EP0550694A4 - Electrical microcurrent transmitting elastomeric or rigid materials - Google Patents

Electrical microcurrent transmitting elastomeric or rigid materials

Info

Publication number
EP0550694A4
EP0550694A4 EP19910919726 EP91919726A EP0550694A4 EP 0550694 A4 EP0550694 A4 EP 0550694A4 EP 19910919726 EP19910919726 EP 19910919726 EP 91919726 A EP91919726 A EP 91919726A EP 0550694 A4 EP0550694 A4 EP 0550694A4
Authority
EP
European Patent Office
Prior art keywords
biocompatible material
latex
butanol
propanol
fibers
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.)
Withdrawn
Application number
EP19910919726
Other languages
French (fr)
Other versions
EP0550694A1 (en
Inventor
Robert Findley Echols Jr.
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from GB909021085A external-priority patent/GB9021085D0/en
Priority claimed from GB909026020A external-priority patent/GB9026020D0/en
Application filed by Individual filed Critical Individual
Publication of EP0550694A1 publication Critical patent/EP0550694A1/en
Publication of EP0550694A4 publication Critical patent/EP0550694A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B10/0058Devices for taking samples of body liquids for taking sperm samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B42/00Surgical gloves; Finger-stalls specially adapted for surgery; Devices for handling or treatment thereof
    • 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • 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
    • A61F6/02Contraceptive devices; Pessaries; Applicators therefor for use by males
    • A61F6/04Condoms, sheaths or the like, e.g. combined with devices protecting against contagion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/12Mammary prostheses and implants
    • 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2/2803Bones for mandibular reconstruction
    • 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones
    • A61F2002/2821Bone stimulation by electromagnetic fields or electric current for enhancing ossification
    • 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30563Special structural features of bone or joint prostheses not otherwise provided for having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
    • 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
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/307Prostheses for animals
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0081Prosthesis for animals

Definitions

  • the present invention is directed to materials capable of transmitting electrical currents naturally found in the bioelectric system of human beings and animals, which material in normal use is impermeable to passage of bacteria or viruses, and articles and prosthetic devices made from them for use with human beings and animals.
  • the material according to the invention is a natural or synthetic polymer material having the physical characteristics of rubber or latex or combinations thereof and also rigid polymers as set forth herein for medical and other uses which bar the passage of bacteria or viruses in normal use and permits the passage of currents of the order of the bioelectric system of the human body and other mam alian bodies, and also the discharge of static electricity which is desirable in surgical operating rooms and clean room work and all other uses for an electrically conductive elastomer. Also, there are rigid, not elastomeric polymers which may be made conductive.
  • polystyrene acrylonitrile butadiene styrene
  • ABS acrylonitrile butadiene styrene
  • PET polyethylene terephthalate
  • EPDM silicone rubber
  • KRATONTM polymethylmethacrylate
  • P A polypropylene
  • PP polyacetal
  • polyamids NYLON 6,66,6/10,12 cellulose acetate
  • polytetrafluroethylene TeflonTM.
  • the material, elastomeric synthetic polymer useful in medicine or latex may have dispersed throughout either carbonaceous filamentous fibers, natural silk fibers or other fibers or combinations thereof capable of conducting electricity with very little resistance when moistened by an electrolyte.
  • carbon filaments ranging from approximately 10-5 millimicrons in diameter up to approximately 2,000 millimicrons or more in length can be dispersed throughout.
  • the fibers can be relatively kinked or coiled or folded so that the material can be stretched.
  • a thin sheet of pure elastomer or polymeric material on each side of the filament containing sheet can be provided.
  • the fibers may be omitted, if desired.
  • the hard polymers are conductive but may be carbon particles, if desired.
  • Figure 1 illustrates a cross section of a sheet of material not requiring stretching or friction resistance properties.
  • Figure 2 illustrates a nonper eable sheet of material which can be stretched and which prevents passage of bacteria, virus or fluids.
  • Figure 3 is a cross section illustrating a prosthetic device which is biocompatible, for example, a chin implant.
  • Figure 4 is the biocompatible material without filaments capable of transmitting microcurrents of the bioelectric system of human beings and animals.
  • Figure 5 illustrates a condom made of the material of Figures 2 or 4.
  • Figure 6 illustrates gloves made from a biocompatible material of Figures 2 or 4 usable in medicine for surgeons, dentists, medical technicians, veterinarians, and the like.
  • Figure 7 is a fragmentary perspective view of a vascular prosthesis made from a conductive medical polymer.
  • Figure 8 is a cross-sectional view of an orthopedic prosthesis having a conductive medical polymer outer coating.
  • Figure 9A is a front view and Figure 9B is a side view of an electrically conductive implantable lens.
  • Figure 10A is a side view and Figure 10B is a front view of an electrically conductive breast implant. Best Mode for Carrying out the Invention
  • the material, products, and prostheses can be made by mold dipping, spraying the material on molds or injection molding with the electrically-conductive filaments or fibers dispersed in the material. In some cases, elastomer without filaments is applied on surfaces, such as by dipping or spraying.
  • the electrically conductive fibers or filaments can be carbonaceous or silk, nylon, dacron, rayon or other filaments moistened with an electrolyte, such as sodium chloride, potassium chloride as found in human blood, which are electrically conductive in a highly humid atmosphere.
  • the carbonaceous filaments should comprise from about 5 percent to 65 percent dry weight of the material if used alone.
  • the silk alone or with other fibers in combination (no carbonaceous material) should comprise about 1 percent to about 55 percent dry weight of the material.
  • the filaments or fibers should be coiled or kinked or folded accordion style.
  • the resulting fiber encasing material has extremely low resistance to electric current, particularly in thin sheets.
  • the electrical resistance is so low that the microcurrents sufficient for the firing of nerve cells actually "jump the gap" on the 4/1,000 inch film when liquid electrolyte is present on both sides of the elastomeric material.
  • the pure non-fiber material of natural latex or synthetic polymer of Figure 4 produced as described subsequently has resistance in ranges of 2000 ohms for 4/1000 inch of thickness of the material.
  • the resistance is in the range of 300-320 OHMS.
  • the material is also a barrier to bacteria or viruses (Figure 2) .
  • the electric resistance does not increase appreciably with stretching of the material. Wherever there are living cells, there is electrical function.
  • This material provides a physical barrier to the passage of bacteria or viruses while permitting electrical functions to continue through the material in almost a normal manner.
  • the antistatic function of the material will help prevent any explosive potential, for example, in operating rooms, chemical plants, and the like. Also, antistatic prevention on electronics, particularly in clean rooms, will be superior. Powdered or especially liquid electrolytes optimize conductivity when used on the surfaces of the elastomeric material. Because of its electrical conductivity, the material is especially suited for both male and female condoms, such as illustrated in Figure 5. As set forth in The Bioelectrical Investigation of Sexuality and Anxiety, Wilhelm Reich, Farrar, Straus and Giroux, New York, 1982, "sexual excitation is functionally identical to the bioenergetic charge of the erogenous zones. Anxiety excitation goes together with a decrease in the surface charge.
  • the sexual function is one of the general electrical processes that occur in nature.
  • the erogenous zones are capable of registering extremely intense sensation and of generating high bioelectrical charge.
  • a higher electrical potential also corresponds to a more intense state of excitation, which is experienced subjectively as a more intense sensation of excitation or current.
  • the arrangement of membranes, boundary surfaces ' , and fluids during sexual intercourse indicates that a complete electrolytic system has been established.
  • the surface of the penis must be seen as one electrode and the vaginal mucosa as the other.
  • the present invention is also well adapted and suited for the collection of semen for artificial insemination for both human and in animal husbandry, i.e., champion bulls, thoroughbred horses, etc. and optimizes physiology in ways not fully understood at the present time, as though the bioelectric circuit was completed as in nature.
  • the present invention is applicable to all devices, prostheses and the like requiring the properties of elasticity or flexibility and electrical conductivity in a solid, three-dimension mass of materials as, for example, plastic surgeons* prosthetic devices, chin implants, ( Figure 3), breast augmentation, etc.; also oral and maxillo-facial surgeon implant materials such as maxillary or mandibular ridge implants in edentulous patients.
  • biocompatibility of this highly conductive material is much more acceptable and compatible for mammalian body items, for example, interuterine devices (IUDs) .
  • rigid polymers may be made electrically conductive by including n-propanol and n-butanol.
  • Figure l illustrates electrically conducting sheeting 10 with short 12 and long 14 coiled electrically conducting fibers not requiring stretching or friction resistance properties.
  • Figure 2 illustrates a sheet 15 which is impermeable to physical items such as bacteria, virus or sperm and is composed of the sheet 10 of Figure 1 having an outer coating or layer 16 of elastomer dipped or sprayed on the sheet 10.
  • Figure 3 illustrates a prosthesis, a superior portion of a chin implant 18 formed of the material 10 of Figure l and coated with a pure elastomer layer 16.
  • Figure 4 illustrates a sheet 20 of an electrically conductive medical polymer without fibers according to the invention.
  • Figure 5 illustrates a condom 21, which can be for male or female, made of the material of Figures 2 or 4.
  • the condom 20 can be for animal husbandry, sperm collection, animal breeding purposes and the like.
  • a glove 22 is illustrated made of electrically conductive material according to the invention.
  • the glove can be used for surgical, general medical, dental, veterinary medicine and clean rooms.
  • the invention is applicable to the full range of medical, dental, veterinary medicine fields for artificial organs and prosthetic devices, which include hard, rigid types, soft elastomer types, combinations of both types and any of the foregoing with metal as needed.
  • Figure 7 illustrates a vascular prosthesis 24 formed of an electrically conductive medical polymer.
  • Figure 8 illustrates an orthopedic joint prosthesis 26 having a metal core 28, an insulating layer 30 covered with a layer of electrically conductive medical polymer.
  • Figures 9A and 9B illustrate a soft lens implant 34, and
  • Figures 10A and 10B illustrate a soft breast implant 36 made of the electrically conductive materials of the invention.
  • Combinations of the electrically conductive medical material with metal are primarily for but not limited to orthopedic prosthesis.
  • the metal is preferably non-magnetic covered with an insulating material 30 ( Figure 8) which can be any compatible material, such as TeflonTM, and the outermost layer 32 is the conductive material. Titanium or titanium alloy is preferred. TeflonTM or other appropriate material is used to cover screws or asteners, and, if feasible, titanium screws are preferred with titanium bodies.
  • Examples of combinations of hard and soft polymers include facial reconstruction with a hard polymer replacing bone and soft conductive polymer replacing the overlying soft tissue. Also, a bone and joint prosthesis with the bone of hard polymer and the articulating surfaces of the joint of softer electrically conductive polymer mimicking cartilage properties. A synovial fluid analog serves as the lubricant.
  • the hard polymers by their nature are limited to decreased electrical resistance. The invention is applicable to all medical prosthesis and organs including cardiovascular, neurosurgical, orthopedic, plastic surgery, dental, sensory and metabolic prosthesis.
  • the silk fibers are naturally occurring triangular shaped (in cross section) filaments usually .00020 inches in diameter.
  • the synthetic fibers may be (in cross section) round, square, rectangular bands, irregular or triangular shaped in the range of .0001 inches to .002 inches in 'diameter.
  • the ideal is .00020 inches in diameter.
  • Fibers should be in "bundles” or a “thread” of about seven fibers.
  • threads or bundles for the thin sheet material i.e. gloves, condoms, dental rubber dams, etc.
  • These threads or bundles for the thin sheet material have a length equal to the thickness of the material. (Example: If 4/1000 inches thick material, use 4/1000 inch length bundles.)
  • one-eighth of the fibrous threads uniformly distributed has a length seven times the length of the shorter fibers.
  • Implant materials have fibers in the same order of size.
  • the fibrous bundles (threads) of filaments are to be saturated with an electrolyte of biocompatible nature and concentration.
  • the electrolyte formula and concentration are not harmful or irritating to human skin (integument) or mucous tissue, even for protracted periods (as a surgical implant would have) .
  • Gloves or condoms male or female, human or animal
  • the saturated bundles are then blotted so they are moist, not dripping wet, and then incorporated into the elastomer at a temperature that is low enough so as not to dry the fibers.
  • Any desired type of electrolytes can be used, such as gels used in making electrical connections to humans in medical testing or sodium chloride or potassium chloride solutions as found in the blood of warm blooded vertebrates.
  • This compartment (within the elastomer) of electrolyte dampened fibers forms a humidor and gives both a conductive property and a capacitor-like function for microcurrents.
  • the relative humidity within this micro chamber should be as high as fabrication techniques will permit, a range of 97, 98 or 99% at body temperature. Therefore, a relatively low fabrication temperature is specified to fulfill this requirement.
  • the multitude of humidor-chambers (filled with electrolyte moistened fibers) is separated from each other, in the main, by capillary walls of elastomer.
  • the capacitor-like effect of the compartments store and build up the current and then effect the current required to jump the gap of the capillary-like walls. This is the basis of the microcurrent transmission with fibers or filaments.
  • the non-fibrous materials of the invention are elastomeric and nonelasto eric materials and the medical polymers previously referred to possessing resistance in the range of 500 ohms per 1/1,000 inch thickness of material. These materials may be classified under the headings of Natural Rubber type and Synthetic type polymers, such as natural rubber, polyurethane, butylrubber (IIF) , neoprene (CCR) , nitrile rubber (NBR) , polyethylene (PE) , polyvinyl alcohol (PVAV) , polyvinyl chloride (PVC) , ethylene vinyl alcohol (PE/EVAL) , TeflonTM (PTFE) , VitronTM (FPM) , SaranexTM
  • Natural Rubber type and Synthetic type polymers such as natural rubber, polyurethane, butylrubber (IIF) , neoprene (CCR) , nitrile rubber (NBR) , polyethylene (PE) , polyvinyl alcohol
  • PVDC/PE Vinyl Visco/PE
  • other materials having the physical properties of rubber or latex.
  • Example 1 The following examples set forth current best modes of preparing the electrically conductive material.
  • a natural rubber material is made with petrochemical origin n-butanol.
  • n-butanol a solution of three alcohols totaling 6 to 14% by volume and natural Latex with the balance water (with solids by weight of 30 to 66%) .
  • the alcohol solution which is used with the petrochemical based butanol only, is made up of 8 to 15% of plant origin (only) ethanol; 3 to 7% n-propanol of either petrochemical or plant origin; and the balance of petrochemical based n-butanol.
  • the natural rubber material was combined with vegetable or animal origin n-butanol.
  • the solution contained two alcohols totaling 6 to 14% by volume and natural latex of 30 to 66% solids by weight and the balance water to 100%.
  • the alcohols comprise from 3 to 7% n-propanol of either petrochemical or vegetable origin with the balance being the vegetable origin n-butanol of a special method of extraction, as later described.
  • Example 3 The synthetic type material is composed of either of the above two alcohol solutions comprising 6 to 14% by volume with 30 to 60% polyurethane by weight and the balance water.
  • Example 4 Presently preferred methods of making these materials include the following. Physically separate (distill) ethanol from products of the selective bacterial fermentation of carbohydrate containing materials such as grains, molasses, or sugars as cane or beet sugar.
  • the ethanol used must be of vegetable origin to gain the unique high solubility between latex and alcohol needed between the vegetable origin latex and the mineral origin of petrochemical n-butanol and n-propanol.
  • Natural latex normally coagulates and is unusable upon the addition of approximately 5% of butanols or other complex alcohols, (propanol or longer chain) .
  • the absorption of butanol is in the range of 12% and higher.
  • n-butanol If the alternative method of using plant origin n-butanol " is used, the fermentation and distillation of carbohydrates will provide this n-butanol. However, since the temperature of 110°C is never to be exceeded with any of the ingredients used, and the boiling point of n-butanol is 117.7°C, a partial vacuum distillation must be needed.
  • Latex should be at room temperature or refrigerated, preferably to 42°F and the solution of alcohols refrigerated to 32°F prior to mixing. The solutions should not be exposed to magnetic fields or electrical fields. Use glass or ceramic preferably, or plastic or nonmagnetic metal vessels for all solutions preferably 24 hours prior to experiment, and do not place solutions closer than eight inches to ferrous or other magnetic metals before or during incorporation of ingredients.
  • Ethanol is to be of organic origin and physically separated (i.e. distilled from natural, not artificially fortified wine or other organic material containing ethanol) when using natural latex. Ethanol can be of petrochemical origin when using polyurethane.
  • Organic origin n-butanol and n-propanol are preferred ingredients, but if unobtainable, these two ingredients can be of petrochemical origin.
  • Example 7 The purpose of this experiment was to determine the amount of alcohol solution mix (ethanol - 10%, n-butanol - 85% and n-propanol - 5%) that can be added to 30% total solids natural rubber latex without any coagulation.
  • Alcohol Solution Mix Formulation ethanol 10% 20 ml n-butanol 85% 170 ml n-propanol 5% 10 ml
  • Latex-Alcohol Compounding Alcohol mix from part C was added to the latex at a rate of 1.6 ml/minute.
  • condoms were made using the natural rubber latex-alcohol compound.
  • Latex-Alcohol Compounding Repeated the procedures given in Example 7 by adding 75 ml alcohol mix into 750 ml of compounded latex.
  • Examples 6, 7 and 8 There was no latex coagulation in Examples 6, 7 and 8.
  • the condoms were made by dipping a glass former into the alcohol-latex compound and drying it in an oven at 70°C until the rubber film became translucent and free from whiteness. The outside was dusted with talc powder and it was stripped from the former by dusting the inside to prevent stickiness.
  • Example 9 In this example fibers as previously described are incorporated in the latex material which provides a satisfactory material capable of conducting microcurrents of the order of the bioelectric system of the human and other mammalian bodies and also discharges static electricity.
  • the electrically conductive material can be used for a wide variety purposes, such as conductive rubber sheeting for general medical, surgical, dental, veterinary medicine and associates fields. It is useful as a viral and bacterial barrier while conducting normal body surface electrical currents; for example, as in holding and nurturing of infected infants and children while allowing exchange and balancing of normal body currents.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Epidemiology (AREA)
  • Reproductive Health (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Dermatology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pathology (AREA)
  • Hematology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Prostheses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Abstract

Disclosed are biocompatible elastomeric and rigid materials (10) capable of transmitting microcurrents of the order of the electric system of human beings and animals, which materials (10) in normal use are impervious to passage of bacteria or viruses, articles and prosthetic devices made from them for use with human beings and animals, and their methods of manufacture.

Description

ELECTRICAL MICROCURRENT TRANSMITTING ELASTOMERIC OR RIGID MATERIALS"
Technical Field
The present invention is directed to materials capable of transmitting electrical currents naturally found in the bioelectric system of human beings and animals, which material in normal use is impermeable to passage of bacteria or viruses, and articles and prosthetic devices made from them for use with human beings and animals. Background Art
Articles and products to be used by surgeons, physicians, dentists, medical technicians, veterinarians, and the general public, such as condoms (male and female) , prostheses, rubber gloves, human and animal implants in current use do not conduct or transmit microcurrents of the order of the bioelectric system of human beings and animals but block or diminish the passage of such microcurrents thereby interrupting and interfering with the natural function of the bioelectric system of human beings and animals. Other products and prosthesis are set forth subsequently. Disclosure of Invention The material according to the invention is a natural or synthetic polymer material having the physical characteristics of rubber or latex or combinations thereof and also rigid polymers as set forth herein for medical and other uses which bar the passage of bacteria or viruses in normal use and permits the passage of currents of the order of the bioelectric system of the human body and other mam alian bodies, and also the discharge of static electricity which is desirable in surgical operating rooms and clean room work and all other uses for an electrically conductive elastomer. Also, there are rigid, not elastomeric polymers which may be made conductive. These include the current polymers used in medicine which are satisfactory for use in the present invention include polystyrene, acrylonitrile butadiene styrene (ABS) , polycarbonate, polyethylene terephthalate (PET) , polyurethane, PET, PET 6, polysulfone, silicone rubber (EPDM) , KRATON™, polymethylmethacrylate (P A) , polypropylene (PP) , polyacetal, polyamids NYLON 6,66,6/10,12, cellulose acetate, polytetrafluroethylene, Teflon™. If desired, the material, elastomeric synthetic polymer useful in medicine or latex, may have dispersed throughout either carbonaceous filamentous fibers, natural silk fibers or other fibers or combinations thereof capable of conducting electricity with very little resistance when moistened by an electrolyte. For example, carbon filaments ranging from approximately 10-5 millimicrons in diameter up to approximately 2,000 millimicrons or more in length can be dispersed throughout. The fibers can be relatively kinked or coiled or folded so that the material can be stretched. Also, a thin sheet of pure elastomer or polymeric material on each side of the filament containing sheet can be provided. The fibers may be omitted, if desired. The hard polymers are conductive but may be carbon particles, if desired. Brief Description of Drawings
Figure 1 illustrates a cross section of a sheet of material not requiring stretching or friction resistance properties.
Figure 2 illustrates a nonper eable sheet of material which can be stretched and which prevents passage of bacteria, virus or fluids. Figure 3 is a cross section illustrating a prosthetic device which is biocompatible, for example, a chin implant.
Figure 4 is the biocompatible material without filaments capable of transmitting microcurrents of the bioelectric system of human beings and animals.
Figure 5 illustrates a condom made of the material of Figures 2 or 4.
Figure 6 illustrates gloves made from a biocompatible material of Figures 2 or 4 usable in medicine for surgeons, dentists, medical technicians, veterinarians, and the like.
Figure 7 is a fragmentary perspective view of a vascular prosthesis made from a conductive medical polymer. Figure 8 is a cross-sectional view of an orthopedic prosthesis having a conductive medical polymer outer coating.
Figure 9A is a front view and Figure 9B is a side view of an electrically conductive implantable lens. Figure 10A is a side view and Figure 10B is a front view of an electrically conductive breast implant. Best Mode for Carrying out the Invention
The material, products, and prostheses can be made by mold dipping, spraying the material on molds or injection molding with the electrically-conductive filaments or fibers dispersed in the material. In some cases, elastomer without filaments is applied on surfaces, such as by dipping or spraying. The electrically conductive fibers or filaments can be carbonaceous or silk, nylon, dacron, rayon or other filaments moistened with an electrolyte, such as sodium chloride, potassium chloride as found in human blood, which are electrically conductive in a highly humid atmosphere. The carbonaceous filaments should comprise from about 5 percent to 65 percent dry weight of the material if used alone. The silk alone or with other fibers in combination (no carbonaceous material) should comprise about 1 percent to about 55 percent dry weight of the material. For stretchable applications, the filaments or fibers should be coiled or kinked or folded accordion style.
The resulting fiber encasing material has extremely low resistance to electric current, particularly in thin sheets. For example, in a sheet having a thickness of 4/1,000 of an inch or the thickness of condoms commercially available, the electrical resistance is so low that the microcurrents sufficient for the firing of nerve cells actually "jump the gap" on the 4/1,000 inch film when liquid electrolyte is present on both sides of the elastomeric material. The pure non-fiber material of natural latex or synthetic polymer of Figure 4 produced as described subsequently has resistance in ranges of 2000 ohms for 4/1000 inch of thickness of the material. For 4/1,000 inch thick material with fibers or filaments (Figures 1 and 2) the resistance is in the range of 300-320 OHMS. The material is also a barrier to bacteria or viruses (Figure 2) . Also the electric resistance does not increase appreciably with stretching of the material. Wherever there are living cells, there is electrical function. This material provides a physical barrier to the passage of bacteria or viruses while permitting electrical functions to continue through the material in almost a normal manner. Among the uses for and products made of the material are the following: Gloves for surgeons, dentists, medical technicians, veterinarians, and all persons working with living mammalian bodies as illustrated in Figure 6. It is well known and accepted that there is electrical potential in all living tissue and electrical aberrations in diseased tissues, ill persons or animals. In general, by establishing an electrical connection through the hands of the healer, the patient tends to be electrically normalized and healing is facilitated. Also, electrical grounding occurs in a surgical operating room. While the doctor is protected from harmful bacteria and viruses, the patient benefits whether from a surgeon, dentist, masseuse, physiotherapist, veterinarian, and the like.
The antistatic function of the material will help prevent any explosive potential, for example, in operating rooms, chemical plants, and the like. Also, antistatic prevention on electronics, particularly in clean rooms, will be superior. Powdered or especially liquid electrolytes optimize conductivity when used on the surfaces of the elastomeric material. Because of its electrical conductivity, the material is especially suited for both male and female condoms, such as illustrated in Figure 5. As set forth in The Bioelectrical Investigation of Sexuality and Anxiety, Wilhelm Reich, Farrar, Straus and Giroux, New York, 1982, "sexual excitation is functionally identical to the bioenergetic charge of the erogenous zones. Anxiety excitation goes together with a decrease in the surface charge. The concept of "libido" as a yardstick of "psychic energy" is no longer a mere metaphor, but applies to energetic processes. Thus, the sexual function is one of the general electrical processes that occur in nature. The erogenous zones are capable of registering extremely intense sensation and of generating high bioelectrical charge. A higher electrical potential also corresponds to a more intense state of excitation, which is experienced subjectively as a more intense sensation of excitation or current. The arrangement of membranes, boundary surfaces', and fluids during sexual intercourse indicates that a complete electrolytic system has been established. The surface of the penis must be seen as one electrode and the vaginal mucosa as the other. The contact between the two is made by the acidic female secretion acting as an electrolyte." This is in nature without a condom the author is referring to. Using the condom, an electrolyte as K-Y Jelly should be applied to the head of the penis which is the male electrod . The acidic secretion of the vaginal mucosa is the other electrolyte. Accordingly, it is highly advantageous and desirable of utilizing a condom, male or female, which conducts bioelectricity or has low electrical resistance to provide the mutual balancing or electrical exchange between male and female partners rather than using an electrically nonconducting condom.
The present invention is also well adapted and suited for the collection of semen for artificial insemination for both human and in animal husbandry, i.e., champion bulls, thoroughbred horses, etc. and optimizes physiology in ways not fully understood at the present time, as though the bioelectric circuit was completed as in nature. The present invention is applicable to all devices, prostheses and the like requiring the properties of elasticity or flexibility and electrical conductivity in a solid, three-dimension mass of materials as, for example, plastic surgeons* prosthetic devices, chin implants, (Figure 3), breast augmentation, etc.; also oral and maxillo-facial surgeon implant materials such as maxillary or mandibular ridge implants in edentulous patients. The biocompatibility of this highly conductive material is much more acceptable and compatible for mammalian body items, for example, interuterine devices (IUDs) . Also, rigid polymers may be made electrically conductive by including n-propanol and n-butanol.
Referring now to the drawings, representative examples of the material of the invention and uses thereof are illustrated. Figure l illustrates electrically conducting sheeting 10 with short 12 and long 14 coiled electrically conducting fibers not requiring stretching or friction resistance properties.
Figure 2 illustrates a sheet 15 which is impermeable to physical items such as bacteria, virus or sperm and is composed of the sheet 10 of Figure 1 having an outer coating or layer 16 of elastomer dipped or sprayed on the sheet 10.
Figure 3 illustrates a prosthesis, a superior portion of a chin implant 18 formed of the material 10 of Figure l and coated with a pure elastomer layer 16.
Figure 4 illustrates a sheet 20 of an electrically conductive medical polymer without fibers according to the invention.
Figure 5 illustrates a condom 21, which can be for male or female, made of the material of Figures 2 or 4. The condom 20 can be for animal husbandry, sperm collection, animal breeding purposes and the like.
Referring now to Figure 6, a glove 22 is illustrated made of electrically conductive material according to the invention. The glove can be used for surgical, general medical, dental, veterinary medicine and clean rooms.
The invention is applicable to the full range of medical, dental, veterinary medicine fields for artificial organs and prosthetic devices, which include hard, rigid types, soft elastomer types, combinations of both types and any of the foregoing with metal as needed.
For example, Figure 7 illustrates a vascular prosthesis 24 formed of an electrically conductive medical polymer. Figure 8 illustrates an orthopedic joint prosthesis 26 having a metal core 28, an insulating layer 30 covered with a layer of electrically conductive medical polymer. Figures 9A and 9B illustrate a soft lens implant 34, and Figures 10A and 10B illustrate a soft breast implant 36 made of the electrically conductive materials of the invention.
Combinations of the electrically conductive medical material with metal are primarily for but not limited to orthopedic prosthesis. The metal is preferably non-magnetic covered with an insulating material 30 (Figure 8) which can be any compatible material, such as Teflon™, and the outermost layer 32 is the conductive material. Titanium or titanium alloy is preferred. Teflon™ or other appropriate material is used to cover screws or asteners, and, if feasible, titanium screws are preferred with titanium bodies.
Examples of combinations of hard and soft polymers include facial reconstruction with a hard polymer replacing bone and soft conductive polymer replacing the overlying soft tissue. Also, a bone and joint prosthesis with the bone of hard polymer and the articulating surfaces of the joint of softer electrically conductive polymer mimicking cartilage properties. A synovial fluid analog serves as the lubricant. The hard polymers by their nature are limited to decreased electrical resistance. The invention is applicable to all medical prosthesis and organs including cardiovascular, neurosurgical, orthopedic, plastic surgery, dental, sensory and metabolic prosthesis.
Specifics of Fibers The silk fibers are naturally occurring triangular shaped (in cross section) filaments usually .00020 inches in diameter.
The synthetic fibers may be (in cross section) round, square, rectangular bands, irregular or triangular shaped in the range of .0001 inches to .002 inches in 'diameter. The ideal is .00020 inches in diameter.
Fibers should be in "bundles" or a "thread" of about seven fibers.
These threads or bundles for the thin sheet material (i.e. gloves, condoms, dental rubber dams, etc.) have a length equal to the thickness of the material. (Example: If 4/1000 inches thick material, use 4/1000 inch length bundles.) Preferably, one-eighth of the fibrous threads uniformly distributed has a length seven times the length of the shorter fibers.
Implant materials have fibers in the same order of size.
The fibrous bundles (threads) of filaments are to be saturated with an electrolyte of biocompatible nature and concentration. The electrolyte formula and concentration are not harmful or irritating to human skin (integument) or mucous tissue, even for protracted periods (as a surgical implant would have) . Gloves or condoms (male or female, human or animal) could have a stronger concentration of electrolytes if desirable electrically. The saturated bundles are then blotted so they are moist, not dripping wet, and then incorporated into the elastomer at a temperature that is low enough so as not to dry the fibers. Any desired type of electrolytes can be used, such as gels used in making electrical connections to humans in medical testing or sodium chloride or potassium chloride solutions as found in the blood of warm blooded vertebrates.
This compartment (within the elastomer) of electrolyte dampened fibers forms a humidor and gives both a conductive property and a capacitor-like function for microcurrents. The relative humidity within this micro chamber should be as high as fabrication techniques will permit, a range of 97, 98 or 99% at body temperature. Therefore, a relatively low fabrication temperature is specified to fulfill this requirement. The multitude of humidor-chambers (filled with electrolyte moistened fibers) is separated from each other, in the main, by capillary walls of elastomer. The capacitor-like effect of the compartments store and build up the current and then effect the current required to jump the gap of the capillary-like walls. This is the basis of the microcurrent transmission with fibers or filaments.
The non-fibrous materials of the invention are elastomeric and nonelasto eric materials and the medical polymers previously referred to possessing resistance in the range of 500 ohms per 1/1,000 inch thickness of material. These materials may be classified under the headings of Natural Rubber type and Synthetic type polymers, such as natural rubber, polyurethane, butylrubber (IIF) , neoprene (CCR) , nitrile rubber (NBR) , polyethylene (PE) , polyvinyl alcohol (PVAV) , polyvinyl chloride (PVC) , ethylene vinyl alcohol (PE/EVAL) , Teflon™ (PTFE) , Vitron™ (FPM) , Saranex™
(PVDC/PE) , or other materials having the physical properties of rubber or latex.
The following examples set forth current best modes of preparing the electrically conductive material. Example 1
In this example a natural rubber material is made with petrochemical origin n-butanol. In this case a solution of three alcohols totaling 6 to 14% by volume and natural Latex with the balance water (with solids by weight of 30 to 66%) . The alcohol solution, which is used with the petrochemical based butanol only, is made up of 8 to 15% of plant origin (only) ethanol; 3 to 7% n-propanol of either petrochemical or plant origin; and the balance of petrochemical based n-butanol. Example 2
In this example the natural rubber material was combined with vegetable or animal origin n-butanol. The solution contained two alcohols totaling 6 to 14% by volume and natural latex of 30 to 66% solids by weight and the balance water to 100%. The alcohols comprise from 3 to 7% n-propanol of either petrochemical or vegetable origin with the balance being the vegetable origin n-butanol of a special method of extraction, as later described.
Example 3 The synthetic type material is composed of either of the above two alcohol solutions comprising 6 to 14% by volume with 30 to 60% polyurethane by weight and the balance water.
Example 4 Presently preferred methods of making these materials include the following. Physically separate (distill) ethanol from products of the selective bacterial fermentation of carbohydrate containing materials such as grains, molasses, or sugars as cane or beet sugar. The ethanol used must be of vegetable origin to gain the unique high solubility between latex and alcohol needed between the vegetable origin latex and the mineral origin of petrochemical n-butanol and n-propanol. Natural latex normally coagulates and is unusable upon the addition of approximately 5% of butanols or other complex alcohols, (propanol or longer chain) .
In the present invention the absorption of butanol is in the range of 12% and higher.
In using solutions of three alcohols, for example plant origin ethanol = 10%; petroleum origin n-butanol =
85%; and petroleum origin n-propanol = 5%. The alcohols are blended as follows.
Add the 85% n-butanol drop by drop to the ethanol 10% while stirring moderately. Let it set for 24 hours. Add the n-propanol 5% to the ethanol-butanol solution drop by drop as before while stirring moderately. Let it set for 24 hours. Preferably, refrigerate alcohol solutions to about 32°F, and preferably refrigerate natural latex solution to about 42°F. Add the alcohol solution drop by drop to the latex constantly stirring. The 10% ethanol is added to the 90% latex material. Careful addition in this manner results in the natural latex accepting in the range of about 9% to about 15% or more alcohol solution without coagulating depending on the solution used. Dip or spray gloves, condoms, or whatever in the latex-alcohol mixture in the usual way. The latex-alcohol liquid when stored should be refrigerated and, preferably, stirred with a slow stirring device to keep the solution from coagulating over a period of days. Example 5
If the alternative method of using plant origin n-butanol" is used, the fermentation and distillation of carbohydrates will provide this n-butanol. However, since the temperature of 110°C is never to be exceeded with any of the ingredients used, and the boiling point of n-butanol is 117.7°C, a partial vacuum distillation must be needed.
Example 6 The following are preferred basic conditions for the preparation of the electrically conductive material. Latex should be at room temperature or refrigerated, preferably to 42°F and the solution of alcohols refrigerated to 32°F prior to mixing. The solutions should not be exposed to magnetic fields or electrical fields. Use glass or ceramic preferably, or plastic or nonmagnetic metal vessels for all solutions preferably 24 hours prior to experiment, and do not place solutions closer than eight inches to ferrous or other magnetic metals before or during incorporation of ingredients. Ethanol is to be of organic origin and physically separated (i.e. distilled from natural, not artificially fortified wine or other organic material containing ethanol) when using natural latex. Ethanol can be of petrochemical origin when using polyurethane. Organic origin n-butanol and n-propanol are preferred ingredients, but if unobtainable, these two ingredients can be of petrochemical origin. Use automatic stirring device with motor and metal parts at least 18 inches away from the latex solution. Paddle and shaft of the device should be made of wood or other nonmetallic material. Beakers and all other containers of ingredients should be stoppered with cork, plastic film sheets or sheet rubber held in place by rubber bands. Preparation of solutions should be on wooden tables keeping ingredients at least eight to twelve inches away from ferrous metals. Use brass or bronze nails or screws on any wooden or plastic apparatus within 8 to 12 inches of the ingredients, either setting or being mixed. Use organic origin ethanol recently distilled (preferably less than 90 days old) that has only been contained in glass, plastic or magnetic metal vessels.
The following examples were made to determine the maximum amount of ethanol-butanol mix that can be added to a 30% by weight total solids quantity of compounded latex, without coagulation.
All the following experiments were conducted on a wooden table at least 8 to 12'inches away from all the electrical connections, magnetic and metal equipment. No metal vessels were used for the experiments. Ethanol used in this experiment was distilled from homemade wine. N-propanol and n-butanol were obtained from the commercial chemical store. N-propanol and n-butanol were kept in a glass bottle for 24 hours before use. An electrical stirrer with a wooden spindle and paddle was used for the experiments. The latex compound used for the experiment was chilled to 42°F and the alcohol mix was chilled to 32°F.
Latex Compounding
Dry Weight Natural Rubber Latex 100
Zinc Oxide 0.35
Butyl Zimate 1.0
Sulfur 0.35
Butyl Namate 1.00 Ammonium Caseinate 0.20
Potassium Hydroxide 0.20
Total solids of the latex were adjusted to 30%. Alcohol Solution Mix Formulation ethanol 10% 20 ml n-butanol 90% 180 ml 20 ml of ethanol was transferred to a 500 ml beaker and n-butanol was added to well stirred ethanol in a very slow manner by using a pipette. Latex-Alcohol Compounding
750 ml of compounded latex was transferred into a 1,000 ml glass beaker. The stirrer was set at 100 rpm. The alcohol solution was added to the latex at a rate of 3 ml/minute by using a fine stream pipette.
Observation and Calculation 121 ml of alcohol mix was added to 750 ml of compounded latex without any coagulation. Coagulation was observed after 121 ml. Volume percentage of alcohol added to 30% T.S. natural rubber latex without any coagulation.=
121 X 100 = 16.13% 750
Example 7 The purpose of this experiment was to determine the amount of alcohol solution mix (ethanol - 10%, n-butanol - 85% and n-propanol - 5%) that can be added to 30% total solids natural rubber latex without any coagulation..
Experiment Conditions Same as in Example 6.
Latex Compounding Same as in Example 6
Alcohol Solution Mix Formulation ethanol 10% 20 ml n-butanol 85% 170 ml n-propanol 5% 10 ml
Mixing Method 20 ml of ethanol was transferred into a 500 ml beaker and then 170 ml of n-butanol was added to well stirred ethanol by using a fine stream pipette. Finally, 10 ml of n-propanol was added to the ethanol-butanol solution.
Latex-Alcohol Compounding Alcohol mix from part C was added to the latex at a rate of 1.6 ml/minute.
Observation and Calculation 104 ml of alcohol mix was added to the latex compound without any coagulation. Coagulation was observed after 104 ml. Volume percentage of alcohol mix added to 30% T.S. natural rubber latex without any coagulation = 104 X 100 = 13.86% 750 Example 8
In this example, condoms were made using the natural rubber latex-alcohol compound.
Experiment Conditions Same as in Example 6. Latex Compounding
Same as in Example 6
Alcohol Solution Mix Same as in Example 7.
Latex-Alcohol Compounding Repeated the procedures given in Example 7 by adding 75 ml alcohol mix into 750 ml of compounded latex.
Observation and Results The above experiments showed that 10% to 12% of alcohol can be added to 30% T.S. natural rubber latex without any coagulation.
There was no latex coagulation in Examples 6, 7 and 8. The condoms were made by dipping a glass former into the alcohol-latex compound and drying it in an oven at 70°C until the rubber film became translucent and free from whiteness. The outside was dusted with talc powder and it was stripped from the former by dusting the inside to prevent stickiness.
Example 9 In this example fibers as previously described are incorporated in the latex material which provides a satisfactory material capable of conducting microcurrents of the order of the bioelectric system of the human and other mammalian bodies and also discharges static electricity. As previously mentioned, the electrically conductive material can be used for a wide variety purposes, such as conductive rubber sheeting for general medical, surgical, dental, veterinary medicine and associates fields. It is useful as a viral and bacterial barrier while conducting normal body surface electrical currents; for example, as in holding and nurturing of infected infants and children while allowing exchange and balancing of normal body currents.
The present invention, therefore, is well suited and adapted to achieve the objects and ends and has the advantages mentioned as well as others inherent therein. While presently preferred embodiments of the invention have been given for purposes of disclosure, changes can be made therein within the spirit of the invention as defined by the appended claims.

Claims

Claims
1. A biocompatible material having the physical characteristics of natural rubber and synthetic polymers or latex characterized by its capability to transmit microcurrents of the order of the bioelectric system of human beings and animals and currents of static electricity.
2. The biocompatible material of Claim 1 where the biocompatible material is elastomeric and has carbonaceous filamentous fibers, silk, nylon or other fibers or particles electrically conductive in an electrolytic humid atmosphere dispersed throughout the material.
3. The biocompatible material of Claim 1 where the biocompatible material is substantially rigid.
4. The biocompatible material of Claim 1 where the biocompatible material is rigid and has carbonaceous particles dispersed throughout.
5. The biocompatible material of Claims 1, 2, or 3 where the material is further characterized by being impervious to the passage of fluids and viruses.
6. The biocompatible material of Claims 1 or 2 which are stretchable or pliable.
7. The biocompatible material of Claims 1, 2, 3, or 4 where the material is a latex-alcohol compound containing n-propanol and n-butanol.
8. The material of Claims 1, 2, 3, or 4 where the material is a latex-alcohol compound containing ethanol, n-butanol and n-propanol. " 9. Medical gloves, prostheses, medical implants, condoms made from the materials of Claims 1, 2, 3, 4, 5, 6, 7, or 8.
10. The biocompatible material of Claim 1 where the material has an electrical resistance of about 500 ohms per 1/1000 inch thickness of the material.
11. A method of making the biocompatible material of Claim 1 comprising, adding without coagulation 6% to 14% by volume of a solution of 8% to 15% ethanol of plant origin, 3 to 7% n-propanol and the balance n- butanol to a material having the physical properties of medical polymers or latex.
12. A method of making the biocompatible material of Claim 1 comprising, adding without coagulation 6% to 14% by volume of a solution of 3% to 7% n-propanol and the balance n-butanol to a material having the physical properties of medical polymers or latex.
13. A biocompatible material made by the method of Claim 11.
14. A biocompatible material made by the method of Claim 13.
15. The method of Claims 10 or 11 where the ethanol, n-propanol, and n-butanol comprise from about 6% to 14% by volume of the biocompatible material.
16. The biocompatible material of Claims 13 or 14 where the n-propanol and n-butanol comprise 6% to 14% by volume of the biocompatible material. 17. The biocompatible material of Claim 2 where the fibers are encased in chambers, bubbles or cells in the biocompatible material effective to provide electrical conductivity and a capacitor-like effect of the microcurrents.
EP19910919726 1990-09-27 1991-09-27 Electrical microcurrent transmitting elastomeric or rigid materials Withdrawn EP0550694A4 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB9021085 1990-09-27
GB909021085A GB9021085D0 (en) 1990-09-27 1990-09-27 Elastomeric materials,articles and prostheses with low resistance to bioelectric currents of human and animals and static electricity
GB9026020 1990-11-29
GB909026020A GB9026020D0 (en) 1990-11-29 1990-11-29 Elastomeric materials,articles and prostheses with low resistance to bioelectric currents of human and animals and static electricity

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EP0550694A4 true EP0550694A4 (en) 1993-09-15

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US6295474B1 (en) 1998-03-13 2001-09-25 Intermedics Inc. Defibrillator housing with conductive polymer coating
EP1171063A1 (en) * 2000-02-11 2002-01-16 Michaela Buske Condom
US6863070B2 (en) * 2003-04-16 2005-03-08 George Shapiro Magnetic condom
US9314321B2 (en) 2007-09-05 2016-04-19 Biolectrics Llc Concurrent treatment of oral and systemic maladies in animals using electrical current
US9168370B2 (en) 2007-09-05 2015-10-27 Biolectrics Llc Concurrent treatment of oral and systemic maladies using direct current electricity
BR112016010479B1 (en) * 2013-11-11 2021-10-26 Hll Lifecare Limited GRAPHENE-BASED POLYMER COMPOUNDS FOR THE PRODUCTION OF CONDOMS WITH HIGH THERMAL TRANSFER, IMPROVED SENSITIVITY AND DRUG ADMINISTRATION CAPACITY
AU2015204825A1 (en) 2014-01-07 2016-07-28 Animal Oralectrics Llc Treatment of oral maladies using electrical current
BR112023001695A2 (en) 2020-07-28 2023-05-02 Biolectrics Llc SYSTEMS AND METHODS RELATED TO INTRAORAL ELECTRICAL STIMULATION

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