Marking buckles to mark locations of clinical interest during surgery

Abstract

The present invention belongs to the technical field of medical devices. A marking buckle for marking a position of clinical concern during surgery includes a buckle body, which is made of a biodegradable material and is provided with a threading hole for inserting a suture. The fixing method thereof includes the following steps: placing the marking buckle at the position of clinical concern, using a surgical suture needle to carry a suture through the threading hole, and suturing and fixing the marking buckle at the position of concern. The present invention fixes the buckle body at the position of concern by using a suture through the threading hole, which can reduce the requirements for the mechanical properties of the material and fix it firmly. The buckle body is made of a biodegradable material, and the image is clearer and free of artifacts during postoperative CT and MRI scanning, and the position of clinical concern can be located more accurately. It also has good compatibility with tissues and is completely degraded in the body after a period of time without leaving any traces, which is beneficial to the patient's later recovery.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and more specifically, relates to a marking buckle for marking a clinically concerned position during an operation and a fixing method thereof. Background Art

[0002] During surgery, doctors usually use titanium clips to mark the clinically concerned areas. Especially after tumor removal, the resection cavity (i.e., tumor bed) needs to be marked to accurately implement subsequent treatments (such as radiotherapy). When marking, a special titanium clip is used to place the titanium clip into the area of ​​concern and then clamp it on nearby tissues.

[0003] For example, breast cancer, breast-conserving surgery plus postoperative radiotherapy has become the standard treatment model for early breast cancer. In the radiotherapy program for breast cancer after breast-conserving surgery, accurate delineation of the tumor bed and its target area is crucial. Currently, the delineation of the tumor bed is mainly based on the metal titanium clips placed at the edge of the surgical cavity, postoperative seroma, postoperative scars and preoperative diagnostic images. The tumor bed target area is mainly obtained by the external boundary of the tumor bed.

[0004] Postoperative seroma is helpful to reduce the difference between observers, but its formation is closely related to the surgical method and changes dynamically over time, so it varies greatly. Postoperative scars can indicate the location of the tumor bed, but it is difficult to ensure that the surgical incision is in the center of the tumor bed in clinical practice, and it is impossible to determine the depth of the location, so it is only a rough indication. Preoperative diagnostic images can provide information about preoperative tumors, and matching them with radiotherapy positioning images can help delineate the tumor bed, but due to the large difference between the two images, their matching is difficult. The titanium clip marking in the surgical cavity is clearer and more intuitive, which can significantly improve the consistency between observers. Although studies have reported that it has problems such as displacement, placement has not been standardized, and variability in the three-dimensional boundary of point definition, it is still considered to be the main reference for tumor bed delineation.

[0005] Although existing titanium clip markers can assist in locating the location of clinical concern (i.e., the tumor bed), there are still some problems. First, there are artifacts during postoperative CT and MRI scans, especially during MRI scans, which significantly interfere with the imaging of surrounding normal tissues; second, they exist in the patient's body for a long time after the treatment, which is not only easy to cause tissue fibrosis, affecting the patient's recovery and cosmetic effects, but also interferes with the MRI images that will be reviewed, affecting the judgment of the efficacy; in addition, since the titanium clip is fixed by clamping it on the tissue, it may shift under the combined effect of surgical traction, postoperative changes and other factors, resulting in inaccurate positioning. In addition, since the titanium clip is made of titanium alloy, it has low rejection with biological tissues, and has ductility and elasticity, and can be easily fixed at the location of clinical concern, so there is no substitute in the current existing technology. Summary of the invention

[0006] The purpose of the present invention is to provide a marking buckle for marking clinically concerned positions during surgery, so as to solve the technical problem in the prior art that titanium clip marking is prone to produce artifacts and affects the patient's later recovery and cosmetic effect.

[0007] To achieve the above object, the technical solution adopted by the present invention is: to provide a marking buckle for marking a position of clinical concern during surgery, including a buckle body, the buckle body is made of biodegradable material and is provided with a threading hole for inserting a suture.

[0008] In one embodiment of the present invention, a thread retaining groove capable of accommodating suture thread is provided at the edge of the button body.

[0009] In one embodiment of the present invention, the wire clamping slot is wide outside and narrow inside, and the bottom of the wire clamping slot is connected to the threading hole, and the width of the bottom of the slot is smaller than the diameter of the suture to prevent the suture in the threading hole from falling out of the bottom of the wire clamping slot.

[0010] In one embodiment of the present invention, teeth are provided on the inner wall of the wire clamping groove.

[0011] In one embodiment of the present invention, the inner walls of the threading hole and the wire clamping groove are provided with a slow-degradation layer, and the degradation rate of the slow-degradation layer is lower than the degradation rate of the buckle body.

[0012] In one embodiment of the present invention, at least two threading holes are provided on the buckle body, and the axes of the two threading holes are arranged at an angle.

[0013] In one embodiment of the present invention, the button body is a flat button-shaped structure with a plurality of threading holes.

[0014] In one embodiment of the present invention, the buckle body is further provided with a normally closed elastic clamp for clamping tissue at a location of interest.

[0015] In one embodiment of the present invention, the button body is one or more of polyester, polyurethane, polyamide, polylactic acid or polyacetic acid materials.

[0016] To achieve the above object, the present invention also adopts a technical solution of: providing a method for fixing a marking buckle for marking a position of clinical concern during surgery, using the above-mentioned marking buckle for marking a position of clinical concern during surgery for fixing, comprising the following steps:

[0017] Place the marker buckle at the clinical position of concern, use a surgical suture needle to carry the suture thread through the threading hole, and suture and fix the marker buckle at the position of concern.

[0018] In one embodiment of the present invention, when a wire clamping groove is provided on the marker buckle, when the marker buckle is sutured and fixed at the position of interest, the knot of the suture thread is placed in the wire clamping groove.

[0019] In one embodiment of the present invention, when a normally closed elastic clip is provided on the marking buckle, before the marking buckle is sutured to the position of clinical concern, the normally closed elastic clip is first opened by surgical forceps, and then the marking buckle is placed at the position of clinical concern, and the normally closed elastic clip is clamped, and then a suitable threading hole is selected to suture the marking buckle to the position of clinical concern.

[0020] The marking buckle provided by the present invention for marking a position of clinical concern during surgery has the following beneficial effects: compared with the prior art, the present invention uses sutures to fix the buckle body at the position of clinical concern through threading holes, which can reduce the requirements for the mechanical properties of the material, and the fixation is reliable. The application position of the sutures is relatively flexible, and suture fixation can be performed according to the characteristics of different parts, and the range of applicable parts is relatively wide. At the same time, the buckle body is made of biodegradable material, and the imaging is clearer and free of artifacts during postoperative CT and MRI scans, and the position of clinical concern can be located more accurately. It has good tissue compatibility and is completely degraded in the body after a period of time without leaving any traces, which is beneficial to the patient's later recovery and will not shift due to gradual degradation of the buckle body during the effective observation period.

[0021] The beneficial effects of the method for fixing a marking buckle for marking a position of clinical concern during surgery provided by the present invention are as follows: compared with the prior art, the present invention can utilize existing surgical instruments such as a laparoscope to complete the operation, and the suturing is simple, the operation is safe, and the reliability is strong. In addition, the application position of the suture is relatively flexible, and suturing and fixing can be performed according to the characteristics of different parts, and the range of parts that can be applied is relatively wide; at the same time, the buckle body is made of biodegradable material, and the imaging is clearer and free of artifacts during postoperative CT and MRI scans, and the position of clinical concern can be located more accurately, and the buckle body has good compatibility with tissues, and is completely degraded in the body after a period of time without leaving any traces, which is beneficial to the patient's later recovery and will not shift due to gradual degradation of the buckle body during the effective observation period. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0023] Figure 1 A schematic diagram of the structure of a marking buckle for marking a position of clinical concern during surgery provided by an embodiment of the present invention;

[0024] Figure 2 A schematic diagram of a top view of a marking buckle for marking a position of clinical concern during surgery provided by an embodiment of the present invention;

[0025] Figure 3 A schematic diagram of the structure of a marking buckle for marking a position of clinical concern during surgery provided by another embodiment of the present invention;

[0026] Figure 4 A schematic diagram of the structure of a marking buckle for marking a position of clinical concern during surgery provided by yet another embodiment of the present invention;

[0027] Figure 5 An artifact comparison diagram of a marking buckle and a titanium clip for marking a position of clinical concern during surgery provided in an embodiment of the present invention, wherein the marking buckle for marking a position of clinical concern during surgery is made of a biodegradable polymer material of polyglycolide (PGA), and the marking buckle and the titanium clip are substantially the same in size.

[0028] Among them, the reference numerals in the figures are as follows:

[0029] 10. Buckle body; 21. Threading hole; 22. Wire slot; 23. Slow degradation layer; 24. Normally closed elastic clip;

[0030] 30. Titanium clips; 40. Pudding used for scanning (used to simulate biological tissue). DETAILED DESCRIPTION

[0031] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0032] A marking buckle for marking a position of clinical concern during surgery and a fixing method thereof provided by the present invention are now described.

[0033] Please also read Figures 1 to 4 The marking buckle provided by the present invention for marking a position of clinical concern during surgery includes a buckle body 10, which is made of a biodegradable material and is provided with a threading hole 21 for inserting a suture.

[0034] Biodegradable materials are materials that are compatible with biological tissues and can be slowly decomposed and absorbed. Figure 5 As can be seen from the comparative examples in the figure, the artifacts of the buckle body 10 are significantly smaller than those of the titanium clip 30. The results show that, according to the preliminary test of Pudding, the buckle body 10 can locate the position of clinical concern more accurately than the titanium clip 30.

[0035] Compared with the prior art, the marking buckle provided by the present invention for marking the position of clinical concern during surgery uses sutures to fix the buckle body 10 at the position of concern through the threading hole 21, which can reduce the requirements for the mechanical properties of the material, and the fixation is reliable. The application position of the sutures is relatively flexible, and suture fixation can be performed according to the characteristics of different parts, and the range of applicable parts is relatively wide. At the same time, the buckle body 10 is a biodegradable material, and the imaging is clearer and free of artifacts during postoperative CT and MRI scans, and the position of clinical concern can be located more accurately. It has good compatibility with tissues and is completely degraded in the body after a period of time without leaving any traces, which is beneficial to the patient's later recovery and will not shift due to gradual degradation of the buckle body 10 during the effective observation period.

[0036] Please also read Figure 1 , Figure 2 and Figure 4 As a specific embodiment of the marking buckle provided by the present invention for marking a position of clinical concern during surgery, the edge of the buckle body 10 is provided with a wire clamping groove 22 capable of accommodating sutures.

[0037] The wire clamping groove 22 is wide outside and narrow inside, and the bottom of the wire clamping groove 22 is connected to the threading hole 21, and the width of the bottom of the groove is smaller than the diameter of the suture, so as to prevent the suture in the threading hole 21 from slipping out of the bottom of the wire clamping groove 22. This can help to clamp the suture and the knot by using the wire clamping groove 22 when tying the suture, and prevent the suture from loosening due to the decomposition of the buckle body 10 in the later stage.

[0038] The inner wall of the wire clamping groove 22 is provided with teeth to facilitate the fixation of the suture thread and prevent the suture thread from being loosened due to being in a shaking state for a long time when the patient moves.

[0039] The inner walls of the threading hole 21 and the wire clamping groove 22 are provided with a slow-degradation layer 23 , the decomposition rate of the slow-degradation layer 23 is lower than the degradation rate of the buckle body 10 , so as to prevent the suture from loosening due to the decomposition of the buckle body 10 in the later stage.

[0040] At least two threading holes 21 are provided on the buckle body 10, and the axes of the two threading holes 21 are arranged at an angle, so as to facilitate selection according to the specific situation of the position of interest, so as to more conveniently fix the buckle body 10 at the position of interest.

[0041] The button body 10 is a flat button-shaped structure, which may be a cylindrical structure, a prism structure, a rounded prism structure, etc., and there are a plurality of threading holes 21 .

[0042] The buckle body 10 is also provided with a normally closed elastic clip 24 for clamping the tissue at the position of interest, which can be more conveniently and accurately fixed in position by cooperating with the threading hole 21 and the fixation of the suture thread. The normally closed elastic clip 24 can be provided with a positioning hole or a limit block and other structures to facilitate the use of surgical instruments to open and close the normally closed elastic clip 24.

[0043] The threading hole 21 can also be set on the clamping arm of the normally closed elastic clamp 24. On the one hand, it can facilitate the fixation of surgical instruments. On the other hand, when the buckle body 10 is in place, it can be easily fixed to the surrounding tissue through sutures to avoid the possibility of the normally closed elastic clamp 24 being unreliable.

[0044] The buckle body 10 is made of biodegradable material that does not produce artifacts or produces relatively small artifacts, and can be a metal material, a non-metal material, or a composite material that can reduce or eliminate artifacts after special treatment. In actual use, the material type can be selected, compounded, or processed in other forms as needed.

[0045] The button body 10 is preferably made of non-metallic material to eliminate the influence of metal artifacts. It can be one or more biodegradable materials such as polyester, polyurethane, polyamide, polylactic acid or polyacetic acid materials, and can be mixed and prepared in proportion in specific applications.

[0046] The method for fixing a marking buckle for marking a position of clinical concern during surgery provided by the present invention uses the above-mentioned marking buckle for marking a position of clinical concern during surgery for fixing, and comprises the following steps:

[0047] The marker buckle is placed at a clinically concerned position, and a surgical suture needle is used to carry a suture thread through the threading hole 21 to suture and fix the marker buckle at the concerned position.

[0048] Compared with the prior art, the fixing method of the marking buckle for marking the position of clinical concern during surgery provided by the present invention can be completed by using existing surgical instruments such as laparoscopy, and the suturing is simple, the operation is safe, and the reliability is strong. In addition, the application position of the suture is relatively flexible, and the suturing and fixation can be performed according to the characteristics of different parts, and the range of applicable parts is relatively wide. At the same time, the buckle body is made of biodegradable material, and the imaging is clearer and free of artifacts during postoperative CT and MRI scans, and the position of clinical concern can be located more accurately. In addition, the buckle body has good compatibility with tissues and is completely degraded in the body after a period of time without leaving any traces, which is beneficial to the patient's later recovery and will not shift due to gradual degradation of the buckle body 10 during the effective observation period.

[0049] As a specific implementation of the method for fixing a marking buckle for marking a position of clinical concern during surgery provided by the present invention, when a wire clamping groove 22 is provided on the marking buckle, when the marking buckle is sutured and fixed at the position of clinical concern, the knot of the suture thread is placed in the wire clamping groove 22.

[0050] When the marking buckle is provided with a normally closed elastic clip body 24, before the marking buckle is sutured to the position of clinical concern, the normally closed elastic clip body 24 is first opened by surgical forceps, and then the marking buckle is placed at the position of clinical concern, and the normally closed elastic clip body 24 is clamped, and then a suitable threading hole 21 is selected to suture the marking buckle to the position of clinical concern.

[0051] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A marking buckle for marking a location of clinical concern during surgery, characterized in that: include: The button body (10) is made of a biodegradable material and is provided with a threading hole (21) for inserting a suture, wherein the button body (10) is fixed to a position of interest by means of a suture through the threading hole (21) so as to be imaged during CT and MRI scanning; The edge of the button body (10) is provided with a thread retaining groove (22) capable of accommodating the suture thread; The wire clamping groove (22) is wide on the outside and narrow on the inside, and the groove bottom of the wire clamping groove (22) is connected to the threading hole (21), and the groove bottom width is smaller than the diameter of the suture thread, so as to prevent the suture thread in the threading hole (21) from falling out of the groove bottom of the wire clamping groove (22); The inner wall of the wire clamping groove (22) is provided with teeth; The inner walls of the threading hole (21) and the wire clamping groove (22) are provided with a slow-degradation layer (23), and the degradation rate of the slow-degradation layer (23) is lower than the degradation rate of the buckle body (10).

2. The marking buckle for marking a position of clinical concern during surgery as claimed in claim 1, characterized in that: The button body (10) is made of one or more materials selected from polyester, polyurethane, polyamide, polylactic acid or polyacetic acid.

3. The marking buckle for marking a position of clinical concern during surgery as claimed in claim 1, characterized in that: The buckle body (10) is provided with at least two threading holes (21), and the axes of the two threading holes (21) are arranged at an angle; the buckle body (10) is a flat buckle-shaped structure, and the threading holes (21) are multiple.

4. The marking buckle for marking a position of clinical concern during surgery as claimed in claim 1, characterized in that: The buckle body (10) is also provided with a normally closed elastic clamp (24) for clamping tissue at a location of interest.

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