CN114028626B - Individualized complicated surface of a wound drainage device of laminating highly - Google Patents

Individualized complicated surface of a wound drainage device of laminating highly Download PDF

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Publication number
CN114028626B
CN114028626B CN202111347299.4A CN202111347299A CN114028626B CN 114028626 B CN114028626 B CN 114028626B CN 202111347299 A CN202111347299 A CN 202111347299A CN 114028626 B CN114028626 B CN 114028626B
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sponge
customized
hydrogel
drainage device
inner layer
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CN114028626A (en
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郝永强
李家鑫
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Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
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Ninth Peoples Hospital Shanghai Jiaotong University School of Medicine
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    • 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/05Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/00357Wound bandages implanted wound fillings or covers

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention discloses a personalized high-fitting complex wound drainage device, which comprises: the inner layer of the customized sponge and the hydrogel coated on the outer side of the customized sponge; the shape of the customized sponge is customized in a personalized way; introducing primary amine groups on the surface of the customized sponge to form covalent cross-links with the hydrogel; the hydrogel comprises the following components: polyvinyl alcohol, polyacrylic acid grafted with N-hydroxysuccinimide ester. The negative pressure drainage device may further comprise: a slow release carrier embedded in the hydrogel; the slow release carrier comprises: the trigger inner layer and the functional outer layer coating the trigger inner layer release after the functional outer layer release is finished, and the connection between the hydrogel and surrounding tissues is released. The inner layer of the drainage device is made of customized sponge, so that personalized customized foam materials are allowed to be matched with the wound; the outer layer of the high-adhesion hydrogel is adhered to the surface of wet tissues; the noninvasive removal device can be conveniently removed after the treatment is finished.

Description

Individualized complicated surface of a wound drainage device of laminating highly
Technical Field
The invention relates to the field of medical instruments, in particular to a personalized high-fitting complex wound drainage device.
Background
The wound negative pressure drainage technology (Vaccun Sealing Drainage, VSD) is an emerging wound treatment technology, is widely applied to wounds or operation incisions of patients suffering from wounds, infections and tumors, is a clinical difficult problem for complex wound treatment with more infection and exudation, forms a plurality of cavities around deep tissues after operation due to the reasons of wounds, operation excision tissues, local special anatomical structures and the like, and causes local infection due to bleeding, exudation or necrosis of the wound surface accumulated in the cavities. The VSD device used at present is formed by combining biological sponges with a certain thickness in a cutting way and then matching with a sealing film to realize wound surface sealing and negative pressure drainage, the treatment device can effectively suck out pollutants and necrotic exudation in a wound surface, keep the wound surface clean, and simultaneously can stimulate cell proliferation by generating mechanical stimulation on wound surface cells to promote tissue regeneration, so that the VSD device is a clinically common wound surface treatment method. However, the prior method is limited by the size and shape of the sponge material, can not be perfectly attached to the complex wound surface, dead cavities which can not be filled possibly exist in the sponge material, the texture of the sponge surface is harder after shrinkage, the sponge surface is often adhered to surrounding tissues, and side damage is easy to generate when the sponge surface is removed.
The negative pressure sponge part is mainly made into blocks with standard sizes by polyurethane foam (PU) and polyvinyl alcohol foam (PVA) at present, and has the following defects in the aspects although the wound surface can be closed: (1) the sponge size and shape may not match the wound; (2) The sponge is internally provided with only drainage channels distributed in a plane, and the drainage channels can be extruded to generate drainage disorder after negative pressure sponge is contracted and deformed; (3) Gaps exist between the inside of the wound with irregular morphology and the common sheet negative pressure drainage sponge, so that the filling of complete matching cannot be realized, perfect fit cannot be realized, and partial tiny dead cavities possibly remain; (4) When infection and tumor wounds are subjected to negative pressure drainage, liquid can flow on the inner surface, wherein the inner part refers to a gap between the wound and a common sheet-shaped negative pressure drainage sponge, the common sheet-shaped sponge is usually connected with only 1-2 negative pressure pipes, the negative pressure at the pipe orifice is large, and when the amount of liquid at a bleeding and seepage point in the depth of the wound is large, the liquid can flow along the gap between the wound and the sponge for a certain distance and then enter the negative pressure pipe orifice, so that exudation liquid pollutes a relatively clean area of the wound; (5) Exudation, bleeding, dry knot, stiffening of the sponge, adhesion to surrounding tissue, and side damage when removed.
The wound surface sealing film is a transparent plastic film and is adhered to the outside of the wound and the negative pressure sponge to form a negative pressure environment. Although convenient and quick, the following disadvantages exist: (1) The adhesive capability is limited, and the adhesive can be easily torn off and air leakage is easily caused when the adhesive is applied to the skin facing sweat; and (2) the film can be damaged and air leakage occurs under the action of external force.
Polyvinyl alcohol (PVA) and polyacrylic acid (PAA) grafted with N-hydroxysuccinimide ester (NHS) can constitute a bioadhesive that forms a crosslinked network on the wet tissue surface by moisture absorption and forms physical or covalent crosslinks with the tissue while the bioadhesive converts to a tough hydrogel. The crosslinking between the bioadhesive and the tissue can be released by a trigger consisting of Sodium Bicarbonate (SBC) and Glutathione (GSH) (Chen X, yuk H, wu J, et al, instant tough bioadhesive with triggerable benign detachment [ J ]. Proceedings of the National Academy of Sciences,2020,117 (27): 202006389.). Such bioadhesives are not currently used in drainage devices.
Disclosure of Invention
In view of the defects of the existing negative pressure drainage device, the invention provides a negative pressure drainage device which can be more attached to a wound surface.
In order to achieve the above purpose, the present invention provides a personalized high-fitting complex wound drainage device, which comprises: the hydrogel comprises an inner-layer customized sponge and hydrogel coated on the outer side of the customized sponge; the shape of the customized sponge is customized in a personalized way; introducing primary amine groups to the surface of the customized sponge to form covalent crosslinks with the hydrogel; the hydrogel comprises the following components: polyvinyl alcohol, polyacrylic acid grafted with N-hydroxysuccinimide ester.
Preferably, the negative pressure drainage device further comprises: a slow release carrier embedded in the hydrogel; the slow release carrier comprises: the trigger agent comprises a trigger agent inner layer and a functional outer layer coating the trigger agent inner layer, wherein after the release of the functional outer layer is finished, the trigger agent inner layer is released to release the connection between the hydrogel and surrounding tissues.
Preferably, the functional outer layer comprises: bioactive factors, antibacterial components or antitumor components.
Preferably, the trigger inner layer comprises: sodium bicarbonate and L-glutathione.
Preferably, the method for obtaining the customized sponge comprises the following steps: and manufacturing a three-dimensional sponge foaming mold by using 3D printing equipment according to the required shape, and mixing the sponge raw material and the foaming agent in the mold for foaming molding.
Preferably, the customized sponge is treated with plasma or hexamethylenediamine to introduce primary amine groups at the surface of the customized sponge.
Compared with the prior art, the invention has the following beneficial effects:
(1) Through the mould design, the wound is matched to the shape, and the wound can be better filled.
(2) The drainage channel with the internal optimization design is provided, and the drainage efficiency is improved.
(3) The high-adhesion hydrogel layer can effectively adhere to surrounding tissues to fill up tiny gaps, eliminate dead cavities, realize zonal independent drainage (the hydrogel around each branched negative pressure air hole can swell to form a zone), and avoid polluting liquid flowing in a wound and polluting a relatively clean area. The split-region closed independent drainage can lead liquid into the negative pressure pipe through the sponge in a small region which is relatively limited, and does not flow through the gap between the wound surface and the sponge.
(4) The gel layer is compounded with a bioactive substance release carrier to realize corresponding biological functions.
(5) The trigger agent is arranged in the carrier, can be released after the release of the bioactive substances is finished, reacts with the gel, and breaks the reverse connection of the chemical bonds to realize noninvasive separation.
Drawings
Fig. 1 is a top view of the negative pressure drainage device of the present invention.
Fig. 2 is a cross-sectional view of the negative pressure drainage device shown in fig. 1.
FIG. 3 is a schematic structural diagram of a sustained release carrier.
Detailed Description
The technical scheme of the invention is further described below with reference to the accompanying drawings and examples.
Fig. 1 and 2 are schematic structural views of a negative pressure drainage device according to the present invention. The negative pressure drainage device 100 of the present invention includes: an inner layer of customized sponge 10 and hydrogel 20 coated on the outer side of the customized sponge 10.
The shape of the customized sponge 10 is personalized; the shape of the wound can be matched through personalized customization, and the optimal design of the internal drainage pipelines of the sponge can be performed (the directional distribution of the internal drainage pipelines is designed according to the shape of the customized sponge). The highly conformable hydrogel 20 is coated on the outer layer of the customized biological sponge, is required to have good biocompatibility and to be able to closely conform to surrounding tissue, eliminate dead space, be able to be removed easily and non-invasively and increase the tightness of the overall system.
The hydrogel 20 comprises the following components: polyvinyl alcohol, polyacrylic acid grafted with N-hydroxysuccinimide ester. Primary amine groups are introduced to the surface of the customized sponge 10 to form covalent crosslinks with the hydrogel 20. The hydrogel 20 can be tightly and firmly bonded to the moist surrounding tissue by physical forces such as van der Waals forces and covalent bonds, and can fill various small gaps.
The conventional hydrogel is uniformly swelled in all directions, and the hydrogel has the characteristics of larger swelling performance in the vertical direction, namely higher longitudinal expansion and almost no transverse expansion, and the reason is that the graphene oxide GO is changed into reduced graphene oxide rGO when meeting water to form a transverse cross-linked network to limit the transverse swelling of the hydrogel, and almost no swelling is realized in the horizontal direction, so that the hydrogel can adapt to different forms of local tissues through the characteristics, and high fit is realized.
Example 1
The sponge is plasma treated or hexamethylene diamine treated to introduce primary amine groups at the surface of the custom sponge. The plasma treatment means that inert gas or oxygen-containing gas is used for generating plasma by methods of discharge, high-frequency electromagnetic oscillation, shock wave, high-energy radiation and the like, and the surface to be bonded is treated to change the surface property, thereby being beneficial to improving the bonding performance and improving the bonding strength. The treatment can be performed by a plasma cleaning machine under the condition of introducing inert protective gas.
The geometric shape of the sponge to be placed is designed according to the region to be excised or debrided before the operation, and the three-dimensional sponge foaming mold with the specific geometric shape is manufactured by 3D printing equipment. The sponge raw material and the foaming agent are mixed in a mould for foaming and molding, and the foaming sponge obtained through the special customized mould has good permeability and appearance matched with the height of a wound.
In the mold design, the inside of the sponge can be provided with a special drainage channel 11 according to the overall shape and the function requirement, so that the negative pressure pipeline can be conveniently inserted. Specifically, the internal drainage pipeline is flexibly designed according to different shapes of the customized sponge 10, including the trend and bifurcation of the pipeline, so as to be beneficial to better leading out liquid.
The resulting sponge is combined with a specially made highly conformable hydrogel 20 (hydrogel is coated around each negative pressure drainage port on the surface of the sponge, the negative pressure drainage port has a longitudinal backbone inside the sponge and connected with a plurality of transverse branches, and each transverse branch is separated by a plurality of vertical ports at fixed intervals). The sponge is treated with plasma or hexamethylenediamine to introduce primary amine groups on the surface of the sponge material, which are capable of forming covalent crosslinks with the hydrogel 20. The high-adhesion hydrogel layer has good biocompatibility and anisotropic swelling characteristics. The hydrogel 20 component includes polyvinyl alcohol (PVA) and polyacrylic acid (PAA-NHS) grafted with N-hydroxysuccinimide ester, and other modifying components such as Graphene Oxide (GO) may be added to create anisotropic swelling properties. The hydrogel layer has good fitting characteristics, and the airtight reliability of the device is greatly improved. The external surface of the drainage device can be also coated with a film for normal VSD drainage, so that the air tightness can be improved. The drainage device can be removed non-invasively by a solution containing sodium bicarbonate and glutathione.
Example 2
Unlike example 1, a sustained release carrier 30 was provided in the hydrogel 20 layer (see fig. 3). The sustained-release carrier 30 has a double-layer structure, comprising: the hydrogel comprises a trigger inner layer 31 and a functional outer layer 32 coating the trigger inner layer 31, wherein after the release of the functional outer layer 32 is finished, the trigger inner layer 31 is released to release the connection between the hydrogel 20 and surrounding tissues. Sustained release carrier 30 may be prepared based on polylactic-co-glycolic acid (PLGA) or polyvinylpyrrolidone (PVP) coating techniques.
The functional outer layer 32 is a bioactive factor or an antibacterial and antitumor component, and is flexibly configured according to the needs of the disease. When negative pressure treatment is carried out, the outer layer high-adhesion hydrogel 20 can be effectively adhered to wound tissues to form physical and chemical connection, so that dead cavities are effectively eliminated, and internal active substances are released. The trigger inner layer 31 is composed of sodium bicarbonate and L-glutathione, the sodium bicarbonate cleaves hydrogen bonds, and the L-glutathione cleaves covalent bonds. When the release of the outer layer slow release factor is finished, the inner layer trigger is released, the connection between the hydrogel 20 and surrounding tissues is released, and the whole device is convenient to remove.
In summary, the inner layer of the drainage device of the present invention is a customized sponge, allowing personalized customized foam materials to more match the wound; the outer layer high-adhesion hydrogel can realize anisotropy in the vertical direction, and the swelling is perfectly adhered to tissues around the wound and is adhered to the surface of wet tissues; the hydrogel can be internally provided with a slow release carrier with a double-layer structure, the outer layer is loaded with antibacterial drugs, the inner layer is loaded with triggering agents, and the interface lamination can be completely reversed after the treatment is finished, so that the noninvasive removing device is convenient.
While the present invention has been described in detail through the foregoing description of the preferred embodiment, it should be understood that the foregoing description is not to be considered as limiting the invention. Many modifications and substitutions of the present invention will become apparent to those of ordinary skill in the art upon reading the foregoing. Accordingly, the scope of the invention should be limited only by the attached claims.

Claims (6)

1. A personalized high-fit complex wound drainage device, comprising: the hydrogel comprises an inner-layer customized sponge and hydrogel coated on the outer side of the customized sponge;
the shape of the customized sponge is customized in a personalized way; introducing primary amine groups to the surface of the customized sponge to form covalent crosslinks with the hydrogel;
the hydrogel comprises the following components: polyvinyl alcohol, polyacrylic acid grafted with N-hydroxysuccinimide ester and graphene oxide;
the inside of the customized sponge is provided with:
a longitudinal backbone flow passage in communication with the negative pressure suction device;
a plurality of transverse branch flow passages communicated with the longitudinal main flow passage; and
And a plurality of vertical through holes are arranged on the transverse branch flow passage at intervals, and are used as drainage holes for communicating the outside of the customized sponge.
2. The personalized high fit complex wound drainage device of claim 1, wherein the negative pressure drainage device further comprises: a slow release carrier embedded in the hydrogel; the slow release carrier comprises: the trigger agent comprises a trigger agent inner layer and a functional outer layer coating the trigger agent inner layer, wherein after the release of the functional outer layer is finished, the trigger agent inner layer is released to release the connection between the hydrogel and surrounding tissues.
3. The personalized high fit complex wound drainage device of claim 2, wherein the functional outer layer comprises: bioactive factors, antibacterial components or antitumor components.
4. The personalized high fit complex wound drainage device of claim 2, wherein the trigger inner layer comprises: sodium bicarbonate and L-glutathione.
5. The personalized high fit complex wound drainage device of claim 1, wherein the method of obtaining the customized sponge comprises: and manufacturing a three-dimensional sponge foaming mold by using 3D printing equipment according to the required shape, and mixing the sponge raw material and the foaming agent in the mold for foaming molding.
6. The personalized high fit complex wound drainage device of claim 1, wherein the custom sponge is treated with plasma or hexamethylenediamine to introduce primary amine groups at the custom sponge surface.
CN202111347299.4A 2021-11-15 2021-11-15 Individualized complicated surface of a wound drainage device of laminating highly Active CN114028626B (en)

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CN115444977B (en) * 2022-09-20 2023-11-28 齐齐哈尔医学院 Polyurethane filling micelle for restoring excision empty slot after minimally invasive breast cancer operation

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CN101669855A (en) * 2009-09-25 2010-03-17 宋炜 Wound-protecting product with disposable negative pressure drainage
WO2013096605A1 (en) * 2011-12-20 2013-06-27 Bionova Medical, Inc. Systems and methods for delivering an agent to a wound under negative pressure
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全创面封闭式负压引流治疗皮肤软组织化脓性感染;乔建国!430071武汉,尹玉春!430071武汉,陈义发,裘华德;华中医学杂志;第21卷(第01期);第15-16页 *

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