Ultrasonic scalpel blade

Abstract

The present disclosure relates to the field of medical instruments. Provided is an ultrasonic scalpel blade, which is applied to an ultrasonic scalpel comprising a clamp. The blade comprises a connecting rod and a blade body, wherein the blade is further provided with a cutting groove, which is located in the connecting rod and extends toward the blade body; the blade body comprises a tissue shearing side, a back cutting side, a first arc side and a second arc side, the tissue shearing side being arranged opposite the back cutting side, and the first arc side being arranged opposite the second arc side; the distal end of the blade body deviates from the central axis of the connecting rod; and the back cutting side comprises a first cutting surface and a second cutting surface which form a cutting edge. In the structural arrangement, the blade has a certain curvature, so that the blade can be used in a surgical operation on human tissue having a certain curvature, and can reduce the wound and thermal injury during the surgical operation; moreover, the cutting groove and other structures in the blade can fit with curvature parameters of the blade body, such that the large-curvature blade has a stable vibration mode when working at a designed resonant frequency, thereby improving the surgical operation safety.

Description

Ultrasonic surgical blade

[0001] This application claims priority from application number 202311243079.6 filed with the China Patent Office on September 26, 2023; the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present disclosure relates to the technical field of medical devices, and in particular to an ultrasonic surgical knife head. Background Art

[0003] An ultrasonic scalpel is a surgical instrument that uses an ultrasonic transducer to generate ultrasonic vibration waves and then drive the blade to cut and coagulate human tissue. Clinically, this instrument can achieve lesion removal at a lower temperature and with less bleeding, and can ensure minimal lateral thermal damage to the tissue.

[0004] Because tissue shapes vary across different locations, the same ultrasonic scalpel tip will produce different cutting effects and thermal damage, so the same tip cannot be used to treat all tissue locations. To minimize the incision and thermal damage caused by ultrasonic scalpels during surgery, different shaped tips are used for cutting and sealing tissues in different locations.

[0005] However, since ultrasonic scalpels are driven by ultrasonic vibration waves, blade heads of different shapes, especially those with larger curvatures, will affect the overall resonant frequency and vibration mode of the ultrasonic scalpel, reducing the working stability of the ultrasonic scalpel. In addition, some tissues with larger curvatures, such as thyroid tissue, require blade heads with larger curvatures during surgery to reduce wounds and thermal damage. Therefore, there is an urgent need for an ultrasonic scalpel with improved curvature and effective length while maintaining working stability.

[0006] Summary of the Invention

[0007] The present disclosure provides an ultrasonic surgical blade head to solve the problems of unstable vibration mode and low working stability of an ultrasonic surgical blade head with a high bending curvature and a long effective length.

[0008] According to a first aspect of an embodiment of the present disclosure, there is provided an ultrasonic surgical blade head, which is applied to an ultrasonic surgical blade. The ultrasonic surgical blade includes a clamp, and the blade head includes a connecting rod and a blade head body in sequence from the proximal end to the distal end, wherein: the blade head is provided with a cutting groove, the cutting groove is located on the connecting rod and extends to the blade head body; the blade head body includes a tissue shearing side, a back cutting side, a first arc side and a second arc side, the tissue shearing side is arranged opposite to the back cutting side, and the first arc side and the second arc side are arranged opposite to each other; the tissue shearing side is used to shear tissue and / or clamp tissue in cooperation with the clamp to achieve tissue separation and hemostasis; the first arc side and the second arc side are respectively located on both sides of the tissue shearing side; the tissue shearing side is a curved surface structure, and the first arc side and the second arc side are perpendicular to the plane formed by the two side edges of the curved surface structure; the distal end of the blade head body deviates from the central axis of the connecting rod; the back cutting side includes a first cutting surface and a second cutting surface, and the first cutting surface is located between the first arc side and the second cutting surface to form a cutting edge with the second cutting surface.

[0009] A second aspect of an embodiment of the present disclosure provides an ultrasonic scalpel, comprising a clamp, and also comprising the aforementioned ultrasonic scalpel head, as well as a scalpel rod, a transducer and a sleeve, wherein: the scalpel head comprises a connecting rod and a scalpel head body, the connecting rod is arranged at the distal end of the scalpel rod, and the scalpel head body is arranged at the distal end of the connecting rod; the proximal end of the scalpel rod is connected to the transducer; the sleeve is arranged outside the scalpel rod, the proximal end of the sleeve is connected to the transducer, and the distal end of the sleeve is connected to the clamp.

[0010] The third aspect of the embodiment of the present disclosure also provides an ultrasonic surgical knife, including a clamp, the ultrasonic surgical knife head mentioned above, and a transducer, wherein: the knife head includes a connecting rod and a knife head body, and the knife head body is arranged at the distal end of the connecting rod; the proximal end of the connecting rod is connected to the transducer, and the clamp is hinged to the transducer so that the clamp and the knife head body cooperate to clamp tissue.

[0011] It can be seen from the above technical solution that the present application provides an ultrasonic surgical knife head, which is used for an ultrasonic surgical knife including a clamp, and the blade head includes a connecting rod and a blade head body in sequence from the proximal end to the distal end, wherein the blade head is provided with a cutting groove, the cutting groove is located on the connecting rod and extends toward the blade head body, and the blade head body includes a tissue shearing side, a back cutting side, a first arcuate side and a second arcuate side, the tissue shearing side is arranged opposite to the back cutting side, the first arcuate side and the second arcuate side are arranged opposite to each other, the tissue shearing side is used to shear tissue and / or clamp tissue with the clamp to achieve tissue separation and hemostasis, the first arcuate side and the second arcuate side are respectively located on both sides of the tissue shearing side, the tissue shearing side is a curved surface structure, the first arcuate side and the second arcuate side are perpendicular to the plane formed by the two side edges of the curved surface structure, the distal end of the blade head body deviates from the central axis of the connecting rod, the back cutting side includes a first cutting surface and a second cutting surface, the first cutting surface is located between the first arcuate side and the second cutting surface to form a cutting edge with the second cutting surface. Through structural settings, the blade head has a certain curvature, so that the blade head can be used in operations on human tissue with a certain curvature, reducing intraoperative wounds and thermal damage. At the same time, the grooves and other structures set on the blade head can be coordinated with the curvature parameters of the blade head body, so that when the large curvature blade head works at the designed resonant frequency, the vibration mode is stable, thereby improving surgical safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following briefly introduces the drawings required for use in the embodiments or descriptions of the prior art. Obviously, the drawings described below are only some embodiments of the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0013] FIG1 is a schematic structural diagram of an ultrasonic surgical blade head provided in accordance with an embodiment of the present disclosure at one viewing angle;

[0014] FIG2 is a schematic structural diagram of an ultrasonic surgical knife head provided in accordance with an embodiment of the present disclosure from another perspective;

[0015] FIG3 is a schematic structural diagram of a cross-section of a main body of an ultrasonic surgical blade head provided according to an embodiment of the present disclosure;

[0016] FIG4 is a bottom view of an ultrasonic surgical blade head according to an embodiment of the present disclosure;

[0017] FIG5 is a side view of an ultrasonic surgical blade head according to an embodiment of the present disclosure;

[0018] FIG6 is a schematic diagram of structural parameters of an ultrasonic surgical blade head provided according to an embodiment of the present disclosure;

[0019] FIG7 is a schematic top view of an ultrasonic surgical blade head provided according to an embodiment of the present disclosure;

[0020] FIG8 is another schematic diagram of structural parameters of an ultrasonic surgical blade head provided according to an embodiment of the present disclosure;

[0021] FIG9 is a schematic structural diagram of an ultrasonic surgical knife provided according to an embodiment of the present disclosure;

[0022] FIG10 is a schematic structural diagram of another ultrasonic surgical knife provided according to an embodiment of the present disclosure;

[0023] FIG11 is a simulated schematic diagram of an ultrasonic surgical knife head and a knife shaft according to an embodiment of the present disclosure;

[0024] FIG12 is a schematic diagram of vibration nodes of an ultrasonic surgical knife head and a knife shaft according to an embodiment of the present disclosure;

[0025] FIG13 is a schematic diagram of the amplitude of the distal end of an ultrasonic surgical blade provided according to an embodiment of the present disclosure.

[0026] Illustrations: 100- blade head; 110- connecting rod; 120- blade head body; 130- cutting groove; 121- tissue shearing side; 122- back cutting side; 123- first arcuate side; 124- second arcuate side; 1221- first cutting surface; 1222- second cutting surface; 1223- cutting edge; 1224- first transition surface; 1225- second transition surface; 200- blade rod; 300- clamp; 400- transducer; 500- cannula. DETAILED DESCRIPTION

[0027] The following will clearly describe the technical solutions in the embodiments of the present application in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on the embodiments of the present application, other embodiments obtained by ordinary technicians in this field without making any creative work are all within the scope of protection of this application.

[0028] The terms "first," "second," and "third" in this specification and claims are used to distinguish between different objects, not to limit a specific order. In the description of this application, unless otherwise specified, "at least one" means one, two, or more than two.

[0029] In the embodiments of this application, words such as "exemplary" or "for example" are used to indicate examples, illustrations, or explanations. Any embodiment or design described as "exemplary" or "for example" in the embodiments of this application should not be interpreted as being preferred or advantageous over other embodiments or designs. Rather, the use of words such as "exemplary" or "for example" is intended to present the relevant concepts in a concrete manner.

[0030] The terms used in the implementation section of this application are only used to explain the specific embodiments of this application and are not intended to limit this application. The embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0031] An ultrasonic scalpel is a surgical instrument that uses an ultrasonic transducer to generate ultrasonic vibration waves, driving the blade to cut and seal human tissue. It is used in laparoscopic minimally invasive surgery. Driven by ultrasound, the ultrasonic scalpel can rapidly cut and seal wounds, minimizing intraoperative wound and thermal damage to tissue, thereby improving surgical safety and postoperative recovery.

[0032] Because the shapes of tissues in different parts of the human body are different, the cutting effects and thermal damage caused by the same shape of ultrasonic surgical blade to tissues of different shapes are different. Therefore, the same blade cannot achieve the same therapeutic effect on all tissue parts. Therefore, in order to reduce the wounds and thermal damage caused during the operation, ultrasonic surgical blades need to use blades of different shapes when cutting and coagulating tissues in different parts.

[0033] Ultrasonic surgical blades can be categorized as gun-type ultrasonic surgical blades or scissor-type ultrasonic surgical blades, depending on the transducer and the connection method between the blade head and the transducer. Gun-type ultrasonic surgical blades have a longer blade shaft between the blade head and the transducer, while scissor-type ultrasonic surgical blades have a shorter blade shaft between the blade head and the transducer, or the blade head is directly connected to the transducer. The disclosed embodiments do not limit the type of ultrasonic surgical blade used with the blade head.

[0034] In the disclosed embodiments, an ultrasonic scalpel is required to perform surgery on tissue with a large curvature, such as the thyroid gland. In this case, a straight blade or a blade with a small curvature causes significant incision and thermal damage to the tissue, hindering postoperative recovery. A blade with a large curvature is required to minimize the incision and thermal damage caused by the surgery. However, since the ultrasonic scalpel is driven by ultrasonic vibration waves, blades of different shapes, especially those with a large curvature, can affect the overall resonant frequency and vibration mode of the ultrasonic scalpel, thereby reducing its operational stability and affecting its normal application.

[0035] It should be noted that the ultrasonic vibration waves emitted by an ultrasonic transducer are mechanical waves. Mechanical waves have the characteristic of varying wave velocity with the medium, and their wavelength is determined by both wave velocity and frequency. Therefore, the wavelength of a mechanical wave is related to the material of the ultrasonic scalpel and the frequency of the mechanical wave. The ultrasonic transducer used in an ultrasonic scalpel is handle-shaped, and the blade of the ultrasonic scalpel can be connected to the ultrasonic transducer via a blade shaft. The ultrasonic waves emitted by the ultrasonic transducer drive the blade shaft and blade head to vibrate at high frequencies. In the embodiments disclosed herein, the ultrasonic waves emitted by the ultrasonic transducer are longitudinal waves.

[0036] In some embodiments, the ultrasonic scalpel is designed to have an operating frequency of 55.6 kHz. The blade head and blade shaft of the ultrasonic scalpel are made of titanium alloy. The transmission speed of ultrasonic waves in the blade head and blade shaft is approximately 5000 m / s. Based on the relationship between the frequency, wavelength and speed of mechanical waves, it can be seen that the wavelength of ultrasonic waves in the blade head and blade shaft is approximately 90 mm.

[0037] It should be understood that the area where the ultrasonic scalpel ultimately achieves effects such as cutting and coagulation is the area from the farthest node to the antinode, which corresponds to 1 / 4 wavelength. Taking the aforementioned wavelength of 90mm as an example, 1 / 4 wavelength is 22.5mm. In order to achieve sufficient physiological effects, there must be a sufficiently large amplitude. It should be noted that the effective working length defined by the ultrasonic scalpel product is the distance between the maximum amplitude point of the farthest antinode and the point where the maximum amplitude is 50%. Therefore, based on the length of the area from the farthest node to the antinode, it can be concluded that the effective working length is 1 / 6 wavelength, which is about 15mm. The effective working length of 15mm cannot meet all surgical scenarios, so a blade with a longer effective working length is required for surgery.

[0038] In order to solve the above problems, the present disclosure proposes an ultrasonic surgical blade head, which is applied to an ultrasonic surgical blade including a clamp, so as to provide better treatment effects for human tissues with a large curvature, such as the thyroid gland. Referring to Figures 1 and 2, there are shown schematic diagrams of the structure of an ultrasonic surgical blade head in an embodiment of the present application from two different perspectives. As shown in Figures 1 and 2, the ultrasonic surgical blade head 100 includes a connecting rod 110 and a blade body 120 from the proximal end to the distal end, wherein the blade head 100 is provided with a groove 130, which is arranged on the connecting rod 110 and extends toward the blade body 120. The groove 130 can reduce the unstable vibration generated by the blade body 120 with a large curvature.

[0039] It should be understood that the distal end and the proximal end in the embodiments of the present disclosure are determined by the distance between the ultrasonic scalpel and the user during use. The end closer to the user is the proximal end, while the end farther away from the user is the distal end. The distal end and the proximal end are relative concepts, that is, the end closer to the user in the same component is the proximal end, and the end farther away from the user is the distal end. The relationship between the distal end and the proximal end of different components needs to be determined based on the arrangement of the components. For example, taking the blade head 100 and the connecting rod 110 and the blade head body 120 in the embodiment of the present application as an example, the ultrasonic scalpel blade head 100 includes the connecting rod 110 and the blade head body 120 from the proximal end to the distal end, and the proximal end of the blade head body 120 is set at the distal end of the connecting rod 110. When a blade rod is provided in the ultrasonic scalpel, the proximal end of the connecting rod 110 is set at the distal end of the blade rod, and the proximal end of the blade rod is set in the ultrasonic transducer, thereby connecting and fixing the blade rod, the blade head 100 and the ultrasonic transducer.

[0040] In some embodiments, the blade body 120 is the main component for realizing the tissue cutting and coagulation functions. In order to realize the above functions, the blade body 120 includes a tissue shearing side 121, a back cutting side 122, a first curved side 123 and a second curved side 124, wherein the tissue shearing side 121 is arranged opposite to the back cutting side 122, and the first curved side 123 is arranged opposite to the second curved side 124, that is, the first curved side 123 and the second curved side 124 are respectively located on both sides of the tissue shearing side 121 and the back cutting side 122.

[0041] For example, the tissue shearing side 121 may be a curved structure, with the first curved side 123 and the second curved side 124 both perpendicular to the plane formed by the two sides of the curved structure. It should be understood that the tissue shearing side 121 can be driven by ultrasonic vibration waves to cut diseased tissue, or it can cooperate with the clamp to clamp the cut tissue to achieve tissue separation and hemostasis.

[0042] In order to be able to perform surgery on tissue with a larger curvature and reduce the wounds and thermal damage caused during the operation, the blade 100 needs to have a larger curvature. Specifically, the distal end of the blade body 120 in the blade 100 deviates from the central axis of the connecting rod 110, that is, the blade body 120 gradually moves away from the central axis of the connecting rod 110 from the proximal end to the distal end, so that the blade 100 has a certain curvature, thereby causing less wounds and thermal damage when cutting tissue with a larger curvature, thereby improving the surgical effect. In some embodiments, the first vertical distance can be 3mm to 7mm, and the first vertical distance is the vertical distance between the distal end of the blade body 120 and the central axis of the connecting rod 110. The first vertical distance can be used to specifically limit the degree of deviation between the blade body 120 and the connecting rod 110, thereby obtaining a blade 100 with a larger curvature. In some embodiments, as shown in Figure 6, the first vertical distance can be d1.

[0043] In some embodiments, the back cutting side 122 can also cut tissue, while also balancing the overall vibration stability of the ultrasonic surgical blade head 100. As shown in Figures 3 and 4, the back cutting side 122 includes a first cutting surface 1221 and a second cutting surface 1222. The first cutting surface 1221 is located between the first curved side 123 and the second cutting surface 1222, and the second cutting surface 1222 is located between the first cutting surface 1221 and the second curved side 124. That is, the first cutting surface 1221 and the second cutting surface 1222 are adjacent to each other, thereby forming a cutting edge 1223. It should be understood that, based on the fact that the first curved side 123 and the second curved side 124 both have a certain curvature, the first cutting surface 1221 and the second cutting surface 1222 also have a certain curvature.

[0044] As shown in FIG3 , the cross-sectional structure of the blade body 120 resembles a "barn" structure with a circular bottom surface, i.e., a structure formed by a combination of a triangle and a rectangle. In the cross-sectional view, the angle formed by the two sides of the triangle that do not contact the rectangle is an obtuse angle, i.e., the cutting edge 1223 has an obtuse angle. For example, the cutting edge 1223 can have an angle of 90° to 150°, thereby providing the cutting edge 1223 with better cutting performance while reducing thermal damage to tissue caused by vibration during cutting.

[0045] Furthermore, the cutting surface length of the back-cutting side 122 is 10 mm to 14 mm, and the transition surface length of the back-cutting side 122 is 6 mm to 10 mm. The cutting surface length is the projected length of the cutting edge 1223 along the central axis of the connecting rod 110, and the transition surface length is the projected length of the first transition surface 1224 and the cutting groove 130 along the central axis of the connecting rod 110. By limiting the blade angle and cutting surface length of the cutting edge 1223, the back-cutting side 122 can meet the cutting effect required during surgery. The transition surface can increase the overall length of the cutting head 100, and combined with the overall structural design of the cutting head 100, the effective working length of the cutting head 100 is extended.

[0046] As shown in FIG5 , the length of the cutting surface in this embodiment can be L1, and the length of the transition surface can be L2. For example, L1 and L2 can be constrained by a first ratio, wherein the first ratio can be In this embodiment, the first ratio satisfies This further limits the length of the cutting surface to match the overall structural design and extend the effective working length of the cutter head 100 .

[0047] In some embodiments, in order to extend the effective working length of the cutter head 100, it is also necessary to set the length structure of the first curved side 123 and the second curved side 124 so that the structure of the cutter head body 120 can extend the effective working length of the cutter head 100. For example, the first arc length of the first curved side 123 can be 25mm~29mm. On this basis, the second arc length of the second curved side 124 can be 23mm~27mm. The length of the first curved side is 16mm~20mm, and the length of the second curved side is 15mm~19mm.

[0048] The first arcuate side length is the projected length of the first arcuate side 123 along the central axis of the connecting rod 110, and the second arcuate side length is the projected length of the second arcuate side 124 along the central axis of the connecting rod 110. By setting the arc lengths of the two arcuate sides and the projected lengths along the central axis of the connecting rod 110, the length, curvature, and other structures of the cutter head body 120 can be controlled, thereby ensuring that the cutter head 100 has a high degree of curvature while also maintaining good operational stability.

[0049] In some embodiments, the structure of the tool head body 120 can be defined by defining the relationship between the first arc length, the first arc side length, and the second arc length, the second arc side length. As shown in FIG6 , the first arc length is R1, the first arc side length is L3, the second arc length is R2, and the second arc side length is L4. For example, the difference between the ratio of R1 to L3 and the ratio of R2 to L4, i.e. The shape of the cutter head body 120 is limited by the value of .

[0050] Where R1 represents the first arc length, R2 represents the second arc length, L3 represents the length of the first arc side, and L4 represents the length of the second arc side. In some embodiments, since the blade body 120 is gradually thinner, the curvature of the second arc side 124 is different from the curvature of the first arc side 123, so that the distance between the first arc side 123 and the second arc side 124 is smaller in the direction from the proximal end to the distal end. For example, The length and curvature of the first curved side 123 and the second curved side 124 are limited. Therefore, by limiting the ratio of the arc length and projected length between the first curved side 123 and the second curved side 124, the curvature and shape of the tool head body 120 can be limited. This improves the vibration stability of the tool head 100 through the overall shape setting of the tool head 100.

[0051] It should be noted that since the effective working length and curvature of the blade head 100 are related to the wavelength and frequency of the ultrasonic waves driving the blade head 100, the above structure is intended to reduce the vibration frequency of the ultrasonic waves transmitted to the blade head 100 via the blade shaft, thereby increasing the wavelength of the ultrasonic waves at the distal end of the blade head 100 and thereby increasing the effective working length of the blade head 100. This arrangement can increase the 1 / 4 wavelength length at the distal end of the ultrasonic surgical blade to 30 mm, thereby increasing the effective working length of the blade head 100 to 20 mm.

[0052] By positioning the distal end of the blade body 120 offset from the central axis of the connecting rod 110, the blade body 120 has a defined curvature. This allows the blade head 100 to be used in surgeries involving curvatures of human tissue, minimizing intraoperative wound incision and thermal damage. The slots 130 provided on the blade head 100 coordinate with the curvature of the blade body 120, ensuring stable vibration modes when operating at the designed resonant frequency, even for blade heads with large curvatures, thereby improving surgical safety.

[0053] The presence of the cutting edge 1223 on the back cutting side 122 affects the smoothness of the transition region where the back cutting side 122 is connected to the connecting rod 110, thereby affecting the overall vibration stability of the cutter head 100. In some embodiments, as shown in FIG4 , the back cutting side 122 further includes a first transition surface 1224 and a second transition surface 1225 , wherein the first transition surface 1224 is disposed between the first cutting surface 1221 , the second transition surface 1225 , and the cutting groove 130 . Therefore, the first transition surface 1224 is a plane formed by the adjacent edges of the first cutting surface 1221 , the second transition surface 1225 , and the cutting groove 130 , providing a transition surface from the first cutting surface 1221 to the cutting groove 130 .

[0054] The second transition surface 1225 is arranged between the second cutting surface 1222, the second curved side 124 and the first transition surface 1224. It should be understood that the second transition surface 1225 is a curved surface structure and is formed by the adjacent edge lines of the second cutting surface 1222, the second curved side 124 and the first transition surface 1224. The curvature of the second transition surface 1225 is the same as the curvature of the second curved side 124 in contact with the second transition surface 1225, so that the second transition surface 1225 provides a transition surface from the second cutting surface 1222 to the connecting rod 110.

[0055] For example, the length of the cutter head body can be 15 mm to 19 mm, and the length of the connecting rod 110 can be 1 mm to 5 mm, where the length of the cutter head body is the projected length of the curved side of the cutter head body 120 along the central axis of the connecting rod 110. It should be understood that the connecting rod 110 is a straight section of the cutter head 100, i.e., a structure coaxially arranged with the cutter head in the cutter head 100. The connecting rod 110 primarily serves as a transition from the cutter rod to the cutter head 100.

[0056] The cutter head body 120 of the above-mentioned structure can make the cutter head 100 have a length greater than or equal to 15 mm in the direction of the central axis of the connecting rod 110, and then increase the effective working length of the cutter head 100 through the arc-shaped cutter head body 120. Moreover, through the above-mentioned structural setting, the cutter head 100 can improve its working stability on the basis of extending the effective working length.

[0057] By setting two transition surfaces on the back cutting side 122, the overall length of the cutter head body 120 is increased, so that the effective distance of the cutter head body 120 is closer to the far end. At the same time, the setting of the transition surface can optimize the shape of the first cutting surface 1221, the second cutting surface 1222 and the cutting edge 1223, so that the cutter head body 120 and the connecting rod 110 and the cutting groove 130 have a smooth transition, so as to reduce the bumps and concavities of the cutter head 100 and improve the vibration stability of the cutter head 100 during operation.

[0058] In some embodiments, as shown in Figure 7, in order to provide a better tissue cutting effect, the width of the blade body 120 gradually decreases from the proximal end to the distal end, wherein the width of the blade body 120 is the vertical distance between the first curved side 123 and the second curved side 124, and the width of the blade body 120 has a maximum value at the proximal end of the blade body 120 and a minimum value at the distal end of the blade body 120.

[0059] It should be understood that although the width of the cutter head body 120 gradually decreases from the proximal end to the distal end, that is, the first curved side 123 and the second curved side 124 gradually approach each other from the proximal end to the distal end, in the cross-section of the cutter head body 120, the edge line corresponding to the first curved side 123 is parallel to the edge line corresponding to the second curved side 124, thereby maintaining the shape of the cutter head 100.

[0060] For example, the width of the blade body 120 can be 0.5 mm to 3 mm. It should be noted that the above range applies to both the proximal and distal ends of the blade body 120. Because the width of the blade body 120 gradually decreases from the proximal end to the distal end, the minimum width of the proximal end of the blade body 120 is greater than or equal to the maximum width of the distal end of the blade body 120. The tapered thickness of the blade body 120 allows the distal end of the blade 100 to achieve a better cutting effect. Furthermore, during the cutting process, the smaller blade width can also reduce surgical incisions, facilitating postoperative recovery for patients.

[0061] In some embodiments, the first cross-sectional diameter of the connecting rod 110 is 2 mm to 3 mm, and the second end face width of the distal end of the cutting head body 120 is 0.5 mm to 2 mm. The first cross-sectional diameter is the cross-sectional diameter of the connecting rod 110, and the second end face width is the distal end width of the cutting head body 120. In some embodiments, as shown in FIG6 , the second end face width may be d5. Because the proximal end of the connecting rod 110 is adjacent to the proximal end of the cutting head body 120, to ensure a smooth transition between the cutting head body 120 and the connecting rod 110, the proximal end width of the cutting head body 120 may be the same as the first cross-sectional diameter, that is, the proximal end width of the cutting head body 120 may be 2 mm to 3 mm. It should be understood that if the proximal end width of the cutting head body 120 is 2 mm, the second end face width cannot be 2 mm. The second end face width may be 2 mm only when the proximal end width of the cutting head body 120 is greater than 2 mm.

[0062] Because the groove 130 in the cutting head 100 extends from the connecting rod 110 to the cutting head body 120, and the groove 130 has a certain depth, the proximal height of the cutting head body 120 is less than the proximal width of the cutting head body 120. For example, the proximal first end surface height of the cutting head body is 1.8 mm to 3 mm, and the depth of the groove 130 can be 0.2 mm to 0.4 mm. The groove 130 can balance the unstable vibration generated by the cutting edge 1223 provided on the back-cutting side 122. It should be understood that the first end surface height is the vertical distance between the tissue-cutting side 121 and the back-cutting side 122 at the proximal end of the cutting head body 120. In some embodiments, the first end surface height can be the vertical distance between the bottom end of the curved surface structure of the tissue-cutting side 121 and the first transition surface 1224.

[0063] In some embodiments, the blade body 120 gradually decreases in height as its width gradually decreases from the proximal end to the distal end. Specifically, the height of the second end surface of the distal end of the blade body 120 can be 0.5 mm to 2 mm. The second end surface height is the vertical distance between the tissue shearing side 121 and the back cutting side 122 at the distal end of the blade body. Since the back cutting side 122 at the distal end of the blade body 120 includes a cutting edge 1223, the second end surface height can also be the vertical distance between the cutting edge 1223 and the bottom end of the curved surface structure of the tissue shearing side 121. This can further limit the overall structural size of the blade 100. By having a smaller width and height at the distal end of the blade body 120, the wound caused by the blade 100 during surgery can be smaller, making the blade 100 more suitable for minimally invasive surgery.

[0064] As shown in FIG5 and FIG8, in some embodiments, the length of the cutter head body may be L5, the length of the connecting rod may be L6, the first cross-sectional diameter may be d2, the first end face height may be d3, and the second end face height may be d4. In order to ensure that the overall structure of the cutter head 100 maintains vibration stability during operation, the dimensions of L5, L6, d2, d3, and d4 have a certain relationship. For example, Due to the dimensional relationship between the structures at different positions of the cutter head 100, the overall structure of the cutter head 100 can meet the working frequency of the ultrasonic surgical knife and maintain working stability.

[0065] Based on any of the aforementioned ultrasonic surgical blade heads, as shown in Figure 9, the present disclosure also provides an ultrasonic surgical blade, including a clamp 300, and also including any of the aforementioned ultrasonic surgical blade heads 100, as well as a blade rod 200, a transducer 400 and a sleeve 500, wherein the blade head 100 includes a connecting rod 110 and a blade head body 120, the connecting rod 110 is arranged at the distal end of the blade rod 200, the blade head body 120 is arranged at the distal end of the connecting rod 110, the proximal end of the blade rod 200 is connected to the transducer 400, the sleeve 500 is sleeved on the outside of the blade rod 200, the proximal end of the sleeve 500 is connected to the transducer 400, and the distal end of the sleeve 500 is connected to the clamp 300.

[0066] The blade head 100 and the blade shaft 200 can be made of the same material and formed integrally. When replacing the blade head 100, the blade shaft 200 and the blade head 100 must be replaced together. Because the clamp 300 can cooperate with the blade head 100 for clamping, the clamp 300 is hingedly connected to the distal end of the cannula 500, allowing the clamp 300 to rotate to cooperate with the blade head 100 for operations such as clamping tissue.

[0067] Because the blade head 100 and the blade rod 200 can be made of the same material and are an integrally formed structure, through the structural limitation of the blade head 100 in the aforementioned embodiment, the blade head 100 has better processability under conditions of a larger curvature, is easy to process and obtain, and reduces the processing difficulty of the ultrasonic surgical knife.

[0068] It should be understood that the vibration stability of an ultrasonic scalpel can be evaluated by the ratio of the radial to axial vibration of the ultrasonic scalpel shaft 200. The smaller this ratio, the greater the axial component of vibration, that is, the greater the component in the shaft direction of the scalpel shaft 200, indicating higher vibration stability. Conversely, the larger the radial component of vibration, the greater the bending or torsional vibration of the scalpel shaft 200, i.e., the worse the stability. However, the blade head 100 requires a certain radial vibration component to achieve the cutting and sealing effect, so it is necessary to configure the blade head 100 as described above to achieve this.

[0069] Based on any of the aforementioned ultrasonic surgical blade heads, as shown in FIG10 , the present disclosure further provides an ultrasonic surgical blade, which is a scissor-type ultrasonic surgical blade. Specifically, the ultrasonic surgical blade includes a clamp 300, and also includes any of the aforementioned ultrasonic surgical blade heads 100 and a transducer 400, wherein the blade head 100 includes a connecting rod 110 and a blade head body 120, and the blade head body 120 is disposed at the distal end of the connecting rod 110; the proximal end of the connecting rod 110 is connected to the transducer 400, and the clamp 300 is hinged to the transducer 400 so that the clamp 300 and the blade head body 120 cooperate to clamp tissue.

[0070] Among them, the blade body 120 is directly connected to the transducer 400 through the connecting rod 110, and the clamp 300 is hinged to the shell of the transducer 400 so that the clamp 300 can rotate at a certain angle, thereby cooperating with the blade body 120 to clamp the tissue and release the clamped tissue.

[0071] In some embodiments, as shown in Figures 11 to 13, taking a gun-type ultrasonic surgical knife as an example, the structural features of the ultrasonic surgical knife can be verified by modeling and simulation. For example, as shown in Figure 11, through the embodiment of the aforementioned blade head 100, a blade head 100 with a first arc length of 27 mm, a second arc length of 25 mm, a first arc side length of 18 mm, a second arc side length of 17 mm, a cutting surface length of 12 mm, a transition surface length of 8 mm, a blade head body length of 17 mm, a connecting rod length of 3 mm, a first vertical distance of 5.5 mm, a first cross-sectional diameter of 2.6 mm, a first end face height of 2.3 mm, a second end face height of 1 mm, and a second end face width of 1 mm can be constructed. The blade head 100 is combined with a blade shaft 200 to form a blade shaft 200 and a blade head 100 of an ultrasonic surgical knife with a total length of 100 mm.

[0072] As shown in Figure 12, to ensure better vibration stability for the ultrasonic surgical scalpel, the point where the proximal end of the shank 200 connects to the transducer 400 is the vibration antinode, also known as the third antinode. The distal end of the blade head 100 is also the vibration antinode, also known as the first antinode, where the amplitude is maximum. The points between the two, from distal to proximal, are the first node, the second antinode, and the second node, respectively. It should be understood that the third antinode is the antinode with the smallest amplitude, and the vibration of the shank 200 and blade head 100 is gradually amplified from proximal to distal.

[0073] In this embodiment, the perpendicular plane between the proximal antinode and the central axis serves as the proximal connection plane and serves as the reference plane for simulation of the shank 200 and the blade head 100. For ease of description, a three-dimensional coordinate system is established, as shown in Figure 11. The Y-axis is the axis of the shank 200; the X-axis is perpendicular to the shank 200, i.e., the radial direction of the shank 200, and the X-axis is aligned with the bending direction of the blade head 100; and the Z-axis is perpendicular to the plane formed by the X- and Y-axes. Vibration morphology analysis of the shank 200 and the blade head 100 reveals the average vibration amplitude along the Y- and X-axes on the proximal end face of the shank 200. As shown in Figure 13, the amplitude ratio of the ultrasonic surgical blade in this embodiment at the distal end of the blade head 200 is approximately X / Y = 1 / 1.2. At the antinode of the proximal end face of the shank 200, the amplitude ratio is approximately X / Y = 1 / 200.

[0074] In the entire vibration morphology analysis of the blade head 100 and blade shaft 200 in this embodiment, only axial vibration occurs at any position on the shaft, and its radial amplitude does not change with changes in the ultrasonic waveform. Even in the antinode area where the vibration amplitude is relatively large, the radial vibration ratio is still less than 1%, which is negligible. Traditional ultrasonic scalpels are different. The radial amplitude on their blade shaft fluctuates with the ultrasonic waveform, and the areas on the blade shaft with larger vibration amplitudes have relatively high radial vibration and poor stability. Therefore, the design structure in the embodiment can improve the vibration stability of the blade shaft 200 and increase the radial amplitude on the blade head 100. In addition, the ultrasonic scalpel shown in the embodiment can reduce the impact of the high radial amplitude of the blade head 100 on the vibration stability of the blade shaft 200 on the basis of having good treatment effects, thereby improving the overall operational stability of the ultrasonic scalpel.

[0075] As can be seen from the above technical solutions, the present disclosure provides an ultrasonic surgical blade head, which is applied to an ultrasonic surgical blade including a clamp 300. The blade head 100 includes a connecting rod 110 and a blade head body 120 from the proximal end to the distal end, wherein the blade head 100 is provided with a cutting groove 130, the cutting groove 130 is located on the connecting rod 110 and extends to the blade head body 120, and the blade head body 120 includes a tissue shearing side 121, a back cutting side 122, a first curved side 123 and a second curved side 124, the tissue shearing side 121 is arranged opposite to the back cutting side 122, the first curved side 123 and the second curved side 124 are arranged opposite to each other, and the tissue shearing side 121 is used to shear tissue. And / or cooperate with the clamp 300 to clamp tissue to achieve tissue separation and hemostasis, the first arcuate side 123 and the second arcuate side 124 are respectively located on both sides of the tissue shearing side 121, the tissue shearing side 121 is a curved surface structure, the first arcuate side 123 and the second arcuate side 124 are perpendicular to the plane formed by the two side edges of the curved surface structure, the distal end of the blade body 120 deviates from the central axis of the connecting rod 110, the back cutting side 122 includes a first cutting surface 1221 and a second cutting surface 1222, the first cutting surface 1221 is located between the first arcuate side 123 and the second cutting surface 1222 to form a cutting edge 1223 with the second cutting surface 1222. Through structural settings, the blade head 100 has a certain curvature, so that the blade head 100 can be used in surgeries on human tissue with a certain curvature, reducing wounds and thermal damage during surgery. At the same time, the cutting grooves 130 and other structures set on the blade head 100 can be coordinated with the curvature parameters of the blade head body 120, so that when the large-curvature blade head 100 operates at the designed resonant frequency, the vibration mode is stable, thereby improving surgical safety.

[0076] Similar parts between the embodiments provided in this application can be referenced to each other. The specific implementation methods provided above are only a few examples under the overall concept of this application and do not constitute a limitation on the scope of protection of this application. For those skilled in the art, any other implementation methods expanded based on the scheme of this application without expending creative work shall fall within the scope of protection of this application.

Claims

1. An ultrasonic surgical knife head, applied to an ultrasonic surgical knife, the ultrasonic surgical knife comprises a clamp, the head comprises a connecting rod and a head body from the proximal end to the distal end, wherein: The cutter head is provided with a cutting groove, the cutting groove is located on the connecting rod and extends to the cutter head body; The blade body comprises a tissue shearing side, a back cutting side, a first arcuate side and a second arcuate side, wherein the tissue shearing side is arranged opposite to the back cutting side, and the first arcuate side and the second arcuate side are arranged opposite to each other; the tissue shearing side is used for shearing tissue and / or cooperating with the clamp to clamp tissue to achieve tissue separation and hemostasis; The first arcuate side and the second arcuate side are respectively located on both sides of the tissue shearing side; the tissue shearing side is a curved surface structure, and the first arcuate side and the second arcuate side are perpendicular to the plane formed by the two side edges of the curved surface structure; the distal end of the blade body deviates from the central axis of the connecting rod; The back-cut side includes a first cutting surface and a second cutting surface, wherein the first cutting surface is located between the first arc-shaped side and the second cutting surface, and the second cutting surface is located between the first cutting surface and the second arc-shaped side, and the first cutting surface and the second cutting surface form a cutting edge.

2. The ultrasonic surgical blade head according to claim 1, wherein: The back-cut side also includes a first transition surface and a second transition surface; The first transition surface is arranged between the first cutting surface, the second transition surface and the cutting groove, and the first transition surface is a plane formed by the first cutting surface, the second transition surface and the cutting groove; The second transition surface is arranged between the second cutting surface, the second curved side and the first transition surface. The second transition surface is an arc surface formed by the second cutting surface, the second curved side and the first transition surface. The curvature of the second transition surface is the same as the curvature of the second curved side.

3. The ultrasonic surgical blade head according to claim 2, wherein: The cutting edge has an angle of 90° to 150°, the cutting surface length of the back-cut side is 10mm to 14mm, and the transition surface length of the back-cut side is 6mm to 10mm; the cutting surface length is the projection length of the cutting edge in the direction of the central axis of the connecting rod, and the transition surface length is the projection length of the first transition surface and the cutting groove in the direction of the central axis of the connecting rod.

4. The ultrasonic surgical blade head according to claim 3, wherein: Wherein, L1 represents the length of the cutting surface, and L2 represents the length of the transition surface.

5. The ultrasonic surgical blade head according to claim 1, wherein: The width of the cutter head body is the vertical distance between the first arc-shaped side and the second arc-shaped side, and the width of the cutter head body is 0.5 mm to 3 mm; the width of the cutter head body has a maximum value at the proximal end of the cutter head body and a minimum value at the distal end of the cutter head body, and the width of the cutter head body gradually decreases from the proximal end to the distal end of the cutter head body; The first arc length of the first arc side is 25mm~29mm, and the second arc length of the second arc side is 23mm~27mm; the first vertical distance is 3mm~7mm; the length of the first arc side is 16mm~20mm, and the length of the second arc side is 15mm~19mm; the first vertical distance is the vertical distance between the distal end of the blade body and the central axis of the connecting rod, the length of the first arc side is the projection length of the first arc side in the direction of the central axis of the connecting rod, and the length of the second arc side is the projection length of the second arc side in the direction of the central axis of the connecting rod.

6. The ultrasonic surgical blade head according to claim 5, wherein: Wherein, R1 represents the first arc length, R2 represents the second arc length, L3 represents the first arc side length, L4 represents Table Length of the second arc side.

7. The ultrasonic surgical blade head according to claim 5, wherein: The length of the cutter head body is 15mm-19mm, and the length of the connecting rod is 1mm-5mm; the length of the cutter head body is the projection length of the arc side of the cutter head body in the direction of the central axis of the connecting rod.

8. The ultrasonic surgical blade head according to claim 7, wherein: The first cross-sectional diameter of the connecting rod is 2 mm to 3 mm, the first end surface height of the proximal end of the cutter head body is 1.8 mm to 3 mm, the second end surface height of the distal end of the cutter head body is 0.5 mm to 2 mm, and the second end surface width of the distal end of the cutter head body is 0.5 mm to 2 mm; Among them, the first cross-sectional diameter is the diameter of the cross-section of the connecting rod, the first end face height is the vertical distance between the tissue shearing side and the back-cutting side at the proximal position of the blade body, the second end face height is the vertical distance between the tissue shearing side and the back-cutting side at the distal position of the blade body, and the second end face width is the distal width of the blade body.

9. The ultrasonic surgical knife head according to claim 8, characterized in that: Among them, L5 represents the length of the tool head body, L6 represents the length of the connecting rod, d2 represents the first cross-sectional diameter, d3 represents the first end surface height, and d4 represents the second end surface height.

10. An ultrasonic surgical knife, comprising a clamp, and also comprising an ultrasonic surgical knife head as claimed in any one of claims 1 to 9, and a knife rod, a transducer and a sleeve, wherein: The cutter head comprises a connecting rod and a cutter head body, wherein the connecting rod is arranged at the distal end of the cutter rod, and the cutter head body is arranged at the distal end of the connecting rod; The proximal end of the knife rod is connected to the transducer; the sleeve is sleeved outside the knife rod, the proximal end of the sleeve is connected to the transducer, and the distal end of the sleeve is connected to the clamp.

11. An ultrasonic surgical knife, comprising a clamp, an ultrasonic surgical knife head as claimed in any one of claims 1 to 9, and a transducer, wherein: The cutter head comprises a connecting rod and a cutter head body, wherein the cutter head body is arranged at the distal end of the connecting rod; The proximal end of the connecting rod is connected to the transducer, and the clamp is hinged to the transducer so that the clamp cooperates with the cutter head body to clamp tissue.

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