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WO1997003819A1 - Manchon d'aspiration en silicone transparent - Google Patents

Manchon d'aspiration en silicone transparent Download PDF

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Publication number
WO1997003819A1
WO1997003819A1 PCT/US1996/012353 US9612353W WO9703819A1 WO 1997003819 A1 WO1997003819 A1 WO 1997003819A1 US 9612353 W US9612353 W US 9612353W WO 9703819 A1 WO9703819 A1 WO 9703819A1
Authority
WO
WIPO (PCT)
Prior art keywords
elongation
silicone rubber
liquid silicone
compound
hundred
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.)
Ceased
Application number
PCT/US1996/012353
Other languages
English (en)
Inventor
Aldo A. Laghi
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
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO1997003819A1 publication Critical patent/WO1997003819A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
    • B29C70/681—Component parts, details or accessories; Auxiliary operations
    • B29C70/683—Pretreatment of the preformed part, e.g. insert
    • 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
    • A61F2/00—Filters 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/80—Sockets, e.g. of suction type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
    • B29C70/72—Encapsulating inserts having non-encapsulated projections, e.g. extremities or terminal portions of electrical components
    • 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
    • A61F2/00—Filters 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/5044—Designing or manufacturing processes
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/3009—Transparent or translucent
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • A61F2002/3021—Three-dimensional shapes conical frustoconical
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • A61F2002/30217—Three-dimensional shapes conical hollow cones, e.g. tubular-like cones
    • 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The 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
    • A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30324—The prosthesis having different structural features at different locations within the same prosthesis differing in thickness
    • 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
    • A61F2/00—Filters 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2002/5081—Additional features
    • A61F2002/5083—Additional features modular
    • 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
    • A61F2/00—Filters 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
    • A61F2/50—Prostheses not implantable in the body
    • A61F2/78—Means for protecting prostheses or for attaching them to the body, e.g. bandages, harnesses, straps, or stockings for the limb stump
    • A61F2/80—Sockets, e.g. of suction type
    • A61F2002/802—Suction sockets, i.e. utilizing differential air pressure to retain the prosthesis on the stump
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0091—Additional features; Implant or prostheses properties not otherwise provided for transparent or translucent
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2083/00—Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2083/00—Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
    • B29K2083/005—LSR, i.e. liquid silicone rubbers, or derivatives thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7532—Artificial members, protheses

Definitions

  • This invention relates, generally, to an interface member worn upon the residual limb of an amputee to provide a cushion between the residual limb and a prosthesis. More particularly, it relates to a transparent silicone interface.
  • Prosthesis sockets are hard, rigid devices that receive the residual limb, also known as the stump, of an amputee. Individuals requiring the use of such sockets typically wear several layers of socks over their residual limbs in an effort to provide a cushioning means between the stump and the socket; the socks work reasonably well as a cushioning means but do not serve the function of holding the socket onto the residual limb.
  • U. S. patent No. 4,923,475 to Gosthnian et. al. discloses a stump-receiving socket having a plurality of inflatable bladders, each of which includes a relatively soft, flexible membrane made of a suitable material such as polyurethane.
  • the idea behind the design is to maximize the weight-bearing area while minimizing or eliminating pressure points through the judicious use of the inflatable bladders.
  • U. S. patent No. 4,923,474 to Klasson et. al. discloses a cushioning member made of an elastomeric material having a fiber embedded therein to increase its strength.
  • some of the earlier interface members have a shape and thickness similar to that of the present invention, they are opaque and thus pose problems to the prosthetist when fitting the interface member to a patient.
  • Most of the earlier interface members also lack strength and durability.
  • the earlier members that do have adequate strength and durability are expensive to manufacture because they rely upon fabric embedded within the material of which they are made to supply the needed strength.
  • the conventional device employed to secure the interface member to the socket is typically bonded to the lowermost end of the interface member; it is releasably connected to the socket.
  • the device is formed of a nonsilicone material, however, and suitable bonding techniques for bonding such a device to a silicone interface member have not been found.
  • a transparent silicone socket interface member having strength and durability derived from its formulation and not from fabrics embedded therein.
  • a transparent, fabric-free socket interface member having enhanced strength and durability would enable the prosthetist to observe socket pressures and tensions, especially in high load areas. Scar tissue, skin grafts, and invaginated areas could be easily monitored to ensure total contact, and silicone putty could be applied where needed to eliminate voids. The position of the interface member and all putty applications could be checked for proper positioning during and after socket application.
  • it was not obvious to those of ordinary skill in this art how such a silicone suction socket could be provided, nor was it obvious that a clear silicone suction socket should be provided.
  • the socket liner or interface member of this invention is made of clear, fabric-free silicone having high elongation. It allows the prosthetist to see if there are any skin folds or air bubbles when the liner is fitted onto the residual limb.
  • a connector has an upper part embedded within the lowermost end of the liner and an exposed lower part of the connector releasably connects the liner to the socket.
  • low viscosity silicone tends to lack high tear strength; for this reason, the art has taught the use of fabric embedded within a low viscosity silicone.
  • a commercially available silicone-based compound of the silicone rubber type is purchased.
  • the elongation enhancer is added to this compound.
  • the elongation enhancer is a polydimethyl siloxane polymer methyl terminated, free of hydroxyl groups, and of low viscosity.
  • it may be a polydimethyl siloxane, vinyl terminated of high viscosity, or a cyclo siloxane with 4 or 5 silicone atoms.
  • the insert at the closed end of the liner that attaches the liner to the socket is a nonsilicone member, as aforesaid.
  • the bonding of silicone to a nonsilicone substrate is somewhat problematic; this invention includes a novel method for accomplishing the bonding. More particularly, electrons are first removed from the surface of the substrate (the insert at the closed end of the liner) ; the removal is accomplished by applying strong oxidizing or reducing agents such as acids, by subjecting the substrate to the corona effect, by application of an oxidizing flame, or by plasma ionization. In all respects, the electron removal is a temporary effect.
  • a commercially available organo- functional silane primer is applied under controlled conditions as an adhesion promoter.
  • the organic portion of the primer bonds the substrate, and the silane portion of the adhesion promoter is then hydrolized to silicone.
  • the insert is placed in the mold and then the silicone compound is injected into the mold and vulcanized at elevated temperature. This forms the silicone compound into the desired shape and bonds it to the insert.
  • the result is a puncture and tear-resistant clear silicone that has been proven effective as a limb-socket interface.
  • the flexibility of the interface helps to improve circulation and substantially eliminates noticeable shear and friction forces against the skin.
  • the embedding of the insert into the bottom of the interface ensures that the insert and interface will not separate from one another.
  • an important object of this invention is to provide a comfortable limb-socket interface.
  • Another important object is to provide such an interface in transparent or translucent form so that the prosthetist can observe socket pressures and tensions, especially in high load areas, and can assure the avoidance of air entrapment.
  • Fig. 1 is a front elevational view of the novel socket- limb interface
  • Fig. 2 is a longitudinal sectional view thereof
  • Fig. 3 is a perspective view of the nonsilicone insert.
  • Fig. 4 is a sectional view taken along line 4-4 in Fig. 3.
  • the novel limb-socket interface of this invention is denoted by the reference numeral 10 as a whole.
  • Many sizes are produced to fit most patients, having a circumference measured at six centimeters above the distal end from ten for upper extremities of children to sixty for above knee amputees of large size.
  • Interface 10 has an open upper end 12 for receiving a residual limb, not shown, a closed bottom end 14, and sidewalls 16 of predetermined thickness.
  • the preferred thickness of the sidewalls is about 1.5 mm. Note that the thickness is greater at the bottom end than in the sidewalls; the preferred thickness of the silicone at said bottom end is about 12.0 mm.
  • silicone compound A & B is purchased. This compound can be of two types commonly referred to as
  • Component A A polydimethylsiloxane polymer that is vinyl terminated.
  • the viscosity of this polymer strictly correlates with its molecular weight and, as a consequence, with its vinyl activity.
  • the viscosity of this polymer is as follows: typical 50,000 cps preferred 20,000 to 60,000 cps adequate 5,000 to 100,000 cps
  • concentration of this element of component A is established at 100 parts as a reference.
  • the compound further includes a silica filler which can be of either of the following types:
  • Fumed silica which is called such because it is produced by the combustion of a silane, typically trichlorosilane; this is the preferred type.
  • Precipitated silica called such because it is produced by precipitation from an aqueous solution.
  • the silica must be treated to neutralize the electronically active sites present on its surface. If such sites are not neutralized, the interaction between the electronic orbitals of the polydimethysilicone polymer and the active sites of the silica is such that the compound will become so viscous as to be unprocessable.
  • the treatment of the filler is effected by using a silane or a cyclic siloxane polymer; the preferred treating agents are hexamethyldisilazane and octyl methyl tetra siloxane.
  • the concentration of the filler is as follows: typical 25 parts preferred 15 to 35 parts adequate 10 to 40 parts
  • the platinum catalyst is cycloplatinic acid in a solution of octyl alcohol.
  • the concentration of active platinum is as follows: typical 15 ppm preferred 10 to 30 ppm adequate 5 to 50 ppm
  • Component B A polydimethylsiloxane polymer vinyl terminated identical to the one in Component A. Concentration: 100 parts (reference)
  • Component B further includes a polydimethylsiloxane polymer with hydrogen on the chain, commonly called methyl hydrogen, which acts as a crosslinker.
  • Viscosity typical 40 cps preferred 20 to 5,000 cps adequate 10 to 3,000 cps
  • the typical hydrogen concentration is the following: mmoles of SiH per mmoles of vinyl in the "B" component typical 5.0:1 preferred 4.0:1 to 6.0:1 adequate 3.0:1 to 10.0:1
  • the Inhibitor of Compound B is acetylenic alcohol or tertiary isobutyl alcohol.
  • a silicone oil as elongation enhancer, is added to the purchased compound at the time components A & B are mixed together.
  • Components A & B and the silicone oil are all mixed at the same time in an automatic mixing and dispensing machine and mixed through a static mixer.
  • An alternative method employs a batch mixer and includes the step of evacuating the mixture to remove the entrapped air.
  • the elongation enhancer consists of either of the following:
  • Polydimethylsiloxane methyl terminated polymer (preferred type). Its viscosity is as follows: typical 100 cps preferred 10 to 500 adequate 5 to 20,000 Cyclic siloxane such as octyl methyl tetra siloxane or decamethylpentasiloxane. Polydimethylsiloxane vinyl terminated having the following viscosity: typical 165,000 cps preferred 65,000 to 180,000 adequate 10,000 to 200,000 The concentration of either to be used for 100 parts of Components A and B is as follows: typical 23 preferred 20 to 30 adequate 15 to 35 The silicone oil modifies the elongation characteristics of the vulcanized compound; specifically, the modulus is reduced. This results in a more comfortable socket for the amputee. Final Properties typical preferred adequate
  • the insert is placed in the mold and the silicone is injected and vulcanized at elevated temperature.
  • a silicone base is purchased that consists of the following:
  • This alternative compound includes silica filler identical in composition and concentration as described in connection with the preferred (addition cure, platinum catalyst) type of compound.
  • crosslinking agent such as tetraorthosilicate or a partially hydrolizated silicate. These are commonly used and widely available commercially.
  • concentration of the crosslinking agent is as follows: typical 3 parts preferred 2 to 4 parts adequate 1.5 to 6 parts
  • a polydimethylsiloxane methyl terminated polymer is used as an elongation enhancer. This is identical to the elongation enhancer used in the preferred type of compound.
  • concentration used is as follows: typical 23 parts preferred 20 to 30 parts adequate 15 to 35 parts
  • a commercially available stannous tin octoate or dibutyl tin laureate is also employed, the concentration of which is as follows: typical 0.5 parts preferred 0.1 to 1 parts adequate 0.05 t 3 parts
  • the ingredients are mixed in a batch mixer or in a continuous mixer and evacuated to remove the air entrapped during mixing.
  • the compound is then injected into the mold and then vulcanized at room temperature or slightly thereabove. Molding Parameters
  • Materials having an elongation of less than eight hundred per cent are within the scope of this invention, but most patients report that such materials produce a feel of being excessively tight.
  • materials having less than seventy-five ppi tear are within the scope of this invention but they rip easily in service and they are difficult to remove from the mold without tearing. (The high temperatures of a mold greatly reduce tear strength) .
  • Materials having a tensile strength higher than nine hundred psi are also within the scope of this invention, but produce a feel considered too tight by most patients. Materials having a tensile strength below six hundred psi were not tested because their elongation and tear properties would be unacceptable.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Composite Materials (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Materials For Medical Uses (AREA)

Abstract

On modifie un caoutchouc silicone liquide transparent en y ajoutant un activateur d'élongation. On moule le composé silicone obtenu en une forme qui recouvre la partie restante du membre d'un amputé et constitue un élément d'interface (10) entre le membre restant et une prothèse. On intègre partiellement au fond de l'élément d'interface (10) un substrat non silicone (18), dont la partie non intégrée assure la jonction avec la prothèse. On élimine les électrons de la surface du substrat, on applique un promoteur d'adhésion et on vulcanise le polymère de silicone transparent sur le substrat de façon à le souder à la partie silicone du promoteur d'adhésion.
PCT/US1996/012353 1995-07-24 1996-07-24 Manchon d'aspiration en silicone transparent Ceased WO1997003819A1 (fr)

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US50627895A 1995-07-24 1995-07-24
US08/506,278 1995-07-24

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WO1998048741A1 (fr) * 1997-04-29 1998-11-05 Centri Ab Procede de realisation d'un manchon attache a une partie corporelle et manchon realise selon ce procede
US6918936B2 (en) 1997-04-29 2005-07-19 Kennet Hellberg Thermoplastic liner blank

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998048741A1 (fr) * 1997-04-29 1998-11-05 Centri Ab Procede de realisation d'un manchon attache a une partie corporelle et manchon realise selon ce procede
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US6918936B2 (en) 1997-04-29 2005-07-19 Kennet Hellberg Thermoplastic liner blank

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