Image-body surface homologous registration operation positioning developing film and preparation method and application thereof

Abstract

The invention relates to the technical field of medical instruments and surgical positioning, in particular to a surgical positioning developing film for image-body surface homologous registration as well as a preparation method and application of the surgical positioning developing film. The film comprises an outer-layer transparent substrate, an inner-layer transparent substrate, a flexible developing line structure located between the outer-layer transparent substrate and the inner-layer transparent substrate, a visual ink mark pattern arranged on the inner surface of the inner layer and a medical pressure-sensitive adhesive layer, and the visual ink mark pattern corresponds to the track of the developing line structure. Image examination is completed in the film pasting state, ink marks are reserved on the skin surface after the pasting film is removed, and therefore precise planning of an incision or a channel is achieved by comparing a developing line with the body surface ink marks in an operation. The invention provides an anti-artifact and quantitative calibration design of development line intermittent rhythm and grid main and auxiliary scales, and provides a silk-screen printing / coating-compounding-die cutting-sterilizing integrated preparation method. The film provided by the invention can reduce perspective times and radiation exposure in an operation, reduces registration errors, and is simple in structure, low in cost and suitable for disposable sterile use.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices and surgical positioning technology, in particular to a kind of image-surface homologous registration surgical positioning development film and its preparation method, application, it is suitable for orthopedics, neurosurgery, pain department, intervention needs based on X-ray / CT image to carry out surface incision or channel planning Clinical scenarios. BACKGROUND

[0002] Surgical positioning development is to clearly and accurately show the position of internal target structures such as tumors, blood vessels, nerves, bones, etc. or surgical instruments before, during or after surgery through imaging equipment such as X-ray, CT, ultrasound, MRI, etc. to guide surgeons to perform precise operations. The role of surgical positioning development is: (1) accurate positioning: help doctors accurately find small, deep or poorly defined lesions, such as early lung nodules, liver tumors; (2) reduce damage: by clearly showing the adjacent relationship between lesions and important blood vessels and nerves, guide doctors to plan the optimal surgical path and maximize the protection of normal tissue to reduce surgical trauma. (3) confirm the range: in tumor resection surgery, clearly define the boundaries of the tumor to ensure complete removal while avoiding excessive resection. (4) Real-time navigation: monitor the position of the instrument and target in real time during surgery, like car navigation, to ensure that the surgery proceeds as planned. (5) verify the effect: immediately confirm the surgical effect after surgery, such as whether the fracture reduction is good, whether the implant position is accurate, and whether the tumor has been completely removed.

[0003] Clinically, intraoperative fluoroscopy, surface marker pen line, metal wire / needle temporary placement or radiopaque film are often used for surgical area positioning. However, there are the following disadvantages: (1) high radiation exposure: multiple fluoroscopy increases the dose of patients and medical staff; (2) registration error: surface line and image markers are usually not homologous, affected by body position changes, skin slip and scale deformation, the error can reach millimeter level; (3) complex process / high cost: repeated image-surface comparison or the use of metal positioning parts brings discomfort and infection risk. SUMMARY

[0004] Based on the above technical problems, the present application provides a kind of image-surface homologous registration surgical positioning development film, which can "transfer" the image development mark to reliable ink on the surface after one image examination, and the trajectories of the two are homologous, quantifiable calibration, high positioning accuracy.

[0005] The specific technical solutions provided by the present application are as follows: In a first aspect of the present application, a surgical positioning development film is provided, comprising: an outer transparent substrate; A flexible radiopaque line structure is arranged on the surface of the outer transparent substrate, the radiopaque line structure is arranged in a predetermined grid, scale or positioning target pattern, and the radiopaque line structure contains X-ray and / or CT radiopaque filling materials; an inner transparent substrate is arranged on the upper layer of the radiopaque line structure so that the radiopaque line structure is located between the outer transparent substrate and the inner transparent substrate, and the inner surface of the inner transparent substrate in contact with the radiopaque line structure is provided with a visible ink pattern corresponding to the track of the radiopaque line structure; and a medical pressure-sensitive adhesive layer is arranged on the outer surface of the inner transparent substrate; wherein the imageological examination is carried out in the state of the film being attached, and the visible ink pattern is left on the skin surface after the film is removed, so that the positioning is carried out by comparing the radiopaque line and the ink on the skin in the image during the operation.

[0006] As a preferred embodiment of the present application, the filling material of the radiopaque line structure is tungsten, barium sulfate, bismuth oxide, tungsten carbide, or any one or combination thereof.

[0007] As a preferred embodiment of the present application, the radiopaque line structure is a grid line structure, and the grid line structure is formed by alternately arranging thick lines and thin lines, the line width of the thin line is 0.2 mm, the line width of the thick line is 0.4 mm, and the spacing between the thin line and the thick line is 8 mm to 12 mm. The intermittent rhythm structure of the radiopaque line structure can reduce CT stripe artifacts and improve automatic recognition.

[0008] As a preferred embodiment of the present application, the radiopaque line structure further includes a main scale with a width of 10 mm and an auxiliary scale with a width of 2 mm, and a length scale and a direction reference arrow are arranged at the edge of the film.

[0009] As a preferred embodiment of the present application, the visible ink pattern is formed by quick-drying or microcapsule transfer ink verified by ISO 10993 skin compatibility, the ink line width after the film is removed is 0.2 mm to 0.5 mm, and the readability within 8 hours is ≥90%.

[0010] As a preferred embodiment of the present application, the outer transparent substrate and the inner transparent substrate are both polyurethane or thermoplastic polyurethane films, and the total thickness is ≤150 μm.

[0011] As a preferred embodiment of the present application, the medical pressure-sensitive adhesive layer is a low-sensitization acrylic adhesive, the 180° peeling force is ≥7 N / 25 mm, and a zoned coating structure with low adhesion at the edge and medium adhesion at the center can be used.

[0012] As a preferred embodiment of the present application, the inner surface of the inner transparent substrate has a micro-roughened texture, and the average roughness Ra is 0.5 μm to 3.0 μm, so as to improve the ink transfer clarity and wiping resistance.

[0013] As a preferred embodiment of the present application, the optical recognition mark is arranged at the four corners of the film, which can be read by a visible light image recognition algorithm but not developed on X-ray / CT, so as to facilitate the visual registration of the image-surface by the external terminal.

[0014] As a preferred embodiment of the present application, the size of the film is 80mm*120mm, 150mm*200mm or 220mm*300mm, and the film edge is provided with a tearable notch for cutting as needed.

[0015] As a preferred embodiment of the present application, the surface of the outer transparent substrate has a hydrophilic anti-fog coating to reduce the reflection and water droplet effect caused by the preoperative disinfectant.

[0016] As a preferred embodiment of the present application, the development line structure is formed by screen printing or coating, and the deviation of the line position from the track of the visible ink pattern is ≤±0.5mm.

[0017] As a preferred embodiment of the present application, the coverage area of the development line structure is any one of full grid type, frame type or local cross target type to adapt to different surgical areas.

[0018] As a preferred embodiment of the present application, the film is a disposable sterile package, sterilized by ethylene oxide or gamma rays, and the ethylene oxide residue meets the requirements of YY / T 0689.

[0019] In the second aspect of the present application, a preparation method of the surgical positioning development film is provided, comprising: printing or coating a development line structure on the outer transparent substrate according to a predetermined pattern; printing a visible ink layer on the inner surface of the inner transparent substrate according to a pattern corresponding to the track of the development line structure; forming a medical pressure-sensitive adhesive layer on the outer surface of the inner transparent substrate; registering and aligning the outer transparent substrate and the inner transparent substrate, and compounding them to form a stack with the development line structure sandwiched therebetween, die cutting, sterilizing and packaging to obtain the film.

[0020] As a preferred embodiment of the present application, when the outer transparent substrate provided with the development line structure is compounded with the inner transparent substrate provided with the visible ink layer, a common reference hole and visual AOI alignment detection are used to ensure that the deviation of the track of the two is ≤±0.5mm.

[0021] As a preferred embodiment of the present application, the development line structure uses ink containing tungsten or barium sulfate, and is printed through a 150-50 mesh screen, and after drying or curing, a line width of 0.2-0.4mm is formed.

[0022] As a preferred embodiment of the present application, the ink of the visible ink layer is quick-drying or microcapsule transfer type, and the adhesion after curing reaches ASTM D3359 4B and above.

[0023] As a preferred embodiment of the present application, the compounding is performed by hot pressing or solvent-free adhesive compounding, and the compounding temperature is 50-90 DEG C and the pressure is 0.2-0.6 MPa.

[0024] As a preferred embodiment of the present application, ethylene oxide sterilization or gamma ray sterilization is adopted, and the residual oxygen and humidity in the packaging cavity are controlled to stabilize the ink performance.

[0025] In a third aspect, the present application provides a use of the surgical positioning and developing film in surgical positioning.

[0026] As a preferred embodiment of the present application, the surgical positioning and developing film is suitable for orthopedics, neurosurgery, pain department, intervention and other clinical scenarios which need to plan the body surface incision or channel based on X-ray or CT image.

[0027] The surgical positioning and developing film with image-body surface homologous registration provided by the present application has the following characteristics: 1. Interlayer structure: the outer transparent substrate, the developing line structure, the inner transparent substrate with visible ink layer and the medical pressure-sensitive adhesive layer form a laminated structure.

[0028] 2. Homologous track: the developing line structure and the inner visible ink pattern are aligned through the common reference hole and the visual AOI, and the track deviation is ≤±0.5 mm.

[0029] 3. Anti-artifact and calibration: the developing line adopts intermittent rhythm or periodic line width variation design with alternating arrangement of thick line and thin line, the grid contains 10 mm main scale and 2 mm auxiliary scale, and the edge is provided with absolute length scale and direction reference.

[0030] 4. Skin-friendly and stable ink trace: low-sensitization acrylic medical pressure-sensitive adhesive is used; the inner surface is micro-roughened to cooperate with quick-drying or microcapsule ink, and the readability is ≥90% within 8 hours after the film is removed.

[0031] 5. Optional visual marker: optical markers arranged at four corners are only visible to light, which is convenient for external terminal to perform image-body surface automatic registration.

[0032] The structure of the simple, low-cost disposable film makes the visible developing mark in the image consistent with the visible ink track on the body surface, thereby improving the image-body surface registration accuracy and reducing radiation exposure.

[0033] Compared with the existing body surface line drawing or metal positioning scheme, the present application has the following beneficial effects: (1)Less perspective / low radiation: preoperative image once, intraoperative planning more body surface ink.

[0034] (2)High consistency: development and ink co-source trajectory, reduce the registration error caused by body position change / skin slip.

[0035] (3)Quantifiable: grid main and auxiliary scales and edge ruler provide scale reference, easy to measure distance and algorithm recognition. (4)Wide adaptation: full grid or frame or cross target multi-form, covering different surgical areas. (5)Easy industrialization: conventional silk screen, composite, die cutting process can mass production, materials can be MRI compatible selection, such as BaSO4, Bi2O3 system. BRIEF DESCRIPTION OF DRAWINGS

[0036] Figure 1 is the application diagram of the developed film. DETAILED DESCRIPTION

[0037] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific embodiments of the present application are described in detail below. In the following description, a lot of specific details are set forth in order to fully understand the embodiments of the present application. It should be understood that the specific embodiments described herein are only used to explain the present application, and are not used to limit the present application. The embodiments of the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the scope of the present application. Therefore, the embodiments of the present application are not limited by the specific embodiments disclosed below.

[0038] Example 1 Standard grid type film The film comprises an outer transparent substrate, a flexible developing line structure, an inner transparent substrate and a medical pressure sensitive adhesive layer. The flexible developing line structure is arranged on the surface of the outer transparent substrate, and the developing line structure is distributed according to the predetermined grid, scale or positioning target pattern. The developing line structure contains a developable filling material. The inner transparent substrate is arranged on the upper layer of the developing line structure, and the developing line structure is located between the outer transparent substrate and the inner transparent substrate. The inner surface of the inner transparent substrate connected with the developing line structure is provided with a visible ink pattern corresponding to the developing line structure track. The medical pressure sensitive adhesive layer is arranged on the outer surface of the inner transparent substrate.

[0039] The film is prepared according to the following steps: (1) Printing the developing line structure on the outer transparent substrate according to the predetermined pattern; the developing line structure contains tungsten powder filled ink, the viscosity is controlled at 1000 mPa·s~2500 mPa·s, and the content of the tungsten powder filled ink is 80 wt%, which is printed twice by 150 mesh silk screen, and after 10 min of curing at 80°C, a 0.3 mm line width is formed, and the line is set in a 5 mm intermittent rhythm, i.e. 3 mm solid line + 2 mm gap, to reduce CT stripe artifacts and improve automatic recognition; and a 10 mm width main grid + 2 mm width auxiliary grid is formed, and a length scale and a direction reference arrow are provided at the edge of the film; the outer transparent substrate surface has a hydrophilic anti-fog coating to reduce the influence of reflection and water droplets caused by preoperative disinfectant; (2) Printing the visible ink layer on the inner surface of the inner transparent substrate according to the pattern corresponding to the developing line structure track, and UV or heat curing; the visible ink layer is formed by using quick-drying black ink, and the adhesion after curing reaches ASTM D3359 4B and above; the read rate within 8 hours is ≥90%, and the quick-drying black ink has passed the ISO 10993 skin compatibility verification; the inner surface of the inner transparent substrate also has a micro-roughened texture with an average roughness Ra of 0.5 μm to improve the clarity of ink transfer and wiping resistance; the outer transparent substrate and the inner transparent substrate are both thermoplastic polyurethane films with a thickness of 50 μm; (3) Forming a medical pressure sensitive adhesive layer on the outer surface of the inner transparent substrate, with a 180° peeling force ≥7 N / 25 mm, and using a zoned coating structure with low edge adhesion or central medium adhesion; the medical pressure sensitive adhesive layer is a low sensitization acrylic adhesive with a dry adhesive thickness of 30 μm; (4) Aligning the outer transparent substrate and the inner transparent substrate through the positioning hole and automatic optical detection, so that the track deviation of the developing line structure and the visible ink layer is ≤±0.5 mm; and hot pressing at 60°C and 0.4 MPa to form a laminated structure with the developing line structure sandwiched, die cutting, using ethylene oxide, and the ethylene oxide residue meets the requirements of YY / T 0689; single piece bubble shell + aluminum plastic bag sterile packaging, and controlling the residual oxygen and humidity in the packaging cavity to stabilize the ink performance, and the finished product is obtained. The finished product size is 150 mm×200 mm, and a tearable notch is provided at the edge for on-demand cutting; the four corners of the film are arranged with non-developable optical recognition marks, which can be read by visible light image recognition algorithm but not developed on X-ray / CT, so as to facilitate the visual registration of image-surface by external terminal.

[0040] The residual oxygen volume fraction in the packaging cavity is 0.1% to 1.0%, and the optimal control is ≤0.5%; the relative humidity in the packaging cavity is 10% RH to 30% RH, and the optimal control is 15% RH to 25% RH. To achieve the above goals, vacuum pumping and filling with dry nitrogen or direct nitrogen filling can be performed before packaging, and an appropriate amount of desiccant such as silica gel or molecular sieve can be placed to maintain a low-humidity environment in the packaging.

[0041] The film is attached to the pigskin and silicone body surface model, and then photographed at 120 kVp CT and 80 kVp DR, with CNR≥5; the CT stripe artifact score is better than the equal line diameter continuous line by ≥1 level. After removing the film, the ink trace can be recognized for ≥90% in 8 hours, and is still clear and readable after 30 times of alcohol wiping.

[0042] The patient completes the imaging examination in the state of attaching the film, and the visible ink trace pattern remains on the skin surface after removing the film, so that the positioning is performed by comparing the developing line in the image and the skin ink during the operation, as shown in Figure 1

[0043] Example 2 The difference from Example 1 is only that the visible ink trace pattern is formed by microcapsule transfer type ink verified by ISO 10993 skin compatibility, and the ink trace line width is 0.2 mm after removing the film, with a readability of ≥90% within 8 hours Example 3 The difference from Example 1 is only that the outer transparent substrate and the inner transparent substrate are both polyurethane films, and the thicknesses are both 70 μm.

[0044] Example 4 The difference from Example 1 is only that the developing line structure adopts ink containing barium sulfate, and the grid line structure is formed by coating and shaping after drying and curing, and the grid line structure is formed by alternately arranging thick lines and thin lines, the line width of the thin line is 0.2 mm, the line width of the thick line is 0.4 mm, and the spacing between the thin line and the thick line can be changed within 8 mm to 12 mm.

[0045] Example 5 The difference from Example 1 is only that the outer transparent substrate and the inner transparent substrate are compounded by hot pressing, and the compounding temperature is 50°C and the pressure is 0.6 MPa.

[0046] Example 6 The difference from Example 1 is only that the outer transparent substrate and the inner transparent substrate are compounded by hot pressing, and the compounding temperature is 90°C and the pressure is 0.2 MPa.

[0047] Example 7 ​The difference from example 1 is only that the composite of the outer transparent substrate and the inner transparent substrate uses solvent-free adhesive composite, and the average roughness Ra of the micro-roughened texture on the inner surface of the inner transparent substrate is 3.0 μm.

[0048] Example 8 MRI compatible material selection The difference from example 1 is only that the visible line structure uses bismuth oxide filled polymer filaments, which are extruded into filaments and then hot-pressed into the visible line structure to avoid ferromagnetic materials. It is suitable for preoperative planning of MRI and CT dual-mode images, and is displayed as a weak contrast reference in MRI.

[0049] The technical features of the above examples can be combined in any way. In order to make the description simple, all possible combinations of the technical features in the above examples are not described, but as long as the combinations of the technical features do not exist, they should be considered as the scope of the description.

[0050] The above examples only express several embodiments of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the patent. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the scope of the present application. Therefore, the scope of the patent protection of the present application should be subject to the appended claims.

Claims

1. A surgical localization and imaging patch for image-surface homologous registration, characterized in that, It includes: Outer transparent substrate; A flexible radiopaque structure is disposed on the surface of the outer transparent substrate, the radiopaque structure being distributed according to a predetermined grid, scale or positioning target pattern, and the radiopaque structure containing X-ray and / or CT radiopaque filling material; An inner transparent substrate is disposed on the upper layer of the developing line structure so that the developing line structure is located between the outer transparent substrate and the inner transparent substrate. The inner surface of the inner transparent substrate that is in contact with the developing line structure is provided with a visible ink pattern corresponding to the trajectory of the developing line structure. and A medical pressure-sensitive adhesive layer disposed on the outer surface of the inner transparent substrate; In this procedure, imaging examinations are performed while the film is in place. After the film is removed, the visible ink pattern remains on the skin surface, allowing for localization during surgery by comparing the imaging lines with the ink pattern on the skin.

2. The surgical localization and imaging patch for image-surface homologous registration according to claim 1, characterized in that, The filling material of the developing line structure is one or a combination of tungsten, barium sulfate, bismuth oxide, and tungsten carbide.

3. The surgical localization and imaging patch for image-surface homologous registration according to claim 1, characterized in that, The developing line structure is a grid line structure, and the grid line structure is formed by alternating thick and thin lines. The line width of the thin line is 0.2 mm, the line width of the thick line is 0.4 mm, and the spacing between the thin line and the thick line is 8 mm to 12 mm.

4. The surgical localization and imaging patch for image-surface homologous registration according to claim 3, characterized in that, The developing line structure also includes a main scale with a width of 10 mm and an auxiliary scale with a width of 2 mm, and the edge of the film is provided with a length scale and a direction reference arrow.

5. The surgical localization and imaging patch for image-surface homologous registration according to claim 1, characterized in that, Both the outer transparent substrate and the inner transparent substrate are polyurethane or thermoplastic polyurethane films, and the total thickness of the outer transparent substrate and the inner transparent substrate is ≤150 μm; The inner surface of the inner transparent substrate has a slightly roughened texture, and the average roughness is 0.5 μm to 3.0 μm; The outer transparent substrate surface has a hydrophilic anti-fog coating; The medical pressure-sensitive adhesive layer is an acrylic adhesive with a 180° peel force ≥7 N / 25 mm and adopts an edge-adhesive partitioned coating structure. Optical identification marks are set at the four corners of the film. These optical identification marks are used to be read by visible light image recognition algorithms but are not visible on X-ray / CT.

6. A method for preparing a surgical localization and imaging patch for image-surface homologous registration as described in any one of claims 1 to 5, characterized in that, Includes the following steps: A radiopaque line structure is printed or coated on the outer transparent substrate according to a predetermined grid, scale, or positioning target pattern; a visible ink layer is printed on the inner surface of the inner transparent substrate according to a pattern corresponding to the trajectory of the radiopaque line structure; a medical pressure-sensitive adhesive layer is formed on the outer surface of the inner transparent substrate; the outer transparent substrate and the inner transparent substrate are registered, aligned, and laminated to form a stack with the radiopaque line structure sandwiched in it; the stack is then die-cut, sterilized, and individually packaged to obtain the final product.

7. The method for preparing the surgical localization and imaging patch for image-surface homologous registration according to claim 6, characterized in that, When the outer transparent substrate with a developing line structure is laminated with the inner transparent substrate with a printed visible ink layer, a common reference hole and visual AOI alignment detection are used to ensure that the trajectory deviation between the two is ≤ ±0.5 mm.

8. The method for preparing the surgical localization and imaging patch for image-surface homologous registration according to claim 6, characterized in that, The composite is achieved by hot pressing or solvent-free adhesive bonding, with a bonding temperature of 50 ℃~90 ℃ and a pressure of 0.2MPa~0.6MPa.

9. The application of the surgical localization imaging film with image-body surface homologation as described in any one of claims 1 to 5 in surgical localization.

10. The application of the surgical localization imaging film with image-surface homologous registration according to claim 9 in surgical localization, characterized in that, The aforementioned image-surface homologous registration surgical localization contrast-enhancing film is used for clinical surgical localization where surface incisions or access planning is required based on X-ray or CT images.

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