Note: Descriptions are shown in the official language in which they were submitted.
<br/> ~069~1<br/> S~r~ARY OF THE INVENTION:<br/> The invention is directed to an apparatus for dispensing<br/>a material, as a drug, into the canals of the Fallopian tubes.<br/>The apparatus has a housing having a chamber. Container means<br/>storing the material is located in the chamber. ~ieans having<br/>a passage for receiving the material from the container means<br/>is associated with the housing. r~eans, as a needle, is operable<br/>to puncture a part of the container means whereby material<br/>from the container means passes to the passage and the means<br/>for receiving the fluid. Actuator means cooperate with the<br/>container means and means for piercing the container means<br/>whereby material within the container means flows from the<br/>container means into the passage for receiving material.<br/> One form of the container means has a collapsible side<br/>wall surrounding a chamber for storing one unit of fluid. The<br/>needle is located within the chamber whereby the container<br/>means material and needle are a compact assembly with the<br/>needle protected by the container means. The bottom wall of<br/>the container means has a tubular member closed with a diaphragm.<br/>The needle pierces the diaphragm when the container means is<br/>collapsed whereby the material is dispensed from the container.<br/> One form of the apparatus has a body with a pair of<br/>chambers and an elongated first tube adapted to be inserted<br/>into the uterine caavity. A second tube within the first tube<br/>is connected to one of the chambers. An expandable sleeve<br/>attached to the end of the first tube fills the uterine cavity.<br/>Fluid, as water or air, under pressure within the sleeve holds<br/>the sleeve in firm engagement with the inner wall of the uterus.<br/>Containers storing materials are located in the chambers. An<br/>actuator mechanism cooperates with the containers to sequent-<br/>ially dispense the materials into the first tuhe to expand the<br/>sleeve and then into the second tube to discharge material, as<br/>a drug, tissue adhesive, or the like, into the uterine cavity.<br/>- 2 -<br/><br/> 1(Y~;97~1<br/>More specifically, the invention is directed to a methodand apparatus for introducing a predetermined amount of tissue<br/>adhesive into the canals of the Fallopian tubes of a female<br/>from the uterine cavity. The apparatus has an elongated probe<br/>having a forward end carrying an expandable balloon assemhly.<br/> A dispensing housing having an actuator is used to expand the<br/>balloon assembly and discharge material into the uterine cavity.<br/> The dispenser has a first drive assembly operable to initially<br/>partially expand the balloon assembly to form a seal and hold-<br/>ing structure in the lower portion of the uterine cavity.Continued movement of the actuator discharges the material into<br/>the uterine cavity above the partially expanded balloon assembly.<br/> Further continued movement of the actuator continues the expan-<br/>sion of the balloon assembly to displace the remaining space<br/>in the uterine cavity. The balloon assembly expands and forces<br/>the material into both canals of the Fallopian tubes. Substan-<br/>tially all of the material introduced into the uterine cavity<br/>is moved by the expanding balloon assembly into the canals of<br/>the Fallopian tubes in a short period of tiem. When a tissue<br/>adhesive is placed in the canals, it reacts with the tissue<br/>to polymerize the adhesive and thereby occlude the canals.<br/> The tissue adhesive is eventually replaced with scar tissue<br/>which permanently occludes the canals. The balloon assembly<br/>is contracted whereby it can be readily removed from the uterine<br/>cavity by withdrawing the actuator from the housing.<br/> The material can be a mixture of materials which set up<br/>after they are mixed. Separate materials are moved to the<br/>discharge end of the dispenser and mixed at the end. The mix-<br/>ture of materials is directed into the uterine cavity. The<br/>expansion of the balloon assembly forces the mixture of<br/>material into the canals of the Fallopian tubes.<br/><br/> ~69 7~<br/> The invention includes the method of occluding the canals<br/>of the Fallopian tubes by inserting an instrument having an<br/>expandable sleeve into the uterine cavity through the cervical<br/>opening. The expandable sleeve is subjected to fluid under<br/>pressure to hold the sleeve in firm uniform engagement with<br/>the inner wall of the uterus. A fluid, as a drug, tissue<br/>adhesive or the like, is delivered via the instrument to the<br/>upper section of the uterine caivty. The fluid flows over the<br/>top of the expanded sleeve and into the canals of the Fallopian<br/>tubes. Tissue adhesive fluids react with the moisture in the<br/>tissue of the Fallopian tubes to set up the adhesive, thereby<br/>blocking the canals. Other types of fluids can be injected<br/>into the canals to kill the tissue of the canal linings. This<br/>tissue is replaced with scar tissue which occludes the canals.<br/> The instrument is removed from the uterine cavity after the<br/>sleeve is deflated by draining the fluid therefrom.<br/> An object of the invention is to provide an apparatus and<br/>method of introducing a predetermined minimum amount of material<br/>into both canals of the Fallopian tubes of a female from the<br/>uterine cavity. Another object of the invention is to provide<br/>a dispensing apparatus and method which has an actuator movable<br/>to discharge tissue adhesives into the uterine cavity and move<br/>the tissue adhesives from the uterine cavity into the canals<br/>of the Fallopian tubes of a female before the adhesives can<br/>set up in the uterine cavity. Another object of the invention<br/>is to provide an apparatus for introducing in a short period<br/>of time a controlled amount of material into the canals of the<br/> Fallopian tubes under low pressure with a single and continuous<br/>action on the part of the operator. A further object of the<br/>invention is to provide an apparatus for introducing material<br/>into the canals of the Fallopian tubes which places a minimum<br/>amount of force on the walls of the uterus and can accommodate<br/><br/> 106~791<br/>different sizes, shapes and characteristics of uteri. A<br/>further object of the invention is to provide an apparatus<br/>and method for introducing material into both canals of the<br/> Fallopian tubes which is not position sensitive and does not<br/>apply substantial pressure to the material, whereby the material<br/>is not forced into the blood stream or body cavity. Yet an-<br/>other object of the invention is to provide an apparatus and<br/>method of introducing material into both canals of the Fallopian<br/>tubes with the balloon assembly subjected to a maximum predeter-<br/>mined pressure to eliminate over-expansion of the uterus. A<br/>still further object of the invention is to provide an apparatus<br/>for placing material into the canals of the Fallopian tubes<br/>which is simple to operate and is used with a minimum of mani-<br/>pulative delay. Another object of the invention is to provide<br/>an apparatus and method for mixing separate materials, directing<br/>the mixed materials into the uterine cavity and forcing the<br/>mixed materials in the uterine cavity into the canals of the<br/> Fallopian tubes. Other objects and advantages of the apparatus<br/>and method of the invention are set out in the following speci-<br/>fication and accompanying drawings.IN THE DRAWINGS:<br/> Figure 1 is a longitudinal sectional view of the genital<br/>system of a female primate with the dispensing instrument<br/>extended into the uterine cavity;<br/> Figure 2 is a top elevational view of the dispensing<br/>unit of the instrument;<br/> Figure 3 is an enlarged sectional view taken along the<br/>line 3-3 of Figure l;<br/> Figure 4 is an enlarged sectional view taken along the<br/>line 4-4 of Figure 3;<br/> Figure 5 is a sectional view taken along the line 5-5<br/>of Figure 4;<br/><br/> 7g.1<br/> Figure 6 is a sectional view similar to Figure 4 showing<br/>the dispensing unit actuated to discharge fluid therefrom;<br/> Figure 7 is a cross sectional view o-f a modified dispen-<br/>sing unit for the dispenser;<br/> Figure 8 is a sectional view taken along the line 8-8<br/>of Figure 7;<br/> Figure 9 is a sectional view similar to Figure 7 showing<br/>the dispensing unit in the discharge position;<br/>Figure 10 is a diagrammatic view of a further modification<br/>of the dispensing unit in a non-dispensing position;<br/>: Figure 11 is a sectional view similar to Figure 10 showing<br/> the dispensing unit in the discharge position;<br/> Figure 12 is a longitudinal sectional view of a further<br/>modified dispensing unit in the non-dispensing position;<br/> Figure 13 is a view similar to Figure 12 showing the<br/>dispensing unit in the discharge position;<br/> Figure 14 is a side elevational view of a container spaced<br/>from a needle adapted to carry fluid from the container;<br/> Figure 15 is an end elevational view of the sealed end<br/>of the container of Figure 14;<br/> Figure 16 is a longitudinal sectional view taken along<br/>the line 16-16 of Figure 15;<br/> Figure 17 is an enlarged sectional view of the sealed<br/>end of the container;<br/> Figure 18 is a sectional view taken along the line 18-18<br/>of Figure 14;<br/> Figure 19 is a sectional view similar to Figure 16 showing<br/>the container in assembled relation with the needle;<br/> Figure 20 is a top plan view of a modified dispensing<br/>instrument of the invention;<br/> Figure 21 is an enlarged sectional view taken along the<br/>line 21-21 of Figure 20;<br/><br/> 106~791<br/> Figure 22 is a sectional view taken along the line 22-22<br/>of Figure 21;<br/> Figure 23 is an enlarged sectional view taken along the<br/>line 23-23 of Figure 20;<br/> Figure 24 is a sectional view similar to Figure 23 shol~ing<br/>the lock in the release position;<br/> Figure 25 is a sectional view similar to Figure 23 showing<br/>a modification of the lock;<br/> Figure 26 is a top plan view of another modification of<br/>the dispensing instrument of the invention;<br/> Figure 27 is an enlarged sectional view taken along the<br/>line 27-27 of Figure 26;<br/> Figure 28 is a sectional view taken along the line 28-28<br/>of Figure 27;<br/> Figure 29 is an enlarged sectional view taken along the<br/>line 29-29 of Figure 27;<br/> Figure 30 is a view similar to Figure 29 showing the<br/>movable member in the second position;<br/> Figure 31 is an enlarged sectional view of the fluid<br/>container assembly used in the dispensing instrument;<br/> Figure 32 is a foreshortened sectional view o a repro-<br/>ductive system of a female accommodating a dispensing instrument<br/>of the invention for locating drug material in both canals of<br/>the Fallopian tubes;<br/> Figure 33 is a longitudinal sectional view of the dispen-<br/>sing assembly of the instrument of the invention;<br/> Figure 34 is a sectional view taken along the line 34-34<br/>of Figure 32;<br/> Figure 35 is a foreshortened sectional view of the female<br/>reproductive system accommodating the dispensing instrument<br/>shown in section with the balloon assembly partially inflated<br/>in the uterine cavity and drug material in the uterine cavity;<br/> -- 7<br/><br/> 1069791<br/> Figure 36 is a foreshortened sectional view similar to<br/> Figure 35 showing the balloon assembly fully expanded in the<br/>uterine cavity;<br/> Figure 37 is a foreshortened plan view, partly sectioned,<br/>similar to Figure 35, of a modification of the dispensing<br/>instrument; and<br/> Figure 38 is an enlarged sectional view of the discharge<br/>end of the dispensing instrument of Figure 37.<br/> DESCRIPTION OF PREFERRED E~BODIMENTS:<br/> Referring to the drawing, there is shown in Figure 1 a<br/> - diagrammatic female genital system indicated generally at 20.<br/> An intrauterine catheter indicated generally at 21 is located<br/>in the genital system to direct a fluid9 as a drug, tissue<br/>adhesive, or other material, into the canals of the Fallopian<br/>tubes. The tissue adhesive can be isobutyl 2-cyanoacrylate<br/>monomer, silver nitrate or quinacrine materials. The cyano-<br/>acrylate monomer is a liquid plastic which sets up or polymer-<br/>izes in response to moisture and thereby functions to occlude<br/>the canals of the Fallopian tubes. The drug materials can be<br/>of the type that temporarily block or occlude the canals of<br/>the Fallopian tubes. After a period of time the canals will<br/>reopen to resume their normal function.<br/> The genital system 20 has an elongated vagina 22 defined<br/>by the cylindrical vaginal wall 23. The vagina 22 opens into<br/>the vestibule 24. The opposite end of the vagina is attached<br/>to the uterus, indicated generally at 26. Uterus 26 is a pear-<br/>shaped, thick walled, hollow organ situated between the bladder<br/>and rectum. Uterus 26 has a uterine cavity 27 which is flat-<br/>tened and triangular in shape. The size of the uterine cavity<br/>varies from female to female. The top or fundus 28 of uterus<br/>26 is joined to the uterus body 29. The lower end of the body<br/>contains the cervix 31 which separates the vagina 22 from the<br/><br/> ~0ti9791<br/>uterine cavity 27. The uterine wall is composed of an outer<br/>serosal layer, or peritoneum; a firm, thick, intermediate coat<br/>of smooth muscle tissue, or myometrium; and an inner mucosal<br/>lining, or endometrium 32.<br/> Leading to the upper part of opposite sides of the uterus<br/>26 are Fallopian tubes 33 and 34. The Fallopian tubes are<br/>paired, trumpet-shaped, muscular members which extend from the<br/>superior angles of the uterine cavity to the ovaries (not shown).<br/>The ovaries are solid, slightly irregular shaped bodies situ-<br/>uated on either side of the uterus behind and below the Fallopiantubes.<br/> Fallopian tubes 33 and 34 each have a canal or aqueduct<br/>36 and 37 respectively. The Fallopian tubes are musculomem-<br/>branous structures about 12 cm. in length. The are commonly<br/>divided into isthmus, intramural and ampullary sections. The<br/>canals 36 and 37 provide passages for the movement of ova from<br/>the ovaries into the uterine cavity. The intramural section<br/>- of the Fallopian tubes traverses the uterine wall in more or<br/> less straight fashion. It has an ampulla-like dilation just<br/>before it communicates with the uterine cavity 27. The canals<br/>36 and 37 are narrowest at the intramural sections. The walls<br/>of the Fallopian tubes consist of three layers; a serosal layer,<br/>a muscular layer and a mucosal lining. The muscular layer<br/>includes longitudinal muscle fibers which, when contracted,<br/>bring the ends of the Fallopian tubes in close contact with<br/>the surface of the ovaries. Blood vessels are abundant in<br/>the muscular layer where they form with the muscle bundles<br/>a kind of erectile tissue which, if engorged, moves the<br/>Fallopian tubes to sweep over the surface of the ovaries.<br/>This movement of the Fallopian tubes is impaired when the<br/>tubes are severed and tied. Occluding the canals 36 and 37<br/>with the drug material according to the invention does not<br/>g<br/><br/> -<br/>1~6~791<br/>j.~ ..~<br/>interfere with the erectile action and movement of the Fallop-<br/>ian tubes.<br/> Catheter 21 has an elongated first tube 38 having a<br/>length sufficient to extend through the vagina and into the<br/>uterine cavity 27. An expandable sleeve member 39, as a<br/>balloon or the like, is secured to the upper end of tube 38<br/>with bands 40. The outer end of sleeve member 39 terminates<br/>at the outer end of tube 38. Sleeve member 39 is a flexible<br/>elastic member made of relaxed rubber material. The rubber<br/>material has uniform surface tension and uniform expansion<br/>characteristics. Sleeve member 39 is expanded into uniform<br/>and firm engagement with the inner wall o-f the uterus regard-<br/>less of the size of the uterine cavity. This enables the same<br/>catheter construction to be used on all types of primate<br/>females. Expanded sleeve member 39 has a generally pear-shaped<br/>chamber 41 filled with fluid, as water, air or the like. The<br/>tube 38 has a plurality of holes 42 connecting the passage of<br/>tube 38 with chamber 41. The upper end of tube 39 is closed<br/>with a plug 43.<br/> The end of tube 38, projected from the vestibule 24, is<br/>attached to a fluid dispensing unit indicated generally at 44.<br/>Tube 38 can be releasably attached to dispensing unit 44 or<br/>fixed to dispensing unit 44. The dispensing unit has a body<br/>46 carrying a movable plunger 47. When plunger 47 is moved<br/>in the direction of arrow 48, a fluid, preferably water, is<br/>forced from the dispensing unit 44 into the expandable sleeve<br/>member 39 to form a closure and fill the uterine cavity 27.<br/> Located within the tube 38 are a pair of smaller tubes<br/>49 and 52 for carrying fluids into the uterine cavity 27.<br/>Tube 49 has a portion extended outwardly from the tube 38 and<br/>attached to a dispensing unit 51. Tube 52 is attached to a<br/>dispensing unit 53. Dispensing units 51 and 53 are identical<br/> - 10 -<br/><br/> 1C~69791<br/> .~<br/> in construction and can be used to dispense the same fluids<br/>or different fluids at separate time intervals. One of the<br/>dispensing units can dispense a neutralizer fluid into the<br/>uterine cavity. The following description is limited to dis-<br/>pensing unit 51.<br/> Referring to Figures 2 to 5, dispensing unit 51 has a<br/>body or housing 57 comprising a cylindrical side wall 58 and<br/>an end wall 59. Housing 57 has a chamber 61 and outwardly<br/>directed ears 62 and 63. Ears 62 and 63 extend in diametric-<br/>ally opposite directions from opposite sides of the open endof body 57 and cylindrical side wall 58. A collapsible con-<br/>tainer or ampulla indicated generally at 64 is located in<br/>chamber 61. The container holds a drug or similar material<br/> ; used in the treatment and/or occlusion of the canals of the<br/> - Fallopian tubes. The container 64 has an accordion cylind-<br/>rical side wall 66 secured to a transverse generally flat<br/>bottom wall 67. The center portion of bottom wall 67 has<br/>longitudinal tubular member 68. Member 68 has an outwardly<br/>projected portion 68A and an inwardly directed portion 68B.<br/> The tubular member 68 is closed with a transverse diaphragm<br/>69. Diaphragm 69 is a relatively thin disc member located<br/>in the transverse plane of bottom wall 67. The opposite end<br/>of the container 64 is closed with a transverse seal 71.<br/> Container 64 is preferably made of a deformable lead<br/>alloy having good moisture and vapor barrier properties.<br/> Other deformable material having good moisture and vapor<br/>barrier properties can be used to fabricate the container.<br/> These properties are important to prevent moisture and vapor<br/>sensitive material from polymerizing or setting up during<br/>storage periods. The material of the container is also chem-<br/>ically inert to the fluid stored in the container.<br/><br/> 1069791<br/> Located within the container 64 is a longitudinal needle<br/>73. Needle 73 is a hollow member terminating in an inclined<br/>end having a point 74 located adjacent the inside of diaphragm<br/>69. The opposite end of needle 73 is attached to a circular<br/>head 76. As shown in Figures 4 and 5, needle 73 has a longi-<br/>tudinal passage 77 extended through the pointed end of the<br/>needle.The side wall of needle 73 has a hole 78 to provide<br/>for the flow of liquid form the container through the needle.<br/>Needle 73 can have a plurality of holes or an elongated slot<br/> to provide for the flow of fluid through the needle.<br/> The chamber 61 is closed with a plunger or movable member<br/>79. A portion of the movable member fits into the chamber<br/>and has outwardly directed ribs 81 and 82 extended into longi-<br/>tudinal grooves 83 and 84 in the inside portions of the cylin-<br/>drical side wall 58. The ribs 81 and 82 hold the plunger 79<br/>in assembled relation with the body and guide the body linearly<br/>into the chamber 61. Plunger 79 has in inwardly open recess<br/>- 86 for accommodating the outer end of container 64. The bottom<br/>central portion of recess 86 has a cavity 87 providing a space<br/>for the sealed top 71. Plunger 79 can be removed from the side,<br/>wall 58, enabling the container 64 to be removed from the<br/>chamber and replaced with a new container.<br/> Referring to Figure 6, the dispensing unit 51 is operated<br/>by moving the plunger 79 into the chamber 61. This is accom-<br/>plished by applying a force on the outer end of plunger 79<br/>in the direction of arrow 88. The first and second fingers<br/>are placed under the ears 62 and 63. The thumb is used to<br/>apply force to the plunger 79. The needle 73 will be moved<br/>through the diaphragm 69. The fluid within container 64 will<br/>be placed under pressure and forced through the hole 78 along<br/>passage 77 and into the tube 49. The tube 49 carries the fluid<br/>up into uterine cavity 27. The fluid is discharged from the<br/> - 12 -<br/><br/> ~)697~<br/>end 54 and flows along the inner wall of the f~mdus into the<br/>canals 36 and 37 of the Fallopian tubes. Pressure is applied<br/>to plunger 79 until all of the fluid in the container 64 is<br/>dispensed therefrom. The sleeve member 39, being in engagement<br/>with the inner wall of the fundus, limits the amount of fluid<br/>that can collect on the inner wall.<br/> The dispensing unit 51 is a disposable item that contains<br/>a single dosage or unit of a drug or fluid. The dispensing<br/>unit can be used as part of a syringe to inject drugs into a<br/>body. The tube 49 can be replaced with a tubular needle which<br/>is placed on the outwardly directed tubular member 68. Tubular<br/>member 68 can contain threads to releasably hold the needle.<br/>Member 68 can be releasably or permanently attached to an<br/>elongated delivery tube.<br/> Referring to Figures 7, 8 and 9, there is shown a modi-<br/>fication of the dispensing unit, indicated generally at 100,<br/>operable to discharge fluid, as a drug, under pressure into a<br/>tube or hypodermic needle. Tube 101 can be one of the delivery<br/>tubes of catheter 21. Dispensing unit 100 has a body or hous-<br/>ing 102 comprising a cylindrical side wall 103 joined to a flat<br/>end wall 104. Side wall 103 surrounds a cylindrical chamber<br/>106 having an open end opposite end wall 104. Oppositely<br/>directed ears 107 and 108 are secured to the open end of the<br/>side wall 103.<br/> Located within chamber 106 is a container or ampulla<br/>indicated generally at 109 for storing fluid, as drugs, tissue<br/>adhesive, water, air, gas, semi-fluids, and the like. Con-<br/>tainer 109 is a collapsible structure having a cylindrical<br/>side wall 111 and bottom wall 112. Bottom wall 112 is located<br/>in flat surface engagement with the inside surface of end wall<br/>104. The center portion of bottom wall 112 has a longitudinal<br/>tubular member 113. A portion of tubular member 113 extends<br/> - 13 -<br/><br/> '10697~1<br/>through a hole 114 in bottom wall 112. Member 113 has an out-<br/>wardly projected portion 113A and an inwardly directed portion<br/>113B. The midportion of tubular member 113 has a transverse<br/>diaphragm or disc 116 closing the passage through the tubular<br/>member 113. The opposite or top end of the container is closed<br/>with a folded seal 117. A longitudinal needle 118 is located<br/>in the container 109. Needle 118 has a point 119 located in<br/>the upper or inner portion of the tubular member 113. The<br/>opposite end of needle 118 is attached to a transverse head<br/>121. Head 121 is located adjacent the inside of the top wall<br/>of the container 109. As shown in Figure 8, needle 118 is a<br/>generally U-shaped cross section. One side of the needle is<br/>open to the fluid in the container. This allows the fluid to<br/>flow longitudinally along the container past the point 119<br/>when the point pierces the diaphragm 116. The needle can be<br/>a longitudinal tubular member having one or more holes provid-<br/>ing access to the passage in the needle, as shown by needle<br/>73 in Figure 6.<br/> A plunger 122 closes the open end of the housing 102.<br/>Plunger 122 has a pair of diametrically opposite ribs or<br/>projections 123 and 124. The ribs 123 and 124 are located<br/>in longitudinally extended grooves 126 and 127 in the inside<br/>of side wall 103 of the housing to guide the longitudinal<br/>movement of the plunger into the housing. The inner face of<br/>plunger 122 has an annular recess 128 to accommodate portions<br/>of the container when the plunger 122 is moved into chamber<br/>106. The center portion of plunger 122 has a cavity 129 for<br/>accommodating the seal 117 of the container.<br/> In use, referring to Figure 9, force is applied to plunger<br/>122 in the direction of arrow 121. This moves plunger 122<br/>into the chamber 106. The plunger 122 collapses the container<br/>109 and moves the needle through the diaphragm 116. As soon<br/> - 14 -<br/><br/> 106i9791<br/>as the point 119 of the needle penetrates t}le diaphragm 116,<br/>the fluid within container 109 can flow through the needle<br/>118 into the tube or receiver 101. Fluid will continue to<br/>flow through the needle 118 as long as force is applied to<br/>the plunger 122. Plunger 122 can be moved into chamber 106<br/>until the head abuts against the inner portion of tubular<br/>member 113.<br/> Referring to Figures 10 and 11, there is shown a modifi-<br/>cation of the needle and container arrangement. The bottom<br/>~0 portion of container 132 has a generally flat end wall 133.<br/> The midportion of the end wall has a longitudinal tubular<br/>member 134. The tubular member 134 has an outwardly directed<br/>outer portion 134A and an inwardly projected inner portion<br/>134B. The midportion of the tubular member 134, in general<br/>alignment with the end wall 133, has a diaphragm or disc 136.<br/> A needle indicated generally at 137 is longitudinally aligned<br/>with the passage in the tubular member 134. Needle 137 has<br/>a cone-shaped head 138 terminating in a point. Head 138 is<br/>connected to an elongated shank 139. As shown in Figure 11,<br/>when needle 137 is moved in the direction of arrow 141, head<br/>138 punctures the diaphragm 136. The hole in the diaphragm<br/>136 is larger than the shank 139, allowing the fluid in the<br/>container to flow past the diaphragm 136 into the discharge<br/>portion of the tubular member 134. The outer portion 134C of<br/>the tubular member has threads 142 adapted to receive a female<br/>threaded member, as a nut or sleeve, or a fluid receiving<br/>apparatus. Other types of connections can be used to couple<br/>the tubular member 124 to the fluid receiving apparatus.<br/> Referring to Figures 12 and 13, there is shown a fluid<br/>dispensing container or ampulla indicated generally at 143.<br/> The container has a cylindrical side wall 144 surrounding a<br/>chamber 145 for storing fluid, as drugs, tissue adhesive,<br/><br/> -<br/>~o6~791<br/>water and the like. Wall 144 is made of non-collapsible<br/>material. A generally flat transverse end wall 146 is integral<br/>with one end of side wall 144. The center portion of end wall<br/>146 has an elongated longitudinal tubular member 147. Tubular<br/>member 147 has an outer portion 147A extended outwardly from<br/>end wall 146 and an inner portion 147B projected into chamber<br/>145. The midportion of tubular member 147 is closed with a<br/>diaphragm 148. Diaghragm 148 is located in transverse align-<br/>ment with the end wall 146 and is of a material that can be<br/> pierced with a needle.<br/> An elongated longitudinal needle 149 is located within<br/>chamber 145. Needle 149 has a forward end located within the<br/>passage of inner portion 147B and terminates in a point 151.<br/>The opposite end of needle 149 is attached to a transverse<br/>head 152. Head 152 has an annular outer peripheral surface<br/>which forms a seal 153 with the adjacent inner wall of side<br/>wall 144. The outer peripheral surface of the head 152 is in<br/>sealing frictional fit with the inner surface of the side wall<br/>144. The outer peripheral surface of the head 152 is in<br/>sealing frictional fit with the inner surface of side wall 144<br/>so as to prevent moisture, air or other substances from enter-<br/>ing chamber 145. Needle 149 has a generally U-shaped cross<br/>section as shown by needle 118 in Figure 8. Alternatively,<br/>needle 149 can be a tubular member having one or more side<br/>holes to provide a passage for the movement of fluid in chamber<br/>146 out the end of needle 149. The needle can also have the<br/>shape of needle 137, as shown in Figures 10 and 11. Other<br/>shapes and structures can be used to permit the flow of fluid<br/>along the needle through the diaphragm once the diaphragm has<br/>been pierced by the point of the needle.<br/> In use, head 152 is moved into chamber 145 in the direction<br/>of arrow 154 shown in Figure 13. The point 151 of the needle<br/> - 16 -<br/><br/> ~OG9791<br/>will penetrate and pierce the diaphragm 148. Ihe fluid in<br/>chamber 145 is forced along the needle through the pierced<br/>diaphragm and discharged via the outer portion 147~ of the<br/>tubular member.<br/> Referring to Figures 14 and 19, there is shown a con-<br/>tainer or ampulla indicated generally at 160 for storing a<br/>fluid, as a drug, liquid tissue adhesive, semi-liquid material<br/>or a gas. Container 160 is located in longitudinal alignment<br/>with a tubular needle 161. Needle 161 is secured to a gener-<br/>ally transverse base 162 and has a point or sharp edge 163 at<br/>its forward end. Base 162 is mounted in a housing (not shown)<br/>to fix the position of the needle 161.<br/> Container 160 is a one-piece body having a continuous<br/>side wall 164. Side wall 164 has an accordion shape and<br/>is of a cylindrical configuration and surrounds a chamber 166<br/>for storing the fluid. The forward end 167 is closed with a<br/>diaphragm or cylindrical disc member comprising an end wall<br/>167. An outwardly directed longitudinal sleeve 168 is attached<br/>to the outer peripheral edge of the end wall 167 forming an<br/>extension of the container. A disc or pad 169 of resilient<br/>material, as sponge rubber, plastic foam or the like, is<br/>located within sleeve 168 and covers the end wall 167. Sleeve<br/>168 has a rolled outer edge or bead 171 holding the pad within<br/>the sleeve 168.<br/> The rear end of the container is closed with an end wall<br/>172. End wall 172 has a transverse seam 173 closed to moisture<br/>and vapor to seal the container. As shown in Figure 17, the<br/>seam 173 has lapped and inturned edges that are sealed together.<br/>The container is made of a material having moisture and vapor<br/>impervious properties. Preferably the material is deformable<br/>lead alloy which is chemically inert to the fluid stored in<br/>- the container. Other deformable materials having good moisture<br/> - 17 -<br/><br/> ~069791<br/>and vapor barrier properties can be used to form the container.<br/>These properties are essential to prevent moisture and vapor<br/>sensitive materials from setting up or polymerizing during<br/>lengthy storage periods. For example, the cyanoacrylate monomer<br/>is extremely sensitive to moisture and vapor. It must be<br/>stored in a sealed container which does not allow ingress of<br/>moisture and vapor. The monomer will set up in a short period<br/>of time when exposed to moisture, including the moisture of<br/>tissues.<br/> In use, force is applied to the end wall 172 in the<br/>direction of arrow 174. This force moves the container 160<br/>into operative engagement with needle 161. The force will<br/>also collapse the side wall 164 and apply sufficient force<br/>to the container whereby the needle 161 will cut through or<br/>pierce both the pad 169 and end wall 167. Pad 169, being made<br/>of resilient elastic material, will be formed with a hole 176<br/>in tight sealing engagement with the outer peripheral surface<br/>of needle 161. Needle 161 will also make a hole 177 in the<br/>end wall 167. Needle 161, being a hollow tubular member,<br/>provides a passage for the flow of fluid from chamber 166 into<br/>a fluid receiver such as the tube of the dispensing catheter.<br/> Referring to Figure 20, there is shown a catheter dis-<br/>penser having a dispensing unit indicated generally at 200<br/>attached to an elongated balloon catheter 202. The dispensing<br/>unit has a body or housing 201 attached to an elongated linear<br/>tube 203 of the catheter. Tube 203 can be an integral extension<br/>of the body or releasably connected to the body 201. The outer<br/>end of the catheter has an expandable sleeve member or balloon<br/>204 adapted to confine fluid, as water or gas, to enlarge the<br/>expandable sleeve member 204. As shown in Figure 22, a second<br/>smaller tube 2n6 is located within the tube 203. Tube 206<br/>extends the entire length of the tube 203 and has an outlet<br/> - 18 -<br/><br/> 9791<br/>opening 205 at the outer end whereby fluid can be discharged<br/>from the catheter. The outer end o-f tube 203 can be recessed<br/>to insure the flow of fluid from outlet opening 205.<br/> The body 201, as shown in Figure 22, has a pair of longi-<br/>tudinally extended chambers 207 and 208. Chambers 207 and<br/>208 are located side-by-side in a generally horizontal plane.<br/>The chambers can be located in a generally vertical plane.<br/>A passage 209 connects the chamber 207 with the passageway of<br/>tube 203. A similar passage 211 connects the chamber 208 with<br/> the passage in tube 206. A short tubular needle 212 extends<br/>longitudinally into passage 207. Needle 212 is attached to<br/>a transverse base 213 positioned at the end of chamber 207<br/>having the passage 209. The outer peripheral edge of base 213<br/>is located in a groove in the housing to fix the position of<br/>the base and needle relative to the passage 207. The needle<br/>212 has a passage in alignment with passage 209 so that fluid<br/>flows through the needle into the passage 209.<br/> A second tubular needle 214 is located longitudinally in<br/>passage 208. Needle 214 is attached to a base 216 located at<br/>the end of chamber 208 adjacent the passage 211. The outer<br/>peripheral edge of base 216 is located in grooves in the housing<br/>201 to fix the position of the base and needle relative to<br/>passage 208. The passage of needle 214 is aligned with the<br/>passage 211 so that the fluid can flow through the needle and<br/>into passage 211.<br/> A container or ampulla 217 having a chamber 218 for<br/>fluid, as drugs, water OT other material, is located in chamber<br/>207. Container 217 has an end or diaphragm 219 facing the<br/>needle 212. A pad 221 of resilient cushioning material is<br/>located between diaphragm 219 and the pointed end of needle<br/>212. A plunger 222 is attached to the opposite end of con-<br/>tainer 217. A suitable dovetail or tongue and groove 237 can<br/> - 19 -<br/><br/> ~69791<br/>be used to connect the container to the plunger. Other types<br/>of connections can be used to attach the container to the<br/>plunger. A longitudinal rod 223 is connected to plunger 222<br/>and extended into a bore 224 in the housing 201. A coil spring<br/>226 is positioned around rod 223 and engages the housing 201<br/>and the plunger 222 to bias the plunger toward the needle 212.<br/> A releasable lock 227 engages the rod 222 to hold the<br/>plunger 221 in a cocked position whereby the diaphragm 219<br/>is held from the needle 212. P~eferring to Figures 23 and 24,<br/>releasable lock 227 comprises a cylindrical member or body 228<br/>extended downwardly into a hole 229 in housing 201 through a<br/>cutout or groove 230 in rod 223. The body 228 has a semi-<br/>- circular cutout 231 in alignment with rod 223. The upper or<br/>exposed end of the body 228 has a handle 232. The handle 232<br/>is movable in the direction of arrow 233 shown in Figure 20<br/>to move the cutout 231 in registration with rod 223. When<br/>the cutout 231 is in registration with rod 223, as shown in<br/>Figure 18, the rod is free to move. The spring 226 will bias<br/>plunger 222 toward the needle 212. This moves the container<br/>217 and the diaphragm 219 into the needle 212. The pointed<br/>end of the needle will pass through the pad 221 and puncture<br/>diaphragm 218. The needle 212 will form a seal with the dia-<br/>phragm 219 whereby the fluid in chamber 218 will -flow through<br/>the needle, passage 209 and into the passage of catheter tube<br/>203. The biasing force of the spring 226 will force substan-<br/>tially all of the fluid in chamber 218 through needle 212.<br/>An upwardly directed finger 234, shown in Figure 21, is<br/>attached to plunger 222. The finger 234 extends through a<br/>longitudinal slot 236 in the housing 201. The upper end of<br/>finger 234 is enlarged so that it can be gripped. Plunger<br/>222 and container 217 have cooperating connections such as a<br/>dovetail connection 237, shown in Figure 22. When force is<br/> - 20 -<br/><br/> ~(}6979~<br/>applied to finger 234, the plunger 222 can be moved in a reverse<br/>direction, expanding the container 217. This withdraws the<br/>fluid from the catheter, decreasing the size of the expandable<br/>member 204. The plunger 222 can be moved until lock 227 can<br/>be moved to fix the position of the plunger 222 in the housing.<br/>Other types of retraction structure can be used to withdraw<br/>and expand the container 217 to relieve the fluid from the<br/>expandable member 204.<br/> A container or ampulla 238 is located in chamber 208<br/>adjacent the needle 214. Container 238 has a chamber 239 for<br/> storing drugs, tissue adhesive and other materials. Container<br/>238 has an end or diaphragm 241 spaced from the pointed end<br/>of needle 214 with a resilient pad 242. Some drugs that are<br/>moisture and vapor sensitive require a container made of<br/>material having good moisture and vapor barrier properties.<br/>Preferably a deformable lead alloy is used to make this type<br/>of container. These properties are important to prevent<br/>moisture and vapor sensitive materials from polymerizing or<br/>setting up during storage periods. The material of the con-<br/>tainer is also chemically inert to the fluid stored in the<br/>container. Located adjacent the opposite end of container<br/>238 is a plunger 243. A longitudinal rod 244 attached to<br/>plunger 243 extends into a bore 246 in housing 201. A spring<br/>247 located in ch amber 208 engages the housing 201 and plunger<br/>243 to bias the plunger toward the needle 214. The rod 244<br/>is held with a releasable lock 248. Lock 248 is identical to<br/>lock 227. It is operated by moving the handle of the lock to<br/>the dotted line position, as shown in Figure 14. This releases<br/>the rod 214 whereby the spring 247 will bias the plunger in<br/>a forward direction, moving the diaphragm 241 toward the needle<br/>214. The pointed end of needle 214 will pierce diaphragm 241,<br/>thereby providing a fluid connection between the chamber and<br/> - 21 -<br/><br/> ~Q69~91<br/>the passage 211 leading to the tube 206. The diaphragm will<br/>be located in sealing realtion with respect to the needle<br/>whereby the fluid in chamber 239 of container 238 will be<br/>forced by the biasing action of the spring 247 through the<br/>needle 214, the passage 211 and the passage of the tube 206.<br/> Body 201 has doors or closure members closing openings<br/>into the chamber 207 and 208 whereby the containers 217 and<br/>238 can be removed and replaced. Other types o containers<br/>as herein disclosed can be inserted into the chambers.<br/> Referring to Figure 25, there is shown a modification<br/>of the releasable lock, indicated generally at 250. Lock 250<br/>has a body or rod 251 having a cylindrical cutout 252. The<br/>rod 223 attached to the plunger has a similar cutout. A spring<br/>253 located in the base of bore 224 biases the body 251 in an<br/>upward direction. The upper end of body 252 is attached to a<br/>head 254.<br/> In use, body 251 has a portion located in the groove or<br/>recess in the side of the rod 223 to hold the rod in the cocked<br/>position, as shown in Figure 22. The rod 223 is released by<br/>pushing head 254 in a downward direction, as indicated by arrow<br/>256, until the cutout 252 is aligned with rod 223. This<br/>releases the holding action on rod 223 whereby the spring 226<br/>can move the rod in a forward direction, forcing the diaphragm<br/>219 into engagement with the needle 212.<br/> Referring to Figures 26, 27, 28 and 29, there is shown<br/>a further modification of a dispenser catheter of the invention<br/>indicated generally at 300 for discharging fluid, as drugs,<br/>tissue adhesives, and the like, into the uterine cavity. The<br/>dispenser catheter 300 has a dispensing unit 301 and an elong-<br/>ated tubular catheter 302. Dispensing unit 301 has a body 303<br/>attached to elongated tube 304 of the catheter. Tube 304 can<br/>be releasably connected or permanently fixed to body 303.<br/><br/> ~06~7~i<br/> Mounted on the end of tube 304 is an expandable sleeve member<br/>or balloon 305. Bands 306 clamp the ends of sleeve member 305<br/>to tube 304. Sleeve member 305 is an elastic sheet member, of<br/>relaxed rubber, plastic or like materials. When the sleeve<br/>member 305 is expanded in the uterine cavity, it applies uniform<br/>outward pressure on the uterine wall. The expanded sleeve<br/>member 305 prevents the drugs injected into the uterine cavity<br/>from contacting substantial portions of the uterine wall and<br/>flowing out of the uterine cavity. Holes 307 in the end of<br/>tube 304 provide the passageway for the fluid, as water, from<br/>within the tube 304 into the area surrounded by the sleeve<br/>member 305 to expand sleeve member 305. An elongated small<br/>tube 308 is located within tube 304. Tube 308 has a discharge<br/>end 3ng at the outer end of tube 304.<br/> Body 303 has a pair of side-by-side chambers 311 and 312.<br/>Chambers 311 and 312 extend in a longitudinal direction and<br/>are located in a common horizontal plane. The chambers can<br/>be located in a common vertical plane whereby one chamber is<br/>positioned over the other chamber. A passage 313 connects<br/>chamber 311 with the tube 304. In a similar manner, a passage<br/>314 connects chamber 312 with the tube 308.<br/>A first plunger 316 is movably positioned in first chamber<br/>311. A rearwardly directed rod 317 is attached to plunger 316.<br/>A second plunger 318 is movably located in chamber 312. A rod<br/>319 is secured to the plunger 318 and extends in a rearward<br/>direction generally parallel to the rod 317. A trigger assembly<br/>or actuator indicated generally at 320 is mounted on the rear<br/>portion of the housing adjacent the rear end of rods 317 and<br/>319.<br/> Trigger assembly 320 has a lever 321. The midportion of<br/>lever 321 has a hole accommodating a transverse pivot pin 322.<br/>Pivot pin 322 is anchored in a downwardly extended handle or<br/><br/> ~n6s7sl<br/>pistol grip 323 secured to the rear portion of the body 303.<br/> Lever 321 has a transverse head 324. A spring 325 engages<br/>the body 303 and upper end of lever 321 to bias the lever in<br/>the rear or cocked position. The forward portion of head 324<br/>is in sliding engagement with the ends of rods 317 and 319.<br/> Referring to Figures 29 and 30, head 324 has a longitud-<br/>inal passage 326 for accommodating rod 319. A transverse bore<br/>327 opens into passage 326. Slidably disposed in bore 327 is<br/>a pin 328. Pin 328 has a reduced diameter neck 329 attached<br/>to an enlarged head 331. A spring 332 engages the head 331<br/>and a plug 333, closing the end of bore 327. Spring 332 biases<br/>the pin 328 into the passage 326. Rod 317 has a rearwardly<br/>directed finger 334. When rod 317 is in the rearward or cocked<br/>position, the finger 334 is located behind the head 331 and<br/>functions as a stop to prevent movement of pin 328 into passage<br/>326.<br/> Returning to Figure 27, rod 317 has a notch or slot 336<br/>in the upper portion thereof. The slot 336 cooperates with<br/>lock 337 to hold rod 317 in the dispensed or "in" position.<br/> Lock 337 comprises a movable pin 338 located in a passage<br/>surrounded by a boss 339. The pin 338 has a head 341 located<br/>above body 303 so that it can be gripped to release the lock.<br/> The forward portion of the pin carries a C-ring or clamp ring<br/>342 providing a stop for a spring 343. Spring 343 is located<br/>concentrically around the pin and engages a portion of the<br/>body 303 to bias the pin 338 toward rod 317. When rod 317 has<br/>been moved to the "in" position, the pin 338 will be biased<br/>into the slot 336, thereby holding the pin in the "in" position.<br/> The rod 319 has a slot 344. A lock 346 on body 303 holds the<br/>pin in the "in" position. Lock 346 is identical to lock 337.<br/> Returning to Figure 30, when the lever 323 has been actu-<br/> - ated, the rod 317 will be held in the "in" position by lock<br/> - 24 -<br/><br/> :`<br/>10~'7~1<br/>337. Rod 319 is not moved because the head 324 will move<br/>relative to rod 319 as rod 319 moves through passageway 326.<br/> When the head 324 is returned by spring 325 to its initial<br/>rearward position, the pin 328 will be biased by spring 332<br/>into passage 326. The second actuation or movement of the<br/>lever 321 toward the handle 323 will move the rod 319 in the<br/>forward direction.<br/> Referring to Figure 28, a first container or ampulla<br/>indicated generally at 350 is located in chamber 311. A for-<br/>wardly directed needle 351 mounted on a transverse base 352<br/>is locat~d at the forward end of chamber 311. Needle 351 is<br/>a hollow member in fluid communication with passage 313.<br/>A second container or ampulla, indicated generally at353, is located in passage 312. The forward end of passage<br/>312 has a longitudinally extended needle 354 mounted on a<br/>transverse base 356. Needle 354 is a hollow tubular member<br/>having a passage in fluid communication with the passage of<br/>the tube 314. The container 353 is an elongated cylindrical<br/> : member of glass~ plastic or the like having a head 357. The<br/>head has a rubber plug (not shown) in alignment with needle<br/> ; 354. Slidably positioned within the container is a plunger<br/>of piston 358 confining fluid 359 in the container. The plunger<br/>318 is slidably positioned within the container and engageable<br/>with the piston 358. On movement of plunger 318 in the forward<br/>direction, head 357 will be driven through needle 354, thereby<br/>providing a fluid communication between the chamber of the<br/>container 353 and tube 314. The piston 358 will be moved in<br/>a forward direction to drive the fluid from the container.<br/>The fluid can be a drug, tissue adhesive, or semi-fluid material<br/>for treating and occluding the canals of the Fallopian tubes.<br/> Container 350, shown in Figure 31, has a cylinder 361 for<br/>storing fluid 362, as drugs, water or the like. The forward<br/> - 25 -<br/><br/> 7~<br/>end of cylinder 361 has a head 363 having a passage closed<br/>with a plug 364. The open end of cylinder 361 is closed with<br/>a plunger 366 carrying a piston 367. The rear portion of<br/>plunger 366 has an outwardly directed flange 368 engageable<br/>with a spring 369. The forward end of spring 369 engages an<br/>annular seat 371 on the cylinder 361 to bias the plunger 366<br/>in an outward direction or out of cylinder 361. Plunger 366<br/>has a central longitudinal bore 372 slidably accommodating an<br/>actuator rod 373. Rod 373 has an axial bore accommodating a<br/>compression spring 374 to provide a yieldable link between<br/>rod 373 and plunger 366.<br/> Plunger 316 attached to rod 317 engages the end of rod<br/>376. On movement of plunger 316 in the forward direction,<br/>spring 374 will be initially compressed applying a uniform<br/>pressure on plunger 366. The cylinder 361 will be moved in<br/>a forward direction whereby needle 351 will pierce plug 364,<br/>providing fluid communication between the container and passage<br/>313. The continued movement of the plunger 316 will drive the<br/>piston 367 toward the plug 364, thereby dispensing the fluid<br/>from cylinder 361. The dispensed fluid will flow through tube<br/>304 and into sleeve member 305 via holes 307 to expand sleeve<br/>member 305, as shown in broken lines in Figure 22. ~leeve<br/>member 305 will expand with a uniform pressure so as to fill<br/>the uterine cavity and exert uniform pressure on the inside<br/>wall of the cavity. The pressure of sleeve member 305 on the<br/>cavity wall will be uniform regardless of the size of the<br/>uterine cavity.<br/> Body 303 has doors or closure members closing openings<br/>into the chambers 311 and 312 whereby the containers 350 and<br/>353 can be removed and replaced. Other types of containers,<br/>as disclosed herein, can be inserted into the chambers.<br/> - 26 -<br/><br/> 1~9791<br/> In use, the dispensing catheter performs a method of<br/>introducing a material, as a drug, tissue adhesive, contra-<br/>ceptive gel or like material, into the canals of the Fallopian<br/>tubes. The method includes the introduction of an elongated<br/>catheter 302, with sleeve member 305 in the contracted position,<br/>through the cervical opening into the uterine cavity. Sleeve<br/>member 305 is expanded with fluid under pressure to fill the<br/>uterine cavity and apply uniform pressure on the inside of<br/>the uterine wall. The fluid under pressure is delivered to<br/> sleeve member 305 via the passage in the tube 304. Actuator<br/>320 is moved in a forward direction to force plunger 316 in a<br/>direction to move the container 350 into operative engagement<br/>with needle 351. Needle 351 will puncture the plug 364, whereby<br/>the fluid 362 will flow via the passage in tube 304 to expand<br/>sleeve member 305. The sleeve member, being a sheet of flex-<br/>ible, elastic rubber or similar material, has a low surface<br/>tension and applies a uniform expansion force to the inside<br/>of the uterine wall. This effects a relatively tight seal and<br/>fit, enabling the same catheter construction to be used on<br/>all types of primate female, regardless of the size of the<br/>uterine cavity.<br/> The material under pressure is then dispensed into the<br/>~- uterine cavity between the expanded sleeve member and the<br/> fundus of the uterus. The material, being under pressure,<br/>moves toward and into the canals of the Fallopian tubes. The<br/>expanded sleeve member, being located against the fundus wall,<br/>aids the movement of the material toward the canals of the<br/>Fallopian tubes. The material can be a fluid tissue adhesive<br/>which will flow into the canals. The moisture in the tissue<br/>of the canals will polymerize or set the tissue adhesive and<br/>thereby block or occlude the canals. The fluid confined by<br/>the sleeve member is drained to contract the sleeve member.<br/><br/> ~Oti979~<br/> The catheter is then withdrawn from the uterine cavity.<br/> Referring to Figure 32, there is shown the dispensing<br/>instrument indicated generally at 420 with the probe located<br/>in the uterine cavity. The female reproductive system shown<br/>generally at 421 has a uterus 422 joined to a pair of Fallopian<br/>tubes 423 and 424. The lower part of uterus 422 is integral<br/>with an elongated vagina 426. Vagina 426 has a vaginal cavity<br/>427 having an opening or entrance 428. The opposite end of<br/>vaginal cavity 427 is in communication with the cervix 429.<br/> Cervix 429 has a cervical opening 431 providing a passage from<br/>vaginal cavity 427 to uterine cavity 432. Fallopian tubes 423<br/>and 424 have exits 433A and 434A at opposite sides of the upper<br/>part of the uterine cavity 432.<br/> The uterus 422 is a generally pear-shaped, thick walled,<br/>hollow organ situated between the bladder and rectum. The<br/>- uteri of females vary in size and shape. Wall thickness, wall<br/>strength and sensitivity to pain may vary from female to female.<br/>The size and configuration of the uterine cavities can vary.<br/>The uterine cavity 432 is generally flattened and triangular<br/>in shape. Some uteri have cavities that have other shapes.<br/>The Fallopian tubes 423 and 424 are paired, trumpet-shaped<br/>muscular members about 12 cm. in length which extend from the<br/>superior angles of the uterine cavity 432 to the ovaries (not<br/>shown). The outlets 433A and 434A of canals 433 and 434,<br/>respectively, can vary in positon relative to the uterine<br/>cavity and relative to each other. Outlets 433A and 434A are<br/>usually symmetrically opposite each other, as shown in Figure<br/>32, and their position and proximity are principally related<br/>to the uterine size and configuration. Also, the size of the<br/>canals 433 and 434 and the size of outlets 433A and 434A vary<br/>from female to female.<br/> - 28 -<br/><br/> 3 0~''3'é~<br/> Fallopian tubes are commonly divided into isthmus, intra-<br/>mural and ampullary sections. Canals 433 and 434 provide<br/>passages for the movement of ova from the ovaries to the uterine<br/>cavity 432 as well as the movement of sperm from the uterine<br/>cavity toward the ovaries. The intramural sections of the<br/> Fallopian tubes traverse the uterine wall generally in a more<br/>or less straight fashion, but their course may be tortuous in<br/>some females. The walls of the Fallopian tubes consist of<br/>three layers; the serosal layer, the muscular layer and the<br/>mucosal lining.<br/> Uterus 422 has a top wall or fundus 436 and side walls<br/>437 and 438 which surround the uterine cavity 432. The inside<br/>of top wall 436 and the insides of side walls 437 and 438 have<br/>an inside lining or membrane 439 which is periodically sloughed<br/>off in the normal cycle of the female.<br/> Dispensing instrument 420 has an elongated probe or tubu-<br/>lar member 441 having a length sufficient to pass through the<br/>vaginal cavity 427 and into uterine cavity 432. Member 441<br/>has a longitudinal passage 442 extended throughout its length.<br/> A balloon assembly indicated generally at 443 is mounted on<br/>the upper or outer end of tubular member 441. Balloon assembly<br/>443 has a flexible and expandable sleeve member 444 surrounding<br/>the upper end of probe 441 A fastener 446, as a collar or<br/>thread, attaches the upper end of sleeve 444 to probe 441.<br/>similar fastener 447 attaches the opposite end of sleeve 444<br/>to the probe 441. Probe 441 has a plurality of openings 448<br/>which provide communication between the passage 442 and a<br/>chamber 449 within sleeve member 444.<br/> Sleeve member 444 is a tubular sheet member of soft and<br/>relaxed, flexib~e and elastic mateiral, as rubber or plastic,<br/>which expands with a miimum of tension. For example, thin<br/>latex rubber having low surface tension is suitable material<br/> - 29 -<br/><br/> 106979~<br/>for sleeve member 444. The low surface tension of the rubber<br/>allows the rubber to uniformly expand with relatively low<br/>pressure. The material of sleeve member 444 readily expands<br/>to displace uterine cavity 432 by conforming to the shape of<br/>the uterine cavity without applying extreme pressure to local-<br/>ized portions of the uterus walls 437 and 438. I~hen cavity<br/>432 is fully displaced with sleeve member 444, as shown in<br/>Figure 36, sleeve member 444 is in uniform surface engagement<br/>with the inside lining 439. Conventional balloon catheters,<br/>being of hard, relatively non-elastic material, do not assume<br/>the configuration of the uterine cavity when expanded.<br/> The upper or outer end of probe 441 is closed with a head<br/>451. Head 451 has a transverse passage 452 open to opposite<br/>sides of head 451. An elongated tube 453 is secured to the<br/>head 451. Tube 453 extends the length of probe 441 and has a<br/>passage 454 for carrying a drug material to the transverse<br/>passage 452 which directs the drug material in opposite direc-<br/>tions in two portions into the upper section of the uterine<br/>cavity 432. Head 451 has a longitudinal section or cap 456<br/>having a top surface or wall adapted to engage the inner wall<br/>of fundus 436. The cap 456 spaces the passage 452 from the<br/>inner wall of fundus 436.<br/> Referring to Figure 33, dispensing instrument 420 has an<br/>elongated housing or body 457 attached to the end of probe 441.<br/>Body 457 has a first chamber 458 accommodating an elongated<br/>cylinder 459. Cylinder 459 has a forwardly directed neck 461<br/>connected to a tube 462. Tube 462 has a passage which is in<br/>communication with passage 442 of the probe 441 so that fluid,<br/>as air, in cylinder 459 can flow via passage 442 into chamber<br/>449 of the balloon assembly and thereby expand the sleeve<br/>member 444. The open end of cylinder 459 is closed with a<br/>piston 463 to trap the fluid in chamber 464. The cylinder 459<br/> - 30 -<br/><br/> 106~791<br/>has a hole 466 adjacent the piston 463 to allow air and steril-<br/>izing gases to flow into the chamber 464.<br/> Located rearwardly of the piston 463 is a first drive<br/>assembly indicated generally at 467 operable to move the piston<br/>463 into cylinder 459. I`he first drive assembly 467 is con-<br/>nected to an actuator 468 projected rearwardly from body 457.<br/> Body 457 has a second chamber 469 located adjacent one<br/>side of the first chamber 458. A tube 471 is mounted in the<br/>body 457 to connect the tube 453 to chamber 469. Tube 471 has<br/>a longitudinally extended needle 472 projected into chamber<br/>469. The opposite end of tube 471 is mounted in a plug 473<br/>closing the end of probe 441 and connected to the tube 453<br/>which leads to head 451. Chamber 469 has an elongated shape<br/>and is open to the top of body 457, as shown in Figure 32. A<br/>cylindrical container or ampulla 474 is located in chamber 469<br/>in alignment with needle 472. I'he forward end of container<br/>474 has a pierceable plug 476 aligned with needle 472. The<br/>open end of container 474 is closed with a slidable piston 477<br/>to trap drug material 478 in container 474.<br/>A second drive assembly indicated generally at 479 extends<br/>rearwardly form container 474 and is drivably connected to<br/>actuator 468. Actuator 468 is operable to complete the entire<br/>dispensing of drug material into the canals of the Fallopian<br/>tubes in a single stroke. The rear portion of housing 457<br/>has outwardly and oppositely directed flanges 481 and 482<br/>which serve as finger grips during actuation of actuator 468.<br/>Actuator 468 has a hole 483 for accommodating a pin 483A to<br/>hold the actuator 468 in the operative position. The pin 483A<br/>prevents accidental actuation of the dispensing instrument.<br/> Drive assembly 467 is a force-transmitting mechanism<br/>operable to move piston 463 into cylinder 459 and thereby<br/>increase the pressure in the fluid system for the balloon<br/><br/> :1069791.<br/>assembly 443 and expand sleeve member 444. Drive assembly<br/>467 has a cylinder or sleeve 484 slidably carrying a body 486.<br/>The opposite or upper end of sleeve 484 is attached to a head<br/>487. Head 487 has a central hole 488 which provides access<br/>into sleeve 484. The outer end of piston 463 has a cone-shaped<br/>portion 48g to accommodate the cone-shaped outer end of head<br/>487. The hole 488 is aligned with an adjusting screw 491<br/>threaded into body 486. The position of screw 491 relative<br/>to body 486 can be changed with the use of a tool, as a screw-<br/>driver, extended through hole 488. A pair of springs 492 and<br/>493 bias the sleeve 484 and body 486 in opposite directions<br/>whereby the first drive assembly 467 is biased into its elong-<br/>ated position. Spring 492 abuts against head 487. Spring 493<br/>rests on screw 491. Adjusting the positon of screw 491 adjusts<br/>the tension or force of the spring 493 which biases the head<br/>487 and body 486 in opposite directions. Screw 491 performs<br/>a fine adjustment of the spring force to accommodate variations<br/>in spring 493 and to provide for desired fluid pressure in<br/>chamber 449. A washer 494 having a central hole for rod 488<br/>is located between springs 492 and 493. Spring 492 is a light<br/>or weak spring as compared to spring 493. The weak spring 492<br/>will compress under a light load, for example 2-3 psi, whereby<br/>the washer 494 will abut against head 487. This insures the<br/>partial expansion of sleeve member 444 at low predetermined<br/>maximum pressure. The predetermined maximum pressure is deter-<br/>mined by the compression force characteristics of spring 493<br/>and permits the instrument to be used with all shapes and sizes<br/>of uteri, as the spring 493 adjusts for the differences in the<br/>uteri.<br/> Sleeve 484 and body 486 are held in assembled relation<br/>with a pin 496 extended through elongated longitudinal slot<br/> 497 in sleeve 484. Slot 497 permits the sleeve 484 to move<br/><br/> ~069791<br/>relative to body 486 as the springs 492 and 493 are compressed.<br/> Pin 496 projects through slot 497 into an elongated linear<br/>groove 498 in the housing 457 and thereby prevents rotational<br/>movement of the drive assembly 467 relative to housing 457.<br/> Body 486 has a transverse passage 499 accommodating a<br/>drive link 501. The drive link S01 has spherical members at<br/>its opposite ends joined with a transverse member or tube.<br/> The first end of drive link 501 is located in a recess 502 in<br/>the side of actuator 468. Actuator 468 has a second recess<br/>503 for accommodating the link 501. Located below recess 503<br/>is a shoulder 504 adapted to engage the end of body 486 when<br/>link 501 is in recess 5n3. Housing 457 has a recess 506 adapted<br/>to accommodate the opposite or right end of drive link 501.<br/> Recess 506 is located in a forward direction from the initial<br/>- position of drive link 501, as shown in Figure 33, so that the<br/>actuation of drive assembly 467 is temporarily halted or inter-<br/>rupted until the end of body 486 engages the shoulder 504, at<br/>which time the movement of the drive assembly 467 is contin-<br/>ued. The locations of recesses 506 and 521 in housing 457 can<br/>be coordinated with each other so that the initial expansion<br/>of sleeve member 444 overlaps the discharge of drug material<br/>into the uterine cavity and the continued expansion of sleeve<br/>member 444. In this case, sleeve member 444 has a continuous<br/>expansion until the sleeve member 444 has been subjected to the<br/>maximum fluid pressure.<br/> A lock unit indicated generallv at 507 is movably located<br/>in a bore 508 iII body 486. Lock unit 507 has a plunger 509<br/>carrying an outwardly directed finger or projection 510. Finger<br/>510 is adapted to engage one of a plurality of teeth 511 loc-<br/>ated in housing 457. The teeth 511 face drive assembly 467.<br/> Teeth 511 are ratchet teeth which allow only reverse movement<br/>o-f the drive assembly when lock unit 507 is in operation posi-<br/><br/> ~(~69791<br/>tion with teeth 511. Plunger 509 is biased in an outward<br/>direction with a spring 512 located at the base of bore 508.<br/> Sleeve 484 has a hole 513 spaced forwardly from finger 510.<br/> On compression of springs 492 and 493, the body 486 moves<br/>relative to sleeve 484 until the finger 510 is aligned with<br/>hole 513, at which time spring 512 will bias finger 510 through<br/>hole 513 into engagement with one of the teeth 511. This<br/>prevents further movement of the drive assembly 467 in a forward<br/>direction and limits the pressure of the fluid in the chamber<br/>449 of sleeve 444.<br/> The second drive assembly 479 is operable to drive the<br/>container 474 onto needle 472 and force piston 477 into the<br/>container and thereby drive the drug material 478 through<br/>needle 472 into tube 453. Tube 453 carries the fluid to head<br/>451 where it is discharged in opposite directions into the<br/>upper portion of uterine cavity 432. Returning to Figure 2,<br/>second drive assembly 479 has an elongated linear plunger 514<br/>slidably located in a longitudinal passage 515 in housing 457.<br/> Plunger 514 has a forward end 516 adapted to engage piston 477.<br/> The opposite end of plunger 514 has a transverse passage 517.<br/> A movable drive link 518 is located in passage 5170 Link 518<br/>has spherical ends that are connected with a rigid member such<br/>as a tube. One end of drive link 518 is located in a semi-<br/>spherical recess 519 located in the side of actuator 468. The<br/>opposite end of drive link 518 rides on the side wall of the<br/>housing 457 forming part of passage 515, thereby retaining<br/>the link in recess 519. Housing 457 has a recess 521 forward<br/>of the link 518 so that the link 518 will remain in driving<br/>relationship with actuator 468 until the link is aligned with<br/>recess 521. At this time the link 518 will be forced into<br/>recess 521 whereby actuator 468 will continue to move in a<br/>forward direction and plunger 514 will remain stationary.<br/> - 34 -<br/><br/> ~069791<br/> In use, the dispensing instrument 420 is packaged with<br/>container 474 located in chamber 469. Actuator 468 is locked<br/>in an inoperative position with a pin 483A extended through<br/>hole 483. Pin 483A engages the end of housing 457 to prevent<br/>actuator 468 from moving into the housing. The entire dispen-<br/>sing instrument is sterilized before it is used.<br/>The operating procedure begins with inserting the balloon<br/>assembly 443 into the vaginal cavity 427, through cervical<br/>opening 431 and into uterine cavity 432, as shown in Figure 32.<br/>Sleeve member 444 is in the collapsed condition so that the<br/>balloon assembly can be readily positioned in the uterine<br/>cavity. The probe 441 is moved into the uterine cavity until<br/>head 451 engages the fundus 436. It is known that uteri can<br/>vary in size, shape and position so that the balloon assembly<br/>may or may not be symmetrically located relative to the Fallop-<br/>ian tubes 423 and 424. As shown in Figure 32, balloon assembly<br/>443 is centrally located in the uterine cavity 432. In some<br/>cases, the balloon assembly may be angularly positioned in the<br/>uterine cavity adjacent one side of the cavity. Dispensing<br/>instrument 420 is effective in placing drug material into both<br/>canals of the Fallopian tubes regardless of the position of<br/>the balloon assembly in uterine cavity 432.<br/> Pin 483A is removed from hole 483, making plunger 468<br/>ready to be moved into the housing 457 to inflate the expandable<br/>sleeve member 444 and dispense drug material into uterine<br/>cavity 432 and then fully expand the sleeve member 444 to pump<br/>or force the drug material into the canals of the Fallopian<br/>tubes. The operator uses -f~anges 481 and 482 as finger rests<br/>so that inwardly directed force can be applied to the actuator<br/>468. As shown in Figure 35, the actuator 468 has been moved<br/>into housing 457 a short distance such that the first drive<br/>assembly has moved the piston 463 into cylinder 59. This<br/> - 35 -<br/><br/> ~n~<br/>expands sleeve member 444 so that it forms a plug or seal in<br/>the lower portion of the uterine cavity 432. Sleeve member 444<br/>is expanded into firm engagement with the inside lining or<br/>membrame 439. Drive link 501 couples actuator 468 to the<br/>first drive assembly 467 to transmit the motion of actuator<br/>468 to the first drive assembly 467. This moves piston 463<br/>into chamber 464. The drive link 518 couples plunger 514 with<br/>actuator 468 so that the forward end 516 of the actuator engages<br/>piston 477 in the container 474. This moves the entire con-<br/>tainer 474 in a forward direction. The needle 472 pierces<br/>plug 476, thereby moving the needle through plug 476 and into<br/>the chamber containing the drug material 478. The drive link<br/>101 is aligned with recess 506 in the housing 457. This<br/>permits the drive link 501 to move to the right, as shown in<br/> Figure 35,releasing the drive link from the actuator 468. The<br/>continued movement of the actuator 468 applies force to plunger<br/>416 which moves piston 477 into container 474. Drug material<br/>478 is forced via tubes 471 and 453 to head 451. The drug<br/>material is discharged in opposite directions via the trans-<br/>verse passage 452 into the upper part of uterine cavity 432.<br/> As shown in Figure 36~the continued movement o-f actuator<br/>468 places the shoulder 504 in engagement with the bottom of<br/>body 486. At the same time drive link 501 moves into recess<br/>503, thereby releasing drive link 501 from recess 506. Actu-<br/>ator 468 is moved into housing 457, thereby increasing the<br/>pressure in chamber 464. This further expands sleeve member<br/>444. The expanding sleeve member 444 drives the drug material<br/>from the upper portion of the uterine cavity through exit<br/>openings 433A and 434A of the canals 433 and 434 of the Fallop-<br/>ian tubes. The sleeve member 444 continues to expand until<br/>the fluid pressure in the system containing the sleeve member<br/>and chambers 449 and 464 is approximately 8 psi. Other pressures<br/> - 36 -<br/><br/> ~)69791<br/>can be selected as the upper pressure limit. This pressure is<br/>determined by the compression characteristics of the springs<br/>492 and 493 and adjusting screw 491. The compression of spr~ngs<br/>492 and 493 permits body 486 to move into sleeve 484. This<br/>movement continues until finger 510 is aligned with opening 513.<br/> When finger 510 and hole 513 are aligned, the spring 512 forces<br/>finger 510 through hole 513 and into the space between adjacent<br/>teeth 511. Finger 510 anchors on a forward tooth, thereby<br/>preventing further movement of the actuator 468 into housing<br/>457. Since actuator 468 is prevented from moving into the<br/>housing 457 by lock unit 507, the pressure in the balloon<br/>chamber 449 is limited to a selected maximum pressure, depend-<br/>ing on the compression characteristics of springs 492 and 493.<br/> As the actuator 468 is moved into housing 457 from the<br/>position shown in Figure 35 to the position shown in Figure 36,<br/>drive link 518 moves from recess 519 into recess 521. This<br/>terminates the forward motion of plunger 514 to stop dispensing<br/>the drug material into uterine cavity 432. The continued<br/>movement of actuator 468 increases the fluid pressure in the<br/>chamber 449, thereby expanding sleeve member 444 to pump or<br/>push the drug material from uterine cavity 432 into canals 433<br/>and 434 of the Fallopian tubes. The pumping action ceases<br/>when the sleeve member 444 is fully expanded, as shown in Figure<br/>36. This locates the drug material in the Fallopian tubes as<br/>the pumping force applied to the drug material is insufficient<br/>to move the drug material through the Fallopian tubes into the<br/>body cavity.<br/> The actuator 468 is then pulled out of housing 457. Drive<br/>link 501, being located in recess 503, provides a drive con-<br/>nection between body 486 and plunger 468. Finger 510 of lock<br/>unit 507 slips over teeth 511. This pulls the piston 463 out<br/>of chamber 464. The fluid in chamber 449 flows back into<br/> - 37 -<br/><br/> ~6979~<br/>chamber 464, contracting sleeve member 444. This releases<br/>sleeve member 444 from engagement with lining 439 and enables<br/>balloon assembly 443 to be withdrawn from the uterus of the<br/>patient.<br/>When drug materials of the cyanoacrylate tissue adhesive<br/>type are used, canals 433 and 434 will be permanently occluded.<br/>Tissue adhesives, as the cyanoacrylate type, cause fibroblastic<br/>proliferation which in time closes the canals 433 and 434. The<br/>tissue adhesives polymerize when exposed to a hydroxyl ion<br/>source, such as water. The cells adjacent the adhesive are<br/>damaged and are eventually replaced with fibrous tissue. Cer-<br/>tain other tissue adheisves will polymerize in response to body<br/>heat or other stimuli.<br/>- In terms of method, the dispensing instrument is used to<br/>place drug material in both canals of the Fallopian tubes via<br/>the uterine cavity. The contracted balloon assembly is initi-<br/>ally placed in the uterine cavity, as shown in ~igure 32,"b~y<br/>inserting the balloon assembly 443 through cervical opening<br/>431. The actuator 468 is then released so that it can be moved<br/>into housing 457. The operator moves the single actuator 468<br/>with a continuous movement into housing 457 to complete the<br/>operation. The first drive assembly 467 and second drive<br/>assembly 479 are coordinated to sequentially operate to parti-<br/>ally expand the sleeve member 444 to displace the lower portion<br/>of the uterine cavity and form a seal with the lower walls of<br/>the uterine cavity. The plunger 514 then engages the piston<br/>477 to force the container onto needle 472 and force drug<br/>material 478 from the container and discharge the drug material<br/>in opposite directions into the uterine cavity 432 above the<br/>partially expanded sleeve member 444. This operation is shown<br/>in Figure 35. The continued movement of actuator 468 further<br/>expands the partially expanded sleeve member 444 to fully<br/> - 38 -<br/><br/> ~069791<br/>displace uterine cavity 432. This is done by subjecting the<br/>sleeve member 444 to fluid under pressure by moving the piston<br/>463 into chamber 464. The actuator 468 will continue to move<br/>until lock unit 507 engages one of the teeth 511, thereby<br/>preventing further expansion of the sleeve member 444. The<br/>sleeve member 444 can only be subjected to a maximum predeter-<br/>mined pressure so as not to place undue pressure on the walls<br/>of the uterus. The expanding sleeve member 444 forces or pumps<br/>the drug material that has been discharged into the uterine<br/>cavity through the openings 433A and 434A and into canals 433<br/>and 434 of the Fallopian tubes. Sleeve member 444 is then<br/>contracted by relieving the pressure applied thereto. This is<br/>done by pulling actuator 468 out of housing 457 so that the<br/>fluid can move into container chamber 464. The instrument is<br/>then removed from the uterine cavity via the cervical opening<br/>and vaginal passage.<br/> The drug material can be one of a number of fluids or<br/>semi-fluids used to test, treat or occlude the canals of the<br/> Fallopian tubes. For example, the drug material can be a<br/>tissue adhesive. The tissue adhesive can be a cyanoacrylate-<br/>type material or like material used as surgical glue. Cyano-<br/>acrylate is a liquid plastic which sets up or polymerizes in<br/>response to moisture and thereby functions to occlude the<br/>canals of the Fallopian tubes. The cyanoacrylates include,<br/>but are not limited to, methyl cyanoacrylate, methyl-2-cyano-<br/>acrylate, ethyl cyanoacrylates, n-propyl cyanoacrylates, n-butyl<br/>cyanoacrylates, n-amyl cyanoacrylates, n-hexyl cyanoacrylates,<br/>n-heptyl cyanoacrylates, isobutyl-2-cyanoacrylates and n-octyl<br/>cyanoacrylates. The drug material can also be of a type that<br/>sets up in response to body heat or other stimuli. It may be<br/>a type which produces permanent occlusion or of a type which<br/>will temporarily block or occlude the canals of the Fallopian<br/> - 39 -<br/><br/> ~1)6979~<br/>tubes, after which the canals will be reopened and resume<br/>their normal function. Examples of other types of drug mater-<br/>ials are contraceptive gels, water, silicone elastomers,<br/>formaldehyde-type materials and like materials.<br/> Referring to Figures 37 and 38, there is shown a modifi-<br/>cation of the dispensing instrument indicated generally at<br/>420A. Dispensing instrument 420A and the fenale reproductive<br/>system associated therewith follow the dispensing instrument<br/>shown in Figures 32-36. Corresponding parts of the instrument<br/>and reproductive system have the same reference numerals with<br/>the suffix A.<br/> Dispensing instrument 420A uses a two-part drug material<br/>which is mixed at the end of the probe as it is forced into<br/>the upper part of the uterine cavity 432A. The mixed drug<br/>material of the sleeve member 444A to displace uterine cavity<br/>432A.<br/> Head 651 is mounted on the outer end of the probe or<br/>tubular member 441A. The head 651 has a transverse passage<br/>652 having oppositely directed discharge openings for directing 20 the drug material in two parts into the upper part of the<br/>uterine cavity 432A. A first tube 653 and a second tube 654<br/>are connected to the head 651. The head has a mixing chamber<br/>or passage 655 in fluid communication with the passages of<br/>tubes 653 and 654 and the transverse passage 652. The drug<br/>materials flow through the tubes 653 and 654 and are mixed in<br/>chamber 655. The mixing continues as the drug materials are<br/>separated and forced in opposite directions in passage 652, as<br/>indicated by the arrows.<br/> Housing 457A has a pair of chambers 656 located adjacent<br/>chamber 458A for accommodating a pair of ampullae or containers<br/>657 and 659. Container 657 stores a first drug material 658.<br/>Container 659 stores a second drug material 660. A first<br/> - 40 -<br/><br/> 1069791<br/>piston 661 is slidably located in container 657. In a similar<br/>manner, a piston 662 is slidably located in container 659.<br/>Plunger 514A of the second drive assembly 479A has a bifurcated<br/>end forming a pair of fingers 663 and 664. Finger 663 is posi-<br/>tioned in container 657 and engages piston 661. Finger 664 is<br/>located in container 659 and engages piston 662. The tubes<br/>653 and 654 extend into housing 457A and terminate in needles<br/>666 and 667. Needles 666 and 667 are in alignment with the<br/>pierceable end portions of containers 657 and 659.<br/>ln On actuation of single actuator 468A, the first drive<br/> assembly 467A will operate to initially expand the sleeve<br/>member 444A to fill and seal the lower portion of the uterine<br/>cavity 432A. Continued movement of actuator 468A will engage<br/>the second drive assembly 479A to move the fingers 663 and<br/>664. Plunger 514A moves in a forward or upward direction, as<br/>shown in Figure 6, to drive the containers 657 and 659 onto<br/>needles 666 and 667, respectively. Fingers 663 and 664, being<br/>in engagement with pistons 661 and 662, simultaneously force<br/>the drug materals 658 and 660 through the tubes 654 and 653.<br/>The drug materials are simultaneously discharged into the mix-<br/>ing chamber 655. Substantially the same amounts of drug mater-<br/> - ials are introduced into the mixing chamber 655 so that the<br/> mixture of drug materials contains about 50 per cent of the<br/>first drug and 50 per cent of the second drug material. The<br/>mixed drug material, indicated at 668 in Figure 37, is intro-<br/>duced into the up er part of uterine cavity 432A. The mixed<br/>drug material 668 flows in opposite directions in substantially<br/>equal amounts. The flow is continuous until plunger 414A has<br/>reached the end of its stroke. At this time, the continuous<br/>movement of the actuator 468A further expands the sleeve member<br/>434A forcing the mixed drug material into the canals 433A and<br/>434A of the Fallopian tubes.<br/> - 41 -<br/><br/> 069791<br/> Drug materials 658 and 660 can be the type which when<br/>mixed will set up to form a sem-rigid plastic material. The<br/>mixture can be responsive to moisture in the tissues to set up<br/>or responsive to body heat or other factors to set up. The<br/>mixture has a reaction time such that it can be introduced<br/>into canals 433A and 434A before it will set up. The following<br/>is an example of the materials o-f the two-part drug material.<br/>The two-part drug materials may be two-part epoxies, two-part<br/>tissue adhesives, silicone RTV, or a polymer consisting of Dow<br/>~a~ 2Cr4~en~q~fk)<br/>10 ~ Corning Silasticl382 Medical Elastomer and 360 Medical Fluid.<br/> It is understood that other types of drug materials that are<br/>mixed and set up can be used. Furthermore, the ratio of the<br/>drug material can be varied by increasing the si~e of one of<br/>the containers. ~or example, two parts of the first drug<br/>material can be mixed with one part of the second drug material<br/>by using the appropriate size containers in the housing 457A.<br/> The drug material can be a contraceptive drug for local<br/>action in the Fallopian tubes and uterus. For example, bio-<br/>absorbable microspherules having contraceptive drugs, as pro-<br/>gestins, can be delivered to the canals of the Fallopian tubes.<br/>The microspherules break down over a period of time, i.e., one<br/>year, thereby inhibiting conception during this period.<br/> Biologicals, as fibrinolytic enzymes, can be introduced<br/>into the canals of the Fallopian tubes and uterine cavity to<br/>treat the tissues. The biologicals are used to treat-inflam-<br/>mation and prevent adhesions from forming around the ends of<br/>the Fallopian tubes.<br/> Diagnostic materials can be introduced into the canals of<br/>the Fallopian tubes with the apparatus and method of the inven-<br/>tion. These materials include oil base and aqueous base X-ray<br/>dyes and color indicator dyes, as methylene blue and indigo<br/>carmine and the like.<br/> - 42 -<br/><br/> ~069~<br/> Anesthetic materials can be introduced into the canals<br/>of the Fallopian tubes with the apparatus of the invention.<br/> The drug material can be of the type which treats the<br/>canals and uterus to enhance the flow of ova and sperm in the<br/>canals and uterus. The drug material can include material<br/>which expands or opens the canals or passages of the Fallopian<br/>tubes to enhance fertilization or conception. At the present<br/>time there are several materials or chemicals which are used to<br/> . .<br/>treat the canals of the Fallopian tubes to enhance fertilization<br/> - 10 or conception. Anti-inflammatory agents, as cordocoids, can<br/>be used to locally treat inflammation. Antibiotics can also be<br/>used for local treatment of the Fallopian tubes.<br/>It is believed that in some cases of infertility the sperm<br/>are blocked or unable to transport themselves across the cervix<br/>and endometrial cavity. The apparatus and method of the inven-<br/>tion is usable to deliver sperm into the uterine cavity and canals<br/>of the Fallopian tubes to enhance conception.<br/> While there have been shown and described preferred<br/>embodiments of the dispensing instrument and method of intro-<br/>ducing materials into both canals of the Fallopian tubes of<br/>a female, it is understood that various changes in the structure<br/>and method may be made by those skilled in the art without<br/>departing from the spirit of the invention.<br/> - 43 -<br/> -<br/>
