles are not nece~ry. One skilled in the art will also realize that any agent-ret~ining m~t~ri~l may be substituted for a polymer matrix, hydrogel, or foam.
Although the description of vaginal inserts and methods has been quite specific, it is contemplated that various modifications could be made.
Accordingly, it is intentletl that the scope and spirit of the present invention can be dictated by the appended claims, rather than by the foregoing description.
.
Claims (39)
1. A vaginal insert for delivering an agent to a urogenital tract in a patient, the patient having a vagina, the vagina having anterior and posterior walls, the vaginal insert comprising:
a main portion;
first and second portions operably connected to the main portion, the first and second portions each having an end projecting outward from the main portion, at least one of the projecting ends being configured to contain the agent;
a first electrode proximate the projecting end of the first portion and a second electrode remote from the first electrode, the first and second electrodes configured to be placed in electrical communication with a power source so that the first and second electrodes have opposite polarity; and wherein the projecting ends of the first and second portions are configured to be positioned proximal diametrically opposed points of the urinary tract.
a main portion;
first and second portions operably connected to the main portion, the first and second portions each having an end projecting outward from the main portion, at least one of the projecting ends being configured to contain the agent;
a first electrode proximate the projecting end of the first portion and a second electrode remote from the first electrode, the first and second electrodes configured to be placed in electrical communication with a power source so that the first and second electrodes have opposite polarity; and wherein the projecting ends of the first and second portions are configured to be positioned proximal diametrically opposed points of the urinary tract.
2. The vaginal insert of claim 1 wherein the second electrode is proximate the projecting end of the second portion, thereby creating a bipolar electrode configuration.
3. The vaginal insert of claim 2 further comprising an internal power source, the power source being operably connected to the first and second electrodes.
4. The vaginal insert of claim 1 further comprising a third electrode proximate the projecting end of the second portion, the first and third electrodes being configured to have the same polarity.
5. The vaginal insert of claim 3 wherein the power source is an inductive circuit that generates a current when subjected to a magnetic field.
6. The vaginal insert of claim 5 wherein the inductive circuit is a resonant circuit having a resonant frequency.
7. The vaginal insert of claim 1 wherein the first portion defines a chamber anda port that is in fluid communication with the chamber.
8. The vaginal insert of claim 7 wherein the main portion defines a lumen, the lumen being in fluid communication with the chamber, further wherein the apparatus comprises a balloon formed from a porous membrane and in fluid communication with the port.
9. The vaginal insert of claim 7 wherein the second portion defines a chamber and a port that is in fluid communication with the chamber, the vaginal insert further comprising:
a first balloon formed from a porous membrane, the first balloon being operably connected to the first portion and in fluid communication with the port of the first portion; and a second balloon formed from a porous membrane, the second balloon being operably connected to the second portion and in fluid communication with the port of the second portion.
a first balloon formed from a porous membrane, the first balloon being operably connected to the first portion and in fluid communication with the port of the first portion; and a second balloon formed from a porous membrane, the second balloon being operably connected to the second portion and in fluid communication with the port of the second portion.
10. The vaginal insert of claim 1 wherein the means for containing an agent includes foam covering a portion of the projecting end of the first portion, the foam configured to be impregnated with the agent.
11. The vaginal insert of claim 10 wherein the means for containing an agent includes foam covering a portion of the projecting end of the first portion and the second portion, the foam configured to be impregnated with the agent.
12. The vaginal insert of claim 11 wherein the foam is configured to release theagent when placed in contact with the vaginal wall.
13. The vaginal insert of claim 1 wherein the means for containing an agent includes a polymer matrix covering a portion of the projecting end of the first portion, the polymer matrix configured to be impregnated with the agent.
14. The vaginal insert of claim 13 wherein the means for containing an agent includes a first polymer matrix covering a portion of the projecting end of the first portion and a second polymer matrix covering a portion of the projecting end of the second portion, the first and second polymer matrixes configured to be impregnated with the agent.
15. The vaginal insert of claim 14 wherein the polymer matrix is configured to release the agent when place in contact with the vaginal wall.
16. The vaginal insert of claim 14 wherein the polymer matrix is configured to dissolve when place in the vagina, thereby releasing the agent.
17. The vaginal insert of claim 14 wherein the polymer matrix contains magnetic particles, wherein the magnetic particles vibrate when subjected to an oscillating magnetic field.
18. The vaginal insert of claim 17 further comprising an internal circuit, the internal circuit being configured to generate an oscillating magnetic field thereby causing the magnetic particles to vibrate.
19. The vaginal insert of claim 18 wherein the internal circuit is a resonant circuit.
20. The vaginal insert of claim 1 further comprising an ultrasonic transducer operably connected to the first portion, the ultrasonic transducer being configured to be placed in electrical communication with a power source, thereby causing the ultrasonic transducer to emit ultrasonic waves and drive the agent toward the urogenital tract.
21. The vaginal insert of claim 20 further comprising an internal power source being operably connected to the ultrasonic transducer.
22. The vaginal insert of claim 21 wherein the internal power source is an inductive circuit that generates a current when subjected to a magnetic field.
23. A vaginal insert for delivering an agent to a urogenital tract in a patient, the patient having a vagina, the vagina having anterior and posterior walls, the vaginal insert comprising:
an elongated member configured to extend lengthwise in the vagina;
first and second portions operably connected to the main portion, the first and second portions each having an end projecting outward from the elongated member thereby forming a gap for receiving tissue surrounding a portion of the urogenital tract, at least one of the projecting ends being configured to contain the agent; and wherein the projecting ends of the first and second portions being configured to engage the anterior vaginal wall, thereby positioning the projecting end of the first portion proximal to one side of the urogenital tract and positioning the projecting end of the second portion proximal to an opposite side of the urogenital tract.
an elongated member configured to extend lengthwise in the vagina;
first and second portions operably connected to the main portion, the first and second portions each having an end projecting outward from the elongated member thereby forming a gap for receiving tissue surrounding a portion of the urogenital tract, at least one of the projecting ends being configured to contain the agent; and wherein the projecting ends of the first and second portions being configured to engage the anterior vaginal wall, thereby positioning the projecting end of the first portion proximal to one side of the urogenital tract and positioning the projecting end of the second portion proximal to an opposite side of the urogenital tract.
24. A vaginal insert for delivering an agent to a urogenital tract in a patient the patient having a vagina. the vagina having anterior and posterior walls, the vaginal insert comprising:
a main portion;
first and second portions operably connected to the main portion, the first and second portions each having an end projecting outward from the main portion, at least one of the projecting ends being configured to contain the agent;
wherein the first and second portions define an opening, have an open state, and have a closed state, the opening being configured to receive the bladder neck when the first and second portions are in the open state, and the first and second openings are configured to substantially circumscribe the bladder neck when in the closed state.
wherein the projecting ends of the first and second portions being configured to engage the anterior vaginal wall, thereby positioning the projecting end of the first portion proximal to one side of the urogenital tractand positioning the projecting end of the second portion proximal to an opposite side of the urogenital tract.
a main portion;
first and second portions operably connected to the main portion, the first and second portions each having an end projecting outward from the main portion, at least one of the projecting ends being configured to contain the agent;
wherein the first and second portions define an opening, have an open state, and have a closed state, the opening being configured to receive the bladder neck when the first and second portions are in the open state, and the first and second openings are configured to substantially circumscribe the bladder neck when in the closed state.
wherein the projecting ends of the first and second portions being configured to engage the anterior vaginal wall, thereby positioning the projecting end of the first portion proximal to one side of the urogenital tractand positioning the projecting end of the second portion proximal to an opposite side of the urogenital tract.
25. The vaginal insert of claim 24 wherein the first and second portions each have a C-shaped segment.
26. A method of delivering an agent to a urogenital tract within a patient, the patient having a vagina, the vagina having an anterior wall and a posterior wall, the method comprising the steps of:
inserting a vaginal insert into the vagina, the vaginal insert having a first and second projecting portions, the first projecting portions containing an agent;
positioning the first projecting portion on one side of the urogenital tract and the second portion on an opposite side of the urogenital tract; and transporting the agent from the first projecting portion to the urogenital tract.
inserting a vaginal insert into the vagina, the vaginal insert having a first and second projecting portions, the first projecting portions containing an agent;
positioning the first projecting portion on one side of the urogenital tract and the second portion on an opposite side of the urogenital tract; and transporting the agent from the first projecting portion to the urogenital tract.
27. The method of claim 26 wherein the vaginal insert includes a first electrodeoperably connected to the first projecting portion, the step of transporting the agent including the steps of:
placing a second electrode in contact with the patient's body: and conducting a current between the first and second electrode so that the current flows proximate the urogenital tract.
placing a second electrode in contact with the patient's body: and conducting a current between the first and second electrode so that the current flows proximate the urogenital tract.
28. The method of claim 26 wherein the vaginal insert contains a first electrodeoperably connected to the first projecting portion and a second electrode operably connected to the second projecting portion, the step of transporting the agent including the step of conducting a current between the first and second electrode so that the current flows proximate the urogenital tract.
29. The method of claim 28 wherein the vaginal insert includes an inductive circuit that generates a current when subjected to a magnetic field. the step oftransporting the agent further includes the step of subjecting the inductive circuit to a magnetic field.
30. The method of claim 28 wherein the agent contained by the first projecting portion has one polarity and the second projecting portion contains an agent having an opposite polarity and a second electrode, the step of transporting the agent including the steps of:
transporting the agent having one polarity from the first projecting portion to tissue proximate the urogenital tract; and transporting the agent having an opposite polarity from the second projecting portion to tissue proximate the urogenital tract.
transporting the agent having one polarity from the first projecting portion to tissue proximate the urogenital tract; and transporting the agent having an opposite polarity from the second projecting portion to tissue proximate the urogenital tract.
31. The method of claim 26 wherein the first projecting portion includes a polymer matrix for contain the agent and magnetic particles, the step of transporting the agent includes the step of subjecting the magnetic particles to an oscillating magnetic field.
32. The method of claim 26 wherein the first and second projecting portions define a gap, have an open state, and have a closed state, the gap being configured to receive the bladder neck when in the open state and configured to substantially surround the bladder neck when in the closed state, the method comprising the additional steps of:
placing the bladder neck in the gap while the first and second projecting portions are in the open state; and shifting the first and second projecting portions from the open state to the closed state so that the first and second projecting portions substantially circumscribe the bladder neck.
placing the bladder neck in the gap while the first and second projecting portions are in the open state; and shifting the first and second projecting portions from the open state to the closed state so that the first and second projecting portions substantially circumscribe the bladder neck.
33. An apparatus for delivering an agent to a urogenital tract within a patient, the patient having a vagina, the vagina having an anterior wall and a posterior wall, the apparatus comprising:
means for inserting a vaginal insert into the vagina. the vaginal insert having a first and second projecting portions, the first projecting portions containing an agent;
means for positioning the first projecting portion on one side of the urogenital tract and the second portion on an opposite side of the urogenital tract; and means for transporting the agent from the first projecting portion to the urogenital tract.
means for inserting a vaginal insert into the vagina. the vaginal insert having a first and second projecting portions, the first projecting portions containing an agent;
means for positioning the first projecting portion on one side of the urogenital tract and the second portion on an opposite side of the urogenital tract; and means for transporting the agent from the first projecting portion to the urogenital tract.
34. The apparatus of claim 33 wherein the vaginal insert includes a first electrode operably connected to the first projecting portion, the means for transporting the agent including:
means for placing a second electrode in contact with the patient's body; and means for conducting a current between the first and second electrode so that the current flows proximate the urogenital tract.
means for placing a second electrode in contact with the patient's body; and means for conducting a current between the first and second electrode so that the current flows proximate the urogenital tract.
35. The apparatus of claim 33 wherein the vaginal insert contains a first electrode operably connected to the first projecting portion and a second electrode operably connected to the second projecting portion, the means for transporting the agent including means for conducting a current between the first and second electrode so that the current flows proximate the urogenital tract.
36. The apparatus of claim 35 wherein the vaginal insert includes an inductive circuit that generates a current when subjected to a magnetic field, the means for transporting the agent further including means for subjecting the inductive circuit to a magnetic field.
37. The apparatus of claim 35 wherein the agent contained by the first projecting portion has one polarity and the second projecting portion contains an agent having an opposite polarity and a second electrode, the means for transporting the agent further including:
means for transporting the agent having one polarity from the first projecting portion to tissue proximate the urogenital tract; and means for transporting the agent having an opposite polarity from the second projecting portion to tissue proximate the urogenital tract.
means for transporting the agent having one polarity from the first projecting portion to tissue proximate the urogenital tract; and means for transporting the agent having an opposite polarity from the second projecting portion to tissue proximate the urogenital tract.
38. The apparatus of claim 33 wherein the first projecting portion includes a polymer matrix for contain the agent and magnetic particles, the means for transporting the agent including means for subjecting the magnetic particles to an oscillating magnetic field.
39. The apparatus of claim 33 wherein the first and second projecting portions define a gap, have an open state, and have a closed state. the gap being configured to receive the bladder neck; when in the open state and configured to substantiallysurround the bladder neck when in the closed state, the apparatus further comprising:
means for placing the bladder neck in the gap while the first and second projecting portions are in the open state; and means for shifting the first and second projecting portions from the open state to the closed state so that the first and second projecting portions substantially circumscribe the bladder neck.
means for placing the bladder neck in the gap while the first and second projecting portions are in the open state; and means for shifting the first and second projecting portions from the open state to the closed state so that the first and second projecting portions substantially circumscribe the bladder neck.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/625,809 | 1996-03-29 | ||
| US08/625,809 US5988169A (en) | 1996-03-29 | 1996-03-29 | Vaginal insert and method for treating urogenital disorders |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2250113A1 true CA2250113A1 (en) | 1997-10-09 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002250113A Abandoned CA2250113A1 (en) | 1996-03-29 | 1997-03-21 | Vaginal insert and device for treating urogenital disorders |
Country Status (3)
| Country | Link |
|---|---|
| US (1) | US5988169A (en) |
| CA (1) | CA2250113A1 (en) |
| WO (1) | WO1997036641A1 (en) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6773418B1 (en) | 1999-08-18 | 2004-08-10 | Iotek, Inc. | Device and method for delivery of agents to the female reproductive tract |
| US7079882B1 (en) | 2000-01-22 | 2006-07-18 | Richard Schmidt | Method and apparatus for quantifying nerve and neural-muscular integrity related to pelvic organs or pelvic floor functions |
| US6478726B1 (en) | 2001-04-19 | 2002-11-12 | Kimberly-Clark Worldwide, Inc. | Method for alleviating female urinary incontinence |
| US6458072B1 (en) | 2001-04-19 | 2002-10-01 | Kimberly-Clark Worldwide, Inc. | Urinary incontinence device |
| US6558370B2 (en) | 2001-06-05 | 2003-05-06 | Kimberly-Clark Worldwide, Inc. | Urinary incontinence device |
| US6770025B2 (en) | 2002-09-18 | 2004-08-03 | Kimberly-Clark Worldwide, Inc. | Molar shaped vaginal incontinence insert |
| US6676594B1 (en) | 2002-09-18 | 2004-01-13 | Kimberly-Clark Worldwide, Inc. | C-shaped vaginal incontinence insert |
| US6808485B2 (en) | 2002-12-23 | 2004-10-26 | Kimberly-Clark Worldwide, Inc. | Compressible resilient incontinence insert |
| US8217219B2 (en) * | 2003-12-29 | 2012-07-10 | Kimberly-Clark Worldwide, Inc. | Anatomically conforming vaginal insert |
| US10004584B2 (en) | 2006-07-10 | 2018-06-26 | First Quality Hygienic, Inc. | Resilient intravaginal device |
| US7717892B2 (en) | 2006-07-10 | 2010-05-18 | Mcneil-Ppc, Inc. | Method of treating urinary incontinence |
| US8613698B2 (en) | 2006-07-10 | 2013-12-24 | Mcneil-Ppc, Inc. | Resilient device |
| US10219884B2 (en) | 2006-07-10 | 2019-03-05 | First Quality Hygienic, Inc. | Resilient device |
| EP2043570B1 (en) | 2006-07-10 | 2018-10-31 | First Quality Hygienic, Inc. | Resilient device |
| US9072582B2 (en) | 2013-03-14 | 2015-07-07 | Ryan Maaskamp | Rectocele device |
| US9216105B2 (en) | 2013-03-14 | 2015-12-22 | Medicele, Llc. | Rectocele and cystocele device |
| US11896823B2 (en) | 2017-04-04 | 2024-02-13 | Btl Healthcare Technologies A.S. | Method and device for pelvic floor tissue treatment |
| US11259957B2 (en) | 2019-09-25 | 2022-03-01 | Ryan Maaskamp | Rectocele guide |
Family Cites Families (87)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US527788A (en) * | 1894-10-23 | Electric uterine battery | ||
| US487655A (en) * | 1892-12-06 | Electro-therapeutic process and apparatus | ||
| US1790801A (en) * | 1931-02-03 | Louis dickstehst | ||
| US600290A (en) * | 1898-03-08 | Therapeutic electrode | ||
| US866180A (en) * | 1907-06-13 | 1907-09-17 | Cutler Taylor Ball | Combined applicator and dilator. |
| US1030543A (en) * | 1909-02-16 | 1912-06-25 | Leslie R Saunders | Syringe with electric attachment. |
| US1253955A (en) * | 1917-05-22 | 1918-01-15 | Edward H Galligan | Surgical implement. |
| US1584464A (en) * | 1923-03-07 | 1926-05-11 | Clarence H Maranville | Medicinal applicator |
| US1852351A (en) * | 1928-04-02 | 1932-04-05 | Lewis Everett Marion | Vaginal douche pipe |
| US1740240A (en) * | 1928-06-11 | 1929-12-17 | Charles F Honey | Cataphoric electrode |
| US2711172A (en) * | 1952-06-19 | 1955-06-21 | Booth William Irving | Rectal and vaginal applicator |
| US3967618A (en) * | 1969-04-01 | 1976-07-06 | Alza Corporation | Drug delivery device |
| US3993073A (en) * | 1969-04-01 | 1976-11-23 | Alza Corporation | Novel drug delivery device |
| US3948262A (en) * | 1969-04-01 | 1976-04-06 | Alza Corporation | Novel drug delivery device |
| US3705575A (en) * | 1969-09-26 | 1972-12-12 | Lynn Euryl Edwards | Incontinence device for female use |
| US3726277A (en) * | 1970-08-31 | 1973-04-10 | S Hirschman | Feminine hygienic pad |
| US3995631A (en) * | 1971-01-13 | 1976-12-07 | Alza Corporation | Osmotic dispenser with means for dispensing active agent responsive to osmotic gradient |
| US3865108A (en) * | 1971-05-17 | 1975-02-11 | Ortho Pharma Corp | Expandable drug delivery device |
| BE788910A (en) * | 1971-09-17 | 1973-03-15 | Alemany R | GYNECOLOGICAL MEANS |
| US3948254A (en) * | 1971-11-08 | 1976-04-06 | Alza Corporation | Novel drug delivery device |
| US3938515A (en) * | 1971-12-20 | 1976-02-17 | Alza Corporation | Novel drug permeable wall |
| GB1452262A (en) * | 1972-07-13 | 1976-10-13 | Devices Implants Ltd | Pessary ring electrode system |
| US3815600A (en) * | 1972-07-24 | 1974-06-11 | H Groves | Vaginal medicator |
| US3817248A (en) * | 1972-11-06 | 1974-06-18 | Alza Corp | Self powered device for delivering beneficial agent |
| US3921636A (en) * | 1973-01-15 | 1975-11-25 | Alza Corp | Novel drug delivery device |
| US3902493A (en) * | 1974-05-13 | 1975-09-02 | Procter & Gamble | Medicated catamenial tampon |
| US3993072A (en) * | 1974-08-28 | 1976-11-23 | Alza Corporation | Microporous drug delivery device |
| US4155991A (en) * | 1974-10-18 | 1979-05-22 | Schering Aktiengesellschaft | Vaginal ring |
| US4066075A (en) * | 1975-05-16 | 1978-01-03 | The Procter & Gamble Company | U-shape intravaginal device |
| US4144317A (en) * | 1975-05-30 | 1979-03-13 | Alza Corporation | Device consisting of copolymer having acetoxy groups for delivering drugs |
| US4031886A (en) * | 1975-09-11 | 1977-06-28 | Morhenn Vera B | Occlusive pessary |
| US3995634A (en) * | 1975-12-02 | 1976-12-07 | The Procter & Gamble Company | Vaginal cavity dispensing means and method |
| US3991760A (en) * | 1975-12-02 | 1976-11-16 | The Procter & Gamble Company | Vaginal medicament dispensing means |
| US3995633A (en) * | 1975-12-02 | 1976-12-07 | The Procter & Gamble Company | Vaginal Medicament dispensing device |
| US4169804A (en) * | 1976-08-19 | 1979-10-02 | Minnesota Mining And Manufacturing Company | Magnetically responsive composite microparticle |
| US4286596A (en) * | 1978-02-27 | 1981-09-01 | Herbert Rubinstein | Tampon containing a liquid medicant |
| US4553965A (en) * | 1978-05-17 | 1985-11-19 | Shepard Conn | Fluid-expansible contraceptive tampon and applicator |
| US4286587A (en) * | 1978-10-11 | 1981-09-01 | Alza Corporation | Vaginal drug delivery system made from polymer |
| US4217898A (en) * | 1978-10-23 | 1980-08-19 | Alza Corporation | System with microporous reservoir having surface for diffusional delivery of agent |
| US4291014A (en) * | 1979-01-11 | 1981-09-22 | Key Pharmaceuticals, Inc. | Polymeric diffusion matrix containing estradiol diacetate |
| US4210139A (en) * | 1979-01-17 | 1980-07-01 | Alza Corporation | Osmotic device with compartment for governing concentration of agent dispensed from device |
| US4235236A (en) * | 1979-02-12 | 1980-11-25 | Alza Corporation | Device for dispensing drug by combined diffusional and osmotic operations |
| US4304232A (en) * | 1979-03-14 | 1981-12-08 | Alza Corporation | Unit system having multiplicity of means for dispensing useful agent |
| DE3068649D1 (en) * | 1979-03-23 | 1984-08-30 | Upjohn Co | Medicated device for controlled drug release |
| US4237888A (en) * | 1979-03-23 | 1980-12-09 | The Upjohn Company | Two-membrane medicated device for rate-controlled administration of prostaglandins |
| US4250611A (en) * | 1979-04-19 | 1981-02-17 | Alza Corporation | Process for making drug delivery device with reservoir |
| US4438139A (en) * | 1979-08-14 | 1984-03-20 | Key Pharmaceuticals, Inc. | Polymeric diffusion matrix containing estrogens |
| US4402695A (en) * | 1980-01-21 | 1983-09-06 | Alza Corporation | Device for delivering agent in vagina |
| FR2475890A1 (en) * | 1980-02-18 | 1981-08-21 | Roussel Uclaf | DEVICE FOR THE ADMINISTRATION OF MEDICINAL MATERIALS |
| US4312347A (en) * | 1980-02-25 | 1982-01-26 | Iowa State University Research Foundation, Inc. | Positive pressure drug releasing device |
| AU538961B2 (en) * | 1980-06-09 | 1984-09-06 | Alex Harvey Industries Limited | Intra-vaginal device |
| DE3040978A1 (en) * | 1980-10-28 | 1982-05-27 | Schering Ag, 1000 Berlin Und 4619 Bergkamen | VAGINAL RING |
| GB2090535B (en) * | 1981-01-06 | 1984-09-19 | Osman Mohammad Fekry | Medical inserts |
| US4402693A (en) * | 1981-05-07 | 1983-09-06 | The Upjohn Company | Medicated device holder |
| DE3267569D1 (en) * | 1981-07-14 | 1986-01-02 | Cimber Hugo | Occlusive pessary |
| US4439196A (en) * | 1982-03-18 | 1984-03-27 | Merck & Co., Inc. | Osmotic drug delivery system |
| US4582052A (en) * | 1982-03-23 | 1986-04-15 | Repromed, Inc. | Povidone-iodine dispensing fiber |
| NZ200564A (en) * | 1982-05-10 | 1987-03-06 | Ahi Operations Ltd | Device for slowly releasing chemicals into body cavities of animals |
| US4629449A (en) * | 1982-07-29 | 1986-12-16 | Alza Corporation | Vaginal dispenser for dispensing beneficial hormone |
| US4961931A (en) * | 1982-07-29 | 1990-10-09 | Alza Corporation | Method for the management of hyperplasia |
| US4469671A (en) * | 1983-02-22 | 1984-09-04 | Eli Lilly And Company | Contraceptive device |
| US4564362A (en) * | 1983-07-07 | 1986-01-14 | Burnhill Michael S | Vaginal device |
| US4601714A (en) * | 1983-07-07 | 1986-07-22 | Burnhill Michael S | Vaginal device |
| US4578076A (en) * | 1984-03-20 | 1986-03-25 | The Population Council, Inc. | Medicated intracervical and intrauterine devices |
| US4846824A (en) * | 1984-05-21 | 1989-07-11 | Kimberly-Clark Corporation | Labial sanitary pad |
| EP0180264A1 (en) * | 1984-10-12 | 1986-05-07 | Akzo N.V. | Release system for two or more active substances |
| SE8602666D0 (en) * | 1986-06-16 | 1986-06-16 | Leo Ab | INTRAVAGINAL DEVICES |
| US5019372A (en) * | 1986-06-27 | 1991-05-28 | The Children's Medical Center Corporation | Magnetically modulated polymeric drug release system |
| ES2030732T3 (en) * | 1986-10-14 | 1992-11-16 | Zedlani Pty. Limited | DEVICE FOR URINARY INCONTINENCE. |
| US5386836A (en) * | 1986-10-14 | 1995-02-07 | Zedlani Pty Limited | Urinary incontinence device |
| US4860754A (en) * | 1987-04-01 | 1989-08-29 | E. R. Squibb & Sons, Inc. | Electrically conductive adhesive materials |
| GB8713938D0 (en) * | 1987-06-15 | 1987-07-22 | West H R | Female urinary incontinence devices |
| US4804380A (en) * | 1987-08-06 | 1989-02-14 | Kimberly-Clark Corporation | Anatomically shaped, self-aligning, sanitary protection device |
| ATE131081T1 (en) * | 1988-01-21 | 1995-12-15 | Massachusetts Inst Technology | MOLECULAR TRANSPORT THROUGH TISSUES USING ELECTROPORATION. |
| DE3809815A1 (en) * | 1988-03-23 | 1989-10-12 | Peter Zimmer | Internal electrode for introduction in a body cavity |
| US4881526A (en) * | 1988-05-27 | 1989-11-21 | Empi, Inc. | Intravaginal electrode and stimulation system for controlling female urinary incontinence |
| US5070889A (en) * | 1988-10-13 | 1991-12-10 | Leveen Harry H | Contraceptive sponge and tampon |
| US4932421A (en) * | 1989-01-23 | 1990-06-12 | Steven Kaali | Electrified intrauterine device |
| US5007894A (en) * | 1989-02-10 | 1991-04-16 | Goran Enhorning | Female incontinence device |
| US5188122A (en) * | 1989-06-20 | 1993-02-23 | Rocket Of London Limited | Electromagnetic energy generation method |
| DE69119917T2 (en) * | 1990-01-15 | 1996-10-24 | Cino Rossi | Iontophoresis device |
| JPH03297475A (en) * | 1990-04-16 | 1991-12-27 | Ken Ishihara | Controlling method for emission of medicine by means of resonance sound wave |
| US5499971A (en) * | 1990-06-15 | 1996-03-19 | Cortrak Medical, Inc. | Method for iontophoretically delivering drug adjacent to a heart |
| US5299581A (en) * | 1990-07-05 | 1994-04-05 | Donnell John T | Intravaginal device |
| GB9108677D0 (en) * | 1991-04-23 | 1991-06-12 | Byrne Phillip O | Drug release device |
| US5458568A (en) * | 1991-05-24 | 1995-10-17 | Cortrak Medical, Inc. | Porous balloon for selective dilatation and drug delivery |
| US5298017A (en) * | 1992-12-29 | 1994-03-29 | Alza Corporation | Layered electrotransport drug delivery system |
-
1996
- 1996-03-29 US US08/625,809 patent/US5988169A/en not_active Expired - Fee Related
-
1997
- 1997-03-21 CA CA002250113A patent/CA2250113A1/en not_active Abandoned
- 1997-03-21 WO PCT/US1997/004599 patent/WO1997036641A1/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| US5988169A (en) | 1999-11-23 |
| WO1997036641A1 (en) | 1997-10-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |