WO2019041783A1 - 一种一次性手术定位膜及定位膜包 - Google Patents

一种一次性手术定位膜及定位膜包 Download PDF

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Publication number
WO2019041783A1
WO2019041783A1 PCT/CN2018/078918 CN2018078918W WO2019041783A1 WO 2019041783 A1 WO2019041783 A1 WO 2019041783A1 CN 2018078918 W CN2018078918 W CN 2018078918W WO 2019041783 A1 WO2019041783 A1 WO 2019041783A1
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WO
WIPO (PCT)
Prior art keywords
positioning film
positioning
film
disposable surgical
soft
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PCT/CN2018/078918
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English (en)
French (fr)
Inventor
蒙显章
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蒙显章
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Publication of WO2019041783A1 publication Critical patent/WO2019041783A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/31—Carrying cases or bags, e.g. doctors' bags

Definitions

  • the present application relates to the field of medical devices, and in particular to a disposable surgical positioning film and a positioning film package.
  • the surgical positioners are mainly used for preoperative positioning of the thoracolumbar spine and other operations. When positioning, they are placed directly above the positioning point. After positioning, the positioning point needs to be marked with a marker. After positioning, the positioner needs to be removed.
  • One of the purposes of the present application is to provide a disposable surgical positioning film which has at least one of the advantages of good skin fitting effect, accurate positioning, protection of surgical incision, simple structure, simple positioning operation, and real-time positioning.
  • Another object of the present application is to provide a disposable surgical positioning film package, which comprises a disposable surgical positioning film with good skin fitting effect, accurate positioning, protection of surgical incision, simple structure, simple positioning operation, and real-time operation. At least one of the advantages of positioning, as well as sterility, hygiene, and efficiency.
  • a disposable surgical positioning film comprising: a bottom plate and a positioning film, wherein the positioning film comprises a first transparent film, a soft coordinate developing layer and a second transparent film which are sequentially connected, and the first transparent film is away from the second transparent film
  • the side is provided with an adhesive layer, and the adhesive layer is detachably connected to the bottom plate.
  • the soft coordinate developing layer is a soft positioning net
  • the soft positioning net is provided with a plurality of cross-connected soft developing lines and a plurality of positioning holes surrounded by a plurality of soft developing lines.
  • the soft developing line includes a plurality of first soft coordinate lines arranged side by side along the longitudinal direction of the positioning film and a plurality of second soft coordinate lines arranged side by side in the width direction of the positioning film.
  • the soft developing line is mainly prepared by mixing and curing at least one of silica gel, polyurethane and polyvinyl chloride with barium sulfate; preferably, the soft developing line is mainly composed of at least silica gel, polyurethane and polyvinyl chloride. It is made by mixing with barium sulfate and methylene blue.
  • the soft coordinate developing layer includes a plurality of soft development dots.
  • a plurality of soft development dots are distributed in a matrix array manner.
  • the positioning film is mainly made of silica gel and a developing material capable of developing under X-rays, the developing material being mainly located in the soft coordinate developing layer.
  • the soft developing layer may be produced by mixing and solidifying a material such as, but not limited to, barium sulfate, methylene blue, and silica gel or polyvinyl chloride PVC or polyurethane PU.
  • a material such as, but not limited to, barium sulfate, methylene blue, and silica gel or polyvinyl chloride PVC or polyurethane PU.
  • the developing material comprises barium sulfate and methylene blue.
  • the positioning film is mainly made of polyurethane and a developing material capable of developing under X-rays, the developing material being mainly located in the soft coordinate developing layer.
  • the soft coordinate developing layer is mainly made of a silica gel and a developing material capable of developing under X-rays, and the soft coordinate developing layer is bonded to the first transparent film and the second transparent film.
  • the developing material comprises barium sulfate and methylene blue; optionally, the first transparent film and the second transparent film are both silica gel.
  • the first transparent film and the second transparent film are both polyurethane films.
  • the first transparent film and the second transparent film are both polyvinyl chloride.
  • the bottom plate is primarily made of a hard material to keep the disposable surgical positioning film flat before use.
  • the bottom plate is provided with a release coating to facilitate separation of the bottom plate from the positioning film; preferably, the release coating is a silicone oil layer; preferably The bottom plate is a release paper.
  • At least one edge of the bottom plate has a first urging portion extending outward; preferably, the shape of the first urging portion is a rectangle with a circular chamfer.
  • the positioning film is provided with a first measuring member extending along the length direction thereof, and the first measuring member is arranged with a plurality of first positioning members side by side in the extending direction.
  • the positioning film is provided with a second measuring member extending along the width direction thereof, and the second measuring member is provided with a plurality of second positioning members side by side in the extending direction.
  • the side of the positioning film away from the bottom plate is provided with a top plate, and the edge of the top plate is detachably connected or not connected to the bottom plate.
  • a side of the positioning film away from the bottom plate is provided with a top plate, and the top plate, the bottom plate and the positioning film have substantially the same shape and size.
  • At least one edge of the top plate has a second urging portion that extends outward or folds; preferably, the shape of the second urging portion is a rectangle with a circular chamfer.
  • an observation window is opened in the middle of the top plate.
  • a disposable surgical positioning film package comprising: an aseptic packaging housing and the above-described disposable surgical positioning film, the disposable surgical positioning film being disposed in the aseptic packaging housing.
  • the disposable surgical positioning film provided by the embodiment of the present application can realize the positioning operation by the illumination of the C-arm X-ray machine. Since the soft coordinate developing layer is flexible and can be bent at will, the positioning film can be adhered to the surface of any surgical skin by the adhesive layer at random, so that the positioning film completely and stably adheres to the skin surface.
  • the positioning film has a high degree of conformity with the skin surface, and there is no gap (ie, overhead phenomenon) with the unevenness of the skin; at the same time, the positioning film adheres to the skin surface with high stability, and is not affected by the patient's breathing, limb swinging, Slippage occurs due to changes in body position, such as small deviation and accurate positioning.
  • the positioning film When positioning operation, the positioning film is closely attached to the skin surface of the operation area and can be positioned with the C-arm X-ray machine. It can be removed without positioning, aseptic packaging, disposable use, no need to prepare for high temperature and high pressure before surgery, avoid crossover. Infection, easy to operate, safe and efficient.
  • the positioning film can allow the scalpel and other surgical devices to be cut or passed through, and can be attached to the skin surface of the operation area for pre-operative and intraoperative positioning, which can meet the needs of the positioning at any time during the operation. At the same time, the positioning film can be located at the same time. It is always applied around the wound during surgery to protect the wound.
  • the disposable surgical positioning film package provided by the embodiment of the present application is aseptically packaged in the aseptic packaging casing to prevent the disposable surgical positioning film from infecting bacteria before use, thereby being more sanitary and convenient to use.
  • FIG. 1 is a schematic structural view of a disposable surgical positioning film according to Embodiment 1 of the present application.
  • Figure 2 is a cross-sectional view of the disposable surgical positioning film provided in Example 1 of the present application.
  • FIG. 3 is a schematic structural view of a positioning film provided in Embodiment 1 of the present application.
  • FIG. 4 is a schematic structural view of a disposable surgical positioning film according to Embodiment 2 of the present application.
  • FIG. 5 is a schematic structural view of a disposable surgical positioning film according to Embodiment 3 of the present application.
  • Figure 6 is a cross-sectional view of the disposable surgical positioning film provided in Example 4 of the present application.
  • FIG. 7 is a schematic structural view of a disposable surgical positioning film according to Embodiment 5 of the present application.
  • Icon 100-disposable surgical positioning film; 110-bottom plate; 120-positioning film; 121-first transparent film; 122-soft coordinate developing layer; 1221-soft development line; 1222-positioning hole; Soft coordinate line; 1224-second soft coordinate line; 123-second transparent film; 130-first measuring piece; 131-first indicator piece; 140-second measuring piece; 141-second indicator piece 150-top plate; 151-observation window; 200-disposable surgical positioning film; 210-soft development line; 211-positioning hole; 300-disposable surgical positioning film; 310-soft development point; 400-one-time operation Positioning film; 410-bottom plate; 420-positioning film; 450-top plate; 500-disposable surgical positioning film; 510-first force applying portion; 520-second force applying portion.
  • the embodiment provides a disposable surgical positioning film 100 , which includes a bottom plate 110 and a positioning film 120 .
  • the positioning film 120 is detachably connected to a side of the bottom plate 110 adjacent to the positioning film 120 . On the surface. Further, before the disposable surgical positioning film 100 is used, the bottom plate 110 and the positioning film 120 are in a state of being adhered to each other. When used, the bottom plate 110 may be peeled off from the surface of the positioning film 120.
  • the positioning film 120 includes a first transparent film 121, a soft coordinate developing layer 122, and a second transparent film 123, which are sequentially connected, and an adhesive layer is disposed on a side of the first transparent film 121 away from the second transparent film 123 ( The figure is not shown).
  • the positioning film 120 is detachably connected to the bottom plate 110 through the adhesive layer and achieves a conformation to the skin surface.
  • an adhesive layer (not shown) is connected to the bottom surface of the first transparent film 121.
  • the bottom surface of the first transparent film 121 has an adhesive and can be formed on the bottom surface of the first transparent film 121 by coating or the like.
  • the adhesive on the bottom surface of the first transparent film 121 is protected by the bottom plate 110.
  • the bottom plate is removed and the bottom surface of the first transparent film 121 is attached to the surface of the surgical field.
  • the surface of the bottom plate 110 contacting the adhesive layer may be provided with a release coating to facilitate separation of the bottom plate 110 from the positioning film 120; preferably, the release coating is a silicone oil layer; more preferably, the bottom plate is released. paper. Further, the peeling force of the bottom plate 110 and the positioning film 120 can be made 0.10-1.00 N/25 mm.
  • the bottom plate 110 is primarily made of a hard material to keep the disposable surgical positioning film flat before use.
  • the soft coordinate developing layer 122 is provided with a structure which is soft, non-toxic, opaque, and has a certain elasticity and plasticity, and can be used as a coordinate positioning structure, so as to facilitate the irradiation with a C-arm X-ray machine or the like.
  • the first transparent film 121 and the second transparent film 123 cooperate to fix the soft coordinate developing layer 122, and prevent the soft coordinate developing layer 122 from being unbalanced by one side, which may cause structural deformation thereof to cause overall positioning;
  • the film 121 and the second transparent film 123 may also be an integrally fused structure and fuse the soft coordinate developing layer 122 therebetween.
  • the positioning film 120 may be mainly made of a silica gel and a developing material capable of being developed under X-rays, and the developing material is mainly located on the soft coordinate developing layer 122. Further, the positioning film 120 may also be mainly made of polyurethane and a developing material capable of developing under X-rays, and the developing material is mainly located on the soft coordinate developing layer 122.
  • the soft coordinate developing layer is coated with silica gel or polyurethane and integrated, that is, there is no clear interface between the first transparent film 121, the soft coordinate developing layer 122 and the second transparent film 123, and the three-layer structure is integrated.
  • the main component of the positioning film 120 may be silica gel or polyurethane, and the developing material has been coated therein. Therefore, the positioning film 120 can allow the scalpel and other surgical devices to be cut or passed.
  • the developing material which can be developed under X-rays includes most of the metal or a compound thereof, and the soft coordinate developing layer 122 can be prepared by using the powder together with silica gel or polyvinyl chloride or polyurethane.
  • the developing material further comprises a pigment, optionally methylene blue, which imparts a blue color to the developing material under natural light and is more easily observed by the naked eye.
  • the soft coordinate developing layer is mainly made of silica gel and a developing material capable of developing under X-ray, and the soft coordinate developing layer is bonded to the first transparent film and the second transparent film; alternatively, soft
  • the coordinate developing layer is mainly made of polyurethane and a developing material which can be developed under X-ray, and the soft coordinate developing layer is bonded to the first transparent film and the second transparent film.
  • the developing material comprises barium sulfate and methylene blue; preferably, the first transparent film and the second transparent film may be made of silica gel or polyurethane or polyvinyl chloride.
  • the soft coordinate developing layer 122 may be formed by using a developing material by using a mold, or may be placed in a predetermined pattern by using a twisted wire, and then wrapped in a silicone or polyurethane or polyvinyl chloride. Curing forms a film-like structure. Or the three-layer structure of the positioning film 120 is integrally formed and fabricated.
  • the thickness of the positioning film 120 of the present embodiment may be on the order of millimeters, preferably 1 mm and below, such as 0.01-1 mm, further, 0.01-0.05 mm, and the like.
  • the positioning film 120 is mainly made of a soft and elastic silicone or polyurethane or polyvinyl chloride material, the soft coordinate developing layer 122 is also soft.
  • the positioning film 120 is fixed to the skin by bonding, and the positioning film 120 has a high degree of adhesion to the skin surface, and there is no gap with the unevenness of the skin; and the positioning film adheres to the skin surface with high stability, which does not It is affected by the patient's breathing, limb swing, body position change, etc., resulting in small deviation and accurate positioning.
  • the positioning film 120 formed by the cooperation of the first transparent film 121, the soft coordinate developing layer 122 and the second transparent film 123 has flexibility and can be bent at will, and the positioning film 120 can be adhered to any skin surface of the surgery field through the adhesive layer.
  • the positioning film 120 has a high degree of fit with the skin surface, and there is no gap with the unevenness of the skin; at the same time, the positioning film 120 has high stability to the skin surface, and is not affected by the patient's breathing and limb swinging. Slippage occurs due to changes in body position, such as small deviation and accurate positioning.
  • the positioning film 120 when the positioning film 120 is used for the positioning operation, the positioning film 120 only needs to be attached to the skin surface of the operation area and the C-arm X-ray machine is used for positioning, and the positioning film 120 need not be directly removed after the positioning mark. Paste until the surgery is complete. It is aseptic packaging, can be used once, and can be used when the packaging shell is removed. It is not necessary to prepare for autoclaving before positioning surgery, which can avoid cross infection, and is easy to use, hygienic, safe and efficient.
  • the positioning film 120 can allow the scalpel and other surgical devices to be cut or passed through, and can be always attached to the surface of the skin for pre-operative and intraoperative positioning, which can meet the needs of the positioning at any time during the operation; the positioning film 120 can be It is always applied around the wound during surgery to protect the wound.
  • the soft coordinate developing layer 122 is a soft positioning net, and the positioning net shape may be square, circular, elliptical, and other regular or irregular shapes.
  • the soft positioning net is provided with a plurality of interlaced soft development lines 1221 and a plurality of positioning holes 1222 surrounded by a plurality of soft development lines 1221.
  • the soft developing line 1221 can be thick and thin, and can be selected according to the needs of use. It is used as a coordinate structure of the soft coordinate developing layer 122, and can separate the skin surface and the deep structure below the positioning film 120 into a plurality of The area is marked by the positioning hole 1222, and the positioning is more convenient and accurate.
  • the soft development line 1221 includes a plurality of first soft coordinate lines 1223 arranged side by side along the longitudinal direction of the positioning film 120 and a plurality of second soft coordinate lines 1224 arranged side by side along the width direction of the positioning film 120.
  • the plurality of first soft coordinate lines 1223 are arranged substantially parallel and equidistantly, and the extending directions of the plurality of first soft coordinate lines 1223 are perpendicular to the longitudinal direction of the positioning film 120; the plurality of second soft coordinate lines 1224 are along
  • the arrangement is substantially perpendicular to the direction of the first soft coordinate line 1223, and the extending direction of the plurality of second soft coordinate lines 1224 is perpendicular to the width direction of the positioning film 120.
  • the setting method makes the soft developing line 1221 form a structure of a substantially rectangular coordinate net, and the positioning thereof is more accurate and convenient, the structure is simple, and the operation is convenient.
  • the plurality of first soft coordinate lines 1223 and the plurality of second soft coordinate lines 1224 may also be disposed at non-equal intervals, such as may be set to have a small pitch near the middle portion.
  • the arrangement of the spacing near the edge is large, so that the positioning hole 1222 in the middle portion is denser and the positioning in the middle portion is more accurate.
  • the first coordinate line and the second coordinate line are not necessarily arranged side by side along the longitudinal direction or the width direction of the positioning film 120, as long as the positioning hole 1222 can be formed to separate the positioning film 120 into a plurality of regions for positioning.
  • the shape of the positioning hole 1222 is not necessarily a quadrangle such as a rectangle or a rhombus.
  • other soft coordinate lines may be provided to form a positioning hole 1222 of a triangle, a hexagon, an ellipse, a circle, or the like.
  • the positioning film 120 is provided with a first measuring member 130 extending along the length thereof, and the first measuring member 130 is connected to the first transparent film 121 and the second transparent film 123.
  • the first measuring member 130 is disposed at an edge of the soft coordinate developing layer 122 and extends in a direction perpendicular to the extending direction of the first soft developing line 1221.
  • the first measuring members 130 are arranged side by side in the extending direction with a plurality of first positioning members 131, and each of the first positioning members 131 corresponds to a first soft coordinate line 1223.
  • the first coordinate line is arranged in a one-to-one correspondence with the first measuring component 130, so that the length distance of the positioning point to the starting point of the positioning film 120 is directly read by the first measuring component 130, so that the disposable surgical positioning film 100 is positioned.
  • it has a measurement function in the longitudinal direction, which is convenient for recording the position of the positioning point, and is more convenient for positioning and operation.
  • the positioning film 120 is provided with a second measuring member 140 extending along the width direction thereof, the second measuring member 140 is connected between the first transparent film 121 and the second transparent film 123, and the second measuring member 140 is disposed
  • the edge of the soft coordinate developing layer 122 is extended perpendicular to the extending direction of the second soft developing line 1221.
  • the second measuring members 140 are arranged side by side in the extending direction with a plurality of second positioning members 141, and each of the second positioning members 141 corresponds to a second soft coordinate line 1224.
  • the first coordinate line is arranged in a one-to-one correspondence with the second measuring member 140, so that the width distance of the positioning point to the starting point of the positioning film 120 is directly read by the second measuring member 140, so that the disposable surgical positioning film 100 is positioned.
  • it has a measurement function in the width direction, which is convenient for recording the position of the positioning point, and is more convenient for positioning and operation.
  • the side of the positioning film 120 away from the bottom plate 110 is provided with a top plate 150, and the edge of the top plate 150 is detachably connected or not adhered to the bottom plate 110.
  • the first transparent film 121, the soft coordinate developing layer 122, and the second transparent film 123 of the positioning film 120 have substantially the same shape and dimensions, and cover a partial area of the upper surface of the bottom plate 110, before the top plate 150 is disposed, on the bottom plate 110.
  • the surface has a blank area along its edge for one week, in other words, the positioning film 120 substantially covers the central portion of the upper surface of the bottom plate 110.
  • the top plate 150 is slightly larger in size than the positioning film 120, and the edge of the top plate 150 is joined to the edge of the bottom plate 110.
  • the top plate 150 may not be connected to the bottom plate 110, and even the top plate 150 may be separated from the width of the positioning film 120, the bottom plate 110 and the like.
  • the top plate 150 is arranged to facilitate the positioning of the film 120 after it is detached from the bottom plate 110 by using the disposable surgical positioning film, and then it is not easy to be stuck or deformed when the film is attached to the skin.
  • Top plate 150 and bottom plate 110 can be a transparent material or an opaque material.
  • the shape, specification, and model of the positioning film 120 can be directly observed, and the use is more convenient.
  • the viewing window 151 is opened in the middle of the top plate 150.
  • the shape, specification and model of the positioning film 120 are observed through the viewing window 151, and the use is more convenient.
  • the observation window 151 may be omitted for direct observation.
  • This embodiment provides a disposable surgical positioning film package (not shown), including a sterile packaging housing (not shown) and the above-described disposable surgical positioning film 100, wherein the disposable surgical positioning film 100 is aseptically processed. It is placed in a sterile packaging housing.
  • the aseptic packaging shell is a sterilization packaging bag, which may be a hard shell or a soft bag body, and may be a transparent material or an opaque material, and the aseptic packaging shell may be a paper plastic package, a paper paper package, a plastic package. Wait.
  • the paper-plastic packaging has good gas permeability, can pass the sterilization factor, and blocks the entry of microorganisms in the air, and is convenient for observing the appearance, specifications and models of the products in the bag.
  • the disposable surgical positioning film 100 is encapsulated and sterilized and stored for use, so as to avoid contamination of the positioning film 120 caused by pollution sources or misoperations in the storage process of the disposable surgical positioning film 100, and the sanitary condition is good. It is safer to use and more convenient for long-term storage.
  • the present embodiment provides a disposable surgical positioning film 200 which is different from the disposable surgical positioning film 100 of the first embodiment in that the soft developing line of the disposable surgical positioning film 200 is
  • the 210 is composed of soft coordinate lines which are arranged at equal intervals in three directions which are formed at an angle of substantially 60°, and the cross section of the positioning holes 211 surrounded by the soft coordinate lines in the three directions is a substantially equilateral triangle.
  • the present embodiment provides a disposable surgical positioning film 300 which is different from the disposable surgical positioning film 100 of the first embodiment in that the soft coordinate development of the disposable surgical positioning film 300 is performed.
  • Layer 122 includes a plurality of soft development dots 310.
  • the actual occupied area of the developing material in the soft coordinate developing layer 122 is small, which increases the flexibility and tortuosity of the positioning film 120, and the surface of the skin is The fit fit is higher.
  • the plurality of soft development dots 310 are distributed in a matrix array manner, and the soft development dots 310 on the same row are arranged side by side along the longitudinal direction of the positioning film 120, and the soft development dots 310 on the same column are positioned along the positioning film.
  • the width direction of 120 is set side by side. It evenly separates the positioning film 120, and the positioning is more convenient and accurate.
  • the plurality of soft development dots 310 can be large or small, and can be determined according to the needs of use. Further, the plurality of soft development dots 310 may have a shape of a rectangular shape, a circular shape, a triangular shape or the like, and the shapes of the plurality of soft development dots 310 of the same soft coordinate development layer 122 may be the same or different.
  • the present embodiment provides a disposable surgical positioning film 400 that includes or a bottom plate 410 , a positioning film 420 , and a top plate 450 .
  • the first transparent film, the soft coordinate developing layer and the second transparent film are integrated and have no obvious interface.
  • the top plate 450, the bottom plate 410, and the positioning film 420 have substantially the same shape and size.
  • This disposable surgical positioning film 400 is similar to a sandwich structure in which the positioning film 420 is sandwiched between the top plate 450 and the bottom plate 410.
  • the lower surface of the positioning film 420 may be provided with an adhesive layer, and the surface of the bottom plate 410 that is in contact with the adhesive layer is provided with an anti-stick coating to facilitate separation of the bottom plate 410 and the positioning film 420 before use.
  • the lower surface of the top plate 450 may also be coated with a layer of adhesive that can be separated from the positioning film 420.
  • the top plate 450 can be made of a material that can be bonded to the silicone, or the lower surface of the top plate 450 can be coated with a material that can be bonded to the silicone.
  • the present embodiment provides a disposable surgical positioning film 500 comprising a bottom plate (not labeled), a positioning film (not labeled), and a top plate 550.
  • At least one edge of the top plate 550 may have a second urging portion 520 that extends outward.
  • one of the edges of the top plate 550 has a second urging portion 520 that extends outward.
  • the shape of the second urging portion 520 is a rectangle with a circular chamfer. In other embodiments, other shapes of the second urging portion 520 may also be selected.
  • At least one edge of the bottom plate may have a first force applying portion 510 extending outward.
  • one of the edges of the bottom plate has a first urging portion 510 that extends outward.
  • the shape of the first urging portion 510 is a rectangle with a circular chamfer. In other embodiments, other shapes of the first force applying portion 510 may also be selected.
  • the top plate and the bottom plate may each have a force applying portion, or one of them may have such a force applying portion.
  • the first urging portion 510 is a portion that is connected to the bottom plate and is not bonded to the positioning film, and is more easily held by the hand or the tool, so that it is easier to find a point of application on the bottom plate, and the bottom plate and the positioning film are more easily separated by human.
  • the second urging portion 520 has a similar effect as the first urging portion 510.
  • the disposable surgical positioning film provided by the embodiment of the present application has the advantages of good skin bonding effect, accurate positioning, protection of surgical incision, simple structure, simple positioning operation, and positioning at any time.
  • the disposable surgical positioning film package provided by the embodiment of the present application performs aseptic packaging on the disposable surgical positioning film to avoid contamination of the positioning film caused by pollution sources or misoperations in the storage process of the disposable surgical positioning film. Good conditions, safer use and easy storage for long periods of time.
  • the disposable surgical positioning film provided by the embodiment of the present application can realize the positioning operation by the illumination of the C-arm X-ray machine or the like. Since the soft coordinate developing layer is flexible and can be bent at will, the positioning film can be adhered to the surface of any surgical skin by the adhesive layer at random, so that the positioning film completely and stably adheres to the skin surface. During the positioning operation, the positioning film is closely attached to the skin surface of the operation area and can be positioned by the C-arm X-ray machine, etc., and can be removed after positioning, aseptic packaging, disposable use, without pre-operative preparation for high temperature and high pressure sterilization. Avoid cross infection and easy to operate.
  • the positioning film can allow the scalpel and other surgical devices to be cut or passed through, and can be attached to the skin surface of the operation area for pre-operative and intraoperative positioning, which can meet the needs of the positioning at any time during the operation. At the same time, the positioning film can be located at the same time. It is always applied around the wound during surgery to protect the wound.
  • the disposable surgical positioning film package provided by the embodiment of the present application is aseptically packaged in the aseptic packaging casing to prevent the disposable surgical positioning film from infecting bacteria before use, thereby being more sanitary and convenient to use.

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Abstract

一种一次性手术定位膜(100, 200, 300, 400, 500)及定位膜包，属于医疗设备技术领域。一次性手术定位膜(100, 200, 300, 400, 500)包括底板(110, 410)及定位贴膜(120, 420)。定位贴膜(120, 420)包括依次连接的第一透明薄膜(121)、软质坐标显影层(122)以及第二透明薄膜(123)，第一透明薄膜(121)的远离第二透明薄膜(123)的一侧设置有胶粘层，胶粘层与底板(110, 410)可拆卸连接。具备与皮肤贴合效果好、定位准确、可保护手术切口、结构简单、定位操作简单且可随时定位等优点。一次性手术定位膜包包括无菌包装壳体以及一次性手术定位膜(100, 200, 300, 400, 500)，一次性手术定位膜(100, 200, 300, 400, 500)设置于无菌包装壳体内。卫生条件好、使用的安全性更佳且便于长时间存放。

Description

一种一次性手术定位膜及定位膜包
本申请要求于2017年08月29日提交中国专利局的申请号为CN201710758779.7、名称为“一次性手术定位膜及定位膜包”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗设备领域，特别是涉及一种一次性手术定位膜及定位膜包。
背景技术
目前，在外科、骨科等手术过程中，许多手术都需要在对病员患处准确定位的条件下才能进行，以达到微创、安全、高效的手术目的。例如脊柱、椎间盘手术，骨科内固定微创植入或内固定物取出、异物的取出，经皮的各种各科手术等等，都需要在准确定位的条件下手术。对患处定位准确与否直接关系到手术能否成功，手术质量的好差以及病员的痛苦与康复。
目前大部分的手术***主要为脊柱胸腰椎等手术的术前定位用，定位时放置于定位点正上方，定位后需以记号笔标记定位点，定位好后需要拿开***。
发明内容
本申请的目的之一在于提供一种一次性手术定位膜，其具备与皮肤贴合效果好、定位准确、可保护手术切口、结构简单、定位操作简单且可实时定位等优点至少之一。
本申请的另一目的在于提供一种一次性手术定位膜包，其包括的一次性手术定位膜具备与皮肤贴合效果好、定位准确、可保护手术切口、结构简单、定位操作简单、可实时定位等优点，以及无菌、卫生、高效等优点至少之一。
本申请的实施例是这样实现的：
一种一次性手术定位膜，其包括：底板及定位贴膜，定位贴膜包括依次连接的第一透明薄膜、软质坐标显影层以及第二透明薄膜，第一透明薄膜的远离第二透明薄膜的一侧设置有胶粘层，胶粘层与底板可拆卸连接。
进一步地，软质坐标显影层为软质定位网，软质定位网设有多个交错连接的软质显影线以及由多个软质显影线围成的多个定位孔。
进一步地，软质显影线包括沿定位贴膜的长度方向并排设置的多个第一软质坐标线以及沿定位贴膜的宽度方向并排设置的多个第二软质坐标线。
所述软质显影线主要由硅胶、聚氨酯和聚氯乙烯中的至少一种与硫酸钡混合固化制作而成；优选地，所述软质显影线主要由硅胶、聚氨酯和聚氯乙烯中的至少一种与硫酸钡及亚甲蓝混合固化制作而成。
进一步地，软质坐标显影层包括多个软质显影点。
进一步地，多个软质显影点以矩阵阵列方式分布。
进一步地，所述定位贴膜主要由硅胶和能够在X射线下显影的显影材料制成，所述显影材料主要位于所述软质坐标显影层。
软质显影层可由硫酸钡、亚甲蓝和硅胶或聚氯乙烯PVC或聚氨酯PU等材料(但不限于此)混合固化制作而成。
优选地，所述显影材料包括硫酸钡和亚甲蓝。
进一步地，所述定位贴膜主要由聚氨酯和能够在X射线下显影的显影材料制成，所述显影材料主要位于所述软质坐标显影层。
进一步地，所述软质坐标显影层主要由硅胶和能够在X射线下显影的显影材料制成，所述软质坐标显影层与所述第一透明薄膜及所述第二透明薄膜粘接而成；优选地，所述显影材料包括硫酸钡和亚甲蓝；可选地，所述第一透明薄膜及所述第二透明薄膜均为硅胶。可选地，所述第一透明薄膜及所述第二透明薄膜均为聚氨酯膜。可选地，所述第一透明薄膜及所述第二透明薄膜均聚氯乙烯。
进一步地，所述底板主要由硬质材料制成，以使所述一次性手术定位膜在使用前保持平整。
进一步地，至少所述底板的与所述胶粘层接触的表面设置有防粘涂层以利于所述底板与所述定位贴膜分离；优选地，所述防粘涂层为硅油层；优选地，所述底板为离型纸。
进一步地，所述底板的至少一个边缘具有向外延伸的第一施力部；优选地，所述第一施力部的形状为带有圆弧倒角的长方形。
进一步地，定位贴膜设有沿其沿长度方向延伸的第一测量件，第一测量件沿延伸方向并排设置有多个第一示位件。
进一步地，定位贴膜设有沿其沿宽度方向延伸的第二测量件，第二测量件沿延伸方向并排设置有多个第二示位件。
进一步地，定位贴膜的远离底板的一侧设置有顶板，顶板的边缘与底板可拆卸连接或不连接。
进一步地，所述定位贴膜的远离所述底板的一侧设置有顶板，所述顶板、所述底板及所述定位贴膜的形状尺寸基本一致。
进一步地，所述顶板的至少一个边缘具有向外延伸或翻折的第二施力部；优选地，所述第二施力部的形状为带有圆弧倒角的长方形。
进一步地，顶板的中部开设有观察窗。
一种一次性手术定位膜包，其包括：无菌包装壳体以及上述的一次性手术定位膜，一次性手术定位膜设置于无菌包装壳体内。
本申请实施例的有益效果是：
本申请实施例提供的一次性手术定位膜，软质坐标显影层可配合C形臂X光机的照射实现定位操作。由于软质坐标显影层具有柔性、可随意弯折，定位贴膜可通过胶粘层随意紧密粘贴于任意的术野皮肤表面，使定位贴膜完全且稳定地贴合于皮肤表面。定位贴膜与皮肤表面的贴合度高，其与皮肤的凹凸之处不存在空隙(即架空现象)；同时定位贴膜贴合于皮肤表面稳定性高，其不会受患者的呼吸、肢体摆动、***改变等影响而产生滑移，偏差小、定位准确。定位操作时将定位贴膜紧密粘贴于术区皮肤表面配合C形臂X光机定位即可，无需定位后移除，无菌包装，一次性使用，无需术前再作高温高压消毒准备、避免交叉感染，操作方便、安全、高效。定位贴膜能够允许手术刀及其他手术器件切开或穿过，术前及术中均可贴合于术区皮肤表面进行随时定位，能够满足手术中随时可能的定位需要；同时，定位贴膜可在术中一直贴合于创口周围，能够对创口进行保护。
本申请实施例提供的一次性手术定位膜包，将上述一次性手术定位膜无菌封装于无菌包装壳体内，避免一次性手术定位膜在使用前感染细菌，因此更卫生，使用更方便。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本申请的某些实施例，因此不应被看作是对范围的限定，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他相关的附图。
图1为本申请实施例1提供的一次性手术定位膜的结构示意图；
图2为本申请实施例1提供的一次性手术定位膜的剖视图；
图3为本申请实施例1提供的定位贴膜的结构示意图；
图4为本申请实施例2提供的一次性手术定位膜的结构示意图；
图5为本申请实施例3提供的一次性手术定位膜的结构示意图；
图6为本申请实施例4提供的一次性手术定位膜的剖视图；
图7为本申请实施例5提供的一次性手术定位膜的结构示意图。
图标：100-一次性手术定位膜；110-底板；120-定位贴膜；121-第一透明薄膜；122-软质坐标显影层；1221-软质显影线；1222-定位孔；1223-第一软质坐标线；1224-第二软质坐标线；123-第二透明薄膜；130-第一测量件；131-第一示位件；140-第二测量件；141-第二示位件；150-顶板；151-观察窗；200-一次性手术定位膜；210-软质显影线；211-定位孔；300-一次性手术定位膜；310-软质显影点；400-一次性手术定位膜；410-底板；420-定位贴膜；450-顶板；500-一次性手术定位膜；510-第一施力部；520-第二施力部。
具体实施方式
为使本申请实施例的目的、技术方案和优点更加清楚，下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本申请实施例的组件可以以各种不同的配置来布置和设计。
因此，以下对在附图中提供的本申请的实施例的详细描述并非旨在限制要求保护的本申请的范围，而是仅仅表示本申请的选定实施例。基于本 申请中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。
在本申请的描述中，需要说明的是，术语“中心”、“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，或者是该发明产品使用时惯常摆放的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
此外，术语“第一”、“第二”等仅用于区分描述，而不能理解为指示或暗示相对重要性。
此外，术语“垂直”、“平行”、“并排”等术语并不表示要求部件之间一定绝对平行或垂直，也是可以稍微倾斜。如“垂直”仅仅是指其方向相对“平行”而言更加垂直，并不是表示该结构之间一定要完全垂直，也是可以稍微倾斜。
在本申请的描述中，还需要说明的是，除非另有明确的规定和限定，术语“设置”、“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。
实施例
实施例1
请一并参阅图1及图2，本实施例提供一种一次性手术定位膜100，包括底板110及定位贴膜120，定位贴膜120可拆卸地连接于底板110的靠近定位贴膜120的一侧的表面上。进一步地，该一次性手术定位膜100在使用前，底板110与定位贴膜120处于相互贴合状态，使用时，可以先将底板110从定位贴膜120的表面剥离。
具体地，定位贴膜120包括依次连接的第一透明薄膜121、软质坐标显影层122以及第二透明薄膜123，第一透明薄膜121的远离第二透明薄膜123的一侧设置有胶粘层(图未示)。定位贴膜120通过该胶粘层与底板110可拆卸连接并实现对皮肤表面的贴合。
请参阅图2，第一透明薄膜121的底面连接有胶粘层(图未示)，第一透明薄膜121的底面有胶粘剂，可以通过涂覆等方式形成于第一透明薄膜121的底面。
在未使用时，通过底板110保护第一透明薄膜121底面的胶粘剂，使用时，将底板去除并将第一透明薄膜121的底面贴在术野皮肤表面即可。
进一步地，至少底板110的与胶粘层接触的表面可以设置防粘涂层，以利于底板110与定位贴膜120分离；优选地，防粘涂层为硅油层；更优选地，底板为离型纸。进一步地，可以使底板110与定位贴膜120的剥离力处于0.10-1.00N/25mm。
进一步地，底板110主要由硬质材料制成，以使所述一次性手术定位膜在使用前保持平整。
软质坐标显影层122设有质软、无毒、不透光、且具有一定弹性和可塑性的性能稳定材料制成的能够起坐标定位作用的结构，便于配合C形臂X光机等照射时对目标位置定位并进行标记。
第一透明薄膜121及第二透明薄膜123配合对软质坐标显影层122进行固定，防止软质坐标显影层122因单面固定不平衡可能导致其结构变形而造成整体定位可能影响；第一透明薄膜121及第二透明薄膜123也可以是一体融合的结构并将软质坐标显影层122融合于二者之间。
进一步地，定位贴膜120可以主要由硅胶和能够在X射线下显影的显影材料制成，显影材料主要位于软质坐标显影层122。进一步地，定位贴膜120也可以主要由聚氨酯和能够在X射线下显影的显影材料制成，显影材料主要位于软质坐标显影层122。软质坐标显影层被硅胶或者聚氨酯包覆且成为一体，即第一透明薄膜121、软质坐标显影层122及第二透明薄膜123之间可以没有明确的分界面，三层结构一体化。
定位贴膜120主要成分可以是硅胶或者聚氨酯，而且显影材料都已经被包覆其中，因此，定位贴膜120能够允许手术刀及其他手术器件切开或穿过。
能够在X射线下显影的显影材料包括绝大部分金属或其化合物，可以通过其粉末与硅胶或聚氯乙烯或聚氨酯一起制备软质的坐标显影层122。优选地，显影材料还包括颜料，可选亚甲蓝，亚甲蓝可以赋予显影材料在自然光下显示蓝色，更容易被肉眼观察到。
进一步地，软质坐标显影层主要由硅胶和能够在X射线下显影的显影材料制成，软质坐标显影层与第一透明薄膜及第二透明薄膜粘接而成；可选地，软质坐标显影层主要由聚氨酯和能够在X射线下显影的显影材料制成，软质坐标显影层与第一透明薄膜及第二透明薄膜粘接而成。优选地，显影材料包括硫酸钡和亚甲蓝；优选地，第一透明薄膜及第二透明薄膜可以由硅胶或者聚氨酯或聚氯乙烯制成。
此外，软质的坐标显影层122可以采用显影材料借助模具制作出预设的显影图案，也可以采用钡线摆放成预设图案，再用硅胶或聚氨酯或 聚氯乙烯将其包裹于其中并固化形成薄膜状结构。或定位贴膜120三层结构一体化成型制作。
进一步地，本实施例的定位贴膜120的厚度可以是毫米级，优选1mm及以下，例如0.01-1mm，进一步地，0.01-0.05mm等。
由于定位贴膜120主要由柔软且具有弹性的硅胶或聚氨酯或聚氯乙烯等材料制成，而且软质坐标显影层122也是软质的。定位贴膜120通过粘接的方式固定于皮肤，定位贴膜120与皮肤表面的贴合度高，其与皮肤的凹凸之处不存在空隙；同时定位贴膜贴合于皮肤表面稳定性高，其不会受患者的呼吸、肢体摆动、***改变等影响而产生滑移，偏差小、定位准确。
第一透明薄膜121、软质坐标显影层122及第二透明薄膜123配合形成的定位贴膜120具有柔性、可随意弯折，定位贴膜120可通过胶粘层随意紧密粘贴于任意的术野皮肤表面，定位贴膜120与皮肤表面的贴合配合度高，其与皮肤的凹凸之处不存在空隙；同时定位贴膜120贴合于皮肤表面的稳定性高，其不会受患者的呼吸、肢体摆动、***改变等影响而产生滑移，偏差小、定位准确。
同时，采用上述设置的定位贴膜120进行定位操作时，仅需将定位贴膜120粘贴于术区皮肤表面配合C形臂X光机等进行定位标记，定位标记后无需直接移除定位贴膜120，可一直粘贴直至术毕再取出。其为无菌包装，一次性使用，需要时拆除包装外壳即可使用，无需在定位手术前再作高压消毒准备，可避免交叉感染，其使用操作方便，卫生、安全、高效。该定位贴膜120能够允许手术刀及其他手术器件切开或穿过，术前及术中均可始终贴合于皮肤表面进行随时定位，能够满足手术中随时可能的定位需要；定位贴膜120可在术中一直贴合于创口周围，能够对创口进行保护。
请参阅图2、3，软质坐标显影层122为软质定位网，定位网形状可以为方形、圆形、椭圆形及其他规则形或不规则形等。在本实施例中，软质定位网设有多个交错连接的软质显影线1221以及由多个软质显影线1221围成的多个定位孔1222。软质显影线1221可粗可细，可根据使用需要进行选择，其用作软质坐标显影层122的坐标结构，能够将与定位贴膜120贴合的皮肤表面及其下深层结构分隔为多个区域，并通过定位孔1222进行标记记录，定位更加方便、准确。
进一步地，本实施中软质显影线1221包括沿定位贴膜120的长度方向并排设置的多个第一软质坐标线1223以及沿定位贴膜120的宽度方向并排设置的多个第二软质坐标线1224。即多个第一软质坐标线1223大致平行且等间距的设置，且多个第一软质坐标线1223的延伸方向与定位贴膜120的长度方向垂直；多个第二软质坐标线1224沿大致垂直于第一软质坐标线1223的方向等间距的设置，且多个第二软质坐标线1224的延伸方向与定位贴膜120的宽度方向垂直。该设置方式使软质显影线1221形成大致的矩形坐标网的结构，其定位更加准确方便，结构简单、操作方便。
需要说明的是，在本申请其他的实施例中，多个第一软质坐标线1223和多个第二软质坐标线1224也可以非等间距设置，如可以设置为靠近中部的间距小而靠近边缘的间距大的设置方式，使中部的定位孔1222更加密集，中部的定位更准确。第一坐标线和第二坐标线不一定沿定位贴膜120的长度方向或宽度方向并排设置，只要是能够形成定位孔1222将定位贴膜120分隔为多个区域实现定位即可。定位孔1222的形状也不一定是如矩形、菱形等的四边形，如还可以设置其他软质坐标线形成三角形、六边形、椭圆形、圆形等的定位孔1222。
请继续参阅图3，在本实施例中，定位贴膜120设有沿其沿长度方向延伸的第一测量件130，该第一测量件130连接于第一透明薄膜121和第二透明薄膜123之间，该第一测量件130设置于软质坐标显影层122的边缘且其延伸方向与第一软质显影线1221的延伸方向垂直。
第一测量件130沿延伸方向并排设置有多个第一示位件131，且每个第一示位件131对应一个第一软质坐标线1223。上述的第一坐标线与第一测量件130一一对应的设置方式，便于通过第一测量件130直接读取定位点到定位贴膜120起点的长度距离，使一次性手术定位膜100在定位的同时具有长度方向的测量功能，便于记录定位点的位置，定位及手术操作更方便。
进一步地，定位贴膜120设有沿其沿宽度方向延伸的第二测量件140，该第二测量件140连接于第一透明薄膜121和第二透明薄膜123之间，该第二测量件140设置于软质坐标显影层122的边缘且其延伸方向与第二软质显影线1221的延伸方向垂直。
第二测量件140沿延伸方向并排设置有多个第二示位件141，且每个第二示位件141对应一个第二软质坐标线1224。上述的第二坐标线与第二测量件140一一对应的设置方式，便于通过第二测量件140直接读取定位点到定位贴膜120起点的宽度距离，使一次性手术定位膜100在定位的同时具有宽度方向的测量功能，便于记录定位点的位置，定位及手术操作更方便。
请继续参阅图2、3，在本实施例中，定位贴膜120的远离底板110的一侧设置有顶板150，顶板150的边缘与底板110为可拆卸连接或不粘连。
定位贴膜120的第一透明薄膜121、软质坐标显影层122以及第二透明 薄膜123的形状尺寸基本一致，其覆盖于底板110上表面的部分区域，在未设置顶板150之前，底板110的上表面沿其边缘存在一周的空白区域，换句话说，定位贴膜120基本上覆盖于底板110上表面的中部区域。顶板150尺寸略大于定位贴膜120，顶板150的边缘与底板110的边缘连接。当然，顶板150也可以与底板110不连接，甚至顶板150也可以与定位贴膜120、底板110等宽等大边缘断面相游离。
顶板150的设置为使用一次性手术定位膜时便于定位贴膜120先脱离底板110后仍保持平整，再贴合于皮肤时也不容易发生定位贴膜粘手或变形皱着等情况。
顶板150和底板110可为透明材料或不透明材料。采用透明材料制备顶板150和/或底板110时，可以直接观察到定位贴膜120的形态、规格、型号，使用更加方便。
本实施例中顶板150的中部开设有观察窗151，透过观察窗151观察定位贴膜120的形态、规格、型号，使用更加方便。当然，在本申请其他的实施例中，如采用透明材料制备顶板150或底板110时，也可以不设置观察窗151即可直接观察。
本实施例提出一种一次性手术定位膜包(图未示)，包括无菌包装壳体(图未示)以及上述的一次性手术定位膜100，其一次性手术定位膜100为无菌处理设置于无菌包装壳体内。
无菌包装壳体即灭菌包装袋，可以是硬质壳体或者软质袋体等，可以是透明材料或不透明材料，无菌包装壳体可以是纸塑包装，纸纸包装，塑塑包装等。优选纸塑包装，其透气性好，可透过灭菌因子，同时阻隔空气中的微生物进入，又方便于观察袋内产品外观、规格、型号等。其将一次性手术 定位膜100封装于内进行灭菌处理后保存待用，避免一次性手术定位膜100在存放过程中因环境中污染源或误操作等造成对定位贴膜120的污染，卫生条件好、使用的安全性更佳，且更便于较长时间存放。
实施例2
请参阅图4，本实施例提出一种一次性手术定位膜200，其与实施例1提出的一次性手术定位膜100相比，不同之处在于：一次性手术定位膜200的软质显影线210由互成大致60°的夹角的三个方向上并排等间距设置的软质坐标线组成，该三个方向的软质坐标线围成的定位孔211的截面为大致的正三角形。
实施例3
请参阅图5，本实施例提出一种一次性手术定位膜300，其与实施例1提出的一次性手术定位膜100相比，不同之处在于：一次性手术定位膜300的软质坐标显影层122包括多个软质显影点310。
多个软质显影点310将定位贴膜120进行分隔的同时，软质坐标显影层122中显影材料的实际所占的面积小，增大了定位贴膜120的柔性可曲折性，其对皮肤表面的贴合配合度更高。
在本实施例中，多个软质显影点310以矩阵阵列方式分布，同一行上的软质显影点310沿定位贴膜120的长度方向并排设置，同一列上的软质显影点310沿定位贴膜120的宽度方向并排设置。其将定位贴膜120均匀分隔，定位更方便、准确。
需要说明的是，多个软质显影点310可大可小，其可以根据使用的需要决定。此外，多个软质显影点310可以为截面为矩形、圆形、三角形等的形状，同一软质坐标显影层122的多个软质显影点310的形状可以相同 或不同。
实施例4
请参阅图6，本实施例提出一种一次性手术定位膜400，其包括或底板410、定位贴膜420及顶板450。其中第一透明薄膜、软质坐标显影层以及第二透明薄膜融合呈一体并且没有明显分界面。
顶板450、底板410及定位贴膜420的形状尺寸基本一致。这种一次性手术定位膜400类似三明治结构，定位贴膜420被夹在顶板450和底板410之间。如前所述，定位贴膜420的下表面可以设置胶粘层，底板410上与胶粘层接触的表面设有防粘涂层，以利于在使用前将底板410和定位贴膜420分离。此外，顶板450的下表面也可以涂覆一层能够与定位贴膜420分离的不干胶，进一步地，当定位贴膜420主要由硅胶制成时，由于硅胶自身具有一定的粘接能力，可以选用能够与硅胶粘接的材料制作顶板450，或者在顶板450的下表面涂覆能够与硅胶粘接的材料。
实施例5
请参阅图7，本实施例提出一种一次性手术定位膜500，其包括底板(未标注)、定位贴膜(未标注)及顶板550。
为了便于施加作用力使顶板550与定位贴膜分离，顶板550的至少一个边缘可以具有向外延伸的第二施力部520。在本实施例中，顶板550的其中一个边缘具有向外延伸的第二施力部520。优选地，第二施力部520的形状为带有圆弧倒角的长方形。在其他实施例中，第二施力部520的也可以选择其他形状。
为了便于施加作用力使底板与定位贴膜分离，底板的至少一个边缘可以具有向外延伸的第一施力部510。在本实施例中，底板的其中一个 边缘具有向外延伸的第一施力部510。优选地，第一施力部510的形状为带有圆弧倒角的长方形。在其他实施例中，第一施力部510的也可以选择其他形状。
在一个实施例中，顶板和底板可以均具有施力部，也可以是其中一者具有这种施力部。
当底板与定位贴膜尺寸和大小均完全一致时，底板与定位贴膜的分离可能会存在困难。第一施力部510作为与底板连接且不与定位贴膜粘接的部分，更容易被手或者工具夹持，这样更容易在底板上找到施力点，使底板和定位贴膜更容易人为地分离。第二施力部520具有与第一施力部510类似的作用。
综上所述，本申请实施例提供的一次性手术定位膜，其具备与皮肤贴合效果好、定位准确、可保护手术切口、结构简单、定位操作简单且可随时定位等优点。
本申请实施例提供的一次性手术定位膜包，将一次性手术定位膜进行无菌包装，避免一次性手术定位膜在存放过程中因环境中污染源或误操作等造成对定位贴膜的污染，卫生条件好、使用的安全性更佳且便于长时间存放。
以上所述仅为本申请的优选实施方式而已，并不用于限制本申请，对于本领域的技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的保护范围之内。
工业实用性
本申请实施例提供的一次性手术定位膜，软质坐标显影层可配合C形 臂X光机等的照射实现定位操作。由于软质坐标显影层具有柔性、可随意弯折，定位贴膜可通过胶粘层随意紧密粘贴于任意的术野皮肤表面，使定位贴膜完全且稳定地贴合于皮肤表面。定位操作时将定位贴膜紧密粘贴于术区皮肤表面配合C形臂X光机等透视照射定位即可，无需定位后移除，无菌包装，一次性使用，无需术前再作高温高压消毒准备、避免交叉感染，操作方便。定位贴膜能够允许手术刀及其他手术器件切开或穿过，术前及术中均可贴合于术区皮肤表面进行随时定位，能够满足手术中随时可能的定位需要；同时，定位贴膜可在术中一直贴合于创口周围，能够对创口进行保护。本申请实施例提供的一次性手术定位膜包，将上述一次性手术定位膜无菌封装于无菌包装壳体内，避免一次性手术定位膜在使用前感染细菌，因此更卫生，使用更方便。

Claims (19)

  1. 一种一次性手术定位膜，其特征在于，包括：底板及定位贴膜，所述定位贴膜包括依次连接的第一透明薄膜、软质坐标显影层以及第二透明薄膜，所述第一透明薄膜的远离所述第二透明薄膜的一侧设置有胶粘层，所述胶粘层与所述底板可拆卸连接。
  2. 根据权利要求1所述的一次性手术定位膜，其特征在于，所述软质坐标显影层为软质定位网，所述软质定位网设有多个交错连接的软质显影线以及由多个所述软质显影线围成的多个定位孔。
  3. 根据权利要求2所述的一次性手术定位膜，其特征在于，所述软质显影线包括沿所述定位贴膜的长度方向并排设置的多个第一软质坐标线以及沿所述定位贴膜的宽度方向并排设置的多个第二软质坐标线。
  4. 根据权利要求1至3任一项所述的一次性手术定位膜，其特征在于，所述软质显影线主要由硅胶、聚氨酯和聚氯乙烯中的至少一种与硫酸钡混合固化制作而成；优选地，所述软质显影线主要由硅胶、聚氨酯和聚氯乙烯中的至少一种与硫酸钡及亚甲蓝混合固化制作而成。
  5. 根据权利要求1所述的一次性手术定位膜，其特征在于，所述软质坐标显影层包括多个软质显影点。
  6. 根据权利要求5所述的一次性手术定位膜，其特征在于，多个所述软质显影点以矩阵阵列方式分布。
  7. 根据权利要求1至6任一项所述的一次性手术定位膜，其特征在于，所述定位贴膜主要由硅胶和能够在X射线下显影的显影材料制 成，所述显影材料主要位于所述软质坐标显影层；优选地，所述显影材料包括硫酸钡和亚甲蓝。
  8. 根据权利要求1至6任一项所述的一次性手术定位膜，其特征在于，所述定位贴膜主要由聚氨酯和能够在X射线下显影的显影材料制成，所述显影材料主要位于所述软质坐标显影层。
  9. 根据权利要求1至6任一项所述的一次性手术定位膜，其特征在于，所述软质坐标显影层主要由硅胶和能够在X射线下显影的显影材料制成，所述软质坐标显影层与所述第一透明薄膜及所述第二透明薄膜粘接而成；优选地，所述显影材料包括硫酸钡和亚甲蓝；可选地，所述第一透明薄膜及所述第二透明薄膜均为硅胶；可选地，所述第一透明薄膜及所述第二透明薄膜均为聚氨酯膜。
  10. 根据权利要求1至9任一项所述的一次性手术定位膜，其特征在于，所述底板主要由硬质材料制成，以使所述一次性手术定位膜在使用前保持平整。
  11. 根据权利要求1至10任一项所述的一次性手术定位膜，其特征在于，至少所述底板的与所述胶粘层接触的表面设置有防粘涂层以利于所述底板与所述定位贴膜分离；优选地，所述防粘涂层为硅油层；优选地，所述底板为离型纸。
  12. 根据权利要求1至11任一项所述的一次性手术定位膜，其特征在于，所述底板的至少一个边缘具有向外延伸的第一施力部；优选地，所述第一施力部的形状为带有圆弧倒角的长方形。
  13. 根据权利要求1至12任一项所述的一次性手术定位膜，其特征在于，所述定位贴膜设有沿其沿长度方向延伸的第一测量件，所述第一测量件沿延伸方向并排设置有多个第一示位件。
  14. 根据权利要求13所述的一次性手术定位膜，其特征在于，所述定位贴膜设有沿其沿宽度方向延伸的第二测量件，所述第二测量件沿延伸方向并排设置有多个第二示位件。
  15. 根据权利要求1至14任一项所述的一次性手术定位膜，其特征在于，所述定位贴膜的远离所述底板的一侧设置有顶板，所述顶板的边缘与所述底板可拆卸连接。
  16. 根据权利要求1至15任一项所述的一次性手术定位膜，其特征在于，所述定位贴膜的远离所述底板的一侧设置有顶板，所述顶板、所述底板及所述定位贴膜的形状尺寸基本一致。
  17. 根据权利要求15或16所述的一次性手术定位膜，其特征在于，所述顶板的至少一个边缘具有向外延伸或翻折的第二施力部；优选地，所述第二施力部的形状为带有圆弧倒角的长方形。
  18. 根据权利要求15至17任一项所述的一次性手术定位膜，其特征在于，所述顶板的中部开设有观察窗。
  19. 一种一次性手术定位膜包，其特征在于，包括：无菌包装壳体以及权利要求1至18任一项所述的一次性手术定位膜，所述一次性手术定位膜设置于所述无菌包装壳体内。
PCT/CN2018/078918 2017-08-29 2018-03-14 一种一次性手术定位膜及定位膜包 WO2019041783A1 (zh)

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CN107913105A (zh) * 2017-12-15 2018-04-17 泗洪县正心医疗技术有限公司 一种用于断层扫描的体表显影片
CN108042186A (zh) * 2017-12-15 2018-05-18 泗洪县正心医疗技术有限公司 一种立体显影定位装置
CN107913094A (zh) * 2017-12-15 2018-04-17 泗洪县正心医疗技术有限公司 一种组合式定位穿刺装置及其定位穿刺方法
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CN108451538A (zh) * 2018-03-05 2018-08-28 常州瑞神安医疗器械有限公司 一种用于放射显影定位板的显影材料及其制备方法

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