IL44358A

IL44358A - Fluid dispensing instrument for placing a fluid material in the uterine cavity

Info

Publication number: IL44358A
Application number: IL44358A
Authority: IL
Original assignee: Population Res Inc
Priority date: 1973-03-09
Filing date: 1974-03-05
Publication date: 1977-10-31
Also published as: DK142043B; FI62768C; JPS5946550U; IE41522B1; GB1470572A; AR203193A1; MY8100012A; NL7403145A; MY8100013A; KE3015A; HK3280A; ATA191374A; KE3016A; FI62768B; ZM4974A1; ES424097A1; DK142043C; JPS5026394A; FR2220286A1; AT369269B

Abstract

1470571 Catheters; syringes POPULATION RESEARCH INC 8 March 1974 [9 March 1973 31 Jan 1974] 10593/74 Heading A5R A uterine catheter tube 441 has an expandable member 443 at or near the dental end, the expandable member being made of soft, relaxed, flexible, elastic material having a low modulus of elasticity e.g. rubber, and being of sufficient size relative to the dimensions of the catheter tube to expand longitudinally of the catheter tube at least as far as one end thereof, whereby the expandable member can be expanded to substantially fill the uterine cavity and conform to the shape thereof. The instrument comprises a tube 441 insertable into the uterus and through which a balloon 443 on the innermost end may be inflated via apertures 448 from a container 459 by actuating a piston 463. One or more tubes 453 extend through the tube 441 to an outlet passage 452 in a head 417 at the innermost end of the tube 441 and convey medicaments from one or more containers 474 to the outlet passage 452 on operating a piston or pistons 477. The pistons 463, 477 controlling the inflation of the balloon and the dispensing of the medicaments are operated under the control of a single actuator 468 or a pistol grip trigger (320) Figure 27 (not shown) so that the balloon is first partially inflated, the medicament is then dispensed and, finally, the balloon is inflated sufficiently to fill the uterus and thus drive the medicament into the Fallopian tubes. The actuator 468 is initially connected to the plungers 486, 514 of the pistons 463, 477, respectively, by links 501, 518. On first projecting the actuator 468 the plungers 486, 514 are moved to displace the piston 463 and partially inflate the balloon and to project the medicament container 479 so that its forward end is pierced by a needle 472 which communicates with the dispensing tube 471. On continued movement of the actuator, the link 501 is moved away from the actuator but the plunger 514 continues to be displaced to cause discharge of medicament via the tube 471. The link 518 is then. disconnected from the actuator and the first link 501 reconnected so that projection of the plunger 486 recommences and inflation of the balloon is completed. The inflation fluid may be atmospheric air which enters the container 459 through a hole 466. Two medicament containers may be discharged simultaneously using a bifurcated plunger (514A) Figure 37 (not shown). The head (651) may include a chamber in which the contents of the two containers are mixed before discharge. The medicament and inflation fluid containers (44, 51, 53) Figure 1 (not shown) may be separate and independently operable, each container, Figures 4 to 19, (not shown) comprising a sealed cylinder or collapsible container from which the contents are ejected by a manually operable piston which also causes a needle to pierce a wall of the container. The containers may be contained in the same or separate housings. The balloon may be fully expanded to fill the uterus before the fluid is dispensed into the uterus. [GB1470571A]

Description

MG I1ENDING INGTRUHENT Λ ίΙ i FTHOD- ABSTRACT A fluid dispensing instrument and method for placing a material in the uterine cavity and moving the material from the uterine cavity to the canals of the Fallopian tubes of a female. The instrument lias an elongated probe carrying an expandable sleeve. A housing connected to the probe has a chamber for a container storing the material. A plunger is operable to move the container onto a needle and force the material through the probe and into the uterine cavity. In . one form, an actuator is continuously moved into the housing to initially partially expand the sleeve member to displace part of the uterine cavity. Further movement of the actuator dispenses the material from the probe into the uterine cavity Continued movement of the actuator fully expands the sleeve member to displace the entire uterine cavity and pump the material into the canals o the Fallopian tubes. After the n e n h SUMMARY 01; Tllli INVI;NTION: The invention is directed to an apparatus for dis ensin^_ a material, as a drug, into the canals of the Fallopian tubfes . The apparatus has a housing having a chamber. Container means storing the material is located in the c-hamb.er. Means having a passage for receiving the material from the container means is associated with the housing. Means, as a needle, is operable to puncture a part of the container means whereby material from the container means passes to the passage and the means for receiving the fluid. Actuator means cooperate with the container means and means for piercing the container means whereby material within the container means flows from the container means into the passage for receiving material.

One form of the container means has a collapsible side wall surrounding a chamber for storing one unit of fluid. The needle is located within the chamber whereby the container means material and needle are a compact assembly with the needle protected by the container means. The bottom wall of the container means has a tubular member closed with a diaphragm. The needle pierces the diaphragm when the container means is collapsed whereby the material is dispensed from the container.

One form of the apparatus has a body with a pair of chambers and an elongated first tube adapted to be inserted into the uterine caavity. A second tube within the first tube is connected to one of the chambers. An expandable sleeve attached to the end of the first tube fills the uterine cavity. Fluid, as water or air, under pressure within the sleeve holds the sleeve in firm engagement with the inner wall of the uterus. Containers storing materials are located in the chambers. An actuator mechanism cooperate ith the containers to sequentially dispense the materials into the first tube to expand the More specifically, the invention is directed to a method and apparatus for introducing a predetermined amount of t adhesive into the canals of the Fallopian tubes of a female from the uterine cavity. The apparatus lias an elongated probe having a forward end carrying an expandable balloon assembly. Λ dispensing housin having an actuator is used to expand the balloon assembly and discharge material into tle uterine cavity. The dispenser has a first drive assembly operable to initially partially expand the balloon assembly to form a seal and holding structure in the lower portion of the uterine cavity.

Continued movement of the actuator discharges the material into the uterine cavity above the partially expanded balloon assembly. Further continued movement of the actuator continues the expansion of the balloon assembly to displace the remaining space in the uterine cavity. The balloon assembly expands and forces the material into both canals of the Fallopian tubes. Substantially all of the material introduced > into the uterine cavity is moved by the expanding balloon assembly into the canals of the Fallopian tubes in a short period of tiem. When a tissue adhesive is placed in the canals, it reacts with the tissue to polymerize the adhesive and thereby occlude the canals.

The tissue adhesive is eventually replaced with scar tissue which permanently occludes the canals. The balloon assembly is contracted whereby it can be readily removed from the uterine cavity. by withdrawing the actuator from the housing.

The material can be a mixture of materials which set up after they are mixed. Separate materials are moved to the discharge end of the dispenser and mixed at the end. The mixture of materials is directed into the uterine cavity. The expansion of the balloon assembly forces the mixture of The invention includes the method of occluding the can.yfs^ of the Fallopian tubes by inserting an instrument having an expandable sleeve into the uterine cavity through the cervical opening. The expandable sleeve is subjected to fluid under pressure to hold the sleeve in firm uniform engagement with the inner wall of the uterus. A- fluid, as a drug, tissue adhesive or the like, is delivered via the instrument to the upper section of the uterine caivty. The fluid flows, over the top of the expanded sleeve and into the canals of the Fallopian tubes. Tissue adhesive fluids react with the moisture in the tissue of the Fallopian tubes to set up the adhesive, thereby blocking the canals. Other types of fluids can be injected into the canals to kill the tissue of the canal linings. This tissue is replaced with scar tissue which' occludes the canals. The instrument is removed from the uterine cavity after the sleeve is deflated by draining the fluid therefrom.

An object of the invention is to provide an apparatus and method of introducing a predetermined minimum amount of material into both canals of the Fallopian tubes of a female from the uterine' cavit . Another object of the invention is to provide a dispensing apparatus and method which has an actuator movable to discharge tissue adhesives into the uterine cavity and move the tissue adhesives from the uterine cavity into the canals of the Fallopian tubes of a female before the adhesives can set up in the uterine cavity. Another object of the invention is to provide an apparatus for introducing in a short period of time a controlled amount of material into the canals of the Fallopian tubes under low pressure with a single and continuous action on the part of the operator. A further object of the invention is to rovide an a aratus for introducin material different sizes, shapes and characteristics of uteri. Λ further .obj ect of the invention is to provide' an apparatus ^ and method for introducing material into both canals of the Fallopian tubes which is not position sensitive and does not apply substantial pressure to the materi'al, whereby the material is not forced into the blood stream or body cavity. Yet another object of the invention is to provide an apparatus and method of introducing material into both canals of the Fallopian tubes with the balloon assembly subjected to a maximum predetermined pressure to eliminate over- expansion of the uterus. A still further object of the invention is to provide an apparatus for placing material into the canals of the Fallopian tubes which- is simple to operate and is used with a minimum of manipulative delay. Another object of the invention is to provide an apparatus and method for mixing separate materials, directing the mixed materials into the uterine cavity and forcing the mixed materials in the uterine cavity into the canals of the Fallopian tubes. Other objects and advantages of the apparatus and method of the invention are set out in the following specification and accompanying drawings.

IN THE DRAWINGS : Figure 1 is a longitudinal sectional view of the genital system of a female primate with the dispensing instrument extended into the uterine cavity; Figure 2 is a top elevational view of the dispensing unit of the instrument; Figure 3 is an enlarged sectional view taken along the line 3-5 of Figure Figure 4 is an enlarged sectional view taken along the line 4-4 of Figure 3; ..

Figure 6 is a sectional view similar the dispensing Unit actuated to discharge Figure 7 is a cross sectional view of a modified dispensing unit for the dispenser; Figure 8 is a sectional view taken along the line S-8 of Figure 7 ; Figure 9 is .a sectional view similar to Figure 7 showing the dispensing unit in the discharge position; Figure 10 is a diagrammatic view of a further modification of the dispensing unit in a non-dispensing position; Figure 11 is a sectional .view similar to Figure 10 showing the dispensing unit in the discharge position; Figure 12 is a longitudinal sectional view of a further modified dispensing unit in the non-dispensing position; Figure .13 is a view similar to Figure 12 showing the dispensin unit in the discharge position; Figure 14 is a side elevational view of a container spaced from a needle adapted to carry fluid from the container; Figure 15 is an end elevational view of the sealed end of the container of Figure 14; Figure 16 is a longitudinal sectional view taken along the line 16-16 of Figure 15; Figure 17 is an enlarged sectional view of the sealed end of the container; Figure 18 is a sectional view taken along the line 13-18 of Figure 14 ; Figure 19 is a sectional view similar to Figure 16 showing the container in assembled relation with the needle; ' Figure 20 is a top plan view of a modified dispensing instrument 'o the invention; Figure 22 is a sectional view taken along the line 22-22. of Figure 21; Figure 23 is an enlarged sectional view taken along the line 23-25 of Figure 20; Figure 24 is a sectional view similar to Figure 25 showing the lock in the release position; Figure 25 is a sectional view similar to Figure '25 showing a modification of the lock; Figure 26 is a top plan view of another modification of the dispensing instrument of the invention; Figure 27 is an enlarged sectional view taken along the line 27-27 of Figure 26; Figure 28 is a sectional view taken along the line 28- 28 of Figure 27; Figure 29 is an enlarged sectional view taken along the line 29-29 'of Figure 27 ; Figure 50 is a view similar to Figure 29 showing the movable member in the second position; Figure 31 is an enlarged sectional view of, the fluid container assembly used in the dispensing instrument; Figure 32 is a foreshortened sectional view of a reproductive system of a female accommodating a dispensing instrument of the invention for. locating drug material in both canals of the Fallopian tubes; Figure 33 is a longitudinal sectional view. of the dispensing assembly of the instrument of the inve tion; Figure 54 is a sectional view taken along the line. 54-54 of Figure 52 ; Figure 55 is a foreshortened sectional view of the female reproductive system accommodating the dispensing instrument Figure 36 is a foreshortened sectional view similar to Figure 35 showing the balloon assembly fully expanded in the uteri e cavity; Figure 37 is a foreshortened plan view, partly sectioned, similar to .Figure 35, of a modification of the dispensing instrument; and Figure 38 is an enlarged sectional view of the discharge end of the dispensing instrument of Figure 37.

DESCRIPTION O PREFERRED EMBODIMENTS: Referring to the drawing, the. e is shown in Figure 1 a diagrammatic female genital system indicated generally at 20. An intrauterine catheter indicated generally at 21 is located in the genital system to direct a fluid, as a drug, tissue adhesive, or other material, into the canals of the Fallopian tubes. The tissue adhesive can be isobutyl 2- cyanoacry late monomer, silver nitrate or quinacrine materials. The cyano-acrylate monomer is a liquid plastic which sets up or polymerizes in response to moisture and thereby functions to occlude the canals of the Fallopian tubes. The drug material's can be of the type that temporarily block or occlude the canals of the Fallopian tubes. After a period of time the canals will reopen to resume their normal function.

The genital system 20 l as an elongated vagina 22 defined by the cylindrical vaginal wall 23. The vagina 22 opens into the vestibule 24. The opposite end of the vagina is attached to the uterus, indicated generally at 26. Uterus 26 is a pear-shaped, thick walled, hollow organ situated between the bladder and rectum. Uterus 26 has a' uterine cavity 27 which is flattened and triangular in shape. The size of the uterine cavity varies from female to female. The top or fundus 28 of uterus uterine cavity 27. The uterine wall is composed o an outer serosal layer, or peritoneum; a firm, thick, intermediate c Leading to the upper part of opposi-te sides of the uterus 26 are Fallopian tubes 33 and 34. The Fallopian tubes are paired, trumpet-shaped, muscular members which extend from the superior angles of the uterine cavity to the ovaries (not shown) . The ovaries are solid, slightly irregular shaped bodies situ-uated on either side of the uterus behind and below the Fallopian tub es .

Fallopian tubes 33 and 34 each have a canal or aqueduct 56 and 57 respectively. The Fallopian tubes are musculomem-branous structures about 12 cm. in length. The are commonly divided into isthmus, intramural and ampullar)' sections. The canals 56 and 37 provide passages for the movement of ova from the ovaries into the uterine cavity. The intramural section of the Fallopian tubes traverses the uterine wall in more or less straight fashion. It lias an ampulla- like dilation just before it communicates with the uterine cavity 27. The canals 36 and 57 arc narrowest at the intramural sections. The walls of the Fallopian tubes consist of three layers; a serosal layer, a muscular layer and a mucosal lining. The muscular layer includes longitudinal muscle fibers which, when contracted, bring the ends of the Fallopian tubes in close contact with the surface of the ovaries. Blood vessels are abundant in the muscular layer where tliey form with the muscle, bundles a kind of erectile tissue which, if engorged, moves the Fallopian tubes to sweep over the surface of the ovaries.

This movement of the Fallopian tubes is impaired when the interfere with the erectile action and movement of the Fallopian tubes.

• Catheter 21 has an elongated first tube 38 having a. length sufficient to extend through the vagina and into the uterine cavity 27. Λη expandable sleeve member 39, as a balloon or the like, is secured to the upper end of tube 38 with bands 40. The outer end of sleeve member 39 terminates at the outer end of tube 38. Sleeve member 39 is a flexible elastic member made of relaxed rubber material. The rubber ' material has uniform surface tension and .uniform expansion characteristics. Sleeve member 39 is expanded into uniform and firm engagement with the inner wall of the uterus regard- less of the size of the uterine cavity. This enables the same catheter construction to be used on all types of primate females. Expanded sleeve member 39 lias a generally pcar-sha cd chamber 41 filled with fluid, as water, air or the like. The tube 38 has a plurality of holes 42 connecting the passage of tube 58 witli chamber 41. The upper end of tube 38 is closed with a plug 43.

The end of tube 38, projected from the vestibule 24, is attached to a fluid dispensing unit indicated generally at 44. Tube 38 can be releasably -attached to dispensing unit 44 or fixed to dispensing unit 44. The dispensing unit has a body 46 carrying a movable plunger 47. When plunger 47 is moved in the direction of arrow 48, a fluid, preferably water, is forced from the dispensing unit 44 into he expandable sleeve member 39 to form a closure and fill the uterine cavity 27.

Located within the tube 58 are a pair of smaller tubes 49 and 52 for carrying fluids into the uterine cavity 27.

Tube 49 has a portion extended outwardly from the tube 58 and ill construction and can be used to dispense the same fluids or different fluids at separate time intervals. One of the' dispensing units can dispense a neutralizer fluid into the uterine cavity. The following description is limited to dis pensing unit 51.

Referring to Figures 2 to 5, dispensing unit 51 has a body or housing 57 comprising a cylindrical side wall 58 and an end wall 59. Housing 57 lias a chamber 61 and outwardly directed ears 62 and 63. Ears 62 and 63 extend in diametric ally opposite directions from opposite sides of the open end of body 57 and cylindrical side wall 58. Λ collapsible container or ampulla indicated generally at .64 is located in chamber 61. Die container holds a drug or similar material used in the treatment and/or occlusion of the canals of the Fallopian tubes. The container 64 has an accordion cylindrical side wall 66 secured to a transverse generally flat bottom wall 67. The center portion of bottom wall 67 lias longitudinal tubular member 68. Member 68 lias an outwardly projected portion 68A'and an -inwardly directed portion 6SB. The tubular member 68 is closed with a transverse diaphragm 69. Diaphragm 69 is a relatively thin disc member located in the transverse plane of bottom wall 67. The opposite end of the container 64 is closed with a transverse seal 71.

Container 64 is preferably made of a deformable lead alloy having good moisture and vapor barrier properties.

Other deforma le material having good moisture and vapor barrier properties can be used to fabricate the container. These properties are important to prevent moisture and vapor sensitive material from polymerizin or setting up during storage periods.. The material of the container is also chem Located within the container 64 is a longi udinal needle- 73. Needle 73 is a hollow member terminating in an inclined'' end having a point 74 located adjacent the inside of diaphragm 69. The opposite end of needle 75 is attached to a circular head 76. As shown in Figures 4 and 5, needle 75 lias a longitudinal passage 77 extended through the pointed end of the needle. The side wall of needle 73 has a hole 78 to provide for the flow of liquid form tlie container through the needle. Needle 73 can have a plurality of holes or an elongated slot to provide for the flow of fluid through the needle.

The chamber 61 is closed with a plunger or movable member 79. A portion of the movable member fits into the chamber' and has outwardly directed ribs 81 and 82 extended into' longitudinal grooves 83 and 84 in the inside portions of the cylindrical side wall 58. The ribs 81 and 82 hold the plunger 79 in assembled relation with the body and guide the body linearly into the chamber 61. Plunger 79 l as in inwardly open recess 86 for accommodating the outer end of container 64. The bottom central portion of recess 86 has a cavity 87 providing a space for the sealed top 71. Plunger 79 can be removed from the side wall 58, enabling the container 64 to be removed from the chamber and replaced with a new container.

Referring to Figure 6, the dispensing unit 51 is operated by moving the plunger 79 into the chamber 61. This is accomplished by applying a force on the outer end of plunger 79 in the direction of arrow 88. The first and second fingers are placed under the ears 62 and 63. The thumb is used to apply force to the plunger 79. The needle 75 will be' moved through the diaphragm 69. The fluid within container 64 will be placed under pressure and forced through the hole 78 along end 54 and flows along the inner wall of the fundus into the* canals 36 and 37 of the Fallopian tubes. Pressure is applied to plunger 79 until all of the fluid in the container 64 is dispensed therefrom. The sleeve member 39, being in engagemen with the inner wall of the fundus, limits the amount of fluid that can collect on the inner wall.

The dispensing unit 51 is a disposable item that contains a single dosage or unit of a drug or fluid. The dispensing unit can be used as part of a syringe to inject drugs into a body. The tube 49 can be replaced with a tubular needle which is placed on the outwardly directed tubular member 68. Tubular member 68 can contain threads to relea ably hold the needle. Member 68 can be releasably or permanently attached to an elongated delivery tube.

Referrin to Figures 7, 8 and 9, there is shown a modification of the dispensing unit, indicated generally at 100, operable to discharge fluid, as a drug, under pressure into a tube or hypodermic needle. Tube 10.1 can be one of the delivery tubes of catheter 21. Dispensing unit 100 has a body or housing 102. comprising a cylindrical side wall 103 joined to a flat end wall 104. Side wall 103 surrounds a cylindrical chamber 106 having an open end opposite end wall 104. Oppositely directed ears 107 and 108 are secured to the open end of the side wall 103.

Located within chamber 106 is a container or ampulla indicated generally at 109 for storing fluid, as drugs, tissue adhesive, water, air, gas, semi-fluids, and the like. Container 109 is a collapsible structure having a cylindrical side wall 111 and bottom wall 112. Bottom wall 112 is located in flat surface engagement with the inside surface of end wail through a hole .114 in bottom wall 112. Member 115 has . an out,* wardly projected portion 11.3A and an inwardly directed portion 113E. The midportion of tubular member 113 has a transverse diaphragm or disc 116 closing the passage through the tubular member 113. The opposite or top end of "the container is closed with a folded seal 117. A longitudinal needle 118 is located in the container 109. Needle 118 has a point 119 located in the upper or inner portion of the tubular member 115. The opposite end of needle 118 is attached to a transverse head 121. Head 121 is located adjacent the inside of the top wall of the container 109. As shown in Figure 8, needle 118 is a generally U-shaped cross section. One side of the needle is open to the fluid in the container. This allows the fluid to flow longitudinally along the container past the point 119 when the point pierces the diaphragm 116. The needle can be a longitudinal tubular member having one or more holes providing access to the passage in the needle, as shown by needle 75 in Figure 6.

A plunger 122 closes the open end of the housing 102.

Plunger 122 has a pair of diametrically opposite ribs or projections 123 and 124. The- ribs 123 and 124 are located in longitudinally extended grooves 126 and 127 in the inside of side. all 103 of the housing to guide the longitudinal movement of the plunger into the housing. The inner face of plunger 122 has an annular recess 128 to accommodate portions of the container when the plunger 122 is moved into chamber 106. The center portion of plunger 122 has a cavity 12.9 for accommodating the seal 117 of the- container.

In use, referring to Figure 9, force is applied to plunger 122 in the direction of arrow 121. This moves plunger 122 as the point 119 of the needle penetrates the diaphragm 116, the fluid within container 109 can flow through the needle '' 118 into the tube or receiver 101. Fluid will continue to flow through the needle 11 S as long as force is applied to the plunger 122. Plunger 122 can be moved into chamber 106 until the head abuts against the inner portion of tubular member 113.

Referring to Figures 10 and 11, there is shown a modification of the needle and container arrangement. The bottom portion of container 132 lias a generally flat end wall 155. The midportion of the end wall has a longitudinal tubular member 134. The tubular member 134 has an outwardly directed outer portion 154A and an inwardly projected inner portion 154B. The midportion of the tubular member 134, in general alignment with the end wall 135, -has a diaphragm or disc 156. Λ needle indicated generally at 137 is longitudinally aligned with the passage in the tubular member1 154. Needle 157 has a cone-shaped head 158 terminating in a point. Head 158 is connected to an elongated shank 139. As shown in Figure 11, when needle 137 is moved in the direction of arrow 141, head 158 punctures the diaphragm 136. The hole in the diaphragm 136 is larger than the shank 159, allowing the fluid in tiie container to flow past the diaphragm 156 into the discharge portion of the tubular member 134. The outer portion 154C of the tubular member has threads 142 adapted to receive a female threaded member, as a nut or sleeve, or a fluid receiving apparatus. Other types of connections can be used to couple the tubular member .124 to the fluid receiving apparatu .

Referring to Figures 12 and 13, there is shown a fluid dispensing container or ampulla indicated generally at 145. water and the like'. Wall 144 is made of non-collapsible material. Λ generally flat transverse end wall 146 is integral V with one end of side wall 144. The center portion of end wa.ll 146 has an elongated longitudinal, tubular mem er 147. Tubular member 147 has an outer portion 147A extended outwardly from end wall 146 and an inner portion 14713 projected into chamber 145. The idportion of tubular member 147 is closed ..with a diaphragm 148. Diaghragm 148 is located in transverse alignment with the end wall 146 and is of a material that can be pierced with a needle.

An elongated longitudinal needle 149 is located within chamber 145. Needle 149 has a forward end located within the passage of inner portion 147B and terminates in a point 151. The opposite end of needle 149 is attached to a transverse head 152. liead 152 has an annular outer peripheral surface which forms a seal 153 with, the adjacent inner wall of side wall 144. The outer peripheral surface of the head 152 is in sealing frictional fit with the inner surface of the side wall 144. The outer peripheral surface of the head 152 is in sealing frictional fit with the inner surface of side wall 144 so as to prevent moisture, air or other substances from entering chamber 145. Needle 149 l as a generally U-shaped cross section as shown by needle 118 in Figure 8. Alternatively, needle 149 can be a tubular member having one or more side holes to provide a passage for the movement of fluid in chamber 146 out the end of needle 149. The needle can also the shape of needle 157, as shown in Figures 10 and 11. Other shapes and structures · can be used to permit the flow of fluid along the needle through the diaphragm once the diaphragm has been pierced by the point of the needle. nt h m er 145 in the direction will penetrate and- pierce the diaphragm 148. The fluid in chamber 145 is forced along the needle through the pierced diaphragm and discharged via the outer portion 147Λ of the - tubular member.

Referring to Figures 14 and 19, there is shown a container or ampulla indicated generally at 160 for storing a fluid, as a drug, liquid tissue adhesive, semi- liquid material or a gas. Container 160 is located in longitudinal alignment with a tubular needle 161. Needle 161 is secured to a gencr-, ally transverse base 162 and has a point or sharp edge 165 at its forward end. Base 162 is mounted in a housing (not shown) to fix the position of the needle 161.

Container 160 is a one-piece body having a continuous side wall 164. Side wall 164 l as an accordion shape and is of a cylindrical configuration and surrounds a chamber 166 for storing the fluid. The forward end 167 is closed with a diaphragm or cylindrical disc member comprising an end wall 167. An outwardly directed longitudinal sleeve 168 is attached to the outer peripheral edge of the end wall 167 forming an extension of the container. A disc or pad 169 of resilient material, as sponge rubber, plastic foam or the like, is located within sleeve 168 and covers the end wall 167. Sleeve 168 l as a rolled outer edge or bead 171 holding the pad within the sleeve 168.

The rear end of the container is closed wi h an end wall 172. F;nd wall .172 has a transverse seam 175' closed to moisture and vapor to seal the container. As shown in Figure 17, the seam 175 has lapped and inturned edges that are sealed together The container is made of a material having moisture and vapor impervious properties. Preferably the material is deformablc and vapor barrier properties can be used to form the container. These properties are essential to prevent moisture and vapor sensitive materials from setting up or polymerizing during lengthy storage periods. For example, the cyanoacrylate monomer is extremely sensitive to moisture and vapor. It must be stored in a sealed container which does not allow ingress of moisture and vapor. The monomer will set up in a short period of time when exposed to moisture, including the moisture of tissues .

In use, force is applied to the end wall 172 in the direction of arrow 174. This force moves the container 160 into operative engagement with needle 161. The force will also collapse the side wall 164 and apply sufficient force to the container whereby the needle .161 will cut through or pierce both the pad 169 and end wall 167. Pad 169, being made of resilient elastic material, will be formed with a hole 176 in tight sealing engagement with the outer peripheral surface of needle 161. Needle 161 will also make a hole 177 in the end wall 167. Needle 161, being a hollow tubular member, provides a passage for the flow of fluid from chamber 166 into a fluid receiver such as the tube of the dispensing catheter.

Referring to Figure 20, there is shown a catheter dispenser having a dispensing unit indicated generally at 200 attached to an elongated balloon catheter 202. The dispensing unit lias a body or housing 201 attached to an elongated linear tube 203 of the catheter. Tube 203 can be an integral extension of the body or rcleasably connected to the body 201. · The outer end of the catheter has an expandable sleeve member or balloon 204 adapted to confine fluid, as water or gas, to enlarge the opening 205 at the- outer end whereby fluid can be discharged from the catheter. The outer end of tube 203 can be recesse.rf to insure the flow of fluid from outlet opening 205.

The body 201, as show in Figure 22, has a pair of longitudinally extended chambers 207 and 208.· Chambers 207 and 208 are located side-by-side in a generally horizontal plane. The chambers can be located in a. generally vertical plane. Λ passage 209 connects the chamber 207 with the passageway oT: tube 203. Λ similar passage 211 connects the chamber 2US with the passage in tube 206. Λ short .tubular needle 212 extends lon itudinally into passage 207. Needle 212 is attached to a transverse base 213 positioned at the end of chamber 207 having the passage 209. Tlie outer peripheral edge of base 213 is located in a groove in the housing to fix the position of the base and needle relative to the passage 207. The needle 212 has a passage in alignment with passage 209 so that fluid flows through the needle into tlie passage 209. Λ second tubular needle 214 is located longitudinally in passage 208. Needle 214 is attached to a base 216 located at the end of chamber 208 adjacent the passage 211. The outer peripheral edge of base 216 is located in grooves in the housin 201 to fix the position of the base and needle relative to .passage 208. The passage of needle 214 is aligned with the passage 211 so that the fluid can flow through the needle and into passage 211. Λ container or ampulla 217 having a chamber 218 for fluid, as drugs, water or other material, is located in chamber 207. Container 217 has an end or diaphragm 219 facing the needle 212. Λ pad. 221 of resilient cushioning material is located between diaphragm 219 and the pointed end of needle 212. Λ plun er 222 is attached to the opposite end of con be used' to connect the container to the plunger. Other types/*" of connections can be used to attach the container to the plunger. Λ longitudinal rod 223 is connected to plunger 222 and extended into a bore 224 in the housing 201. Λ coil spring 226 is positioned around rod 225 and engages the housing 201 and the plunger 222 to bias the plunger toward the needle 212. Λ rclcasable lock 227. engages the rod 222 to hold the plunger 221 in a cocked position whereby the diaphragm 219 is held from the needle 212. Referring to Figures 25 and 24, releasable lock 227 comprises a cylindrical member or body 228 extended downwardly into a hole 229 in housing 201 through a cutout or groove 230 in rod 225. The body 228 has a semicircular cutout 25.1 in alignment witli rod 225. The upper or exposed end of: the body 228 has a handle 252. The handle 252 is movable in the direction of arrow 253 shown in Figure 20 to move the cutout 231 in registration with rod 225. When the cutout 231 is in registration with rod 223, as shown in Figure 18, the rod is free to move. The spring 226 will bias plunger 222 toward the needle' 212. This moves the container 217 and. the diaphragm 219 into the needle 212. The pointed end of the needle will pass through the pad 221 and puncture diaphragm 218. The needle 212 will form a seal with the diaphragm 219 whereby the fluid in chamber 218 will flow through the needle, passage 209 and into the passage of catheter tube 203. The biasing force of the spring 226 will force substantially all of the fluid in chamber 218 through needle 2.12.

An upwardly directed finger 254, shown in Figure 21, is attached to plunger 222. The finger 254 extends through a longitudinal slot' 256 in the housing 201. The upper end of finger 254 is enlarged so that it can be gripped. Plunger applied: to finder 234 , the plunger 222 can be moved in a reverse direction, expanding the container 217. This withdraws the ' fluid from the catheter, decreasing the size of tlve expandable member 204. The plunger 222 can be moved until lock 227 can be moved to fix the position of the plun-ger 222 in the housing. Other types of retraction structure can be used to withdraw and expand the container 217 to relieve the fluid fro-m the expandable member 204.

A container or ampulla 238 is located in chamber 208 adjacent the needle 214. Container 238 lias a chamber 259 for storing drugs, tissue adhesive and other materials. Container 258 has an end or diaphragm 241 spaced from the pointed end of needle 214 with a resilient pad 242. Sonic drugs that are moisture and vapor sensitive require a container made of material havin good moisture and vapor barrier properties.

Preferably a de.formable lead alloy is used to make this type of container. These properties are important to prevent moisture and vapor sensitive materials from polymerizing or setting up during storage periods. The material of the container is also chemically inert to the fluid stored in the container. Located adjacent the opposite end of container 238 is a plunger 243. A longitudinal rod 244 attached to plunger 245 extends into a bore 246 in housing 201. A spring 247 located in ch amber 208 engages the housing 201 and plunger 243 to bias the plunger toward the needle 214. The rod 244 is held with a. rcleasablc lock 24S. bock 248 is identical to lock 227. I is operated by moving the handle of the lock to the dotted line position, as shown in Figure 14. This releases the rod 214 whereby the spring 247 will bias the plunger in a forward direction, moving the diaphragm 241 toward the needle the passage 211 leading to the tube 206. The dia hragm will be located in sealing realtion witlr respect to the needle whereby the fluid in chamber 239 of container 23S will be forced by t!ic biasing action of the spring 247 through the needle 214, the passage 211 and the passage of the tube 206.

Body 201 lias doors or closure members closing openings into the chamber 207 and 208 whereby the containers 217 and 238 can be removed and replaced. Other types of containers as herein disclosed can be inserted into the chambers.

Referring to Figure 25, there is shown a modification of the releasable lock, indicated generally at 250. Lock 250 has a body or rod 251 having a cylindrical cutout 252. The rod 223 attached to the plunger has a similar cutout. Λ spring 253 located in the base of bore 224 biases the body 251 in an upward direction. The u p.er end of body 252 is attached to a head 254.

In use, body 251 has a portion located in the groove or recess in the side of the rod 223 to hold the rod in the cocked position, as shown in Figure 22. The rod 223 is released by pushing head 254 in a downward direction, as indicated by arrow 256, until the cutout 252 is aligned with rod 223. This releases the holding action on rod 223 whereby the spring 226 can move the rod in a forward direction, forcing the diaphragm 219 into engagement with the needle 212.

Referring to Figures 26, 27,' 28 and 29, there is shown a further mod ficat on of' dispenser catheter of the inve ion indicated generally at 300 for discharging flu Id, as drugs, tissue adhesives, and the like, into the uterine cavity. The dispenser catheter 300 has a dispensin unit 301 and an elongated tubular catheter 302. Dispensing unit 301 has a body 303 he ca heter. Tube 304 can Mounted on the end of tube 304 is an expandable sleeve memb^T" or balloon 505. Bands 506 clamp the ends of sleeve member 505 to tube 504. Sleeve member 505 is an elastic sheet member, of relaxed rubber, plastic or like materials. When the sleeve member 305 is expanded in the uterine cavity, it applies uniform outward pressure on the uterine wall. The expanded sleeve member 305 prevents the drugs injected into the uterine cavity from contacting substantial portions of the uterine wall and flowing out of the uterine cavity. Holes 307 in the end of tube 504 provide the passageway fo.r the fluid, as water, from within the tube 504 into the area surrounded by the sleeve member 505 to expand sleeve member 505. An elongated small tube 508 is located within tube 504. Tube 50S has a discharge end 509 at the outer end of tube 504.

Body 303 has a pair of side-by-sidc chambers 511 and 512. Chambers 511 and 512 extend in a longitudinal direction and are located in a common horizontal plane. The chambers can be located in a common vertical plane whereby one chamber is positioned over the other chamber. A passage 513 connects chamber 311 with the tube 504. In a similar manner, a passage 314 connects chamber 312 with the tube 308.

A first plunger 316 is movably positioned in first chamber 511. A. rearwardly directed rod 517 is attached to plunger 316. A second plunger 318 is mo.vably located in chamber 512. A rod 319 is secured to the plunger 318 and extends in a rearward direction .generally parallel to the rod 317. A trigger assembly or actuator indicated generally at 320 is mounted on the rear portion o the housing adjacent the rear end of rods 317 and 319.

Trigger, assembly 320 has a lever 32.1. The mldportion of pistol grip 523 secured to the rear portion of the body 505.^-Lever 321 has a transverse head 324. Λ spring 325 engages the body 503 and upper end of lever 521 to bias the lever in the rear or cocked position. The forward portion of head 524 is in sliding engagement with the ends o rods 517 and 5.19.

Referring to Figures 29 and 50, head 524 has a longitudinal passage 526 for accommodating rod 519. A transverse bore 527 opens into passage 326. Slidably disposed in bore 327 Is a pin 32S. Pin 528 lias a. reduced diameter neck 529 attached to an enlarged head 551. Λ spring- 552 engages the head 551 and a plug 555, closing the end of bore 527. Spring 552 biases the pin 528 into the passage 526. Rod 517 has a rearwardly directed finger 334. When rod 317 is in t!ie rearward or cocked position, the finger 354 is located behind the head 551 and functions as a stop to prevent movement of pin 528 into passage 526.

Returnin to Figure 27, rod 517 l as a notch or slot 556 in the upper portion thereof. The slot 556 cooperates with lock 557 to hold rod 517 in the dispensed or "in" position.

Lock 557 comprises a movable pin 558 located in a passage surrounded by a boss 559. The pin 558 l as a head 541 located above body 303 so that it can be gripped to release the lock. The forward portion of the pin carries a C-ring or clamp ring 542 providing a stop for a spring 545. Spring 545 is located concentrically around the pin and engages a portion of the body 505 to bias the pin 558 toward rod 517. When rod 517 lias been moved to the "in" position, the pin 558 will be biased into the slot 556, thereby holding the pin in the "in" position The rod 319 has a slot 544. Λ lock 546 on body 503 holds the pin in the "in" position. Lock 346 is identical to lock 557. 557. Rod 519 is not moved because the head 524 will move relative to rod 519 as rod 519 moves through passageway i When the head 324 is returned by spring 325 to its initial rearward position, the pin 32S will be biased by spring 552 into passage 526. 'D e second actuation; or movement of the lever 321 toward the handle 323 will move the rod 319 in the forward direction.

Referring to Figure 28, a first container or ampulla indicated generally at 350 is located in chamber 311. Λ for-wardly directed needle 351 mounted on a transverse base 352 is located at the forward end of chamber 511. Needle 551 is a hollow member in fluid communica ion with passage 515. Λ second container or ampulla, indicated generally at 353, is located in passage 512. The forward end of passage 512 has a longitudinally extended needle 354 mounted on a transverse base 356. Needle 354 is a hollow tubular member ha\''ing a passage in fluid communication with the passage of the tube 314. The container 355 is an elongated cylindrical member of glass, plastic or the like having a head 557. The head has a rubber plug (not shown) in alignment with needle 354. Slidably positioned, within the container is a plunger of piston 558 confining fluid 359 in the container. The plunger 518 is slidably positioned within the container and engageable with the piston 358. On movement of plunger 318 in the forward direction, head 557 will be driven through needle 554, thereby providing a fluid communication between the chamber of the container 555 and tube 314. The piston 358 will be moved in a forward direction to drive the fluid from the container.

The fluid can be a drug, tissue adhesive, or semi-fluid material for treating and occluding the canals of the Fallopian tubes. end o L: cylinder 561 has a head 565 havin a passage closed with a plu 364. The open end of cylinder 561 is closed wi a plunger 566 carrying a piston 567. The rear portion of plunger 566 has an outward!)' directed . flange 56S cngagcable with a spring 569. The forward end of spring 569 engages an annular seat 571 on the cylinder 561 to bias the plunger 566 in an outward direction or out of cylinder 561. Plunger 566 has a central longitudinal bore 572 slidably accommodating an actuator rod 575. Rod 575 has an axial bore accommodating a compression spring 574 to provide -a yieldable link between rod 575 and plunger 566.

Plunger 516 attached to rod 517 engages the end of rod 576. On movement of plunger 516 in the forward direction, sprin 574 will be initially compressed applying a uniform pressure on plunger 566. The cylinder 561 will be moved in a forward direction whereby- needle 551 will pierce plug 564, providing fluid communication between the container and passage 515. The continued inovement of the plunger 516 will drive the piston 567 toward the plu 564, thereby dispensing the fluid from cylinder 561. The dispensed fluid will flow through tube 504 and into sleeve member 505 via holes 507 to expand sleeve member 505, as shown in broken lines in Figure 22. Sleeve member 505 will expand with a uniform pressure so as to fill the uterine cavity and exert uniform pressure on the inside wall of the cavity. The pressure of sleeve member 305 on the cavity wall will be uniform regardless of. the size of the uterine cavity.

Body 303 has doors or closure members closing openings into the chambers 511 and 512 whereby the containers 550 and 555 can be removed, and replaced. Other types of containers, In use, the dispensing catheter performs a method of introducing a material, as a drug, tissue adhesive, contra- ceptive gel or like material, into the canals of the Fallopian tubes. The method includes the introduction of an elongated catheter 302, with sleeve member 305 in 'the contracted position, through the cervical opening into the uterine cavity. Sleeve member 305 is expanded with fluid under pressure to fill the uterine cavity and apply uniform pressure- on the inside o !: the uterine wall. The fluid under pressure is delivered to sleeve member 305 via the passage .in the tube 304. Actuator 520 is moved in a forward direction to force plunger 516- in a direction to move the container 350 into operative engagement with needle 351. Needle 351 will puncture the plug 564, wherein" the fluid 302 will flow via the passage in tube 504 to expand sleeve member 305. The sleeve member, being a sheet of flexible, elastic rubber or similar material, has a low surface tension and applies a uniform expansion force to the inside of the uterine wall. This effects a relatively tight seal and fit, enabling the same catheter construction to be used on all types of primate female, regardless of the size of the uterine cavity.

The material under pressure is then dispensed into the uterine cavity between the expanded sleeve member and the fundus of the uterus. The material, being under pressure, moves toward and into the ca'nals of the Fallopian tubes. The expanded sleeve member, being located against the fundus wall, aids the movement of the material toward the canals o I: the Fallopian tubes. The material can be a fluid tissue adhesive which will flow into the canals. The moisture in the tissue of the canals will polymerize or set the tissue adhesive and The catheter is then withdrawn from the uterine cavity.

Referring to Figure 52, there is shown the dispensing instrument indicated generally at 420 with the probe located in the uterine cavity. The female reproductive system shown generally at 421 has a uterus 422 joined to a pair of Fallopian tubes 423 and 424. The lower part of uterus 422 is integral with an elongated vagina 426. \'agina 426 has a vaginal cavity 427 having an openin or entrance 428. The opposite end of vaginal cavity 427 is in communication with the cervix 429.

Cervix 429 lias a cervical opening .451 providing a passage from vaginal cavity 427 to uterine cavity 452. Fallopian tubes 425 and 424 have exits 453A and 434Λ at opposite sides o L: the upper part of the uterine cavity 452.

The uterus 422 is a generally pear-shaped, thick walled, hollow organ situated between the bladder and rectum. The uteri of females vary in size and shape. Wall thickness, wall strength and sensitivity to pain may vary from female to female. The size and configuration of the uterine cavities can vary.

The uterine cavity 432 is generally flattened and triangular in. shape. Some uteri, have cavities that have other shapes.

The Fallopian tubes 425 and 424 are paired, trumpet-shaped muscular members about 12 cm. in length which extend from the superior angles of the uterine cavity 452 to the ovaries (not shown). The outlets 455A and 434A of canals 435 and 454, respectively, can vary in positon relative to the uterine cavity and relative to each other. Outlets 455Λ and 454Λ are usually symmetrically opposite each other, as shown in -Figure 52, and their position and proximity are principally related to the uterine size and configuration. Also, the size of the canals 453 and 434 and the size of outlets 433Λ and 454Λ vary Fallopian tubes are commonly divided into isthmus, intra- _ mural and ampullar)' sections. Canals 453 and 434 provide passages for the movement of ova from the ovaries to the uterine cavity 432 as well as the movement of sperm from the uterine cavity toward the ovaries. The intramural sections of the Fallopian tubes traverse the uterine wall generally in a more or less straight fashion, but their course may be tortuous in some females. The walls of the Fallopian tubes consist of three layers; the serosal layer, the muscular layer and the mucosal lining.

Uterus 422 l as a top wall or fundu '436 and side walls 437 and 458 which surround the uterine cavity 452. The inside of top wall 436 and the insides of side walls 437 and 458 have an inside linin or membrane 459 which is periodically sloughed off in the normal cycle of the female.

Dispensing instrument 420 has an elongated probe or tubular member 441 having a length sufficient to pass through the vaginal cavity 427 and into uterine cavity 452. Member 441 has a longitudinal passage 44.2 extended throughout its length. A balloon, assembly indicated generally at 445 is mounted on the upper or outer end of tubular member 441. Balloon assembly 445 has a flexible and expandable sleeve member 444 surrounding the upper end of probe 441. A fastener 446, as a collar or thread, attaches the upper end of sleeve 444 to probe 441. Λ similar fastener 447 attaches the Opposite end of sleeve 444 to the probe 441. Probe 441 has a plurality o I: openings 448 which provide communication between the passage 442 and a chamber 449 within sleeve member 444.

Sleeve member 444 is a tubular sheet member of soft and relaxed, flexible and elastic mateiral, as rubber or plastic, for sleeve member 444. The low surface tension of the rubber allows the rubber to uniformly expand with relatively low ^ pressure. The material of sleeve member 444 readily ex ands to displace uterine cavity 432 by conforming to the shape of the uterine cavity without -applying extreme pressure to localized portions of the uterus walls 457 and 458. When cavity 432 is fully displaced with sleeve member 444, as shown in Figure 36, sleeve member 444 is in uniform surface engagement with the inside lining 439. Conventional balloon catheters, bein of hard, relatively non- elastic material, do not assume the configuration of the uterine cavity when expanded.

The upper or outer end of probe 441 is closed with a head 451. Head 451 has a transverse passage 452 open to opposite sides of head 451. An elongated tube 455 is secured to the head 451. Tube 455 extends the length of probe 441 and lias a passage 454 for carrying a drug material to the transverse passage 452 which directs the drug material in opposite directions in two portions into the upper section of the uterine cavity 432. Head 451 has a longitudinal section or cap 456 having a top surface or wall adapted to engage the inner Avail of fundus 436. The cap 456 spaces the passage 452 from the inner wall of fundus 436.

Referring to Figure 35, .dispensing instrument 420 lias an elongated housing or body 457 attached to the end of probe 441. Body 457 has a first chamber 458 accommodating an elongated cylinder 459. Cylinder 459 l as a forward ly directed neck 461 connected to a tube 462. Tube 462 has a passage which is in communication with passage 442 of the probe 441 so that fluid, as air, in cylinder 459 can flow via passage 442 into chamber 449 of the balloon assembly and thereby expand the sleeve m er 444 The o en end of c linder 459 is closed witli a has a hole 466 adjacent the piston 463 to allow air and steri l- izing gases to flow into the chamber 464. ' Located rearwardly of the pi ton 463 is a fir drive assembly indicated generally at 467 operable to move the piston 463 into cylinder 459. The first drive -'assembly 467 is connected to an actuator 468 projected rearwardly from body 457.

Body 457 has a second chamber 469 located adjacent one side of the first chamber 458. A tube 471 is mounted in the body 457 to connect the tube 453 to chamber 469. Tube 471 has a longitudinally extended needle 472 projected into chamber 469. The opposite end of tube 471 is mounted in a plug 475 closing the end of probe 441 and connected to the tube 453 which, leads to head 451. Chamber 469 lias an elongated .shape and is open to the top of body 457, as shown in Figure 32. A cylindrical container or ampulla 474 is located in chamber 469 in alignment with needle 472. The forward end of container 474 lias a pierceable plug 476 aligned 'with needle 472. The open end of container 474 is closed with a slidable piston 477 to trap drug material 478 in container 474. Λ second drive assembly indicated generally at 479 extends rearwardly form container 474 and is drivably connected to actuator 468. Actuator 468 is operable to complete the entire dispensing of7 drug material into the canals of the Fallopian tubes in a single stroke. The rear portion of housing 457 has outwardly and oppositely directed flanges 481 and 482 which serve as finger grips during actuation of actuator 468. Actuator 468 has a hole 485 for accommodating a pjn 485Λ to hold the actuator 468 in the operative position. The pin 483Λ prevents, accidental actuation of the dispensing instrument.

Drive assembly 467 is a force- transmitting mechanism assembly 445 and expand sleeve member 444. Drive assembly ^ 467 lias a cylinder or sleeve 484 slidably carrying a body 4S6. The opposite or upper end of sleeve 484 is attached to a head 487. Head 487 has a central hole 488 which provides access into sleeve 484. The outer end of piston 463 lias a cone-shaped portion 489 to accommodate the cone-shaped outer end of head 487. The hole 488 is aligned' ith an adjustin screw' 491 threaded into body 486. The position of screw 491 relative to body 486 can be changed with the use o a tool, as a screw-driver, extended through hole 4SS.. Λ pair of springs 492 and 493 bias the sleeve 484 and body 486 in opposite directions whereby the first drive assembly 467 is biased into its elongated position. Spring 492 abuts against head 487. Spring 495 rests on screw 491. Adjusting the positon of screw 491 adjusts the tension or force of tire spring 495 which biases the head 487 and body 486 in opposite directions. Screw 491 performs a fine adjustment of the spring force to accommodate variations in sprin 495 and to provide for desired fluid pressure in chamber 449. Λ washer 494 having- a central hole for rod 488 is located between springs 492 and 493. Sprin 492 is a light or weak spring as compared to spring 493. The weak spring 492 will compress under a light load, for example 2-3 psi, whereby the washer 494 will abut against head 487. This insures the partial expansion of sleeve - member 444 at low predetermined maximum pressure. The predetermined maximum pressure is determined by t e compression force characteri tics of spring 493 and permits the instrument to be used with all shapes and sizes of uteri, as the spring 495 adjusts for the dif erences in the uteri .

Sleeve 484 and body 486 are held in assembled relation relative to body 486 as the springs 492 and 493 are compressed. Pin 496 projects through slot 497 into ah elongated linear groovc 498 in the housing 457 and thereby prevents' rotational movement o the drive assembly 467 relative to housing 457.

Body 486 has a transverse passage 4-99 accommodating a drive link 50.1. The drive link 501 has spherical members at its opposite ends joined with a transverse member or -tube.

The first end oE drive link 501 is located in a recess 502 in the side of actuator 468. Actuator 468 has a second recess-503 for accommodating the link 501. Located below recess 505 is a shoulder 504 adapted to engage the end of body 486 when link. 501 is in recess 503. Housing 457 lias a recess 506 adapted to accommodate the opposite or right end of drive link 501.

Recess 506 is located in a forward direction from the initial position of drive link 501, as shown in Figure 53, so that the actuation of drive assembly 467 is temporarily halted or interrupted until the end of body 486 engages the shoulder 504, at which time the movement of the drive assembly 467 is continued. The locations of recesses 506 and 521 in housing 457 can be coordinated with each other so that the initial expansion of sleeve member 444 overlaps the discharge of drug material into the uterine cavity and the continued expansion of sleeve member 444. In this case, sleeve member 444 lias a continuous expansion until the sleeve member 444 has been subjected to the maximum fluid pressure.

A lock unit indicated generally at 507 is movably located in a bore 508 in body 486. Lock unit 507 l as a plunger 509' carrying an outwardly directed finger or projection 510. Linger 510 is adapted to engage one of a plurality of teeth 511 loc-ated in housing 457. The teeth 511 face drive as s embly .467.

Teeth 511 arc ratchet teeth which allow onl reverse movement ticn with teeth 511. Plunger 509 is biased in an outward direction with a spring 512 located at. the base of bore 508. ^ Sleeve 484 has a hole 513 spaced forwardly from finger 5.1.0.

On compression of springs 492 and 495, the bod 486 moves relative to sleeve 484 until the finger ;51U is aligned with hole 513, at which time spring 512 will bias finger 510 t!irough hole 513 into engagement with one of the teeth 511.. -This prevents further movement of the 'drive assembly 467 in a forward direction and limits the pressure- of the fluid in the chamber 449 of sleeve 444.

The second drive assembly 479 is operable to drive the container 474 onto needle 472 and force piston 477 into the container and thereby drive the drug material 478 through needle 472 into tube 453. lube 453 carries the fluid to head 451 where it is discharged in opposite directions into the upper portion of uterine cavity 432. Returning to 'Figure 2, second drive assembly 479 lias an elongated linear plunger 514 slidably located in a longitudinal passage 515 in housing 457. Plunger 514 has a forward end 516 adapted to engage piston 477. The opposite end of plunger 514 has a transverse passage 517.

A movable drive link 518 is located in passage 517. Link. 518 has spherical ends that are connected with a rigid member such as a tube. One end of drive link 518- is located in a semi-spherical recess 519 located in the side of actuator 468. The opposite end of drive link 518 rides on the side wall of the housing 457 forming part of passage 515, thereby retaining the link in recess 519. Housing 457 has a recess 521 forward of the link 518 so that the link 518 will remain in driving relationship with actuator 468 until the link is aligned with recess 521. At this time the link 518 will be forced into w b actuator 468 will continue to move in a Ιιι use, the dispensing instrument 420 is packaged wif.li container 474 located in chamber 469. Actuator 46S is locked ' in an inoperative position with a pin 4 S 5Λ extended through hole 483. Pin 4S3A engages the end of housing 457 to prevent actuator 468 from moving into the housing. The entire dispensing instrument is sterilized before it is used.

The operating procedure begins with inserting the balloon assembly 443 into the vaginal cavity 427, through cervical opening 431 and into uterine cavity 452, as shown in Figure 52. Sleeve member 444 is in the collapsed condition so that the balloon assembly can be readily positioned in the uterine cavity! The probe 441 is moved into the uterine cavity until head _451 engages the fundus 456. It is known that uteri can vary in size, shape and position so that the balloon assembly may or may not be symmetrically located relative to the Fallopian tubes 423 and 424. As shown in Figure 32, balloon assembly 443 is centrally located in the uterine cavity 452. In some cases, the balloon assembly may be angularly positioned in the uterine cavity adjacent one side of the cavity. Dispensing instrument 420 is effective in placing drug material into both canals of the Fallopian tubes regardless of the position of the balloon assembly in uterine cavity 452.

Pin 4S5A is removed from hole 485, makin plunger 468 ready to be moved into the housing 457 to inflate the expandable sleeve member 444 and dispense drug material into uterine cavity 452 and then fully expand the sleeve member 444 to pump or force the drug material into the canals of the Fallopian tubes. The operator uses flanges 481 and 482 as finger . ests so that inwardly directed force can be applied to the actuator 468. As shown in Figure 55, the actuator 468 lias been moved into housin 457 a short distance such that the first drive expands' sleeve member 444 so that it forms a pint; or seal in the lower portion of the uterine cavity 432. Sleeve member 444 is expanded into firm engagement with the inside lining or membrane 45!). Dr. c link SOI couples actuator 468 to the first drive assembly 467 to transmit the: motion of actuator 468· to the first drive assembly 467. This moves piston 463 into chamber 464. The drive link 518 couples plunger 514 with actuator 468 so that the forward end 516 of the actuator engages piston 477 in the container 474. This moves the entire con-' tainer 474 in a forward direction.. The needle 472 pierces plug 476, thereby moving the needle through plug 476 and into the chamber containing the drug material 478. The drive link 101 is aligned with recess 506 in the housing 457. This permits the drive link 501 to move to the right, as shown in Figure 55, releasing the drive link from the actuator 46S. The continued movement of the actuator 468 applies . force to plunger 416 which moves piston 477 into container 474. Drug material 478 is forced via tubes 471 and 453 to head 451. The drug material . is discharged in. opposite directions via the trans- verse passage 452 into 'the upper part of uterine cavity 452.

As shown in Figure 56, the continued movement of actuator 468 places tlie shoulder 504 in engagement with the bottom of body 486. At the same time drive link 501 moves into recess 503, thereby releasin drive link 501 from recess 506. Actuator 468 is moved into housing 457, thereby increasing the pressure in chamber 464. This further ex nds sleeve member 444. The expanding sleeve member 444 drives the drug material from the upper portion of the uterine cavity through- exit openings 453Λ and 454A of the canals 455 and 454 of the Fallop- ian tubes. The sleeve member 444 continues to expand until can be selected as the upper pressure limit. This pressure is^''~ determined by the compression characteristics of the springs 492 and 495 and adjusting screw 491. The compression of springs 492 and 493 permits body 486 to move into sleeve 4S4. This movement continues until finger 510 is aligned with opening 515. When finger 510 and hole 515 are aligned, the spring 512 forces finger 510 throug.li hole 513 and into the space between adjacent teeth 511.. Finger 510 anchors on a forward tooth, thereby preventing further movement of the actuator 408 into housing, 457. Since actuator 468 is prevented from moving into the housing 457 by lock unit 507, the pressure in the balloon chamber 449 is limited to a selected maximum pressure, depending on the compression characteristics of springs 492 and 493.

As the actuator 468 is moved into housing 457 from the position shown in Figure 35 to the position shown in Figure 36, drive link 518 moves from recess 519 into recess 521. This terminates the forward motion of plunger 5.14 to stop dispensing the dru material into uterine cavity 452. The continued movement of actuator 468 increases the fluid pressure in the chamber 449, thereby expanding sleeve member 444 to pump or push the drug material from uterine cavity 432 into canals 433 and 434 of the Fallopian- tubes . The pumpin action ceases when the sleeve member 444 is fully expanded, as shown in Figure 36. This locates the drug material in the Fallopian tubes as the pumping force applied to the drug material is insufficient to move the drug material through the Fallo ian tubes into the body cavity.

The actuator 468 is then pulled out of housing 457. Drive link 501, bein located in recess 503, provides a drive connection between body 486 and plunger 468. Finger 510 of lock chamber- 464 , contracting sleeve member 444. This releases sleeve member 444 from engagement with lining 439 and enables balloon assembly 443 to be withdrawn from the uterus of the atie t.

When drug materials of the cyanoacry late tissue adhesive type are used, canals 433 and 454 will be permanently occluded. Tissue adhesives, as the cyanoacrylate type, cause fibroblastic proli eration which in tine closes the canals 435 and 454. The tissue adhesives polymerize when exposed to a hydroxyl ion source, such as water. The cells adjacent the adhesive are damaged and are eventually replaced with fibrous tissue. Certain other tissue aclheisves will polymerize in response to body heat or other stimuli.

In terms of method, the dispensing instrument is used to place drug material in both canals of the Fallopian tubes via the uterine cavity. The contracted balloon assembly is initially placed in the uterine cavity, as shown in Figure 32, b insertin the balloon assembly 445 through cervical opening 451. The actuator 468 is then released so that it .can be moved into housing 457. The operator moves the single actuator 468 with a continuous movement into housing 457 to complete the operation. The first drive assembly 467 and second drive assembly 479 are coordinated to- sequentially operate to partially expand the sleeve member 444. to displace the lower portion of the uterine cavity and form a seal with the lower walls of the uterine cavity. The plunger 514 then engages the piston 477 to force the container onto needle 472 and force drug material 478 from the container and discharge the drug material in opposite directions into the uterine cavity 452 above the partially expanded sleeve member 444. This operation is shown displace uterine cavity 452. This is done by subjecting the sleeve member 444 to fluid under pressure by moving the piston 465 into chamber 464. Tlie actuator 468 will continue to move until lock unit 507 engages one of the teeth 511, thereby preventing further expansion of the sleeve member 444. The sleeve member 444 can only be subjected to a maximum predetermined pressure so as not to place undue pressure on the walls of the uterus. The expandin sleeve member 444 forces or pump the drug material that has been discharged into the uterine cavity through the openings 455A and 454Λ and into canals 455 and 454 of the Fallopian tubes. Sleeve member 444 is then contracted by relievin the pressure applied thereto. This is done by pulling actuator 468 out of housing 457 so that- the fluid can move into container chamber 464. The instrument is then removed from the uterine cavity via the cervical opening and vaginal passage.

The drug material can be one of a' number of fluids or seni- fluids used to test, treat or occlude the canals of the Fallopian tubes. For example., the drug material can be a tissue adhesive. The tissue adhesive can be a cyanoacrylate-type material or like material used as surgical glue. Cyanoacrylate is a liquid plastic which sets up or polymerizes in response to moisture and thereby functions to occlude the canals of the Fallopian tubes. The cyanoacrylates include, but are not limited to, methyl cyanoacrylate, methyl- 2-cyano-acrylate, ethyl cyanoacrylate , n- ropyl cyanoacrylates, cyanoacrylates, n-amyl cyanoacrylates, n-hexyl cyanoacryla es, n-heptyl cyanoacrylates, isobutyl- 2- cyanoacrylates and n-octyl cyanoacrylates. The drug material can also be of a type that sets up in response to body heat or other stimuli. It may be tubes, after which the canals will be reopened and resume their normal function. Examples of other types of drug materials arc cont aceptive gels, water, silicone elastomers, formaldehyde - type materials and like materials.

Referring to Figures 57 and 58, there is shown a modification of the dispensing instrument indicated generally at 420Λ. Dispensin instrument 420Λ and the female reproductive system associated therewith follow the dispensing instrument shown in Figures 52-56. Corresponding parts of the instrument and reproductive system have the same reference numerals with the suffix Λ.

Dispensing instrument 420 Λ uses a two-part drug material which is mixed at the end of the probe as it is forced into the upper part, of the uterine cavity 452A. The mixed drug material of the sleeve member 444A to displace uterine cavity 452 A.

Head 651 is mounted on the outer 'end of the probe or tubular member 441A. The head 65.1 has a transverse passage 652 having oppositely directed discharge openings for directing the drug material in two parts into the upper part of the uterine cavity 452A. A first tube 655 and a second tube 654 are connected to the head 651. The head lias a mixing chamber or passage 655 in fluid communication with the passages of tubes 655 and 654 and the transverse passage 652. The drug materials flow through the tubes 6'55 and 654 and are mixed in chamber 655. The mixing continues as the drug materials a e separated and forced in opposite directions in. passage 652 , as indicated by the arrows.

Mousing 457A has a pair of chambers 656 located adjacent chamber 458A for accommodating a pair of ampullae or containers piston 661 is sliclably located in container 657. In a similar manner, a piston 662 is slidably located in container 659.

Plunger 514Λ of the second drive assembly 479Λ lias- a bifurcated end forming a pair of fingers 665 and 664. Finger 665 is positioned in container 657 and engages ' pis ton 66.1. Finger 664 is located in container 659 and engages piston 662. The tubes 655 and 654 extend into housing 457Λ and terminate in. needles 666 and 667. K'eedles 666 and 667 are in alignment with the picrccable end portions of containers 657 and 659.

On actuation of single, actuator 468Λ, the first drive assembly 467Λ will operate to initially expand the sleeve member 444Λ to fill and seal the lower portion of the uterine cavity 432Λ. Continued movement of actuator 468Λ will engage the second drive assembly 479Λ to move the fingers 665 and ■664. Plunger 514A moves in a forward or upward direction, as shown in Figure 6, to drive the containers 657 and 659 onto needles 666 and 667, respectively. Fingers 663 and 664, being in. engagement with p:isto s 661 and 662 , simultaneously force the drug niaterals 65S and 660 through the tubes 654 and 653. The drug materials are simultaneously discharged into the mixing chamber 655. Substantially the same amounts of drug materials are introduced into the mixing chamber 655 so that the mixture of drug materials contains about 50 per cent of the first drug and 50 per cent of the second drug material. The mixed drug material, indicated at 66S in Figure 57, is introduced into the upper part of uterine cavity 452Λ. The mjxed drug material 6 8 flows in opposite dire tions in subs an ially equal amounts. The flow is continuous until plunger 414Λ has reached the end. of its stroke. At this time, the continuous movement of the actuator 468A further expands the sleeve member 434Λ forcin the mixed drug material into the canals 455Λ and Drug materials 658 and 660 can be the type which when mixed will set up to form a sem-rigid plastic material. The mixture can be responsive to moisture -in the tissues to set up or responsive to body heat or other factors to set up. The mixture has a reaction time such that it can be introduced into canals 455Λ and 454A before it- will set up. The following is an example of the materials of the two-part drug material. The two-part drug materials may be two-part epoxies , two-part tissue adhesives, silicone RTV, or a polymer consisting of Dow Corning Silastic 582 Medical Flastomcr and 560 Medical Fluid. It is understood that other types of drug materials that are mixed and set up can be used. Furthermore, the ratio of the drug material can be varied by increasing the size of one of the containers. For example, two parts of the first drug material can be mixed with one part of the second drug material by using the appropriate size containers in the housing 457Λ.

The drug material can be a contraceptive drug for local action in the Fallopian tubes and uterus. For example, bio-absorbable microspherules having contraceptive drugs, as progestins, can be delivered to the canals of the Fallopian tubes. The microspherules break down over a period of time, i.e. , one year, thereby inhibiting conception during this period.

Biologicals, as fibrinol tic enzymes, can be introduced into the canals of the Fallopian tubes and uterine cavity to treat the tissues. The biologicals are used to treat inflammation and. prevent adhesions from forming around the ends o the Fallopian, tubes.

Diagnostic materials can be introduced into the canals of the Fallopian tubes with the apparatus and method of the invention. These materials include oil base and aqueous base X-ray Anesthetic materials can be introduced into the canals of the Fallopian, tubes with the apparatus of the invention.

The drug material can be of the type which treats the canals and uterus to enhance the. flow of ova and sperm in the canals and uterus. The drug material can include material which expands or opens the canals or passages of the Fallopian tubes to enhance fe r t i li zat i on . or conception. At the. present time there are several materials or chemicals which arc used to treat the canals of the Fallopian tubes to enhance fertilization or conception. Anti- inflammatory agents, as cordocoids, can be, usecl to locally treat inflammation. Antibiotics can' also be used for local treatment of the Fallopian tubes.

It is believed that in some cases of i fe tility the sperm are blocked or unable to transport themselves across the cervix and endometrial cavity. The apparatus and method of the invention is usable to deliver s erm into the uterine cavity and canal of the Fallopian tubes to enhance conception.

While there have been shown. and described preferred embodiments of the dispensing instrument and method of introducing materials into both canals of the Fallopian tubes of a female, it is understood that various changes in the structure and method may be made by those skilled in the art without departing from the spirit of the invention.

Claims

1. WHAT WE CLAIM IS: 1. An instrument for dispensing fluid material into the Fallopian tubes of. a female body, comprising an elongate member having at, or near one end thereof an expandable member and at least one outlet for fluid material, said expandable member and the or each outlet being positionable within a uterine cavity, and a dispensing unit coupled to said elongate member at a position remote from said one end, the dispensing unit having means for expanding said expandable member, dispensing means for dispensing fluid material through the or each outlet, and a single actuator for operating both said means for expanding said expendable member and said dispensing means.

2. The instrument claimed in claim 1 wherein: said: further means comprises expansion means for selective expansion with fluid at. a predetermined pressure.

3. The instrument claimed in claim 1 wherein: said further means comprises expansion means for expanding under constant pressure to substantially completely fill the uterine cavity to force the material from the uterine cavity into the canals of the Fallopian tubes.

4. The instrument claimed in any of the preceding claims further comprising: control means connected to said* dispensing means and said further means for. automatically continuously operating' said further means as material is dispensed by said dispensing means into the uterine . cavity to move the material into the Fallopian tubes as operation of said further means is completed. 44358/2 comprising: control means connected to said expansion means for automatically dispensing the material into the -r uterine cavity before the expansion means substantially completely fills the uterine cavity. 6. The instrument of any of the claims 2 through 5 further comprising; lock means to stop expansion when the fluid in said expansion means reaches a predetermined pressure, 7. The instrument claimed in any of the claims 2 through 5 wherein: said expansion means includes means for monitoring and maintaining the fluid pressure substantially constant after expansion. 8. The instrument claimed in claims 1 or 4 wherein: the further means comprises pump means selectively operable $o force the dispensed material into both Fallopian tubes. 9. The instrument claimed in claims 1 or 4 wherein: said further means includes an expendable member position-able in the uterine cavity of a female and expansion means operable to expand the expendable member in the uterine cavity to effect a pumping action. 10. The instrument claimed in claim 9 wherein: said expansion means further comprises a container for storing an expansion fluid; and actuator means for moving the expansion fluid from the fluid storage container to the 44358/2 expandable member for expanding said expendable member in the uterine cavity. r~ 11. The instrument claimed in claims 9 or 10 wherein: said expansion means further comprises actuator means being adapted to pump th^r1 materials from the uterine cavity into the canals of the Fallopian tubes, and contracting said expendable member to allow withdrawal of said instrument from the uterine cavity. 12. The instrument claimed in any of the preceding claims wherein: said dispensing means includes an elongated tubular catheter having a material passage therethrough terminating at one end of said catheter with a material exit positionable within the uterine cavity. 13. The instrument claimed in claims 11 or 12 wherein: the dispensing means includes a housing having a first chamber and a second chamber, a fluid storage container being located in the first chamber, a material storage container being located in the second chamber, first needle means operable to puncture said fluid storage container, second needle means operable to puncture said ; material storage container, a tubular catheter having a fluid passage coupled to said first needle means for receiving fluid from said fluid storage container, and a material passage coupled to said second needle means for receiving material from said material storage container, first movable means operable to cause the first needle means to pierce a portion of said fluid storage container 44358/2 whereby fluid moves through the fluid passage to hthe expandable member, and second movable means operable to cause the second needle means to pierce a portion of said material storage container whereby material moves through the material passage into the uterine cavity, and said actuator means is operable to sequentially move the first movable means and the second movable means whereby the expandable member is at least partly expanded before the material is dispensed. 14. The instrument claimed in any of the claims 9 through 13 wherein: said expansion means is further operable to hold the expandable member in engagement with the side inside walls of the uterus and spaced from the fundus aad areas, said dispensing means is operable to dispense said material into the uterine cavity between the expandable member and the fundus, said material being directed to the corneal areas and into the canals; and comprising further dispensing means for dispensing an inert fluid into the uterine cavity between the expandable member and the fundus, said inert fluid forcing the material into the canals · 1

5. The instrument claimed in claim 2 together with any of the claims 9 - 14 further comprising: pressure supply means for supplying said fluid under pressure and; pressure control means associated with said pressure supply means for limiting the pressure within said expandable member to a predetermined maximum 44358/2 pressure and the resulting displacement of the uterine cavity to an amount sufficient to pump the material ,HT~ into, but not all the way through, the canals of the Fallopian tubes . 1

6. The instrument claimed in claims 11 or 13 wherein: said dispensing means includes a first drive assembly operably coupled to said actuator means and movable in response to movement of the actuator means to supply fluid under pressure to said expandable member whereby the expandable member expands to displace the uterine cavity. 1

7. The instrument lclaimel iin claim 16 including: lock "r means associated with said first drive assembly to stop movement of the drive assembly when a predetermined fluid pressure is present in the expandable member. 1

8. The instrument claimed in claim 16 wherein: said dispensing means includes a housing, said housing having a plurality of teeth facing said first drive assembly, said first drive assembly having lock means engageable with one of the teeth to stop movement of the first drive assembly when a predetermined fluid pressure is present in said expandable member. 1

9. The instrument claimed in claim 18 wherein: said lock means includes a body having a projection, and; biasing means for moving the projection between adjacent teeth when the predetermined pressure is attained. 20. The instrument claimed in any of the claims 16 through 19 wherein: said dispensing means includes a r second drive assembly operably coupled to said actuator means and movable in response to movement of the actuator means to dispense material into the uterine cavity. 21. The instrument claimed in; claim 20 including: first releasable means to drivably connect said actuator means with said first drive assembly means, and; second releasable means to drivably connect said second drive assembly means to said actuator means. 22. The instrument claimed in any of the claims 9 through 21 further comprising: head means located adjacent the forward portion of the expendable member, said head means, having passage means for receiving a plurality of materials whereby the materials are mixed in the passage means and d¾:harged into the uterine canity. 23. The instrument claimed in claim 22 wherein: said dispensing means includes first and second material storage containers for storing the previously mentioned material and a second material; means for releasing the previously mentioned material and the second material from the first and second material storage containers; means for mijcing said materials; and means for dispensing the mixed materials into the uterine cavity. 24. The instrument claimed in any of the claims 13 through 23 including: head means having side material discharge openings on the forward end of said tubular catheter member to divide and direct the material into the uterine cavity. 25. The instrument claimed in claim 24 wherein: said head means includes an enlarged portion adapted to contact the fundus and space the discharge openings from the fundus. 26. The instrument claimed in any of the claims 1 through 25 wherein: said dispensing means includes a stop member for locating the portion of the dispensing means position-able within the uterine cavity in a position spaced from the top inside wall, or fundus, of the uterus. 27. The instrument claimed in any of the claims 8 through 25 wherein: the expandable member is an expandable tubular sheet member having low surface tension properties and substantially uniform expansion characteristics. 28. The instrument claimed in any of the claims 9 through 25 wherein the expandable member comprises a balloon of material sufficiently flexible to generally conform to the shape of the uterine cavity of the female. 29. The instrument claimed in any of the claims 9 through 25 wherein: the expandable member comprises material means sufficiently flexible to generally conform to the shape of the uterine cavity and expandable to substantially 30. The instrument claimed in claim 29 wherein the material means comprises latex rubber. 31. The . instrument claimed in claim 30 wherein the material means comprises plastic.. 32. The instrument claimed in any of the claims 1 - 29 wherein: said material is a diagnostic radiopaque dye or a mixture of such dyes. 33.. The instrument claimed in any of the claims 1 -29 wherein: said material is an anesthetic or a mixture of anesthetics. 34i Instruments or. apparatus for introducing material into the Fallopian .tubes, substantially as hereinbefore described with reference to the accompanying drawings; .