FI62768C - INSTRUMENT FOER INFOERING AV ETT PREPARAT I AEGGLEDARKANALERNA - Google Patents

Description

R3r71 rBi the so-called HEARING PUBLICATION 0 „. Q

lBJ (11) UTLÄCGNINGSSKRIFT 62/68 C Patent granted 10 03 1903 (45> Patent cedJelst (51) Ky.ik.Vci.3 A 61 M 31/001 A 61 B 17Λ2, A 61 F 5 / ½ FINLAND — FINLAND ( *) Ptunttlhikamut - P «« nnfw6knJn | 715/7 ^ (22) HakwnlspUv · —Ameknlngtdai 08.03.71 * * * (23) AlkuptWft — Giltl | h «t» da (08.03-7 ^ (41) Tulkit JglklMksI - Bltvtt off «ntH | 10.09-7 ^ ΐη? Ϊ rrtl · * ^ 11 '·" .1 * ”(44) κι ***, -» r—

Patent- ocn registerstyrelsan Amdktn uttafd och utUkrtton pubdcmd 30 * 11.02 (32) (33) (31) hrr * «« y wuelksus — Bsfirt pHorlttt 09.03.73 31.01.71 * USA (US) 339911, ^ 38202 (71) Population Research Incorporated, 7875 Beech Street NE, Minneapolis, Minnesota, USA (') Lee Robin Bolduc, Minneapolis, Minnesota, Eugene Arthur Dickhudt,

The present invention relates to an instrument for introducing a substance into the fallopian tubes through the uterine cavity, in particular to a device for introducing a substance into the fallopian tubes through the uterine cavity, in particular to an instrument for introducing a substance into the fallopian tubes through the uterine cavity. for sterilization, the instrument comprising a dispensing device having a portion supporting the expandable sheath and placed in the uterine cavity, means for expanding said sheath to form a seal in the lower part of the uterine cavity, and feeding means for introducing the substance into the uterine cavity sealed by said sheath.

Such a device was previously known from an article by Stevenson and Taylor published in The Journal of Obstetrics and Gynecology of the British Common Wealth, Nov. 1972, p. 1028-1039.

According to the article, the instrument is held inside the uterine cavity by means of a ball at the front end of the instrument. The sterilant is then injected in an amount sufficient to fill the uterine cavity and so that it also flows into the fallopian tubes. However, this has been found to be disadvantageous because it requires significant amounts of material, and due to this large amount of material required to fill the fallopian tubes, special measures have been taken to prevent the active substance from migrating to the cervix when the instrument is withdrawn.

In the instrument of the present invention, these disadvantages are avoided by implementing the sheath and dilation devices to allow further expansion of the sheath to fill the uterine cavity substantially completely after the substance has been introduced into the cavity and to make tight contact with the inner wall of the uterine cavity, including the base.

Due to these properties, only small amounts of the substance can be used, which is pressed into the fallopian tubes by expanding more of the sheath after the substance is introduced or injected into the uterine cavity. As a result, substantially all of the substance is transferred from the uterine cavity to the fallopian tubes and the above-mentioned disadvantages associated with the prior art are avoided. The instrument of the present application is not based on injecting and delivering such a large amount of substance into the uterine cavity as a result of applying pressure to a part of the substance in the fallopian tubes, but in contrast to known devices, the present invention uses dilators and sheath. further dilation of the substance after introduction into the uterine cavity so that an additional expanding sheath presses the substance into the fallopian tubes.

Other objects and advantages of the instrument according to the invention will become apparent from the following description of the invention and the accompanying drawings.

Figure 1 shows a longitudinal sectional view of the female person's genital system with the drug delivery instrument extending into the uterine cavity.

Figure 2 shows a top view of the drug delivery unit of the instrument.

Figure 3 shows an enlarged sectional view taken along line 3-3 of Figure 1.

Figure 4 shows an enlarged sectional view taken along line 4-4 of Figure 3.

Fig. 5 shows a sectional view taken along line 5-5 of Fig. 4.

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Fig. 6 shows a sectional view similar to Fig. A, and shows a drug delivery unit effected to supply fluid therefrom.

Figure 7 shows a cross-sectional view of a modified form of a drug delivery unit of a drug delivery device.

Fig. 8 shows a sectional view taken along line 8-8 of Fig. 7.

Fig. 9 is a sectional view similar to Fig. 7 and showing the drug delivery unit in the feed position.

Figure 10 shows a schematic diagram of another modification of the drug delivery unit in the non-drug delivery position.

Fig. 11 shows a sectional view similar to Fig. 10, and shows the drug delivery unit in the feed position.

Figure 12 shows a longitudinal sectional view of another modified drug delivery unit in a non-drug delivery position.

Fig. 13 shows a view similar to Fig. 12, and shows the drug delivery unit in the feed position.

Figure 1A shows a side view of a container spaced from a needle adapted to remove fluid from the container.

Figure 15 shows an end view of the sealed end of the container of Figure 1A.

Fig. 16 is a longitudinal sectional view taken along line 16-16 of Fig. 15.

Figure 17 shows an enlarged sectional view of the sealed end of the container.

Fig. 18 is a sectional view taken along line 18-18 of Fig. 1A.

Fig. 19 shows a sectional view similar to Fig. 16, and shows the container in an assembled relation with the needle.

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Figure 20 is a plan view of a modified drug delivery instrument of the invention.

Fig. 21 shows an enlarged sectional view taken along line 21-21 of Fig. 20.

Fig. 22 is a sectional view taken along line 22-22 of Fig. 21.

Fig. 23 is an enlarged sectional view taken along line 23-23 of Fig. 20.

Fig. 24 shows a sectional view similar to Fig. 23, and shows the closure in the release position.

Fig. 25 shows a sectional view similar to Fig. 23, and shows a modification of the closure.

Figure 26 is a top plan view of another modification of a drug delivery instrument of the invention.

Fig. 27 is an enlarged sectional view taken along line 27-27 of Fig. 26.

Fig. 28 is a sectional view taken along line 28-28 of Fig. 27.

Fig. 29 is an enlarged sectional view taken along line 29-29 of Fig. 27.

Fig. 30 shows a view similar to Fig. 29, and shows the moving part in the second position.

Fig. 31 is an enlarged sectional view of a fluid reservoir structure used in a drug delivery instrument.

Fig. 32 is a front sectional view of a female genital system fitted with a drug delivery instrument according to the invention for inserting drug material into each of the fallopian tubes.

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Figure 33 shows a longitudinal sectional view of a drug delivery structure of an instrument according to the invention.

Fig. 34 is a sectional view taken along line 34-34 of Fig. 32.

Fig. 35 is a front sectional view of a female genital system fitted with a drug delivery instrument, shown in cross-section with the spherical structure partially expanded in the uterine cavity and the drug material in the uterine cavity.

Fig. 36 shows a front-sectioned view similar to Fig. 35, and shows the spherical structure fully enlarged in the uterine cavity.

Fig. 37 is a partially sectioned front condensed plan view similar to Fig. 35 of a modification of a drug delivery instrument.

Fig. 38 is an enlarged sectional view of the feed end of the drug delivery instrument of Fig. 37.

Referring to the drawings, Figure 1 schematically illustrates a female sex system, generally designated 20. An intrauterine catheter, generally designated 21, located in the sexual system to direct fluid such as a drug, tissue adhesive, or other material into the fallopian tubes. The tissue adhesive may be isobutyl 2-cyanoacrylate monomer, silver nitrate or pentavalent acrylic materials.

Cyanoacrylate monomer is a liquid plastic material that cures or polymerizes upon moisture and therefore acts to close the ducts of the fallopian tubes. The drug materials may be of a type that momentarily occludes or closes the ducts of the fallopian tubes. After a certain period of time, the channels reopen and have their normal operation again.

Gender system 20 is cylindrical vaginal wall 23 defined by an elongated vagina 22. Vagina 22 leads to a vaginal opposite end 24 of the vagina in the uterus, which is generally designated by the reference numeral 26. Uterus 26 is pear-shaped, thick walled, hollow organ situated between 6 62 768 bladder and rectum. The uterus 26 has a uterine cavity 27 that is flat and triangular in shape. The size of the uterine cavity varies from one female to another. The upper part of the uterus 26, i.e. the base 28, engages the main part of the uterus 29. The lower end of the main part includes a neck 31 separating the vagina 22 from the uterine cavity 27. The uterine wall consists of an outer blood-like layer (peritoneum), a solid thick intermediate layer of small muscle tissue of the inner layer or endometrium 32.

The fallopian tubes 33 and 34 lead to the top of the opposite sides of the uterus 26. The fallopian tubes are paired, horn-shaped, muscular parts that extend from the upper corners of the uterine cavity to the ovaries (not shown). The ovaries are solid, slightly irregularly shaped entities located on either side of the uterus behind and below the fallopian tubes.

Each of the fallopian tubes 33 and 34 has a channel or water tube 36 and 37, respectively. The fallopian tubes have a muscular membrane-like structure and are approximately 12 cm long. They are generally divided into a slit part, a part inside the slit and a bottle-like part. Channels 36 and 37 form the passageways through which the eggs move from the ovaries to the uterine cavity. The part inside the fallopian tube groove passes through the uterine wall in a more or less straight form. It has a bottle-like dilation just before it comes into contact with the uterine cavity 27. Channels 36 and 37 are narrowest in the interior of the slot. The walls of the fallopian tubes consist of three layers: a blood-like layer, a layer of muscle, and an inner layer that secretes mucus. The muscle layer contains longitudinal bundles of muscle which, when contracted, bring the ends of the fallopian tubes into close contact with the surface of the ovaries. The blood vessels are abundant in the muscle layer, where they form a kind of swollen tissue with the muscle bundles, which in the blood clot moves the fallopian tubes to curve them over the surface of the ovaries. This movement of the fallopian tubes occurs when the fallopian tubes are separated and prevented. Closing the channels 36 and 37 with the drug according to the invention does not interfere with the expansion function and the movement of the fallopian tubes.

The catheter 21 has an elongate first tube 38 of sufficient length to extend through the vagina and uterine cavity 27. An expandable sleeve portion 39, such as a balloon or the like, is secured to the upper end of the tube 38 by strips 7 62768 40. The outer end of the sleeve portion 39 terminates at the outer end. The sleeve portion 39 is a flexible elastic portion made of a released rubber material. The rubber material has an equal surface tension and an equal expansion property. The sleeve portion 39 is expanded for smooth and firm engagement with the father wall of the uterus s regardless of the size of the uterine cavity. This makes it possible for the same catheter construction to be used for all types of female individuals. The expanded sleeve portion 39 has a generally pear-shaped chamber 41 filled with a liquid such as water, air or the like. The tube 38 has a plurality of holes 42 which connect the passage of the tube 38 to the chamber 41. The upper end of the tube 39 is closed by a plug 43.

The end of the tube 38 extending from the vaginal opening 24 is attached to a fluid delivery unit, generally designated 44. The tube 38 may be releasably attached to the delivery unit 44 or it may be attached to the delivery unit 44. The delivery unit has a body 46 supporting a movable piston 47 . When the piston 47 moves in the direction of the arrow 48, the liquid, preferably water, is urged antamisyksiköstä 44 of expandable sleeve member 39 to form the closure 27 and to meet the uterine cavity.

Inside the tube 38 are two smaller tubes 49 and 52 which conduct fluids to the uterine cavity 27. The tube 49 has a portion extending outwardly from the tube 38 and attached to the delivery unit 51. The tubes 52 are attached to the delivery unit 53. The delivery units 51 and 53 are identical in construction and can be used to deliver the same fluids or different fluids at different time intervals. The second delivery unit may deliver neutralizing fluid to the uterine cavity. The following explanation is limited to the delivery unit 51.

Referring to Figures 2-5, the delivery unit 51 has a body or housing 57 comprising a cylindrical side wall 58 and an end wall 59. The housing 57 has a chamber 61 and outwardly extending lugs 62 and 63. The lugs 62 and 63 extend from the open side of the body 57 and the cylindrical side wall 58 parallel to the diameter in opposite directions. A collapsible container or ampoule, generally designated 64, is located in the chamber 61. The container contains a drug or similar material used to treat and / or close the fallopian tubes. The container 64 has an accordion-shaped cylindrical side wall 66 attached to a transverse generally flat bottom wall 67. At the center of the bottom wall 67 is a longitudinal tubular portion 68. The portion 68 has an outwardly extending portion 68A and an inwardly extending portion 68B. The tubular portion 68 is closed by a transverse membrane 69. The membrane 69 is a relatively thin plate-like portion located in the transverse plane of the bottom wall 67. The opposite end of the container 64 is closed by a transverse seal 71.

The container 64 is preferably made of a deformable lead alloy having good moisture and vapor barrier properties. Other deformable material with good anti-wetting and anti-evaporation properties can also be used to make the container. These properties are important to prevent moisture and vapor sensitive material from polymerizing or curing during storage periods. The material of the tank is also chemically noble compared to the liquid stored in the tank.

The container 64 is located inside a longitudinal needle 73. The needle 73 is a hollow portion terminating in an inclined end section 74, which is located adjacent to the inner side 69 of the film. The opposite end of the needle 75 is attached to a circular end 76. As shown in Figures 4 and 5, the needle 73 has a longitudinal channel 77 extending through the inclined end of the needle. The side wall of the needle 73 has a hole 78 which provides fluid flow from the reservoir through the needle. The needle 73 may have a plurality of holes or an elongate notch to allow fluid to flow through the needle.

The chamber 61 is closed by a piston or movable part 79. A part of the movable part fits into the chamber and has outwardly directed thickenings 81 and 82 extending into longitudinal grooves 83 and 84 in the inner parts of the cylindrical side wall 58. Thicknesses 81 and 82 hold the piston 79 in relation to the body and guide the body linearly into the chamber 61. The piston 79 has an inwardly open recess 86 for accommodating the outermost end of the container 64. At the center of the bottom of the recess 86 is a cavity 87 which provides space for a sealed tip portion 71. The piston 79 can be removed from the side wall 58, allowing the container 64 to be removed from the chamber and replaced with a new container.

Referring to Figure 6 antamisyksikköä 51 is used to move the piston 79 in the chamber 61. This is accomplished by aligning the piston 79 to an external force from the direction of the arrow 88. The first and second fingers are placed under the lugs 62 and 63. The thumb is used to apply a force to the plunger 79. The needle 73 moves through the membrane 69. The pressurized fluid within the reservoir 64 flows through the hole 78 into the channel 77 and further into the tube 49. The tube 49 leads to the uterine cavity 27. The fluid is fed from the end 54 and flows along the inner wall of the uterus to the fallopian tubes 36 and 37. the liquid in the tank 64 has flowed out of it. The sleeve portion 39, which is in communication with the inner wall of the uterine base, limits the amount of fluid that accumulates on the inner wall.

The administration unit 51 can be used to contain a simple dosage or a drug or liquid unit. The administration unit can be used like a small hand syringe to inject drugs into the body. Tubes 49 may be replaced with a tubular needle disposed in the outwardly directed tubular portion 68. The tubular portion 68 may include threads that releasably secure the needle. The portion 68 may be releasably or permanently attached to the elongate supply tube.

Referring to Figures 7, 8 and 9, there is shown a modification of a delivery unit, generally indicated at 100, which operates to deliver a liquid, such as a drug, under pressure to a tube or needle for subcutaneous injection. The tubes 101 may be the feed tube of the catheter 21. The delivery unit 100 has a body or housing 102 comprising a cylindrical side wall 103 associated with a flat end wall 104. The side wall 103 surrounds a cylindrical chamber 106 having an open end on the opposite side of the end wall 104. Opposite lugs 107 and 108 are attached to the open end of the side wall 103.

Inside the chamber 106 is a container or ampoule, generally designated 109, which stores a liquid such as drugs, tissue adhesive, water, air, gas, semi-liquids, and the like. The container 109 is a prefabricated structure having a cylindrical side wall 111 and a bottom wall 112. The bottom walls 112 are located on a flat surface connected to the inner surface of the end wall 104. At the center of the bottom wall 112 is a longitudinal tubular portion 113. A portion of the tubular portion 113 extends through an opening 114 in the bottom wall 112. The portion 113 has an outwardly extending portion 113A and an inwardly extending portion 113B. At the center of the tubular member 113 is a transverse membrane or plate 116 which closes the passage through the tubular member 113. The opposite or tip end of the container is closed by a bent seal 117.

ίο 62768 A longitudinal needle 118 is located in the container 109. The needle 118 has a tip 119 located at the top or interior of the tubular portion 113. The opposite end of the needle is attached to the transverse end 121. The end 121 is located near the inside of the end wall of the container 109. As shown in Figure 8, the needle 118 is usually U-shaped in cross section. One side of the needle is open to the liquid in the reservoir. This allows the liquid to flow longitudinally along the reservoir past the tip 119 as the tip pierces the membrane 116. The needle may be a longitudinal tubular portion with one or more holes providing access to the channel in the needle, as in the needle 73 in Figure 6. has been presented.

The piston 122 closes the open end of the housing 102. The piston 122 has two diametrically opposed bulges or protrusions 123 and 124. The thickeners 123 and 124 are located in longitudinally extending grooves 126 and 127 within the housing sidewall 103 to guide longitudinal movement of the piston into the housing. The inner surface of the piston 122 has an annular recess 128 that mates with the portions of the container as the piston 122 moves into the chamber 106. At the center of the piston 122 is a cavity 129 for accommodating the seal 117 of the container.

Referring to Figure 9, in use the force applied to the piston 122 in the direction of arrow 121. This moves the piston 122 into the chamber 106, the piston 122 moves around the container 109 and moves the needle through the membrane 116. As soon as the needle tip 119 penetrates the membrane 116, the liquid inside the reservoir 109 can flow through the needle 118 into the tube, i.e. the receiver 101. The liquid continues to flow through the needle 118 as long as the force is applied to the piston 122. The piston 122 can be moved into the chamber 106 until the end is abutting against the interior of the tubular portion 113.

Referring to Figures 10 and 11, a modification of the needle and reservoir system is shown. The bottom portion of the container 132 has a generally flat end wall 133. At the center of the end wall is a longitudinal tubular portion 134. The tubular portion 134 has an outwardly extending outer portion 134A and an inwardly extending inner portion 134B. At the center of the tubular member 134 is generally a membrane or plate 136 parallel to the end wall 133. The needle, generally indicated at 137, is located longitudinal to the channel in the tubular member 134. The needle 137 has a conical end 138 that terminates in a tip. The end 138 is connected to an elongated mandrel 139. 11 62 768 As shown in Figure 11, the needle 137 moves in the direction of arrow 141, the end 138 punctures the membrane 136. The membrane 136 of the hole is larger than the spindle 139, which allows the liquid in the container can flow past the membrane 136 into the feed portion of the tubular portion 134. The outer portion 134A of the tubular portion has threads 142 adapted to receive a threaded counterpart, such as a nut or sleeve, i.e., a fluid vnstaanoLto device. Other types of connections may also be used to connect the tubular member 134 to the fluid receiving device.

Referring to Figures 12 and 13, there is shown a liquid delivery container or ampoule, generally designated 143. The container has a cylindrical sidewall 144 surrounding a fluid, such as a drug, tissue adhesive, water, and the like, storage chamber 145. Wall 144 is made of non-assembled material. Usually, the flat transverse end wall 146 is an integral part with the other end of the side wall 144. At the center of the end wall 146 is an elongate longitudinal tubular portion 147. The tubular portion 147 has an outer portion 147Λ extending outwardly from the end wall 146 and an inner portion 147B extending into the chamber 145. The center of the tubular portion 147 is closed by a membrane 148. The membrane 148 is located transversely 146 and is made of a material that can be pierced by a needle.

The elongate longitudinal needle 149 is located in the chamber 145. The needle 149 has a forward end located within the channel of the inner portion 147B and terminating at the tip 151. The opposite end of the needle 149 is attached to the transverse end 152. The end 152 has an annular outer circumferential surface forming an inner wall 144 of the seal 153 with the wall. The outer circumferential surface of the end 152 is in a sealing frictional fit with the inner surface of the side wall 144. The outer circumferential surface of the end 152 is in a sealing frictional fit with the inner surface of the side wall 144 so that moisture, air or other substances do not enter the chamber 145. The needle 149 is usually U-shaped in cross-section, as shown in Figure 8 by the needle 118. Alternatively, the needle 149 may be a tubular member with one or more side holes that allow fluid in the chamber 146 to flow out of the end of the needle 149. The needle may also have the shape of a needle 137, as shown in Figures 10 and 11. Other shapes and structures may be used to allow fluid flow along the 12 6 2 7 6 8 needle through the membrane as soon as the tip of the needle has punctured the membrane.

In use, the end 152 of the chamber 145 is moved in the direction of arrow 154 direction, as shown in Figure 13. The needle tip 151 penetrates and punctures the membrane 148. The fluid in the chamber 145 is forced along the needle through the perforated membrane and fed through the outer portion 147A of the tubular portion.

Referring to Figures 14 and 19, there is shown a container or ampoule, generally designated 160, for storing a liquid, such as a drug, liquid tissue adhesive, semi-liquid material, or gas. The container 160 is located longitudinally with respect to the tubular needle 161. The needle 161 is usually attached to the transverse base 162 and the needle has a tip or sharp edge 163 at its forward end. The base 162 is attached to the housing (not shown) to secure the position of the needle 161.

The container 160 is a one-piece body with a continuous sidewall 164. The sidewall 164 is accordion-shaped and cylindrical in construction and surrounds a fluid storage chamber 166. The forward end 167 is closed by a membrane or cylindrical plate portion comprising an end wall 167. Outwardly facing outward. 168 is attached to the outer peripheral edge of the end wall 167, which end wall forms an extension of the container. A plate or seal 169 of resilient material, such as sponge rubber, foam, or the like, is located within the sleeve 168 and protects the end wall 167. The sleeve 168 has a rolled outer edge or bead support structure 171 that retains the seal within the sleeve 168.

The rear end of the container is closed by an end wall 172. The end wall 172 has a transverse seam 173 which seals the container so that it is closed to moisture and steam. As shown in Figure 17, the seam 173 has wrapped and folded edges sealed together. The tank is made of a material whose properties are such that it is impermeable to moisture and steam. The material is preferably a deformable lead alloy that is chemically noble relative to the liquid stored in the container. Other deformable materials with good moisture and vapor barrier properties can also be used to make the container. These properties are essential to prevent moisture and vapor sensitive materials from curing or polymerizing during prolonged storage periods.

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For example, cyanoacrylate monomer is extremely sensitive to moisture and steam. It must be stored in a sealed container that prevents moisture and steam from entering. The monomer cures over a short period of time when exposed to moisture, including moisture in tissues.

In use, force is applied to the end wall 172 in the direction of arrow 174. This force moves the reservoir 160 into operative engagement with the needle 161. The force also resizes the sidewall 164 and applies a sufficient force to the reservoir, causing the needle 161 to puncture both the seal 169 and the end wall 167. The seal 169 made of resilient elastic material forms a tight sealing engagement with the outer circumferential surface of the needle 161. The needle 161 also forms an opening 177 in the end wall 167. The needle 161, being a hollow tubular portion, provides a channel for fluid flow from the chamber 166 to a fluid recipient such as a catheter tube.

Referring to Fig. 20, there is shown a catheter delivery device having a delivery unit, generally indicated at 200, attached to an elongate spherical catheter 202. The delivery unit has a body, or housing 201, attached to an elongate linear tube 203 of the catheter. or may be releasably attached to the body 201. The outer end of the catheter has an expandable sleeve portion or ball structure 204 adapted to enclose a liquid, such as water or gas, to enlarge the expandable sleeve portion 204. As shown in Figure 22, there is a second smaller tube 206 inside the tube 203. The tube 206 extends the entire length of the tube 203 and has an outlet 205 at its outer end through which fluid can be delivered from the catheter. The outer end of the tube 203 may be provided with a recess to ensure fluid flow from the outlet 205.

As shown in Figure 22, the body 201 has two longitudinally extending chambers 207 and 208. The chambers 207 and 208 are located in parallel in a substantially horizontal plane. The chambers may also be located in a substantially vertical plane. The channel 209 connects the chamber 207 to the passage of the pipe 203. A similar channel 211 connects the chamber 208 to the passage in the tube 206. The short tubular needle 212 extends longitudinally into the channel 207. The needle 212 is attached to a transverse base 213 located at the end of the chamber 207 having the channel 209. The outer peripheral edge of the base 213 is located in a groove in the housing to secure the position of the base and needle relative to the channel 207. The needle 62768 has a passage parallel to the channel 209 so that fluid flows through the needle into the channel 209.

The second tubular needle 214 is located longitudinally in the channel 208. The needle 214 is attached to a base 216 located at the end of the chamber 208 near the channel 211. The outer peripheral edge of the base 216 is located in grooves in the housing 201 to secure the base and needle position relative to the channel 208. The passage in the needle 214 is parallel to the channel 211 so that fluid can flow through the needle into the channel 211.

A container or ampoule 217 having a chamber 218 for a liquid such as drugs, water or other material is located in the chamber 207. The container 217 has an end or membrane 219 opposite the needle 212. A seal 221 of resilient damping material is located between the membrane 219 and the needle 212. between the tip. The piston 222 is attached to the opposite end of the container 217. A suitable dovetail or tongue and notch 237 can be used to connect the container to the piston. Other types of joints can also be used to secure the tank to the piston. A longitudinal rod 223 is connected to the piston 222 and the rod 223 extends into a bore 224 in the housing 201. A helical spring 226 is positioned around the rod 223 and engages the housing 201 and the piston 222 to force the piston toward the needle 212.

The releasable lock 227 engages the rod 222 to hold the piston 221 in the impact position, causing the diaphragm 219 to be kept separate from the needle 212. Referring to Figures 23 and 24, the releasable lock 227 comprises a cylindrical portion 228 extending downwardly into a hole 22 in the housing 201. through a notch or groove 230. The body 228 is a 223-way semi-circular groove 231. The rod 228 of the frame upper end with a handle 232. The handle 232 can be moved in the direction of arrow 233, as shown in Figure 20, the groove 231 to move in such a way that it is centered with respect to the rod 223. When the groove 231 is centered with respect to the rod 223, as shown in Fig. 24, the rod can move freely. The spring 226 forces the piston 222 toward the needle 212. This moves the reservoir 217 and the diaphragm 219 to the needle 212. The tip of the needle passes through the seal 221 and pierces the diaphragm 219. The needle 212 forms a seal with the diaphragm 219, causing fluid in chamber 218 to flow through the needle 209 through the catheter tubes 203. The force of the spring 226 forces substantially all of the liquid in the chamber 218 through the needle 212.

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The upwardly facing finger 234 shown in Figure 21 is attached to the piston 222. The finger 234 extends through a longitudinal notch 236 in the housing 201.

The upper end of the finger 234 is magnified so that it can be gripped. The piston 222 and the reservoir 217 have cooperating connections such as a dovetail connection 237, as shown in Figure 22. When a force is applied to the finger 234, the piston 222 can be moved in the opposite direction to expand the container 217. This draws fluid back from the catheter by reducing the size of the expanding portion 204. The piston 222 can be moved until the lock 227 can move to secure the position of the piston 222 in the housing. Other types of retraction structures may also be used to retract and expand the container 217 to release fluid from the expanding portion 204.

The container or ampoule 238 is located in the chamber 208 adjacent the needle 214. The container 238 has a chamber 239 for storing drugs, tissue adhesive or other materials. The container 238 has an end or membrane 241 located away from the tip end of the needle 214 together with the resilient seal 242. Some drugs that are sensitive to moisture and vapor require that the container be made of a material that has good moisture and vapor barrier properties.

The deformable lead alloy is preferably used to make this type of container. These properties are important to prevent moisture and vapor sensitive materials from polymerizing or curing during storage periods. The material of the tank is also chemically noble compared to the liquid stored in the tank. At the opposite end of the reservoir 238 is a piston 243. A longitudinal rod 244 attached to the piston 243 extends into a bore 246 in the housing 201. A spring 247 in the chamber 208 engages the housing 201 and the piston 243 to force the piston toward the needle 214. The rod 244 is held free. through. The lock 248 is identical to the lock 227. It is controlled by moving the lock handle to the position indicated by the broken line shown in Fig. 20. This releases the rod 244, causing the spring 247 to force the piston in the forward direction, moving the diaphragm 241 toward the needle 214. The tip end of the needle 214 punctures the diaphragm 241 and thus provides fluid communication between the chamber and the channel 211 leading to the tube 206. The membrane is in a sealing counter-action with respect to the needle, as a result of which the force of the spring 247 forces the liquid in the chamber 239 of the container 238 through the needle 214, the channel 211 and the tube 206.

The body 201 has closure portions for closing the openings leading to the chambers 207 and 208, as a result of which the containers 217 and 238 can be removed and replaced with new ones.

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Containers of other types than those shown herein may also be placed in the chambers.

Referring to Fig. 25, there is shown a modification of a releasable lock, generally designated 250. The lock 250 has a body, i.e., a rod 251, with a cylindrical groove 252. The rod 223 is secured to the piston and has a similar groove. A spring 253 at the bottom of the bore 229 forces the body 251 in the upward direction. The upper end of the body 251 is attached to the end 254.

In use, the body 251 has a portion located in a groove or recess on the side of the rod 223 to hold the rod in the impact position, as shown in Figure 22. The rod 223 is released by pushing the end 254 in the downward direction, as indicated by arrow 256, until the groove 252 is parallel to the rod 223. This releases the retaining effect on the rod 223, as a result of which the spring 226 can move the rod in the forward direction, forcing the membrane 219 into contact with the needle 212.

Referring to Figures 26, 27, 28 and 29, there is shown another modification of a delivery catheter of the invention, generally designated 300, for delivering fluid such as drugs, tissue adhesives, and the like to the uterine cavity. The catheter 300 has a delivery unit 301 and an elongate tubular catheter 302. The delivery unit 301 has a body 303 attached to the catheter elongate tube 304. The tube 304 may be releasably connected or permanently attached to the body 303. An expandable sleeve portion or spherical structure 30 is attached to the end of the tube 304.

The strips 306 secure the ends of the sleeve portion 305 to the tube 304. The sleeve portion 305 is an elastic film portion of released rubber, plastic or similar materials. When the sleeve portion 305 is expanded in the uterine cavity, it applies equal outward pressure to the uterine wall. The expanded sleeve portion 305 prevents contact of drugs injected into the uterine cavity with most of the uterine wall and their outflow from the uterine cavity. The holes 307 at the end of the tube 304 provide a passage for a liquid such as water from the inside of the tube 304 to the area surrounded by the sleeve portion 305 to expand the sleeve portion 305. The elongate small tube 308 is located inside the tube 304. Tube 308 has a feed end 309 at the outer end of tube 304.

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The body 303 has two adjacent chambers 311 and 312. The chambers 311 and 312 are located longitudinally and in a common horizontal plane. The chambers may be located in a common vertical plane, with one chamber being located above the other chamber. Duct 313 connects chamber 311 to pipe 304. Similarly, duct 314 connects chamber 312 to pipe 308.

A first movable piston 316 is located in the first chamber 311. A rearwardly directed rod 317 is attached to the piston 316. A second movable piston 318 is located in the chamber 312. The rod 319 is attached to the piston 318 and extends in a rearward direction generally parallel to the rod 317. A trigger structure or actuator, generally designated 320, is attached to the rear of the housing adjacent the rear end of the rods 317 and 319.

The trigger structure 320 has an arm 321. At the center of the arm 321 is a hole into which a transverse pivot pin 322 is fitted. The pivot pin 322 is locked to a downwardly extending handle or gun handle 323 attached to the rear of the body 303. The arm 321 has a transverse end 324. The spring 325 engages the body 303 and the upper end of the arm 321 to force the arm to the rear or impact position. The forward portion of the end 324 is in sliding engagement with the ends of the rods 317 and 319.

Referring to Figures 29 and 30, the end 324 has a longitudinal passage 326 to accommodate the rod 319. The transverse bore 327 opens into the passage 326. A bore 328 is slidably located in the bore 327. The pin 328 has a smaller diameter neck 329 attached to a larger diameter end 331. A spring 332 connects the end 331 and the plug 333 to close the end of the bore 327. The spring 332 forces the pin 328 into the passage 326. The rod 317 has a rearward facing finger 334. When the bar 317 is in the rearward position, i.e., the impact position, the finger 334 is located behind the end 331 and acts as a stop to prevent the pin 328 from moving through the passage 326.

Returning to Figure 27, the rod 317 has a notch 336 at the top thereof. The notch 336 cooperates with the lock 337 to hold the rod 317 in the give or "in." Position. The lock 337 comprises a movable pin 338 located in a channel surrounding the stop 339. The pin 338 has an end 341 located above the body 303 so that it can be gripped to release the lock.The forward part of the pin has a C-ring or pin ring 18 62768 342 which forms a stop for the spring 343. The spring 343 is centrally located around the pin and joins the body 303 to force the pin 338 toward the rod 317. When the rod 317 is moved to the "in" position, the pin 338 is forced into the notch 336, and thus the pin is held in the "in" position.

The rod 319 has a notch 344. The lock 346 on the body 303 holds the pin "s in the male position. The lock 346 is identical to the lock 337.

Returning to Figure 30 when the arm 323 is actuated, the rod 317 is held in the "in" position by the lock 337. The rod 319 is not moved because the end 324 moves relative to the rod 319 as the rod 319 moves through the passage 326.

Once the spring 325 has returned the end 324 to its original rearward position, the spring 332 forces the pin 328 to pass through 326. A second operation or movement of the arm 321 toward the handle 323 moves the rod 319 in the forward direction.

Referring to Figure 28, a first container or ampoule, generally designated 350, is located in the chamber 311. A forward facing needle 351 attached to the transverse base 352 is located at the forward end of the chamber 311. The needle 351 is a hollow portion in fluid communication with the channel 313.

A second container or ampoule, generally designated 353, is located in the channel 312. At the forward end of the channel 312 is a longitudinally extending needle 354 attached to the transverse base 356. The needle 354 is a hollow tubular portion having a passageway which is a liquid. in communication with the channel 314 of the tube. The container 353 is an elongate cylindrical portion made of glass, plastic or the like with an end 352. The end has a rubber stopper (not shown) parallel to the needle 354. The piston 358 is slidably located in the container, which restricts the liquid 359 in the container. The piston 318 is slidably positioned inside the container and can engage the piston 358. As the piston 318 moves in the forward direction, the end 357 protrudes through the needle 354 and thus provides fluid communication between the chamber 353 of the container 353 and the tube 314. The piston 358 moves forward to push the fluid out of the reservoir. The fluid may be a drug, tissue adhesive, or semi-fluid material used to treat and occlude the fallopian tubes.

The container 350 shown in Figure 31 has a cylinder 361 for storing a liquid such as drugs, water or the like. At the forward end of the cylinder 361 is an end 363 with a channel closed by a plug 364. The open end of the cylinder 361 is closed by a plunger 366 carrying the piston 367. The rear of the plunger 366 has an outwardly directed flange 368 which engages the spring 369. The forward end of the spring 369 engages the annular support surface 371 in the cylinder 361 to force the plunger 366 in the outward direction, i.e. out of the cylinder 361. The plunger 366 has a central longitudinal bore 372 slidably fitted to the actuator rod 373. The rod 373 has an axial bore 37 , which forms a flexible connection between the rod 373 and the plunger 366.

A plunger 316 attached to the rod 317 engages the end of the rod 376. As the plunger 316 moves in the forward direction, the spring 374 compresses and applies equal pressure to the plunger 366. The cylinder 361 moves in the forward direction, causing the needle 351 to puncture the plug 364, providing fluid communication between the reservoir and the channel 313. The continued movement of the plunger 316 pushes the piston 367 toward the plug 364 and thus the fluid is discharged from the reservoir 361. The drained fluid flows through the tube 304 and through the holes 307 into the sleeve portion 305, extending the sleeve portion 305 as shown in phantom in Figure 28. The sleeve portion 305 expands to have equal pressure and fills the uterine cavity and provides equal pressure to the inner wall of the cavity. The pressure of the sleeve portion 305 on the cavity wall is equal regardless of the size of the knocked cavity.

The body 303 has closure portions for closing the openings leading to the chambers 311 and 312, as a result of which the containers 350 and 353 can be removed and replaced with a new one. Containers of other types than those described herein may also be placed in the chambers.

In use, a method of introducing a material such as a drug, tissue adhesive, anti-fertilization gel, or the like into the fallopian tubes is performed with a delivery catheter. The method includes guiding an elongate catheter 302 with the sleeve portion 305 in the contracted position through a cervical opening into the uterine cavity. The sleeve portion 305 is expanded with a fluid under pressure to fill the uterine cavity and apply equal pressure to the inner wall of the uterine wall. Under pressure] The sole fluid is introduced into the sleeve portion 305 through a passage in the tube 304. The actuator 20 6 2 7 6 8 320 is moved in a forward direction to force the plunger 316 in the direction in which it moves the container 350 into operative engagement with the needle 351. The needle 351 punctures the plug 364, causing fluid 362 to flow through the channel in the tube 304 to expand the sleeve portion 305. The sleeve portion made of a flexible elastic rubber or similar material has a low surface tension and applies an equal expansion force to the inner wall of the uterine wall. This provides a relatively tight seal and fit, allowing the same catheter construction to be used for all types of female individuals regardless of the size of the uterine cavity.

The pressurized material is then introduced into the uterine cavity between the expanded sleeve portion and the base of the uterus. The pressurized material moves toward and within the channels of the egg guides. An expanded sleeve portion located against the wall of the base of the uterus helps the material move toward the fallopian tubes. The material may be a liquid tissue adhesive that flows into the channels. Moisture in the tissue of the ducts polymerizes or cures the tissue adhesive and thus clogs or closes the ducts. The liquid in the sleeve part is drained to reduce the sleeve part. The catheter is then withdrawn from the uterine cavity.

Figure 32 shows a delivery instrument, generally designated 420, with a probe located in the uterine cavity. The female sex system, generally designated 421, has a uterus 422 associated with two fallopian tubes 423 and 424. The lower part of the uterus 422 is integral with the elongate vagina 426. The vagina 426 has a vaginal cavity 427 with a vaginal opening 428. The opposite end of the vaginal cavity 427 communicates with the neck 429. The neck 429 has a neck-like opening 431 that forms a channel from the vaginal cavity 427 to the uterine cavity 432. The fallopian tubes 423 and 424 have outlets 433A and 434A on opposite sides of the top of the uterine cavity 432.

Uterus 422 is a generally pear-shaped, thick walled, hollow organ situated between the bladder and the rectum. The uteri of females vary in size and shape. Wall thickness, wall strength, and sensitivity to maternity burns may vary from female to female. The size and structure of the uterine cavity can vary. The uterine cavity 432 is usually flat and triangular in shape. Some uterine cavities are oval in shape.

The fallopian tubes 423 and 424 are paired, horn-shaped, muscular sections * about 12 cm long and extending from the upper corners of the uterine cavity 432 to the ovaries (not shown). The outlets 433Λ and 434Λ of the channels 433 and 434 may vary in position relative to the uterine cavity and relative to each other. The outlets 433A and 434A are usually symmetrically opposed to each other, as shown in Figure 32, and their position and proximity depend in principle on the size and structure of the uterus. Also, the size of channels 433 and 434 and the size of outputs 433A and 434A vary from one female to another.

The fallopian tubes are generally divided into a slit part, a part inside the slit and a bottle-like part. Channels 433 and 434 provide pathways for the movement of oocytes from the ovaries to the uterine cavity 432 as well as for the movement of semen from the uterine cavity to the ovaries. The portion of the fallopian tubes inside the groove usually passes through the uterine wall in a more or less straight form, but their orientation may be tortuous in some female individuals. The walls of the fallopian tubes consist of three layers: a blood-like layer, a layer of muscle, and an inner layer that secretes mucus.

The uterus 422 has an upper portion 436 and 438 surrounding the uterine cavity 432. The inner surface of the upper wall 436 and the inner surfaces of the sidewalls 437 and 438 have an inner layer or membrane 439 that periodically detaches during a normal menstrual cycle.

The delivery instrument 420 has an elongate probe or tubular portion 441 of sufficient length to pass through the vaginal cavity 427 into the uterine cavity 432. The portion 441 has a longitudinal channel 442 extending its entire length. The spherical structure, generally designated 443, is attached to the upper or outer end of the tubular member 441. The ball structure 443 has a resilient and expandable sleeve portion 444 surrounding the upper end of the probe 441. A fastener 446, such as a latch or wire, secures the top end of the sleeve 444 to the probe 441. A similar fastener 447 secures the opposite end of the sleeve 444 to the probe 441. The probe 441 has a plurality of 22 62768 openings 448 communicating between the channel 442 and the chamber 449 inside the sleeve portion 444.

The sleeve portion 444 is a tubular membrane portion made of a soft and released, flexible and elastic material, such as rubber or plastic, that expands to have a minimum tensile stress. For example, a thin latex rubber having a low surface tension is a suitable material for the sleeve portion 444. The low surface tension of the rubber allows the rubber to expand evenly at a relatively low pressure. The material of the sleeve portion 444 expands easily and displaces the uterine cavity 432 by conforming to the shape of the uterine cavity without applying high pressure to local locations on the uterine walls 437 and 438. When the cavity 432 is completely displaced together with the sleeve portion 444, as shown in Fig. 36, the sleeve portion 444 is in equal surface contact with the inner layer 439. Conventional spherical catheters made of a hard, relatively inelastic material do not adopt the structure of the uterine cavity when expanded.

The upper or outer end of the probe 441 is closed at the end 451. The end 451 has a transverse channel 452 that opens to opposite sides of the end 451. The tube 453 extends the length of the probe 441 and has a channel 454 for introducing the drug into the transverse channel 452, which directs the drug material at two points in opposite directions inside the top of the uterine cavity 432. The end 451 has a longitudinal portion, i.e., a base 456, with an upper surface or wall adapted to engage the inner wall of the uterine base 436.

The base 456 places the channel 452 at a distance from the inner wall of the uterine base 436.

Referring to Figure 33, the delivery instrument 420 has an elongate housing or body 457 attached to the end of the probe 441. The body 457 has a first chamber 458 to accommodate an elongate cylinder 459. The cylinder 459 has a forward nozzle 461 connected to the tube 462. The tube 462 has a passageway communicating with the passage 442 in the probe 441 so that a liquid such as air in the cylinder 459 can flow through the passage 442 into the ball structure chamber 449 and thus expand the sleeve portion 444. The open end of the cylinder 459 is closed by a piston 463 to retain fluid in the chamber 464. The cylinder 459 has a hole 466 near the piston 463, allowing air and sterilization gases to flow into the chamber 464.

23 62768 To the rear of the piston 463 is a first actuator, generally designated 467, which operates to move the piston 463 to the cylinder 459. The first actuator 467 is connected to an actuator 468 which is directed rearward from the body 457.

The body 457 has a second chamber 469 located adjacent one side of the first chamber 458. Attached to the body 457 is a tube 471 connecting the tube 453 to the chamber 469. The tube 471 has a longitudinally extending needle 472 extending into the chamber 469. The opposite end of the tube 471 is attached to a plug 473 enclosing the end of the probe 441 and connecting to the tube 453 leading to the end 451. The chamber 469 is elongate in shape and is open toward the top of the body 457, as shown in Figure 32. In the chamber 469 there is a cylindrical container, i.e. a ampoule 474, which is parallel to the needle 472. At the forward end of the container 474 is a pierceable plug 476 parallel to the needle 472. The open end of the container 474 is closed by a sliding piston 477 to retain the drug material 478 in the container 474.

The second actuator, generally designated 479, faces back from the reservoir 474 and is connected to the actuator 468 that actuates it. The actuator 468 operates by simple traction to deliver all of the drug material to the fallopian tubes. The rear of the housing 457 has outwardly and oppositely directed flanges 481 and 482 that act as finger grips during operation of the actuator 468. The actuator 468 has a hole 483 to which a pin 483A fits, which keeps the actuator 468 in the operative position. Pin 483A prevents accidental operation of the delivery instrument.

The drive assembly 467 is a spring-loaded mechanism that moves to move the piston 463 to the cylinder 459 and thus increases the pressure in the fluid system for the ball structure 443 and expands the sleeve portion 444. The actuator 467 has a cylinder or sleeve 484 slidably extending in the body 486. at the end 487. The end 487 has a central hole 488 which provides an entrance to the sleeve 484. The outer end of the piston 463 has a conical portion 489 to which the conical outer end of the end 487 fits.

The hole 488 is parallel to the adjusting screw 491 threaded into the body 486. The position of the screw 491 relative to the body 486 can be changed using a tool such as a screwdriver extending through the hole 488. The two springs 492 and 493 force the sleeve 484 and the body 486 in opposite directions, as a result of which the first drive device 627 of the drive 62768 24 is forced into its extended position. The spring 492 abuts against the end 487. The spring 493 rests on the screw 491. Adjusting the position of the screw 491 adjusts the tightening force of the spring 493, which forces the end 487 and the body 486 in opposite directions. The screw 491 fine-tunes the spring force to accommodate the changes in the spring 493 and provides the desired fluid pressure in the chamber 449. A plate 494 with a central hole for the rod 488 is located between the springs 492 and 493. The spring 492 has a weaker spring force compared to the spring 493. The spring-loaded spring 492 compresses under a light load, e.g., 2-3 psi, causing the plate 494 to abut against the end 487. This ensures partial expansion of the sleeve portion 444 at a low predetermined maximum pressure. The compressive force characteristics of the spring 493 determine this predetermined maximum pressure, and therefore the device can be used for uteri of all shapes and sizes by adjusting the spring 493 to the differences in the uteri.

The sleeve 484 and the body 486 are held in an assembly relationship by a pin 496 extending through an elongate longitudinal slot 497 in the sleeve 484. The slot 497 allows the sleeve 484 to move relative to the body 486 with the springs 492 and 493 compressed. The pin 496 extends through the slot 497 into an elongate linear groove 498 in the housing 457 and thus prevents rotational movement of the actuator 467 relative to the housing 457.

The body 486 has a transverse channel 499 to accommodate a drive joint 501. The drive joint 501 has spherical portions at its opposite ends connected by a transverse portion or tube. The first end of the drive joint 501 is located in the recess 502 on the actuator 468 side. The actuator 468 has a second recess 503 into which the joint 501 fits. Below the recess 503 is a shoulder 504 adapted to engage the end of the body 486 when the joint 501 is in the recess 503. The housing 457 has a recess 506 adapted to accommodate the opposite or right end of the drive joint 501. The recess 506 is located in a direction forward from the initial position of the drive joint 501, as shown in Figure 33, so that the operation of the drive 467 is momentarily stopped or interrupted until the end of the body 486 engages the shoulder 504, at which point the drive 467 continues to move. The locations of the recesses 506 and 521 in the housing 457 may be arranged relative to each other such that the initial expansion of the sleeve portion 444 pushes the supply of drug material into the uterine cavity and the expansion of the sleeve portion 444 continues. In this case, 62,678, the sleeve portion 444 expands continuously until the maximum fluid pressure is applied to the sleeve portion 444.

The lock unit, generally indicated at 507, is movably located in a bore 508 in the body 486. The lock unit 507 has a plunger 509 with an outwardly directed finger or protrusion 510. The finger 5L0 is adapted to engage one of the plurality of teeth 511 in the housing 457. as opposed to 467. The teeth 511 are ratchet teeth that only allow the actuator to move in the opposite direction when the lock unit 507 is in the operative position with the teeth 511. The plunger 509 is forced in the outward direction by a spring 512 located at the bottom of the bore 508. The sleeve 484 has a hole 513 spaced forward from the finger 510. As the springs 492 and 493 compress, the body 486 moves relative to the sleeve 484 until the finger 510 is parallel to the hole 513, at which point the spring 512 forces the finger 510 through the hole 513 to engage one of the teeth 511. This prevents the drive assembly 467 from moving forward in the forward direction and limits the pressure of the fluid in the chamber 449 of the sleeve 444.

The second actuator 479 operates to push the reservoir 474 into the needle 472 and to force the plunger 477 into the reservoir and thus push the drug material 478 through the needle 472 into the tube 453. The tube 453 conveys fluid to the end 451 where it is fed in opposite directions to the top of the uterine cavity 432. Returning to Figure 33, the second drive assembly 479 has an elongate linear plunger 514 slidably located in a longitudinal passage 515 in the housing 457. The plunger 514 has a forward end 516 adapted to engage the piston 477. At the opposite end of the plunger 514 is movable drive joint 518. The joint 518 has spherical ends connected by a rigid part such as a tube. The other end of the drive joint 518 is located in a hemispherical recess 519 located on the actuator 468 side. The opposite end of the drive joint 518 abuts the sidewall of the housing 457 and forms part of the channel 515 and thus holds the joint in the recess 519. The housing 457 has a recess 521 forward of the joint 518 so that the joint 518 remains in operation with the actuator 468 until the joint is in the direction of the recess 521. Currently, the joint 518 is forced into the recess 521, as a result of which the actuator 468 continues to move in the forward direction and the plunger 514 remains stationary.

In use, the delivery instrument 420 is a package in which the container 474 is located in the chamber 469. The actuator 468 is locked in the inoperative position by a pin 483A extending through the hole 483. The pin 483A engages the end of the housing 457 and prevents the actuator 468 from moving into the housing. The entire delivery instrument is sterilized before use.

The procedure is initiated by inserting a ball structure 443 into the vaginal cavity 427, through the cervical opening 431 into the uterine cavity 432, as shown in Figure 32. The sleeve portion 444 is in an assembled condition so that the ball structure can be easily placed in the uterine cavity. The probe 441 is moved into the uterine cavity until the end 451 meets the base 436 of the uterus. It is known that the uteri may vary in size, shape, and position so that the balloon structure may or may not be symmetrical to the fallopian tubes 423 and 424. As shown in Figure 32, the ball structure 443 is located centrally to the uterine cavity 432. In some cases, it may be located in the structure at an angle from the uterine cavity adjacent to the second side of the cavity. The delivery instrument 420 is effective in delivering drug material to both fallopian tube channels despite the position of the balloon structure in the uterine cavity 432.

The pin 483A is removed from the hole 483, allowing the plunger 468 to move into the housing 457 to inflate the expandable sleeve portion 444 and deliver the drug material to the uterine cavity 432 and then completely expand the sleeve portion 444, pumping or forcing the drug material into the fallopian tubes. The operator uses flanges 481 and 482 as finger supports so that an inward force can be applied to the actuator 468. As shown in Figure 35, the actuator 468 has moved a short distance into the housing 457 such that the first actuator has moved the piston 463 into the cylinder 459. This expands the sleeve portion 444 to form a plug or seal in the lower portion of the uterine cavity 432. The sleeve portion 444 is expanded into intimate contact with the inner layer, i.e., the film 439. The drive joint 501 connects the actuator 468 to the first drive 467 to transfer the movement of the actuator 468 to the first drive 467. This moves the piston 463 to the chamber 464. The drive joint 518 engages the plunger 514 with the actuator 468 so that the forward end 516 of the actuator engages the piston 474. in the forward direction of the entire tank 474. The needle 472 pierces the plug 476, and thus the needle moves through the plug 476 into the chamber containing the drug material 478. The drive joint 501 is parallel to the recess 506 in the housing 457. This allows the drive joint 501 to move to the right, as shown in Figure 35, and the drive joint disengages from the actuator 468. Continued movement of the actuator 468 applies a force to the plunger 416 which moves the piston 477 into the reservoir 474. The drug material 478 is forced through the tubes 471 and 453 to the end 451. Drug material is fed in opposite directions through the transverse channel 452 to the top of the uterine cavity 432.

As shown in Figure 36, continued movement of the actuator 468 causes the shoulder 504 to engage the base portion of the body 486. At the same time, the drive joint 501 moves into the recess 503, and thus releases the drive joint 501 from the recess 506. The actuator 468 is moved into the housing 457 and thus the pressure in the chamber 464 increases. This further expands the sleeve portion 444. The expandable sleeve portion 444 pushes the drug material from the top of the uterine cavity through the outlet ports 433A and 434A of the fallopian tubes 433 and 434. The sleeve portion 44 continues to expand until the pressure in the fluid in the system including the sleeve portion and chambers 449 and 464 is about 8 psi. Other sizes of pressure can also be selected as the upper pressure limit. The compression characteristics of the springs 492 and 493 and the adjusting screw 491 determine this pressure. Compression of the springs 492 and 493 allows the body 486 to move into the sleeve 484. This movement continues until the finger 510 is parallel to the opening 513. When the finger 510 and the hole 513 are parallel, the spring 512 forces the finger 510 through the hole 513 into the space between the adjacent teeth 511. The finger 510 locks into the forward tooth, and thus further movement of the actuator 468 into the housing 457 is prevented. Because the lock unit 507 prevents the actuator 468 from moving into the housing 457, the pressure in the ball structure chamber 449 is limited to the selected maximum pressure, which depends on the compression characteristics of the springs 492 and 493.

When the actuator 468 has moved into the housing 457 from the position shown in Figure 35 to the position shown in Figure 36, the drive joint 518 moves from the recess 519 to the recess 521. This stops forward movement of the plunger 514 and stops delivery of drug material to the uterine cavity 432. Extended movement of the actuator 468 thus, the sleeve portion 444 expands to pump or discharge drug material from the uterine cavity 432 into the fallopian tube passages 433 and 434. The pumping operation ceases when the sleeve portion 444 is fully expanded, as shown in Figure 36. This stops the drug material in the fallopian tubes because the pumping force applied to the drug material is insufficient to move the drug material through the fallopian tubes into the body cavity.

28 6 2 7 6 0

The actuator 468 is then withdrawn from the housing 457. The drive joint 501 in the recess 503 provides a drive connection between the body 486 and the plunger 468. The finger 510 of the lock unit 507 slides over the teeth 511. This pulls the piston 463 out of the chamber 464. The fluid in the chamber 449 flows back into the chamber 464, which shrinks the sleeve portion 444. This releases the sleeve portion 444 from contact with its inner layer 439 and allows the balloon structure 443 to be withdrawn from the patient's uterus.

When a cyanoacrylate tissue adhesive type material is used as the drug material, the channels 433 and 434 are permanently closed. Tissue adhesives, such as those of the cyanoacrylate type, cause fibrous profiling, which instantly closes channels 433 and 434. Tissue adhesives polymerize when exposed to a hydroxyl ion source such as water. The cells adjacent to the adhesive are destroyed and eventually replaced by fibrous tissue. Certain other tissue adhesives polymerize under the influence of body temperature or other stimuli.

In the method of the invention, a delivery instrument is used to insert the drug material through the uterine cavity into each of the fallopian tubes. Initially, the shrunk ball structure is inserted into the uterine cavity, as shown in Figure 32, by inserting the ball structure 443 through the neck-like opening 431. The actuator 468 is then released so that it can be moved into the housing 457. The surgeon moves the simple actuator 468 in a continuous motion into the housing 457 to perform the operation. The first actuator 467 and the second actuator 479 are aligned and operate sequentially to partially expand the sleeve portion 444, which displaces the lower portion of the uterine cavity and forms a seal with the lower walls of the uterine cavity. The plunger 514 then engages the plunger 477 to force the reservoir into the needle 472 and to force the drug material 478 from the reservoir and feed the drug material in opposite directions above the partially expanded sleeve portion 444 into the uterine cavity 432. uterine cavity 432. This is accomplished by applying pressurized fluid to the sleeve portion 444 by moving the piston 463 into the chamber 464. The actuator 468 continues to move until the locking unit 507 engages one of the teeth 511 and thus prevents further expansion of the sleeve portion 444. Only the maximum predetermined pressure can be applied to the sleeve portion 444 so that no excessive pressure is applied to the uterine walls. The expandable sleeve portion 444 delivers or pumps the drug material delivered to the uterine cavity through the openings 433A and 434A into the fallopian tube passages 433 and 434. The sleeve portion 444 is then shrunk by releasing the pressure applied thereto. This is accomplished by pulling the actuator 468 out of the housing 457 so that fluid can flow into the reservoir chamber 464. The instrument is then removed from the uterine cavity through the cervical opening and the vaginal passage.

As the drug material, any of a number of fluids or semi-fluids used to examine, treat, or occlude the fallopian tubes can be used. For example, the drug material may be a tissue adhesive. Tissue! the mucus may be a material of the cyanoacrylate type or a material used as a surgical adhesive. Cyanoacrylate is a plastic liquid that cures or polymerizes under the influence of moisture and thus acts so as not to block the fallopian tubes. Cyanoacrylates include methyl isocyanate, methyl 2-cyanoacrylate, ethyl cyanoacrylates, n-propyl cyanoacrylates, n-butyl cyanoacrylates, n-amyl cyanoacrylates, n-hexyl cyanoacrylates, n-hexyl cyanoacrylates, n-h , but cyanoacrylates are not limited to the above. The drug material may also be of a type that cures under the influence of body temperature or other stimuli.

It may be one that forms a permanent closure, or one that momentarily occludes or closes the ducts of the fallopian tubes, after which the ducts reopen and resume their normal operation. Ksi marks for other types of drug materials include contraceptive gels, water, silicone elastomers, formaldehyde-type materials, and the like.

Referring to Figures 37 and 38, there is shown a modification of a delivery instrument generally designated 420A. The administration instrument 420A and the associated female sex system are in accordance with the administration instrument shown in Figures 32-26. The corresponding parts of the instrument and the sex system are marked with the same reference numbers with the suffix A.

The delivery instrument 420A uses a two-component drug material that is mixed at the end of the probe as it is introduced into the top of the uterine cavity 432A. The mixed drug material in the sleeve portion 444A displaces the uterine cavity 432A.

30 62768

Attached to the outer end of the probe or tubular portion 441A is an end 651. The end 651 has a transverse channel 652 with oppositely directed discharge openings for directing drug material in two portions to the top of the uterine cavity 432A. The first tube 653 and the second tube 654 are connected to the end 651. The end has a mixing chamber or channel 655 in fluid communication with the channels of the tubes 653 and 654 and the transverse channel 652. The drug materials flow through tubes 653 and 654 and are mixed in chamber 655. Stirring continues while the drug materials are separated and mixing is forced in channel 652 in opposite directions, as indicated by the arrows.

The housing 457A has two chambers 656 located adjacent the chamber 458A and fitted with two ampoules or reservoirs 657 and 659. The reservoir 657 stores the first drug material 658. The reservoir 659 stores the second drug material 660. The reservoir 657 slidably holds the first piston 66 659, the second piston 662 is slidably located. The plunger 514A of the second drive assembly 479A has a bifurcated end formed by two fingers 663 and 664. Finger 663 is located in reservoir 657 and engages piston 661. Finger 664 is located in reservoir 659 and engages piston 653. extend into housing 457A and terminate in needles 666 and 667. Needles 666 and 667 are parallel to the pierceable end portions of containers 657 and 659.

When the simple actuator 468A operates, the first drive assembly 467A acts to initially expand the sleeve portion 444A, which fills and seals the lower portion of the uterine cavity 432A. Continued movement of the actuator 468A engages the second drive assembly 479A, which moves the fingers 663 and 664. The plunger 514A moves forward, i.e., upward, as shown in Figure 37, to push the reservoirs 657 and 659 into arrows 666 and 667, respectively. coupled to the pistons 661 and 662, the drug materials 658 and 660 are simultaneously forced through the tubes 654 and 653. The drug materials are fed simultaneously to the mixing chamber 655. Substantially the same amounts of drug materials are fed to the mixing chamber 655 so that the mixture of drug materials contains about 50% of the first drug and 50% of the second drug material. The blended drug material, designated 668 in Figure 37, is introduced into the upper portion of the uterine cavity 432A. The blended drug material 668 flows in substantially equal amounts in opposite directions. The flow continues until the plunger 514A reaches the end of its stroke length. At present, the continuous movement of the actuator 468A further expands the sleeve portion 444A and forces the mixed drug medication into the fallopian tubes 433A and 434A.

The drug materials 658 and 660 may be of a type that, when mixed, cures to form a semi-rigid plastic material. The mixture may be sensitive to moisture in the tissues or sensitive to body temperature or other factors that harden the mixture. The reaction time of the mixing is such that the mixing can be passed to channels 433A and 434A before it cures. The following are examples of materials that are two-component drug materials. The two-component drug materials can be two-component epoxies, two-component tissue adhesives, silicone RTV, or a polymer composed of Dow Corning Silastic 382 Medical Elastomer and 360 Medical Fluid. It will be appreciated that other types of pharmaceutical materials which are mixed and cured may also be used. In addition, the ratio of drug material can be varied by increasing the size of the second container. For example, two parts of the first drug material may be mixed with one part of the second drug material using a suitable size in the containers in the housing 457A.

The drug material may be a contraceptive drug that acts locally in the fallopian tubes and uterus. For example, bioabsorbable micron-sized spheres with contraceptive drugs, such as progestins, can be introduced into the fallopian tubes. The microspheres are destroyed after a certain period of time, for example after one year, and thus prevent fertilization during this period.

Biological agents, such as fibrinolytic enzymes, can be introduced into the ducts of the fallopian tubes and the uterine cavity to treat tissues. Biological agents are used to treat inflammation and prevent the formation of adhesions around the ends of the fallopian tubes.

By means of the device and method according to the invention, diagnostic materials can be introduced into the ducts of the fallopian tubes. These materials include oils, water-based X-ray dyes, and dyes used as color indicators, such as methylene blue and indigo carmine and the like.

32 62768

By means of the device according to the invention, anesthetic materials can be introduced into the ducts of the fallopian tubes.

The drug material may be of the type that treats the ducts and uterus so as to improve the flow of oocytes and semen in the ducts and uterus. The drug material may include material that expands or opens the fallopian tubes to increase fertilization. Today, there are several materials or chemicals used to treat fallopian tubes to increase fertilization. Anti-inflammatory agents such as cordocoids can be used topically to treat inflammation. Antibiotics can also be used for topical treatment of fallopian tubes.

It is probable that in some cases of infertility, semen is prevented from passing through the cervical neck and endometrial cavity. The device and method of the invention can be used to deliver semen to the uterine cavity and fallopian tubes to increase fertilization.

Although preferred embodiments of a delivery instrument and method for introducing materials into both ducts of a female person's fallopian tubes have been shown and described above, it will, of course, be apparent to those skilled in the art that various changes may be made to the structure and method of the invention.

Claims (30)

62768 33 An instrument for introducing a substance into the ducts of the fallopian tubes through the uterine cavity, in particular for sterilization, comprising a dispensing device having an expandable diaphragm-bearing and uterine cavity portion, means for expanding said diaper to form a seal in the lower uterine cavity and feeding means for introducing the substance to a seal cavity, characterized in that said sheath (39,204,305,444,444A) and expansion devices (44,21 7,222,31.6, 350,459,459A, 463,463A) are constructed to further expand said sheath (39,204,305,444,444A) to substantially completely fill the uterine cavity after the substance is introduced into said cavity, and to make tight contact with the inner wall of the uterine cavity, including the base portion, regardless of the size of the uterine cavity. An instrument according to claim 1, characterized by optionally operating devices (444,444A, 463,463A, 467,467A, 468,468A, 486,504) for transferring material from the uterine cavity to the fallopian tubes. An instrument according to claim 2, characterized in that said dilating devices (459,459A, 463,463A) and said feeding devices (474,477,657,659,661,662) are operatively connected to each other so that the substance is fed into the uterine cavity after partial dilation of said sheath (444,444A) and the substance moves from the uterine cavity to the fallopian tubes as a result of the subsequent expansion performed to provide a pumping effect of said diaper. An instrument according to claim 3, characterized by sequence control devices (467,467A, 468,468A, 479,479A) coupled to said expansion devices (459,459A, 463,463A) and said feeders (474,477,657,659,661,662) for automatically performing a partial engagement of said sheath (444,444A). expanding, introducing the substance into the uterine cavity, and further expanding said diaper. An instrument according to claim 4, characterized in that said sequence control devices (467,467A, 468,468A, 479,479A) include devices (501,503) for constricting said sheath (444,444A) after the substance has been pumped from the uterine cavity into the fallopian tubes. 34 62768 Instrument according to claim 4 or 5, characterized in that said operating sequence control devices (467,467A, 468,468A, 479,479A) comprise a single continuously operating actuator (468,468A). Instrument according to any one of the preceding claims 1 to 6, characterized in that said expansion devices (459,459A, 463,463A) comprise pressure supply devices (491,492,493,494,507,513,513A) adapted to supply a pressure medium at a certain pressure to said expandable jacket (444.4). An instrument according to claim 7, characterized in that said pressure supply devices (491,492,493,494,507,513,513A) comprise pressure limiting devices (507,513,513A) for limiting the pressure inside the expanded jacket (444,444A) to a certain maximum pressure. An instrument according to claim 8, characterized in that said pressure relief devices (507,513,513A) are adapted to control the maximum pressure inside said sheath (444,444A) and the resulting filling of the uterine cavity so that the substance is pumped into the fallopian tubes but not throughout the channels. Instrument according to any one of claims 7 to 9, characterized in that said pressure supply devices (491,492,493,494,507,513,513Λ) comprise control devices (492,493) for keeping the pressure of the medium substantially constant inside the expanded jacket (444,444A). Instrument according to any one of claims 1 to 10, characterized in that said expansion devices (44,217,222,316, 350,459,459A, 463,463A) comprise a storage tank (217,350,459,459A) for storing a medium for expanding said jacket (39,204,305,444,444A), and actuators (47,226,227) transferring the expansion medium from said storage container to the sheath to expand said sheath in the uterine cavity. Instrument according to any one of the preceding claims, characterized in that said dispensing devices (51,53,100,200,301, 420,420A) comprise an elongate tubular catheter (38,203,302,441,44IA), 35 62768 through which a substance passage (49,52,206,308,453,653,654) terminates in said catheter. at one end to a substance outlet located within the uterine cavity. An instrument according to claims 11 and 12, characterized by a fu housing (201,303,457,457A) having first and second chambers (207,208, 311,312,458,458A, 469,656) receiving said media storage tank (217,350,459,459A) and a substance storage tank (47,6,353), respectively. and communicating with a medium channel (209,313,462,462A) and a substance channel (211,314,471,653,654), respectively, said channels leading to a portion (203,204,302,305, 441,444,441A.444A) to be placed in said uterine cavity. An instrument according to claim 13, characterized in that said substance channel (211,314,471,653,657) communicates with a needle (214,354,472,666,667) for piercing said substance storage container (238,353,474,657,659). An instrument according to claim 12 or 13, characterized in that said medium channel (209,313) communicates with a needle (212,351) for piercing said medium storage container (217,350). An instrument according to any one of claims 11 to 15, characterized by a first actuator (316,317,467,467A) operatively coupled to said actuators (320,468,468A) and movable by movement of said actuators to supply a sublingual medium to said sheath (305,444,444A). to fill the uterine cavity. An instrument according to claim 16, characterized by locking devices (507) associated with said first actuator (467,467A) which stop the movement of the actuator when a predetermined pressure exists within said sheath (444,444A). An instrument according to claim 17, characterized by a plurality of teeth (511) connected to the housing of the instrument and opposite said first actuator (467,467A), said locking means (507) of said 62768 36 engaging one of the teeth when said predetermined pressure is reached. An instrument according to claim 18, characterized in that said locking members (507) include a body (509) having a protrusion (510) and a biasing device (512) for moving the protrusion between adjacent teeth (511) when said predetermined pressure is reached. An instrument according to any one of claims 16 to 19, characterized by a second actuator (318,319,479,479A) operatively connected to said actuators O20,468,468A) which can move under the action of the movement of the actuators to dispense a substance into the uterine cavity. An instrument according to claim 20, characterized by first and second releasable retraction devices (501,518) for operatively connecting said actuators (468,468A) to said first and second actuators (467,467A, 479,479A), respectively. An instrument according to any one of claims 13 to 21, characterized by a further substance storage container (659) for storing another substance and mixing devices (651) for mixing said two substances before they are introduced into the uterine cavity. An instrument according to claim 22, characterized in that said mixing devices consist of a mixing head (651) located near the front of said sheath (444A), said mixing head being provided with channels (652,655) for receiving and mixing said substances and removing the mixture into the uterine cavity. An instrument according to any one of claims 12 to 23, characterized by an end (451,651) having lateral outlets (452,652) for said catheter (441,441A) primarily for dispensing and guiding the substance into the uterine cavity. An instrument according to any one of the preceding claims, characterized in that said dispensing devices (420,420A) include a stop member (456) for locating a portion (441,444,441A, 444A) of the dispensing device 62768 located within the uterine cavity at a distance from the base of the uterus. An instrument according to claims 22 and 23, characterized in that said head (451,651) includes an enlarged portion (456) adapted to contact the base of the uterus and position the removal lugs (452,652) at a distance from the base of the uterus. Instrument according to any one of claims 1 to 26, characterized in that said sheath (39,204,305,444,444Λ) is tubular in shape and is made of an expandable sheet material having low surface tension properties and substantially uniform expansion properties. An instrument according to any one of claims 1 to 27, characterized in that said sheath (39,204,305,444,444A) comprises an inflatable balloon of a material flexible enough to conform to the shape of the uterine cavity. Instrument according to any one of the preceding claims 1 to 28, characterized in that said sheath (39,204,305,444,444A) is a latex rubber. Instrument according to any one of claims 1 to 28, characterized in that said sheath (39,204,305,444,444A) is made of soft elastic plastic. 62763 38