Classifications

• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
  • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
  • A61L24/06—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds

Definitions

• This invention is directed to an improved methyl cyanoacrylate composition for use in female sterilization.
• the improved composition provides improved inhibition and long-term storage i.e., longer "shelf-life" of monomeric methyl cyanoacrylate. It also provides enhanced sterilization results.
• Methyl cyanoacrylate (MCA) is a well known chemical product that has found application in the field of permanent sterilization of human females. Sterilization is accomplished by the introduction of small quantities of MCA into the fallopian tubes. Its contact there with body moisture polymerizes the MCA and blocks the fallopian tubes. With the passage of time, fibrous. tissue growth replaces the MCA and permanent sterilization results. This use and procedure is described in the U.S. Patent Nos.
• MCA polymerizes under a variety of conditions including exposure to even trace amounts of moisture, oxygen, heat, high energy radiation, and exposure to active organic sites. Consequently, it is difficult to store MCA for any period of time due to its tendency to autocatalyze itself into a solid cured polymer during storage.
• the improved composition of this invention not only is the "shelf-life" of the MCA improved to as long as six months to over a year, but successful sterilization results are provided which are comparable to those obtained when uninhibited MCA is used, i.e., in close to 100% of the test cases.
• the invention provides a new inhibited MCA composition including amounts of an acid, sulfur dioxide and either hydroquinone, hydroquinone monomethyl ether or butylated hydroxyanisole (BHA).
• BHA butylated hydroxyanisole
• the constituents are preferably used in a very pure form eg., 99.9% pure or better where possible.
• An improved ampule container arrangement is orovided for MCA.
• Figure 1 is a perspective view of an embodiment of an ampule according to the invention.
• Figure 2 is a cross-sectional view of the ampule shown in Figure 1 taken along line 2-2 of Figure 1, and
• FIG 3 is a perspective view of the piston stopper utilized in the ampule shown in Figures 1 and 2.
• the MCA referred to herein, methyl-2-cyanoacryl te may Be any of the commercial forms thereof in which the supplier's inhibitors have been substantially removed i.e., to a purity level of at least about 99.9%.
• Eastman 910 is an example of the moat readily available commercial form. It may be obtained from Eastman Chemical Products, Inc., Box 431, Kingsport, Tennessee 37662.
• inhibitors eg., hydroquinone, phosphoric acid and phosphoric anhydride may be readily separated by distilling the MCA away from the inhibitors under reduced pressure to remove the MCA as the distillate. This should he repeatedly carried out to obtain a high purity MCA eg., one on the order of 99.9% or higher.
• the MCA will be prepared especially for use in the invention without inhibitors so as to provide high purity material.
• the preparation of MCA is known to those familiar with the chemical arts and need not be described in detail herein. Generally, it is prepared by pyrolyzing the poly Calkyl)-2—cyanoacrylates. produced when formaldehyde is condensed with the corresponding alkyl cyanoacetates. Detailed information is available in U.S. Patent 2,763,677 entitled “Process For Making Monomeric Alfa-cyanoacrylates", issued in 1956.
• an organic carboxylic (containing -COOH group) acid is added ranging in amount from about 12,500 ppm to about 60.,000 ppm, about 15,000 ppm + about 100 being preferred.
• ppm is used herein throughout on a mole/mole basis.
• Glacial acetic acid is the preferred acid although other organic carboxylic acids, not harmful to body tissue, such as propionic acid, butyric acid or benzoic acid and many other organic carboxylic acids may be used. However, preferably such acids will be of high purity eg., 99.9% or better.
• Sulfur dioxide (SO 2 ) is also added to the MCA ranging in amounts from about 500 ppm to about 1500 ppm, about 750 ppm + ahout 250 Being preferred. Satisfactory, moisture free, high, purity SO 2 is commercially available from many suppliers. It is dried by the supplier by passing it through a drying tower and is available. 99.9% pure.
• Hydroquinone, hydroquinone monomethyl ether or butylated hydroxyanisole (BHA) are also added to the MCA eithe individually or as a mixture of any two or three thereof.
• This component of the new composition provided herein may range in amount from about 50 ppm to ahout 250 ppm, about 100. ppm + about 10. being preferred.
• Hydroquinone is. the preferred component.
• the relative amounts of the additives specified above for the MCA composition may be varied within the substantial range specified, as desired. That is, when one or more of the additives are increased in amount it is not necessary to decrease the relative amounts of other additives. Any combination of relative amounts within the specified ranges will provide the improvements of the invention as described herein. Any departure from these ranges will drastically and detrimentally affect the results obtained i.e., "shelf life" and sterilization effectiveness.
• the containers in which MCA sterilization compositions 10 are stored take the form of a sealed ampule comprising a cylindrical tube 12, preferably of polytetrafluorethylene (PTFE) sealed at one end 14 by a stopper or diaphragm 16 of rubber or the like which has been spray coated with PTFE 17.
• a closure member preferably in the form of a movable piston 20 molded from Tefzel 280 from Dupont de Nemours Co. of Wilington, Delaware.
• This material is a block polymer of polytetrafluorethylene and polyethylene.
• Piston stopper 20 For sealing the other end of the ampule and for moving toward the diaphragm stopper 16 to force the MCA composition 10 from the ampule chamber 22 which is formed between the two ends thereof. This is accomplished by inserting the needle of a hypodermic syringe through the diaphragm stopper. The piston is then moved to force the material thru the needle out of the container.
• Piston stopper 20 carries an "O" ring 24 fitted in a seat 26 on the piston. Piston 20 may take a variety of shapes, one of which is shown in the drawing for providing effective sealing in cooperation with the inner diameter of the cylinder 12.
• the materials of the "O" ring will be a high modulus rubber such as butyl, natural, buma, neoprene rubber and the like. Similar materials will be used for diaphragm member 16.
• the "O" ring and inner diameter of cylinder 12 will be relatively sized so as to provide a compression seal therebetween.
• polytetrafluorethylene as is the diaphragm 16.
• Container end 14 includes a neck portion 28 to facilitate the press fitting of a metal cap 30 thereto for the purpose of holding diaphragm 16 in place and sealed to cylinder 12 as shown.
• the various plastic parts of the container are molded to tolerances of about + 1 mil of the desired size and are press fit together.
• Nitrogen of this guaranteed purity level is commercially available from many suppliers.
• the container is assembled and filled in a 0.5 ppm oxygen-free nitrogen environment. Consequently, the nitrogen bubble is readily formed in the container. The presence of this bubble protects the MCA from exposure to oxygen which detrimentally affects MCA.

Landscapes

• Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Reproductive Health (AREA)
• Heart & Thoracic Surgery (AREA)
• Surgery (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Epidemiology (AREA)
• Vascular Medicine (AREA)
• Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
• Closures For Containers (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Medicinal Preparation (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Applications Claiming Priority (2)

Publications (2)

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ID=22120896

Family Applications (1)

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• 1980
  • 1980-09-11 WO PCT/US1980/001171 patent/WO1981000701A1/en not_active Application Discontinuation
  • 1980-09-11 JP JP50219080A patent/JPS56501599A/ja active Pending
  • 1980-09-11 AU AU63386/80A patent/AU6338680A/en not_active Abandoned
  • 1980-09-11 BR BR8008824A patent/BR8008824A/pt unknown
• 1981
  • 1981-03-23 EP EP19800901879 patent/EP0036871A4/en not_active Withdrawn
  • 1981-05-01 DK DK194381A patent/DK194381A/da not_active Application Discontinuation
  • 1981-05-05 NO NO811509A patent/NO811509L/no unknown

Non-Patent Citations (1)

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