High-flexibility multi-groove biopsy device

Abstract

A high-flexibility multi-groove biopsy device comprises a biopsy needle rod, the biopsy needle rod comprises a needle tip, a sampling section, a needle rod flexible section and a needle rod supporting section, the needle tip comprises a first inclined plane and a second inclined plane, the second inclined plane is arranged on the first inclined plane, the angle of the second inclined plane is larger than that of the first inclined plane, the sampling section comprises a first groove and a second groove, and the two grooves are of a semicircular structure; the needle rod smooth section comprises a rigid inner core, a macromolecule outer layer and a connecting section, and the macromolecule outer layer wraps the inner core; the biopsy outer needle tube comprises a cutting section, a needle tube compliant section and a needle tube supporting section, the cutting section comprises a cutting head, the cutting head comprises a first cutting face and a second cutting face, the angle of the first cutting face is smaller than that of the second cutting face, and grooves and straight transition sections are distributed on the two sides of the needle tube compliant section; the stainless steel bending sheath comprises a front-end straight section, a bending section, a rear-end straight section, a polymer piece and a direction indicating piece, and the indicating direction of the direction indicating piece is the same as the bending direction of the bending section.

Description

Technical Field

[0001] The invention patent relates to the field of medical devices, and in particular to a highly flexible multi-slot biopsy device. Background Art

[0002] For pathologies where liver tissue lesions are already very obvious, but clinical symptoms and laboratory changes are absent or mild, and where abnormal clinical and laboratory examinations appear long after liver tissue morphology changes, it is impossible to determine the extent of the lesions through surface testing. Therefore, in order to understand the subtle lesions of liver tissue earlier and more accurately, liver biopsy is currently the only means of evaluation that can be achieved, and only a correct diagnosis is the prerequisite for correct treatment.

[0003] The current methods for intrahepatic biopsy puncture mainly include: (1) percutaneous liver biopsy, which refers to inserting a needle directly into the liver parenchyma through the skin for biopsy. This biopsy method will pierce the liver capsule and there is a risk of massive intra-abdominal bleeding. In rare cases, the puncture needle may happen to pierce the diaphragmatic vein, which can also cause massive intra-abdominal bleeding. (2) transjugular or femoral liver biopsy, which uses a special biopsy needle to insert a catheter into the liver through the jugular or femoral vein through an interventional procedure for biopsy. In theory, it can avoid rupture of the liver capsule and reduce the risk of bleeding. It is particularly suitable for patients with poor coagulation function or a large amount of ascites before surgery. Transjugular liver biopsy (TJLB): The operator inserts a deep vein puncture needle into the jugular vein, inserts a guide wire along the puncture needle, and operates the guide wire under visual monitoring to enter the hepatic vein through the catheter sheath, superior vena cava, right atrium, and inferior vena cava. Hepatic venography is used to confirm the anatomy of the hepatic vein and the position of the sheath head. The guide wire is withdrawn and the puncture biopsy needle is inserted. The biopsy needle is quickly inserted into the liver parenchyma 1~2 cm and the liver tissue specimen is quickly obtained.

[0004] At present, when transjugular liver biopsy (TJLB) is used clinically, a pre-installed puncture set is required to establish the access channel for the biopsy needle. The inner core of this pre-installed puncture set is a curved stainless steel sheath with a pre-shaped distal end. The biopsy needle needs to pass through this curved section for cutting and sampling, which causes the elastic force of the outer needle tube of the biopsy needle to be greatly reduced when it ejects forward for cutting and sampling, and it is impossible to cut and sample completely and effectively. Traditional percutaneous puncture biopsy is mostly used for linear puncture. Since this biopsy needle does not need to bend, its elastic force attenuation is small. Therefore, we propose a device that can reduce the influence of the curved stainless steel sheath on the cutting elastic force of the biopsy needle under TJLB: a highly flexible multi-slot biopsy device.

[0005] At the same time, the sampling groove of the existing transjugular liver biopsy needle is a single groove, and the single sampling volume cannot meet the needs of subsequent pathological analysis. Multiple sampling and puncture sampling are often required, which causes great harm to patients and is more likely to cause complications such as bleeding and infection. Increasing the size of the biopsy needle is not easy to operate and adjust during operation, and will also increase patient harm and cause more complications. Therefore, under the premise that the specifications of the biopsy needle remain unchanged, reducing the number of sampling times and increasing the single sampling volume will help reduce harm to patients and reduce complications. Therefore, we propose a device that increases the single sampling volume under the same specifications: a highly flexible multi-groove biopsy device. Summary of the invention

[0006] The purpose of the present invention is to overcome the above disadvantages and provide a highly flexible multi-groove biopsy device.

[0007] The technical solution adopted by the present invention is as follows: A biopsy needle shaft, the biopsy needle shaft comprising a needle tip, a sampling section, a needle shaft flexible section and a needle shaft supporting section, the needle tip comprising a first bevel and a second bevel, the second bevel being arranged on the first bevel, the angle of the second bevel being greater than that of the first bevel, the sampling section comprising a first groove and a second groove, the first groove being a semicircular structure, the cross-sectional area of ​​the semicircular structure being 40%-80% of the cross-sectional area of ​​the biopsy needle shaft, the second groove being a semicircular structure, the center of the second groove coincides with the center of the first groove, the needle shaft flexible section comprising a rigid inner core, a polymer outer layer and a connecting section, the polymer outer layer being wrapped around the outer surface of the inner core, the polymer outer layer, the connecting section and the needle shaft supporting section having the same diameter; A biopsy outer needle tube, the biopsy outer needle tube comprising a cutting section, a needle tube flexible section and a needle tube supporting section, the cutting section comprising a cutting head, the cutting head comprising a first cutting surface and a second cutting surface, the angle of the first cutting surface is smaller than the angle of the second cutting surface, a plurality of grooves and a straight transition section are distributed on both sides of the needle tube flexible section, wherein the opposite side of one groove is a straight transition section, and the length of the needle tube flexible section is equal to the sum of the lengths of the needle rod flexible section and the sampling section; A stainless steel curved sheath, the stainless steel curved sheath comprising a front straight section, a curved section, a rear straight section, a polymer component and a direction indicator sheet, the direction indicator sheet comprising a sheet tip and a tail end, the indication direction of the sheet tip being the same as the bending direction of the curved section and being used to control the bending direction of the stainless steel curved sheath, the length of the needle rod flexible section being the same as the length of the curved section, and the length of the needle tube flexible section being not less than the length of the curved section.

[0008] Preferably, the angle of the first inclined surface is 20°-40°.

[0009] Preferably, the radius of the second groove is 1 / 3-2 / 3 of the radius of the first groove.

[0010] Preferably, the angle of the first cutting surface is 20°-60°, and the angle of the second cutting surface is 40°-80°.

[0011] Preferably, the material of the polymer outer layer is polytetrafluoroethylene. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 Biopsy needle shaft; Figure 2 Side view of the biopsy needle shaft; Figure 3 Several first grooves and second grooves with different structures; Figure 4 Sampling slot for conventional biopsy needle; Figure 5 Biopsy external needle; Figure 6 Another needle tube flexible section structure; Figure 7 Stainless steel curved sheath; Figure 8 Direction indicator sheet; Fig. 9 The state of the device of the present invention before sampling; Fig.10 The status of the device of the present invention after sampling. DETAILED DESCRIPTION

[0013] The following embodiments of the present invention are described in further detail in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0014] A highly flexible multi-groove biopsy device, characterized in that it comprises: a biopsy needle, a stainless steel curved sheath 300, etc., wherein the stainless steel curved sheath 300 and other components form a biopsy channel, and the biopsy needle samples liver parenchyma tissue through the jugular vein through the biopsy channel. The biopsy needle comprises a biopsy needle shaft 100, a biopsy outer needle tube 200 and a handle 400.

[0015] Biopsy needle shaft 100, such as Figure 1As shown, the biopsy needle shaft 100 is a solid structure, including a needle tip 110, a sampling section 120, a needle shaft flexible section 130, and a needle shaft support section 140. The needle tip 110 is a solid structure, including a first bevel 111 and a second bevel 112, the second bevel 112 is arranged on the first bevel 111, the angle of the first bevel 111 is 20°-40°, and a second bevel 112 with a larger angle is arranged at the tip of the first bevel 111, and the two bevels together constitute the puncture section of the needle tip 110, which increases the sharpness during puncture. The sampling section 120 is a double groove structure, including a first groove 122 and a second groove 121. The first groove 122 is a semicircular structure, and the cross-sectional area of ​​the semicircular structure is 40%-80% of the cross-sectional area of ​​the biopsy needle shaft. The second groove 121 is a semicircular structure, and the center of the second groove 121 coincides with the center of the first groove 122. The radius of the second groove 121 is 1 / 3-2 / 3 of the radius of the first groove 122. Figure 3 As shown. The conventional biopsy needle is only provided with a first groove 122 similar to the present invention. Figure 4 As shown, the present invention has two grooves, which together form a sampling groove, increasing the contact area between the tissue and the groove, reducing the displacement of the tissue when the needle tube is cut during sampling, and reducing the separation of the tissue from the sampling groove. At the same time, it also increases the storage capacity of the tissue in the groove, and increases the biopsy sampling volume. In another embodiment, the first groove or the second groove is an elliptical structure, a U-shaped structure, or a V-shaped structure. The side view of the needle tip 110 and the sampling section 120 is shown in FIG. Figure 2 As shown. Figure 1 As shown, the needle rod flexible section 130 includes a rigid inner core 131, a polymer outer layer 132 and a connecting section 133. The polymer outer layer 132 is wrapped around the outer surface of the inner core 131. The polymer outer layer 132, the connecting section 133 and the needle rod support section 140 have the same diameter. The length of the needle rod flexible section 130 is the same as the length of the curved section 320 of the stainless steel curved sheath, so that when the biopsy needle rod 100 contacts and moves relative to the biopsy outer needle tube 200 at the curved section 320, the friction is reduced. The rigidity of the flexible section of the biopsy needle rod 100 is much lower than that of the two ends of the needle rod, but due to the protection of the biopsy outer needle tube 200, the needle rod will not bend and deform. The rigid inner core 131 is a stainless steel solid core shaft, which is used to provide the needle tip 110 and the sampling section 120 with a forward axial force, so that the needle tip 110 can smoothly puncture into the liver parenchyma. The needle rod supporting section 140 is a solid stainless steel structure, which provides support for the entire biopsy needle to prevent the biopsy needle from bending and deforming during biopsy.

[0016] The biopsy outer needle tube 200 includes a cutting section 210, a needle tube flexible section 220 and a needle tube supporting section 230. Figure 5As shown, the cutting section 210 includes a cutting head 211, and the cutting head 211 includes a first cutting surface 2112 and a second cutting surface 2111. The wall of the biopsy outer needle tube 200 is first beveled at an angle of 20°-60° to form a first cutting surface 2112, and then the first cutting surface 2112 is beveled at an angle of 40°-80° to form a second cutting surface 2111. The angle of the first cutting surface 2112 is smaller than that of the second cutting surface 2111. This double cutting bevel increases the sharpness of the needle tube during cutting, which facilitates better cutting of biopsy tissue. The flexible needle tube section 220 is provided with a plurality of grooves 222 and a straight transition section 221 on both sides. The grooves are V-shaped (such as Figure 5 ) or U-shaped (such as Figure 6 ), wherein the opposite side of the groove on one side is a straight transition section, wherein the opposite side of the straight transition section on one side is a groove. This equidistant dislocation structure ensures that the connection area of ​​the same cross section of the biopsy outer needle tube is kept at the maximum, improves the breaking strength of the biopsy outer needle tube, and prevents the biopsy outer needle tube from breaking when repeatedly bent and used. At the same time, the biopsy outer needle tube has good flexibility, which reduces the friction between the biopsy outer needle tube and the stainless steel sheath when passing through the curved section 320 of the stainless steel curved sheath, thereby improving the cutting performance of the biopsy outer needle tube. The length of the needle tube flexible section 220 is not less than the length of the curved section 320, so as to ensure that the biopsy outer needle tube 200 is smoother when passing through the curved section 320 during the entire sampling process. The length of the needle tube flexible section 220 is equal to the sum of the lengths of the needle rod flexible section 130 and the sampling section 120. The needle tube support section 230 is a hollow stainless steel needle tube structure, which is sleeved on the outer surface of the biopsy needle shaft 100, and the two together provide a good support force for the biopsy sampling process.

[0017] Stainless steel curved sheath 300, such as Figure 7 As shown, the stainless steel curved sheath 300 includes a front straight section 310, a curved section 320, a rear straight section 330, a polymer component 340 and a direction indicator sheet 350, wherein the direction indicator sheet 350 includes a sheet tip 351 and a tail end 352 (see Figure 8 ), the indicated direction of the blade tip 351 is the same as the bending direction of the bending section 320, which is used to control the bending direction of the stainless steel curved sheath. The stainless steel curved sheath 300 is used to provide a channel for the biopsy needle sampling process and play a role in safety protection for the entire sampling process. The front straight section 310 is mainly used to extend into the hepatic vein to prevent the stainless steel sheath from slipping off. Its length is about 15mm-30mm. The curved section 320 is mainly used to facilitate entering the hepatic vein from the inferior vena cava to form a smooth curved biopsy channel. The length of the curved section is 15mm-40mm.

[0018] When sampling, first use the guide sheath and the stainless steel curved sheath 300 to establish the TIPS access channel, and then insert the biopsy needle into the stainless steel curved sheath 300. The biopsy needle penetrates the liver parenchyma through the stainless steel curved sheath 300. When the distal end of the biopsy needle reaches the distal end of the stainless steel curved sheath, first push the needle tip 110 and the sampling section 120 of the biopsy needle shaft 100 into the liver parenchyma, so that the tissue enters the two grooves 121 and 122 of the sampling section 120, and the biopsy outer needle tube 200 remains stationary. At this time, the needle shaft flexible section 130 of the biopsy needle shaft 100 is just at the curved section 320 of the stainless steel curved sheath 300 and crosses the curved section area, and the front end of the needle tube flexible section 220 of the biopsy outer needle tube 200 just overlaps with the front end of the needle shaft flexible section 130 of the biopsy needle shaft 100 or is slightly forward. Then, by activating the spring device on the handle of the biopsy needle, the needle tube is quickly ejected forward, and the tissue entering the sampling groove is cut and sampled. At this time, the tail end of the flexible section 220 of the biopsy outer needle tube 200 just overlaps with the tail end of the flexible section 130 of the biopsy needle shaft 100 or is slightly backward. The sampling process is as follows: Fig. 9 , Fig.10 .

[0019] The described embodiments are to be considered in all respects as illustrative only and not restrictive. Therefore, the scope of the present disclosure is indicated by the appended claims rather than by the preceding description. All changes within the equivalent meaning and scope of the claims are included within their scope. The present invention is not limited to the above-described embodiments, which does not mean that the present invention must rely on the above-described embodiments to be implemented. Those skilled in the art should understand that any improvements to the present invention, equivalent replacement of the raw materials selected by the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the scope of protection and disclosure of the present invention.

Claims

1. A highly flexible multi-groove biopsy device, characterized in that: include: A biopsy needle shaft, the biopsy needle shaft comprising a needle tip, a sampling section, a needle shaft flexible section and a needle shaft supporting section, the needle tip comprising a first bevel and a second bevel, the second bevel being arranged on the first bevel, the angle of the second bevel being greater than that of the first bevel, the sampling section comprising a first groove and a second groove, the first groove being a semicircular structure, the cross-sectional area of ​​the semicircular structure being 40%-80% of the cross-sectional area of ​​the biopsy needle shaft, the second groove being a semicircular structure, the center of the second groove coincides with the center of the first groove, the needle shaft flexible section comprising a rigid inner core, a polymer outer layer and a connecting section, the polymer outer layer being wrapped around the outer surface of the inner core, the polymer outer layer, the connecting section and the needle shaft supporting section having the same diameter; A biopsy outer needle tube, the biopsy outer needle tube comprising a cutting section, a needle tube flexible section and a needle tube supporting section, the cutting section comprising a cutting head, the cutting head comprising a first cutting surface and a second cutting surface, the angle of the first cutting surface is smaller than the angle of the second cutting surface, a plurality of grooves and a straight transition section are distributed on both sides of the needle tube flexible section, wherein the opposite side of one groove is a straight transition section, and the length of the needle tube flexible section is equal to the sum of the lengths of the needle rod flexible section and the sampling section; A stainless steel curved sheath, the stainless steel curved sheath comprising a front straight section, a curved section, a rear straight section, a polymer component and a direction indicator sheet, the direction indicator sheet comprising a sheet tip and a tail end, the indication direction of the sheet tip being the same as the bending direction of the curved section and being used to control the bending direction of the stainless steel curved sheath, the length of the needle rod flexible section being the same as the length of the curved section, and the length of the needle tube flexible section being not less than the length of the curved section.

2. A highly flexible multi-groove biopsy device according to claim 1, characterized in that: The angle of the first inclined surface is 20°-40°.

3. The highly flexible multi-groove biopsy device according to claim 1, characterized in that: The radius of the second groove is 1 / 3-2 / 3 of the radius of the first groove.

4. The highly flexible multi-groove biopsy device according to claim 1, characterized in that: The angle of the first cutting surface is 20°-60°, and the angle of the second cutting surface is 40°-80°.

5. The highly flexible multi-groove biopsy device according to claim 1, characterized in that: The material of the polymer outer layer is polytetrafluoroethylene.

6. The highly flexible multi-groove biopsy device according to claim 1, characterized in that: The groove is V-shaped or U-shaped.

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