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WO2025090560A1 - Revêtements prothétiques en silicone améliorés et leurs procédés de production - Google Patents

Revêtements prothétiques en silicone améliorés et leurs procédés de production Download PDF

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Publication number
WO2025090560A1
WO2025090560A1 PCT/US2024/052492 US2024052492W WO2025090560A1 WO 2025090560 A1 WO2025090560 A1 WO 2025090560A1 US 2024052492 W US2024052492 W US 2024052492W WO 2025090560 A1 WO2025090560 A1 WO 2025090560A1
Authority
WO
WIPO (PCT)
Prior art keywords
silicone
matting
applying
masks
portions
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.)
Pending
Application number
PCT/US2024/052492
Other languages
English (en)
Inventor
Bjorn Eric Sparrman
Steve Kuei
Ariane Christine SCHOENWIESNER
Hesaneh KAZEMI
Hamilton James FORSYTHE
Schendy Guiders Kernizan
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.)
Rapid Liquid Print Co
Original Assignee
Rapid Liquid Print Co
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
Application filed by Rapid Liquid Print Co filed Critical Rapid Liquid Print Co
Publication of WO2025090560A1 publication Critical patent/WO2025090560A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/7812—Interface cushioning members placed between the limb stump and the socket, e.g. bandages or stockings for the limb 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
    • 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
    • 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
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • B29C64/106—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y40/00—Auxiliary operations or equipment, e.g. for material handling
    • B33Y40/20—Post-treatment, e.g. curing, coating or polishing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00—Materials specially adapted for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing

Definitions

  • inventions of this disclosure comprise improvements to silicone prosthetic liners and methods for producing silicone prosthetic liners.
  • Silicone prosthetic liners are used to cover a residual limb and serve as a layer between the residual limb and a prosthetic device.
  • Figure 1 contains a conceptual drawing of a residual limb 101 with a prosthetic liner 102 for insertion into a prosthetic device 103.
  • a well-fitting prosthetic liner improves comfort of the prosthesis and protects skin that would otherwise be in direct contact with the prosthesis.
  • silicone prosthetic liners retain a slightly sticking feel — i.e., a “tacky” feeling. While it is advantageous for the inner surface of a prosthetic liner to be tacky, it is also advantageous for the outer surface to be low tack.
  • a tacky inner surface improves the grip of the liner against the skin and helps reduce slippage.
  • a low-tack outer surface makes it easier to roll the liner on and to insert the liner-covered limb into prosthetics.
  • Current prosthetic liners on the market often use fabric or other coating methods on the outer surface to achieve this effect.
  • Silicone rubber is inherently tacky, in that it sticks to surfaces, especially itself, with minimal pressure, and is not able to slide past another silicone surface. This effect tends to become more pronounced the softer the material is. A softer silicone more easily conforms to an adjoining surface and thereby maximizes surface contact. Liner silicone is relatively soft and is therefore quite tacky. Tackiness may be caused by chemical adhesion, and there is some of such an effect in silicones, but applicant conceptualizes silicone tackiness it as static/sliding friction against its own surface.
  • Nusil MED 10-6670 is a low coefficient of friction silicone coating that may be applied by as a sprayable coating. Such substances are not ideal as they have difficulty bonding to the silicone substrate and will often delaminate when the silicone deforms or strain is otherwise applied to the silicone substrate.
  • the invention of this disclosure solves the foregoing problems by providing a silicone liner wherein a first surface — for example, the inner surface — retains the tackiness that is inherent in silicone, and a second surface — for example, the outer surface — is not tacky or has reduced tackiness without the need for a fabric coating or low friction treatment.
  • a first surface for example, the inner surface — retains the tackiness that is inherent in silicone
  • a second surface for example, the outer surface — is not tacky or has reduced tackiness without the need for a fabric coating or low friction treatment.
  • a silicone article of manufacture may be produced that comprises some surface areas that exhibit silicone’s inherent tacky texture and other surface areas that exhibit a matted texture.
  • the invention of this disclosure entails modifying a first surface of a silicone liner to create a low-friction surface, which should serve as a low tack rubber while retaining the silicone’s inherent tackiness on a second surface.
  • a first surface of a silicone rubber piece with a premixed matting substance added is masked while a second surface of the silicone rubber piece is exposed to vented air and the entire piece is heated for a duration. After heating and unmasking, the first surface of the resulting silicone piece is non-matte and the second surface of the resulting silicone piece is matted.
  • Figure 1 depicts a prosthetic liner forming an interface between a residual limb and a prosthesis.
  • Figure 2 depicts a flow diagram of an exemplary embodiment of the invention.
  • Figure 3A shows silicone piece samples processed under various combinations of process variables without a pre-venting step
  • Figure 3B shows silicone piece samples processed under various combination of process variables with a pre-venting step.
  • Applicant’s method of selective matting uses a friction-lowering or matting additive in the silicone from which a piece is to be manufactured.
  • a friction-lowering or matting additive in the silicone from which a piece is to be manufactured.
  • such an additive creates low friction on all surfaces of the resulting silicone piece.
  • process variables are manipulated to preserve the effect of the low-friction pre-mixing additive on some, but not all, surfaces.
  • Applicant’s method may be applied to two part, or addition curing silicones, in which a liquid comprising a silicone polymer and a catalyst (Part A) is mixed with a liquid comprising a cross-linker or curing agent (Part B).
  • Part A a liquid comprising a silicone polymer and a catalyst
  • Part B a liquid comprising a cross-linker or curing agent
  • Part B in the correct proportions causes a reaction that creates a solid silicone rubber.
  • Matting solutions for silicone are known and commercially available.
  • SLIDETM STD Liquid Surface Tension Diffuser from Smooth-On, Inc. is an additive for platinum cure silicone rubber that greatly reduces surface tension.
  • Cured silicone treated with SLIDETM STD Liquid Surface Tension Diffuser slides across itself and other surfaces.
  • QSil Matting Agent from CHT Germany GmbH is another additive which reduces the coefficient of friction and results in a matte finish on select silicone elastomer.
  • SLIDE 1.5%
  • Qsil 0.5% and 1.0%
  • Matting additives lengthen the cure process of the silicone to which they are added.
  • Applicant concluded that matting additives appear to have a reaction life, which can be manipulated and exploited to selectively matte different surfaces of the same part. Applicant investigated how a number of process variables affect the action of commercial matting additives. For example: whether additives require volatilization; whether require a silicone rubber that is still curing to act upon (i.e., demoldable but not fully cured); whether additives are heat sensitive, either to volatilize more quickly, to act more quickly, or to cure the rubber more quickly; and whether they “run out” — i.e., whether one can induce non-matting in a surface that should still be able to matte (still curing) if all of the additive matting on another surface has been “consumed” or used up.
  • FIG. 2 shows a flow diagram of an exemplary embodiment of the method disclosed herein.
  • a matting additive is pre-mixed with Part B of a two-part silicone.
  • Parts A and B of the two-part silicone are mixed in a predetermined proportion to create a silicone piece.
  • a first surface of the silicone piece is masked.
  • heat is applied to the entire silicone piece for a predetermined amount of time in a vented environment.
  • inventive method disclosed herein can be applied in various methods of silicone manufacturing.
  • the disclosed selective matting approach can be applied following any silicone manufacturing process in which the masking, heating, and venting steps are not precluded.
  • Applicant printed a silicone prosthetic liner on one of its 3D printers with a commercial matting additive mixed in per manufacturer’s instructions.
  • the inside surface of the piece was masked by a mixing tub.
  • the piece was left in a vent box.
  • the outer surface matted as expected, while the inner, masked surface had identical (i.e., tacky) feel to silicone without a matting additive.
  • the inner surface began to feel less tacky.
  • Applicant concluded that matting can be directed to one surface over another, but subsequent matting action on the non-matte surface needs to be inhibited or prevented thereafter.
  • Figures 3 A and 3B show silicone samples treated with various combinations of process variables.
  • sample 301 was baked, covered, and not vented, which yielded no matte
  • sample 302 was not baked, covered, and not vented, which yielded no matte and a very shiny surface
  • sample 303 was baked, not covered, and not vented, which yielded no matte
  • sample 304 was not baked, not covered, and not vented, which yielded a matted surface.
  • sample 305 was baked, covered, and vented, which yielded no matte and a strong smell
  • sample 306 was not baked, covered, and vented, which yielded no matte
  • sample 307 was baked, not covered, and vented, which yielded no matte
  • Table 1 also shows and summarizes the various process variable combinations applied to the silicone samples.
  • the pre-venting process consisted of exposing samples 5-8 to venting for approximately eight hours before other processing. For samples 5-8, all pieces were mixed and smeared on a plate such that the top surface is exposed and the bottom surface remained masked by the plate. After leaving in a vent box for 8 hours, all pieces matted on top surface. Samples 1-4 were not pre-vented in this way. Where baking is indicated, samples were baked at 75° C. Samples 1-4 were baked with a fan blowing over the exposed surface. Samples 5-8 were baked for approximately fifteen hours.
  • sample 5 the piece was moved to 75° C hot plate and covered for approximately 15 hours. The piece was then removed from heat and covering, and the masked surface was then exposed to a vent box overnight. This surface did not matte. Anecdotally, this piece seemed to smell more strongly.
  • sample 6 the piece was covered for approximately 15 hours. The piece was removed from covering, and the masked surface was then exposed to a vent box overnight. This did not matte.
  • sample 7 the piece was moved to a 75° C hot plate for approximately 15 hours. The piece was then removed from heat, and the masked surface was exposed to a vent box overnight. This surface did not matte.
  • At least some low friction additives such as SLIDE, require an actively curing surface to provide a matting property. This initial conclusion is reinforced by the test run on sample 2 — consisting of no heat and minimized volatilization — which did not matte. The matting effect is prevented if the piece is heated. This may be due to heat accelerating the effect on one surface (and “running out” before the second), or potentially accelerating the rubber cure such that the later exposed surface is no longer “active.” It is also possible that heat is volatilizing the reagent more quickly so that it “runs out” faster, but after the test run on sample 2, application concluded that volatilization is likely not important to the action, only to the odor of the part.
  • a process for selective matting of a silicone piece therefore comprises:
  • baking may take place at a temperature of 75° C and baking duration may be approximately six hours.
  • the resulting silicone piece will have a first surface that retains silicone’s inherent tackiness, while other surfaces have a matted texture.
  • This process may be employed in silicone pieces that comprise a plurality of surfaces and the sections of the piece to be matted or non-matte comprise a plurality of surfaces or simply portions of one or more surfaces. Any combination of masking a portion or all of one or more surfaces where tackiness is desired may be accomplished.
  • the choice of temperature for baking may be substantially 75° C or may be higher or lower than 75° C.
  • the choice of duration for baking may be substantially six hours or may be shorter or longer than six hours.
  • Applying the inventive process to a prosthetic liner comprises, for example, fabrication of the liner via an additive manufacturing process, masking the interior surface of the liner that is intended to be in contact with the skin of a residual limb, exposing the prosthetic liner to a baking and venting process, which results in matting on the exterior surface and tackiness on the interior surface.

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Mechanical Engineering (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Des procédés de matage sélectif de certaines surfaces, mais pas de toutes, d'un article de fabrication en silicone sont divulgués. En utilisant un additif de matage de silicone et une manipulation de variables de traitement, un article de fabrication en silicone peut être produit qui comprend certaines zones de surface qui présentent une texture collante inhérente au silicone et d'autres zones de surface qui présentent une texture matée. Selon un mode de réalisation donné à titre d'exemple, un revêtement prothétique en silicone peut être produit dans lequel une surface intérieure est collante et une surface extérieure est matée.
PCT/US2024/052492 2023-10-23 2024-10-23 Revêtements prothétiques en silicone améliorés et leurs procédés de production Pending WO2025090560A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363592280P 2023-10-23 2023-10-23
US63/592,280 2023-10-23

Publications (1)

Publication Number Publication Date
WO2025090560A1 true WO2025090560A1 (fr) 2025-05-01

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Family Applications (1)

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PCT/US2024/052492 Pending WO2025090560A1 (fr) 2023-10-23 2024-10-23 Revêtements prothétiques en silicone améliorés et leurs procédés de production

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080188949A1 (en) * 2007-02-01 2008-08-07 Mackenzie Craig Prosthetic and orthotic liners/sleeves with surfaces having a roughness or reduced coefficient of friction, and related methods
CN101565601A (zh) * 2008-05-14 2009-10-28 广州市回天精细化工有限公司 表面哑光的缩合型有机硅灌封材料组合物
US20180185176A1 (en) * 2015-08-25 2018-07-05 Ossur Iceland Ehf Prosthetic system
US20200297479A1 (en) * 2008-08-13 2020-09-24 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces
US20220314540A1 (en) * 2018-11-12 2022-10-06 Ossur Iceland Ehf Medical device including a structure based on filaments

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080188949A1 (en) * 2007-02-01 2008-08-07 Mackenzie Craig Prosthetic and orthotic liners/sleeves with surfaces having a roughness or reduced coefficient of friction, and related methods
CN101565601A (zh) * 2008-05-14 2009-10-28 广州市回天精细化工有限公司 表面哑光的缩合型有机硅灌封材料组合物
US20200297479A1 (en) * 2008-08-13 2020-09-24 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces
US20180185176A1 (en) * 2015-08-25 2018-07-05 Ossur Iceland Ehf Prosthetic system
US20220314540A1 (en) * 2018-11-12 2022-10-06 Ossur Iceland Ehf Medical device including a structure based on filaments

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