US3822702A - Dispensing method and apparatus - Google Patents
Dispensing method and apparatus Download PDFInfo
- Publication number
- US3822702A US3822702A US00372971A US37297173A US3822702A US 3822702 A US3822702 A US 3822702A US 00372971 A US00372971 A US 00372971A US 37297173 A US37297173 A US 37297173A US 3822702 A US3822702 A US 3822702A
- Authority
- US
- United States
- Prior art keywords
- uterine cavity
- sleeve member
- balloon assembly
- uterus
- top wall
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
- A61K9/0039—Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/20—Vas deferens occluders; Fallopian occluders
- A61F6/22—Vas deferens occluders; Fallopian occluders implantable in tubes
- A61F6/225—Vas deferens occluders; Fallopian occluders implantable in tubes transcervical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
Definitions
- Bilateral disection of Fallopian tubes is a common surgical procedure used to sterilize a female primate. This procedure involves severing and tying the Fallopian tubes.
- Intrauterine devices as plugs and wires, are used to temporarily sterilize a female. These devices include plugs which are inserted into the canals of the Fallopian tubes to prevent ova from passing the canals into the uterus.
- Smith in 1849 described a method to treat sterilityby passing whale bone splints into the canals. These devices do not insure that theova cannot flow through the canals into the uterus.
- 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 adhesives are used, the cells adjacent the tissue are damaged and eventually replaced with a fibrous tissue. A liquid tissue adhesive has been injected into the uterine cavity with a catheter to occlude the canals of the Fallopian tubes. Studies have been conducted into silver nitrate, zinc chloride and methyl cyanoacrylate to occlude the canals of the Fallopian tubes. These materials have been introduced into the uterine cavity with balloon catheters in an effort to place the materials in the canals of, the Fallopian tubes.
- catheters are not designed to accommodate the different sizes, shapes and characteristics of the uteri and do not insure that the materials areplaced in each canal of the Fallopian tubes. Also, these catheters may direct all the material into one canal so that the material is forced through this canal into the body cavity.
- a dispenser operates to initially expand the balloon assembly to displace the lower portion of the uterine cavity and form a low pressure seal with the inner wall of the lower part of the uterus.
- the balloon assembly can be fully expanded to sense the size of the uterine cavity.
- the balloon assembly is partially contracted to maintain a low pressure seal with the inner wall of the lower part of the uterus.
- the dispenser is then again actuated to discharge a drug material, as a tissue adhesive, into the uterine cavity above the balloon assembly.
- the balloon assembly is then further expanded to displace the remaining space of the uterine cavity.
- the balloon assembly expands and initially engages the midportion of the fundus and thereby divides the drug material into separate portions.
- the further expansion of the balloon assembly forces the separate portions of the drug material into the separate canals of the Fallopian tubes.
- Substantially all of the drug materialintroduced into the uterine cavity is moved into the canals of the Fallopian tubes on expansion of the balloon assembly.
- the tissue adhesive is eventually replaced with scar tissue which permanently occludes the canals.
- a flushing fluid as water, can be introduced into the uterine cavity before the balloon assembly is removed from the cavity.
- the balloon assembly is contracted whereby it can be readily removed from the uterine cavity.
- a further object of the invention is to provide a method and apparatus for introducing drug materials into the canals of the Fallopian tubes which places a minimum amount of force on the walls of the uterus and which can accommodate different sizes, shapes and characteristics of uteri.
- Yet another object of the invention is to provide a method and apparatus for introducing a fluid material into both canals of the Fallopian tubes which is not position sensitive and does not apply substantial pressures to the fluid material whereby the fluid material is not forced into the blood stream.
- FIG. 1 is a sectional view of the reproductive system of a primate female accommodating a dispensing instrument to practice the method of the invention of locating drug material in both canals of the Fallopian tubes;
- FIG. 2 is a sectional view of the uterus of FIG. 1 showing the balloon in an expanded position to divide the uterine cavity;
- FIG. 3 is a sectional view similar to FIG. 2 showing the balloon in the full expanded position forcing the drug material into both canals of the Fallopian tubes.
- a dispensing instrument indicated generally at 20 in operative relation with the female reproductive system indicated generally at 21 of a primate female.
- System 21 has a uterus 22 and a pair of Fallopian tubes 23 and 24.
- the lower part of uterus 22 is integral with an elongate vagina 26.
- the vagina 26 has a vaginal cavity 27 having an opening or entrance 28.
- the opposite end of the cavity 27 is in communication with the cervix 31 having a cervical opening providing a passage from the vaginal cavity 27 into the uterine cavity 32.
- the Fallopian tubes 23 and 24 each have a canal or aqueduct 33 and 34 respectively, which open or exit to the upper part of the uterine cavity 32.
- Uterus 22 is a generally pear-shaped, thick-walled, hollow organ situated between the bladder and rectum.
- the uteri of primate females vary in size and shape.
- the wall thicknesses, strength and sensitivity to pain vary from female to female.
- the inner wall of the uterus may contain lymph nodes and vary in size and configuation.
- the uterine cavities of the uteri vary in size and shape. Some uteri have strong walls while others have Weak and realtively elastic walls.
- the uterine cavity 32 is flattened and triangular in shape.
- the Fallopian tubes 23 and 24 are paired, trumpetshaped, muscular linear members which extend from the superior angles of the uterine cavity to the ovaries (not shown).
- the Fallopian tubes of an adult female are musculo-membranous structures about l2 cm. in length.
- the outlet of the canals of the Fallopian tubes can vary in position relative to the uterine cavity 32.
- the size of the canals 33 and 34 vary from female to female.
- the Fallopian tubes are commonly divided into isthmus, intramural and ampullary sections.
- the canals 33 and 34 provide passages for movement of ova from the ovaries into the uterine cavity 32.
- the intramural sections of the Fallopian tubes traverse the uterine wall in more or less straight fashion.
- the walls of the Fallopian tubes con sist of three layers; the serosal layer, the muscular layer, and the mucosa] lining.
- the muscular layer includes longitudinal muscle fibers which, when contracted, bring the outer ends of the Fallopian tubes into close contact with the surfaces 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 with blood, move the Fallopian tubes to sweep over the surfaces of the ovaries. This movement of the Fallopian tubes is impaired when the tubes are severed and tied.
- the occluding of the canals 33 and 34 with drug material according to the invention does not interfere with the erectile action and movement of the Fallopian tubes relative to the ovaries.
- the uterus 21 has a top wall or fundus 36 and side walls 37 and 38 surrounding the uterine cavity 32.
- the inside of the top wall 36 and the side walls 37 and 38 have an inside lining or membrane 39 which periodically is sloughed off in the normal cycle of the female.
- the dispensing instrument 20 has an elongated probe or tubular support 41 of a length to pass through the vaginal cavity 27 and into the uterine cavity 32.
- the longitudinal position of the probe 41 relative to the uterine cavity 32 is determined by an annular stop member or collar 42
- the collar 42 is secured to the probe 41 adjacent the inner end of an expandable balloon assembly indicated generally at 43.
- Balloon assembly 43 has a sleeve member or tubular membrane 44.
- the upper or outer end of the member 44 is secured to the support 41 with an annular fastener as a collar or threads 46.
- a similar annular fastener 47 secures the inner end of the sleeve member 44 to the probe 4].
- the probe 41 has a plurality of openings 45 to provide for communication of fluid from within the probe 41 to the chamber 69 surrounded by the sleeve member 44.
- the sleeve member 44 is a tubular sheet member of soft and relaxed flexible and elastic material, as rubber or plastic, which expands with a minimum of elongation of the material.
- a tubular sheet member of soft and relaxed flexible and elastic material as rubber or plastic, which expands with a minimum of elongation of the material.
- thin latex rubber having low surface tension, whereby the rubber uniformly expands with a relatively low pressure, is suitable material for sleeve member 44.
- the material of sleeve member 44 readily expands to displace the uterine cavity 32 by conforming to the shape of the cavity without applying extreme pressure to localized portions of the uterus.
- the member 44 is in uniform surface engagement with the inside wall 39.
- Conventional balloon cathethers being of hard, relatively non-elastic material, do not assume the configuration of the uterine cavity when expanded under low pressure.
- a dispenser indicated generally at 48 is secured to the outside end of probe 41.
- Dispenser 48 has a housing or body 49.
- a pair of oppositely directed handles 51 and 52 are secured to the body to serve as finger grips in the use of the instrument.
- the housing 49 has chambers for accommodating containers 53 and 54 connected with passages 56 and 57, respectively.
- the passages 56 and 57 are open to the passage in the probe 41.
- Container 58 is adapted to be coupled to elongated tube 59 extended longitudinally through the probe 41.
- Tube 59 has an outer or discharge end 61 at the outer end of the balloon assembly 43.
- Plungers 62, 63, and 64 slideably mounted on the housing 49, are operable to apply forces to the containers 53, 54 and 58 and thereby discharge the fluids in the containers via the probe 41 to the balloon assembly 43 or the uterine cavity 32.
- Each plunger has a separate lock 66, 67 and 68 respectively which holds the plunger in its inactive position. The locks are manually released, which enables the plungers 62, 63 and 64 to be moved into the housing 49 and thereby apply forces to the containers associated with the plungers.
- Dispenser 48 can be constructed in accordance with the dispenser as shown in FIGS. 1 to 10 in pending US. Pat. application Ser. No. 361,418. The disclosure of this application is incorporated herein by reference. Other types of dispensers can be used to provide fluid under pressure to the balloon assembly 43 and discharge drug materials, tissue adhesives and the like into the uterine cavity 32.
- the tissue adhesive can be cyanoacrylate, silver nitrate, quinacrine material and like material used as surgical glues.
- the cyanoacrylate is a liquid plastic which sets up or polymerizes in response to moisture and thereby functions to occlude the canals of the Fallopian tubes.
- the cyanoacrylates include, but are not limited to, methyl cyanoacrylate, methyl-2-cyanoacrylate, ethyl cyanoacrylates, n-propyl cyanoacrylates, n-butyl cyanoacrylates, n-amyl cyanoacrylates, n-hexl cyanoacrylates, n-heptyl cyanoacrylates, isobutyl-Z- cyanoacrylates and n-octyl cyanoacrylates.
- Quinacrine material is a relatively thick or heavy fluid in the nature of a semi-fluid.
- the pumping action due to the expansion of the sleeve member 44, hereinafter described, in the uterine cavity 32 is effective in moving this material from the uterine cavity into the canals of the Fallopian tubes.
- the drugs 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 dispensing instrument is loaded with the containers 53, 54 and 58.
- the containers can be preloaded prior to the operating procedure.
- the collapsed balloon assembly 43 is moved through the vaginal cavity 27 and through the cervical opening in to the uterine cavity 32. This located the balloon assembly 43 in the lower part of the uterine cavity 32.
- the probe 41 is moved up into the uterus until the collar 42 is located against the cervix 31, as shown in FIG. 1.
- the balloon assembly being in a deflated condition, slides readily through the cervical opening and into the uterine cavity 32.
- the balloon assembly 43 shown in FIG. 1 is positioned in the central longitudinal position. This position is not always achieved in theinsertion procedure.
- the balloon assembly 43 may be located on either side and extend at an angle toward one of the Fallopian tubes.
- the method hereinafter described is operable to move drug materials into both canals regardless of the position of the balloon assembly 43 in the uterine cavity. In other words, to be operable, the balloon assembly is not position sensitive.
- the sleeve member 44 then is expanded by introducing fluid, either liquid or air, under pressure into the balloon cavity 69.
- the sleeve member 44 is partially expanded to till the lower part of the uterine cavity 32 to form a seal with the inner surface 71 of the side walls 37 and 38.
- the top of the balloon assembly 43 is spaced from the inner wall of the fundus 36.
- the sleeve member 44 is initially expanded by releasing the lock 66. This permitsthe plunger 62 to move into the housing 49, forcing the fluid in the container 53 into the balloon chamber 69 via the probe 41.
- Sleeve member 44 of the balloon assembly being of a low tension expandable material, places uniform low pressure on the inner surface 7] of the uterus and assumes the shape of the lower part of the uterine cavity without subjecting any specific portion of the uterus to substantial pressure.
- Balloon assembly 43 can be fully expanded to sense the size of the uterine cavity 32.
- the balloon assembly 43 is partially reduced in size to move it away from the inner wall 73 of the fundus, thereby leaving a space between the inner wall 73 and the partially expanded balloon assembly 43, as shown in FIG. 1.
- Drug material 72 is then dispensed from container 58 by releasing the lock 67.
- the plunger 63 applies force amount of pressure.
- the sleeve member 44 is further expanded until it engages the inner wall 73 of the funexpanded by introducing additional fluid into the balloon chamber 69.
- the sleeve member 44 expands to fill or displace the portions of the uterine cavity leading to the canals 33 and 34 of the Fallopian tubes.
- the expansion of the sleeve member 44 forces the drug materials 720 and 7212 under low pressure into the canals 33 and 34.
- the expanding sleeve member 44 functions as a diaphragm pump to force or move the drug materials 72a and 721) into the canals 33 and 34 respectively.
- the sleeve member 44 being in firm engagement with the inside surface 71 and the inner wall 73, prevents the drug materials 72a and 72b from remaining in the uterine cavity 32. As it expands, the sleeve member 44 does not block or hold drug material as it pushes the drug material into the canals of the Fallopian tubes.
- the canals 33 and 34 will be permanently occluded.
- the tissue adhesives as the cyonoacrylate type, cause fibroplastic proliferation which in time will histologically close the canals 33 and 34.
- the tissue adhesives polymerize when subjected to moist living tissue. The cells adjacent the tissue are damaged and eventually replaced by fibrous tissue.
- the sleeve member 44 then is contracted to about the position shown in FIG. 1.
- a second fluid as water, is then injected into the uterine cavity 32 to dilute and wash away any drug material that remains in the cavity 32.
- the sleeve member 44 is then completely contracted by allowing the fluid in the balloon chamber 69 to drain back into the dispenser 48 or into a reservoir or container attached to the dispenser.
- the balloon assembly is withdrawn from the uterine cavity 32 to conclude the operation.
- a method of placing material in both canals of F allopian tubes open to the uterine cavity of a uterus with an expandable balloon assembly comprising: introducing the balloon assembly into the uterine cavity, expanding the balloon assembly into engagement with the inside side walls of the uterus and spaced from the inside top wall of the uterus, discharging material into the uterine cavity between the expanded balloon assembly and the inside top wall of the uterus, further expanding the balloon assembly into engagement with the top inside wall of the uterus dividing the material into two portions and forcing one portion into one canal with one part of the balloon assembly and the other portion into the other canal with the other portion of the balloon assembly, contracting the balloon assembly, and
- the method of claim 1 including: discharging a second material into the uterine cavity before the balloon assembly is contracted.
- a method of placing material in both canals of Fallopian tubes open to the uterine cavity with an expand able sleeve member comprising: introducing the sleeve member into the uterine cavity, expanding the sleeve member into engagement with the inside side walls and top wall of the uterus to displace the uterine cavity, contracting the expanded sleeve member to move the sleeve member out of engagement with the inside top wall of the uterus, discharging material into the uterine cavity between the contracted sleeve member and the inside top wall of the uterus, expanding the sleeve member to displace the uterine cavity by moving the sleeve member into engagement with the inside top wall ofthe uterus thereby dividing the material into two portions and forcing one portion into one canal with one part of the sleeve member and the other portion into the other canal with another part of the sleeve member, contracting the sleeve member, and removing the contracted sleeve member from the
- the method of claim 6 including: discharging a second material into the uterine cavity after the first material has been moved into the canals and before the sleeve member is contracted for removal from the uterine cavity.
- An apparatus for placing material in both canals of Fallopian tubes comprising: a balloon assembly having an expandable sleeve member, elongated means supporting the balloon assembly, means on the elongated means to position the balloon assembly in the uterine cavity spaced from the inside top wall of the uterus, first means operable to expand the sleeve member into engagement with the inside side walls of the uterus, second means for discharging material into the uterine cavity between the expanded sleeve member and the inside top wall of the uterus, said first means being operable to further expand the sleeve member into engagement with the inside top wall of the uterus whereby the material is divided into two separate portions, said further expansion of the sleeve member forcing one portion into one canal of one Fallopian tube and the other portion into the other canal of the other Fallopian tube.
- the sleeve member is made of expandable tubular sheet material having low surface tension properties.
- the elongated means is a tubular member connected to the first means and second means.
Abstract
Description
Claims (13)
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
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US00372971A US3822702A (en) | 1973-06-25 | 1973-06-25 | Dispensing method and apparatus |
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. |
US05/543,875 USRE29207E (en) | 1973-06-25 | 1975-01-24 | Dispensing method and apparatus |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US00372971A US3822702A (en) | 1973-06-25 | 1973-06-25 | Dispensing method and apparatus |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US05/543,875 Reissue USRE29207E (en) | 1973-06-25 | 1975-01-24 | Dispensing method and apparatus |
Publications (1)
Publication Number | Publication Date |
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US3822702A true US3822702A (en) | 1974-07-09 |
Family
ID=23470383
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US00372971A Expired - Lifetime US3822702A (en) | 1973-03-09 | 1973-06-25 | Dispensing method and apparatus |
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US (1) | US3822702A (en) |
Cited By (45)
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US3982537A (en) * | 1974-12-30 | 1976-09-28 | Louis Bucalo | Dynamic implants and method for implanting the same |
US4030499A (en) * | 1974-12-30 | 1977-06-21 | Louis Bucalo | Method and apparatus for providing living beings with absorbable implants |
US4086266A (en) * | 1977-04-06 | 1978-04-25 | Population Research Incorporated | Method of bacterially purifying methyl cyanoacrylate |
US4119098A (en) * | 1977-01-10 | 1978-10-10 | Population Research Incorporated | Material dispensing apparatus |
US4136695A (en) * | 1975-07-09 | 1979-01-30 | Gynetech-Denver, Inc. | Transvaginal sterilization instrument |
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US4185618A (en) * | 1976-01-05 | 1980-01-29 | Population Research, Inc. | Promotion of fibrous tissue growth in fallopian tubes for female sterilization |
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US4637818A (en) * | 1983-11-25 | 1987-01-20 | Johnson Richard K | Apparatus for producing sterility in female animals |
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EP0767688A1 (en) * | 1994-06-27 | 1997-04-16 | InnerDyne, Inc. | Transcervical uterine access and sealing device |
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US10070888B2 (en) | 2008-10-03 | 2018-09-11 | Femasys, Inc. | Methods and devices for sonographic imaging |
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US11045246B1 (en) | 2011-01-04 | 2021-06-29 | Alan N. Schwartz | Apparatus for effecting feedback of vaginal cavity physiology |
US11179178B2 (en) | 2017-08-31 | 2021-11-23 | Cook Medical Technologies Llc | Vaginal positioner for uterine tamponade device and methods of using the same |
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US3459175A (en) * | 1966-04-08 | 1969-08-05 | Roscoe E Miller | Medical device for control of enemata |
US3452749A (en) * | 1966-10-27 | 1969-07-01 | Edwin H Riedell | Contraceptive device |
US3401689A (en) * | 1967-05-23 | 1968-09-17 | Eugene C. Greenwood | Intra-uterine contraceptive device and method and apparatus for inserting and retaining the same |
US3680542A (en) * | 1970-05-11 | 1972-08-01 | Hugo S Cimber | Device for occlusion of an oviduct |
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US6193763B1 (en) | 1998-12-17 | 2001-02-27 | Robert A. Mackin | Apparatus and method for contemporaneous treatment and fluoroscopic mapping of body tissue |
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