CN116746986B

CN116746986B - Ultrasonic vibration assembly, ultrasonic surgical instrument and manufacturing method thereof

Info

Publication number: CN116746986B
Application number: CN202311027115.5A
Authority: CN
Inventors: 赵巍; 史文勇
Original assignee: Hocer Beijing Medical Technologies Co ltd
Current assignee: Hocer Beijing Medical Technologies Co ltd
Priority date: 2023-08-16
Filing date: 2023-08-16
Publication date: 2024-01-12
Anticipated expiration: 2043-08-16
Also published as: CN116746986A

Abstract

The invention discloses an ultrasonic vibration assembly, an ultrasonic surgical instrument and a manufacturing method thereof. The ultrasonic vibration assembly comprises an ultrasonic transmission piece and an end execution part, wherein the end execution part comprises a base part and an extension part; the base is connected with the distal end of the ultrasonic transmission piece; the extension is curved toward a side offset from an axis of the ultrasound transmission member and includes a major surface that serves as a tissue treatment surface, a first side surface, and a second side surface. A first angle between the tissue treatment surface and the first side surface and a second angle between the tissue treatment surface and the second side surface are both greater than or equal to 60 ° and less than or equal to 90 °. The ultrasonic vibration component can form a sharp edge on the open side of the end effector on the premise of ensuring that the end effector has larger bending strength, so that when the end effector is open, the sharp edge can not only open soft tissues, but also can be used as a cutting edge to scratch the soft tissues.

Description

Ultrasonic vibration assembly, ultrasonic surgical instrument and manufacturing method thereof

Technical Field

The embodiment of the invention relates to an ultrasonic vibration assembly, an ultrasonic surgical instrument and a manufacturing method thereof.

Background

In medical procedures, cutting, coagulation and/or separation of tissue may be accomplished by ultrasonic surgical instruments, such as ultrasonic scalpels.

Typically, ultrasonic surgical blades include a blade bar and a blade head disposed at a distal end of the blade bar. The cutter bar is operatively connected to the ultrasonic transducer. An ultrasonic transducer is provided as part of the handle or housed within the handle and is adapted to convert electrical energy (e.g., provided by an external host computer) into motion having vibrations at an ultrasonic frequency. Vibrations generated by the transducer propagate through the length of the blade bar to the tool bit at the distal end.

The tool bit can be propped against tissues through the control handle, when the tool bit vibrates at a certain ultrasonic frequency, the tool bit can cut the tissues, and the tool bit can contact the tissues to break hydrogen bonds and denature tissue proteins, so that viscous coagulum is formed, and the coagulation effect is achieved.

Disclosure of Invention

According to the ultrasonic vibration assembly, the ultrasonic surgical instrument and the manufacturing method thereof, on the premise of ensuring that the end effector has high bending strength, sharp edges are formed on the open side of the end effector, so that when the end effector is opened, the sharp edges can not only open soft tissues, but also can simultaneously cut the soft tissues as cutting edges.

According to a first aspect of the present invention, there is provided an ultrasonic vibration assembly configured to vibrate under excitation of ultrasonic waves and including an ultrasonic transmission member including a proximal end and a distal end opposite to each other along an extending direction thereof, and an end effector including: a base connected to the distal end; an extension extending distally from the base and curving toward a side offset from an axis of the ultrasound transmission member, the extension comprising: the tissue treatment device comprises a main surface, a first side surface and a second side surface, wherein the main surface is used as a tissue treatment surface, the first side surface and the second side surface are respectively positioned on two opposite sides of the tissue treatment surface in a first direction and are respectively connected with the tissue treatment surface, an included angle between the tissue treatment surface and the first side surface is a first included angle, an included angle between the tissue treatment surface and the second side surface is a second included angle, and the first included angle and the second included angle are both larger than or equal to 60 degrees and smaller than or equal to 90 degrees.

In at least some embodiments, the first included angle and the second included angle are each 90 °.

In at least some embodiments, the extension includes: a tip, the tissue treatment surface extending from the base to the tip, wherein the tissue treatment surface is planar and a width of the tissue treatment surface is configured to taper toward the tip.

In at least some embodiments, the first side surface extends from the base to the tip and the width of the first side surface is configured to taper toward the tip; the second side surface extends from the base to the tip, and a width of the second side surface is set to gradually decrease toward the tip.

In at least some embodiments, the first side surface and the second side surface are both arcuate surfaces, and the first side surface is an outer convex surface and the second side surface is an inner concave surface.

In at least some embodiments, the tip has a tip face, and an included angle between a centerline of the tip face and an axis of the ultrasound transmission member is 14 ° -21 ° in a plane in which the tissue treatment surface lies; the tip has a thickness in a direction perpendicular to the tissue treatment surface, the thickness being 1 mm-2.2 mm.

In at least some embodiments, the extension further comprises: a tip, the tissue treatment surface extending from the base to the tip; a third side surface extending from an initial position near the base to the tip, wherein the second side surface includes a first side and a second side opposite each other in a direction perpendicular to the tissue treatment surface, the tissue treatment surface being connected to the first side of the second side surface, the third side surface being connected to the second side of the second side surface; wherein the width of the third side surface is set to gradually increase toward the tip.

In at least some embodiments, the third side surface is concave and cambered.

In at least some embodiments, the tip has a tip face, and the third side surface and the second side surface each extend to the tip face; and on the tail end face, an included angle between the third side surface and the second side surface is 120-150 degrees.

In at least some embodiments, the extension further comprises: a tip, the tissue treatment surface extending from the base to the tip; a fourth side surface extending from the base to the tip, wherein the first side surface comprises a first side and a second side opposite each other in a direction perpendicular to the tissue treatment surface, the tissue treatment surface being connected to the first side of the first side surface, the fourth side surface being connected to the second side of the first side surface, wherein the fourth side surface is provided as a rounded surface.

In at least some embodiments, the extension further comprises: a third side surface extending from an initial position proximate the base to the tip, wherein the third side surface includes first and second sides opposite each other in a direction perpendicular to the tissue treatment surface, the first side of the third side surface being connected to the second side surface; the fourth side surface is connected to the second side of the third side surface on the distal end face of the distal end.

In at least some embodiments, the extension further comprises: a tip, the tissue treatment surface extending from the base to the tip; a fourth side surface extending from the base to the tip, the fourth side surface being connected to the first side surface; a fifth side surface extending from the base toward the tip, the fourth side surface including a first side and a second side opposite to each other in a direction perpendicular to a direction in which the fourth side surface extends, the fifth side surface being connected to the second side of the fourth side surface, the first side of the fourth side surface being connected to the first side surface; wherein the width of the fifth side surface is arranged to gradually decrease towards the end until the width is zero.

According to a second aspect of the present invention there is provided an ultrasonic surgical instrument comprising the ultrasonic vibration assembly described previously.

In at least some embodiments, the ultrasonic surgical instrument further comprises: an ultrasonic generator, connected to the ultrasonic vibration assembly, configured to generate the ultrasonic waves that vibrate the ultrasonic vibration assembly; the transmission assembly is sleeved on the ultrasonic transmission piece; and an end effector comprising the end effector and a clamp pivotally connected to a distal end of the drive assembly; wherein the transmission assembly is configured to move along the extending direction of the ultrasonic transmission piece so as to drive the clamping piece to pivot relative to the end execution part; wherein the clamp includes a side curved away from an axis of the ultrasound transmission member and includes: a first clamp main surface and a second clamp main surface opposite to each other in a thickness direction thereof, the first clamp main surface facing away from the tissue processing surface, and a groove penetrating the first clamp main surface and the second clamp main surface, the second clamp main surface facing toward the tissue processing surface; wherein the groove extends in a length direction of the clip and includes: two first openings are formed in the main surface of the first clamping piece, and the two first openings are arranged side by side along the first direction.

In at least some embodiments, the trough further comprises: a plurality of second openings formed in the first clamping member major surface; wherein the two first apertures comprise a first side and a second side opposite each other in a second direction parallel to the tissue treatment surface, the first side being proximal to the distal end of the clip and the second side being distal to the distal end of the clip; the second holes are arranged on the first side and distributed along the length direction of the clamping piece.

In at least some embodiments, the trough further comprises: a third opening provided on the second clamping member main surface and extending in the direction of extension of the clamping member, the third opening including a first end and a second end opposite to each other in the direction of extension thereof, the first end being close to the distal end of the clamping member, the second end being remote from the distal end of the clamping member; wherein the third opening includes a first opening portion at the second end and a second opening portion connected to the first opening portion, the second opening portion including two first flanges opposing each other in the first direction.

In at least some embodiments, the end effector further comprises: the clamping pad is located between the ultrasonic transmission piece and the clamping piece, a boss is arranged on one side of the clamping pad facing the clamping piece, extends along the length direction of the clamping piece and is configured to be matched with the groove so as to connect the clamping pad to the clamping piece.

In at least some embodiments, the clamping pad is curved toward a side offset from the axis of the ultrasound transmission member and the clamping pad includes a clamping pad major surface facing the tissue-treating surface of the ultrasound transmission member, the clamping pad major surface being toothed.

In at least some embodiments, the ratio between the effective closing length L of the end effector and the thickness T is 3.25-9.5, and the ratio between the thickness T and the thickness T of the end of the extension is 1.8-4.

According to a third aspect of the present invention, there is provided a method of manufacturing an ultrasonic vibration assembly configured to vibrate under excitation of ultrasonic waves, the method comprising: providing an ultrasonic transmission member and an end effector, wherein the ultrasonic transmission member includes a proximal end and a distal end opposite to each other along an extending direction thereof, and the end effector includes a base portion and an extending portion; connecting a base of the end effector with a distal end of the ultrasound transmission member; wherein the extension extends distally from the base and curves toward a side offset from the axis of the ultrasound transmission member; the extension includes: a main surface, a first side surface and a second side surface, the main surface serving as a tissue treatment surface, the first side surface and the second side surface being located on opposite sides of the tissue treatment surface in a first direction and being connected to the tissue treatment surface, respectively; the included angle between the tissue treatment surface and the first side surface is a first included angle, the included angle between the tissue treatment surface and the second side surface is a second included angle, and the first included angle and the second included angle are both larger than or equal to 60 degrees and smaller than or equal to 90 degrees.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following brief description of the drawings of the embodiments will make it apparent that the drawings in the following description relate only to some embodiments of the present invention and are not limiting of the present invention.

Fig. 1 is a schematic structural view of an ultrasonic surgical instrument according to an embodiment of the present invention.

Fig. 2 is a partial exploded view of an ultrasonic surgical instrument according to an embodiment of the present invention.

FIG. 3 is a schematic view of a partial structure of the end effector of FIG. 1.

Fig. 4 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a first viewing angle.

Fig. 5 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a second viewing angle.

Fig. 6 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at different viewing angles, where (a) is a bottom view and (b) is a front view; (c) is a top view.

FIG. 7 is a schematic view of the structure of a tissue-treating surface of an ultrasonic vibration transmission assembly according to an embodiment of the present invention, wherein (a) is a sectional view taken along line A-A and (B) is a sectional view taken along line B-B; (C) is a sectional view along the line C-C.

Fig. 8 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a third view angle.

Fig. 9 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a fourth viewing angle.

Fig. 10 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a fifth viewing angle.

FIG. 11 is a schematic view of an end effector according to an embodiment of the present invention at a first view angle.

FIG. 12 is a schematic view of an end effector according to an embodiment of the present invention in a second view.

Fig. 13 is a schematic structural view of a clamping member according to an embodiment of the present invention, where (a) is a bottom view and (b) is a front view; (c) is a top view.

Fig. 14A and 14B are sectional views taken along the line A-A and the line B-B in (c) of fig. 13, respectively.

Fig. 15 is a schematic structural diagram of a clamping pad according to an embodiment of the present invention, where (a) is a bottom view and (b) is a front view; (c) is a top view.

FIG. 16 is a schematic view of an end effector in a closed configuration according to an embodiment of the present invention.

Fig. 17 is a flowchart of a method for manufacturing an ultrasonic vibration assembly according to an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. It will be apparent that the described embodiments are some, but not all, embodiments of the invention. All other embodiments, which can be made by a person skilled in the art without creative efforts, based on the described embodiments of the present invention fall within the protection scope of the present invention.

Unless defined otherwise, technical or scientific terms used herein should be given the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs. The terms "first," "second," and the like in the description and in the claims, are not used for any order, quantity, or importance, but are used for distinguishing between different elements. The word "comprising" or "comprises", and the like, is intended to mean that elements or items that are present in front of "comprising" or "comprising" are included in the word "comprising" or "comprising", and equivalents thereof, without excluding other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", etc. are used merely to denote relative positional relationships, which may also change accordingly when the absolute position of the object to be described changes.

According to an embodiment of the present invention, there is provided an ultrasonic vibration assembly configured to vibrate under excitation of ultrasonic waves and including an ultrasonic transmission member including a proximal end and a distal end opposite to each other in an extending direction thereof, and an end effector including: a base connected to the distal end; an extension extending distally from the base and curving toward a side offset from the axis of the ultrasound transmission member. The extension includes: a main surface, a first side surface and a second side surface, the main surface serving as a tissue treatment surface, the first side surface and the second side surface being located on opposite sides of the tissue treatment surface in a first direction and being connected to the tissue treatment surface, respectively. The included angle between the tissue treatment surface and the first side surface is a first included angle, the included angle between the tissue treatment surface and the second side surface is a second included angle, and the first included angle and the second included angle are both greater than or equal to 60 degrees and less than or equal to 90 degrees.

In the embodiment of the invention, the first included angle and the second included angle are both larger than or equal to 60 degrees and smaller than or equal to 90 degrees, so that on the premise of ensuring that the end execution part has larger bending strength, a sharp edge is formed on the open side of the end execution part, and when the end effector is opened, the sharp edge can not only open soft tissues, but also can be used as a cutting edge to scratch the soft tissues at the same time.

According to an embodiment of the present invention, there is also provided an ultrasonic surgical instrument including the ultrasonic vibration assembly described above. The ultrasonic vibration assembly has the beneficial effects, and the ultrasonic surgical instrument comprising the ultrasonic vibration assembly has the same beneficial effects.

In embodiments of the present invention, "proximal" refers to the side that is proximal to an operator using an ultrasonic vibration assembly or ultrasonic surgical instrument and "distal" refers to the side that is distal to the operator.

The invention is illustrated by the following specific examples. Detailed descriptions of known functions and known components may be omitted as so as to not obscure the description of the embodiments of the present invention. When any element of an embodiment of the present invention appears in more than one drawing, the element may be referred to by the same reference numeral in each drawing.

Fig. 1 is a schematic structural view of an ultrasonic surgical instrument according to an embodiment of the present invention. Fig. 2 is a partial exploded view of an ultrasonic surgical instrument according to an embodiment of the present invention.

For example, as shown in fig. 1 and 2, an ultrasonic surgical instrument 100 provided by an embodiment of the present invention includes an ultrasonic vibration assembly configured to vibrate under excitation of ultrasonic waves and including a cutter bar 9 (i.e., an ultrasonic transmission member) and a cutter head 10 (i.e., an end effector). The cutter bar 9 includes a proximal end 9A and a distal end 9B opposite to each other in the extending direction thereof (e.g., the direction D shown in the drawing), a cutter head 10 is connected to the distal end 9B, and the cutter bar 9 is configured to transmit vibrations from the proximal end 9A to the distal end 9B to vibrate the cutter head 10.

For example, the ultrasonic surgical instrument 100 further includes an ultrasonic transducer 2 (i.e., an ultrasonic generator), the ultrasonic transducer 2 being coupled to the ultrasonic vibration assembly and configured to generate ultrasonic waves that vibrate the ultrasonic vibration assembly. As shown in fig. 1, for example, the ultrasonic transducer 2 is connected to the proximal end 9A of the cutter bar 9. For example, the ultrasonic transducer 2 is provided with a piezoelectric element (not shown) which is excited by electric energy to vibrate to generate mechanical waves, and the mechanical waves can be transmitted to the cutter bar 9 and the cutter head 10 so that the two vibrate under the excitation of ultrasonic waves

For example, at least a portion of the ultrasound transducer 2 may be disposed in the housing 4, thereby facilitating quick installation or removal of the ultrasound transducer 2 by an operator.

For example, the ultrasonic surgical instrument 100 further includes a transmission assembly 3 that is sleeved on the blade bar 9. For example, the transmission assembly 3 comprises an outer sleeve 311 and an inner sleeve 312, wherein the outer sleeve 311 is sleeved on the cutter bar 9 and is fixed relative to the cutter bar 9. The inner sleeve 312 is located between the outer sleeve 311 and the cutter bar 9 in the radial direction of the cutter bar 9 (i.e. in the diameter direction of the cutter bar 9) and acts as an actuator, being movable relative to the outer sleeve 311 or the cutter bar 9, e.g. being controllable to reciprocate in direction D. For example, it may be moved in the direction D toward or away from the ultrasonic transducer 2.

For example, the ultrasonic surgical instrument 100 further includes an end effector 1, the end effector 1 including a blade 10 and a clamp 20. The clamp 20 has an open position and a closed position, and the end effector 1 has an open state (or open state) and a closed state. In the open state, the cutter head 10 and the clamping piece 20 are separated from each other, and the outer side of the cutter head 10 is a spreading side which can spread soft tissues; in the closed state, soft tissue is clamped between the cutter head 10 and the clamping member 20.

For example, as shown in fig. 3, the transmission member 3 includes a proximal end 3A and a distal end 3B opposite to each other in the extending direction thereof (e.g., the direction D shown in the drawing), and the holder 20 is pivotally connected to the distal end 3B of the transmission assembly 3. The transmission assembly 3 is configured to move in the direction D to pivot the holder 20 relative to the cutter head 10.

For example, the clamp 20 is connected to the distal end of the inner sleeve 312 such that the inner sleeve 312 pivots the clamp 20 relative to the tool bit 10 when moving back and forth in the direction D. When the inner sleeve 312 is moved in the direction D away from the ultrasonic transducer 2, the clamp 20 is brought to open (i.e., in an open position) and separated from the cutter head 10, so that the end effector 1 is in an open state. When the inner sleeve 312 is moved in direction D toward the ultrasonic transducer 2, the clamp 20 is brought to close toward the tool bit 10 (i.e., from the open position to the closed position), thereby generating the required tissue clamping force to place the end effector 1 in the closed state.

For example, the end effector 1 further includes a clamp pad 30, the clamp pad 30 being located between the tool bit 10 and the clamp 20 and being connected to the clamp 20, the clamp pad 30 pivoting with the clamp 20. Without the provision of the clamping pads 30, there is a rigid contact between the clamping member 20 and the tool tip 10, and without tissue being clamped therebetween, the clamping member 20 and the tool tip 10 may contact each other to cause mechanical damage.

In the embodiment of the invention, the clamping pad 30 is arranged, so that mechanical damage caused by direct contact between the clamping pad and the clamping pad can be effectively prevented. Further, when the tissue is clamped between the clamp 20 and the cutter head 10, damage to the tissue can be prevented by providing the clamp pad 30, and the safety of the operation can be improved.

For example, the clamping member 20 swings the clamping pad 30 about the shaft hole as a rotation shaft, so that the surface (e.g., lower surface) of the clamping pad 30 and the tissue treatment surface (e.g., upper surface) of the cutter head are close to or far from each other, thereby achieving the closing or opening.

Fig. 4 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a first view angle; fig. 5 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a second viewing angle. Fig. 6 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at different viewing angles, where (a) is a bottom view and (b) is a front view; (c) is a top view.

For example, the tool bit 10 includes a base 11 and an extension 12. The base 11 is connected to the distal end 9B of the cutter bar 9. The extension 12 extends distally from the base 11 and curves towards a side offset from the axis O of the knife bar 9.

For example, as shown in fig. 6 (c), the axis O of the knife bar 9, which may be understood as the central or rotational axis of the knife bar 9, is for example parallel to a second direction (e.g. the y-direction shown in the figure) parallel to the tissue treatment surface S0. In the xy-plane, the axis O includes a first side (e.g., upper side) and a second side (e.g., lower side) opposite to each other in a first direction (e.g., x-direction shown in the drawing) parallel to the tissue processing surface S0, and the extension 12 is curved from the base 11 to the first side or the second side of the axis O, e.g., to the lower side of the axis O, so that the extension 12 is curved as a whole and the ends of the extension 12 are all located at the lower side.

In the case where the extension direction of the extension 12 is parallel to the y-direction, the knife bar 9 lacks shuttle capability in soft tissue and is not flexible.

In the embodiment of the present invention, by the above arrangement, the front end portion of the cutter head 10 can be curved, so that the shuttle in soft tissues is facilitated, and more soft tissues can be clamped. In addition, the bending design does not affect the normal operation of the tool bit, since the tool bit is only subjected to forces in the clamping direction, even when vibrations occur in the axial direction of the tool bar, it is not affected by the bending design.

For example, the width W12 of the extension 12 is configured to taper distally to facilitate forming a tapered jaw to enhance shuttle in soft tissue. That is, the width W12 of the extension 12 has a maximum value at the farthest distance from the cutter bar 9 and a minimum value at the nearest distance from the cutter bar 9.

For example, the tip 121 has a tip surface ES, and in the plane of the tissue treatment surface S0, an angle β (i.e., a bending angle of the extension 12) between the center line Z of the tip surface ES and the axis O of the cutter bar 9 is 14 ° to 21 °, preferably 15 ° to 18 °, so that the strength of the part and the convenience of the surgical operation can be better considered.

For example, the extension 12 includes a main surface, a first side surface S1, and a second side surface S2. The main surfaces serve as tissue processing surfaces S0, and the first side surfaces S1 and the second side surfaces S2 are located on opposite sides of the tissue processing surface S0 in the x direction and are connected to the tissue processing surface S0, respectively.

For example, as shown in fig. 5, the included angle between the tissue treatment surface S0 and the first side surface S1 is a first included angle α1, the included angle between the tissue treatment surface S0 and the second side surface S2 is a second included angle α2, and the first included angle α1 and the second included angle α2 are both greater than or equal to 60 ° and less than or equal to 90 °.

In some cases, if the first included angle α1 and the second included angle α2 are smaller than 60 °, the first side surface S1 and the second side surface S2 may intersect at the spreading side (for example, below the tissue treatment surface S0), which may result in too little material for the tool bit, resulting in a decrease in the overall strength of the tool bit and a risk of breaking the tool bit.

In other cases, if the first included angle α1 and the second included angle α2 are both greater than 90 °, the end face ES of the extension 12 has a trapezoid shape with a narrower upper part and a wider lower part, so that the cutter head is clumsy, and cannot form a sharp edge, which is not beneficial to expanding tissues.

In the embodiment of the invention, the first included angle alpha 1 and the second included angle alpha 2 are set to be larger than or equal to 60 degrees and smaller than or equal to 90 degrees, so that the strength of the cutter head can be ensured, and sharp edges RB (see fig. 6) can be formed on the expanding side, and the tissue can be expanded while the tissue is expanded.

For example, as shown in fig. 5, the first included angle α1 and the second included angle α2 are both 90 °. By the arrangement, the cutter head can be further ensured to be convenient to form a sharp edge RB on one side close to tissue on the premise of having enough bending strength.

For example, as shown in fig. 3 and 4, extension 12 includes a distal end 121, and tissue treatment surface S0 extends from base 11 to distal end 121. For example, the tip 121 is provided blunt, i.e., with a tip face ES that is planar. This arrangement avoids unnecessary damage to tissue or other instruments by the tool tip, as compared to the case where the tip is pointed (e.g., needle-shaped).

For example, as shown in connection with fig. 4 to 7, the tissue treatment surface S0 is provided as a plane. The planar design can increase the gripping force on the soft tissue, thereby facilitating the clamping of the soft tissue and the blood vessel.

For example, in fig. 7, the width W0 of the tissue processing surface S0 is set to gradually decrease toward the tip 121. That is, the tissue processing surface S0 gradually decreases in width W0 toward the distal end face ES while being curved to one side, and is wedge-shaped.

In the case where the width W0 of the tissue treatment surface S0 is constant at all times, the extension 12 cannot form a tendency to gather toward the distal end face ES, which may deteriorate the shuttle ability of the cutter head, thereby reducing the convenience of the surgical operation.

In the embodiment of the invention, through the arrangement, the tail end 121 of the extension part 12 can be more sharp, so that the shuttle capacity of the cutter head is improved, meanwhile, the material consumption of the cutter head can be saved, and the manufacturing cost is reduced on the premise of ensuring that the cutter head has larger strength.

For example, the width W0 has a maximum value on a side close to the cutter bar and a minimum value on a side close to the tip, and the ratio of the maximum value to the minimum value is 1 to 3, preferably 1.5 to 2.5, and the above range of values can better satisfy both the strength of the cutter head and the convenience of the surgical operation.

Fig. 8 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a third view angle; fig. 9 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a fourth view angle; fig. 10 is a schematic structural diagram of an ultrasonic vibration transmission assembly according to an embodiment of the present invention at a fifth viewing angle.

For example, as shown in fig. 8, the first side surface S1 extends from the base 11 to the tip 121, and the width W1 of the first side surface S1 is set to gradually decrease toward the tip 121, that is, the width W1 gradually decreases toward the tip face ES. As shown in fig. 9, the second side surface S2 extends from the base 11 to the tip 121, and the width W2 of the second side surface S2 is set to gradually decrease toward the tip 121, that is, the width W2 gradually decreases toward the tip face ES.

According to the embodiment of the invention, through the arrangement, the whole cutter head can form a curved cone shape, so that the shuttle capacity of the cutter head is improved, and the flexibility and convenience of operation are improved.

For example, the first side surface S1 and the second side surface S2 are both cambered surfaces, and the first side surface S1 is an outer convex surface and the second side surface S2 is an inner concave surface. Through the arrangement, the cutter head can be further ensured to integrally form a cone shape which is bent towards one side.

In the embodiment of the invention, the cambered surface refers to a surface with a certain curvature, namely a certain curvature. For example, the curvature of the first side surface S1 and the curvature of the second side surface S2 are substantially the same, which is more advantageous for forming a tool bit that is curved to one side. "substantially" means within + -10% of the target curvature.

For example, as shown in fig. 5 to 7, the extension 12 further includes a third side surface S3. As shown in fig. 6 (b), the third side surface S3 extends from an initial position P0 near the base 11 to the tip 121. The second side surface S2 includes a first side C21 and a second side C22 opposite to each other in a direction perpendicular to the tissue processing surface S0 (e.g., a z-direction shown in the drawing), the tissue processing surface S0 is connected to the first side C21 of the second side surface S2, and the third side surface S3 is connected to the second side C22 of the second side surface S2; wherein the width W3 of the third side surface S3 is set to gradually increase toward the tip 121 (also shown in fig. 8 and 9). That is, the width W3 of the third side surface S3 gradually increases from the zero value to the maximum value of the initial position P0 toward the end face ES.

In the embodiment of the present invention, the meaning of the first side of one surface being connected to the other surface is: which surface is connected to the edge of the first side of the other surface. In some special cases, the meaning may also be: the surface is located on a first side of the other surface and is connected to an edge of the first side of the other surface.

As can be seen from fig. 6 (a), (b) and (c), the cross-sectional area of the extension 12 is gradually reduced in the extending direction of the cutter head 10 (i.e., the direction extending distally). That is, the extension 12 has a transition from a thick end to a thin end. At the thick end, the cross-sectional shape of the extension 12 is an approximately rectangular quadrangle shown in (c). At the thin end, the cross-sectional shape of the extension 12 is pentagonal as shown in (a).

In the case where the third side surface S3 is not provided, a rounded corner is formed between the second side surface S2 and a fifth side surface S5 (to be described later in detail), and a sharp edge cannot be formed between the third side surface S3 and the fourth side surface S4.

In the embodiment of the present invention, when the third side surface is provided from the initial position P0, the cross-sectional shape of the extension 12 is changed from four sides to pentagons, thereby forming a sharp edge between the third side surface S3 and the fourth side surface S4, and thus, the end effector 1 can function to open soft tissues when opened.

For example, the length of the third side surface S3 in the y-direction is smaller than the length of each of the first side surface S1 and the second side surface S2 in the y-direction, which ensures a smooth transition of the tool tip from the larger diameter section to the smaller diameter section.

For example, the third side surface S3 is concave and cambered. If the third side surface S3 is planar, the sharp edges formed are not sharp enough. In the embodiment of the invention, the third side surface S3 is provided with the concave surface and the cambered surface, so that sharper sharp edges can be formed at the edge between the third side surface S3 and the fourth side surface S4, and the effect of scratching soft tissues is further enhanced while the soft tissues are stretched.

For example, as shown in fig. 5, on the distal end face ES, the angle between the third side surface S3 and the second side surface S2 is 120 ° to 150 °, preferably 130 ° to 140 °, so that a more reasonable length and position of the sharp edge can be obtained.

For example, as shown in fig. 4, 5, 7 and 10, the extension 12 further includes a fourth side surface S4, the fourth side surface S4 extending from the base 11 to the tip 121; as shown in fig. 4, the first side surface S1 includes a first side C11 and a second side C12 opposite to each other in the z-direction, the tissue processing surface S0 is connected to the first side C11 of the first side surface S1, and the fourth side surface S4 is connected to the second side C12 of the first side surface S1. The fourth side surface S4 is provided as a rounded surface.

In fig. 6 (c), if no rounded surface is provided between the first side surface S1 and the fifth side surface S5, a rib may be formed therebetween, thereby scratching soft tissue during a surgical operation.

According to the embodiment of the invention, through the arrangement, the scratch of the convex edges to the soft tissues can be avoided, and the safety and stability of operation are improved.

In some embodiments, the width W4 of the fourth side surface S4 is a constant value.

For example, as shown in fig. 9, the third side surface S3 includes a first side C31 and a second side C32 opposite to each other in the y-direction, the first side C31 of the third side surface S3 being connected to the second side surface S2; on the distal end face ES of the distal end 121, the fourth side surface S4 is connected to the second side C32 of the third side surface S3.

Without the fourth side surface S4, a rib may be formed between the first side surface S1 and the third side surface S3, thereby scratching soft tissue during a surgical operation.

In the embodiment of the present invention, by connecting the fourth side surface S4 to the second side C32 of the third side surface S3, smooth transition between the first side surface S1 and the third side surface S3 is facilitated, and damage to soft tissues can be avoided.

For example, as shown in fig. 8 and 10, the extension 12 further includes a fifth side surface S5, the fifth side surface S5 extending from the base 11 toward the tip 121, the fourth side surface S4 including a first side C41 and a second side C42 opposite to each other in a direction perpendicular to the extending direction of the fourth side surface S4 (for example, as shown in the drawings, the extending direction of the fourth side surface S4 is the same as the extending direction of the extension 12), the fifth side surface S5 being connected to the second side C42 of the fourth side surface S4, the first side C41 of the fourth side surface S4 being connected to the first side surface S1; the width of the fifth side surface S5 is set to gradually decrease toward the tip 121 until the width is zero.

According to the embodiment of the invention, through the arrangement, the section of the thick end of the cutter head can be ensured to be close to a rectangle, so that the strength of the cutter head is improved.

In the embodiment of the present invention, the tissue treatment surface S0, the first side surface S1, the second side surface S2, the third side surface S3 and the fourth side surface S4 are gathered at the distal end 121 of the extension portion, so that the cutter head 10 is formed in a curved taper shape as a whole, thereby improving the penetration ability in soft tissues.

FIG. 11 is a schematic view of an end effector according to an embodiment of the present invention at a first view angle. FIG. 12 is a schematic view of an end effector according to an embodiment of the present invention in a second view. Fig. 13 is a schematic structural view of a clamping member according to an embodiment of the present invention, where (a) is a bottom view and (b) is a front view; (c) is a top view. Fig. 14A and 14B are sectional views taken along the line A-A and the line B-B in (c) of fig. 13, respectively. Fig. 15 is a schematic structural diagram of a clamping pad according to an embodiment of the present invention, where (a) is a bottom view and (b) is a front view; (c) is a top view.

For example, as shown in fig. 12 and 13, the holder 20 is curved toward a side offset from the axis O (e.g., y direction shown in the drawings) of the cutter bar 9 and includes: first and second clip main surfaces 201 and 202 opposed to each other in a thickness direction thereof (e.g., z direction shown in the drawing), and a groove 21 penetrating the first and second clip main surfaces 201 and 202, the first clip main surface 201 facing away from the tissue processing surface S0, and the second clip main surface 202 facing the tissue processing surface S0.

For example, the clip 20 bends in the same direction as the extension 12, thereby facilitating a tight closure with the tool tip 10. For example, the angle of curvature of the clamp 20 is the same as the angle of curvature of the extension 12 (i.e., the angle β described above) to further achieve a tight closure.

For example, the width W20 of the clamp 20 is configured to taper distally to facilitate forming a tapered jaw to improve shuttle in soft tissue. For example, the clip 20 further includes a first clip side surface 203 and a second clip side surface 204 which are opposite to each other in a direction perpendicular to the extending direction thereof in the xy plane (for example, the x direction shown in the drawing), wherein the first clip main surface 201, the first clip side surface 203, and the second clip side surface 204 are arranged to gather at the distal end 20E of the clip 20, so that the clip 20 as a whole forms a curved taper shape and becomes smaller in thickness, improving its shuttling ability in soft tissues.

For example, as shown in fig. 13 (b), the distal end 20E of the clip 20 is provided with a chamfer, thereby further reducing the thickness of the distal end 20E.

For example, the width W20 of the clamp 20 has a maximum value furthest from the knife bar 9 and a minimum value closest to the knife bar 9. The ratio of the maximum value to the minimum value is 1-3, preferably 1.5-2.5, and the value range can better give consideration to the strength of the cutter head and the convenience of operation.

For example, the first clamp main surface 201 is a curved surface, such as a cylindrical curved surface. With the above arrangement, the jaws are facilitated to be brought into a target position through the cylindrical sleeve. The second clamp major surface 202 is planar to facilitate a tight closure.

For example, as shown in fig. 13, the groove 21 includes a third opening 213, the third opening 213 being opened on the second holder main surface 202 and extending in the extending direction of the holder 20. The third opening 213 includes a first end 213A and a second end 213B opposite to each other in the extending direction thereof, the first end 213A being close to the distal end 20E of the holder 20, the second end 213B being distant from the distal end 20E of the holder 20. When it is desired to install the clamp pad 30 in the slot 21, the clamp pad 30 is inserted from the second end 213B of the slot 21.

For example, the third opening 213 further includes a first opening 221 at the second end 213B and a second opening 222 connected to the first opening 221, the second opening 222 including two first flanges 231 (shown in fig. 14A) opposing each other in the x-direction. For example, two opposite edges (e.g., upper and lower edges shown in (a) of fig. 13) of the second opening portion 222 are respectively defined by two first flanges 231.

In the present application, if two first flanges 231 (for example, only one second flange 232 shown in fig. 14B) are not provided when the clamp pad 30 is inserted into the groove 21 from the second end 213B, the clamp pad 30 receives insufficient clamping force at the start of entering the groove 21, and stable introduction cannot be achieved; in addition, after the clamp pad 30 is installed in the groove 21, the clamp pad 30 may be pulled out of the groove due to the small blocking effect of the single second flange 232 on the clamp pad.

In the embodiment of the present invention, by providing two first flanges 231, the width of the second opening 222 is made smaller than the width (e.g., the dimension in the x direction in the drawing) of the first opening 221, so that not only can stable introduction be provided when the clamp pad 30 starts to enter the groove 21, but also the clamp pad 30 can be prevented from coming out of the groove, and the stability of the clamp pad can be enhanced.

Further, in order to reduce the manufacturing cost, the clamping member 20 may be manufactured by a powder metallurgy forming technique in which metal powder is injected into a mold and then sintered, the mold is formed by combining an upper mold and a lower mold, and a cavity between the upper and lower molds is a powder injection position, that is, the shape of the final clamping member 20. The shape of the clamp 20 must therefore be such that the mould can be opened after sintering has been completed.

In the embodiment of the present invention, two hollowed structures 241 corresponding to the two first flanges 231 as shown in fig. 14A are disposed in the groove 21. Therefore, the clamping piece can be manufactured by utilizing the powder metallurgy forming technology, and the aim of reducing the manufacturing cost is fulfilled.

For example, as shown in fig. 13, the groove 21 extends in the length direction of the holder 20 and includes two first openings 211 (e.g., as shown in fig. 13 (c)) opened on the first holder main surface 201, the two first openings 211 (i.e., a pair of first openings 211) being arranged side by side in the x direction. For example, the two first openings 211 are symmetrically disposed with respect to a central axis between the two first openings 211.

According to the embodiment of the invention, through the arrangement, the shape of the cavity in the upper die can be further ensured to be more regular, so that the forming quality of the clamping piece is improved.

In addition, in some cases, if a plurality of pairs of first openings 211 are provided along the length of the clamping member 20, the hollow structure on the clamping member 20 is too many, so that the overall bending strength of the clamping member 20 is reduced. In the embodiment of the present invention, by providing only a pair of the first openings 211, the stable introduction of the clamping pad 30 can be achieved while ensuring that the clamping member 20 has a sufficient bending strength.

For example, two first flanges 231 are disposed in one-to-one correspondence with two first openings 211. The number of first flanges 231 is the same as the number of first openings 211.

For example, the shape of the two first openings 211 corresponds to the shape of the two first flanges 231 of the groove 21, and the area of the two first openings 211 should be made as small as possible under the condition that the size of the two first flanges 231 is slightly larger, because the larger the hollowed-out area is, the more the amount of material used for manufacturing the clip 20 is reduced, and the greater the influence on the bending strength of the clip 20 (that is, the smaller the bending strength is).

For example, as shown in fig. 13, a pair of first openings 211 includes a first side C1 and a second side C2 opposite each other in a direction parallel to tissue-treating surface S0 (e.g., the y-direction shown in the drawing), first side C1 being adjacent distal end 20E of clip 20, and second side C2 being distal from distal end 20E. The slot 21 further includes a plurality of second openings 212, the plurality of second openings 212 (e.g., three shown) being formed in the first clamping member main surface 201 and disposed on the first side C1 of the pair of first openings 211, the plurality of second openings 212 being distributed along the length of the clamping member 20.

In the embodiment of the present invention, by providing a plurality of second openings, a stable guiding effect can be achieved after the clamping pad 30 penetrates into the groove 21, without affecting the overall bending strength of the clamping member 20.

For example, as shown in fig. 15, the clamp pad 30 is curved toward a side offset from the axis O of the cutter bar 9. For example, the gripping pad 30 bends in the same direction as the extension 12, thereby achieving a tight closure with the tissue treatment surface. For example, the bending angle of the clamp pad 30 is the same as the bending angle of the extension 12 to further achieve a tight closure.

For example, the width W30 of the gripping pad 30 is configured to taper distally to facilitate forming a tapered jaw to enhance shuttle in soft tissue.

For example, the width W30 of the clamping pad 30 has a maximum value nearest to the cutter bar 9 and a minimum value furthest from the cutter bar 9. The ratio of the maximum value to the minimum value is 1 to 1.9, preferably 1.2 to 1.5. Through the arrangement, when the clamping pad 30 and the clamping piece 20 shake slightly relative to the cutter bar, the jaw can be ensured to be in a closed state, and the cutter bar can be comprehensively pressed on the clamping pad.

For example, the clamping pad 30 includes a clamping pad major surface 301 facing the tissue processing surface S0, the clamping pad major surface 301 being a toothed surface that tightens against the tissue processing surface to clamp soft tissue and blood vessels. For example, serrations on the tooth surface may improve grip stability.

For example, the area of clamp pad major surface 301 is greater than the area of tissue treatment surface S0. When the end effector 1 is closed, there is a potential for small amounts of wobble (due to gaps between parts) of the clamp 20 and clamp pad 30 relative to the tool bar 9. With the above arrangement, it is possible to ensure that the tissue processing surface S0 is entirely pressed against the clamp pad main surface 301, achieving close contact.

For example, the clamp pad 30 further includes a first clamp pad side surface 302 and a second clamp pad side surface 303 opposite to each other in a direction perpendicular to the extending direction thereof in the xy plane (for example, x direction shown in the drawing), wherein the clamp pad main surface 301, the first clamp pad side surface 302, and the second clamp pad side surface 303 are arranged to gather at the distal end 30E of the clamp pad 30, so that the clamp pad 30 as a whole forms a curved wedge shape, improving its shuttling ability in soft tissues.

For example, as shown in fig. 15 (a), the distal end 30E of the clip 20 is provided with a rounded shape, thereby further making the width of the distal end 30E narrower.

For example, as shown in fig. 15, the side of the clamp pad 30 facing the clamp 20 is provided with a boss 32, the boss 32 extending along the length of the clamp 20 and configured to mate with the slot 21 to connect the clamp pad 30 to the clamp 20.

For example, the cross-sectional shape of the slot 21 is T-shaped (i.e., T-shaped slot), and the cross-sectional shape of the boss 32 is T-shaped, thereby facilitating a secure connection with the T-shaped slot 21.

For example, as shown in fig. 16, when the clamping member 20 is in the closed position, the jaws are in a closed state, and the ratio between the effective closing length L of the jaws and the thickness T of the jaws is 3.25-9.5.

The known jaws have a relatively short effective closure length, are not convenient to shuttle through soft tissue during surgery, and are relatively inefficient in cutting soft tissue and closing blood vessels.

In the embodiment of the invention, the slender jaw can be provided by setting the ratio range, so that the slender jaw can conveniently shuttle in soft tissues. As the effective closing length of the jaws is increased, more soft tissues can be clamped at a time, and large blood vessels are more easily captured, so that the efficiency of cutting soft tissues and closing blood vessels is improved.

For example, the effective closing length L of the jaws is 13mm to 19mm, preferably 16mm to 18mm. The jaw thickness T is 2 mm-4 mm, preferably 2.5 mm-3 mm. Therefore, the strength of the parts and the convenience and quickness of operation can be better considered.

In embodiments of the present invention, the cutter head 10, the clamping member 20 and the clamping pad 30 are each configured to be longer than existing jaws, thereby further ensuring that a longer effective closure length is formed.

For example, as shown in fig. 6 and 16, the ratio between the thickness T of the end effector 1 and the thickness T of the end 121 of the extension 12 is 1.8 to 4. For example, the thickness t of the end 121 is 1mm to 2.2mm, preferably 1.2mm to 1.5mm, which can better satisfy both strength of the part and convenience of operation.

For example, as shown in fig. 15, the thickness t2 of the clamp pad 30 is 0.5mm to 1.5mm, preferably 0.8mm to 1.2mm. Through the arrangement, the jaw can be ensured to be closed to obtain larger clamping force, the clamping force from the tip to the tail end of the jaw is more balanced, and a better clamping effect on soft tissues and blood vessels can be achieved in operation.

Fig. 17 is a flowchart of a method for manufacturing an ultrasonic vibration assembly according to an embodiment of the present invention. As shown in fig. 17, in a method for manufacturing an ultrasonic vibration assembly configured to vibrate under excitation of ultrasonic waves, according to an embodiment of the present invention, the method includes:

s100: providing an ultrasonic transmission member and an end effector, wherein the ultrasonic transmission member includes a proximal end and a distal end opposite to each other along an extending direction thereof, and the end effector includes a base portion and an extending portion;

s200: connecting the base of the end effector with the distal end of the ultrasound transmission member;

Wherein the extension extends distally from the base and curves toward a side offset from the axis of the ultrasound transmission member; the extension includes: a main surface serving as a tissue treatment surface, a first side surface and a second side surface respectively located on opposite sides of the tissue treatment surface in a first direction and respectively connected with the tissue treatment surface;

the included angle between the tissue treatment surface and the first side surface is a first included angle, the included angle between the tissue treatment surface and the second side surface is a second included angle, and the first included angle and the second included angle are both larger than or equal to 60 degrees and smaller than or equal to 90 degrees.

For example, the above manufacturing method may be used to manufacture the ultrasonic vibration assembly according to any of the previous embodiments, and the description of the ultrasonic vibration assembly according to the previous embodiments may be incorporated into the manufacturing method provided by the embodiments of the present invention, and the description thereof will not be repeated here.

For example, the ultrasonic transmission member and the end effector may be formed separately or integrally.

For example, the ultrasonic transmission piece and the end execution part are of an integrally formed structure, namely, the characteristics shown in the drawings are obtained after milling a single metal rod. Alternatively, the ultrasonic transmission member and the end effector may comprise two or more separable components, which may have the same or different compositions, wherein the components are connected to one another by, for example, bonding, welding, threaded studs, and/or other suitable means known to those skilled in the art.

For example, the clamping member, ultrasonic transmission member and end effector may be made of any material, such as a variety of medically and surgically acceptable materials, such as titanium, titanium alloys (e.g., ti6a 14V), aluminum alloys, or stainless steel.

For example, the gripping pad is formed of a polymeric or other flexible material (compliant material). The clamp pad may be made of a material such as PTFE or Polyimide (PI), with or without the addition of a filler material such as glass, metal, and/or carbon. Further, the clamping pad may include a high temperature resistant material to prevent melting.

The existing ultrasonic knife jaw is short and thick in shape, is inconvenient to shuttle in soft tissues, is short in effective closing size, and is poor in efficiency of cutting soft tissues and closing blood vessels.

In the ultrasonic vibration assembly, the ultrasonic surgical instrument and the manufacturing method thereof provided by the embodiment of the invention, the cutter head 10, the clamping member 20 and the clamping pad 30 are longer than the conventional cutter head, clamping member and clamping pad. The effective closing length L of the jaws is about 138% of the effective closing length of the existing jaws, the thickness T of the jaws after closing is about 63% of the thickness of the existing jaws, the width W0 of the tip end (i.e. at the tip end of the extension 12) is about 71% of the width of the tip end of the existing tool, and the thickness T of the tip end of the tool is about 75% of the thickness of the tip end of the existing tool.

In summary, the ultrasonic vibration assembly provided by the embodiment of the invention has an elongated shape, and is convenient to shuttle in soft tissues; the effective closing size of the jaw is longer, so that more soft tissues can be clamped at one time, large blood vessels can be captured more easily, and the efficiency of cutting soft tissues and closing blood vessels is improved.

In this context, the following points need to be noted:

(1) The drawings of the embodiments of the present invention relate only to the structures related to the embodiments of the present invention, and other structures may refer to the general designs.

(2) The embodiments of the invention and the features of the embodiments can be combined with each other to give new embodiments without conflict.

(3) The foregoing is merely exemplary embodiments of the present invention and is not intended to limit the scope of the invention, which is defined by the appended claims.

Claims

1. An ultrasonic vibration assembly configured to vibrate under excitation of ultrasonic waves and comprising an ultrasonic transmission member including a proximal end and a distal end opposite to each other along an extending direction thereof, and an end effector comprising:

a base connected to the distal end;

an extension extending distally from the base and curving toward a side offset from an axis of the ultrasound transmission member, the extension comprising: a main surface, a first side surface and a second side surface, said main surface serving as a tissue treatment surface, said first side surface and said second side surface being located on opposite sides of and connected to said tissue treatment surface, respectively, in a first direction,

the included angle between the tissue treatment surface and the first side surface is a first included angle, the included angle between the tissue treatment surface and the second side surface is a second included angle, and the first included angle and the second included angle are both larger than or equal to 60 degrees and smaller than or equal to 90 degrees;

Wherein the extension further comprises:

a tip, the tissue treatment surface extending from the base to the tip;

a third side surface extending from an initial position near the base to the tip, wherein the second side surface includes a first side and a second side opposite to each other in a direction perpendicular to the tissue treatment surface, the tissue treatment surface being connected to the first side of the second side surface, the third side surface being connected to the second side of the second side surface, wherein a width of the third side surface is set to gradually increase from a zero value to a maximum value at the initial position toward the tip;

a fourth side surface extending from the base to the tip, the fourth side surface being connected to the first side surface;

wherein the first side surface extends from the base to the tip and a width of the first side surface is configured to taper toward the tip; the second side surface extends from the base to the tip, and a width of the second side surface is set to gradually decrease toward the tip; when the third side surface is set from the initial position, the cross-sectional shape of the extension portion changes from a quadrilateral to a pentagon, thereby forming a sharp edge between the third side surface and the fourth side surface to distract soft tissue when the end effector is opened, the quadrilateral being configured to enhance the strength of the end effector.

2. The ultrasonic vibration assembly of claim 1, wherein the first included angle and the second included angle are each 90 °.

3. The ultrasonic vibration assembly of claim 1, wherein the ultrasonic vibration assembly comprises,

wherein the tissue treatment surface is planar and the width of the tissue treatment surface is arranged to taper towards the tip.

4. The ultrasonic vibration assembly of claim 1, wherein the first side surface and the second side surface are each arcuate surfaces, and wherein the first side surface is an outer convex surface and the second side surface is an inner concave surface.

5. The ultrasonic vibration assembly of claim 1, wherein the ultrasonic vibration assembly comprises,

the tail end is provided with a tail end surface, and an included angle between the central line of the tail end surface and the axis of the ultrasonic transmission piece is 14-21 degrees in the plane of the tissue treatment surface;

the tip has a thickness in a direction perpendicular to the tissue treatment surface, the thickness being 1mm to 2.2mm.

6. The ultrasonic vibration assembly of claim 1, wherein the third side surface is concave and cambered.

7. The ultrasonic vibration assembly of claim 1, wherein the ultrasonic vibration assembly comprises,

The tip having a tip face, the third side surface and the second side surface each extending to the tip face;

and on the tail end face, an included angle between the third side surface and the second side surface is 120-150 degrees.

8. The ultrasonic vibration assembly of claim 1, wherein the first side surface comprises first and second sides opposite each other in a direction perpendicular to the tissue-treating surface, the tissue-treating surface being connected to the first side of the first side surface, the fourth side surface being connected to the second side of the first side surface,

wherein the fourth side surface is provided as a rounded surface.

9. The ultrasonic vibration assembly of claim 8, wherein the third side surface comprises first and second sides opposite each other in a direction perpendicular to the tissue treatment surface, the first side of the third side surface being connected to the second side surface;

the fourth side surface is connected to the second side of the third side surface on the distal end face of the distal end.

10. The ultrasonic vibration assembly of claim 1, wherein the extension further comprises:

A fifth side surface extending from the base toward the tip, the fourth side surface including a first side and a second side opposite to each other in a direction perpendicular to a direction in which the fourth side surface extends, the fifth side surface being connected to the second side of the fourth side surface, the first side of the fourth side surface being connected to the first side surface;

wherein the width of the fifth side surface is arranged to gradually decrease towards the end until the width is zero.

11. An ultrasonic surgical instrument comprising the ultrasonic vibration assembly of any one of claims 1 to 10.

12. The ultrasonic surgical instrument of claim 11, further comprising:

an ultrasonic generator, connected to the ultrasonic vibration assembly, configured to generate the ultrasonic waves that vibrate the ultrasonic vibration assembly;

the transmission assembly is sleeved on the ultrasonic transmission piece; and

an end effector comprising the end effector portion and a clamp pivotally connected to a distal end of the drive assembly;

wherein the transmission assembly is configured to move along the extending direction of the ultrasonic transmission piece so as to drive the clamping piece to pivot relative to the end execution part;

Wherein the clamp includes a side curved away from an axis of the ultrasound transmission member and includes: a first clamp main surface and a second clamp main surface opposite to each other in a thickness direction thereof, the first clamp main surface facing away from the tissue processing surface, and a groove penetrating the first clamp main surface and the second clamp main surface, the second clamp main surface facing toward the tissue processing surface;

wherein the groove extends in a length direction of the clip and includes: two first openings are formed in the main surface of the first clamping piece, and the two first openings are arranged side by side along the first direction.

13. The ultrasonic surgical instrument of claim 12, wherein the slot further comprises:

a plurality of second openings formed in the first clamping member major surface; wherein the two first apertures comprise a first side and a second side opposite each other in a second direction parallel to the tissue treatment surface, the first side being proximal to the distal end of the clip and the second side being distal to the distal end of the clip;

the second holes are arranged on the first side and distributed along the length direction of the clamping piece.

14. The ultrasonic surgical instrument of claim 12, wherein the slot further comprises:

a third opening provided on the second clamping member main surface and extending in the direction of extension of the clamping member, the third opening including a first end and a second end opposite to each other in the direction of extension thereof, the first end being close to the distal end of the clamping member, the second end being remote from the distal end of the clamping member;

wherein the third opening includes a first opening portion at the second end and a second opening portion connected to the first opening portion, the second opening portion including two first flanges opposing each other in the first direction.

15. The ultrasonic surgical instrument of claim 13, wherein the end effector further comprises:

the clamping pad is located between the ultrasonic transmission piece and the clamping piece, a boss is arranged on one side of the clamping pad facing the clamping piece, extends along the length direction of the clamping piece and is configured to be matched with the groove so as to connect the clamping pad to the clamping piece.

16. The ultrasonic surgical instrument of claim 15, wherein the clamp pad is curved toward a side offset from the axis of the ultrasonic transmission member, and wherein the clamp pad includes a clamp pad major surface facing the tissue-treating surface of the ultrasonic transmission member, the clamp pad major surface being a toothed surface.

17. The ultrasonic surgical instrument of claim 13 wherein,

the ratio between the effective closing length L of the end effector and the thickness T is 3.25-9.5, and the ratio between the thickness T and the thickness T of the end of the extension is 1.8-4.

18. A method of manufacturing an ultrasonic vibration assembly configured to vibrate under excitation of ultrasonic waves, the method comprising:

providing an ultrasonic transmission member and an end effector, wherein the ultrasonic transmission member includes a proximal end and a distal end opposite to each other along an extending direction thereof, and the end effector includes a base portion and an extending portion;

connecting a base of the end effector with a distal end of the ultrasound transmission member;

wherein the extension extends distally from the base and curves toward a side offset from the axis of the ultrasound transmission member; the extension includes: a main surface, a first side surface and a second side surface, the main surface serving as a tissue treatment surface, the first side surface and the second side surface being located on opposite sides of the tissue treatment surface in a first direction and being connected to the tissue treatment surface, respectively;

wherein the extension further comprises:

a tip, the tissue treatment surface extending from the base to the tip;

a third side surface extending from an initial position near the base to the tip, wherein the second side surface includes a first side and a second side opposite to each other in a direction perpendicular to the tissue treatment surface, the tissue treatment surface being connected to the first side of the second side surface, the third side surface being connected to the second side of the second side surface, wherein a width of the third side surface is set to gradually increase toward the tip; a fourth side surface extending from the base to the tip, the fourth side surface being connected to the first side surface;