A surgical auxiliary marking tool and marking method

Abstract

The application relates to a surgical auxiliary marking tool and a marking method. The tool comprises a main body which comprises a line drawing contour matched with a designed suture track. Before line drawing, the main body is attached to a valve suture position, the line drawing contour is overlapped with the designed suture track, then a mark is formed by drawing a line along the line drawing contour on the valve suture position, and subsequent suture is performed along the mark. The auxiliary marking tool can accurately mark the suture track and ensure the position accuracy of the valve or patch after suture.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, specifically to an auxiliary marking tool and marking method for surgical procedures. Background Technology

[0002] Aortic valve replacement surgery is the most common surgical procedure for aortic valve disease. It is a treatment method that replaces the diseased aortic valve with an artificial valve. It is mainly used for patients with severe aortic stenosis or regurgitation to restore normal blood flow to the heart, improve symptoms, and reduce the risk of complications. Aortic valve replacement has the advantages of simple surgery and good postoperative artificial valve function.

[0003] When performing aortic root reconstruction or customized aortic valve replacement, it is crucial to ensure accurate suture placement during the suturing of the aortic valve or repair patch. Therefore, this application provides an auxiliary positioning tool to accurately locate the suture position. Summary of the Invention

[0004] Based on the above description, the present invention provides a surgical auxiliary marking tool and marking method to accurately locate the suture position.

[0005] The technical solution of the present invention to solve the above-mentioned technical problems is as follows: In a first aspect, this application provides a surgical auxiliary marking tool, including a body comprising a drawing outline adapted to a designed suture trajectory.

[0006] Preferably, the main body can undergo plastic bending deformation.

[0007] Preferably, the main body includes a tubular portion adapted to the aortic root, and the outline is provided along the edge of one end of the tubular portion.

[0008] Preferably, the outline of the line is set around one end of the tubular portion, and the outline of the line is adapted to the suture trajectory of the aortic valve on the aortic valve annulus.

[0009] Preferably, the tubular portion has at least one notch at one end where the outline is drawn.

[0010] Preferably, the main body includes a support portion and a contour portion. The support portion is tubular and adapted to the aortic root. The contour portion is connected to one end edge of the support portion. The drawing contour is provided on the contour portion and the drawing contour is adapted to the suture trajectory of a single leaflet on the aortic sinus.

[0011] Preferably, the number of the contour portions is one, two, or three, and each of the contour portions is provided with the drawing contour.

[0012] Preferably, a shaping strip is provided on the main body along the outline of the drawn line, and the shaping strip can be plastically bent and deformed.

[0013] Preferably, a marker is provided on the main body along the outline of the drawing line, the marker being used to mark the suture trajectory at the valve suture location.

[0014] Preferably, the marking element includes one or more of dyed thread and heating wire.

[0015] Preferably, the marker includes a dyed line arranged along the outline of the drawing, which transfers dye to the valve suture site when it comes into contact with the valve suture site at room temperature.

[0016] Preferably, the marker includes a heating wire disposed along the outline of the drawing line.

[0017] Preferably, the marking element includes a heating wire and a dyeing thread arranged along the outline of the marking line. The dyeing thread contacts the valve suture position and, when heated by the heating wire, transfers the dye onto the valve suture position.

[0018] Preferably, it also includes a rigid spoon body, which is adapted to bend and deform the contour portion relative to the support portion to fit the sewing position.

[0019] Preferably, a handle is connected to the main body, one end of the handle is connected to the main body, and the handle can be plastically bent and deformed.

[0020] Secondly, this application provides a marking method, employing the surgical auxiliary marking tool described above for auxiliary marking, including: The main body is fitted to the valve suture location, and the drawn outline coincides with the designed suture trajectory; Mark the valve suture location along the outline of the drawn line.

[0021] Preferably, a dyeing line is provided on the main body along the outline of the drawing line, and marking the valve suture position along the outline of the drawing line includes: transferring dye to the valve suture position through the dyeing line to form a mark.

[0022] Preferably, the main body is provided with a heating wire along the outline of the drawing line, and marking the valve suture position along the outline of the drawing line includes: heating the position where the designed suture trajectory is located by the heating wire to denature the tissue and form a mark.

[0023] Preferably, the main body is provided with a heating wire and a dyeing thread along the outline of the drawing line, and the marking along the outline of the drawing line at the valve suture position includes: heating the dyeing thread by the heating wire to transfer the dye to the valve suture position.

[0024] Compared with the prior art, the technical solution of this application has at least the following beneficial technical effects: The auxiliary marking tool of this application, by setting a main body and setting a drawing outline on the main body that matches the designed suture trajectory, allows for precise marking of the suture trajectory before drawing lines. The main body is then fitted to the valve suture position, and the drawing outline is aligned with the designed suture trajectory. A line is then drawn along the drawing outline at the valve suture position to form a mark. Subsequent suturing follows this mark. By using the auxiliary marking tool of this application, the suture trajectory can be accurately marked, ensuring the accurate positioning of the valve or patch after suturing. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the structure of the main body of the surgical auxiliary marking tool provided in an embodiment of the present invention, wherein the main body includes a tubular portion; Figure 2 This is a schematic diagram of the main body of the surgical auxiliary marking tool provided in an embodiment of the present invention, wherein the main body includes a support portion and a contour portion; Figure 3 for Figure 2 The diagram shows another view of the structure of a surgical auxiliary marking tool, in which the outline portion bends outward relative to the support portion; Figure 4 This is a schematic diagram of the structure of the rigid spoon body in the surgical auxiliary marking tool provided in an embodiment of the present invention.

[0026] Explanation of reference numerals in the attached figures: 1. Main body; 11. Outline; 12. Tubular part; 13. Notch; 14. Support part; 15. Outline part; 2. Marking part; 3. Handle; 4. Hard spoon body. Detailed Implementation

[0027] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings, which illustrate embodiments of the present application. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that the disclosure of this application will be thorough and complete.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0029] It is understood that spatial relation terms such as "below," "under," "below," "below," "above," "above," etc., can be used here to describe the relationship between one element or feature shown in the figure and other elements or features. It should be understood that, in addition to the orientation shown in the figure, spatial relation terms also include different orientations of the device in use and operation. For example, if the device in the figure is flipped, the element or feature described as "below" or "below" of the other element or feature will be oriented "above" the other element or feature. Therefore, the exemplary terms "below" and "below" can include both upper and lower orientations. Furthermore, the device may also include other orientations (e.g., rotated 90 degrees or other orientations), and the spatial descriptive terms used herein will be interpreted accordingly.

[0030] It should be noted that when one element is considered to be "connected" to another element, it can be directly connected to the other element or connected to the other element through an intermediary element. In the following embodiments, "connection" should be understood as "electrical connection," "communication connection," etc., if the connected circuits, modules, units, etc., have the transmission of electrical signals or data between them.

[0031] When used herein, the singular forms of “a,” “an,” and “the” may also include the plural forms unless the context clearly indicates otherwise. It should also be understood that the terms “comprising,” “including,” or “having,” etc., specify the presence of the stated feature, whole, step, operation, component, part, or combination thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, components, parts, or combinations thereof.

[0032] Reference Figure 1 As shown, this application provides a surgical auxiliary marking tool, including a main body 1, which includes a drawing outline 11 adapted to the designed suture trajectory.

[0033] Before drawing the lines, first align the main body 1 with the valve suture location and ensure that the drawn line outline 11 coincides with the designed suture path. Then, draw a line along the drawn line outline 11 at the valve suture location to form a mark. During subsequent suturing, simply follow the mark to suture the valve or patch. This method accurately marks the suture path, ensuring the accurate positioning of the valve or patch after suturing.

[0034] The main body 1 is further designed to undergo plastic bending deformation, so that the main body 1 can be arbitrarily shaped and maintained during use, so as to better conform to the tissue shape of the suture position, thereby better fitting the suture position and supporting the tissue.

[0035] A shaping strip is provided on the main body 1 along the outline 11. The shaping strip can be plastically bent and deformed. Specifically, the shaping strip can be made of tin wire, zinc wire, or platinum wire, preferably tin wire, and is fixed to the main body 1 by suture thread. The shaping strip allows the outline 11 area to be plastically bent and deformed, thereby changing the spatial shape of the outline 11 to better fit the tissue at the suture position and ensure the accuracy of the marking position.

[0036] The main body 1 needs to conform to the wall as the outline 11 deforms, without generating excessive resistance. Otherwise, it will fail to adhere to the wall, preventing the outline 11 from fitting properly to the inner wall of the aorta, thus greatly reducing the accuracy of the line drawing. Therefore, the main body 1 is made of a soft material with low hardness, preferably medical-grade silicone rubber with a hardness of 0-20, and is manufactured using a compression molding method.

[0037] In actual marking operations, lines can be drawn manually using a drawing pen.

[0038] Reference Figure 1 As shown, or a marker 2 is provided on the main body 1 along the outline 11, the marker 2 being used to mark the suture trajectory at the valve suture position.

[0039] The marking element 2 includes one or more of dyeing lines and heating wires.

[0040] In one embodiment, the marker 2 includes a dyed line disposed along the outline 11, the dyed line being used to mark the suture trajectory at the valve suture location.

[0041] Specifically, the dyeing thread can be made of cotton or plastic thread, and is set in a tubular shape to cover the shaping strip. It is then sutured and fixed to the main body 1 together with the shaping strip. The dyeing thread is provided with dye. When marking, the main body 1 is attached to the valve suture position, and the outline 11 of the drawing is aligned with the designed suture trajectory. The dyeing thread then contacts the tissue and transfers the dye to the valve suture position to form a mark.

[0042] Alternatively, the staining line can be a capillary tube, arranged in parallel with the shaping strip and also sutured and fixed to the main body 1 by sutures. One end of the capillary tube is connected to a syringe, and multiple holes are set along the length of the capillary tube. When staining and marking, the dye is injected into the capillary tube through the syringe, and the dye seeps out through the holes and imprints on the tissue at the valve suture site. Multiple dot-shaped imprints mark the suture trajectory.

[0043] In another embodiment, the marker 2 includes a heating wire disposed along the outline 11. In this embodiment, the heating wire also serves as a shaping strip and is sewn and fixed to the body by stitching. The heating wire is connected to an external power supply device, and is heated by energizing the heating wire.

[0044] During the marking process, the main body 1 is placed against the valve suture site, and the drawn outline 11 is aligned with the designed suture trajectory. The heating wire then contacts the tissue, using its heat to denature the tissue at the valve suture site and form the mark. In actual design and operation, the temperature of the heating wire must be controlled to prevent it from becoming too high and the heating time from becoming too long, ensuring tissue denaturation to form a visible mark while avoiding irreversible tissue damage.

[0045] In another embodiment, the marker 2 includes a heating wire and a dyeing thread arranged along the outline 11. In this embodiment, the heating wire also serves as a shaping strip, and the dyeing thread, made of cotton or plastic thread, is woven into a tubular shape and sleeved around the heating wire. The dyeing thread and the heating wire are arranged synchronously along the outline 11 and are sutured to the body. The dyeing thread contains a temperature-sensitive dye; at room temperature, the dye will not transfer to the tissue upon contact with it, but only when the dye is heated by the heating wire and melts can it be transferred to the tissue.

[0046] During the marking operation, the main body 1 is attached to the valve suture position, and the outline 11 is aligned with the designed suture trajectory. The dyed line comes into contact with the tissue, and electricity is applied to the heating wire. The heating wire heats up, causing the dye to melt and transfer onto the tissue at the valve suture position to form a mark.

[0047] In actual design, the above implementation method can be selected according to the actual situation. After completing the suture trajectory marking operation, remove the tool and suture the valve or patch according to the marking, which can ensure accurate positioning after suturing.

[0048] Reference Figure 1 and Figure 2 As shown, a handle 3 is further connected to the support 14. One end of the handle 3 is connected to the main body 1, and the handle 3 can be plastically bent and deformed. Specifically, the handle 3 can be made of iron wire, with one end of the iron wire fixed to the support 14. The handle 3 is convenient for doctors to manipulate to adjust the position of the main body 1, and the handle 3 can be plastically bent and deformed at will without interfering with the drawing operation.

[0049] In the embodiment where a heating wire is provided on the main body 1, the wire that supplies power to the heating wire can be directly used as the handle 3.

[0050] The shape of the main body 1 is designed according to different situations, specifically divided into two situations: overall valve replacement and root reconstruction.

[0051] In cases of total valve replacement, the valve needs to be sutured to the aortic root wall. In this case, the suture trajectory is designed as a circular path along the circumference of the vessel wall. This circular path needs to be marked on the vessel wall.

[0052] In this case, refer to Figure 1 As shown, the main body 1 is configured to include a tubular portion 12 adapted to the aortic root, and the outline 11 is provided along the edge of one end of the tubular portion 12.

[0053] The outline 11 is set around one end of the tubular part 12, and the outline 11 is adapted to the suture trajectory of the aortic valve on the aortic valve annulus.

[0054] Reference Figure 1 As shown, the tubular portion 12 is cylindrical, and its outer diameter matches the inner diameter of the aortic root.

[0055] Reference Figure 1 As shown, furthermore, at least one notch 13 is provided at one end of the tubular portion 12 where the outline 11 is provided. The notch 13 divides the outline 11, allowing the area where the outline 11 is located to bend relative to other areas of the main body 1. When the main body 1 is inserted into the blood vessel to open and support it, the area where the outline 11 is located can bend outward relative to other areas of the main body 1 to better fit the inner wall of the blood vessel and coincide with the designed suture trajectory. In this embodiment, three notches 13 are shown for illustration, with two notches 13 symmetrically arranged on both sides of the main body 1.

[0056] In cases of valve root reconstruction, the valve leaflets are partially excised while preserving the sinus region, and then the repaired patch is sutured to the sinus region.

[0057] In this case, refer to Figure 2 and Figure 3 As shown, the main body 1 is configured to include a support portion 14 and a contour portion 15. The support portion 14 is tubular and adapted to the aortic root. The contour portion 15 is connected to one end edge of the support portion 14. A line drawing contour 11 is provided on the contour portion 15 and is adapted to the suture trajectory of a single leaflet on the aortic sinus.

[0058] Reference Figure 2 and Figure 3 As shown, specifically, the contour portion 15 is sheet-like, and one side of the contour portion 15 is connected to the support portion 14. The drawing contour 11 extends along the edge of the contour portion 15 away from the support portion 14. In this embodiment, the suture trajectory is designed as an arc trajectory along the arc contour of the sinus, and correspondingly, the drawing contour 11 is an arc shape adapted to the arc contour of the sinus.

[0059] Reference Figure 3 As shown, during the auxiliary line drawing operation, the support part 14 is inserted into the blood vessel to open and support the blood vessel. The contour part 15 is bent relative to the support part 14 to fit the sinus and make the line drawing contour 11 coincide with the designed suture trajectory. The contour part 15 is kept in this state, and then the line drawing can be marked.

[0060] In actual operation, there may be situations where two or three leaflets need to be reconstructed. Therefore, when processing the auxiliary marking tool, two or three contour portions 15 can be correspondingly provided on the support portion 14 according to the number of reconstructed leaflets. Each contour portion 15 is provided with a drawing contour 11, ensuring that the contour portion 15 corresponds one-to-one with the leaflet position. Alternatively, only one contour portion 15 can be provided, and then the auxiliary marking work for the leaflets that need to be reconstructed can be performed through this single contour portion 15. This embodiment is illustrated with three contour portions 15.

[0061] Reference Figure 4 As shown, in this case, in order to facilitate the doctor's shaping of the main body 1 so that the contour portion 15 fits the sinus, the tool also includes a rigid spoon 4. The rigid spoon 4 is used for the doctor's operation. By passing the rigid spoon 4 through the support portion 14, the contour portion 15 is bent outward so that the drawing contour 11 fits the sinus. At the same time, the rigid spoon 4 separates the surrounding tissue to provide a good operating field of vision and facilitates the marking operation.

[0062] This embodiment also provides a marking method using the surgical auxiliary marking tool described above, specifically including the following steps: First, attach the main body 1 to the valve suture position and make the drawn outline 11 coincide with the designed suture trajectory.

[0063] Mark the valve suture location along the outline 11.

[0064] In one embodiment where a dyeing line is provided on the main body 1, when marking the valve suture position along the outline 11, the dye is transferred to the valve suture position through the dyeing line to form a mark.

[0065] In the embodiment where the main body 1 is equipped with an electric heating wire, when marking the valve suture position along the outline 11, the electric heating wire is energized, and the position where the designed suture trajectory is located is heated by the electric heating wire, causing tissue denaturation to form a mark.

[0066] In the embodiment where the main body 1 is equipped with a heating wire and a dyeing thread, when marking the valve suture position along the outline 11, the heating wire is energized, and the dyeing thread is heated by the heating wire, so that the dye is transferred to the valve suture position.

[0067] The specific marking method, namely the method of using the surgical auxiliary marking tool as described above, is the same as the description of the surgical auxiliary marking tool above, and will not be repeated here.

[0068] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A surgical auxiliary marking tool, characterized in that: Includes a main body (1), which includes a line outline (11) adapted to the design stitching trajectory.

2. The surgical auxiliary marking tool according to claim 1, characterized in that: The main body (1) can undergo plastic bending deformation.

3. The surgical auxiliary marking tool according to claim 1 or 2, characterized in that: The main body (1) includes a tubular portion (12) adapted to the root of the aorta, and the outline (11) is provided along the edge of one end of the tubular portion (12).

4. The surgical auxiliary marking tool according to claim 3, characterized in that: The outline (11) is set around one end of the tubular portion (12), and the outline (11) is adapted to the suture trajectory of the aortic valve on the aortic valve annulus.

5. The surgical auxiliary marking tool according to claim 4, characterized in that: The tubular portion (12) having the outline (11) has at least one notch (13) at one end.

6. The surgical auxiliary marking tool according to claim 1 or 2, characterized in that: The main body (1) includes a support portion (14) and a contour portion (15). The support portion (14) is tubular and adapted to the aortic root. The contour portion (15) is connected to one end edge of the support portion (14). The drawing contour (11) is provided on the contour portion (15). The drawing contour (11) is adapted to the suture trajectory of a single leaflet on the aortic sinus.

7. The surgical auxiliary marking tool according to claim 6, characterized in that: The number of the outline portions (15) is one, two or three, and each of the outline portions (15) is provided with the drawing outline (11).

8. The surgical auxiliary marking tool according to claim 1 or 2, characterized in that: A shaping strip is provided on the main body (1) along the outline (11) of the drawing line, and the shaping strip can be plastically bent and deformed.

9. The surgical auxiliary marking tool according to claim 8, characterized in that: The shaping strip is made of tin wire, zinc wire, or platinum wire.

10. The surgical auxiliary marking tool according to claim 1, characterized in that: The main body (1) is provided with a marker (2) along the outline (11) of the drawing line, and the marker (2) is used to mark the suture trajectory at the valve suture position.

11. The surgical auxiliary marking tool according to claim 10, characterized in that: The marking element (2) includes one or more of dyed thread and heating wire.

12. The surgical auxiliary marking tool according to claim 6, characterized in that: It also includes a rigid spoon body (4), which is adapted to bend and deform the contour portion (15) relative to the support portion (14) to fit the sewing position.

13. The surgical auxiliary marking tool according to claim 1, characterized in that: A handle (3) is connected to the main body (1), one end of the handle (3) is connected to the main body (1), and the handle (3) can be plastically bent and deformed.

14. A marking method, characterized in that, The surgical auxiliary marking tool as described in claim 1 or 2 is used for auxiliary marking, including: The main body (1) is attached to the valve suture position, and the drawn outline (11) coincides with the designed suture trajectory; Mark the valve suture location along the outline (11) of the drawing.

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