WO2022188897A1 - 超声波手术刀头 - Google Patents

超声波手术刀头 Download PDF

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Publication number
WO2022188897A1
WO2022188897A1 PCT/CN2022/089894 CN2022089894W WO2022188897A1 WO 2022188897 A1 WO2022188897 A1 WO 2022188897A1 CN 2022089894 W CN2022089894 W CN 2022089894W WO 2022188897 A1 WO2022188897 A1 WO 2022188897A1
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Prior art keywords
knife
ultrasonic scalpel
head
ultrasonic
tip
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PCT/CN2022/089894
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English (en)
French (fr)
Inventor
颜忠余
王磊
刘振中
骆威
Original Assignee
以诺康医疗科技（苏州）有限公司
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Application filed by 以诺康医疗科技（苏州）有限公司 filed Critical 以诺康医疗科技（苏州）有限公司
Priority to AU2022232114A priority Critical patent/AU2022232114A1/en
Priority to BR112023013060A priority patent/BR112023013060A2/pt
Priority to CA3202846A priority patent/CA3202846A1/en
Priority to KR1020237022776A priority patent/KR20230154168A/ko
Priority to DE212022000100.1U priority patent/DE212022000100U1/de
Priority to GB2308530.1A priority patent/GB2617711A/en
Priority to US18/549,136 priority patent/US20240156484A1/en
Priority to EP22766419.0A priority patent/EP4306064A1/en
Priority to JP2023544061A priority patent/JP2024503524A/ja
Publication of WO2022188897A1 publication Critical patent/WO2022188897A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00982—General structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A61B2017/320073—Working tips with special features, e.g. extending parts probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A61B2017/320074—Working tips with special features, e.g. extending parts blade
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320082—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for incising tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320089—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic node location

Definitions

  • the invention relates to the field of medical instruments, in particular to a cutter head of an ultrasonic scalpel.
  • Ultrasonic scalpel refers to further amplifying the ultrasonic vibration obtained by the piezoelectric converter (electrical energy is transmitted to the piezoelectric converter through the energy generator, and the electrical energy is converted into ultrasonic mechanical energy by the piezoelectric converter), The amplified ultrasonic vibration is used by the scalpel head for cutting and coagulation of soft tissue.
  • the clinical use of this device enables resection of lesions at lower temperatures and less bleeding, while ensuring minimal lateral thermal damage to the tissue. With the popularity of minimally invasive surgery, the ultrasonic scalpel has become a conventional surgical instrument.
  • ultrasonic scalpels generally have short clamping lengths (and working lengths), and most of the single cutting lengths are about 13mm, which results in high frequency of tissue separation operations and long operation time.
  • the diameter of the blood vessel exceeds 3 mm, and the reliability of sealing is greatly reduced, and it is powerless for blood vessels with a diameter of more than 5 mm.
  • the vibration amplitude is too small, the operation time is too long.
  • the present invention provides an ultrasonic scalpel head which can improve the hemostatic effect and increase the effective working length.
  • the technical scheme of the present invention is:
  • An ultrasonic scalpel head comprising a knife tail located at the proximal end and a knife tip located at the distal end, the joint surface of the knife head and the claw pad of the ultrasonic scalpel is a shearing surface, and the ultrasonic scalpel head is located in the
  • the projection on the shear plane is a banana-shaped curved shape, and the thickness changes from the blade end and the blade tip.
  • An ultrasonic scalpel head comprising a knife tail located at the proximal end and a knife tip located at the distal end, the joint surface of the knife head and the claw pad of the ultrasonic scalpel is a shearing surface, and the ultrasonic scalpel head is located in the
  • the projection on the shearing surface is a banana-shaped curved shape, including a front concave surface and a back convex surface, the length of the front concave surface is L1, the radius of the radian is R2, the length of the back convex surface is L2, and the length of the front concave surface is L2, and the length of the front concave surface is L2, and the length of the back convex surface is L2.
  • the first convex surface and the second convex surface close to the tool tip have a smooth transition.
  • the radius of the first convex surface is R4, the radius of the second convex surface is R3, the thickness of the knife tail is T1, and the The thickness of the tool tip is T4, and the angle between the center line and the horizontal line at the tool tip is ⁇ , which satisfies the following formula:
  • the length L1 of the front concave surface is between 15mm and 19mm, preferably 17.5mm.
  • the arc radius R2 of the front concave surface is between 19mm and 25mm, preferably 22mm.
  • the length L2 of the rear convex surface is between 13mm and 17mm, preferably 14.5mm.
  • the radius R4 of the first convex surface of the rear convex surface is between 3 mm and 7 mm, preferably 5 mm, and the radius R3 of the second convex surface is between 12 mm and 16 mm, preferably 14 mm.
  • the knife tail 101 at the proximal end has a cylindrical section extending toward the proximal end.
  • the highest point of the tool tip is higher than the highest point of the cylindrical section, and the lowest point of the second convex surface is lower than the lowest point of the cylindrical section.
  • An ultrasonic scalpel head comprising a knife tail located at the proximal end and a knife tip located at the distal end, the joint surface of the knife head and the claw pad of the ultrasonic scalpel is a shearing surface, and the ultrasonic scalpel head is located in the
  • the projection on the shearing surface is a banana-shaped curved shape, and the projection perpendicular to the shearing surface is the shape of a fruit knife.
  • An arc-shaped notch is provided.
  • the radius of the arc-shaped groove is R1, preferably 7mm.
  • the upper end of the cutter head is provided with an arc-shaped cut surface, and the lower end is provided with a V-shaped cut groove.
  • the width of the distal end of the ultrasonic scalpel head in the direction perpendicular to the shearing plane is half of the diameter of the proximal end.
  • An ultrasonic scalpel head comprising a knife tail located at the proximal end and a knife tip located at the distal end, the joint surface of the knife head and the claw pad of the ultrasonic scalpel is a shearing surface, and the ultrasonic scalpel head is located in the
  • the projection on the shear plane is a banana-shaped curved shape, and at least one balance slot is set between the knife tail and the first node of the ultrasonic scalpel.
  • the projection of the balance groove on the shear plane is a boat-shaped structure, or a circular arc structure, or a combination of a boat-shaped structure and a circular arc structure.
  • the projection of the ultrasonic scalpel head of the present invention on the shear plane is a banana-shaped curved shape, from the proximal section to the distal end, the thickness of the cutter head becomes thinner from thicker, thicker and thinner again
  • the projection on the vertical shear plane is the shape of a fruit knife, the height of the knife head changes from high to low, and then gradually decreases, and there is an arc-shaped groove in the middle position, which can cause the swing amplitude of the bending direction of the knife head and the effective working length.
  • Fig. 1 is the schematic diagram that ultrasonic scalpel head of the present invention is used for endoscopic surgical instrument
  • Fig. 2 is the detailed assembly schematic diagram of the ultrasonic scalpel head of the present invention for the endoscopic surgical instrument
  • Fig. 3 and Fig. 4 are the projection schematic diagrams of the ultrasonic scalpel head of the present invention on the shear plane;
  • Fig. 5 is the projection schematic diagram of the ultrasonic scalpel head of the present invention perpendicular to the shear plane;
  • Fig. 6 is the structural representation of the blade tip of the ultrasonic scalpel head of the present invention.
  • Fig. 7 is the schematic diagram of the first embodiment of the balance groove of the ultrasonic scalpel head of the present invention.
  • Fig. 8 is a schematic diagram of a second embodiment of the balance groove of the ultrasonic scalpel head of the present invention.
  • the present invention discloses an ultrasonic scalpel head 100 , which is applied to a laparoscopic surgical instrument 110 or an open surgical instrument.
  • the ultrasonic scalpel head 100 is disposed at the distal end of the surgical instrument, and cooperates with claw pads disposed relative to the pivot axis to perform tissue cutting and/or suturing.
  • the ultrasonic scalpel head 100 includes a knife tail 101 located at the proximal end and a knife tip 102 located at the distal end, and the combination of the knife head and the claw pad of the ultrasonic scalpel The plane is the cut plane.
  • the proximal end of the ultrasonic scalpel head of the present invention is the support end in actual use, in order to maintain the overall rigidity and stability, the maximum size is required.
  • the distal tip must be a minimum size for better separation and finer manipulation.
  • the cutter head itself will generate bending vibration, which will cause lateral vibration of the shaft, resulting in abnormal vibration, abnormal noise and heat generation. Therefore, the present invention ensures the overall balance through the size control of each part of the cutter head.
  • the projected banana-shaped curved shape of the ultrasonic scalpel head on the shearing surface includes a front concave surface and a back convex surface
  • the length 114 of the front concave surface is L1
  • the arc radius 113 is R2
  • the The length 117 of the rear convex surface is L2 and includes a first convex surface close to the knife end 101 and a second convex surface close to the knife tip 102, with a smooth transition between the two
  • the radius 118 of the first convex surface is R4
  • the The radius 116 of the second convex surface is R3, the thickness of the blade tail 101 is T1, the thickness of the blade tip 102 is T4, and the angle 119 between the center line of the blade tip and the horizontal line is ⁇ , which satisfies the following formula:
  • the knife tail 101 at the proximal end has a cylindrical section 111 extending toward the proximal end.
  • the highest point 115 of the tool tip 102 is higher than the highest point of the cylindrical section 111
  • the lowest point of the second convex surface 116 is lower than the highest point of the cylindrical section 111 lowest point.
  • the difference between the arc lengths of the front concave surface and the rear convex surface is determined by the joint action of the diameter T1 of the rear end support section and the thickness of the tip T4.
  • the tool bar designed by the above formula can ensure the overall design center of gravity of the curved tool head shape to the greatest extent.
  • the center line of the body so as to ensure the stability of the mode shape.
  • the highest point of the tip of the cutter head is higher than the highest point of the cylindrical section 111, and the lowest point of the second convex surface 116 is lower than the lowest point of the cylindrical section 111.
  • This design can maximize the bending curvature of the bending cutter head on the basis of ensuring the stability of the vibration pattern. In this way, the swing amplitude along the bending direction can be significantly increased, and a faster heat accumulation rate can also be generated, which is helpful for firmer coagulation between blood vessel walls, thereby achieving a more reliable blood vessel closure effect.
  • the length L1 of the front concave surface is between 15mm and 19mm, preferably 17.5mm. This length determines the shear length of the final product. Too long will lead to a decrease in the resonance frequency, an increase in the processing difficulty and an increase in the resonance stress. The comprehensive selection of 17.5mm is an ideal parameter.
  • the arc radius R2 of the front concave surface is between 19mm and 25mm, preferably 22mm.
  • the length L2 of the rear convex surface is between 13 mm and 17 mm, preferably 14.5 mm.
  • the radius R4 of the first convex surface of the rear convex surface is between 3mm and 7mm, preferably 5mm
  • the radius R3 of the second convex surface is between 12 mm and 16 mm, preferably 14 mm.
  • the thickness T1 of the blade tail is between 2.2 mm and 2.8 mm, preferably 2.6 mm.
  • the thickness T4 of the blade tip is between 0.8 mm and 1.2 mm, preferably 0.9 mm. If the thickness of the tip is too thick, the cutting surface will be too wide, which is not conducive to fine operation; if it is too narrow, the strength will decrease, and the cutter head will be easily deformed.
  • the preferred 0.9mm is an ideal parameter.
  • the angle ⁇ between the center line of the tool tip and the horizontal line is about 30°.
  • the projection of the ultrasonic scalpel head perpendicular to the shearing plane is a fruit knife shape, and the height gradually decreases from the knife tail 101 to the knife tip 102 , and A circular arc-shaped notch 112 is provided near the knife end 101 .
  • the tapered structure design of this progressive shape can achieve an increase in the effective working length. A longer working length can achieve better closure of large-diameter blood vessels, and can also achieve faster tissue separation, effectively reducing the duration and frequency of a single operation, and reducing the fatigue intensity of medical staff.
  • the radius of the arc-shaped cut groove 112 is R1, preferably 7 mm.
  • the most distal width T5 is half the proximal diameter T1. The design of this size can ensure that the lowest point of the tip of the cutter head is just on the center line of the shaft, and the space volume removed by the arc-shaped notch 112 can just compensate for the unstable vibration caused by the progressive tapered structure at the distal end. On the premise of ensuring stability, the improvement of the effective length of the progressive tapered structure is maximized.
  • the upper end of the cutter head is provided with an arc-shaped cut surface 120
  • the lower end is provided with a V-shaped cut groove 121 .
  • the angle formed by the inclined surfaces on both sides of the V-shaped cut groove 121 is preferably 100°.
  • the arc-shaped cut surface 120 cooperates with the paw pad to achieve the effect of cutting and coagulation of soft tissue.
  • the sharp edge formed by the V-shaped cut groove 121 is helpful for better separation of the thin film tissue.
  • the ultrasonic scalpel head is provided with at least one balance slot between the blade tail 101 and the first node 122 of the ultrasonic scalpel.
  • the projection of the balance groove on the shear plane may be the boat-shaped structure 123 shown in FIG. 7 , the arc structure 124 shown in FIG. 8 , or a combination of the boat-shaped structure and the circular arc structure.
  • Such a structure is used to improve the stability of ultrasonic vibration.
  • the shape design of the cutter head and the curved asymmetric cutter head structure design easily lead to unstable operation of the cutter head.
  • the final product may produce very large bending vibration, torsional vibration or other forms of vibration. This can reduce system stability, produce abnormal noise, reduce ultrasonic transmission efficiency, and produce adverse effects such as abnormal heating.
  • the present invention proposes to add one or more balanced grooves.
  • the compensation position is located between the most distal node and the middle position of the cutter head.

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Abstract

一种超声波手术刀头(100)，该刀头(100)在剪切面的投影为香蕉形弯曲状，从近段至远端，刀头(100)厚度由厚变薄，再变厚再变薄。垂直剪切面的投影为水果刀形状，刀头(100)高度由高变低，再逐步递减，并在中间位置有一个圆弧状切槽。该刀头(100)的弯曲方向摆振幅度以及有效工作长度增加，最远端节点至刀头(100)尖端之间有船型（123）或圆弧型（124）平衡切槽，可提高超声波振动的稳定性。

Description

超声波手术刀头 技术领域
本发明涉及医疗器械领域，尤其涉及一种超声波手术刀的刀头。
背景技术
超声波手术刀(简称超声刀)，是指将通过压电转换器(通过能量发生器将电能传递至压电转换器，由压电转换器将电能转换为超声机械能)获得的超声振动进一步放大，并由手术刀的头部将放大后的超声振动用于对软组织的切割和凝闭的器械。临床用这种器械可在较低温度和较少出血的情况下实现病灶切除，并能确保最小的组织侧向热损伤。随着微创外科手术的普及，超声波手术刀已经成为一种常规手术器械。
目前超声波手术刀普遍夹持长度(及工作长度)较短，单次切割长度绝大多数都在13mm左右，造成术中组织分离操作频次过高且手术时间也较长；夹持长度偏短也导致血管直径超过3mm，封闭可靠性大大下降，对于直径超过5mm的血管更是无能为力。并且由于振动幅度偏小，也导致手术时间过长。
发明内容
本发明为了解决上述现有技术的问题，提供了一种能提高止血效果、增加有效工作长度的超声波手术刀头。
为解决以上技术问题，本发明的技术方案为：
一种超声波手术刀头，包括位于近端的刀尾和位于远端的刀尖，所述刀头与超声波手术刀的爪垫的结合面为剪切面，所述超声波手术刀头在所述剪切面上的投影为香蕉形弯曲状，从刀尾和刀尖形成厚度变化，厚度依次分别为T1，T2，T3，T4，T1>T3>T2>T4，且T1＝T2+T3+T4、误差±10％。
一种超声波手术刀头，包括位于近端的刀尾和位于远端的刀尖，所述刀头与超声波手术刀的爪垫的结合面为剪切面，所述超声波手术刀头在所述剪切面上的投影 为香蕉形弯曲状，包括前凹面和后凸面，所述前凹面的长度为L1、弧度半径为R2，所述后凸面的长度为L2，且包括靠近所述刀尾的第一凸面和靠近所述刀尖的第二凸面，两者圆滑过渡，所述第一凸面的半径为R4，所述第二凸面的半径为R3,所述刀尾的厚度为T1，所述刀尖的厚度为T4，所述刀尖处中心线与水平线的夹角为α，满足如下公式：
Figure PCTCN2022089894-appb-000001
误差±10％。
优选的，所述前凹面的长度L1在15mm至19mm之间，优选的为17.5mm。
优选的，所述前凹面的弧度半径R2在19mm至25mm之间，优选的为22mm。
优选的，所述后凸面的长度L2在13mm至17mm之间，优选的为14.5mm。
优选的，所述后凸面的第一凸面的半径R4在3mm至7mm之间，优选的为5mm，所述第二凸面的半径R3在12mm至16mm之间，优选的为14mm。
优选的，所述位于近端的刀尾101具有一向近端延伸的圆柱段。
优选的，在所述剪切面上的投影上，所述刀尖的最高点高于所述圆柱段的最高点，所述第二凸面的最低点低于所述圆柱段的最低点。
一种超声波手术刀头，包括位于近端的刀尾和位于远端的刀尖，所述刀头与超声波手术刀的爪垫的结合面为剪切面，所述超声波手术刀头在所述剪切面上的投影为香蕉形弯曲状，在垂直于所述剪切面上的投影为水果刀形状，从所述刀尾向所述刀尖高度逐步递减，并在靠近所述刀尾处设置有一圆弧状切槽。
所述圆弧状切槽的半径为R1，优选7mm。
优选的，所述刀头上端设有一个弧形切面，下端设有一个V型切槽。
优选的，所述超声波手术刀头在垂直于所述剪切面方向上远端的宽度为近端直径的一半。
一种超声波手术刀头，包括位于近端的刀尾和位于远端的刀尖，所述刀头与超声波手术刀的爪垫的结合面为剪切面，所述超声波手术刀头在所述剪切面上的投影 为香蕉形弯曲状，所述刀尾与超声波手术刀的第一节点间设置有至少一个平衡槽。
优选的，所述平衡槽在所述剪切面上的投影为船型结构，或为圆弧结构，或为船型结构与圆弧结构的组合。
本发明的有益效果主要体现在：本发明的超声波手术刀头在剪切面的投影为香蕉形弯曲状，从近段至远端，刀头厚度由厚变薄，再变厚再变薄，在垂直剪切面的投影为水果刀形状，刀头高度由高变低，再逐步递减，并在中间位置有一个圆弧状切槽，可以导致刀头的弯曲方向摆振幅度以及有效工作长度的增加；该超声波手术刀头的最远端节点至刀头尖端之间有船型或圆弧型平衡切槽，用以提高超声波振动的稳定性。
附图说明
图1是本发明超声波手术刀头用于腔镜手术器械的示意图；
图2是本发明超声波手术刀头的用于腔镜手术器械的详细装配示意图；
图3和图4是本发明超声波手术刀头在剪切面上的投影示意图；
图5是本发明超声波手术刀头在垂直于剪切面上的投影示意图；
图6是本发明超声波手术刀头的刀尖的结构示意图；
图7是本发明超声波手术刀头的平衡槽的第一实施例的示意图；
图8是本发明超声波手术刀头的平衡槽的第二实施例的示意图。
具体实施方式
以下将结合附图所示的具体实施方式对本发明进行详细描述。但这些实施方式并不限于本发明，本领域的普通技术人员根据这些实施方式所做出的结构、方法、或功能上的变换均包含在本发明的保护范围内。
如图1和图2所示，本发明揭示了一种超声波手术刀头100，应用于腔镜手术器械110或者开放式手术器械。所述超声波手术刀头100设置在所述手术器械的远端，与相对枢轴设置的爪垫配合进行组织的切割和/或缝合。
结合图3至图6所示，本发明优选实施例的超声波手术刀头100包括位于近端的刀尾101和位于远端的刀尖102，所述刀头与超声波手术刀的爪垫的结合面为剪切面。
所述超声波手术刀头在所述剪切面上的投影为香蕉形弯曲状，从刀尾101和刀尖102形成厚度变化，厚度依次分别为T1，T2，T3，T4，T1>T3>T2>T4，且T1＝T2+T3+T4、误差±10％。
由于本发明的超声波手术刀头在实际使用中其近端为支撑端，为保持整体的刚性与稳定性，须尺寸最大值。远端的尖端为了实现更好的分离与更精细的操作，须为尺寸最小值。对于弯曲形状的刀头，刀头本身会产生弯曲振动，进而引起杆身的横向振动，造成乱振异响发热等异常。因此本发明通过刀头各部位的尺寸控制来保证整体的平衡性。
具体的，本发明所述超声波手术刀头在所述剪切面上的投影的香蕉形弯曲状包括前凹面和后凸面，所述前凹面的长度114为L1、弧度半径113为R2，所述后凸面的长度117为L2，且包括靠近所述刀尾101的第一凸面和靠近所述刀尖102的第二凸面，两者圆滑过渡，所述第一凸面的半径118为R4，所述第二凸面的半径116为R3,所述刀尾101的厚度为T1，所述刀尖102的厚度为T4，所述刀尖处中心线与水平线的夹角119为α，满足如下公式：
Figure PCTCN2022089894-appb-000002
误差±10％。
所述位于近端的刀尾101具有一向近端延伸的圆柱段111。在所述剪切面上的投影上，所述刀尖102的最高点115高于所述圆柱段111的最高点，所述所述第二凸面116的最低点低于所述圆柱段111的最低点。
前凹面与后凸面弧线长度的差值，受后端支撑段直径T1与尖端厚度T4共同作用来决定，满足上述公式设计的刀杆可以最大程度的保证弯曲刀头形状的整体设计重心位于杆身的中心线上，从而保证振型的稳定性。且可以实现刀头尖端的最高点 高于圆柱段111的最高点，所述所述第二凸面116的最低点低于所述圆柱段111的最低点。这种设计可以保证振动形态稳定的基础上，最大程度得实现弯曲刀头的弯曲曲率。这样，可以显著地增加沿弯曲方向的摆振幅度，也可以产生更快的热量积累速度，有助于血管壁之间凝结的更牢固，从而实现更可靠的血管闭合效果。
本优选实施例中，所述前凹面的长度L1在15mm至19mm之间，优选的为17.5mm。该长度决定了最终产品的剪切长度，过长会导致谐振频率的下降，加工难度的提高以及谐振应力的提高，综合选择17.5mm是比较理想的参数。
本优选实施例中，所述前凹面的弧度半径R2在19mm至25mm之间，优选的为22mm。
本优选实施例中，所述后凸面的长度L2在13mm至17mm之间，优选的为14.5mm。
本优选实施例中，所述后凸面的第一凸面的半径R4在3mm至7mm之间，优选的为5mm
本优选实施例中，所述第二凸面的半径R3在12mm至16mm之间，优选的为14mm。
本优选实施例中，所述刀尾的厚度T1在2.2mm至2.8mm之间，优选的为2.6mm。
本优选实施例中，所述刀尖的厚度T4在0.8mm至1.2mm之间，优选的为0.9mm。尖端厚度过厚会导致剪切面过宽，不利于精细操作；过窄会出现强度下降，且刀头易变形，尖端过于尖锐会提高手术过程中对健康组织误伤的风险程度，因此本优选实施例优选的0.9mm是较理想的参数。
本优选实施例中，所述刀尖处中心线与水平线的夹角α约30°左右。
具体如图5所示，本发明中，所述超声波手术刀头在垂直于所述剪切面上的投影为水果刀形状，从所述刀尾101向所述刀尖102高度逐步递减，并在靠近所述刀尾101处设置有一圆弧状切槽112。这种渐进形态的锥形结构设计可以实现有效工作长度的增加。更长的工作长度可以实现对大直径血管进行更好的闭合，也可以实现更快的组织分离速度，有效地减少单次手术时长和操作频次，降低医务人员的疲 劳强度。
本优选实施例中，所述圆弧状切槽112的半径为R1，优选7mm。最远端宽度T5为近端直径T1的一半。该尺寸的设计可以保证刀头尖端的最低点恰好位于杆身的中心线上，所述圆弧状切槽112去除的空间体积恰好可以补偿远端渐进锥形结构带来的不稳定振动，在保证稳定的前提下，最大程度地实现渐进锥形结构对于有效长度的提升幅度。
具体如图6所示，沿刀头尖端的中轴线方向投影来看，所述刀头上端设有一个弧形切面120，下端设有一个V型切槽121。所述V型切槽121两侧斜面形成的夹角优选的为100°。所述弧形切面120与爪垫共同作用，可以实现对软组织的切割、凝血的效果。所述V型切槽121形成的锋利刃口，有助于对薄膜组织进行更好的分离。
如图7和图8所示，所述超声波手术刀头在所述刀尾101与超声波手术刀的第一节点122之间设置有至少一个平衡槽。所述平衡槽在所述剪切面上的投影可以为图7所示的船型结构123，或为图8所示的圆弧结构124，或为船型结构与圆弧结构的组合。这样的结构用以提高超声波振动的稳定性。如前文所述的刀头形状设计，弯曲的非对称刀头结构设计，本身容易导致刀头工作不稳定。考虑到加工本身的偏差，以及长直刀杆的弯曲等实际情况，最终产品可能会产生非常大的弯振，扭振或其他形态的振动。这会降低系统稳定性，产生异常噪音，降低超声传输效率，产生异常发热等不利结果。鉴于此，本发明提出增加一个及以上的平衡切槽，优选的，补偿位置位于最远端节点与刀头中部位置之间。
以上仅是本发明的优选实施方式，应当指出的是，上述优选实施方式不应视为对本发明的限制，本发明的保护范围应当以权利要求所限定的范围为准。对于本技术领域的普通技术人员来说，在不脱离本发明的精神和范围内，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (13)

  1. 一种超声波手术刀头，包括位于近端的刀尾(101)和位于远端的刀尖(102)，所述刀头与超声波手术刀的爪垫的结合面为剪切面，其特征在于，所述超声波手术刀头在所述剪切面上的投影为香蕉形弯曲状，从刀尾(101)和刀尖(102)形成厚度变化，厚度依次分别为T1，T2，T3，T4，T1>T3>T2>T4，且T1＝T2+T3+T4、误差±10％。
  2. 一种超声波手术刀头，包括位于近端的刀尾(101)和位于远端的刀尖(102)，所述刀头与超声波手术刀的爪垫的结合面为剪切面，其特征在于，所述超声波手术刀头在所述剪切面上的投影为香蕉形弯曲状，包括前凹面和后凸面，所述前凹面的长度(114)为L1、弧度半径(113)为R2，所述后凸面的长度(117)为L2，且包括靠近所述刀尾(101)的第一凸面和靠近所述刀尖(102)的第二凸面，两者圆滑过渡，所述第一凸面的半径(118)为R4，所述第二凸面的半径(116)为R3,所述刀尾(101)的厚度为T1，所述刀尖(102)的厚度为T4，所述刀尖处中心线与水平线的夹角(119)为α，满足如下公式：
    Figure PCTCN2022089894-appb-100001
    误差±10％。
  3. 根据权利要求2所述的超声波手术刀头，其特征在于，所述前凹面的长度(114)L1在15mm至19mm之间。
  4. 根据权利要求2所述的超声波手术刀头，其特征在于，所述前凹面的弧度半径(113)R2在19mm至25mm之间。
  5. 根据权利要求2所述的超声波手术刀头，其特征在于，所述后凸面的长度(117)L2在13mm至17mm之间。
  6. 根据权利要求2所述的超声波手术刀头，其特征在于，所述后凸面的第一凸面的半径(118)R4在3mm至7mm之间，优选的为5mm，所述第二凸面的半径(116)R3在12mm至16mm之间。
  7. 根据权利要求2所述的超声波手术刀头，其特征在于，所述位于近端的刀尾 (101)具有一向近端延伸的圆柱段(111)。
  8. 根据权利要求7所述的超声波手术刀头，其特征在于，在所述剪切面上的投影上，所述刀尖(102)的最高点(115)高于所述圆柱段(111)的最高点，所述第二凸面(116)的最低点低于所述圆柱段(111)的最低点。
  9. 一种超声波手术刀头，包括位于近端的刀尾(101)和位于远端的刀尖(102)，所述刀头与超声波手术刀的爪垫的结合面为剪切面，其特征在于，所述超声波手术刀头在所述剪切面上的投影为香蕉形弯曲状，在垂直于所述剪切面上的投影为水果刀形状，从所述刀尾(101)向所述刀尖(102)高度逐步递减，并在靠近所述刀尾(101)处设置有一圆弧状切槽(112)。
  10. 根据权利要求9所述的超声波手术刀头，其特征在于，所述刀头上端设有一个弧形切面(120)，下端设有一个V型切槽(121)。
  11. 根据权利要求9所述的超声波手术刀头，其特征在于，所述超声波手术刀头在垂直于所述剪切面方向上远端的宽度为近端直径的一半。
  12. 一种超声波手术刀头，包括位于近端的刀尾(101)和位于远端的刀尖(102)，所述刀头与超声波手术刀的爪垫的结合面为剪切面，其特征在于，所述超声波手术刀头在所述剪切面上的投影为香蕉形弯曲状，所述刀尾(101)与超声波手术刀的第一节点(122)之间设置有至少一个平衡槽。
  13. 根据权利要求12所述的超声波手术刀头，其特征在于，所述平衡槽在所述剪切面上的投影为船型结构(123)，或为圆弧结构(124)，或为船型结构与圆弧结构的组合。
PCT/CN2022/089894 2021-03-08 2022-04-28 超声波手术刀头 WO2022188897A1 (zh)

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Publication number Priority date Publication date Assignee Title
CN113017777A (zh) * 2021-03-08 2021-06-25 以诺康医疗科技（苏州）有限公司 超声波手术刀头
CN114587509B (zh) * 2022-03-09 2024-04-05 苏州锐诺医疗技术有限公司 无绳超声刀
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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010027325A1 (en) * 1998-06-29 2001-10-04 Jean M. Beaupre Curved ultrasonic blade having a trapezoidal cross section
US20170119425A1 (en) * 2015-10-30 2017-05-04 Ethicon Endo-Surgery, Llc Ultrasonic surgical instrument clamp arm with proximal nodal pad
CN107595368A (zh) * 2017-10-19 2018-01-19 以诺康医疗科技（苏州）有限公司 一种超声波手术刀头、刀杆及超声波手术刀
CN107690484A (zh) * 2015-03-10 2018-02-13 伊西康有限责任公司 具有抗疲劳性能的外科刀
CN107750141A (zh) * 2015-06-17 2018-03-02 伊西康有限责任公司 与超声外科器械一起使用的超声外科刀
CN110327100A (zh) * 2019-08-15 2019-10-15 上海题屏医疗科技有限公司 一种超声手术刀
CN110662497A (zh) * 2017-05-22 2020-01-07 爱惜康有限责任公司 具有弯曲超声刀的组合超声和电外科器械
CN113017777A (zh) * 2021-03-08 2021-06-25 以诺康医疗科技（苏州）有限公司 超声波手术刀头
CN215584294U (zh) * 2021-03-08 2022-01-21 以诺康医疗科技（苏州）有限公司 超声波手术刀头

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010027325A1 (en) * 1998-06-29 2001-10-04 Jean M. Beaupre Curved ultrasonic blade having a trapezoidal cross section
CN107690484A (zh) * 2015-03-10 2018-02-13 伊西康有限责任公司 具有抗疲劳性能的外科刀
CN107750141A (zh) * 2015-06-17 2018-03-02 伊西康有限责任公司 与超声外科器械一起使用的超声外科刀
US20170119425A1 (en) * 2015-10-30 2017-05-04 Ethicon Endo-Surgery, Llc Ultrasonic surgical instrument clamp arm with proximal nodal pad
CN110662497A (zh) * 2017-05-22 2020-01-07 爱惜康有限责任公司 具有弯曲超声刀的组合超声和电外科器械
CN107595368A (zh) * 2017-10-19 2018-01-19 以诺康医疗科技（苏州）有限公司 一种超声波手术刀头、刀杆及超声波手术刀
CN110327100A (zh) * 2019-08-15 2019-10-15 上海题屏医疗科技有限公司 一种超声手术刀
CN113017777A (zh) * 2021-03-08 2021-06-25 以诺康医疗科技（苏州）有限公司 超声波手术刀头
CN215584294U (zh) * 2021-03-08 2022-01-21 以诺康医疗科技（苏州）有限公司 超声波手术刀头

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