Body surface positioning device

Abstract

The present invention relates to a body surface positioning device, comprising a shaping part for fitting a breast and being able to shape according to the shape of the breast, and an orientation marking part arranged on the shaping part, wherein the orientation marking part is used to determine the orientation of the shaping part and the orientation of the marked tumor. The body surface positioning device provided by the present invention has a simple structure, low cost, and is easy to use. It is not only convenient for medical staff to accurately, quickly, and efficiently locate the tumor, but also can non-invasively and accurately mark the projection position of the tumor on the patient's body surface, thereby accurately determining the resection range of the primary lesion, making it easier to perform breast-conserving surgery for breast cancer.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a body surface positioning device. Background Art

[0002] Although most breast tumors are benign, breast cancer is a common malignant tumor in women and has a high incidence rate in China.

[0003] At present, when breast cancer (i.e., malignant breast tumor) is diagnosed, adjuvant chemotherapy is usually required first, especially for large tumors, and then surgery is performed to remove the primary lesion. In the actual treatment process, with the application of adjuvant chemotherapy, the tumor usually gradually becomes smaller or even disappears. When performing breast-conserving surgery for breast cancer in the later stage, medical staff need to clearly know the position of the tumor relative to the body surface before chemotherapy, so as to more accurately determine the resection range of the primary lesion.

[0004] In the prior art, before chemotherapy, medical staff usually draw the surface projection of the tumor on the patient's body surface according to the location and size of the tumor (or tumor mass), so as to more accurately determine the location of the primary lesion in the later stage; however, the commonly used methods in the prior art are: tattoo marking method and marking clip marking method. The former is to use the tattoo embroidery method to draw the surface projection of the tumor on the patient's body surface before adjuvant chemotherapy, and the latter is to use color ultrasound to guide the placement of marking clips in the four directions of the upper, lower, left and right of the tumor. Although both methods can mark the location of the primary lesion, both methods will cause different degrees of trauma to the patient, not only bringing new pain to the patient and increasing the risk of infection, but also greatly increasing the workload of medical staff and the treatment costs of the patient. In particular, when the tattoo marking method is used, a permanent mark will be left on the patient's breast skin, seriously affecting the appearance. Summary of the invention

[0005] The purpose of the present invention is to improve the deficiencies in the prior art and provide a body surface positioning device with simple structure, low cost, and easy use. It can non-invasively and accurately mark the projection position of the tumor on the patient's body surface, thereby accurately determining the resection range of the primary lesion and making it easier to perform breast-conserving surgery for breast cancer.

[0006] The technical solution adopted by the present invention is:

[0007] A body surface positioning device comprises a shaping part which is used to fit a breast and can be shaped according to the shape of the breast, and a position marking part arranged on the shaping part, wherein the position marking part is used to determine the position of the shaping part and the position of a marked tumor. For patients diagnosed with breast cancer, the positioning device can be used to mark the position of the primary lesion before adjuvant chemotherapy. The specific method is: the patient lies flat, the medical staff places the shaping part on the patient's breast, and adjusts the shaping part according to the orientation marking part, and then uses external force to deform the shaping part and fit the patient's breast, and keeps shaping for a certain period of time; the medical staff can determine the projection position of the tumor on the patient's body surface according to the position and size of the tumor, so that the size and / or position of the tumor can be marked at the corresponding position of the shaping part, and finally the positioning device can be removed; when breast cancer conserving surgery is performed after the completion of adjuvant chemotherapy, the medical staff only needs to fit the shaping part in the positioning device on the patient's breast, and adjust the shaping part using the orientation marking part. At this time, the mark made in advance on the shaping part just corresponds to the body surface projection of the primary lesion, so that the projection position of the tumor on the patient's body surface before adjuvant chemotherapy can be conveniently and accurately determined, and then the resection range of the primary lesion can be accurately determined; it can be seen that the positioning device is not only easy to use, but also can mark the projection position of the tumor on the patient's body surface without trauma, which can effectively solve the shortcomings of the existing technology.

[0008] Preferably, the molding part is made of thermoplastic material, so that the molding part can be softened at a certain temperature and hardened after the temperature is lowered, so as to achieve a good molding effect.

[0009] Furthermore, the molding part includes a low-temperature thermoplastic plate. The low-temperature thermoplastic plate is a special synthetic high-molecular polyester, a new type of medical material processed by a series of physical and chemical methods; the low-temperature thermoplastic plate has outstanding properties such as not absorbing radiation, having a good molding effect after heating and softening, and a unique shape memory function (when the molding is not satisfactory, it can be heated again, molded again, or locally heated and molded again), which fully meets the needs of the positioning device.

[0010] Furthermore, the low-temperature thermoplastic plate is provided with a plurality of mesh holes, so that the low-temperature thermoplastic plate forms a mesh structure. The provision of the mesh holes not only facilitates the low-temperature thermoplastic plate to deform after softening and increases air permeability, but also when the low-temperature thermoplastic plate is covered on the patient's breast, the patient's skin can be directly reached through the mesh holes, which is convenient for positioning the shaping part on the breast and for making reference marks directly on the patient's skin through the mesh holes, thereby being more conducive to accurately determining the projection position of the tumor on the patient's body surface before adjuvant chemotherapy.

[0011] Preferably, the orientation marking part includes orientation marking lines arranged on the surface of the low-temperature thermoplastic plate, and the orientation marking lines include horizontal orientation marking lines arranged horizontally and / or vertical orientation marking lines arranged vertically. In the process of placing and positioning the molding part, the horizontal orientation marking lines arranged horizontally and / or the vertical orientation marking lines arranged vertically are used as references, so that the molding part can be more conveniently, accurately and efficiently aligned.

[0012] Furthermore, the position marking line is a protrusion or a groove arranged on the low-temperature thermoplastic plate, so as to realize the position marking.

[0013] In order to distinguish the horizontal orientation marking line from the vertical orientation marking line, the orientation marking part further includes a distinguishing mark arranged on the surface of the low-temperature thermoplastic plate. With the distinguishing mark, medical staff can easily distinguish the horizontal orientation marking line from the vertical orientation marking line, so as to accurately determine the projection position of the tumor on the patient's body surface before adjuvant chemotherapy.

[0014] Preferably, the distinguishing mark is an azimuth, text and / or a map.

[0015] To facilitate the shaping operation, the shaping part further includes a gripping part, which is arranged at the edge of the low-temperature thermoplastic plate so that the medical staff can hold it.

[0016] Preferably, the gripping portion is a side strip arranged around the edge of the low-temperature thermoplastic plate, or the gripping portion is two side strips arranged on the left and right sides of the low-temperature thermoplastic plate and are independent of each other. This is convenient for gripping and does not affect the shaping of the low-temperature thermoplastic plate. The side strips are provided to make the edge of the low-temperature thermoplastic plate smoother and easier to use, and also conducive to stable shaping.

[0017] Furthermore, the low-temperature thermoplastic plate is a circular or rectangular structure.

[0018] To facilitate positioning the center of the low-temperature thermoplastic plate, the nipple of the breast can be used as a reference. Furthermore, the orientation marking portion also includes a positioning hole, which is arranged at the center of the low-temperature thermoplastic plate for positioning the nipple. When it is necessary to mark the size and / or position of the tumor on the low-temperature thermoplastic plate, the low-temperature thermoplastic plate is placed on the breast for the first time. During the positioning of the low-temperature thermoplastic plate, the positioning hole can be used to accommodate the nipple and the nipple can be located at the center of the positioning hole. Combined with the orientation marking line, the low-temperature thermoplastic plate can be accurately adjusted; when it is necessary to use the positioning device to determine the projection size and / or position of the tumor on the body surface, the low-temperature thermoplastic plate is placed on the breast again, the positioning hole is used to accommodate the nipple and the nipple can be located at the center of the positioning hole. Combined with the orientation marking line, the low-temperature thermoplastic plate can be accurately determined, so that the current position and orientation of the low-temperature thermoplastic plate are exactly the same as the previous position and orientation of the low-temperature thermoplastic plate, so that the tumor size and / or position marked on the current low-temperature thermoplastic plate can be used to accurately, quickly and efficiently determine the projection position of the tumor on the patient's body surface before adjuvant chemotherapy, so as to perform breast-conserving surgery for breast cancer.

[0019] Furthermore, the edge of the positioning hole is provided with a side strip, which can increase the rigidity of the positioning hole, prevent the shape of the positioning hole from changing during the molding process of the low-temperature thermoplastic plate, and facilitate accurate positioning.

[0020] Compared with the prior art, the body surface positioning device provided by the present invention has the following beneficial effects:

[0021] 1. This positioning device has a simple structure, low cost, and is easy to use. It can non-invasively and accurately mark the projection position of the tumor on the patient's body surface, thereby accurately determining the resection range of the primary lesion and making it easier to perform breast-conserving surgery for breast cancer.

[0022] 2. This positioning device is simple to operate and easy to use. Medical staff can accurately, quickly and efficiently make the two placement positions of the shaping part consistent, which is conducive to accurately determining the projection position of the tumor on the patient's body surface before adjuvant chemotherapy.

[0023] 3. This positioning device uses a non-invasive method to mark and locate the position of the primary tumor lesion, which can effectively avoid the problems caused by the existing invasive marking method. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0025] Figure 1 This is a schematic structural diagram (top view) of the first body surface positioning device provided in Example 1 of the present invention.

[0026] Figure 2 This is a schematic structural diagram of the second body surface positioning device provided in Example 1 of the present invention.

[0027] Figure 3 This is a schematic structural diagram of the third body surface positioning device provided in Example 1 of the present invention.

[0028] Figure 4 This is a schematic structural diagram of the fourth body surface positioning device provided in Example 1 of the present invention.

[0029] Figure 5 For the picture Figure 3 Schematic diagram of a partial cross section.

[0030] Figure 6 This is a schematic diagram of the structure of a body surface positioning device provided in Example 2 of the present invention.

[0031] Figure 7 This is a schematic diagram of the structure of another body surface positioning device provided in Example 2 of the present invention.

[0032] Description of symbols in the figure

[0033] Low-temperature thermoplastic plate 101 , mesh 102 , side strip 103 , horizontal orientation marking line 104 , vertical orientation marking line 105 , orientation angle 106 , label 107 , and positioning hole 108 . DETAILED DESCRIPTION

[0034] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. The components of the embodiments of the present invention generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative work belong to the scope of protection of the present invention.

[0035] Example 1

[0036] See also Figure 1-Figure 4In this embodiment, a body surface positioning device is provided, including a shaping portion for fitting to a breast and being shaped according to the shape of the breast, and an orientation marking portion arranged on the shaping portion, wherein the orientation marking portion is used to determine the orientation of the shaping portion and the orientation of the marked tumor. For patients diagnosed with breast cancer, the positioning device can be used to mark the location of the primary lesion before adjuvant chemotherapy. The specific method is: the patient lies flat, the medical staff places the shaping part on the patient's breast, and aligns the shaping part according to the orientation marking part (as a reference orientation), and then uses external force to deform the shaping part and fit the patient's breast, and keeps shaping for a certain period of time; the medical staff can determine the projection position of the tumor on the patient's body surface according to the position and size of the tumor, so that the size and / or position of the tumor can be marked at the corresponding position of the shaping part, such as using a water pen to mark on the shaping part, and finally remove the positioning device; when breast cancer conserving surgery is performed after the completion of adjuvant chemotherapy, the medical staff only needs to fit the shaping part in the positioning device on the patient's breast, and use the orientation marking part to align the shaping part (that is, coincide with the reference orientation). At this time, the mark made in advance on the shaping part just corresponds to the body surface projection of the primary lesion, so that the projection position of the tumor on the patient's body surface before adjuvant chemotherapy can be conveniently and accurately determined, and then the resection range of the primary lesion can be accurately determined. The positioning device is not only easy to use, but also can mark the projection position of the tumor on the patient's body surface without trauma, and can effectively solve the shortcomings of the existing technology.

[0037] Preferably, the molding part is made of thermoplastic material, so that the molding part can soften at a certain temperature and harden after the temperature drops, so as to achieve a good molding effect.

[0038] For example, in one embodiment, the molding part includes a low-temperature thermoplastic plate 101 (or called a low-temperature thermoplastic film, which will not be described in detail later). The low-temperature thermoplastic plate 101 is a special synthetic high-molecular polyester, a new type of medical material processed by a series of physical and chemical methods; the low-temperature thermoplastic plate 101 has outstanding properties such as not absorbing radiation, having a good molding effect after heating and softening, and a unique shape memory function (when the molding is not satisfactory, it can be heated again, molded again, or locally heated and molded again), which fully meets the needs of the positioning device.

[0039] It can be understood that the low-temperature thermoplastic plate 101 is a commonly used molding plate in the prior art: 1. It has strong plasticity. It can be completely transparent and softened when placed in 60-70℃ hot water. It can be stretched and molded at will. The operation is simple and quick. 2. It has a memory function: if the molding is not satisfactory, it can be put back into 60-70℃ hot water to soften again. The material can restore its previous size and shape, and can be molded again and reused. 3. Light weight, thin thickness, high strength: The thickness of the low-temperature thermoplastic plate 101 is 1.6-4.0mm, and it has high toughness, is not easy to be damaged or broken, and is safe and reliable to use.

[0040] As an example, Figure 2 As shown, the low temperature thermoplastic plate 101 may be a plain plate. As another example, the low temperature thermoplastic plate 101 is provided with a plurality of meshes 102, such as Figure 1 , Figure 3 and Figure 4 As shown, the mesh 102 is used to form a mesh structure of the low-temperature thermoplastic plate 101; it is not only convenient for the low-temperature thermoplastic plate 101 to deform after softening and increase air permeability, but also when the low-temperature thermoplastic plate 101 is covered on the patient's breast, the mesh 102 can directly reach the patient's skin, which is convenient for positioning the shaping part on the breast and making reference marks directly on the patient's skin through the mesh 102, thereby being more conducive to accurately determining the projection position of the tumor on the patient's body surface before adjuvant chemotherapy.

[0041] It can be understood that the shape of the mesh 102 can be a round hole, a square hole, a triangular hole, a parallelogram hole, etc., and examples are not given here one by one.

[0042] The shape of the low temperature thermoplastic plate 101 can be determined according to actual conditions. Preferably, the low temperature thermoplastic plate 101 can be a circular or rectangular structure, such as Figure 3 or Figure 4 shown.

[0043] To facilitate the shaping operation, in a further solution, the shaping part further includes a gripping part, which is arranged at the edge of the low-temperature thermoplastic plate 101 so that the medical staff can hold it.

[0044] As an example, Figure 3 As shown, the gripping portion is a side strip 103 arranged around the edge of the low-temperature thermoplastic plate 101; as another example, Figure 4 As shown, the gripping portion is two side strips 103 which are arranged on the left and right sides of the low-temperature thermoplastic plate 101 and are independent of each other; this is convenient for gripping and does not affect the shaping of the low-temperature thermoplastic plate 101 .

[0045] Since at least two breast positioning operations need to be performed during the use of the positioning device, in a preferred embodiment, the position marking portion includes position marking lines arranged on the surface of the low-temperature thermoplastic plate 101, and the position marking lines include horizontal position marking lines 104 arranged horizontally and / or vertical position marking lines 105 arranged vertically, such as Figure 1-Figure 4 In the process of placing and positioning the shaping part, the horizontal orientation marking line 104 and / or the vertical orientation marking line 105 are used as references to determine the relative position of the shaping part and the breast, so that the shaping part can be more conveniently, accurately and efficiently aligned (in this embodiment, the alignment refers to placing in the same orientation, for example, the orientation when the horizontal orientation marking line 104 coincides with the lateral direction of the patient lying flat can be used as the alignment orientation, and the orientation when the vertical orientation marking line 105 coincides with the longitudinal direction (i.e., along the height direction of the human body) of the patient lying flat can also be used as the alignment orientation).

[0046] Preferably, in this embodiment, the orientation marking line is a protrusion or groove provided on the low-temperature thermoplastic plate 101 to achieve orientation marking. It can be understood that the protrusion or groove is smaller than the thickness of the low-temperature thermoplastic plate 101 to avoid affecting the molding.

[0047] In order to distinguish the horizontal azimuth marking line 104 from the vertical azimuth marking line 105, in a further solution, the azimuth marking part further includes a distinguishing mark set on the surface of the low-temperature thermoplastic plate 101. With the distinguishing mark, medical staff can easily distinguish the horizontal azimuth marking line 104 from the vertical azimuth marking line 105, so as to accurately determine the projection position of the tumor on the patient's body surface before adjuvant chemotherapy. It can be understood that the distinguishing mark can be an azimuth angle 106, text and / or a map, etc., as an example, Figure 1-Figure 4 As shown, in this embodiment, the distinguishing mark is an azimuth angle 106 set at the azimuth mark line.

[0048] It can be understood that after each breast cancer patient is individually equipped with the positioning device provided in this embodiment, in order to facilitate the distinction of the positioning devices of different patients, the gripping portion is provided with a label 107, and the label 107 is used to fill in the patient's information, such as name, bed number, hospitalization number, etc., for the purpose of distinction. For example, Figure 3 or Figure 4 As shown, in this embodiment, the label 107 is disposed on the edge strip 103 .

[0049] Example 2

[0050] In order to facilitate the positioning of the center of the low-temperature thermoplastic plate 101, the nipple of the breast can be used as a reference. Therefore, the main difference between the present embodiment 2 and the above-mentioned embodiment 1 is that in the positioning device provided in the present embodiment, the orientation marking portion further includes a positioning hole 108, and the positioning hole 108 is arranged at the center of the low-temperature thermoplastic plate 101. Figure 6 or Figure 7 As shown, the positioning hole 108 is used to position the nipple.

[0051] Before adjuvant radiotherapy, when it is necessary to mark the size and / or position of the tumor on the low-temperature thermoplastic plate 101, the low-temperature thermoplastic plate 101 is placed on the breast for the first time, and during the positioning of the low-temperature thermoplastic plate 101, the positioning hole 108 can be used to accommodate the nipple, and the nipple can be located at the center of the positioning hole 108. In combination with the orientation marking line, the low-temperature thermoplastic plate 101 can be accurately aligned, so that the size and / or position of the tumor can be marked on the low-temperature thermoplastic plate 101;

[0052] After adjuvant radiotherapy and before surgery, when it is necessary to use the positioning device to determine the projection size and / or position of the tumor on the body surface, the low-temperature thermoplastic plate 101 is placed on the breast again, and the positioning hole 108 is used to accommodate the nipple, and the nipple is located at the center of the positioning hole 108. Combined with the orientation marking line, the low-temperature thermoplastic plate 101 can be accurately determined, so that the current position and orientation of the low-temperature thermoplastic plate 101 are exactly the same as the previous position and orientation of the low-temperature thermoplastic plate 101, so that the tumor size and / or position marked on the current low-temperature thermoplastic plate 101 can be used to accurately, quickly and efficiently determine the projection position of the tumor on the patient's body surface before adjuvant chemotherapy, so as to perform breast-conserving surgery for breast cancer.

[0053] like Figure 6 or Figure 7 As shown, in a further solution, the edge of the positioning hole 108 is provided with a side strip 103. This prevents the shape of the positioning hole 108 from changing during the molding process of the low-temperature thermoplastic plate 101, which is conducive to achieving precise positioning.

[0054] The above description is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A body surface positioning device, characterized in that: It comprises a shaping part for fitting to a breast and shaping according to the shape of the breast, and a position marking part arranged on the shaping part, wherein the position marking part is used to determine the position of the shaping part and the position of the marked tumor; the shaping part comprises a low-temperature thermoplastic plate; The orientation marking part includes an orientation marking line arranged on the surface of the low-temperature thermoplastic plate, a distinguishing mark arranged on the surface of the low-temperature thermoplastic plate, and a positioning hole, wherein the orientation marking line includes a horizontal orientation marking line arranged horizontally and a vertical orientation marking line arranged vertically; The distinguishing mark is used to distinguish the horizontal azimuth marking line from the vertical azimuth marking line, and the distinguishing mark is an azimuth angle set at the azimuth marking line; the positioning hole is set at the center of the low-temperature thermoplastic plate to locate the nipple; the edge of the positioning hole is provided with a first edge strip, and the first edge strip can prevent the shape of the positioning hole from changing during the molding process of the low-temperature thermoplastic plate; The molding part further includes a gripping part, which is a second side strip arranged around the edge of the low-temperature thermoplastic plate. The gripping part is provided with a label, which is arranged on the second side strip; the label is used to fill in the patient's information; Before adjuvant radiotherapy, when it is necessary to mark the size and / or position of the tumor on the low-temperature thermoplastic plate, the low-temperature thermoplastic plate is placed on the breast for the first time, and during the positioning of the low-temperature thermoplastic plate, the positioning hole is used to accommodate the nipple and the nipple is located at the center of the positioning hole, and then the low-temperature thermoplastic plate is accurately aligned in combination with the orientation marking line, and the size and / or position of the tumor is marked on the low-temperature thermoplastic plate; After adjuvant radiotherapy and before breast-conserving surgery for breast cancer, when it is necessary to use the body surface positioning device to determine the projection size and / or position of the tumor on the body surface, the low-temperature thermoplastic plate is placed on the breast again, the nipple is accommodated by the positioning hole, and the nipple is located at the center of the positioning hole, and then combined with the orientation marking line, the current position and orientation of the low-temperature thermoplastic plate are made to be exactly the same as the position and orientation of the low-temperature thermoplastic plate placed on the breast before adjuvant radiotherapy, and the projection position of the tumor on the patient's body surface before adjuvant radiotherapy is determined using the tumor size and / or position marked on the current low-temperature thermoplastic plate.

2. The body surface positioning device according to claim 1, characterized in that: The low-temperature thermoplastic plate is provided with a plurality of mesh holes, and the mesh holes are used to form a mesh structure of the low-temperature thermoplastic plate.

3. The body surface positioning device according to claim 1, characterized in that: The low-temperature thermoplastic plate is a circular or rectangular structure.

4. The body surface positioning device according to claim 1, characterized in that: The orientation marking line is a protrusion or a groove arranged on the low-temperature thermoplastic plate.

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