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CN-122005959-A - Wound surface periphery molding sealing overflow-resisting cofferdam glue set and preparation method thereof

CN122005959ACN 122005959 ACN122005959 ACN 122005959ACN-122005959-A

Abstract

The invention belongs to the field of medical appliances, and provides a wound surface periphery molding sealing overflow-preventing cofferdam glue set and a preparation method thereof. According to the invention, a core-shell silica microgel intermediate is taken as a functional core, core-shell particles are composed of a silica microgel core and a polydopamine shell layer, a first component A (vinyl-terminated polydimethylsiloxane, zero-valent platinum-1, 3-divinyl-1, 3-tetramethyl disiloxane complex and the core-shell silica microgel intermediate) and a second component B (polymethyl hydrogen siloxane, vinyl-terminated polydimethylsiloxane and the core-shell silica microgel intermediate) are respectively introduced, and the two components are mixed and cured according to a mass ratio of 0.8:1-1.2:1, so that a thixotropic anti-collapse, geometrically stable cofferdam structure with certain optical visibility is formed, reliable sealing adhesion is realized on moist skin and low-pain uncovering is supported, the dynamics contradiction between a processing window and quick shaping and overflow blocking are cooperatively solved, and the invention has wide application value in clinical scenes such as chronic wound nursing and local administration sealing.

Inventors

  • LI XIAOQIN
  • CHEN YONG
  • LI YAN
  • DING PINRONG

Assignees

  • 黄石市中心医院(市普爱医院、湖北理工学院附属医院、鄂东医疗集团)

Dates

Publication Date
20260512
Application Date
20260320

Claims (10)

  1. 1. The wound surface periphery forming sealing overflow-resisting cofferdam glue set is characterized by comprising a first component A and a second component B which are respectively packaged, wherein: The first component A comprises vinyl-terminated polydimethylsiloxane, zero-valent platinum-1, 3-divinyl-1, 3-tetramethyl disiloxane complex and core-shell silicon microgel intermediate; The second component B comprises polymethyl hydrosiloxane, vinyl end-capped polydimethylsiloxane and a core-shell silicon microgel intermediate; The core-shell silicon microgel intermediate is core-shell particles, the core-shell particles comprise a silicon microgel core and a polydopamine shell layer coated on the surface of the silicon microgel core, wherein the polydopamine shell layer is formed by self-polymerizing dopamine hydrochloride in a water phase, the mass ratio of the dopamine hydrochloride to the silicon microgel core is 0.5-20:100 when the polydopamine shell layer is prepared, at least one of the first component A and the second component B also comprises fumed silica, and the content of the fumed silica is 0.5-wt% -15 wt%; The first component A and the second component B are mixed according to the mass ratio of 0.8:1-1.2:1 and then are solidified and molded to obtain the cofferdam glue, and the cofferdam glue is used for shaping the periphery of the wound surface to form a cofferdam so as to limit the overflow of the flowable biogel applied to the wound surface at the wound surface.
  2. 2. The cofferdam gum set of claim 1, wherein the silicone microgel core is prepared by the steps of: a1, preparing an aqueous phase, namely adding polyvinyl alcohol into deionized water, heating to 80-95 ℃ and stirring for 0.5-2.0 h to obtain an aqueous phase solution with the mass fraction of the polyvinyl alcohol of 1-wt-10 wt%, cooling and adjusting the pH value of the aqueous phase solution to 6.0-8.5; A2, preparing an oil phase, namely mixing vinyl-terminated polydimethylsiloxane with polymethylhydrosiloxane to enable the molar ratio of Si-H to vinyl to be 0.8-1.3, and adding a zero-valent platinum-1, 3-divinyl-1, 3-tetramethyl disiloxane complex to enable the content of the zero-valent platinum to be 0.5-50 ppm relative to the total mass of the oil phase; A3, emulsifying, namely adding the oil phase into the aqueous phase solution, and emulsifying for 1-10 min at a shearing rotating speed 3000 rpm~20000 rpm to obtain emulsion; a4, curing, namely keeping the emulsion at 40-70 ℃ for 0.5-6.0 h to obtain a silicon microgel emulsion; A5, after separating the silicon microgel emulsion, washing with deionized water for 1 to 5 times and ethanol for 1 to 3 times, and vacuum drying at a temperature of between 60 and 80 ℃ for 8 to 24 hours to constant weight under 0.0005 MPa~0.02 MPa to obtain a silicon microgel core; A6, controlling the gel fraction of the silicon microgel core to be 80 wt% -99 wt%.
  3. 3. The cofferdam gum set of claim 1, wherein the core shell silicone microgel intermediate is prepared by the steps of: B1, dispersing, namely dispersing the silicon microgel core in deionized water to ensure that the solid content is 0.5 wt% -10 wt%; b2, buffering and alkali adjustment, namely adding tris (hydroxymethyl) aminomethane to ensure that the concentration is 10 mmol/L-200 mmol/L, and adjusting the pH value to 8.0-9.0 by using sodium hydroxide; B3, coating polymerization, namely adding dopamine hydrochloride in an air atmosphere to enable the mass ratio of the dopamine hydrochloride to the silicon microgel core to be 0.5-20:100, and reacting for 0.5-6.0 h at 15-35 ℃; b4, after-treatment, washing the obtained solid with deionized water for 2-6 times, and vacuum drying at 0.0005 MPa~0.02 MPa-80 ℃ for 8-24 hours to obtain a core-shell silicon microgel intermediate; And B5, quality control, wherein the residual quantity of unreacted dopamine hydrochloride in the core-shell silicon microgel intermediate is not higher than 100 ppm.
  4. 4. The cofferdam gum set of claim 1, wherein the first component a is prepared by the steps of: taking 60-95 wt% of vinyl-terminated polydimethylsiloxane, adding 1-wt-30-wt% of core-shell silicon microgel intermediate, wherein the mass fraction of the vinyl-terminated polydimethylsiloxane and the sum of the mass fraction of the core-shell silicon microgel intermediate and the core-shell silicon microgel intermediate is not more than 100 wt% based on the total mass of the first component A, and adding zero-valent platinum-1, 3-divinyl-1, 3-tetramethyl disiloxane complex to enable the content of the zero-valent platinum relative to the total mass of the first component A to be 0.5-50 ppm; C2, mixing, namely stirring and mixing for 5-60 min at 15-30 ℃; c3, defoaming, namely defoaming for 5-30 min under 0.0005 MPa~0.02 MPa; and C4, post-treatment and quality control, namely sub-packaging and sealing the defoamed materials, wherein the volatile content in the first component A is not higher than 0.5 wt percent.
  5. 5. The cofferdam gum set of claim 1, wherein the second component B is prepared by the steps of: Taking 50-95 wt% of vinyl-terminated polydimethylsiloxane, 1-20 wt% of polymethylhydrosiloxane and 1-wt-30 wt% of core-shell silicone microgel intermediate, wherein the mass fraction of the vinyl-terminated polydimethylsiloxane and the total mass of the second component B are not more than 100% and wt%; d2, mixing, namely stirring and mixing for 5-60 min at 15-30 ℃; D3, defoaming, namely defoaming for 5-30 min under 0.0005 MPa~0.02 MPa; and D4, post-treatment and quality control, namely sub-packaging and sealing the defoamed materials, wherein the volatile content in the second component B is not higher than 0.5 wt percent.
  6. 6. The cofferdam glue set as claimed in claim 1, wherein the mass fraction of vinyl-terminated polydimethylsiloxane in the first component a is 60 wt% -95 wt%, the mass fraction of core-shell silicone microgel intermediate is 1 wt% -30 wt%, the sum of the mass fractions is not more than 100 wt% based on the total mass of the first component a, and the content of the zero-valent platinum-1, 3-divinyl-1, 3-tetramethyl disiloxane complex is 0.5 ppm-50 ppm based on platinum; The mass fraction of vinyl-terminated polydimethylsiloxane in the second component B is 50 wt% -95 wt%, the mass fraction of polymethylhydrosiloxane is 1 wt% -20 wt%, the mass fraction of core-shell silicone microgel intermediate is 1 wt% -30 wt%, the mass fraction of the three is calculated by the total mass of the second component B, and the sum of the mass fractions of the three is not more than 100 wt%.
  7. 7. The cofferdam glue set of claim 1, wherein at least one of the first component a and the second component B further comprises fumed silica, the fumed silica content being 0.5 wt% -15 wt%; In a mixed system formed by mixing the first component A and the second component B, the molar ratio of Si-H to vinyl is 0.8-1.3.
  8. 8. The cofferdam gum set of claim 1, wherein the residual amount of ethanol in the core-shell silicone microgel intermediate is no more than 500 ppm.
  9. 9. The cofferdam glue set of claim 1, wherein the cofferdam glue can be used And forming a cofferdam structure by manual molding, and maintaining the molded cofferdam structure after curing and molding, wherein the height of the cofferdam structure is 2-20 mm, and the width of the cofferdam structure is 2-30 mm.
  10. 10. A method of making the cofferdam gum set of claim 1, comprising the steps of: s1, preparing a silicon microgel core; S2, preparing a core-shell silicon microgel intermediate; s3, preparing a first component A and sub-packaging; S4, preparing a second component B and sub-packaging; And the first component A and the second component B are respectively and independently sealed and packaged to obtain the cofferdam glue set.

Description

Wound surface periphery molding sealing overflow-resisting cofferdam glue set and preparation method thereof Technical Field The invention relates to the field of medical instrument materials, in particular to a wound surface periphery molding sealing overflow-resisting cofferdam glue set and a preparation method thereof. Background The local treatment of the wound surface and the nursing of the wound surface are very challenging important fields in clinical medicine, and along with the wide clinical popularization of advanced therapies such as flowable biogel, cell suspension, injectable hydrogel dressing, negative pressure wound surface treatment and the like, how to realize reliable sealing around the wound surface has become a key technical problem affecting the treatment effect. In the above-mentioned therapeutic scenario, the flowable biotherapeutic medium must be maintained in the effective area of the wound surface in a targeted manner, preventing it from overflowing to the wound surface, contaminating healthy tissue or reducing local therapeutic concentration, which clinical requirement requires the construction of a geometrically stable cofferdam structure formed in situ around the wound surface to limit diffusion and overflow of the medium from the physical boundary level. The cofferdam material has proper plasticity and fluidity in a complex clinical environment, so that a clinical operator can finish fitting on irregular wound surface peripheral skin by bare-handed shaping, has enough elastic energy storage to realize stable geometric form and prevent collapse deformation due to gravity or external pressure after shaping in a shaping function link, has reliable adhesion sealing performance on wet skin in a sealing adhesion link, prevents leakage of a treatment medium from the bottom of the cofferdam, has no obvious mechanical damage to skin tissues when uncovering, and meets the requirement of controllable uncovering of low pain, and has higher requirement on optical visibility of the material so as to ensure timely judgment and intervention on wound surface healing process by directly observing wound surface state and treatment medium distribution condition through a cofferdam structure in a visual monitoring link. In combination, the wound cofferdam material has urgent clinical demands in terms of plastic operability, rapid geometric shaping, wet sealing adhesion, optical visibility and other multidimensional performances, and the continuous exploration and development of related novel material technology are promoted. Aiming at the clinical requirements, the prior art has developed relevant research, but has obvious defects in terms of multi-dimensional performance. The platinum catalyzed addition type bi-component silicone rubber system has been tried to be used in the fields of medical sealing and wound surface contact materials because of the characteristics of room temperature solidification, good biocompatibility and the like, but the solidification dynamics is mainly determined by the catalyst concentration and the cross-linking agent structure, the dual requirements of wide operation window and rapid shaping are difficult to realize at the same time, the adhesion sealing performance on the skin around the moist wound surface depends on the body viscosity of a matrix, and the reliability is obviously insufficient under the condition of seepage infiltration. For example, chinese patent publication No. CN104922721a discloses a skin-adhering tape or sheet, which realizes room temperature curing molding and skin contact compatibility by adjusting component proportions, but the patent does not propose a special solution for the operation window-shaping rate dynamics contradiction of cofferdam molding scenes, and the design and verification of the sealing adhesion performance of wet skin are insufficient, so that the multiple performance requirements of wound cofferdam are difficult to meet. On the other hand, in order to improve the thixotropic anti-collapse performance of cofferdam materials, strategies of introducing inorganic fillers such as fumed silica and the like into a silicon rubber matrix are partially studied. In addition, the patent does not provide an effective solution to the problem of wet skin adhesion and sealing, and has obvious disadvantages in terms of the above-mentioned contradictory properties. Disclosure of Invention The invention aims to provide a wound periphery forming sealing overflow-resistant cofferdam glue set and a preparation method thereof, which solve the defects of the existing cofferdam material in terms of dynamic contradiction between a processing operation window and quick setting overflow resistance in double-component site construction, interface-biomechanical coupling contradiction between high-reliability sealing adhesion and low-pain controllable uncovering under a wet skin environment, optical-enhancement mechanism contradiction which leads to r