CN115120309A

CN115120309A - Ultrasonic surgical scalpel

Info

Publication number: CN115120309A
Application number: CN202111435825.2A
Authority: CN
Inventors: 邓荣海; 张学刚; 左鹏飞
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Priority date: 2021-03-29
Filing date: 2021-11-29
Publication date: 2022-09-30
Also published as: CN217408913U

Abstract

An ultrasonic surgical blade having a blade tip portion including a tissue treatment portion and a back cutting portion. The tissue processing part and the back cutting part are oppositely arranged on two sides of the middle shaft of the knife tip along the longitudinal direction. In the structure of the tool nose, along the direction extending from the far end or the near end of the tool nose to the near end, the topology of the cross section is kept unchanged, and the geometric shape is continuously changed, so that the tool nose has no folding surface structure with cusp change in the longitudinal direction, and the longitudinal section is continuously contracted, thereby avoiding the stress from being excessively concentrated at the cusp change part of the tool nose and reducing the risk of the breakage of the tool nose.

Description

Ultrasonic surgical scalpel

Technical Field

The application relates to the field of medical equipment, in particular to an ultrasonic surgical scalpel structure.

Background

The application principle of the ultrasonic scalpel is that electric energy is converted into mechanical vibration through the transducer, and the vibration is transmitted to the scalpel tip through the waveguide rod, so that the scalpel tip generates mechanical oscillation, and the cutting and blood coagulation effects on animal or human tissues are achieved. The ultrasonic scalpel has the advantages of high cutting precision, less bleeding, less thermal injury and the like, and is widely applied to surgical operations.

During cutting and coagulation with a typical ultrasonic blade, the blade tip portion directly contacts animal or human tissue and transmits vibrational energy from the transducer to the target tissue region through force. In the process, the tool nose is limited by the structure of the tool nose, and often bears certain reaction force, the stress of the part of the tool nose is concentrated along with the accumulation of time, and the tool nose is easily broken under the condition that the stress at the tool nose cannot be eliminated in time, so that the smooth operation of the surgical process is influenced. Among them, the stress concentration problem at the back cutting edge of the knife tip is the most prominent.

Disclosure of Invention

The present application mainly provides an ultrasonic surgical knife, and above-mentioned ultrasonic surgical knife can effectively prevent the stress concentration on the knife tip to reduce the cracked risk of knife tip.

In accordance with the above purposes, there is provided in one embodiment an ultrasonic surgical blade including a blade tip for directly engaging a tissue object and a waveguide rod for transmitting vibrations to the blade tip, the blade tip having a proximal end and a distal end, the blade tip being connected to the waveguide rod at the proximal end and curving away from the waveguide rod in a longitudinal direction to extend to the distal end,

the main body of the knife tip is provided with a tissue processing part and a back cutting part, and the tissue processing part and the back cutting part are oppositely arranged on two sides of a central axis of the knife tip along the longitudinal direction;

the knife tip at least comprises a first symmetrical or approximately symmetrical V-shaped structure and a second symmetrical or approximately symmetrical V-shaped structure on a cross section which is close to the far end and is vertical to the longitudinal direction of the knife tip; the first V-shaped structure is the outer contour of the tissue treatment part on the cross section, and the second V-shaped structure is the outer contour of the back cutting part on the cross section;

the cross section of the far end or the near end is a polygon, the cross section of the position, connected with the waveguide rod, of the near end is any one or a combination of more than two of a circle, an approximate circle and a polygon, and the topology of the cross section is kept unchanged and the geometric shape is continuously changed along the direction extending from the far end or the near end of the tool nose to the near end.

In one embodiment, the cross-section boundary curve has a continuity of not less than one order and the derivative of the shape of the cross-section has a continuity of not less than one order on the tip.

In one embodiment, the tissue treatment part has a tissue treatment surface formed by one or more of a cusp, a curved surface and a plane, wherein the bottom bulge of the first V-shaped structure is a corresponding outer contour of the tissue treatment surface in the cross section;

the back cutting part is provided with a back cutting surface formed by one or more structures of a pointed protrusion, a curved surface and a plane in a continuous smooth transition along the longitudinal direction, and the bottom of the second V-shaped structure protrudes to form a corresponding outer contour of the back cutting surface on the cross section;

the first V-shaped structure and the second V-shaped structure are arranged on the cross section in a central symmetry mode or an approximately central symmetry mode, or the first V-shaped structure and the second V-shaped structure are arranged on the cross section in an axial symmetry mode or an approximately axial symmetry mode.

In one embodiment, the knife tip is further provided with a side part, the side part is arranged between the tissue processing part and the back cutting part, and the side part, the tissue processing part and the back cutting part are in continuous smooth transition on the outer circumferential surface of the knife tip along the longitudinal direction, so that the boundary curve of the cross section of the knife tip in the direction perpendicular to the longitudinal direction has continuity not less than one order.

In one embodiment, the blade tip is further provided with at least two side portions, the side portions being respectively disposed between the tissue treatment portion and the back cutting portion, such that the tissue treatment portion and the back cutting portion are not adjacent to each other on the outer periphery of the blade tip; and on the cross section of the tool nose, the outer profiles of two side parts correspondingly formed by the side parts are symmetrically or approximately symmetrically arranged, and the pair is called as axial symmetry or central symmetry.

In one embodiment, the outer contour of the side part on the cross section is one or a combination of a straight line and a curved broken line;

on the cross section, the corresponding outer contour of the tissue processing part is connected with the outer contour of any one adjacent side part through a curve or a straight line in a continuous and smooth transition manner; the corresponding outer contour of the back cutting part is connected with the outer contour of any one adjacent side part through a curve or straight line in a continuous and smooth transition mode, so that the cross section boundary curve corresponding to the cross section has continuity not less than one order.

In one embodiment, the tissue treatment portion is provided with a first curved surface which is curved along the peripheral direction of the knife tip and extends along the longitudinal direction of the knife tip, and the width of the first curved surface in the peripheral direction of the knife tip gradually increases or gradually decreases or regularly changes from the distal end side to the proximal end side.

In one embodiment, the back cutting edge includes a pointed edge and/or a curved edge, the pointed edge has a pointed edge structure, the curved edge has a second curved surface which is curved along the peripheral direction of the tip and extends along the longitudinal direction of the tip, and the width of the second curved surface in the peripheral direction gradually decreases or changes regularly from the distal end side to the proximal end side.

In one embodiment, the distal end is provided with a spherical structure, and the radius of curvature of the spherical structure is not smaller than the radius of an inscribed circle of the cross section of the end of the tool tip at the distal end.

In one embodiment, the blade tip extends from the proximal end to the distal end in a direction away from the waveguide rod axis and then in a direction closer to the waveguide rod axis.

In one embodiment, the tissue treatment section and/or the back cut section is provided with a first material layer having a surface energy less than the surface energy of the substrate comprising the body of the tip.

In one embodiment, a second material layer is disposed on at least one of the tissue treatment portion, the dorsal cutting portion and the lateral portion, the second material layer having a surface energy greater than the first material layer and a hardness greater than the first material layer.

In one embodiment, the first material layer does not overlap, partially overlaps, or completely overlaps the second material layer, and the first material layer or the second material layer is conductive.

In accordance with the above purposes, there is provided in one embodiment an ultrasonic surgical blade comprising a blade tip for directly engaging a tissue object, and a waveguide rod for transmitting vibrations to the blade tip, the blade tip having a proximal end and a distal end, the blade tip being connected to the waveguide rod at the proximal end and curving away from the waveguide rod in a longitudinal direction to extend to the distal end,

the knife tip at least comprises a first V-shaped structure which is symmetrical or approximately symmetrical and a second V-shaped structure which is symmetrical or approximately symmetrical on a cross section which is close to the far end and perpendicular to the longitudinal direction of the knife tip; the first V-shaped structure is the outer contour of the tissue treatment part on the cross section, and the second V-shaped structure is the outer contour of the back cutting part on the cross section;

the cross section of the far end or the near and far end is a polygon, and the cross section of the connecting position of the near end and the waveguide rod is any one of or the combination of more than two of a circle, an approximate circle and a polygon; the resulting profile through the waveguide rod along the longitudinal axis has a topology that remains constant and a geometry that varies continuously in a direction around the axis.

In one embodiment, on the nose, a section line along the longitudinal direction corresponding to the section plane has a continuity of not less than one order, and a shape derivative of the section plane has a continuity of not less than one order.

In one embodiment, the knife tip is further provided with a side part, the side part is arranged between the tissue processing part and the back cutting part, and the side part, the tissue processing part and the back cutting part are in continuous smooth transition on the outer circumferential surface of the knife tip along the longitudinal direction, so that the boundary curve of the cross section of the knife tip in the direction perpendicular to the longitudinal direction has continuity of not less than one order, and the section obtained by passing through the axis of the wave guide rod along the longitudinal direction has continuity of not less than one order on the outer contour along the longitudinal direction.

In one embodiment, the blade tip is further provided with at least two side portions, the side portions being respectively disposed between the tissue treatment portion and the back cutting portion, such that the tissue treatment portion and the back cutting portion are not adjacent to each other on the outer periphery of the blade tip; and on the cross section of the tool nose, the two side section lines correspondingly formed by the side parts are symmetrically or approximately symmetrically arranged, and the pair is called as axial symmetry or central symmetry.

In one embodiment, the tissue treatment portion is provided with a first curved surface which is curved along the peripheral direction of the knife tip and extends longitudinally along the knife tip, and the width of the first curved surface in the peripheral direction of the knife tip is gradually increased or gradually reduced or regularly changed from the far end side to the near end side.

In one embodiment, the tip extends from the proximal end to the distal end in a direction away from the waveguide rod axis and then in a direction toward the waveguide rod axis.

In one embodiment, the tissue treatment section and/or the back cutting section is provided with a first material layer having a surface energy smaller than that of a substrate constituting the blade tip body.

According to the ultrasonic surgical blade of the above embodiment, the blade tip portion includes the tissue processing portion and the back cutting portion. The tissue processing part and the back cutting part are oppositely arranged on two sides of the middle shaft of the knife tip along the longitudinal direction. In the tool nose structure, along the direction extending from the far end or the near end of the tool nose to the near end, the topology of the cross section is kept unchanged, and the geometric shape is continuously changed, so that the tool nose has no folding surface structure with tip change in the longitudinal direction, and the longitudinal section is continuously contracted, thereby avoiding the stress from being excessively concentrated at the tip change part of the tool nose and reducing the risk of breakage of the tool nose.

Drawings

FIG. 1 is a schematic view of the structure of the blade tip (tissue treatment facing upwards) of an ultrasonic surgical blade according to an embodiment of the present disclosure;

FIG. 2 is a schematic cross-sectional view of several different locations in the structure of FIG. 1;

FIG. 3 is a schematic view of the structure of the point of an ultrasonic surgical blade (back cut facing upwards) according to an embodiment of the present disclosure;

FIG. 4 is a schematic cross-sectional view of several different locations in the structure of FIG. 3;

FIG. 5 is a schematic view of the structure of the blade tip (tissue treatment facing upwards) of an ultrasonic surgical blade according to an embodiment of the present disclosure;

FIG. 6 is a schematic cross-sectional view of several different locations in the structure of FIG. 5;

FIG. 7 is a schematic view of the structure of the point of the ultrasonic surgical blade (back cut facing upwards) according to an embodiment of the present disclosure;

FIG. 8 is a schematic cross-sectional view of several different locations in the structure of FIG. 7;

FIG. 9 is a cross-sectional view of a tip of an ultrasonic surgical blade according to an embodiment of the present disclosure;

FIG. 10 is a cross-sectional view of a blade tip of an ultrasonic surgical blade in accordance with an embodiment of the present application;

figures 11 through 13 are top, side and bottom views of a tip in one embodiment of the present application;

figures 14 and 15 are perspective views of the tip shown in figures 11 to 13;

FIG. 16 is a schematic view of the construction of a tip and waveguide rod in an embodiment of the present application;

FIG. 17 illustrates a handle of an ultrasonic surgical blade of an embodiment of the present application;

FIG. 18 is a schematic view of an ultrasonic surgical blade according to an embodiment of the present application;

FIG. 19 is a schematic view of an ultrasonic blade system according to an embodiment of the present application.

Detailed Description

The present invention will be described in further detail with reference to the following detailed description and accompanying drawings. Wherein like elements in different embodiments are numbered with like associated elements. In the following description, numerous details are set forth in order to provide a better understanding of the present application. However, one skilled in the art will readily recognize that some of the features may be omitted or replaced with other elements, materials, methods in different instances. In some instances, certain operations related to the present application have not been shown or described in detail in order to avoid obscuring the core of the present application from excessive description, and it is not necessary for those skilled in the art to describe these operations in detail, so that they may be fully understood from the description in the specification and the general knowledge in the art.

Furthermore, the features, operations, or characteristics described in the specification may be combined in any suitable manner to form various embodiments. Also, the various steps or actions in the method descriptions may be transposed or transposed in order, as will be apparent to one of ordinary skill in the art. Thus, the various sequences in the specification and drawings are for the purpose of describing certain embodiments only and are not intended to imply a required sequence unless otherwise indicated where such sequence must be followed.

The numbering of the components as such, e.g., "first", "second", etc., is used herein only to distinguish the objects as described, and does not have any sequential or technical meaning. The term "connected" and "coupled" when used in this application, unless otherwise indicated, includes both direct and indirect connections (couplings).

The present application provides an ultrasonic blade system, and in particular, an improvement in the blade tip portion of an ultrasonic surgical blade in an ultrasonic blade system. The ultrasonic scalpel system can convert electric energy into mechanical vibration, and the vibration is transmitted to the scalpel tip through the waveguide rod, so that the scalpel tip generates mechanical oscillation, and the cutting and blood coagulation effects on animal or human tissues are achieved. It should be noted that the blade tip and the waveguide rod mentioned in the embodiments of the present application are generally an integral structure, and the description of the "blade tip" is only used as a description of a specific part of the waveguide rod, and should not be regarded as a change or limitation of the waveguide rod structure.

In the design of the knife tip of a common ultrasonic surgical knife, the most common is that the middle section of the cross-sectional area of the knife tip part from the near end to the far end and the vertical axis (along the extending direction of the waveguide rod, also called the longitudinal direction) is suddenly changed, so that the stress concentration at the position of the suddenly changed cross-sectional area is caused, and the problem of knife rod fracture is easily caused. Where proximal end is defined as the end near the handle of the ultrasonic surgical blade and distal end is defined as the end of the handle of the principle ultrasonic scalpel instrument.

Referring to fig. 1 to 16, the present embodiment provides an ultrasonic surgical blade including a blade tip 100 and a waveguide rod 200 for transmitting vibration to the blade tip 100. The tip 100 is in the form of a strip, the tip 100 having a proximal end 101 for connection to a waveguide rod and a distal end 102 opposite the proximal end 101, the tip 100 being connected to the waveguide rod 200 at the proximal end 101 and curving away from the waveguide rod 200 in a longitudinal direction to extend to the distal end 102. The knife tip 100 includes a tissue processing portion 110 and a back cutting portion 120, and the tissue processing portion 110 and the back cutting portion 120 are disposed opposite to each other on both sides of a central axis of the knife tip 100 in the longitudinal direction.

In one embodiment, the tissue treatment section 110, the back cut section 120, and the side section 130 connected between the tissue treatment section 110 and the back cut section 120. Alternatively, in other embodiments, the side portion 130 may be omitted such that the tissue treating section 110 is directly connected to the back cut section 120, e.g., as shown in fig. 10, the lower end of the tissue treating section 110 is directly connected to the upper end of the back cut section 120.

The tissue treatment section 110 is used for cutting and coagulating operations, for example, as shown in fig. 16, the knife tip 100 forms a jaw space by cooperating with the holding arm 400, the jaw space can hold tissue, organ or other parts of animal or human body, and the tissue treatment section 110 directly acts on the tissue to perform cutting or coagulating operations. The movement of the clamp arm 400 may be controlled by the clamp assembly 300 or other structure in the handle 1000 of the ultrasonic surgical blade.

In one embodiment, shown in FIG. 3 is a perspective view of a tip in which the tissue treating section 110 is disposed away from the back-cutting section 120, the back-cutting section 120 having a back-cutting edge 121, the back-cutting edge 121 extending longitudinally from the distal end 102 to the proximal end 101 of the tip 100 forming a blade-like structure. The back cutting edge 121 can also be used to cut tissue, organs or other parts of an animal or human body under the operation of a user. However, when the back cutting edge 121 is used to perform a cutting operation, stress concentration is likely to occur, which may easily cause the breakage of the cutting edge due to the stress at the back cutting edge 121 exceeding the upper limit that the ultrasonic surgical blade can bear, and particularly, the stress concentration at the middle region of the back cutting edge 121 is more severe, which is a place where the breakage probability of the back cutting edge 121 is the greatest.

In order to solve the above problems, the present application provides an ultrasonic surgical blade having a continuous smooth transition at the outer surface of the blade tip, which is continuously and smoothly transitioned along the longitudinal extension direction of the blade tip 100 and further continuously and smoothly transitioned at the periphery perpendicular to the longitudinal extension direction of the blade tip 100 as shown in fig. 3, so that the risk of blade tip fracture caused by stress concentration on the blade tip 100 can be effectively reduced, and the working efficiency of the ultrasonic blade can be effectively improved due to the design of the continuous and smooth transition surface structure at each position.

In one embodiment, the tip 100 comprises, at least in a cross-section taken near the distal end 102 and perpendicular to the longitudinal direction of the tip 100, a first type of symmetrical or approximately symmetrical V-shaped structure and a second type of symmetrical or approximately symmetrical V-shaped structure. Referring to fig. 9 and 10, the first type of V-shaped configuration is the outer contour of the tissue treatment section 110 in cross-section, and the second type of V-shaped configuration is the outer contour of the back cut section 120 in cross-section. Wherein the symmetry or approximate pair described herein is referred to as axial symmetry or central symmetry.

The cross section of the distal end 102 or the proximal end (a part close to the distal end 102) is a polygon, the cross section of the position where the proximal end 101 is connected with the waveguide rod 200 is any one or a combination of two of a circle, an approximate circle and a polygon, and along the direction extending from the distal end 102 or the proximal end to the proximal end 101 of the blade tip 100, the topology of the cross section is kept unchanged, and the geometric shape is continuously changed. The continuous change of the geometric shape means that the derivative on the longitudinal section line is continuous, so that the outer contour along the longitudinal smooth transition is formed.

In a more specific embodiment, the cross-section boundary curve has a continuity of not less than one order and the derivative of the shape of the cross-section has a continuity of not less than one order when the topology of the cross-section remains the same and the geometry changes continuously at the tip 100.

Alternatively, the topology of the cross-section remains constant and the geometry changes continuously with respect to the embodiment along the direction extending from the distal end 102 or proximal end to the proximal end 101 of the tip 100. In another embodiment, the profile obtained through the wave guide rod 200 along the longitudinal axis has a topology that remains constant and a geometry that changes continuously in the direction around the axis, so that the outer peripheral profile of the tip 100 is in a continuous smooth transition.

In a more specific embodiment, the section line corresponding to the section plane along the longitudinal direction on the tip 100 has a continuity of not less than one order, and the shape derivative of the section plane has a continuity of not less than one order.

Here, the transverse direction in this embodiment means a direction perpendicular to the longitudinal direction, and the cross section is a cross section obtained by cutting the cutting edge 100 in a direction perpendicular to the longitudinal direction (axial direction) (i.e., transverse direction), and may also be referred to as a radial cross section of the cutting edge.

Further, referring to fig. 1-16, in one embodiment, the tissue treatment portion 110 has a tissue treatment surface 111 formed by one or more of a cusp, a curved surface and a flat surface continuously and smoothly transitioning in a longitudinal direction, and the bottom of the first V-shaped structure is convex and has a corresponding outer contour of the tissue treatment surface 111 in cross section.

The back-cut portion 120 has a back-cutting edge 121 formed by one or more of a pointed protrusion, a curved surface and a flat surface which are continuously and smoothly transited along the longitudinal direction, and the bottom of the second type of V-shaped structure is protruded to be a corresponding outer contour of the back-cutting edge 121 in cross section.

The first V-shaped structure and the second V-shaped structure are arranged in a central symmetry manner or an approximately central symmetry manner on the cross section, or the first V-shaped structure and the second V-shaped structure are arranged in an axial symmetry manner or an approximately axial symmetry manner on the cross section.

Wherein, the V-shaped structure is a structure similar to V shape, which comprises a bottom part protruding to one side and two extending parts protruding to the other side.

Further, in an embodiment, the relief cutting edge 121 transitions smoothly at least in a central region in the longitudinal extension direction, preferably the relief cutting edge 121 transitions smoothly from the proximal end to the distal end. The smooth transition is a folding surface (e.g., a sharp or obtuse pointed shape) without sharp deformation in the longitudinal extension direction, and there is no abrupt position, which includes but is not limited to a smooth transition, a planar transition, a prismatic transition (e.g., a knife-edge-like longitudinal extension), and the like, such as a tangent at the joint between adjacent curved surfaces or curves, so that the longitudinal cross-sectional dimension on the tip 100 can be gradually changed. For the pointed structure on the back cutting edge of the prior art, the smooth transition of the back cutting edge 121 can reduce the sudden change of the section size and cause the local increase of stress, and the stress generated in the use process of the ultrasonic surgical knife can be distributed to each longitudinal position of the back cutting edge 121, so that the stress is prevented from being excessively concentrated in the middle area of the back cutting edge 121, and the risk of breakage of the middle area of the back cutting edge 121 is reduced.

Wherein the middle region refers to the portion of the back cutting edge 121 where the stress is most concentrated at the middle position. Referring to fig. 3 and 7, in one embodiment, the back cutting edge 121 is a middle region from one third of the distal end 102 to two thirds of the distal end 102. The middle region is distal in one third of the region near the distal end 102 of the tip 100 and proximal in one third of the region near the proximal end 101 of the tip 100. Of course, in other embodiments, the distal region, the middle region, and the proximal region may be sized differently, for example, the middle region may have a greater or lesser length in the longitudinal direction than the distal region and/or the proximal region, which may be flexibly set depending on the particular configuration, length, shape, etc. of the tip 100.

In an embodiment, considering that the stress concentration phenomenon is also severe at the connection position between the blade tip 100 and the waveguide rod 200, especially, the region of the back cutting edge 121 corresponding to the connection position (e.g., a portion of the proximal region close to the connection portion 201 in fig. 5) is also prone to be broken due to the stress concentration, so referring to fig. 3 and 7, in an embodiment, the region of the back cutting edge 121 from at least one third of the distance from the distal end 102 to the proximal end 101 is smoothly transited in the longitudinal direction, that is, the central region and the proximal region of the back cutting edge 121 are smoothly transited in the longitudinal direction, so as to disperse the stress in these regions of the back cutting edge 121 and avoid the stress concentration.

In another embodiment, referring to fig. 3-7, the entire outer wall of the relief cutting edge 121 may also be smoothly transitioned in the longitudinal direction. Thus, the entire relief cutting edge 121 can be configured to disperse stress, and further avoid the problem of stress concentration. For the smooth transition area on the back cutting edge 121, no specific limitation is made in the embodiment of the present application, and the back cutting edge 121 smoothly transitioning from the proximal end to the distal end can enable the radial section of the tool nose 101 from the proximal end to the distal end to be continuously tapered, so that stress concentration caused by section change can be effectively avoided.

Further, in the conventional design of the lancet tip 100, since the function of the back cutting edge 121 includes cutting, which requires a relatively small contact surface for cutting tissue, the back cutting edge 121 is generally designed to be a single edge or a small surface, and the middle section of the back cutting edge 121 is the most stressed area for cutting in practical use. When the back cutting edge 121 is an edge at the position where the stress is the largest, the middle area of the back cutting edge 121 is more prone to generate stress concentration, and the probability of breakage of the tool nose 101 is greatly improved.

In order to solve this problem, in one embodiment of the present invention, the tissue treatment section 110 is provided with a first curved surface which is curved along the peripheral direction of the cutting tip 100 and extends along the longitudinal direction of the cutting tip 100, and the width of the first curved surface in the peripheral direction of the cutting tip 100 gradually increases or gradually decreases or changes regularly from the distal end 102 side to the proximal end 101 side.

Specifically, referring to fig. 3 and 7, at least a middle region of the back cutting edge 121 is a first curved surface which is curved around the outer circumferential direction of the tip 100 and extends along the longitudinal direction of the tip 100, and the width of the first curved surface in the outer circumferential direction gradually increases from the distal end 102 side to the proximal end 101 side. Further, the curvature radius of the curved surface may be varied in a radial section of the cutting edge 100.

In this embodiment, the back cutting edge 121 is the place with the greatest stress during cutting, and the back cutting edge 121 is in curved surface transition in the middle section (middle area) with the greatest stress, so that the stress can be dispersed to the peripheral direction of the tool nose 100, the stress concentration in the middle area is avoided, and the problem of tool bar fracture is not easy to occur.

Referring to fig. 3 and 4, in a more specific embodiment, the back cutting edge 121 is a curved surface with a width gradually increasing from the distal end 102 to the proximal end 101. The back cutting edge 121 is a complete strip-shaped curved surface, the overall shape transition is more consistent, the sudden change of the area and the shape of the radial section of the cutter tip is further avoided, and the stress is more easily dispersed to each area of the cutter tip by the structure of the curved surface.

In another embodiment, the back cutting edge 121 includes a pointed edge having a pointed edge structure and/or a curved edge having a second curved surface bent in a circumferential direction of the tip 100 and extending in a longitudinal direction of the tip 100. The width of the second curved surface in the circumferential direction gradually decreases or changes regularly from the distal end 102 side to the proximal end 101 side.

Specifically, referring to fig. 7 and 8, an embodiment provides a tip that increases the force area at the location where the stress is most concentrated (e.g., the middle section of the back cutting edge 121). The back cutting edge 121 may gradually transition from a second curved surface (curved surface edge 1212) to a side (sharp edge 1211). Alternatively, the transition from a second curved surface to a smaller curved surface (circular arc) may be gradual. All of the above manners can be realized, and the force-bearing area of the middle section of the back cutting edge 121 is larger than that of the far end, so as to reduce the stress concentration of the middle section of the back cutting edge 121.

Specifically, referring to fig. 7 and 8, the back cutting edge 121 includes a pointed edge 1211 and a curved edge 1212, and the pointed edge 1211 has a pointed structure, and has a smaller contact area and a better cutting effect when cutting is performed in contact with tissue. In this embodiment, the sharp protruding edge 1211 extends from the distal end 102 to the curved edge 1212 along the longitudinal direction of the tip 100, and the curved edge 1212 extends to the proximal end 101 along the longitudinal direction of the tip 100, so as to form a back cutting edge having a smooth transition from the distal end 102 to the proximal end 101 and no abrupt change in cross-sectional shape. Further, the curved blade 1212 is curved around the outer circumference of the tip 100 and extends in the longitudinal direction of the tip 100, and the junction between the protruding blade 1211 and the curved blade 1212 is smoothly transitioned in the longitudinal direction so as to prevent an abrupt change from being formed in the radial cross section of the tip 100. The sharp edge 1211 is more advantageous for the back cutting edge 121 to cut the object, and the curved edge 1212 increases the strength of the back cutting edge 121 and disperses the stress to reduce the probability of breakage of the back cutting edge 121.

In the structure shown in fig. 7, at least the middle region of the back cutting edge 121 is ensured to be the curved surface edge 1212, so that the portion of the back cutting edge 121 with the largest stress can be ensured to be the curved surface structure, and the stress concentration phenomenon of the portion can be further reduced.

Further, referring to fig. 1-9, in one embodiment, the back cutting portion 120 includes a back cutting base portion 122, and the back cutting edge 121 is disposed on the back cutting base portion 122. The back-cut edge 121 and the back-cut base 122 are smoothly transitioned not only in the longitudinal direction (the smooth transition may be a curved surface or other transition surface) but also in the peripheral direction of the blade tip 100 (except for the pointed projecting edge 1211), and the back-cut portion 120 can better disperse stress and further reduce the concentration of attractive force.

Further, the tissue treatment section is described in more detail below.

Referring to fig. 1, 2, 5 and 6, in one embodiment, the tissue treatment section 110 is configured to transition smoothly in the longitudinal direction of extension or at least from a third of the distance from the distal end 102 to a portion near the proximal end 101.

Specifically, in one embodiment, the tissue treatment portion 110 has a tissue treatment surface 111 thereon, the tissue treatment surface 111 extends from the distal end 102 to the proximal end 101 along the longitudinal direction of the knife tip 100, and the tissue treatment surface 111 has no abrupt change of the structural shape in the longitudinal extending direction and is smoothly transited as a whole. Similar to the smooth transition design of the back cutting edge 121, the smooth transition structure can also reduce the stress concentration problem on the tissue processing portion, and particularly, when the tissue processing portion 110 is used for performing a surgical operation, the stress applied to the tissue processing portion 110 can be dispersed to every position in the longitudinal direction, so as to avoid the stress concentration.

To this end, referring to fig. 1, 2, 5 and 6, in an embodiment, the tissue processing surface 111 has a curved surface that is curved around the peripheral direction of the knife tip 100 and extends along the longitudinal direction of the knife tip 100, and the width of the curved surface in the peripheral direction gradually increases from the distal end 102 side to the proximal end 101 side after the curved surface is unfolded, so that the tissue processing surface 111 forms a tapered surface structure, and when the tissue processing surface 111 contacts with the processed part, the contact area does not change greatly, so that the pressure applied to the processed part can be ensured to be stable, and the blood coagulation effect can be further improved.

Specifically, the tissue processing surface 111 is a surface located in the middle of the tissue processing portion 110, the difference between the cutting pressure of the surface and the position beside the surface is small, the cutting speed is moderate in the blood vessel coagulation process, the folded and sealed length of the blood vessel is also lengthened, and the blood coagulation effect is improved. The tissue treatment surface 111 may taper from the proximal end 101 to the distal end 102, although the tissue treatment surface 111 may maintain the same width or may not change according to a tapering law.

In a design of the knife tip 100, the tissue processing surface 111 is an edge disposed on the tissue processing portion 110, and when in use, the cutting pressure of the edge is larger than that of the adjacent region, so that the clinical cutting effect is good, the speed is high, but the length of the overlapped and sealed blood vessel is also shorter, and the blood coagulation effect is reduced. The design scheme of the tool nose 100 in the embodiment of the application can effectively solve the contradiction between the cutting effect and the blood coagulation effect when the ultrasonic surgical scalpel is used, and realize synchronous balance of cutting and blood coagulation.

Further, referring to fig. 1, 2, 5 and 6, in an embodiment, the tissue treatment portion 110 has a tissue treatment base 112, the tissue treatment surface 111 is located in the middle of the tissue treatment base 112, and the tissue treatment surface 111 and the tissue treatment base 112 smoothly transition to each other, and both form the tissue treatment portion 110 of the present embodiment on the outer circumferential surface of the knife tip 100. Thus, the tissue processing portion 110 is smoothly transitioned not only in the longitudinal direction (the smooth transition may be a curved surface or other transition surface), but also in the peripheral direction of the cutting tip 100 (except for the sharp projection 1211), so that the tissue processing portion 110 can better disperse the stress, and further reduce the concentration of the stress.

Further, in one embodiment, the tip 100 is provided with a side portion 130. The side portion 130 is disposed between the tissue processing portion 110 and the back cutting portion 120, and the side portion 130, the tissue processing portion 110, and the back cutting portion 120 are continuously and smoothly transited between two of them on the outer circumferential surface of the knife tip 100 in the longitudinal direction, so that the boundary curve of the cross section of the knife tip 100 in the direction perpendicular to the longitudinal direction has continuity of not less than one order. In this embodiment, the side portion 130 may be one or two, for example, one side of the tissue treatment portion 110 and the back cutting portion 120 is connected by the side portion 130, and the other side is directly connected.

When the topology of the obtained cross section passing through the axis of the waveguide rod 200 in the longitudinal direction is kept constant in the direction around the axis and the geometry is continuously changed, the obtained cross section passing through the axis of the waveguide rod 200 in the longitudinal direction has continuity of not less than one order in the outer contour in the longitudinal direction.

In another embodiment, the tip 100 is further provided with at least two side portions 130, the side portions 130 being disposed between the tissue treating section 110 and the back cutting section 120, respectively, such that the tissue treating section 110 and the back cutting section 120 are not adjacent to each other on the outer periphery of the tip 100. And in the cross section of the tool tip 100, the side part 130 is symmetrically or approximately symmetrically arranged corresponding to the outer contour of the two side parts (namely, the side wall 131), which is called as axial symmetry or central symmetry.

More specifically, referring to fig. 1-9, in one embodiment, the side portion 130 has two oppositely disposed side walls 131, and in the cross section of the cutting tip 100, the two side walls 131 are preferably symmetrically disposed on both sides of the center line of the back cutting edge 121, i.e., the symmetry axes of the two side walls 131 preferably coincide with the center line of the back cutting edge 121. Alternatively, the axes of symmetry of the two side walls 131 may be offset from the midline of the back cutting edge 121 by a distance, for example, the offset distance between the axes of symmetry of the two side walls 131 and the midline of the back cutting edge 121 is less than or equal to one third of the cross-sectional width. The axes of symmetry (or planes of symmetry) of the two side walls 131 and the median line of the back cutting edge 121 may be parallel or at an angle. In a preferred embodiment, the width of the cross-section is the distance between the widest points in the left-right direction of the figure of fig. 9.

In one embodiment, the outer contour of the side portion 130 in cross section is one or a combination of straight lines and curved broken lines. In cross section, the corresponding outer contour of the tissue processing part 110 is connected with the outer contour of any one of the adjacent side parts 130 through a curve or a straight line in a continuous and smooth transition manner; the corresponding outer contour of the back cut part 120 is connected with the outer contour of any one of the adjacent side parts 130 through a curve or straight line continuous smooth transition, so that the cross-section corresponding cross-section boundary curve has continuity of not less than one order.

In some embodiments, the tissue treatment section 110 and the back cut section 120 may also be both symmetrical structures and have respective axes of symmetry. Wherein, the symmetry axis (or symmetry plane) of the tissue processing part, the symmetry axis (or symmetry plane) of the back cutting part and the symmetry axis (or symmetry plane) between the two side walls can be completely non-coincident (can be crossed or parallel), or at least two can be coincident.

In a knife tip 100 design scheme, back cutting edge 121 is the synthesis of convex circular arc and concave circular arc, leads to back cutting edge 121 symmetry center line not to correspond unanimously with the cutting direction, and the circular arc atress is uneven about during the cutting, produces the cutting route easily and follows the deviation of actual demand, leads to cutting inaccurate. Referring to fig. 9, in the present embodiment, the back cutting edge 121 is centered and symmetrical, so that the cutting is more accurate. For example, the relief cutting edge 121 is formed by a plane (straight surface), a folded surface, or a curved surface (curved surface) of symmetry.

Further, in a specific design of the lancet tip 100, the side walls of the distal end 102 of the lancet tip 100 are sometimes parallel or nearly parallel to the vertical cutting plane, and thus the lancet tip 100 is bulky in appearance.

In this regard, referring to fig. 9, in one embodiment, the distance between the two sidewalls 131 gradually decreases from the tissue treatment portion 110 to the back cut portion 120. On the premise that the gravity center of the whole tool nose 100 is balanced and normal operation and use are not affected, the side wall 131 can be of a symmetrical plane (straight surface), folded surface or curved surface (arc surface) structure. Back cutting edge 121 symmetry center line is preferred to be the same with the cutting direction, and the curved surface atress is even about during the cutting, is difficult to produce the cutting route and follows the deviation of actual demand, cuts more accurately. Also, in a preferred embodiment, the two sidewalls 131 of the cross-section of the tip 100 are not parallel, so that the tip 100 has a small cross-section and can be finely manipulated, and the mass of the tip 100 can be more lightweight while ensuring the width of the tissue treatment surface 111, thereby improving the amplitude amplification efficiency and thus the cutting efficiency.

Referring to FIG. 9, in one embodiment, the cross-section of the tip 100 is a diamond-like depth-wise cross-section, i.e., a cross-section of a circular diamond-like along its depth, optionally through the center line of the diamond; in the cross-sectional shape in the depth direction of the diamond-like stone, the V-shaped structure at the lower part of the cross section includes a first V-shaped structure composed of two side walls 131 and a second V-shaped structure composed of a back cut portion 120, wherein the included angle of the two side walls 131 in the first V-shaped structure is smaller than the included angle of the two side walls (back cut portion 120) in the second V-shaped structure. For example, in a more specific cross-sectional embodiment, the tissue treatment portion 110 is substantially symmetrical V-shaped (an inverted V-shape as shown in the upper part of fig. 9), the protrusion of the tip of the lower portion of the V-shape is a pointed protrusion or a rounded tissue treatment surface 111, the undercut 120 is substantially symmetrical V-shaped, one end of the two sidewalls 131 is connected to the V-shaped tissue treatment portion 110, and the other end is connected to the V-shaped undercut 120, wherein the distance between the two sidewalls 131 decreases from the tissue treatment portion 110 side to the undercut 120 side, and the symmetry axes (or symmetry planes) of the tissue treatment portion 110, the undercut 120 and the two sidewalls 131 preferably coincide. In particular, the term "bulge" in the embodiments of the present application refers to the turning position of the V-shape and the inverted V-shape.

To further enhance the stress distribution of the tip 100 in the longitudinal direction, referring to fig. 1-9, in one embodiment, the entire outer wall of the tip 100 is in a smooth transition from the distal end 102 to the proximal end 101 in the longitudinal direction, rather than in only some local areas. In this way, stress concentration of the tip 100 due to a change in the sectional area perpendicular to the longitudinal direction can be reduced.

Further, in order to make the stress more easily dispersed in the peripheral direction of the cutting edge 100, please refer to fig. 1-9, in an embodiment, the joints between the tissue processing portion 110 and the side portion 130 and between the side portion 130 and the back cutting portion 120 are arc transition surfaces, so that the entire cutting edge 100 forms a smooth transition in the peripheral direction (except for the sharp protruding edge 1211), and the stress of each portion can be more easily dispersed to other portions in the peripheral direction, thereby further improving the effect of the cutting edge 100 in dispersing the stress.

In one embodiment, referring to fig. 1-8, the distal end 102 of the tip 100 has a non-circular cross-section and the proximal end 101 of the tip 100 has a circular cross-section, and referring to fig. 2, 4, 6, and 8, the non-circular shape of the distal end 102 gradually changes to a circular shape of the proximal end 101 through a smooth transition.

Further, in typical lancet tip 100 designs, the distal end 102 of the back cutting edge 121 has a sharp tip, which is prone to tissue damage accidents.

Referring to fig. 1-15, in one embodiment of the present application, the distal end 102 of the back cutting edge 121 is formed with a transition design, such as a rounded chamfer, without a sharp tip, to avoid accidental tissue damage. Specifically, the distal end 102 is provided with a spherical structure having a radius of curvature not smaller than the radius of an inscribed circle of a cross section of the tip 100 at the distal end 102.

Further, referring to fig. 11-15, in one embodiment, the tip 100 can be curved in a longitudinal direction, such as from the distal end 102 of the tip 100 in a direction away from the center of the tip 100, and then gradually approaching and returning to the center of the tip 100 in a central region, thereby ensuring that the center of gravity of the entire tip 100 is centered on the axis.

Further, in one embodiment, in order to meet the wear requirements of the tissue treatment portion 110, the tissue treatment portion 110 is provided with a first material layer in consideration of the fact that the tissue treatment portion 110 is often in contact with and rubbed against the treatment object. Further, to reduce the effect of the first material layer on the impedance of the ultrasonic tip, the first material layer is a coating of a first material applied to the tissue treatment site 110.

Specifically, in the conventional coating process, the surface coating is bonded with the metal substrate of the ultrasonic blade tip through the primer glue, the glue bonding force is generally not large, particularly, the atomic distance between the coating and the substrate is not dense for the coating with a small friction coefficient, such as a fluorine coating, so that the coating is easy to fall off. Therefore, a layer of priming coating is often required to be arranged on the metal base material of the ultrasonic knife tip, and then a coating with higher wear resistance is coated on the priming coating, so that the coating on the outer side of the ultrasonic knife tip is too thick, the impedance of the ultrasonic knife tip is increased rapidly, the heat of the transducer is increased greatly, and the reliability of a product is reduced. In contrast, in this embodiment, the first material is a plating layer on the tissue processing portion 110, and the plating layer can be more firmly attached to the tissue processing portion 110 without providing a primer coating, so that the thickness of the plating layer can be more flexibly selected, and thus, on the premise of meeting the wear-resistant requirement, the impedance of the ultrasonic knife tip is reduced, and the reliability of the ultrasonic knife tip is improved.

In addition, in the present embodiment, at least the tissue treatment portion 110 is ensured to be provided with a plating layer, and other areas, such as the sidewall 131 and the back cut portion 120, can determine whether to provide a plating layer according to actual scene requirements. Compared with the prior art that the whole outer wall of the ultrasonic blade tip is provided with the coating, when the areas of the side wall 131 or the back cut part 120 are not provided with the coating or are provided with the thinner coating, the impedance of the areas can be further reduced, and the reliability of the ultrasonic blade tip is further improved. Moreover, the surface energy of the first material layer is lower than the surface energy of the surface of the cutting tip 100, so that the tissue processing part 110 is less prone to adhere to the tissue relative to the surface of the cutting tip 100 (e.g., the surface of the cutting tip 100 exposed directly outside), and even further prevents the cutting tip from catching the tissue.

In one embodiment, the plating layer disposed on the tissue treatment section 110 may be disposed on the tissue treatment section 110 in a patterned manner to partially or entirely cover the tissue treatment section. The coating material can be inorganic or organic or a combination of the two, and in some cases, the inorganic used for the coating material can be a metal simple substance or a compound.

In one embodiment, when the plating layer formed of the first material is used as the wear-resistant layer, the thickness a of the first material layer may be set to a range of values: a is more than or equal to 5 nanometers and less than or equal to 0.3 millimeter, the value range can not only ensure that the tissue processing part 110 meets the wear-resistant requirement, but also control the impedance of the region of the tissue processing part 110 in a smaller range, and is favorable for ensuring the reliability of the ultrasonic knife tip.

In the value range of a, there is a difference between different small ranges, and in one embodiment, the value range of the thickness a of the first material layer is set as follows: a is more than or equal to 5 microns and less than or equal to 8 microns. Under this less scope, can satisfy the wear-resisting requirement and impedance control two aspects and obtain a better balance to produce a better final effect than, more do benefit to the reliability of guaranteeing the supersound knife tip.

Further, as previously described, other areas of the ultrasonic tip may or may not be provided with a protective layer in addition to the tissue treatment portion 110. In an embodiment of the present application, a second material layer is disposed on the sidewall 131, and similar to the first material layer, and is different from the coating in the prior art, in which the second material layer is a plating layer formed by processing a second material on the sidewall 131. This cladding material can with the more firm adhesion of lateral wall 131, need not to set up priming coating, and then the thickness of the selection cladding material that can be more nimble to under the prerequisite that satisfies wear-resisting requirement, reduce the impedance of supersound knife tip, improve the reliability of supersound knife tip.

Wherein, the first material and the second material can adopt the same or different materials. For example, to reduce processing costs, a plating layer of the same material may be provided on both the tissue treatment section 110 and the sidewall 131 to form the first material layer and the second material layer. However, since the tissue treatment section 110 and the side wall 131 have different requirements for wear resistance, wherein the side wall 131 has lower requirements for wear resistance than the tissue treatment section 110, the first material layer and the second material layer may be formed by providing plating layers of different materials on the tissue treatment section 110 and the side wall 131, respectively. In this way, the variety of the first material layer and the second material layer is increased, and the tissue treatment portion 110 and the sidewall 131 can be selected to be the most suitable material according to actual requirements.

The first material layer and the second material layer can be strictly separated in respective areas or can be connected with each other into a whole. In some embodiments, the first material layer does not overlap, partially overlaps, or fully overlaps the second material layer. For example, the second material layer may cover a portion or all of the first material layer, or the first material layer may cover a portion or all of the second material layer.

In one embodiment, the second material layer has a surface energy higher than the first material layer and lower than the surface of the body, and the second material layer has a higher wear resistance than the first material.

Further, considering that the side wall 131 requires less wear resistance than the tissue treatment portion 110, the thickness of the second material layer may be set to be smaller than that of the first material layer. With the reduction of the thickness of the second material layer, the impedance of the ultrasonic knife tip can be further reduced, and the reliability of the product is further improved.

For example, when a plating layer formed by the second material is used as the wear-resistant layer, in one embodiment, the thickness b of the second material layer may be in the range of: b is more than or equal to 1 nanometer and less than or equal to 0.3 millimeter. Preferably, in an embodiment, the thickness b of the second material layer has a value range of: b is more than or equal to 1 micron and less than or equal to 2 microns.

In this regard, the present example also provides some experimental data for reference, which are as follows:

according to the above table, when the thickness of the second material layer is smaller than that of the first material layer, the impedance of the sample is obviously reduced while the first material layer is ensured to have the same wear-resisting property (for example, the thickness of the first material layer is kept between 5 and 8 micrometers).

Of course, the thickness of the second material layer may be set to be equal to or greater than the thickness of the first material layer in some embodiments, based on other requirements.

Further, in order to provide better adhesion between the first and second material layers and the ultrasonic tip, in one embodiment, the process of molding the first and/or second material on the tissue treatment portion 110 is a vacuum coating process. The vacuum plating process can ionize under vacuum and then combine positive and negative ions to form a chemical bond with strong binding force, the coating is ionized into atomic particles, the atomic particles impact on a metal base material through an electric field, and the accumulation is dense, so the binding force is strong.

Further, the ultrasonic blade tip is usually made of a metal material, and in consideration of the machining process, the wear resistance and the cost, in one embodiment, the first material and/or the second material is a non-metal material.

In particular, in one embodiment, the first material and/or the second material is a polymeric material or a polymer-containing material. The polymeric materials and polymer-containing materials include, for example but not limited to, copolymers (FEP) including tetrafluorocarbon, hexafluoroethane, hexafluoropropane, heptafluoropropane, octafluoropropane, perfluorobutane, perfluoropentane, decafluoropentane, perfluorohexane, Tetrafluoroethylene (TFE) and Hexafluoropropylene (HFP), FEP/ceramic composites, Polytetrafluoroethylene (PTFE), PTFE/ceramic composites, polypropylene, polyethylene, polycaprolactone. Non-polymers such as, but not limited to, tungsten disulfide, molybdenum disulfide, graphite, aluminum oxide, tungsten oxide, titanium nitride, chromium carbide, tungsten carbide, metalized ceramics. In one embodiment, the first material and/or the second material may also be selected from silica gel, inorganic polysilazane, organic polysilazane, modified inorganic polysilazane, and modified organic polysilazane. Wherein the first material and/or the second material may be formed of one or more of the above in combination. In some embodiments, Polytetrafluoroethylene (PTFE), PTFE/ceramic composites, chromium nitride coatings, organic polysilazanes may be preferred.

Further, the present embodiment also provides a vacuum coating process for specifically performing a coating operation, including:

surface treatment: performing surface treatment on the target area to improve the adhesive force of the target area;

specifically, the target area is surface treated using shot blasting, sand blasting, knurling, engraving, etching, laser engraving, plasma etching, corona discharge point etching, polishing, abrasive flow machining, or other techniques.

In one embodiment, polishing, shot blasting, or sand blasting techniques may be preferred.

Of course, in some embodiments, the vacuum coating process may omit the surface treatment step.

Pretreatment: and performing surface pretreatment on the target area after surface treatment to increase at least one parameter of surface roughness of the target area, bonding area with the material to be plated and surface energy, so that the target area is more easily bonded with the material to be plated.

In one embodiment, the pre-treatment employs a surface plasma treatment process;

specifically, in one embodiment, the surface plasma treatment may be performed using an inorganic oxygen-containing gas or a hydrocarbon-based gas or mixture. The inorganic oxygen-containing gas includes, but is not limited to, at least one of water, hydrogen peroxide, ozone, oxygen, carbon dioxide, nitrogen dioxide, and nitric oxide. The hydrocarbon-based gas includes, but is not limited to, at least one of straight-chain hydrocarbons, epoxy hydrocarbons, aromatic hydrocarbons, alcohols, carboxylic acids, ethers, furans, and organic amines. After the metal base material is ionized, the ionized metal base material is combined with ionized coating molecules to form chemical bonds, so that the binding force of the coating and the metal base material is enhanced.

Plating: and plating the material to be plated on the target area.

In particular, Physical Vapor Deposition (PVD), Chemical Vapor Deposition (CVD), thick film high velocity oxygen flame plasma, and other suitable material application techniques are employed. In some embodiments, Physical Vapor Deposition (PVD), Chemical Vapor Deposition (CVD) techniques may be preferred. In addition, the coating can be formed by one-time processing or can be formed by multiple times of processing.

In the vacuum coating process, the target area is an area on the ultrasonic tip where a coating is to be applied, for example, in one embodiment, the target area includes at least the tissue treatment portion 110, and in other embodiments, the target area may also include the side wall 131 and/or the back cut portion 120.

In the vacuum coating process, the material to be coated can be a first material and/or a second material according to different areas where the coating is arranged.

The application provides a knife tip 100 structure, its surface is along the smooth transition of vertical, reduces stress concentration, avoids knife tip 100 fracture. The tool nose 100 part can be processed and formed at one time without multi-process forming, thereby avoiding the eccentricity and the section difference between the tool nose 100 and the tool bar caused by processing of different processing processes and avoiding the transverse vibration caused by the eccentricity.

Referring to fig. 16, in one embodiment, the tip 100 may be integrally formed with the waveguide rod 200 or separately manufactured and then fixedly attached to transmit vibrations.

Referring to fig. 17, an embodiment further provides a handle 1000 of an ultrasonic surgical blade, the handle 1000 includes the blade tip 100 according to any one of the above embodiments and a clamping assembly 300, the blade tip 100 is mounted on the clamping assembly 300 through a waveguide rod 200.

Referring to fig. 18, an embodiment of an ultrasonic surgical blade is further provided, which includes a handle 1000 and a transducer 2000 as shown in the above embodiments, the transducer 2000 is connected to the handle 1000, the transducer 2000 is capable of converting an electrical signal into mechanical vibration, and the generated vibration can be transmitted to the handle 1000, especially to the waveguide rod 200 and the blade tip 100 in the handle 1000.

Referring to fig. 19, an embodiment of the present invention further provides an ultrasonic scalpel system, which includes the ultrasonic scalpel as shown in the above embodiment, and a host 3000, wherein the host 3000 is in signal connection with the transducer 2000 of the ultrasonic scalpel, so as to control the transducer 2000 to operate and generate mechanical vibration. Meanwhile, the host 3000 may also be used to receive signal feedback from the surgical object and perform correlation analysis.

The present application has been described with reference to specific examples, which are provided only to aid understanding of the present application and are not intended to limit the present application. Variations of the above-described embodiments may occur to those of ordinary skill in the art in light of the teachings of this application.

Claims

1. An ultrasonic surgical blade comprising a blade tip for directly acting on a tissue object, and a waveguide rod for transmitting vibrations to the blade tip, the blade tip having a proximal end and a distal end, the blade tip being connected to the waveguide rod at the proximal end and extending to the distal end in a longitudinal direction curving away from the waveguide rod,

the cross section of the far end or the near end is a polygon, the cross section of the position where the near end is connected with the waveguide rod is any one or a combination of more than two of a circle, an approximate circle and a polygon, and along the direction extending from the far end or the near end of the tool tip to the near end, the topology of the cross section is kept unchanged, and the geometric shape is continuously changed.

2. The ultrasonic surgical blade of claim 1, wherein the cross-sectional boundary curve has a continuity of not less than one order and the derivative of the shape of the cross-section has a continuity of not less than one order at the tip.

3. The ultrasonic surgical blade of claim 1 or 2, wherein the tissue treatment portion has a tissue treatment surface formed by one or more of a cusp, a curved surface, and a flat surface continuously and smoothly transitioning in the longitudinal direction, and the bottom protrusion of the first V-shaped structure is a corresponding outer contour of the tissue treatment surface in the cross-section;

the back cutting part is provided with a back cutting edge formed by one or more structures of a pointed projection, a curved surface and a plane in a continuous smooth transition along the longitudinal direction, and the bottom bulge of the second V-shaped structure is the corresponding outer contour of the back cutting edge on the cross section;

the first V-shaped structure and the second V-shaped structure are arranged on the cross section in a central symmetry mode or approximately in a central symmetry mode, or the first V-shaped structure and the second V-shaped structure are arranged on the cross section in an axial symmetry mode or approximately in an axial symmetry mode.

4. The ultrasonic surgical blade of claim 1 or 2, wherein the blade tip is further provided with a side portion, the side portion is disposed between the tissue processing portion and the back cutting portion, and the side portion, the tissue processing portion and the back cutting portion are continuously and smoothly transited between two of them on the outer circumferential surface of the blade tip along the longitudinal direction, so that a boundary curve of a cross section of the blade tip in a direction perpendicular to the longitudinal direction has continuity of not less than one order.

5. The ultrasonic surgical blade of claim 1 or 2, wherein the blade tip is further provided with at least two side portions disposed between the tissue treatment portion and the back cutting portion, respectively, such that the tissue treatment portion and the back cutting portion are not adjacent to each other on the outer periphery of the blade tip; and on the cross section of the tool nose, the outer profiles of the two side parts correspondingly formed by the side parts are symmetrically or approximately symmetrically arranged, and the pair is called as axial symmetry or central symmetry.

6. The ultrasonic surgical blade of claim 5, wherein the outer contour of the lateral part on the cross section is one or a combination of a straight line and a curved broken line;

7. The ultrasonic surgical blade of claim 1 or 2, wherein the tissue treatment portion has a first curved surface that is curved in a peripheral direction of the blade tip and extends in a longitudinal direction of the blade tip, and a width of the first curved surface in the peripheral direction of the blade tip gradually increases or gradually decreases or changes regularly from the distal end side to the proximal end side.

8. The ultrasonic surgical blade of claim 1 or 2, wherein the back cutting edge comprises a pointed edge having a pointed edge structure and/or a curved edge having a second curved surface curved in a peripheral direction of the blade tip and extending longitudinally of the blade tip, the second curved surface having a width in the peripheral direction gradually decreasing or regularly changing from the distal end side to the proximal end side.

9. The ultrasonic surgical blade of claim 1 or 2, wherein the distal end is provided with a spherical structure having a radius of curvature not smaller than a radius of an inscribed circle of a cross section of a distal end of the blade tip.

10. The ultrasonic surgical blade of claim 1 or 2, wherein the blade tip extends from the proximal end to the distal end in a direction away from the waveguide rod axis and then in a direction closer to the waveguide rod axis.

11. The ultrasonic surgical blade of claim 1 or 2, wherein the tissue treatment portion and/or the back cut portion is provided with a first layer of material having a surface energy less than a surface energy of a substrate comprising the body of the blade tip.

12. The ultrasonic surgical blade of claim 11, wherein at least one of the tissue treatment portion, the back cut portion, and the side portion has a second layer of material disposed thereon, the second layer of material having a surface energy greater than the first layer of material and a hardness greater than the first layer of material.

13. The ultrasonic surgical blade of claim 12, wherein the first layer of material does not overlap, partially overlaps, or fully overlaps the second layer of material, the first layer of material or the second layer of material being electrically conductive.

14. An ultrasonic surgical blade comprising a blade tip for directly acting on a tissue object, and a waveguide rod for transmitting vibrations to the blade tip, the blade tip having a proximal end and a distal end, the blade tip being connected to the waveguide rod at the proximal end and extending to the distal end in a longitudinal direction curving away from the waveguide rod,

the main body of the knife tip is provided with a tissue processing part and a back cutting part, and the tissue processing part and the back cutting part are oppositely arranged on two sides of a central shaft of the knife tip along the longitudinal direction;

15. The ultrasonic surgical blade of claim 14, wherein a section line corresponding to the cross section along the longitudinal direction on the blade tip has a continuity of not less than one order and a shape derivative of the cross section has a continuity of not less than one order.

16. The ultrasonic surgical blade of claim 14 or 15, wherein the tissue treatment portion has a tissue treatment surface formed by a continuous smooth transition in the longitudinal direction of one or more of a cusp, a curved surface, and a flat surface, and the bottom protrusion of the first V-shaped structure is a corresponding outer contour of the tissue treatment surface in the cross-section;

the back cutting part is provided with a back cutting edge formed by one or more structures of a pointed projection, a curved surface and a plane in a continuous smooth transition along the longitudinal direction, and the bottom of the second type of V-shaped structure is raised to be the corresponding outer contour of the back cutting edge on the cross section;

17. The ultrasonic surgical blade of claim 14 or 15, wherein the blade tip is further provided with a side portion disposed between the tissue treatment portion and the back cutting portion, and the side portion, the tissue treatment portion, and the back cutting portion are continuously and smoothly transitioned between two of them on the outer circumferential surface of the blade tip in the longitudinal direction, so that a boundary curve of a cross section of the blade tip in a direction perpendicular to the longitudinal direction has continuity of not less than one order, and a profile obtained on an axis passing through the waveguide rod in the longitudinal direction has continuity of not less than one order on an outer contour in the longitudinal direction.

18. The ultrasonic surgical blade of claim 14 or 15, wherein the blade tip is further provided with at least two side portions disposed between the tissue treatment portion and the back cutting portion, respectively, such that the tissue treatment portion and the back cutting portion are not adjacent to each other on the outer periphery of the blade tip; and on the cross section of the tool nose, the two side section lines correspondingly formed by the side parts are symmetrically or approximately symmetrically arranged, and the pair is called as axial symmetry or central symmetry.

19. The ultrasonic surgical blade of claim 5, wherein the outer contour of the lateral part on the cross section is one or a combination of a straight line and a curved broken line;

20. The ultrasonic surgical blade of claim 14 or 15, wherein the tissue treatment portion has a first curved surface that is curved in a direction of a periphery of the blade tip and extends in a longitudinal direction of the blade tip, and a width of the first curved surface in the direction of the periphery of the blade tip gradually increases or gradually decreases or changes regularly from the distal end side to the proximal end side.

21. The ultrasonic surgical blade of claim 14 or 15, wherein the back cutting edge comprises a pointed edge having a pointed blade structure and/or a curved edge having a second curved surface which is curved in a peripheral direction of the blade tip and extends longitudinally of the blade tip, and a width of the second curved surface in the peripheral direction gradually decreases or changes regularly from the distal end side to the proximal end side.

22. The ultrasonic surgical blade of claim 14 or 15, wherein the distal end is provided with a spherical structure having a radius of curvature not smaller than a radius of an inscribed circle of a cross section of a distal end of the blade tip.

23. The ultrasonic surgical blade of claim 14 or 15, wherein the blade tip extends from the proximal end to the distal end in a direction away from the waveguide rod axis and in a direction toward the waveguide rod axis.

24. The ultrasonic surgical blade of claim 14 or 15, wherein the tissue treatment portion and/or the back cut portion is provided with a first material layer having a surface energy less than a surface energy of a substrate constituting the blade tip body.

25. The ultrasonic surgical blade of claim 24, wherein at least one of the tissue treatment portion, the back cut portion, and the side portion has a second layer of material disposed thereon, the second layer of material having a surface energy greater than the first layer of material and a hardness greater than the first layer of material.

26. The ultrasonic surgical blade of claim 25, wherein the first layer of material does not overlap, partially overlaps, or fully overlaps the second layer of material, and wherein the first layer of material or the second layer of material is electrically conductive.