US3887112A - Apparatus for puncturing and collapsing a container - Google Patents

Apparatus for puncturing and collapsing a container Download PDF

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Publication number
US3887112A
US3887112A US361418A US36141873A US3887112A US 3887112 A US3887112 A US 3887112A US 361418 A US361418 A US 361418A US 36141873 A US36141873 A US 36141873A US 3887112 A US3887112 A US 3887112A
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United States
Prior art keywords
container
fluid
chamber
needle
passage
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US361418A
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Lee R Bolduc
Eugene A Dickhudt
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CRX MEDICAL Inc NORTH A CORP OF NC
PDEW Inc A CORP OF NORTH CAROLINA
Population Research Inc
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Population Research Inc
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Application filed by Population Research Inc filed Critical Population Research Inc
Priority to US361418A priority Critical patent/US3887112A/en
Priority to LU69614A priority patent/LU69614A1/xx
Priority to IT2088074A priority patent/IT1017543B/en
Priority to OA55205A priority patent/OA04650A/en
Priority to EG17674A priority patent/EG11393A/en
Application granted granted Critical
Publication of US3887112A publication Critical patent/US3887112A/en
Assigned to DUNCAN, CLAYTON I., 616 MILOWE ROAD, RALEIGH, NC 27609, EDWARDS, LUCILLE L., ROUTE 10, BOX 245, CHAPEL HILL, NC 27514, PIROTTE, JOHN K., 14240 WYNDFIELD CIRCLE, RALEIGH, NC 27609, WOODY, W. RUFFIN, JR., P.O. BOX 381, ROXBORO, NC 27573 reassignment DUNCAN, CLAYTON I., 616 MILOWE ROAD, RALEIGH, NC 27609 MORTGAGE (SEE DOCUMENT FOR DETAILS). Assignors: BIONEXUS, INC., A MN CORP
Assigned to CRX MEDICAL, INC., NORTH A CORP. OF NC. reassignment CRX MEDICAL, INC., NORTH A CORP. OF NC. ASSIGNMENT OF ASSIGNORS INTEREST. Assignors: EDWARDS, LUCILLE, PIROTTE, JOHN, K., WOODY, W., RUFFIN, JR., DUNCAN, CLAYTON, I.
Assigned to PDEW, INC., A CORP. OF NORTH CAROLINA reassignment PDEW, INC., A CORP. OF NORTH CAROLINA ASSIGNMENT OF ASSIGNORS INTEREST. Assignors: EDWARDS, LUCILLE L., PIROTTE, JOHN, K.,, WOODY, W., RUFFIN, JR.,, DUNCAN, CLAYTON
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/20Vas deferens occluders; Fallopian occluders
    • A61F6/22Vas deferens occluders; Fallopian occluders implantable in tubes
    • A61F6/225Vas deferens occluders; Fallopian occluders implantable in tubes transcervical

Definitions

  • the catheter has an elongated tubular member AS31811: PQPIIIaHORRBSQaYQh Incorporated carrying an expandable sleeve member on its outer Fndley' end.
  • a dispensing unit attached to the tubular member [22] Filed: May 18, 1973 has three chambers for storing containers housing drug materials and fluid to expand the sleeve member. PP' -z 361,418
  • the containers have collapsible bodies which are pierced by needles which carry the first fluid to ex- 52 [1.5. Ci.
  • the drug material is stored in a metal collapsible con- 2 f g; tainer.
  • the actuator has a pair of legs which cooperate 2772026 1956 x with inclined walls to move the container into piercing 3:077:07s 2/1963 Hamilton"I:::::::::::::::::::... 222/82 x engagement the needle and impress and lapse the container and thereby move the drug material from the container via the needle into the uterine cavity.
  • Liquid tissue adhesives have been developed which polymerize when applied to moist living tissue. These adhesives have been used for various surgical procedures. When the tissue adhesive is used, the cells adjacent the adhesive are damaged and eventually replaced with a fibrous tissue.
  • Several types of liquid tissue adhesive have been injected into the uterine cavity with a catheter for the purpose of occluding the canals of the Fallopian tubes.
  • One type of dispensing catheter is disclosed in our copending US. patent application Ser. No. 339,911, filed Mar. 9, 1973.
  • the expanded sleeve on this dispensing catheter is designed to fill the uterine cavity and engage the top wall of the uterus.
  • the catheter does not have a positioning means to limit the insertion of the catheter into the uterine cavity. It is desirable to locate the expanded sleeve member in a position spaced from the top wall of the uterus leaving a cavity adjacent the top wall of the uterus for the flow of the drug materials into the canals of the Fallopian tubes.
  • a second fluid is used to aid the flow of the first fluid into the canals and set up or polymerize the first fluid.
  • the invention is directed to an intrauterine dispensing catheter for dispensing fluids, as drugs, into the canals of the Fallopian tubes of a primate female.
  • the apparatus has a tubular member carrying an expandable sleeve means for filling a substantial portion of the uterine cavity.
  • a positioning means mounted on the tubular member locates the sleeve means in the uterine cavity in a manner so that the sleeve means is spaced from the top wall or fundus of the uterus.
  • a dispensing means attached to the tubular member supplies a first fluid to the sleeve means to expand the sleeve means and sequentially discharge second and third fluids into the uterine cavity.
  • the third fluid functions to force the second fluid out of the uterine cavity into the canals.
  • the third fluid also acts as a polymerizing fluid which sets up the second fluid thereby occluding the canals of the Fallopian tubes.
  • the dispensing unit has a plurality of chambers accommodating containers for storing the fluid. Needles project into the chambers and are operable on movement of the containers to pierce the containers. Sepa rate actuators engageable with the containers function to move the containers into piercing engagement with the needles and collapse the containers whereby the fluid is dispensed into the tubular member and fluid carrying means which deliver the fluid to the outer end of the tubular member. An actuator is hand operated to sequentially dispense fluid from the containers whereby the sleeve means is initially expanded before the second and third fluids are sequentially discharged into the uterine cavity.
  • the apparatus for dispensing fluid from the container includes a body means having spaced converging walls facing a chamber accommodating the container. Needle means project into the container and pierce the container on movement of the container into engagement with the needle means. An actuator having leg means engageable with the converging walls and container moves the container into the needle means and compresses and collapses the container driving the fluid from the container.
  • the container can be of collapsible metal, as lead or lead alloy, hermetically storing a fluid, as a tissue adhesive.
  • the invention includes the method of occluding the canals of the Fallopian tubes by introducing occluding fluids into the canals.
  • the method includes the insertion of a catheter having an expandable sleeve into the uterine cavity through the cervical opening.
  • the expandable sleeve is located in the uterine cavity in a position spaced from the top wall or fundus of the uterus thereby leaving a space between the expandable sleeve and the inside of the top wall.
  • the sleeve member is expanded with a first fluid under pressure to hold the sleeve member in engagement with the side walls of the uterine cavity thereby limiting the space between the sleeve member and the top wall of the uterus.
  • a second fluid as a drug material or tissue adhesive, is dispensed into the uterine cavity space between the sleeve member and the top wall.
  • the second fluid moves toward the canals of the Fallopian tubes. This movement is supplemented with the dispensing of the third fluid into the uterine cavity space.
  • the third fluid as water, aids in the polymerization of the second fluid as well as forcing the second fluid into the canals of the Fallopian tubes.
  • the sleeve member is contracted by draining the first fluid. The entire catheter is then withdrawn from the uterine cavity.
  • FIG. 1 is a longitudinal sectional view of the genital system of a female primate with the dispensing catheter of the invention extended into the uterine cavity;
  • FIG. 2 is a top sectional view of the dispensing catheter of FIG. 1'
  • FIG. 3 is a sectional view taken along the line 3-3 of FIG. 2;
  • FIG. 4 is an enlarged sectional view of a fluid container assembly used in the dispensing catheter
  • FIG. 5 is an enlarged sectional view taken along the line 5-5 of FIG. 3;
  • FIG. 6 is a sectional view similar to FIG. 5 showing the movable member in the second position
  • FIG. 7 is a sectional view similar to FIG. 5 showing the movable member in the third position
  • FIG. 8 is an enlarged plan view of the structure for dispensing fluid from a collapsible container storing a fluid, as shown in FIGS. 2 and 3;
  • FIG. 9 is a view similar to FIG. 8 showing the container partially collapsed.
  • FIG. 10 is a view similar to FIG. 8 showing the container fully collapsed.
  • FIG. 1 a diagrammatic female primate genital system indicated generally at 20.
  • An intrauterine catheter indicated generally at 21 is located in the genital system to direct a fluid, as drugs, tissue adhesive, water, contraceptive gel, or other materials, into the canals of the Fallopian tubes.
  • the tissue adhesive can be isobutyl 2- cyonoacrylate monomer, silver nitrate or quinacrine materials.
  • the cyonoacrylate monomer is a liquid plastic which sets up or polymerizes in response to moisture when placed in the canals of the Fallopian tubes and thereby functions to occlude the canals.
  • the drug materials can be of the type that temporarily block or occlude the canals of the Fallopian tubes. After a period of time the canals will reopen to resume their normal function.
  • the genital system has an elongated vagina 22 de fined by the cylindrical vaginal wall 23.
  • the vagina 22 opens into the vestibule 24.
  • the opposite end of the vagina 22 is attached to the uterus, indicated generally at 26.
  • Uterus 26 is a pear-shaped, thick walled, hollow organ situated between the bladder and rectum.
  • Uterus 26 has a uterine cavity 27 which is generally flattened and triangular in shape. The size and shape of the uterine cavity varies from female to female.
  • the top of uterus 26 or fundus 28 is joined to the uterus body 29.
  • the lower end of the body 29 contains the cervix 31 which separates the vagina 22 from the uterine cavity 27.
  • the uterine wall is composed of an outer serosal layer, or peritoneum, a firm, thick, intermediate coat of smooth muscle tissue, or myometrium; and an inner mucosal lining, or endometrium 32.
  • Fallopian tubes 33 and 34 Leading to the upper part of opposite sides of the uterus 26 are Fallopian tubes 33 and 34.
  • the Fallopian tubes 33 and 34 are paired, trumpet-shaped, muscular tubular members which extend from the superior angles of the uterine cavity 27 to the ovaries (not shown).
  • the ovaries are solid, slightly irregular shaped bodies situated on either side of the uterus 26 behind and below the Fallopian tubes 33 and 34.
  • Fallopian tubes 33 and 34 each have a canal or aqueduct 36 and 37 respectively.
  • the Fallopian tubes 33 and 34 are musculo-membranous structures about 12 cm in length. They are commonly divided into an isthmus, intramural and ampullary sections.
  • the canals 36 and 37 provide passages for the movement of ova from the ovaries into the uterine cavity.
  • the intramural section of the Fallopian tubes traverses the uterine wall in more or less straight fashion. It has an ampulla like dilation just before it communicates with the uterine cav ity 27.
  • the canals 36 and 37 are narrowest at the intramural sections.
  • the walls of the Fallopian tubes consist of three layers: a serosal layer, a muscular layer and a mucosal lining.
  • the muscular layer includes longitudinal muscle fibers which, when contracted, bring the ends of the Fallopian tubes in close contact with the surface of the ovaries. Blood vessels are abundant in the muscular layer where they form with the muscle bundles a kind of erectile tissue which, if engorged, moves the Fallopian tubes to sweep over the surface of the ovaries. This movement of the Fallopian tubes is impaired when the tubes are severed and tied.
  • Dispensing apparatus 21 has an elongated tubular member or catheter 38 having a length sufficient to extend through the vagina 22 and into the uterine cavity 27.
  • An expandable sleeve member 39 as a flexible balloon or the like, is secured to the upper end of tube 38 with bands 40A and 40B.
  • Band 40A holds the outer end of sleeve member 39 in sealing engagement with the terminal end of tube 38.
  • Band 403 secures the inner end of sleeve member 39 to the tube 38.
  • Sleeve member 39 is a flexible elastic cylindrical sheet made of relaxed rubber material. The rubber material has uniform surface tension and uniform expansion characteristics. Member 39 can be expanded into uniform and firm engagement with a major portion of the inner wall of the uterus regardless of the size or shape of the uter ine cavity. This enables the same sleeve member 39 to be used on all types of primate females.
  • the sleeve member 39 defines a cavity or chamber 41.
  • a plurality of holes 42 provide the passages from chamber 41 into the passage of the tube 38 whereby fluid in the tube 38 can flow through the holes 42 to the chamber 41 to increase the size of sleeve member 39.
  • the end of tube 38 is closed with a plug 43.
  • a pair of small tubes 44 and 46 extend longitudinally through tube 38 and are attached to the plug 43.
  • Tube 44 has an open end 44A projected through plug 43.
  • tube 46 has an end 46A projected through plug 43 whereby fluid can flow through the tubes 44 and 46 into the uterine cavity 27.
  • End 46A of tube 46 is tapered or pinched together to close the end of passage or tube 46. This prohibits the flow of fluid from uterine cavity 27 into tube 46.
  • annular col lar or stop member 47 Secured to a mid-portion of tube 38 is an annular col lar or stop member 47. As shown in FIG. 1, stop member 47 engages or abuts against the cervix 31 to limit the insertion of the sleeve member 39 into the uterine cavity 27. The stop member 47 maintains the end of the tubular catheter 38 spaced from the top wall or fundus 28 of the uterus.
  • the sleeve member 39 when expanded fills the major and lower portion of the uterine cavity 27 leaving a small chamber or space 27A at the upper end of the uterine cavity in communication with the canals 36 and 37 of the Fallopian tubes 33 and 34. The expanded sleeve member 39 forces the catheter up into the uterine cavity 27.
  • Chamber 27A provides for the free flow of fluids which are dispensed into the uterine cavity 27 to the canals 36 and 37 of the Fallopian tubes 33 and 34.
  • the outer end of the tubu lar catheter 38 is attached to a dispensing unit, indicated generally at 48.
  • the dispensing unit 48 is operable to initially discharge a first fluid, as air or water, into tube 38 to expand the sleeve member 39.
  • a second fluid, as drug materials, is then discharged via tube 44 into the upper end of the uterine cavity 27.
  • the third actuation of the dispensing unit discharges a third fluid, as water, via the tube 46 into the upper end of the uterine cavity 27.
  • the third fluid functions to promote the flow of the first fluid into the canals of the Fallopian tubes and set up a reaction which promotes the change of the second fluid into a solid in the canals 36 and 37 of the Fallopian tubes and thereby block the canals.
  • dispensing unit 48 has a body or housing 49 having three chambers 51, 52 and 53.
  • the chambers 51, 52 and 53 are located in side-by-side relationship, extending in a longitudinal direction, and are in a common horizontal plane.
  • the chambers 51, 52 and 53 can be located in a common vertical plane whereby the chambers are positioned over each other.
  • a first passage 54 in body 49 connects chamber 51 in the passage within tube 38.
  • a second passage 56 con nects the chamber 53 with the tube 46.
  • the tube 44 ex tends through the inner end wall of tube 38 and into chamber 52.
  • a second container or ampulla 58 is located in chamber 52.
  • the third container or ampulla 59 is located in chamber 53.
  • Containers 57 and 59 are identical in structure, as
  • a first tubular needle 63 is attached to a support or disc 64 located in the base of chamber 51.
  • the needle 63 is in alignment with the center of the forward end of container 57.
  • the end of tube 44 projected into chamber 52 comprises a tubular needle 62 in alignment with the forward end of container 58.
  • Needle 62 is attached to a circular disc or support 66 located in the base of chamber 52.
  • a third tubular needle 63 projects into chamber 53. Needle 63 is mounted on a disc or support 67 located in the base of chamber 53.
  • Container 57 has a cylinder 68 for storing fluid 69, as drugs, water, air, or the like.
  • the forward end of cylinder 68 has a head 71 having a central passage closed with a resilient plug 72.
  • the open end of cylinder 68 is closed with a plunger assembly 73 carrying a piston 74.
  • the rear portion of plunger assembly 73 has an outwardly directed annular flange 76.
  • the flange 76 functions as a stop or bearing member for a compression spring 77.
  • the forward or opposite end of spring 77 is in engagement with an annular seat 78 on the outer wall of cylinder 68.
  • Spring 77 biases the plunger assembly 73 in an outward direction or out of cylinder 68.
  • the plunger assembly 73 has a central longitudinal bore 79 slidably accommodating an actuator rod 81.
  • Actuator 81 has an axial bore 82 open to the bore 79 and accommodating a compression spring 83.
  • Spring 83 provides a yieldable link between rod 81 and plunger assembly 73.
  • a first actuator 84 engageable with the outer end of rod 81.
  • Actuator 84 is movable in a forward direction, as indicated by arrow 86, to move the rod 81 into the cylinder 68.
  • springs 77 and 83 will be initially compressed supplying a uniform pressure on piston 74.
  • the entire cylinder 68 will move in a forward direction until the needle 61 pierces the plug 72 thereby providing fluid communication between the container 57 and the passage 54.
  • the container 59 is actuated in a manner similar to container 57 on movement of an actuator 87.
  • Located between actuators 84 and 87 is a central actuator 88 operable on movement in a forward direction to dispense fluid from the container 58 into the tube 44.
  • Tube 44 carries the fluid to the center portion of the uterine cavity space 27A.
  • Trigger assembly 89 is mounted on the rear portion of housing 49 adjacent the rear ends of the actuators 84, 87 and 88.
  • Trigger assembly 89 has a downwardly directed lever or trigger member 91.
  • the midportion of lever 91 has a hole accommodating a transverse pivot pin 92.
  • Pivot pin 92 is anchored in a downwardly extended handle or pistol grip 93 attached to the rear portion of body 49 and extended downwardly therefrom.
  • Lever 91 has an upper transverse head 94 located in alignment with the ends of actuators 84, 87 and 88.
  • Springs 96 engageable with body 49 and the upper end of lever 91 bias the lever in a rearward or cocked position, as shown in FIG. 3.
  • Head 94 has a first longitudinal passage 97 in alignment with actuator 88 and a second longitudinal passage 98 in alignment with actuator 87.
  • a transverse bore 99 opens to passages 97 and 98.
  • Bore 99 has a forward opening to provide access of the actuators 87 and 88 to the passages 98 and 97, respectively.
  • Slidably disposed in bore 99 is a movable pin or member 101. As shown in FIG. 5, pin 101 has a reduced diameter neck 102 attached to an enlarged head 103.
  • a compression spring 104 engages head 103 and a plug 106 closing the end of bore 99. Spring 104 biases the pin 101 along the bore 99 away from plug 106.
  • First actuator 84 has a rearwardly directed finger 107 engageable with the head 103 to hold the pin 101 in the first or cocked position, as shown in FIG. 5.
  • pin 101 When pin 101 is in the cocked position, it does not provide a driving link or interfere with the actuators 87 and 88.
  • actuator 84 has a notch or slot 109. Similar notches or slots 111 and 112 are located in actuators 88 and 87, respectively.
  • a lock mechanism indicated generally at 113, cooperates with the slot 111 to hold the actuator 88 in the in" or fully dispensed position.
  • Lock 113 comprises a movable pin 114 having a head 116 located above body 49 so that it can be gripped to release the lock.
  • the forward portion of the pin 114 carries a C-ring or clamp ring 117 providing a stop for a spring 118.
  • Spring 118 is located concentrically around pin 114 and engages an inner portion of body 49 to bias the pin 114 into engagement with actuator 88.
  • the trigger 91 has been actuated to move the actuator 84 to the in position.
  • Lock 119 holds the actuator 84 in the in position.
  • the pin 101 will move to its second position in engagement with the finger 108 behind the actuator 88. Finger 108 prevents the pin from moving to the bottom of the bore 99.
  • the trigger 91 is then actuated to dispense the fluid from container 58 into the uterine cavity via the tube 44. Lock 113 will hold the actuator 88 in the in position.
  • the trigger 91 is again moved back to the cocked position by the springs 96.
  • the pin 101 as shown in FIG. 7, is moved by spring 104 to the bottom of bore 99 adjacent the end of actuator 87.
  • the third actuation of the trigger 91 will move actuator 87 to dispense fluid from container 59 via the tube 46 into the uterine cavity.
  • Lock 121 will move into slot 112 to hold the actuator 87 in the in position.
  • Lock 119 is released by raising head 116.
  • the spring 77 will expand container 57 whereby fluid will drain from chamber 41. This collapses sleeve member 39 enabling the catheter to be withdrawn from the uterine cavity.
  • container or ampulla 58 comprises an elongated tubular member having a flexible wall of metal, preferably lead, lead alloy or other material that is liquid impervious.
  • the container 58 stores moisture-sensitive drugs, as tissue adhesives and the like. It is essential that the containers be made of material which prevents the fluids from coming into contact with moisture or other substances which set up these materials.
  • Container 58 has a cylindrical head 122 closed with an end wall or diaphragm 123.
  • the head 122 is integral with a cylindrical and tapering body 124.
  • the body 124 has a closed transverse end 126.
  • the container 58 is located in chamber 52 with the head 122 in the forward and small end of the chamber 52 adjacent the needle 62.
  • Body 124 has facing side walls 127 and 128 forming part of the midsection of chamber 52. Side walls 127 and 128 are angularly disposed relative to each other and taper inwardly in a foward direction toward needle 62. Spring 129 interposed in the small foward end of the chamber between the head 122 and the bottom of chamber 52 holds the wall 123 spaced from the end of needle 62.
  • Actuator 88 has a forward end separated or bifurcated into two spaced members or legs 131 and 132. As shown in FIG. 3, legs 131 and 132 are generally flat and rectangular shaped and are located in the outer end of chamber 52. The legs have convex inner faces 133 and 134 disposed adjacent the body 124.
  • the actuators 84, 88 and 87 can be spring biased as disclosed in FIGS. to of our application Ser. No. 339,91 1
  • the disclosure of this structure of application Ser. No. 339,911 is hereby incorporated by reference in this application.
  • the actuators 84, 88 and 87 can be selectively moved with longitudinal rod members, as disclosed in our application Ser. No. 369,7 IQ for Dispensing instrument. The disclosure of this structure is incorporated by reference in this application.
  • a dispensing catheter 21 performs a method of introducing a material, as a drug, tissue adhesive, contraceptive gel, and like materials, into the canals 36 and 37 of the Fallopian tubes 33 and 34, respectively.
  • the method includes the introduction of an elongated catheter 21 having an expandable sleeve member 39 at the forward end thereof through the cervical opening into the uterine cavity 27.
  • the sleeve member 39 is located in the uterine cavity 27 in a position whereby the top end of the sleeve member is spaced from the top wall 28 of the uterus leaving a small chamber 27A.
  • a stop 47 engages the exterior end of the cervix 31 to prohibit further insertion of the catheter into the uterinc cavity.
  • the sleeve member 39 is expanded with a first fluid, as water, under pressure to fill the major portion of the uterine cavity 27.
  • the expanded sleeve member 39 functions as a plug or sealing member as it is in uniform and continuous engagement with the inner wall of the uterine cavity.
  • the expanded sleeve member tends to move the catheter 21 further into the uterine cavity.
  • the stop 47 prevents this movement and cooperates with the sleeve member to insure a uniform and firm engagement of the sleeve member 39 with the inner wall of the uterine cavity 21.
  • the dispensing unit 21 is actuated by pulling the trigger 91.
  • the actuator 88 is moved in a foward direction forcing the container 58 into piercing engagement with needle 62 and collapsing the container, thereby driving the second fluid, as tissue adhesive and the like, from the container 58 via tube 44 into the center area of chamber 27A of the uterine cavity 27.
  • the second fluid from container 57 being under pressure will flow into the canals 36 and 37 open to the uterine cavity 27.
  • the second fluid will continue to flow until the actuator is locked in the in position by the lock means 113.
  • the dispensing unit is then actuated for a third time by moving the trigger 91.
  • the lock mechanism 119 is released whereby the first fluid in chamber 41 is withdrawn via the tube passage 38 into the container 57. This contracts the sleeve member 39 enabling the catheter to be withdrawn from the uterine cavity 27 While there have been shown and described a preferred embodiment of the dispensing catheter and fluid container, as well as the method of introducing material into the canals of the Fallopian tubes, it is understood that variations and changes in the structures and methods may be made by those skilled in the art without departing from the spirit of the invention. The invention is defined in the following claims.
  • An apparatus for sequentially dispensing a first fluid, a second fluid, and a third fluid comprising: a housing having a first chamber, a second chamber, and a third chamber, first container means storing the first fluid located in the first chamber, second container means storing the second fluid located in the second chamber, third container means storing the third fluid located in the third chamber, first needle means operable to puncture the first container means, second needle means operable to puncture the second container means, third needle means operable to puncture the third container means, means having a passage for receiving a first fluid from the first container means, a second passage for receiving the second fluid from the second container means, and a third passage for receiving the third fluid from the third container means, first movable means operable to cause the first needle means to pierce a portion of the first container means whereby the first fluid flows from the first container means to the first passage.
  • second movable means operable to cause the second needle means to pierce the second container means whereby the second fluid from the second container means flows to the second passage
  • third movable means operable to cause the third needle means to pierce the third container means whereby the third fluid from the third container means flows to the third passage
  • actuator means operable to sequentially move the first movable means, the second movable means, and the third movable means whereby the first fluid, second fluid, and third fluid are sequentially dispensed into the first passage, second passage, and third passage, respectively.
  • the apparatus of claim 1 including: first lock means for holding the first movable means in the fluid dispense position.
  • the apparatus of claim 1 including: second lock means for holding the second movable means in the fluid dispense position.
  • the actuator means has a member located in a first position to engage the first movable means, located in a second position to engage the second movable means, and located in a third position to engage the third movable means.
  • the apparatus of claim 1 including: lock means for holding the first moveable means in the dispense position, said actuator means having a member held in a first position when the first moveable means is held in the dispense position, said member being held in the second position by the second moveable means wherein the member is engageable with the second moveable means, said member being held in the first position by the first moveable means until the first moveable means is locked.
  • the actuator means includes a lever carrying a movable member, said movable member operable to engage the first, second and third movable means.
  • the apparatus of claim 1 including: biasing means located in the second chamber for holding the second container spaced from the second needle means.
  • first lock means holding the first moveable means in the fluid dispensed position
  • second lock means for holding the second moveable means in the fluid dispensed position
  • third lock means for holding the third moveable means in the fluid dispensed position.
  • the housing has spaced walls on opposite sides of the second chamber, said second needle means projected into the forward end of the second chamber and adapted to pierce the second container means on movement of the second container means toward the second needle means, said second moveable means having a pair of spaced legs engageable with separate parts of the second container means whereby on movement of the second moveable means into the second chamber the legs move the second container means onto the second needle means and compress the second container means to force the second fluid from the second container means into the second passage.
  • said pair of spaced legs each have a generally rectangular shape and are laterally spaced from each other.
  • said second container means is a flexible metal tubular member having a head end facing the second needle means.
  • the spaced walls of the housing have portions facing the second chamber, said portions being tapered inwardly toward the second needle means, one of said legs being engaged with the other tapered portion, whereby on movement of said legs into said second chamber said tapered portions force the legs toward each other and thereby compress the second container to force the second fluid from the second container means into the second passage.
  • said second actuator means includes a lever operable to move the second moveable means into the second chamber.
  • the apparatus of claim 9 including: lock means for holding the second moveable means in a forward position wherein the second fluid has been dispensed from the second container means.
  • Apparatus for dispensing fluid from a collapsible container storing a fluid comprising: body means having spaced walls and a chamber between said walls for accommodating the container, needle means projected into the forward end of the chamber adapted to pierce the container on movement of the container into engagement with the needle means, said walls having inside surfaces facing the chamber, said surfaces being angularly disposed relative to each other and tapered inwardly toward the needle means, and actuator means having moveable leg means engageable with said surfaces of the walls and separate opposite parts of the container whereby on movement of the actuator means in a dispensing direction the leg means moves the container into engagement with the needle means whereby the needle means pierces the container and compresses the container to force the fluid in the container through the needle means.
  • the container is a flexible metal tubular member having a head end facing the needle means.
  • the body means has an end wall closing one end of a chamber, said needle means being mounted on said end wall.
  • the apparatus of claim 17 including: biasing means for holding the container spaced from the needle means.
  • the body means has an end wall closing one end of the chamber and an open end, said tapered surfaces of the walls being located forwardly of the open end and spaced from the end wall, said needle means being mounted on said end wall.
  • leg means comprise first leg means engageable with the surface of one wall and the container and second leg means engageable with the surface of another wall and the container said first leg means and second leg means being moveable toward each other on movement of the actuator means in the dispensing direction.
  • first leg means and second leg means are a bifurcated member joined to an actuator member.
  • first leg means and second leg means are generally rectangular members laterally spaced from each other.
  • first leg means and second leg means each have convex faces adapted to engage the container.
  • Apparatus for dispensing fluid from a collapsible container storing a fluid, said container having an end adapted to be opened whereby the fluid can be dispensed from the container comprising: body means having spaced walls and a chamber having a foward end. said chamber located between said walls for accommodating the container, said walls having inside surfaces facing the chamber, said surfaces being angularly disposed relative to each other and tapered inwardly toward the forward end of the chamber, and actuator means having moveable leg means engageable with said surfaces of walls and separate opposite parts of the container whereby on movement of the actuator means in a dispensing direction the leg means move the container into the chamber and compress the container to force fluid from the container.
  • the container is a flexible metal tubular member having a head end at the forward end of the chamber.
  • the apparatus of claim 26 including: biasing means located in the chamber for holding the container spaced from the forward end of the chamber.
  • the body means has an end wall closing the foward end of the chamber and an open end, said tapered surfaces of the walls being located forwardly of the open end and spaced from the end wall.
  • leg means comprise: first leg means engageable with the surface of one wall and the container and second leg means engageable with the surface of the other wall and the container, said first leg means and second leg means being moveable toward each other on movement of the actuator means in the dispensing direction.
  • first leg means and second leg means are generally rectangular members laterally spaced from each other.
  • first leg means and second leg means each have convex faces adapted to engage the separate parts of the container.

Abstract

A dispensing intrauterine catheter and method for injecting fluid, as a drug material or a tissue adhesive, into the canals of the Fallopian tubes of a female primate. The catheter has an elongated tubular member carrying an expandable sleeve member on its outer end. A dispensing unit attached to the tubular member has three chambers for storing containers housing drug materials and fluid to expand the sleeve member. The containers have collapsible bodies which are pierced by needles which carry the first fluid to expand the sleeve member. The fluids in the second and third containers are sequentially dispensed from the outer end of the tubular member into the uterine cavity. A handoperated member is sequentially moved to dispense the fluid from the first container to expand the sleeve member and then sequentially dispense the second fluid and third fluid into the uterine cavity. The drug material is stored in a metal collapsible container. The actuator has a pair of legs which cooperate with inclined walls to move the container into piercing engagement with the needle and compress and collapse the container and thereby move the drug material from the container via the needle into the uterine cavity.

Description

United States Patent 1 [111 3,ss7,1 12 Bolduc et al. 1 June 3, 1975 APPARATUS FOR PUNCTURING AND [57] ABSTRACT COLLAPSING A CONTAINER A dispensing intrauterine catheter and method for in- 75 Inventors; Lee Bomuc Minneapolis; Eugene jecting fluid, as a drug material or a tissue adhesive,
Dickhudt, St Paul both of Minn into the canals of the Fallopian tubes of a female primate. The catheter has an elongated tubular member AS31811: PQPIIIaHORRBSQaYQh Incorporated carrying an expandable sleeve member on its outer Fndley' end. A dispensing unit attached to the tubular member [22] Filed: May 18, 1973 has three chambers for storing containers housing drug materials and fluid to expand the sleeve member. PP' -z 361,418 The containers have collapsible bodies which are pierced by needles which carry the first fluid to ex- 52 [1.5. Ci. 222/85; 222/82; 222/103 P the sleeve member- The fluids the Second and 51 Int. Cl B67]: 7/26 third containers are sequentially di513"!Sed from the [58] n w of Search 222/95, 5, 103, 85, 83 outer end of the tubular member into the uterine cav- 222/82, 92; 123/218 P 224 234, 235 ity. A hand-operated member is sequentially moved to dispense the fluid from the first container to expand [561 References Cited the sleeve member and then sequentially dispense the UNITED STATES PATENTS second fluid and third fluid into the uterine cavity.
The drug material is stored in a metal collapsible con- 2 f g; tainer. The actuator has a pair of legs which cooperate 2772026 1956 x with inclined walls to move the container into piercing 3:077:07s 2/1963 Hamilton"I:::::::::::::::::::.. 222/82 x engagement the needle and impress and lapse the container and thereby move the drug material from the container via the needle into the uterine cavity.
32 Claims, 10 Drawing Figures APPARATUS FOR PUNCTURING AND COLLAPSING A CONTAINER BACKGROUND OF THE INVENTION Liquid tissue adhesives have been developed which polymerize when applied to moist living tissue. These adhesives have been used for various surgical procedures. When the tissue adhesive is used, the cells adjacent the adhesive are damaged and eventually replaced with a fibrous tissue. Several types of liquid tissue adhesive have been injected into the uterine cavity with a catheter for the purpose of occluding the canals of the Fallopian tubes. One type of dispensing catheter is disclosed in our copending US. patent application Ser. No. 339,911, filed Mar. 9, 1973. The expanded sleeve on this dispensing catheter is designed to fill the uterine cavity and engage the top wall of the uterus. The catheter does not have a positioning means to limit the insertion of the catheter into the uterine cavity. It is desirable to locate the expanded sleeve member in a position spaced from the top wall of the uterus leaving a cavity adjacent the top wall of the uterus for the flow of the drug materials into the canals of the Fallopian tubes. A second fluid is used to aid the flow of the first fluid into the canals and set up or polymerize the first fluid.
SUMMARY OF THE INVENTION The invention is directed to an intrauterine dispensing catheter for dispensing fluids, as drugs, into the canals of the Fallopian tubes of a primate female. The apparatus has a tubular member carrying an expandable sleeve means for filling a substantial portion of the uterine cavity. A positioning means mounted on the tubular member locates the sleeve means in the uterine cavity in a manner so that the sleeve means is spaced from the top wall or fundus of the uterus. A dispensing means attached to the tubular member supplies a first fluid to the sleeve means to expand the sleeve means and sequentially discharge second and third fluids into the uterine cavity. The third fluid functions to force the second fluid out of the uterine cavity into the canals. The third fluid also acts as a polymerizing fluid which sets up the second fluid thereby occluding the canals of the Fallopian tubes.
The dispensing unit has a plurality of chambers accommodating containers for storing the fluid. Needles project into the chambers and are operable on movement of the containers to pierce the containers. Sepa rate actuators engageable with the containers function to move the containers into piercing engagement with the needles and collapse the containers whereby the fluid is dispensed into the tubular member and fluid carrying means which deliver the fluid to the outer end of the tubular member. An actuator is hand operated to sequentially dispense fluid from the containers whereby the sleeve means is initially expanded before the second and third fluids are sequentially discharged into the uterine cavity.
The apparatus for dispensing fluid from the container includes a body means having spaced converging walls facing a chamber accommodating the container. Needle means project into the container and pierce the container on movement of the container into engagement with the needle means. An actuator having leg means engageable with the converging walls and container moves the container into the needle means and compresses and collapses the container driving the fluid from the container. The container can be of collapsible metal, as lead or lead alloy, hermetically storing a fluid, as a tissue adhesive.
The invention includes the method of occluding the canals of the Fallopian tubes by introducing occluding fluids into the canals. The method includes the insertion of a catheter having an expandable sleeve into the uterine cavity through the cervical opening. The expandable sleeve is located in the uterine cavity in a position spaced from the top wall or fundus of the uterus thereby leaving a space between the expandable sleeve and the inside of the top wall. The sleeve member is expanded with a first fluid under pressure to hold the sleeve member in engagement with the side walls of the uterine cavity thereby limiting the space between the sleeve member and the top wall of the uterus. A second fluid, as a drug material or tissue adhesive, is dispensed into the uterine cavity space between the sleeve member and the top wall. The second fluid moves toward the canals of the Fallopian tubes. This movement is supplemented with the dispensing of the third fluid into the uterine cavity space. The third fluid, as water, aids in the polymerization of the second fluid as well as forcing the second fluid into the canals of the Fallopian tubes. The sleeve member is contracted by draining the first fluid. The entire catheter is then withdrawn from the uterine cavity.
IN THE DRAWINGS FIG. 1 is a longitudinal sectional view of the genital system of a female primate with the dispensing catheter of the invention extended into the uterine cavity;
FIG. 2 is a top sectional view of the dispensing catheter of FIG. 1',
FIG. 3 is a sectional view taken along the line 3-3 of FIG. 2;
FIG. 4 is an enlarged sectional view of a fluid container assembly used in the dispensing catheter;
FIG. 5 is an enlarged sectional view taken along the line 5-5 of FIG. 3;
FIG. 6 is a sectional view similar to FIG. 5 showing the movable member in the second position;
FIG. 7 is a sectional view similar to FIG. 5 showing the movable member in the third position;
FIG. 8 is an enlarged plan view of the structure for dispensing fluid from a collapsible container storing a fluid, as shown in FIGS. 2 and 3;
FIG. 9 is a view similar to FIG. 8 showing the container partially collapsed; and
FIG. 10 is a view similar to FIG. 8 showing the container fully collapsed.
Referring to the drawings, there is shown in FIG. 1 a diagrammatic female primate genital system indicated generally at 20. An intrauterine catheter indicated generally at 21 is located in the genital system to direct a fluid, as drugs, tissue adhesive, water, contraceptive gel, or other materials, into the canals of the Fallopian tubes. The tissue adhesive can be isobutyl 2- cyonoacrylate monomer, silver nitrate or quinacrine materials. The cyonoacrylate monomer is a liquid plastic which sets up or polymerizes in response to moisture when placed in the canals of the Fallopian tubes and thereby functions to occlude the canals. The drug materials can be of the type that temporarily block or occlude the canals of the Fallopian tubes. After a period of time the canals will reopen to resume their normal function.
The genital system has an elongated vagina 22 de fined by the cylindrical vaginal wall 23. The vagina 22 opens into the vestibule 24. The opposite end of the vagina 22 is attached to the uterus, indicated generally at 26. Uterus 26 is a pear-shaped, thick walled, hollow organ situated between the bladder and rectum. Uterus 26 has a uterine cavity 27 which is generally flattened and triangular in shape. The size and shape of the uterine cavity varies from female to female. The top of uterus 26 or fundus 28 is joined to the uterus body 29. The lower end of the body 29 contains the cervix 31 which separates the vagina 22 from the uterine cavity 27. The uterine wall is composed of an outer serosal layer, or peritoneum, a firm, thick, intermediate coat of smooth muscle tissue, or myometrium; and an inner mucosal lining, or endometrium 32.
Leading to the upper part of opposite sides of the uterus 26 are Fallopian tubes 33 and 34. The Fallopian tubes 33 and 34 are paired, trumpet-shaped, muscular tubular members which extend from the superior angles of the uterine cavity 27 to the ovaries (not shown). The ovaries are solid, slightly irregular shaped bodies situated on either side of the uterus 26 behind and below the Fallopian tubes 33 and 34.
Fallopian tubes 33 and 34 each have a canal or aqueduct 36 and 37 respectively. The Fallopian tubes 33 and 34 are musculo-membranous structures about 12 cm in length. They are commonly divided into an isthmus, intramural and ampullary sections. The canals 36 and 37 provide passages for the movement of ova from the ovaries into the uterine cavity. The intramural section of the Fallopian tubes traverses the uterine wall in more or less straight fashion. It has an ampulla like dilation just before it communicates with the uterine cav ity 27. The canals 36 and 37 are narrowest at the intramural sections. The walls of the Fallopian tubes consist of three layers: a serosal layer, a muscular layer and a mucosal lining. The muscular layer includes longitudinal muscle fibers which, when contracted, bring the ends of the Fallopian tubes in close contact with the surface of the ovaries. Blood vessels are abundant in the muscular layer where they form with the muscle bundles a kind of erectile tissue which, if engorged, moves the Fallopian tubes to sweep over the surface of the ovaries. This movement of the Fallopian tubes is impaired when the tubes are severed and tied. The occluding of the canals 36 and 37 with the drug material according to the invention does not interfere with the erectile action and movement of the Fallopian tubes Dispensing apparatus 21 has an elongated tubular member or catheter 38 having a length sufficient to extend through the vagina 22 and into the uterine cavity 27. An expandable sleeve member 39 as a flexible balloon or the like, is secured to the upper end of tube 38 with bands 40A and 40B. Band 40A holds the outer end of sleeve member 39 in sealing engagement with the terminal end of tube 38. Band 403 secures the inner end of sleeve member 39 to the tube 38. Sleeve member 39 is a flexible elastic cylindrical sheet made of relaxed rubber material. The rubber material has uniform surface tension and uniform expansion characteristics. Member 39 can be expanded into uniform and firm engagement with a major portion of the inner wall of the uterus regardless of the size or shape of the uter ine cavity. This enables the same sleeve member 39 to be used on all types of primate females.
The sleeve member 39 defines a cavity or chamber 41. A plurality of holes 42 provide the passages from chamber 41 into the passage of the tube 38 whereby fluid in the tube 38 can flow through the holes 42 to the chamber 41 to increase the size of sleeve member 39. The end of tube 38 is closed with a plug 43. A pair of small tubes 44 and 46 extend longitudinally through tube 38 and are attached to the plug 43. Tube 44 has an open end 44A projected through plug 43. in a similar manner, tube 46 has an end 46A projected through plug 43 whereby fluid can flow through the tubes 44 and 46 into the uterine cavity 27. End 46A of tube 46 is tapered or pinched together to close the end of passage or tube 46. This prohibits the flow of fluid from uterine cavity 27 into tube 46.
Secured to a mid-portion of tube 38 is an annular col lar or stop member 47. As shown in FIG. 1, stop member 47 engages or abuts against the cervix 31 to limit the insertion of the sleeve member 39 into the uterine cavity 27. The stop member 47 maintains the end of the tubular catheter 38 spaced from the top wall or fundus 28 of the uterus. The sleeve member 39 when expanded fills the major and lower portion of the uterine cavity 27 leaving a small chamber or space 27A at the upper end of the uterine cavity in communication with the canals 36 and 37 of the Fallopian tubes 33 and 34. The expanded sleeve member 39 forces the catheter up into the uterine cavity 27. The stop 47 prevents inward movement of the sleeve member 39 and holds sleeve member 39 in firm and continuous engagement with the inner wall of the uterus. Chamber 27A provides for the free flow of fluids which are dispensed into the uterine cavity 27 to the canals 36 and 37 of the Fallopian tubes 33 and 34.
As shown in H65. 1 and 2, the outer end of the tubu lar catheter 38 is attached to a dispensing unit, indicated generally at 48. The dispensing unit 48 is operable to initially discharge a first fluid, as air or water, into tube 38 to expand the sleeve member 39. A second fluid, as drug materials, is then discharged via tube 44 into the upper end of the uterine cavity 27. The third actuation of the dispensing unit discharges a third fluid, as water, via the tube 46 into the upper end of the uterine cavity 27. The third fluid functions to promote the flow of the first fluid into the canals of the Fallopian tubes and set up a reaction which promotes the change of the second fluid into a solid in the canals 36 and 37 of the Fallopian tubes and thereby block the canals.
Referring to FIG. 2, dispensing unit 48 has a body or housing 49 having three chambers 51, 52 and 53. The chambers 51, 52 and 53 are located in side-by-side relationship, extending in a longitudinal direction, and are in a common horizontal plane. The chambers 51, 52 and 53 can be located in a common vertical plane whereby the chambers are positioned over each other. A first passage 54 in body 49 connects chamber 51 in the passage within tube 38. A second passage 56 con nects the chamber 53 with the tube 46. The tube 44 ex tends through the inner end wall of tube 38 and into chamber 52.
A first container or ampulla 57 containing a fluid, as water or air, is located in chamber 51. A second container or ampulla 58 is located in chamber 52. The third container or ampulla 59 is located in chamber 53. Containers 57 and 59 are identical in structure, as
shown in detail in H0. 4. Other containers as disclosed in U.S. application Ser. No. 339,9l i, can be used in the chambers. The disclosure of application Ser. No. 339,911 is incorporated herein for the details of the containers for storing the fluids.
A first tubular needle 63 is attached to a support or disc 64 located in the base of chamber 51. The needle 63 is in alignment with the center of the forward end of container 57. The end of tube 44 projected into chamber 52 comprises a tubular needle 62 in alignment with the forward end of container 58. Needle 62 is attached to a circular disc or support 66 located in the base of chamber 52. A third tubular needle 63 projects into chamber 53. Needle 63 is mounted on a disc or support 67 located in the base of chamber 53.
Container 57, as shown in FIG. 4, has a cylinder 68 for storing fluid 69, as drugs, water, air, or the like. The forward end of cylinder 68 has a head 71 having a central passage closed with a resilient plug 72. The open end of cylinder 68 is closed with a plunger assembly 73 carrying a piston 74. The rear portion of plunger assembly 73 has an outwardly directed annular flange 76. The flange 76 functions as a stop or bearing member for a compression spring 77. The forward or opposite end of spring 77 is in engagement with an annular seat 78 on the outer wall of cylinder 68. Spring 77 biases the plunger assembly 73 in an outward direction or out of cylinder 68. The plunger assembly 73 has a central longitudinal bore 79 slidably accommodating an actuator rod 81. Actuator 81 has an axial bore 82 open to the bore 79 and accommodating a compression spring 83. Spring 83 provides a yieldable link between rod 81 and plunger assembly 73.
Movably disposed in body 49 is a first actuator 84 engageable with the outer end of rod 81. Actuator 84 is movable in a forward direction, as indicated by arrow 86, to move the rod 81 into the cylinder 68. On movement of the actuator 84 in a forward direction, springs 77 and 83 will be initially compressed supplying a uniform pressure on piston 74. The entire cylinder 68 will move in a forward direction until the needle 61 pierces the plug 72 thereby providing fluid communication between the container 57 and the passage 54. Continued movement of the plunger assembly 73 in a forward direction will drive the piston 74 toward the plug 72, thereby dispensing the fluid 69 via needle 62 and passage 54 into the catheter tube 38 to expand the sleeve 39. Sleeve member 39 will expand with a uniform pressure so as to fill the lower area of the uterine cavity and exert uniform pressure on the inside wall of the cavity. Piston 74 is moved into sealing engagement with the needle 61 to trap the fluid in the tube 38 and chamber 41 thereby insuring substantially constant fluid pressure in chamber 41.
The container 59 is actuated in a manner similar to container 57 on movement of an actuator 87. Located between actuators 84 and 87 is a central actuator 88 operable on movement in a forward direction to dispense fluid from the container 58 into the tube 44. Tube 44 carries the fluid to the center portion of the uterine cavity space 27A.
The actuators 84, 87 and 88 are sequentially moved on operation of a trigger assembly, indicated generally at 89. Trigger assembly 89 is mounted on the rear portion of housing 49 adjacent the rear ends of the actuators 84, 87 and 88. Trigger assembly 89 has a downwardly directed lever or trigger member 91. The midportion of lever 91 has a hole accommodating a transverse pivot pin 92. Pivot pin 92 is anchored in a downwardly extended handle or pistol grip 93 attached to the rear portion of body 49 and extended downwardly therefrom. Lever 91 has an upper transverse head 94 located in alignment with the ends of actuators 84, 87 and 88. Springs 96 engageable with body 49 and the upper end of lever 91 bias the lever in a rearward or cocked position, as shown in FIG. 3.
Head 94 has a first longitudinal passage 97 in alignment with actuator 88 and a second longitudinal passage 98 in alignment with actuator 87. A transverse bore 99 opens to passages 97 and 98. Bore 99 has a forward opening to provide access of the actuators 87 and 88 to the passages 98 and 97, respectively. Slidably disposed in bore 99 is a movable pin or member 101. As shown in FIG. 5, pin 101 has a reduced diameter neck 102 attached to an enlarged head 103. A compression spring 104 engages head 103 and a plug 106 closing the end of bore 99. Spring 104 biases the pin 101 along the bore 99 away from plug 106. First actuator 84 has a rearwardly directed finger 107 engageable with the head 103 to hold the pin 101 in the first or cocked position, as shown in FIG. 5. When pin 101 is in the cocked position, it does not provide a driving link or interfere with the actuators 87 and 88.
Returning to FIG. 2, actuator 84 has a notch or slot 109. Similar notches or slots 111 and 112 are located in actuators 88 and 87, respectively. As shown in FIG. 3, a lock mechanism, indicated generally at 113, cooperates with the slot 111 to hold the actuator 88 in the in" or fully dispensed position. Lock 113 comprises a movable pin 114 having a head 116 located above body 49 so that it can be gripped to release the lock. The forward portion of the pin 114 carries a C-ring or clamp ring 117 providing a stop for a spring 118. Spring 118 is located concentrically around pin 114 and engages an inner portion of body 49 to bias the pin 114 into engagement with actuator 88. When actuator 88 is moved to the in position, pin 114 will be biased by spring 118 into the slot 111 thereby holding the actuator 88 in the in position until the lock 113 has been released. Referring to FIG. 1, identical locks 119 and 121 cooperate with the actuators 84 and 87 to lock the actuators in the in position.
Referring to FIG. 6, the trigger 91 has been actuated to move the actuator 84 to the in position. Lock 119 holds the actuator 84 in the in position. When the trigger 91 is returned to the top position by the spring 96, the pin 101 will move to its second position in engagement with the finger 108 behind the actuator 88. Finger 108 prevents the pin from moving to the bottom of the bore 99. The trigger 91 is then actuated to dispense the fluid from container 58 into the uterine cavity via the tube 44. Lock 113 will hold the actuator 88 in the in position. The trigger 91 is again moved back to the cocked position by the springs 96. The pin 101, as shown in FIG. 7, is moved by spring 104 to the bottom of bore 99 adjacent the end of actuator 87. The third actuation of the trigger 91 will move actuator 87 to dispense fluid from container 59 via the tube 46 into the uterine cavity. Lock 121 will move into slot 112 to hold the actuator 87 in the in position. Lock 119 is released by raising head 116. The spring 77 will expand container 57 whereby fluid will drain from chamber 41. This collapses sleeve member 39 enabling the catheter to be withdrawn from the uterine cavity.
Referring to FIGS. 2, 8, 9 and 10, container or ampulla 58 comprises an elongated tubular member having a flexible wall of metal, preferably lead, lead alloy or other material that is liquid impervious. The container 58 stores moisture-sensitive drugs, as tissue adhesives and the like. It is essential that the containers be made of material which prevents the fluids from coming into contact with moisture or other substances which set up these materials. Container 58 has a cylindrical head 122 closed with an end wall or diaphragm 123. The head 122 is integral with a cylindrical and tapering body 124. The body 124 has a closed transverse end 126. The container 58 is located in chamber 52 with the head 122 in the forward and small end of the chamber 52 adjacent the needle 62. Body 124 has facing side walls 127 and 128 forming part of the midsection of chamber 52. Side walls 127 and 128 are angularly disposed relative to each other and taper inwardly in a foward direction toward needle 62. Spring 129 interposed in the small foward end of the chamber between the head 122 and the bottom of chamber 52 holds the wall 123 spaced from the end of needle 62.
Actuator 88 has a forward end separated or bifurcated into two spaced members or legs 131 and 132. As shown in FIG. 3, legs 131 and 132 are generally flat and rectangular shaped and are located in the outer end of chamber 52. The legs have convex inner faces 133 and 134 disposed adjacent the body 124.
On movement of the actuator 88 in the forward or inward direction, as indicated by arrow 136 in FIGS. 8-10, the legs 131 and 132 move into chamber 52 and ride on the inclined or tapered side walls 127 and 128. The side walls 127 and 128 force the legs 131 and 132 toward each other into squeezing engagement with the body 124. The legs 131 and 132 force the container 58 against the spring 129 into the needle 62. As shown in FIG. 9, the container 58 has been driven into needle 62 providing a passage for the fluid in container 58 to the tube 44. Continued movement of the actuator 88in the forward direction collapses the container 58 and transversely squeezes the container whereby the fluid in the container is forced through needle 62 into the tube 44. Tube 44 carries the fluid into the uterine cavity, as shown in FIG. 1.
The actuators 84, 88 and 87 can be spring biased as disclosed in FIGS. to of our application Ser. No. 339,91 1 The disclosure of this structure of application Ser. No. 339,911 is hereby incorporated by reference in this application. Alternatively, the actuators 84, 88 and 87 can be selectively moved with longitudinal rod members, as disclosed in our application Ser. No. 369,7 IQ for Dispensing instrument. The disclosure of this structure is incorporated by reference in this application.
In use, a dispensing catheter 21 performs a method of introducing a material, as a drug, tissue adhesive, contraceptive gel, and like materials, into the canals 36 and 37 of the Fallopian tubes 33 and 34, respectively. The method includes the introduction of an elongated catheter 21 having an expandable sleeve member 39 at the forward end thereof through the cervical opening into the uterine cavity 27. The sleeve member 39 is located in the uterine cavity 27 in a position whereby the top end of the sleeve member is spaced from the top wall 28 of the uterus leaving a small chamber 27A. A stop 47 engages the exterior end of the cervix 31 to prohibit further insertion of the catheter into the uterinc cavity. The sleeve member 39 is expanded with a first fluid, as water, under pressure to fill the major portion of the uterine cavity 27. The expanded sleeve member 39 functions as a plug or sealing member as it is in uniform and continuous engagement with the inner wall of the uterine cavity. The expanded sleeve member tends to move the catheter 21 further into the uterine cavity. The stop 47 prevents this movement and cooperates with the sleeve member to insure a uniform and firm engagement of the sleeve member 39 with the inner wall of the uterine cavity 21.
The dispensing unit 21 is actuated by pulling the trigger 91. The actuator 88 is moved in a foward direction forcing the container 58 into piercing engagement with needle 62 and collapsing the container, thereby driving the second fluid, as tissue adhesive and the like, from the container 58 via tube 44 into the center area of chamber 27A of the uterine cavity 27. The second fluid from container 57 being under pressure will flow into the canals 36 and 37 open to the uterine cavity 27. The second fluid will continue to flow until the actuator is locked in the in position by the lock means 113. The dispensing unit is then actuated for a third time by moving the trigger 91. This will move actuator 87 in a forward direction dispensing the third fluid from container 59 via tube 46 into the uterine cavity. The third fluid, as water, will transport and force the second fluid into the canals 36 and 37. The third fluid will also aid the setting up or polymerization of the second fluid, thereby occluding the canals. Any second fluid remaining in the uterine cavity 27 will be completely polymerized and will not adhere to the uterine wall. This material will be removed from the uterine cavity during the normal discharge therefrom.
The lock mechanism 119 is released whereby the first fluid in chamber 41 is withdrawn via the tube passage 38 into the container 57. This contracts the sleeve member 39 enabling the catheter to be withdrawn from the uterine cavity 27 While there have been shown and described a preferred embodiment of the dispensing catheter and fluid container, as well as the method of introducing material into the canals of the Fallopian tubes, it is understood that variations and changes in the structures and methods may be made by those skilled in the art without departing from the spirit of the invention. The invention is defined in the following claims.
The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. An apparatus for sequentially dispensing a first fluid, a second fluid, and a third fluid comprising: a housing having a first chamber, a second chamber, and a third chamber, first container means storing the first fluid located in the first chamber, second container means storing the second fluid located in the second chamber, third container means storing the third fluid located in the third chamber, first needle means operable to puncture the first container means, second needle means operable to puncture the second container means, third needle means operable to puncture the third container means, means having a passage for receiving a first fluid from the first container means, a second passage for receiving the second fluid from the second container means, and a third passage for receiving the third fluid from the third container means, first movable means operable to cause the first needle means to pierce a portion of the first container means whereby the first fluid flows from the first container means to the first passage. second movable means operable to cause the second needle means to pierce the second container means whereby the second fluid from the second container means flows to the second passage, third movable means operable to cause the third needle means to pierce the third container means whereby the third fluid from the third container means flows to the third passage, actuator means operable to sequentially move the first movable means, the second movable means, and the third movable means whereby the first fluid, second fluid, and third fluid are sequentially dispensed into the first passage, second passage, and third passage, respectively.
2. The apparatus of claim 1 including: first lock means for holding the first movable means in the fluid dispense position.
3. The apparatus of claim 1 including: second lock means for holding the second movable means in the fluid dispense position.
4. The apparatus of claim 1 wherein: the actuator means has a member located in a first position to engage the first movable means, located in a second position to engage the second movable means, and located in a third position to engage the third movable means.
5. The apparatus of claim 1 including: lock means for holding the first moveable means in the dispense position, said actuator means having a member held in a first position when the first moveable means is held in the dispense position, said member being held in the second position by the second moveable means wherein the member is engageable with the second moveable means, said member being held in the first position by the first moveable means until the first moveable means is locked.
6. The apparatus of claim 1 wherein: the actuator means includes a lever carrying a movable member, said movable member operable to engage the first, second and third movable means.
7. The apparatus of claim 1 including: biasing means located in the second chamber for holding the second container spaced from the second needle means.
8. The apparatus of claim 1 including: first lock means holding the first moveable means in the fluid dispensed position, second lock means for holding the second moveable means in the fluid dispensed position, and third lock means for holding the third moveable means in the fluid dispensed position.
9. The apparatus of claim 1 wherein: the housing has spaced walls on opposite sides of the second chamber, said second needle means projected into the forward end of the second chamber and adapted to pierce the second container means on movement of the second container means toward the second needle means, said second moveable means having a pair of spaced legs engageable with separate parts of the second container means whereby on movement of the second moveable means into the second chamber the legs move the second container means onto the second needle means and compress the second container means to force the second fluid from the second container means into the second passage.
10. The apparatus of claim 9 wherein: said pair of spaced legs are joined to an actuator member.
11. The apparatus of claim 9 wherein: said pair of spaced legs each have a generally rectangular shape and are laterally spaced from each other.
12. The apparatus of claim 9 wherein: said pair of spaced legs each having convex faces adapted to engage separate parts of the second container means.
13. The apparatus of claim 9 wherein: said second container means is a flexible metal tubular member having a head end facing the second needle means.
14. The apparatus of claim 9 wherein: the spaced walls of the housing have portions facing the second chamber, said portions being tapered inwardly toward the second needle means, one of said legs being engaged with the other tapered portion, whereby on movement of said legs into said second chamber said tapered portions force the legs toward each other and thereby compress the second container to force the second fluid from the second container means into the second passage.
15. The apparatus of claim 9 wherein: said second actuator means includes a lever operable to move the second moveable means into the second chamber.
16. The apparatus of claim 9 including: lock means for holding the second moveable means in a forward position wherein the second fluid has been dispensed from the second container means.
17. Apparatus for dispensing fluid from a collapsible container storing a fluid comprising: body means having spaced walls and a chamber between said walls for accommodating the container, needle means projected into the forward end of the chamber adapted to pierce the container on movement of the container into engagement with the needle means, said walls having inside surfaces facing the chamber, said surfaces being angularly disposed relative to each other and tapered inwardly toward the needle means, and actuator means having moveable leg means engageable with said surfaces of the walls and separate opposite parts of the container whereby on movement of the actuator means in a dispensing direction the leg means moves the container into engagement with the needle means whereby the needle means pierces the container and compresses the container to force the fluid in the container through the needle means.
18. The apparatus of claim 17 wherein: the container is a flexible metal tubular member having a head end facing the needle means.
19. The apparatus of claim 17 wherein: the body means has an end wall closing one end of a chamber, said needle means being mounted on said end wall.
20. The apparatus of claim 17 including: biasing means for holding the container spaced from the needle means.
21. The apparatus of claim 17 wherein: the body means has an end wall closing one end of the chamber and an open end, said tapered surfaces of the walls being located forwardly of the open end and spaced from the end wall, said needle means being mounted on said end wall.
22. The apparatus of claim 17 wherein: the leg means comprise first leg means engageable with the surface of one wall and the container and second leg means engageable with the surface of another wall and the container said first leg means and second leg means being moveable toward each other on movement of the actuator means in the dispensing direction.
23. The apparatus of claim 22 wherein: the first leg means and second leg means are a bifurcated member joined to an actuator member.
24. The apparatus of claim 22 wherein: the first leg means and second leg means are generally rectangular members laterally spaced from each other.
25. The apparatus of claim 22 wherein: the first leg means and second leg means each have convex faces adapted to engage the container.
26. Apparatus for dispensing fluid from a collapsible container storing a fluid, said container having an end adapted to be opened whereby the fluid can be dispensed from the container comprising: body means having spaced walls and a chamber having a foward end. said chamber located between said walls for accommodating the container, said walls having inside surfaces facing the chamber, said surfaces being angularly disposed relative to each other and tapered inwardly toward the forward end of the chamber, and actuator means having moveable leg means engageable with said surfaces of walls and separate opposite parts of the container whereby on movement of the actuator means in a dispensing direction the leg means move the container into the chamber and compress the container to force fluid from the container.
27. The apparatus of claim 26 wherein: the container is a flexible metal tubular member having a head end at the forward end of the chamber.
28. The apparatus of claim 26 including: biasing means located in the chamber for holding the container spaced from the forward end of the chamber.
29. The apparatus of claim 26 wherein: the body means has an end wall closing the foward end of the chamber and an open end, said tapered surfaces of the walls being located forwardly of the open end and spaced from the end wall.
30. The apparatus of claim 26 wherein: the leg means comprise: first leg means engageable with the surface of one wall and the container and second leg means engageable with the surface of the other wall and the container, said first leg means and second leg means being moveable toward each other on movement of the actuator means in the dispensing direction.
31. The apparatus of claim 30 wherein: the first leg means and second leg means are generally rectangular members laterally spaced from each other.
32. The apparatus of claim 30 wherein: first leg means and second leg means each have convex faces adapted to engage the separate parts of the container.

Claims (32)

1. An apparatus for sequentially dispensing a first fluid, a second fluid, and a third fluid comprising: a housing having a first chamber, a second chamber, and a third chamber, first container means storing the first fluid located in the first chamber, second container means storing the second fluid located in the second chamber, third container means storing the third fluid located in the third chamber, first needle means operable to puncture the first container means, second needle means operable to puncture the second container means, third needle means operable to puncture the third container means, means having a passage for receiving a first fluid from the first container means, a second passage for receiving the second fluid from the second container means, and a third passage for receiving the third fluid from the third container means, first movable means operable to cause the first needle means to pierce a portion of the first container means whereby the first fluid flows from the first container means to the first passage, second movable means operable to cause the second needle means to pierce the second container means whereby the second fluid from the second container means flows to the second passage, third movable means operable to cause the third needle means to pierce the third container means whereby the third fluid from the third container means flows to the third passage, actuator means operable to sequentially move the first movable means, the second movable means, and the third movable means whereby the first fluid, second fluid, and third fluid are sequentially dispensed into the first passage, second passage, and third passage, respectively.
1. An apparatus for sequentially dispensing a first fluid, a second fluid, and a third fluid comprising: a housing having a first chamber, a second chamber, and a third chamber, first container means storing the first fluid located in the first chamber, second container means storing the second fluid located in the second chamber, third container means storing the third fluid located in the third chamber, first needle means operable to puncture the first container means, second needle means operable to puncture the second container means, third needle means operable to puncture the third container means, means having a passage for receiving a first fluid from the first container means, a second passage for receiving the second fluid from the second container means, and a third passage for receiving the third fluid from the third container means, first movable means operable to cause the first needle means to pierce a portion of the first container means whereby the first fluid flows from the first container means to the first passage, second movable means operable to cause the second needle means to pierce the second container means whereby the second fluid from the second container means flows to the second passage, third movable means operable to cause the third needle means to pierce the third container means whereby the third fluid from the third container means flows to the third passage, actuator means operable to sequentially move the first movable means, the second movable means, and the third movable means whereby the first fluid, second fluid, and third fluid are sequentially dispensed into the first passage, second passage, and third passage, respectively.
2. The apparatus of claim 1 including: first lock means for holding the first movable means in the fluid dispense position.
3. The apparatus of claim 1 including: second lock means for holding the second movable means in the fluid dispense position.
4. The apparatus of claim 1 wherein: the actuator means has a member located in a first position to engage the first movable means, located in a second position to engage the second movable means, and located in a third position to engage the third movable means.
5. The apparatus of claim 1 including: lock means for holding the first moveable means in the dispense position, said actuator means having a member held in a first position when the first moveable means is held in the dispense position, said member being held in the second position by the second moveable means wherein the member is engageable with the second moveable means, said member being held in the first position by the first moveable means until the first moveable means is locked.
6. The apparatus of claim 1 wherein: the actuator means includes a lever carrying a movable member, said movable member operable to engage the first, second and third movable means.
7. The apparatus of claim 1 including: biasing means located in the second chamber for holding the second container spaced from the second needle means.
8. The apparatus of claim 1 including: first lock means holding the first moveable means in the fluid dispensed position, second lock means for holding the second moveable Means in the fluid dispensed position, and third lock means for holding the third moveable means in the fluid dispensed position.
9. The apparatus of claim 1 wherein: the housing has spaced walls on opposite sides of the second chamber, said second needle means projected into the forward end of the second chamber and adapted to pierce the second container means on movement of the second container means toward the second needle means, said second moveable means having a pair of spaced legs engageable with separate parts of the second container means whereby on movement of the second moveable means into the second chamber the legs move the second container means onto the second needle means and compress the second container means to force the second fluid from the second container means into the second passage.
10. The apparatus of claim 9 wherein: said pair of spaced legs are joined to an actuator member.
11. The apparatus of claim 9 wherein: said pair of spaced legs each have a generally rectangular shape and are laterally spaced from each other.
12. The apparatus of claim 9 wherein: said pair of spaced legs each having convex faces adapted to engage separate parts of the second container means.
13. The apparatus of claim 9 wherein: said second container means is a flexible metal tubular member having a head end facing the second needle means.
14. The apparatus of claim 9 wherein: the spaced walls of the housing have portions facing the second chamber, said portions being tapered inwardly toward the second needle means, one of said legs being engaged with the other tapered portion, whereby on movement of said legs into said second chamber said tapered portions force the legs toward each other and thereby compress the second container to force the second fluid from the second container means into the second passage.
15. The apparatus of claim 9 wherein: said second actuator means includes a lever operable to move the second moveable means into the second chamber.
16. The apparatus of claim 9 including: lock means for holding the second moveable means in a forward position wherein the second fluid has been dispensed from the second container means.
17. Apparatus for dispensing fluid from a collapsible container storing a fluid comprising: body means having spaced walls and a chamber between said walls for accommodating the container, needle means projected into the forward end of the chamber adapted to pierce the container on movement of the container into engagement with the needle means, said walls having inside surfaces facing the chamber, said surfaces being angularly disposed relative to each other and tapered inwardly toward the needle means, and actuator means having moveable leg means engageable with said surfaces of the walls and separate opposite parts of the container whereby on movement of the actuator means in a dispensing direction the leg means moves the container into engagement with the needle means whereby the needle means pierces the container and compresses the container to force the fluid in the container through the needle means.
18. The apparatus of claim 17 wherein: the container is a flexible metal tubular member having a head end facing the needle means.
19. The apparatus of claim 17 wherein: the body means has an end wall closing one end of a chamber, said needle means being mounted on said end wall.
20. The apparatus of claim 17 including: biasing means for holding the container spaced from the needle means.
21. The apparatus of claim 17 wherein: the body means has an end wall closing one end of the chamber and an open end, said tapered surfaces of the walls being located forwardly of the open end and spaced from the end wall, said needle means being mounted on said end wall.
22. The apparatus of claim 17 wherein: the leg means comprise first leg means engageable with the surface of one wall and the container and second leg means engageable with the surface of another wall and the container said first leg meAns and second leg means being moveable toward each other on movement of the actuator means in the dispensing direction.
23. The apparatus of claim 22 wherein: the first leg means and second leg means are a bifurcated member joined to an actuator member.
24. The apparatus of claim 22 wherein: the first leg means and second leg means are generally rectangular members laterally spaced from each other.
25. The apparatus of claim 22 wherein: the first leg means and second leg means each have convex faces adapted to engage the container.
26. Apparatus for dispensing fluid from a collapsible container storing a fluid, said container having an end adapted to be opened whereby the fluid can be dispensed from the container comprising: body means having spaced walls and a chamber having a foward end, said chamber located between said walls for accommodating the container, said walls having inside surfaces facing the chamber, said surfaces being angularly disposed relative to each other and tapered inwardly toward the forward end of the chamber, and actuator means having moveable leg means engageable with said surfaces of walls and separate opposite parts of the container whereby on movement of the actuator means in a dispensing direction the leg means move the container into the chamber and compress the container to force fluid from the container.
27. The apparatus of claim 26 wherein: the container is a flexible metal tubular member having a head end at the forward end of the chamber.
28. The apparatus of claim 26 including: biasing means located in the chamber for holding the container spaced from the forward end of the chamber.
29. The apparatus of claim 26 wherein: the body means has an end wall closing the foward end of the chamber and an open end, said tapered surfaces of the walls being located forwardly of the open end and spaced from the end wall.
30. The apparatus of claim 26 wherein: the leg means comprise: first leg means engageable with the surface of one wall and the container and second leg means engageable with the surface of the other wall and the container, said first leg means and second leg means being moveable toward each other on movement of the actuator means in the dispensing direction.
31. The apparatus of claim 30 wherein: the first leg means and second leg means are generally rectangular members laterally spaced from each other.
US361418A 1973-03-09 1973-05-18 Apparatus for puncturing and collapsing a container Expired - Lifetime US3887112A (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US361418A US3887112A (en) 1973-05-18 1973-05-18 Apparatus for puncturing and collapsing a container
LU69614A LU69614A1 (en) 1973-03-09 1974-03-11
IT2088074A IT1017543B (en) 1973-03-09 1974-04-08 PARTICULARLY INSTRUMENT FOR INSERTING A SUBSTANCE INTO THE UTERINE CAVITY
EG17674A EG11393A (en) 1973-05-18 1974-05-18 Dispensing instrument and method
OA55205A OA04650A (en) 1973-05-18 1974-05-18 Injection method and apparatus.

Applications Claiming Priority (1)

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US361418A US3887112A (en) 1973-05-18 1973-05-18 Apparatus for puncturing and collapsing a container

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US3887112A true US3887112A (en) 1975-06-03

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5891457A (en) * 1997-05-12 1999-04-06 Neuwirth; Robert S. Intrauterine chemical necrosing method, composition, and apparatus
US6187346B1 (en) 1995-06-07 2001-02-13 Ablation Products, Inc. Intrauterine chemical cauterizing method and composition
US6197351B1 (en) 1995-06-07 2001-03-06 Robert S. Neuwirth Intrauterine chemical necrosing method and composition
US9592375B2 (en) 2006-05-18 2017-03-14 Hyprotek, Inc. Intravascular line and port cleaning methods, methods of administering an agent intravascularly, methods of obtaining/testing blood, and devices for performing such methods
US10076653B2 (en) 2006-05-18 2018-09-18 Hyprotek, Inc. Medical caps and methods of use

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US1979105A (en) * 1934-02-06 1934-10-30 John H Harnish Dispenser
US2733836A (en) * 1956-02-07 Perforator and container for packaged grease
US2772026A (en) * 1955-02-02 1956-11-27 Walter W Bullock Collapsible tube squeezer
US3077078A (en) * 1959-10-13 1963-02-12 Thompson Ramo Wooldridge Inc Injector chamber construction

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Publication number Priority date Publication date Assignee Title
US2733836A (en) * 1956-02-07 Perforator and container for packaged grease
US1979105A (en) * 1934-02-06 1934-10-30 John H Harnish Dispenser
US2772026A (en) * 1955-02-02 1956-11-27 Walter W Bullock Collapsible tube squeezer
US3077078A (en) * 1959-10-13 1963-02-12 Thompson Ramo Wooldridge Inc Injector chamber construction

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6187346B1 (en) 1995-06-07 2001-02-13 Ablation Products, Inc. Intrauterine chemical cauterizing method and composition
US6197351B1 (en) 1995-06-07 2001-03-06 Robert S. Neuwirth Intrauterine chemical necrosing method and composition
US5891457A (en) * 1997-05-12 1999-04-06 Neuwirth; Robert S. Intrauterine chemical necrosing method, composition, and apparatus
US6165492A (en) * 1997-05-12 2000-12-26 Neuwirth; Robert S. Intrauterine chemical necrosing method, composition, and apparatus
US9592375B2 (en) 2006-05-18 2017-03-14 Hyprotek, Inc. Intravascular line and port cleaning methods, methods of administering an agent intravascularly, methods of obtaining/testing blood, and devices for performing such methods
US10076653B2 (en) 2006-05-18 2018-09-18 Hyprotek, Inc. Medical caps and methods of use
US11471245B2 (en) 2006-05-18 2022-10-18 Hyprotek, Inc. Intravascular line and port cleaning methods, methods of administering an agent intravascularly, methods of obtaining/testing blood, and devices for performing such methods

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