DK142043B - Instrument for introducing fluid material into female mammalian fallopian tubes, especially for use in sterilization. - Google Patents

Description

(11) PROMPT 6 ELSCRIPT 142043 DENMARK (51) * nt '^ * · 3 ^ o 7 / oo // a 6i m 31/00' (21) Application No 1 246/74 (22) Filed on 7 · HIST. 1974 (23) Race day 7 · mar. 1974 (44) The application presented and the petition published on the 18th sug. 1980

DIRECTORATE OF J

PATENT AND TRADE MARKET (30) Priority ** on

March 9 1973? 339911a US 31 Jan 1974, 438202, US

(71) POPULATION RESEARCH INCORPORATED, 7875 Beech Street N.E., Minneapolis, Minnesota, US.

(72) Inventor: Lee Rohin Bolduc, 4624 West 28th Street, Minneapolis, Minnesota 55416, US: Eugene ArTvhur Dickhudt, 1417 Juliet Avenue, St. Paul, Mlnne * sota 55105a US.

(74) Plenipotentiary in the proceedings:

International Patent Office.

(54) Instrument for introducing fluid material into female mammalian fallopian tubes, especially for use in sterilization.

The present invention relates to an instrument, a dispensing catheter, for introducing a fluid material into the mammalian fallopian tubes, particularly for sterilization, comprising an elongated tubular body or catheter having at or near one end an expandable member and at least one outlet opening for the fluid material, which expandable means or which orifices can be disposed in the uterine cavity, and comprising a dispensing unit connected to said elongate body at a location remote from the above end of the body, wherein the dispersing unit has a first piston disposed in a first chamber arranged to receive a container of fluid to serve to expand said expandable member, and a second plunger disposed in a second chamber adapted to receive a container of the fluid material to be inserted into the fallopian tubes.

2 142043

An instrument of this type is described in an article by T.C. Stevenson and D.S. Taylor "The effect of methyl cyanoacrylate tissue adhesive on the human Fallopian tube and endometrium" in The Journal of Obstetrics and Gynecology of the British Commonwealth, Volume 79, No. 11, November 1972. In this known instrument, the expandable organ is expanded at the end of the the elongated body to hold the instrument in the uterus and then the fluid material is injected to seal the fallopian tubes in the uterus. This could apparently be done by using an instrument with two actuators, namely one for operating the first piston and a different actuator therefrom for operating the second piston. However, such an instrument would be disadvantageous because of the possibility that the second actuator belonging to the second piston could be unintentionally affected before the first actuator.

This would result in the fluid material being introduced into the uterine cavity prior to the necessary expansion of the expandable device for holding the instrument in the uterine cavity. The object of the present invention is therefore to provide one instrument which does not have this disadvantage and which can be operated in a very simple manner for introducing the fluid material into the fallopian tubes.

According to the invention, this object is achieved by providing a single actuating means for operating both the first piston and the second piston.

In this way, the operation of the instrument is greatly simplified and there is no risk of unintended influence of two separate actuators.

According to a suitable embodiment, according to claim 2, the instrument has a first and a second drive unit extending parallel to one another, a liner. each piston, and the actuator may be connected successively to the first drive assembly and to the second drive assembly. This feature allows the first piston to act when the actuator is connected to the first drive assembly and actuate the second piston when the actuator is connected to the second drive assembly.

According to a particular embodiment of the instrument according to the invention, the driving assemblies consist of a first and a second driving rod, and the actuating means is a rotatable lever with a head at one end, which head has a passage capable of receiving the second driving rod and a bore which extends across the passage and is connected thereto, wherein there is a spring-actuated pin in the bore, which is normally retained by the first drive rod in the bore against the spring force. According to this embodiment, the actuating lever must be operated twice to introduce the fluid material into the fallopian tubes. When the lever is first affected, the first drive lever is moved forward. During this movement, the second drive rod is freely received in the passage of the lever head. After this first impact on the lever, it is released so that it can return to its initial position. During this backward movement of the lever, the pin U 2043 3 is inserted into the passage in the lever head so that this passage is blocked. Therefore, when the actuating lever is affected the second time, the second piston will also be affected.

If, as defined in claim 4, the locking device cooperates with the first drive rod so that, after being actuated by the lever, it is held in the switch-on position, the first drive rod and the first piston are automatically held in the switch-on position when the lever returns to the initial position.

According to another embodiment of the instrument according to the invention, the actuator is a single-stroke actuator and comprises a first coupling link disposed between the actuator and the first drive assembly and a second coupling link disposed between the actuator and the second drive unit, which coupler can move between positions in which the actuators is coupled to the actuator, and positions in which the drive assembly's connection with the actuator is disconnected. This embodiment is even more advantageous than the one mentioned above because it is not necessary to actuate the actuator twice, but by a single actuation of the actuator one can first expand the expandable organ and then introduce the fluid material into the uterine cavity from which it is introduced. fallopian tubes.

Conveniently, in this embodiment, the coupling joints may be disposed in transverse bores in the first and second drive assemblies, and the coupling joints have substantially spherical ends, the actuator having two grooves spaced apart in axial direction, which grooves are arranged to receive one of the spherical ends of the coupling joint of the first drive assembly, and the housing of the dispensing unit having a recess arranged to receive the second spherical end of said coupling joint, and further the actuating means may have a recess arranged to receive one spherical end of the second drive assembly and the housing may have a recess arranged to receive the second spherical end of this coupling joint so that the coupling joint of the first drive assembly in the fully retracted position of the actuator is in the forward of the two cooperating recesses in the actuator; g The coupling joint of the second drive unit is located in the corresponding recess in the actuator. This provides the additional advantage that the expandable organ can be used to pump the fluid material from the uterine cavity into the fallopian tubes. Namely, if an instrument such as the one described above is used, when the actuator is moved forward, the first piston is first affected and causes partial expansion of the expandable member. After partial expansion of said means, the first coupling joint enters the corresponding recess in the housing of the dispensing unit, so that the connection between the first drive unit and the actuator is interrupted. Therefore, with continued movement of the actuator 4 142043, only the second drive assembly will move forward so that fluid material is injected into the uterine cavity until the coupling joint of the second drive assembly enters the corresponding recess in the housing of the dispensing unit. When the actuator has been moved sufficiently forward so that the coupling pin of the first drive assembly can enter the associated recess in the actuator, it is again coupled to the first drive assembly so that the first piston can be further actuated and fully expand the expandable member and pump. the fluid material from the uterine cavity into the fallopian tubes.

In this embodiment, it may be appropriate to use a special arrangement to limit the pressure of the expandable member. This, as claimed in claim 7, may consist of a locking means on the first drive assembly, which locking means can engage a stop formed on the housing of the dispensing unit.

This stop may conveniently consist of a plurality of teeth facing the first drive assembly. When the stop engages in one of the teeth, a further movement of the actuator is prevented and a certain predetermined pressure cannot be exceeded. The locking means may suitably have a spring-actuated body with a projection which can be caused to engage the stopper, and the first drive assembly may conveniently comprise a sleeve and a body which can move in the sleeve and which are the spring is actuated in the rearward direction relative to the cuff, the cuff having an opening through which the projection can pass for engagement with the stopper. This has the advantage that the body of the first drive assembly under the influence of the actuator is moved relative to the drive assembly's cuff until the locking member's tab aligns with the opening in the cuff. This occurs when the predetermined maximum pressure is achieved, and at this point the locking member's tab passes through the opening in the cuff and engages the stop formed on the dispensing unit housing.

The instrument according to the invention will be explained in more detail below with reference to the drawing.

This shows:

FIG. 1 is a top view of an embodiment of the instrument or dispensing catheter of the invention; FIG. 2 is an enlarged cross section along line II-II of FIG. 1, FIG. 3 is a cross-sectional view taken along line III-III of FIG. 2, FIG. 4 is an enlarged cross-section along line IV-IV of FIG. 2, FIG. S is a cross section similar to FIG. 4 showing the movable member in the second position; FIG. 6 is an enlarged cross-sectional view of the fluid reservoir assembly used in the dispenser; FIG. Fig. 7 is a (shortened) cross-section through a female reproductive system with an instrument according to the invention for placing drug in the two fallopian tubes; 8 is a longitudinal section through the dispensing means of the instrument according to the invention; FIG. 9 is a cross section along line IX-IX of FIG. 8; FIG. 10 is a (shortened) cross-section through the female reproductive system with the instrument shown in section with the expandable member partially inflated in the uterine cavity and with drug in the uterine cavity; FIG. 11 is a (shortened) cross-section similar to FIG. 10 showing the expandable organ fully expanded in the uterine cavity; FIG. 12 is a partial side elevation of the instrument (shortened) in section, the figure otherwise corresponding to FIG. 10, and FIG. 13 is an enlarged cross-section through the discharge end of the instrument of FIG. 12th

FIG. Figures 1 to 4 show one embodiment of the instrument or dispensing catheter for discharge of fluid such as drugs, tissue adhesives and the like into the uterine cavity. The dispensing catheter 300 has a dispensing unit 301 and an elongated tubular catheter 302. The dispensing unit 301 has a body 303 attached to an elongated catheter tube 304. The tube 304 may be releasably or firmly connected to the body 303. An expandable end 304 is provided. cuff member or balloon 305. Band 306 secures the end of cuff member 305 to the tube 304. Cuff member 305 is an elastic member made of tensioned rubber, plastic or similar materials.

When the cuff member 305 is expanded in the uterine cavity, it exerts a uniform outward pressure on the uterine wall. Expanded cuff member 305 prevents the drugs injected into the uterine cavity from contacting essential portions of the uterine wall and flowing out of the uterine cavity. Holes 307 at the end of the tube 304 provide passage for the fluid, such as water, from the interior of the tube 304 * to the space provided by the cuff member 305 so that it is expanded.

An elongated narrow tube 308 is disposed within the tube 304. The tube 308 has a discharge end 309 at the outer end of the tube 304.

The body 303 has two adjacent chambers 311 and 312. The chambers 311 and 312 extend longitudinally and are arranged in a common horizontal plane. The chambers may also be arranged in a common vertical plane, whereby one chamber is placed above the other. A passage 313 connects the chamber 311 to the tube 304. Similarly, a passage 314 connects the chamber 312 to the tube 308.

A piston 316 is movably disposed in the first chamber 311. A rearward rod 317 is connected to the piston 316. A second piston 318 is movably disposed in the chamber 312. A rod 319 is attached to the piston 1420 and extends backwards, parallel to rod 317. A trigger or activator, 320, is located at the rear of the housing at the rear of bars 317 and 319.

The trigger 320 has a lever 321. The middle portion of the lever 321 is provided with a hole that matches a pin 322. The pin 322 is secured to a downward handle or gun barrel 323 attached to the rear of the body 303. The lever 321 has a crosshead 324.

A spring 325 abuts the body 303 and the upper end of the lever 321 to hold the lever in the rear or locked position. The front portion of the head 324 is slidingly connected to the ends of the rods 317 and 319.

The head 324 has, cf. FIG. 4 and 5, a longitudinal passage 326 for receiving the rod 319. A transverse bore 327 opens into the passage 326. A bore 328 is provided in the bore 328 which can slide therein. The pin 328 has a smaller diameter neck 329 connected to an enlarged head 331. A spring 332 abuts on the head 331 and against a plug 333 which closes the end of the bore 327. The spring 332 presses the pin 328 into the passage 326. The rod 317 has a rearward finger 334. When the bar 317 is in its rear or locked position, the finger 334 is positioned behind the head 331 and acts as a stop preventing movement of the pin 328 into the passage 326.

Rods 317, cf. FIG. 2, has a notch or slot 336 in its upper side. Slot 336 interacts with a lock 337 to hold rod 317 in dispensing or engaged position. The lock 337 comprises a movable pin 338 disposed in a passage surrounded by a hub 339. The pin 338 has a head 341 disposed over the body 303 so that it can be gripped to release the lock. The front portion of the pin has a C-ring or clamp 342 which forms a stop for a spring 343. The spring 343 is located concentrically around the pin and abuts a portion of the body 303 for pressing the pin 338 against the rod 317. When the rod 317 has been moved to the switch-on position, the pin 338 will be pressed into the slot 336, thereby cooling the pin in the switch-on position. The bar 319 has a slot 344. A lock 346 on the body 303 holds the pin in the engagement position. The lock 346 is identical to the lock 337.

When the lever arm 321, cf. FIG. 5, has been retracted, rod 317 will be held in engagement position by latch 337. Rod 319 will not move as head 324 will move relative to rod 319 as it travels through passage 326. When head 324 of spring 325 is forced back to its initial position, the pin 328 of the spring 332 will be pressed into the passage 326. The second actuation or movement of the lever arm 321 toward the handle 323 will move the rod 319 forward.

In FIG. 3, a first container or ampoule, 350, is shown in chamber 311. At the forward end of chamber 311 is arranged a forward needle 351 mounted on a transverse base 352. Needle 351 is a hollow member in fluid communication with passage 313.

A further container or ampoule, 353. is placed in a chamber 312.

In the forward end of the chamber 312, a needle 354 is longitudinally mounted on a transverse base 356. The needle 354 is a hollow tubular member having a fluid-in-passage passage with the passage of the tube 314. The container 353 is an elongated cylindrical container of glass, plastic or the like with a head 357. The head has a (not shown) rubber stopper aligned with the needle 354. A plunger 358 is arranged so that it can slide into the container, which includes a plunger fluid 359 in the container. A slider 318 in contact with the plunger 358 is disposed in and may slide in the container. Upon forward movement of the slider 318, the head 357 will be driven through the needle 354, thereby forming fluid communication between the chamber 353 of the container 353 and the tube 314. The piston 358 will move forwardly, whereby fluid is driven out of the container. The fluid may be a drug, a tissue adhesive or a semi-liquid material for treating or clogging the ovarian ducts.

Container 350, cf. FIG. 6, has a cylinder 361 for storing fluid 362, such as drugs, water or the like. The front end of the cylinder 361 has a head 363 with a passage closed with a plug 364. The open end of the cylinder 351 is closed with a piston 366 with a piston head 367. The rear end of the piston 366 has an outwardly flange 368 against which a spring 369 rests. The front end of the spring 369 abuts an annular seat 371 on the cylinder 361, whereby the piston 366 is pressed outwardly or out of the cylinder 361. The piston 366 has a central longitudinal bore 372 in which an activating rod 373 can slide. The rod 373 has an axial bore in which a compression spring 324 is provided to provide a resilient connection between the rod 373 and the piston 366.

A piston 316 attached to a rod 317 abuts the end of the rod 373. In the forward movement of the piston 316, the spring 324 will initially be compressed, thereby applying uniform pressure to the piston 366. The cylinder 361 will move forwardly. whereby the needle 351 will penetrate the plug 364 and fluid connection is provided between the container and the passage 313. Continued movement of the plunger 316 will drive the rock piston 367 against the plug 364, thereby discharging fluid from the cylinder 361. The discharged fluid will flow through the tube 304 and into the cuff member 305 through holes 307 for expanding the cuff member 305, as shown in dotted line in FIG. 3. Cuff member 305 will expand at a uniform pressure to fill the uterine cavity and apply uniform pressure to the inner wall of the cavity. The pressure of the cuff member 305 on the cavity wall will be uniform regardless of the size of the uterine cavity.

The body 303 has doors or closures that close openings in chambers 311 and 312, whereby the containers 350 and 353 can be removed and replaced with others. Types of containers other than those shown here may be introduced into the chambers.

With the dispensing catheter, a material such as a drug, a tissue adhesive, a contraceptive gel or similar material can be introduced. fallopian tubes. In use, the elongated catheter 302 is inserted with the cuff member 305 in the contracted state through the uterine opening into the uterine cavity. Cuff member 305 is expanded with fluid under pressure to fill the uterine cavity and apply uniform pressure to the inside of the uterine wall. Said fluid under pressure is delivered to the cuff member 305 through the passage in the tube 304. The activator 320 is moved forward to force the piston 316 in such a direction that the container 350 is moved to contact the needle 351. The needle 351 will puncture the plug 364, whereby the fluid 362 will flows through the passage in the tube 304 to extend the cuff member 305. The cuff member, which consists of a layer of flexible elastic rubber or similar material, has low surface tension and exerts a uniform expanding force on the inside of the uterine wall. This results in a relatively tight seal and fit, which means that the same catheter design can be used for all types of female primates regardless of the size of the uterus.

The pressurized material is then delivered to the uterine cavity between the expanded cuff member and the uterine floor. The material which is pressurized is moved towards and into the ducts of the fallopian tubes. The expanded cuff member positioned against the uterus supports the movement of the material toward the fallopian tubes. The material may be a liquid tissue adhesive that will flow into the ducts. The moisture in the tissues of the ducts will cause polymerization or hardening of the tissue adhesive, thereby blocking or clogging the ducts. The fluid contained in the cuff member is sucked back into contraction of the member.

The catheter is then pulled out of the uterine cavity.

In FIG. 7 shows a dispensing apparatus, 420, with the probe placed in the uterine cavity. The female reproductive system, 421, has a uterus 422 connected to two fallopian tubes 423 and 424. The lower part of the uterus 422 passes into the elongated vagina 426. Vagina 426 has a vaginal cavity 427 with an opening or entrance 428. The opposite end of the vaginal cavity 427 communicates with cervix 429. Cervix 429 has a cervical opening 431 which provides passage from vaginal cavity 427 to the uterine cavity 432. The fallopian tubes 9 142043 423 and 424 have outputs 433A and 434A on opposite sides of the upper part of the uterine cavity 432.

The uterus 422 is a largely bulbous, thick-walled hollow organ located between the bladder and rectum. The appearance of different individuals varies in size and shape. Wall thickness, wall strength and sensitivity to pain can vary from individual to individual. The size and shape of the uterine cavities may vary. The uterine cavity 432 is largely flat and triangular. Some uteri have caverns of a different shape.

Ovary 423 and 424 are two trumpet-shaped muscular organs, ca.

12 cm long, extending from the upper corners of the uterine cavity 432 to the ovaries (not shown). The outputs 433A and 434A of channels 433 and 434 may vary as to their position relative to the uterine cavity and to the female. The outputs 433A and 434A are usually arranged symmetrically opposite each other as shown in FIG. 7, and their position and more are less closely located, depend essentially on the size and shape of the uterus. Also, the size of the channels 433 and 434 and the size of the outputs 433A and 434A vary from individual to individual.

The fallopian tubes are usually divided into isthmus, intramural and ampoule sections. Channels 433 and 434 provide passage for the movement of eggs from the ovaries to the uterine cavity 432 as well as for the movement of semen from the uterus to the ovaries. The intramural sections of the fallopian tubes pass through the wall of the uterus, more or less straight, but their course may be twisted in some individuals.

The wall of the fallopian tubes consists of three layers: the serous layer, the muscular layer and the mucosa.

The uterus 422 has a top or bottom wall 436 and side walls 437 and 438 surrounding the uterine cavity 432. The inside of the bottom wall 436 and the inside of the side walls 437 and 438 have an inner membrane or membrane 439 which is periodically repelled during the female's normal cycle.

The dispensing apparatus 420 has an elongate probe or elongate tubular member 441 of such length as to pass through the vagina 427 and into the uterine cavity 432. The member 441 has an elongate passage 442 extending throughout the length of the member. On the upper end or outer end of tubular member 441 is provided a balloon assembly 443. The balloon assembly 443 has a flexible and expandable sleeve member 444 surrounding the upper end of the probe 441. A fastener 446, such as a collar or thread, secures the upper end of the cuff 444 to the probe 441. A similar fastener 447 attaches the opposite end of the cuff 444 to the probe 441. The probe 441 has multiple apertures 448 providing connection between the passage 442 and a chamber 449 within the cuff member 444.

1420A3 ίο

Cuff member 444 is a tubular member made of soft and tensioned flexible and elastic material, such as kayak or plastic, which expands with a minimum of tension. Eg. For example, thin, low surface tension latex rubber is a suitable material for cuff member 444. The low surface tension of the rubber squeegee allows the rubber to expand uniformly under relatively low pressure. The material of the cuff member 444 expands easily to fill the uterine cavity 432, adapting to the shape of the uterine cavity without exerting extreme pressure on individual portions of the uterine walls 437 and 438. When the cavity 432 is completely filled by the cuff member 444 as shown in FIG. 36, the cuff member 444 is in uniform surface contact with the internal mucosa 439. Conventional balloon catheters consisting of hard, relatively non-elastic material will not assume the shape of the uterine cavity as they expand.

The upper end or outer end of the probe 441 is closed with a head 451. The head 451 has a transverse passage 452 which opens to the two opposite sides of the head. To the head 451 is attached an elongated tube 453. The tube 453 extends throughout the length of the probe 441 and has a passage 454 for transporting a drug to the transverse passage 452 which directs the drug in two opposite directions in two portions into the upper part of the uterus. 432nd

The head 451 has a section or sheath 456 with an upper surface intended to abut the inner wall of the uterine floor 436. The sheath 456 carries the passage 452 at some distance from the uterine floor 436.

The dispensing apparatus 420 shown in FIG. 8, an elongated housing or body 457 is connected to the end of the probe 441. The body 457 has a first chamber 458 enclosing an elongated cylinder 459. The cylinder 459 has a forward neck 461 connected to a tube 462. The tube 462 has a passage, associated with the passage 442 in the probe 441 so that fluid, such as air, in the cylinder 459 can flow through the passage 442 into the chamber 449 of the balloon assembly and thereby expand the sleeve member 444. The open end of the cylinder 459 is closed with a piston 463 for enclosing the fluid in chamber 464. Cylinder 459 has a hole 466 at piston 463 so that air and sterilizing gases can flow into chamber 464.

Behind the piston 463 is arranged a first drive means 467, with which the piston can be moved into the cylinder 459. The drive means 467 is connected to an activator 468 which protrudes at the rear of the body 457.

The body 457 has an additional chamber 469 disposed adjacent to the first chamber 458. In the body 457 is a tube 471 connecting the tube 453 to the chamber 469. The tube 471 has a longitudinal needle 472 extending into the chamber 469. The opposite end of the tube 471 is secured to a plug 473 that closes the end of the probe 441 and is connected to the tube 453 leading to the head 451. The chamber 469 is elongated and is open to the surface of the body 457 as shown in FIG. . 7. A cylindrical container or ampoule 474 is disposed in the chamber 469 in alignment with the needle 472. The front end of the container 474 has a protruding plug 476 in line with the needle 472. The open end of the container 474 is closed with a slidable piston 477 to containment of drug 478 in container 474.

A further drive member, 479, extends backward from the container 474 and is connected to an activator 468. By means of the activator 468, the entire dispensing of drug into the channels of the fallopian tubes can be performed by a single movement. The rear of housing 457 has outwardly facing flanges 481 and 482 which act as finger grips during operation of activator 468. Activator 468 has a hole 483 into which a tab 483A may be inserted to hold activator 468 in position. Pin 483A prevents accidental activation of the dispensing apparatus.

The drive assembly 467 is a force transmitting mechanism by which the piston 463 can be moved into the cylinder 459, thereby increasing the pressure in the fluid system of the balloon assembly 443 and expanding the sleeve member 444. The drive means 467 has a cylinder or sleeve 484 in which a body 486 can slide.

The opposite or upper end of the cuff 484 is connected to a head 487. The head 487 has a central hole 488 which provides access to the cuff 484. The end of the piston 463 has a cone-shaped portion 489 which fits into the cone-shaped end of the head 487. The hole 488 is aligned with an adjusting screw 491 that is screwed into the body 486, the position of the screw 491 relative to the body 486 can be changed by a tool such as a screwdriver passing through the hole 488. Two springs 492 and 493 actuate the cuff 484 and the body 486 in opposite directions, whereby the first drive assembly 467 is actuated to assume its extended position. The spring 492 rests on the head 487. The spring 493 rests on the screw 491. When adjusting the position of the screw 491, the force is controlled by the spring 493 which affects the head 487 and the body 486 in opposite directions. The screw 491 performs a fine adjustment of the spring strength corresponding to variations in the spring 493, thereby obtaining the desired fluid pressure in the chamber 449. A spring plate 494 with a central hole is disposed between the springs 492 and 493. The spring 492 is a weak spring compared to the spring 493. The weak spring 492 will compress under a slight pressure, e.g. 2-3 psi, whereby the spring plate 494 will bump against the head 487. This ensures a partial expansion of the cuff member 444 at a low predetermined maximum pressure. The predetermined maximum pressure is determined by the compressive force characteristics of the spring 493 and allows the apparatus to be used in all uterine shapes and sizes, with the spring 493 regulating the differences between the different uteri.

Cuff 484 and body 486 are held together by a pin 496 passing through a longitudinal slot 497 in cuff 484. Slot 497 allows sleeve 484 to move relative to body 486 when springs 492 and 493 are compressed. The pin 496 projects through the slot 497 and into an elongated linear groove 498 in the housing 457, thereby preventing rotary movement between the drive assembly 467 and the housing 457.

The body 486 has a transverse passage 499 in which is provided a connector 501. The connector 501 has spherical members at the ends connected to a transverse member or tube. One end of the coupling link 501 is located in a recess 502 in the side of the activator 468. The activator 468 has a further recess 503 which can receive the coupling link 501. Below the recess 503 is a shoulder 504 against which the end of the body 486 rests when the coupling link 501 is in the recess 503. The housing 457 has a recess 506 intended to receive the opposite or the right end of the coupling link 501. The recess 506 is as shown in FIG. 8, above the starting position of the coupling link 501 *, so that the actuation of the drive assembly 467 is temporarily stopped or interrupted until the end of the body 486 abuts the shoulder 504, at which time the movement of the drive assembly 467 continues. The locations of the recesses 506 and 521 in the housing 457 may be coordinated such that the initial expansion of the cuff member 444 overlaps with the discharge of drug into the uterine cavity and the continued expansion of the cuff member 444. In this case, the cuff member 444 undergoes continuous expansion until the member is subjected to maximum fluid pressure.

A locking unit, 507, is movably disposed in a bore 508 of the body 486. The locking unit 507 has a plunger 509 carrying an outward finger or an outward protrusion 510. The finger 510 is arranged to contact one of several teeth 511 disposed in the housing 457. The teeth 511 face the drive assembly 467. The teeth 511 are paw teeth which allow reciprocal movement of the drive assembly only when the locking unit 507 engages the teeth. Piston 509 is pressed outwardly by means of a spring 512 located at the bottom of bore 508. Cuff 484 has a hole 513 disposed over finger 510. By compression of springs 492 and 493, body 486 is moved relative to cuff 484 until finger 510. is aligned with the hole 513, at which time the spring 512 will push the finger 510 through the hole 513 in contact with one of the teeth 511. This further prevents movement of the drive assembly 467 in the forward direction and limits the fluid pressure in the chamber 449 of the sleeve 444.

142043 13

The second drive assembly 479 is adapted to drive the container 474 towards the needle 472 and force the plunger 477 into the container, whereby the drug 478 is driven through the needle 472 into the tube 453. The tube 453 carries the fluid to the head 451, in which it discharges in opposite directions into the the upper parts of the uterine cavity 432. The second drive assembly 479, cf. FIG. 8, has an oblong linear piston 514 disposed for sliding in a longitudinal passage 515 of housing 457. Piston 514 has a front end 516 arranged to contact piston 477. The opposite end of piston 514 has a transverse passage. 517.

In the passage 517 there is a movable connector 518. The connector 518 has spherical ends connected to a rigid member such as a pipe. One end of the coupling link 518 is located in a hemispherical recess 519 located on the side of the activator 468. The opposite end of the coupling link 518 rests on the side wall of the housing 457 which forms part of the passage 515, whereby the coupling link is held in the recess 519. The housing 457 has a recess 521 in front of the coupling link 518 so that it will remain in driving engagement with the activator 468 until the coupling link is adjacent to the recess 521. At this point, the coupling link 518 will be forced into the recess 521, whereby the activator 468 will continue to move forward and the piston 514 will retain its position.

In use, the dispensing apparatus 420 is packed with the container 474 disposed in the chamber 469. The activator 468 is locked in idle position by a pin 483A extending through the hole 483. The pin 483A abuts the end of the housing 457 to prevent the activator 468 moves into the house. The entire dispensing apparatus is sterilized before use.

The use of the apparatus begins with balloon assembly 443 being inserted into vaginal cavity 427 through cervical opening 431 and into uterine cavity 432 as shown in FIG. 7. The cuff member 444 is in the collapsed state so that the balloon assembly can be easily placed in the uterine cavity. Probe 441 is moved into the uterine cavity until the head 451 touches the uterine floor 436. It is known that the uterus may vary in size, shape and position so that the balloon assembly may or may not be symmetrically disposed with the fallopian tubes 423 and 424. As shown. in FIG. 7, the balloon assembly 443 is positioned centrally in the uterine cavity 432. In some cases, the balloon assembly may be inclined in the uterine cavity against one of its sides. By means of the dispensing apparatus 420, drug can be placed in either of the two fallopian tubes regardless of the position of the balloon assembly in the uterine cavity 432.

The pin 483A is removed from the hole 483 whereby the plunger 468 can be moved into the housing 457 for inflating the expandable cuff member 444 and delivery of drug into the uterine cavity 432 followed by full expansion of the cuff member 444, whereby the drug can be pumped or forced into eggs. The operator uses the flanges 481 and 482 as finger supports so that an inward pressure can be exerted on the activator 468. As shown in FIG. 10, the activator 468 has been moved into the housing 457 one short distance so that the first drive assembly has moved the piston 463 into the cylinder 459. Thus, the cuff member 444 expands to form a plug or seal in the lower part of the uterine cavity 432. Cuff member 444 is expanded to firm contact with mucous membrane 439. Coupling link 501 connects activator 468 to first drive assembly 467 so that movement of activator 468 is transmitted to first drive assembly 467. Piston 463 is then moved into chamber 464. Coupling link 518 engages piston 514 so that the front end 516 of the plunger abuts the plunger 477 in the container 474. This moves the entire container 474 forward. The needle 472 penetrates the stopper 476, whereby the needle moves through the stopper 476 and into the chamber containing drug 478. The connector 501 is aligned with the recess 506 in housings 457. This allows the connector 501 to move to the right, as shown in FIG. 10, thereby releasing the coupling link from activator 468.

In the continued movement of the activator 468, pressure is applied to the plunger 416 which moves the plunger 477 into the container 474. Drug 478 is forced through the tubes 471 and 453 to the head -451. The drug is discharged in opposite directions through transverse passage 452 in the upper part of the uterine cavity 432.

As shown in FIG. 11, the continued movement of the activator 468 brings the shoulder 504 into contact with the bottom of the body 486. At the same time, the coupling link 501 moves into the recess 503, releasing the coupling link from the recess 506. The activator 468 moves into the housing 457, thereby increasing the pressure in the chamber 464. This causes a further expansion of the cuff member 444,

Expanding cuff member 444 drives the drug from the upper part of the uterine cavity through apertures 433A and 434A of fallopian tubes 433 and 434. Cuff member 444 continues to expand until the fluid pressure in the system comprising the cuff member and chambers 449 and 464 is approx. 8 psi. Other pressures can be selected as the upper pressure limit. This pressure is determined by the compression properties of the springs 492 and 493 * and by the adjusting screw 491. The compression of the springs 492 and 493 allows the body 486 to move into the cuff 484. This movement continues until the finger 510 is aligned with the opening 513. When the finger 510 and the hole 513 is aligned, the spring 512 forces the finger 510 through the hole 513 and into the space between adjacent teeth 511. The finger 510 leans against an edge in front, thereby preventing further movement of the activator 468 into the housing 457. Since the activator 468 is prevented from moving into the housing 457 by the locking unit 507, the pressure 1420 in the balloon chamber 449 is limited to a predetermined maximum pressure which depends on the compression properties of the springs 492 and 493.

As the activator 468 is moved into the housing 457 from the one shown in FIG. 10 to the position shown in FIG. 11, the coupling link 518 will move from the recess 519 to the recess 521. This terminates the forward movement of the piston 514, thereby stopping the delivery of drug to the uterine cavity 432. With continued movement of activator 468, fluid pressure in chamber 449 is increased, whereby cuff member 444 is expanded and drug from or pumped into the uterine cavity 432 into fallopian tubes 433 and 434. Pump operation ceases when cuff member 444 is completely expanded. 11. In this way, the drug is placed in the fallopian tubes, since the pumping force exerted on the drug is insufficient to move this through the fallopian tubes into the body cavity.

The activator 468 is then pulled out of the housing 457. The coupling link 501 disposed in the recess 503 constitutes a drive connection between the body 486 and the piston 468. The finger 510 of the locking unit 507 slides over the teeth 511. The piston 463 is then pulled out of the chamber 464. chamber 449 flows back into chamber 464, whereby cuff member 444 is contracted. Hereby the cuff member 444 is released from the contact with the mucosa 439 and it becomes possible to pull the balloon assembly 443 out of the patient's uterus.

When cyanoacrylate tissue adhesive type treatment agents are used, channels 433 and 434 will be permanently clogged. Tissue adhesives, such as cyanoacrylate type adhesives, cause fibroblast formation, which eventually 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 damaged and replaced with fibers. . Certain other tissue adhesives will polymerize as a result of body heat or other stimuli.

As for the mode of application, the dispensing instrument is used to place material in the two fallopian tubes through the uterine cavity. The contracted balloon assembly is first placed in the uterine cavity as shown in FIG. 7 by inserting balloon assembly 443 through cervix 431. Thereafter, activator 468 is released so that it can be moved into housing 457. The operator moves with one continuous motion this one activator · 468 into housing 457 to complete the operation. The first drive assembly 467 and the second drive assembly 479 are coordinated to act successively for partial expansion of the cuff member 444 to fill the lower portion of the uterine cavity and form a seal with the lower walls of the uterine cavity. The plunger 514 then abuts the plunger 477 so that the container is forced against the needle 472 and the drug or other material 478 is forced out of the container and discharged in opposite directions into the uterine cavity 432 above the partially expanded cuff member 444. This operation is shown in FIG. 35th

With the continued movement of the activator 468, the partially expanded cuff member 444 is further expanded to completely fill the uterine cavity 432. This is done by exposing the cuff member 444 to pressurized fluid by moving the plunger 463 into the chamber 464. The activator 468 will continue to move. until the locking unit 507 abuts one of the teeth 511, thereby preventing further expansion of the cuff member 444. Cuff member 444 can only be subjected to a predetermined maximum pressure so that the walls of the uterus are not subjected to undue pressure. Expanding cuff member 444 forces or pumps processing material; which have been discharged into the uterine cavity, through the openings 433A and 434A and into the passageways 433 and 434. The cuff member 444 is then contracted by releasing the pressure thereon. This is done by pulling the activator 468 out of the housing 457 so that the fluid can move into the vessel chamber 464. The instrument is then removed from the cervix through the cervix and vagina.

The treatment material may be any of a large number of fluid or semi-fluid materials used to examine, treat or clog the fallopian tubes. The material can e.g. be a tissue adhesive. The tissue adhesive may be a cyanoacrylate type material or similar material used as surgical adhesive. Cyanoacrylate is a liquid plastic that cures or polymerizes by touch with moisture, thereby clogging the fallopian tubes. Examples of the cyanoacrylates include methylcyanoacrylate, methyl-2-cyanoacrylate, ethylcyanoacerylates, n-propylcyanoacrylates, n-butylcyanoacrylates, n-amylcyanoacrylates, n-hexylcyanoacrylates, n-heptylcyanoacrylates, isobutyl-isobutyl The material may also be of a type that cures upon exposure to body heat or other stimuli. It can be of a type that causes permanent blockage or of a type that will temporarily block or clog the fallopian tubes, after which the channels will reopen and resume their normal function. Examples of other types of treatment materials are contraceptive gels, water, silicone elastomers, formaldehyde-type materials and similar materials.

In FIG. 12 and 13 are shown a modification of the dispensing instrument, 420A. The dispensing instrument 420A and the female reproductive system in which it is disposed correspond to that of FIG. 7-11. Corresponding parts of the instrument and propagation system are denoted by the same reference numerals with Appendix A.

The dispensing instrument 420A is intended for a two-component treatment material which is mixed at the end of the probe as it is forced into the upper part of the uterine cavity 432A.

142043 17

A head 651 is disposed on the outer end of the probe or tubular member 441A. The head 651 has a cross passage 652 with two oppositely directed discharge openings which serve to guide the material in two portions into the upper portion of the uterine cavity 432A. A first tube 653 and a second tube 654 are connected to the head 651. The head has a mixing chamber or mixing passage 655 which is in fluid communication with the passages in the tubes 653 and 654 and the cross passage 652. The materials flow through the tubes 653 and 654 and are mixed in the chamber. 655. The mixing continues while the material is divided and forced in opposite directions in passage 652 as shown by arrows.

The housing 457A has two chambers 656 located adjacent to the chamber 458A, which chambers can receive two ampoules or holders 657 and 659. The container 657 contains a first material 658. The container 659 contains a second material 660. In the container 657 is a piston 661 which can slide therein, and a similar piston 662 is found in the container 659. The piston 514A of the second drive assembly 479A has a double split end forming two fingers 663 and 664. The finger 663 is disposed in the container 657 and adjacent to the piston 661. The finger 664 is disposed in the container 659 and adjacent to the piston 662. The tubes 653 and 654 extend into the housing 457A and terminate in needles 666 and 667. The needles 666 and 667 are aligned with the permeable end portions of the containers 657 and 659, respectively.

When actuator 468A is actuated, the first drive assembly 467A causes an initial expansion of the cuff member 444A so that the lower portion of the uterine cavity 432A is filled and sealed. Upon continued movement of the activator 468A, the second drive assembly 479A will be actuated, thereby moving the fingers 663 and 664. The piston 514A is moved forward or upward, as shown in FIG. 36, whereby the containers 657 and 659 are driven into the needles 666 and 667, respectively. The fingers 663 and 664 which are in contact with the pistons 661 and 662 simultaneously force the materials 658 and 660 through the pipes 654 and 653. The materials are simultaneously discharged into the mixing chamber 655. Substantially sensible amounts of material are introduced into the mixing chamber 655 so that the mixture of materials contains approx. 50% of the first material and 50% of the second material. The mixed material, indicated at 668 in FIG. 12, is inserted into the upper portion of the uterine cavity 432A. Mixed material 668 flows in opposite directions in substantially equal amounts. The current is continuous until piston 414A has reached its final position. At this point, the continuous movement of the activator 468A will cause further expansion of the cuff member 434A, forcing the mixed material into the channels 433A and 434A of the fallopian tubes.

Materials 658 and 660 may be of the kind that, when blended, will harden to form a semi-solid plastic material. The mixture may harden as a result of moisture in the tissues or due to the heat of the body or other factors. The mixture may have a reaction time such that it can be introduced into channels 433A and 434A before it will cure. The following is an example of materials of which the two-component material may comprise: two-component epoxy resins, two-component tissue adhesives, Silicon RTV or a polymer consisting of Dow Corning Silastic 382 Medical Elastomer and 360 Medical Fluid. Of course, other types of materials can be used that mix and cure. Furthermore, the ratio of the material components can be varied by increasing the size of one of the containers. Eg. For example, two portions of the first material may be mixed with a portion of the second material using containers of the corresponding sizes in housing 457A.

The treatment material may be a contraceptive material for local action in the fallopian tubes and uterus. Eg. For example, bioabsorbable microspheres containing contraceptive agents, such as progestins, may be introduced into the fallopian tubes. The microspheres degrade over a period of time, e.g. during one year, thereby obstructing conception during this time period.

Biologically active substances, such as fibrinolytic enzymes, can be introduced into the fallopian tubes and into the uterine cavity to treat the tissue. The biologically active substances are used to treat inflammation and to prevent the formation of adhesions around the ends of the fallopian tubes.

Diagnostic materials can be introduced into the duct of the fallopian tubes by the apparatus and by the method of the invention. These materials include, among others, oil-based and aqueous-based rayon dyes and color indicator dyes such as methylene blue and indigocarmine and the like.

Furthermore, with the apparatus according to the invention, anesthetic materials can be introduced into the fallopian tubes.

Furthermore, the material may be of the kind used to treat the ducts and uterus to increase the flow of eggs and sperm into the ducts and uterus. Furthermore, the material may be material that expands or opens the fallopian tubes or passageways to enhance fertility or conception. There are presently a large number of materials or chemicals used to treat the fallopian tubes to increase fertility or conception. Anti-inflammatory agents such as cordocoids can be used to treat local inflammation. Antibiotics can also be used for local treatment of fallopian tubes.

It is believed that in some cases of sperm, sperm is blocked or unable to transport itself through the cervix and the endometrial cavity. The apparatus and method of the invention can be used to insert semen into the uterine cavity and the fallopian tubes to enhance conception.

Claims (6)

142043 19 An instrument, dispensing catheter, for introducing a fluid material into female mammalian fallopian tubes, especially for sterilization, comprising an elongated tubular body or catheter having at or near one end an expandable member and at least one outlet opening for the fluid material, which expands -a passable means and which outlet (s) may be placed in the uterine cavity, and comprising a dispensing unit connected to said elongate body at a location spaced from the above end of the body, the dispensing unit having a first piston disposed in a first chamber arranged for receiving a container of fluid to serve to expand said expandable member, and a second piston disposed in a second chamber adapted to receive a container of fluid material to be inserted into the fallopian tubes, characterized by a single actuating means ( 320, 468,468A) to operate both the first piston (316, 463, 463A) and the second piston temple (318, 477, 661-662), 2, An instrument according to claim 1, characterized in that a first and a second drive assembly (317, 319; 467, 479; 467A, 479A) extend parallel to one another for each piston (316, 318; 463, 477; 463A, 661-662), and in that the actuating means (320,468,468A) can be connected successively to the first drive assembly (317, 467, 467A) and the second drive assembly (319,479,479A). Instrument according to claim 2, characterized in that the drive assemblies (317, 319) consist of a first and a second drive rod and the actuator (320) is a rotatable lever (321) with a head (324) at one end, said head having a passage (326) capable of accommodating said second drive rod (319) and a bore (327) extending transversely of said passage and connected thereto, wherein said bore (327) includes a spring-loaded pin (328), which is normally retained by the first driving rod (317) in the bore (327) against the spring force. Instrument according to claim 3, characterized by a lock (337) which cooperates with the first drive rod (317) so that after being actuated by the lever, it is held in the switch-on position. Instrument according to claim 2, characterized in that the actuator (468) is a single-layer actuator and the actuator comprises a first coupling link (501) disposed between the actuator (468) and the first drive assembly (467) and a second coupling link ( 518) disposed between the actuator (468) and the second drive assembly (479), which coupling link (501, 518. can move between positions in which the drive assemblies (467, 479) are coupled to the actuator (468) and positions in which the drive assemblies ( 467, 479) connection to the actuator is disconnected. Instrument according to claim 5, characterized in that