WO2024055527A1 - Partie de coupe et partie de transition pour scalpel à ultrasons, et scalpel à ultrasons - Google Patents

Partie de coupe et partie de transition pour scalpel à ultrasons, et scalpel à ultrasons Download PDF

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Publication number
WO2024055527A1
WO2024055527A1 PCT/CN2023/078380 CN2023078380W WO2024055527A1 WO 2024055527 A1 WO2024055527 A1 WO 2024055527A1 CN 2023078380 W CN2023078380 W CN 2023078380W WO 2024055527 A1 WO2024055527 A1 WO 2024055527A1
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WO
WIPO (PCT)
Prior art keywords
cutting
ultrasonic scalpel
cutting edge
ultrasonic
tooth
Prior art date
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PCT/CN2023/078380
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English (en)
Chinese (zh)
Inventor
王磊
郑少腾
刘柯
颜忠余
骆威
Original Assignee
以诺康医疗科技 (苏州) 有限公司
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Publication of WO2024055527A1 publication Critical patent/WO2024055527A1/fr

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Classifications

    • 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
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320069—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for ablating 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
    • A61B2017/32007—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with suction or vacuum means
    • 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
    • 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
    • A61B2017/320078—Tissue manipulating surface
    • 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
    • A61B2017/320098—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with transverse or torsional motion

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a cutting part, a transition part and an ultrasonic scalpel for an ultrasonic scalpel.
  • the operator hopes that the tissue to be ablated and resected will be tightly adherent to the normal tissue that he wishes to retain. If conventional resection methods are used, it will be difficult to completely ablate and resect the diseased tissue while maintaining normal tissue.
  • the existing technology provides an ultrasonic scalpel with longitudinal vibration mode. Through the longitudinal vibration mode of the ultrasonic scalpel, it can effectively ablate and remove diseased tissue while avoiding damage to normal tissue. .
  • the ultrasonic scalpel in longitudinal vibration mode includes an ultrasonic scalpel head and a vacuum suction system set up to cooperate with the ultrasonic scalpel head.
  • a simple ultrasonic scalpel head combined with a vacuum suction system can meet the needs of surgery, but for In some fiber-rich pathological connective tissue, fibrous tissue, or more complex soft tissue cutting or bone and other hard tissue cutting, due to the large adhesion and friction between the blade and the tissue, only longitudinal vibration can occur.
  • the mode cannot cut quickly and accurately, especially in application scenarios that require grinding or debridement.
  • the ultrasonic scalpel with only longitudinal vibration mode cannot meet the needs of high-precision surgeries. It is difficult to effectively remove diseased tissue with conventional ultrasonic scalpel.
  • a simple ultrasonic blade combined with a vacuum suction system can meet the surgical needs, but for some fiber-rich diseased connective tissue, fibrous tissue, or more complex soft tissue cutting or hard bones and other hard For tissue cutting, it is difficult for conventional ultrasonic scalpels to effectively remove diseased tissue.
  • embodiments of the present application provide a cutting part, a transition part and an ultrasonic scalpel for an ultrasonic scalpel.
  • a first aspect of an embodiment of the present application provides a cutting part for an ultrasonic scalpel.
  • the end of the cutting part is provided with a plurality of cutting teeth.
  • the cutting teeth are provided with first cutting edges connected at the tooth tops. and a second cutting edge, the first cutting edge and the second cutting edge being located on the outer circumferential surface of the cutting part;
  • the cutting teeth are also provided with a third cutting edge connected to the first cutting edge and the second cutting edge at the tooth top;
  • the third cutting edge gradually approaches the axis of the cutting part from the distal end to the proximal end.
  • the first cutting edge and the second cutting edge are arc-shaped structures and form a certain angle with the axis of the cutting part.
  • a fourth cutting edge is further provided between two adjacent cutting teeth.
  • the inside of the end surface where the fourth cutting edge is located is closer to the proximal end than the outside, where the inside refers to the direction close to the axial direction of the cutting part, and the outside refers to the direction away from the axial direction of the cutting part.
  • the line connecting the cutting tooth from the tooth root to the tooth tip is parallel to the axis of the cutting part, or forms a certain inclination angle with the axis of the cutting part.
  • the tooth tips of the cutting teeth have a blunt surface structure.
  • the cutting part is provided with a pre-suction hole, and the pre-suction hole is connected to the central through hole of the cutting part.
  • the second aspect of the embodiment of the present application provides a transition part for an ultrasonic scalpel, the transition part is provided between the connecting part and the cutting part, the proximal end of the connecting part is coupled to the ultrasonic handle,
  • At least one torsion part is provided on the transition part to convert the longitudinal vibration provided by the ultrasonic handle into a composite vibration, and transmit the converted composite vibration to the cutting part, where the composite vibration includes longitudinal vibration and torsional vibration;
  • the transition part is also provided with at least one stabilizing part, and the stabilizing part is located in the proximal direction of the torsion part to eliminate the torsional vibration transmitted to the proximal end of the torsion part.
  • the distance from the center of the torsion part to the end of the cutting part is an odd multiple of ⁇ /4, where ⁇ is the wavelength of the torsional vibration.
  • the distance between the stable part and the torsional part is such that the longitudinal vibration node is between the stable part and the torsional part and at the proximal end of the torsional vibration node, and the The distance between the longitudinal vibration node and the torsional vibration node is less than ⁇ /4, ⁇ is the wavelength of the torsional vibration, and the torsional vibration node is the center of the torsion part.
  • the distance between the center of the stabilizing portion and the torsional vibration node is n ⁇ /2, ⁇ is the wavelength of the torsional vibration, and n is an integer.
  • the stabilizing part is at least one of a beveled groove, a corrugated groove, and a threaded groove structure
  • the torsion part is at least one of a beveled groove corrugated groove and a threaded groove structure.
  • the torsion portion is a chamfered groove arranged circumferentially of the transition portion, and the axis of the chamfered groove forms a certain angle with the axis of the transition portion.
  • a third aspect of an embodiment of the present application provides an ultrasonic surgical knife, which includes a connecting portion, wherein the connecting portion is proximally coupled to an ultrasonic handle, and the ultrasonic surgical knife also includes the cutting portion for the ultrasonic surgical knife provided in the first aspect of the embodiment of the present application, and also includes the transition portion for the ultrasonic surgical knife provided in the second aspect of the embodiment of the present application.
  • embodiments of the present application provide a cutting part, a transition part and an ultrasonic scalpel for an ultrasonic scalpel.
  • the end of the cutting part is provided with a plurality of cutting teeth, and the cutting teeth are provided with The first cutting edge and the second cutting edge connected at the tooth top, the first cutting edge and the second cutting edge are on the outer circumferential surface of the cutting part; that is, the first cutting edge and the second cutting edge
  • the cutting edge is located within the minimum outer diameter coverage range of the end of the cutting part, thereby ensuring the accuracy of the cutting range and ensuring the safety of tissues outside the minimum outer diameter range of the end of the cutting part, thereby improving tissue ablation and/or resection. Safety of surgery.
  • the cutting teeth are also provided with a third cutting edge connected to the first cutting edge and the second cutting edge at the tooth top; the third cutting edge gradually moves toward the edge of the cutting part from the distal end to the proximal end.
  • the axis is close. That is, through the structural design of the third cutting edge, the cutting teeth form a structure with a small distal end and a large proximal end, and can effectively convert the longitudinal vibration work of the ultrasonic knife into a combination of longitudinal vibration and torsional vibration.
  • the overall strength of the cutting teeth is ensured and is in line with the cutting habits of the cutting teeth.
  • the relatively sharp portion of the cutting teeth closer to the end can complete tissue removal more quickly; when performing deep tissue removal, the sharper portion of the cutting teeth closer to the end is responsible for cutting.
  • the passage is opened to ensure that the tissue is broken and segmented relatively far away from the end.
  • the thicker part of the cutting teeth far away from the end provides stable support to ensure the overall strength and smoothness of the cutting teeth.
  • the blade crushes the edge of the tissue, making it easier for the cutting teeth to penetrate into the tissue, and ensuring that the removed tissue block is within the center hole of the instrument.
  • embodiments of the present application provide a transition part for an ultrasonic scalpel.
  • a torsion part is provided on the transition part to provide ultrasonic vibration torsional vibration energy, so that the cutting part comes into contact with the tissue part through a combination of longitudinal vibration and torsional vibration.
  • Pushing force and shearing force are generated at the same time to achieve the purpose of rapid cutting of the cutting part; in addition, by setting up the stabilizing part to produce Produces torsional vibration opposite to the torsion part, minimizing the influence of the torsional vibration of the torsion part on the connection part, ensuring the stable connection between the connection part and the handle while maintaining the efficient cutting and smooth operation of the ultrasonic knife; further, The setting of the stabilizing part prevents the connecting part from being affected by the torsional vibration of the torsional part, so that the position of the connecting part does not need to be increased or decreased by 1/2 the torsional vibration wavelength of the torsional part, so that the connecting part can be freely set according to specific needs.
  • the length makes it easier for the user to choose a suitable surgical operating distance; during the cutting process at the end of the cutting part, the maximum torsional stress position is designed to be between the stable part and the torsional part, thereby reducing the impact of stress on the cutting part and ensuring that the cutting part is not easy to It will break under the influence of stress, improving its stability and reliability in use.
  • Figure 1 is a schematic structural diagram of a first implementation of a cutting part for an ultrasonic scalpel provided by an embodiment of the present application;
  • Figure 2 is a schematic structural diagram of a second implementation of a cutting part for an ultrasonic scalpel provided by an embodiment of the present application;
  • Figure 3 is a schematic structural diagram of a third implementation of a cutting part for an ultrasonic scalpel provided by an embodiment of the present application;
  • Figure 4 is a schematic structural diagram of a fourth implementation of a cutting part for an ultrasonic scalpel provided by an embodiment of the present application;
  • Figure 5 is a schematic structural diagram of the fifth implementation of the cutting part of the ultrasonic scalpel provided by the embodiment of the present application.
  • Figure 6 is a schematic structural diagram of a sixth implementation of a cutting part for an ultrasonic scalpel provided in the application embodiment
  • Figure 7 is a schematic structural diagram of a seventh implementation of a cutting part for an ultrasonic scalpel provided in the application embodiment
  • Figure 8 is a schematic structural diagram of an eighth implementation of a cutting part for an ultrasonic scalpel provided in the application embodiment
  • Figure 9 is a schematic structural diagram of the first implementation of the transition portion for an ultrasonic scalpel provided by an embodiment of the present application.
  • Figure 10 is a schematic structural diagram of the transition portion provided with only the torsion portion provided by the embodiment of the present application.
  • Figure 11 is a schematic structural diagram of a second implementation of the transition portion for an ultrasonic scalpel provided by an embodiment of the present application.
  • Figure 12 is a schematic structural diagram of a third implementation of a transition portion for an ultrasonic scalpel provided by an embodiment of the present application.
  • Figure 13 is a schematic structural diagram of a fourth implementation of the transition portion for an ultrasonic scalpel provided by an embodiment of the present application.
  • Figure 14 is a schematic structural diagram of a fifth implementation of the transition portion for an ultrasonic scalpel provided by an embodiment of the present application.
  • Figure 15 is a schematic diagram of the overall structure of the ultrasonic scalpel provided by the embodiment.
  • the end of the surgical instrument inserted into the human body is called the distal end, and the distal end is mainly used to perform surgical operations on tissues; the end located outside the body is called the proximal end. , the proximal end is mainly used by the surgical operator to perform operations.
  • the distal end of each component refers to the end close to the side inside the body, and the proximal end of each component refers to the end close to the side outside the body.
  • a simple ultrasonic blade combined with a vacuum suction system can meet the surgical needs, but for some fiber-rich diseased connective tissue, fibrous tissue, or more complex soft tissue cutting or bone, etc.
  • a conventional ultrasonic scalpel it is difficult for a conventional ultrasonic scalpel to effectively remove diseased tissue.
  • a first aspect of an embodiment of the present application provides a cutting part for an ultrasonic scalpel.
  • the proximal end of the cutting part 3 is coupled to the ultrasonic handle through the transition part 2 and the connecting part 1.
  • the end of the cutting part 3 is provided with a plurality of cutting teeth 5, and the cutting teeth 5 are provided with a tooth top
  • the first cutting edge 51 and the second cutting edge 52 are connected at the outer circumferential surface of the cutting part 3; that is, the first cutting edge 51 and the second cutting edge 52
  • the second cutting edge 52 is located within the minimum outer diameter coverage range of the end of the cutting part 3, thereby ensuring the accuracy of the cutting range and ensuring the safety of tissues outside the minimum outer diameter range of the end of the cutting part 3, thereby improving Safety of tissue ablation and/or resection procedures.
  • the cutting tooth 5 is also provided with the first cutting edge 51 and the second cutting edge 52.
  • the third cutting edge 53 connected to the tooth tips; from the distal end to the proximal end, the third cutting edge 53 gradually extends toward the axis direction of the cutting part 3, that is, through the structure of the third cutting edge 53
  • the design makes the cutting teeth 5 form a structure with a small distal end and a large proximal end, which can effectively convert the longitudinal vibration work of the ultrasonic knife into a combination of longitudinal vibration and torsional vibration to improve its work efficiency and cutting accuracy; In the actual working process, by setting the cutting teeth 5 in a shape that is far smaller and near larger, the overall strength of the cutting teeth 5 is ensured and conforms to the cutting habits of the cutting teeth 5.
  • the overall strength of the cutting teeth 5 is ensured.
  • the relatively sharp part of the cutting teeth 5 closer to the end can complete tissue resection more quickly; when performing deep tissue removal, the sharper part of the cutting teeth 5 closer to the end is responsible for opening up the cutting path to ensure that it is relatively far away from the end.
  • the upper part of the cutting tooth 5 crushes and divides the tissue.
  • the thicker part far away from the end of the cutting tooth 5 provides stable support to ensure the overall strength of the cutting tooth 5 and the smoothness of cutting.
  • the third cutting edge 53 cuts the edge of the tissue. The crushing process is implemented to make it easier for the cutting teeth 5 to penetrate deeply into the tissue, and to ensure that the removed tissue pieces are within the range of the central hole of the instrument.
  • a fourth cutting edge 31 is also provided between two adjacent cutting teeth 5 to connect the first cutting edge 51 and the second cutting edge 51 of the first cutting tooth 5.
  • the second cutting edge 52 of the first cutting tooth 5 , or the second cutting edge 52 of the first cutting tooth 5 and the first cutting edge 51 of the second cutting tooth 5 are connected.
  • the first cutting edge 51 of the first cutting tooth 5 is connected to the second cutting edge 52 of the second cutting tooth 5 through the fourth cutting edge 31;
  • the cutting edge 51 is connected to the second cutting edge 52 of the third cutting tooth 5 via the fourth cutting edge 31 .
  • the tooth top positions of the cutting teeth 5 are discontinuous and have multi-point distribution and discontinuous characteristics, which not only ensures cutting efficiency, but also ensures the effectiveness and reliability of cutting. sex.
  • the inside of the end surface where the fourth cutting edge 31 is located is closer to the proximal end than the outside, where the inside refers to the direction close to the axial direction of the cutting part 3,
  • the outside is the direction away from the axial direction of the cutting part 3, that is, the end surface S where the fourth cutting edge 31 is located is deeper inside and shallower outside, where the inside (inside) refers to the direction closer to the axis of the cutting part 3, and the outside ( External) refers to the direction away from the axis of the cutting part 3, deep refers to the direction closer to the proximal end, and shallow refers to the direction closer to the distal end.
  • the fourth cutting edge 31 is located at the outermost side of the end face S and on the outer circumferential surface of the cutting part 3.
  • the end face S is deep inside and shallow outside. , while ensuring the maximum cutting range of the fourth cutting edge 31, it can also ensure that the edge of the cut tissue is squeezed by the end face S to form a certain cutting angle (fitting the end face S), so that it can pass through all parts smoothly.
  • the central hole of the cutting part 3 is away from the surgical site.
  • the end surface S is designed into a structure with a deep inside and a shallow outside, so as to ensure the maximum cutting range of the cutting part 3 and at the same time ensure that the edge of the cut tissue has a certain angle and can smoothly cut the tissue. It is far away from the surgical site through the central hole.
  • the end face is not limited to be designed to have a deep inside and shallow outside structure.
  • the end face S can be designed into a more suitable structure according to the needs, for example, as shown in Figure 4 As shown in Figure 5, design the end face S to be shallow on the inside and deep on the outside, or, as shown in Figure 5, design the end face S to be flush on the inside and outside.
  • the end surface S is designed to be shallow on the inside and deep on the outside. Compared with the design of deep on the inside and shallow on the outside, the design of shallow on the inside and deep on the outside reduces the cutting range of the cutting part 3, but can further enhance the cutting. The reliability of the lower tissue passing through the central hole reduces the possibility of obstruction of the central hole.
  • the end surface S is designed to be flush with the inside and outside, so that the angle between the structural surfaces on adjacent sides of the first cutting edge 51, the second cutting edge 52 and the fourth cutting edge 31 becomes larger, that is, the angle of the edge The sharpness decreases and the cutting ability decreases.
  • this design has obvious advantages in the resection process when targeting shallow-depth tissues, that is, the cutting effect is mainly provided by the third cutting edge 53, the first cutting edge 51, and the second cutting edge. 52 and the fourth cutting edge 31 provide less cutting effect, but the end face S provides stronger shearing force to facilitate cutting by the third cutting edge 53 .
  • the cutting efficiency of the three design methods of end face S is: the cutting efficiency of deep inside and shallow outside is greater than the cutting efficiency of shallow inside and deep outside. At the same time, the cutting efficiency of shallow inside and deep outside is greater than the cutting efficiency of flush inside and outside. ;
  • the cutting efficiency of the three design methods of end face S is: the processing difficulty of deep inside and shallow outside is less than the processing difficulty of shallow inside and deep outside. At the same time, the processing difficulty of shallow inside and deep outside is less than the processing difficulty of flush inside and outside. Users can according to Different types of blades are selected for different usage scenarios to achieve surgical results while taking into account the cost of the instrument.
  • the first cutting edge 51 and the second cutting edge 52 are arc-shaped structures and form a certain angle with the axis of the cutting part 3.
  • the first cutting edge 51 and the second cutting edge 52 have a certain angle with the axis of the cutting part 3 and are arc-shaped structures that comply with mechanical principles and bear non-linear forces during the cutting process to ensure that the The reaction force received by the cutting teeth 5 is within the allowable range, and due to the existence of torsional vibration, the first cutting edge 51 and the second cutting edge 52 will generate shearing force on the tissue to be removed, thereby cutting the tissue more quickly.
  • the connecting line L from the tooth root to the top of the cutting tooth 5 forms a certain inclination angle with the axis of the cutting part 3 ; that is, in the cutting part 3
  • the end portion forms inclined teeth arranged clockwise or counterclockwise around the axis, wherein the inclination direction of the cutting teeth 5 and the torsion direction of the torsion portion 21 (oblique groove) can be in the same direction or in different directions.
  • the obliquely designed cutting teeth 5 can achieve better cutting effects, but in the embodiment of the present application, it is not limited to the oblique arrangement of the cutting teeth 5.
  • the cutting teeth 5 can extend along the axial direction, that is, as shown in FIG. 7 , the connecting line L from the tooth root to the tooth top of the cutting teeth 5 is parallel to the axis of the cutting part 3 .
  • the top of the cutting tooth 5 is a blunt surface structure, for example, the top of the cutting tooth 5 is set to a blunt surface structure of a substantially triangular or arc chamfered surface.
  • the top of the cutting teeth 5 is a blunt structure. When in contact with normal tissue, due to the high toughness of the normal tissue, the blunt structure contacts the surface of the normal tissue, ensuring that the cutting teeth 5 will not cause damage to the normal tissue. .
  • the embodiment of the present application relates to the ultrasonic scalpel.
  • the transition part 2 and the cutting part 3 are hollow structures with a central through hole inside.
  • the central through hole is connected to the vacuum equipment to provide an adjustable negative pressure flow.
  • the cutting part 3 is provided with a pre-suction hole 4, and the pre-suction hole 4 is connected to the central through hole of the cutting part 3.
  • the pre-suction hole 4 provided, it is ensured that the central hole will not be completely blocked to avoid threats to healthy tissue and ensure the stable operation of the vacuum equipment, thus ensuring the safe and smooth operation of the entire system.
  • the cooling perfusion fluid cannot pass through the central through hole and enter the inside of the handle, and a complete cooling circuit cannot be formed, resulting in increased heat generation of the handle, deviation of the working point, and reduced work effect.
  • the pressure inside the pipe will rise sharply, forming a relatively large pulling tension on the tissue near the wound, causing unexpected pulling damage.
  • the existence of the pre-suction hole 4 is equivalent to artificially creating a damage at the front end of the waveguide rod (the position of the rod where the pre-suction hole 4 is located). Careful design is required to prevent the pre-suction hole 4 from affecting the overall performance and Strength produces unpredictable damage.
  • the position of the pre-suction hole 4 needs to be close to the tip of the cutter head, so that the pressure can be released in time when the cutter tip is clogged.
  • the pre-suction hole 4 may also be blocked. risk.
  • the existence of the pre-suction hole 4 will locally increase the internal stress and increase the probability of damage to the cutting part 3 .
  • the position of the pre-suction hole 4 needs to be placed in an area with less stress.
  • the pre-suction hole 4 it is not suitable to place the pre-suction hole 4 in a cone gradient (the diameter of the cutting part 3 gradually becomes smaller from the proximal end to the distal end). ) area needs to be placed in an area with uniform diameter. And the position should not be too close to the tip of the cutter head.
  • the optimal design distance is 4mm to 8mm, and the optimal design is 6mm.
  • the shape of the pre-suction hole 4 should not be polygonal.
  • the polygonal structure has uneven transitions and is prone to stress concentration problems. A circular structure is preferred.
  • the diameter should not be too large. Excessive hole diameter will significantly reduce the strength of the cutter head and increase the risk of breakage.
  • the diameter of the pre-suction hole is d
  • the diameter of the central through hole is D
  • the central angle ⁇ corresponding to the diameter d of the pre-suction hole is 2arcsin(d/2D) , preferably the ratio of the central angle ⁇ to ⁇ /2 is less than or equal to 0.1, where ⁇ is the pi ratio. If the diameter of the pre-suction hole 4 is too small, it will be difficult to achieve the designed effect. If the diameter is too large, the risk of damage to the cutter head will increase.
  • the optimal diameter of the pre-suction hole 4 in this embodiment is between 0.7mm and 0.9mm, which is preferably is 0.8mm.
  • the ultrasonic scalpel with the traditional longitudinal vibration mode cuts soft tissues such as the liver or hard tissues such as bones during surgery
  • the longitudinal vibration mode along the axis of the blade cannot meet all surgical needs. In grinding, debridement, etc.
  • effective ultrasonic vibration torsional vibration energy is needed to ensure higher working efficiency of the ultrasonic cutter head. Therefore, an ultrasonic cutter head with both longitudinal vibration and torsional vibration combined ultrasonic vibration working modes was born.
  • the traditional composite vibration ultrasonic cutter head is to set a torsion part on the handle or the connecting part to cause the cutter head to produce longitudinal vibration and torsional vibration.
  • this composite vibration mode can achieve higher work efficiency, it Due to the presence of torsional vibration on the tool handle or the connecting part, the connection between the tool handle or the connecting part and the handle is unstable, resulting in looseness between the tool handle or the connecting part and the handle.
  • Example The second aspect provides a transition part for an ultrasonic scalpel.
  • the transition part 2 is provided between the connecting part 1 and the cutting part 3.
  • the connecting part 1 is proximally coupled to the ultrasonic handle.
  • the ultrasonic handle is used to provide a vibration source (longitudinal vibration), and the cutting part 3 is used to perform resection and/or ablation of tissue.
  • transition part 2 provided in the second aspect of the embodiment of the present application is not limited to the cutting part 3 of the present application. In actual application, it can be applied to other cutting structures that need to achieve vibration conversion.
  • the ultrasonic handle provides longitudinal vibration.
  • the The torsional part 21 converts longitudinal vibration into composite vibration, and transmits the converted composite vibration to the cutting part 3 , wherein the composite vibration includes longitudinal vibration and torsional vibration, and the longitudinal vibration and torsional vibration are transmitted to the cutting part 3 , to achieve the resection and/or ablation action of the cutting part 3 .
  • the transition part 2 is also provided with at least one stabilizing part 22.
  • the stabilizing part 22 is located in the proximal direction of the torsion part 21.
  • the composite vibration converted by the torsion part 21 There are longitudinal vibrations and torsional vibrations. Among them, the torsional vibration will be transmitted bidirectionally to the proximal end and the distal end. After the torsional vibration transmitted to the proximal end reaches the stable part 22, due to the action of the stable part 22, the energy of the torsional vibration is gradually consumed. , thereby eliminating the torsional vibration transmitted to the proximal end of the torsion part 21.
  • the transmission of torsional vibration to the connecting portion 1 is effectively eliminated, thereby avoiding the traditional compound vibration (longitudinal vibration + torsional vibration) of the cutter head, resulting in the connection
  • the connection between the part 1 and the ultrasonic handle is unstable, causing the problem of looseness between the connecting part 1 and the ultrasonic handle.
  • the transition part can also be 2.
  • the length is specially designed to reduce the impact of torsional vibration on the connecting part 1 as much as possible.
  • the distance from the proximal end of the connecting part 1 to the transition part 2 in the torsional vibration stage is ⁇ . /2, that is, the distance from the proximal end of the connecting part 1 to the torsional vibration stage of the transition part 2 is n ⁇ /2, where ⁇ is the wavelength of the torsional vibration and n is a positive integer.
  • the vibration wave transmission principle synchronizes the amplitude of the proximal position of the connecting part 1 with the amplitude of the torsional vibration node.
  • This design method can reduce the impact of torsional vibration on the connecting part 1 to a certain extent.
  • the overall length of the transition part 2 and the cutting part 3 is too long, which affects the surgical operation, or the overall length of the transition part 2 and the cutting part 3 is too short, resulting in insufficient working length of the cutting part 3, making it impossible to complete the operation. Surgical action.
  • the stabilizing portion 32 by arranging the stabilizing portion 32, the position of the stabilizing portion 32 on the transition portion 2 can be adjusted, or the structural form of the stabilizing portion 32 can be provided with the torsion portion.
  • 21 has opposite vibrations to the torsional vibration generated at the thread (connection part 1), so that the torsional (joint) vibration at the thread is zero, and only longitudinal vibration exists. Therefore, as shown in Figure 11, the proximal end of the connection part 1 is far away from the torsional vibration.
  • the vibration node distance can be any value that meets the driving signal requirements, eliminating the restriction that the distance from the proximal end of the connecting part 1 to the transition part 2 in the torsional vibration stage is an integer multiple of ⁇ /2, thereby ensuring that the transition part 2 can According to the actual use requirements, the corresponding length design is realized to avoid the overall length of the transition part 2 and the cutting part 3 being too long or too short.
  • the distance from the center of the twisting part 21 to the end of the cutting part 3 is ⁇ /4 An odd multiple of (m ⁇ /4), where ⁇ is the wavelength of torsional vibration, m is an odd number, the center torsional vibration node of the torsion part 21, so that when the torsion part 21 of the same structure is configured, the cutting part The torsional vibration at the 3 end is the most efficient.
  • the distance between the stabilizing part 22 and the torsion part 21 is such that the longitudinal vibration node is between the stabilizing part 22 and the torsion part 21. It is between the stable part 22 and the torsional part 21 and is at the proximal end of the torsional vibration node, and the distance between the longitudinal vibration node and the torsional vibration node is less than ⁇ /4, which is the wavelength of the torsional vibration.
  • FIG. 10 it is a schematic structural diagram of a composite vibrating cutter head with only a torsional structure.
  • the maximum stress position of the composite vibrating cutter head with only a torsional structure is generated at the connection position between the cutting part 3 and the transition part 2, so The diameter of the cutting part 3 is small, thereby limiting the maximum cutting force that the cutting part 3 can withstand.
  • the maximum stress point of the ultrasonic scalpel is located between the stable part 22 and the torsion part 21, so that under the joint action of the torsion part 21 and the stable part 22, the maximum stress of the ultrasonic scalpel is The position is generated on the cylindrical outer surface between the torsion part 21 and the stable part 22.
  • the diameter of the transition part 2 is larger and the shape changes gently. , further away from the cutting part 3, thereby improving the safety performance of the ultrasonic scalpel.
  • the torsion part 21 is a chamfered groove arranged circumferentially in the transition part 2 , and the axis of the chamfered groove is in contact with the transition part 2 The axis is at a certain angle.
  • the structural forms of the stabilizing part 22 and the twisting part 21 may be consistent, that is, as shown in FIGS. 11 to 13 , the stabilizing part 22 and the twisting part 21 may be realized in the form of chamfered grooves, where as shown in FIG. In 11, the axial directions of the inclined grooves of the stabilizing part 22 and the torsion part 21 are inconsistent.
  • the axial directions of the inclined grooves of the stabilizing part 22 and the torsion part 21 are consistent; or, as shown in Figure 14 , the structural forms of the stabilizing portion 22 and the torsion portion 21 are inconsistent, and the stabilizing portion 22 is at least one of a beveled groove, a corrugated groove, and a threaded groove structure.
  • the torsion part 21 is not limited to being provided in the form of a chamfered groove, but may also be provided in other forms that can rotate longitudinal vibrations.
  • Change to the composite vibration structure for example, at least one of a beveled groove, a threaded groove and a corrugated groove structure.
  • the corrugated groove is a corrugated strip groove, and the strip groove can be along the transition portion. 2 can also be arranged at a certain angle with the axial direction of the transition portion 2 .
  • FIG. 9 , FIG. 11 to FIG. 14 only show a schematic diagram of one stabilizing portion 22 .
  • the multiple stabilizing portions 22 can be distributed side by side along the axial direction of the transition portion 2 , if multiple stabilizing portions 22 are provided, when determining the torsional vibration node and longitudinal vibration node of the transition portion 2, the multiple stabilizing portions 22 can be considered as an integral structure.
  • a stable part 22 is not limited to a set of beveled grooves or threaded groove structures, but may also be a stable part 22 including components along the axial direction of the transition part 2 Multiple sets of oblique grooves or threaded groove structures distributed side by side, or vibration compensation structures that can be thought of by those skilled in the art.
  • the position and structure of the stabilization part 22 are adjusted according to different vibration frequencies and wavelengths.
  • the stabilization part 22 If the part 22 is a beveled groove, then the parameters such as the deflection central axis angle of the beveled groove, the depth of the chute, the width of the chute, the number of the chute and other parameters are adjusted.
  • the depth range of the chute is in the range of 1-1.2mm, and its width is in the range of 0.6-1.5mm, preferably 1mm; its number is 3-8, preferably 6; its inclination angle is -60 ° to 60°, preferably 20° ⁇ 10° or -20° ⁇ 10°.
  • the center node (not shown in the figure) of the stabilizing portion 22 is in contact with the torsional vibration.
  • the distance between nodes is n ⁇ /2, ⁇ is the wavelength of torsional vibration, and n is an integer.
  • the second aspect of the embodiment of the present application provides a transition part for an ultrasonic scalpel.
  • the transition part 2 is provided between the connecting part 1 and the cutting part 3.
  • the connecting part 1 is proximally coupled to an ultrasonic handle, and the At least one torsion part 21 is provided on the transition part 2 to convert the longitudinal vibration provided by the ultrasonic handle into a composite vibration, and transmit the converted composite vibration to the cutting part 3.
  • the composite vibration includes longitudinal vibration and torsional vibration;
  • the transition portion 2 is also provided with at least one stabilizing portion 22 , which is located in the proximal direction of the torsion portion 21 to eliminate the torsional vibration transmitted to the proximal end of the torsion portion 21 .
  • the stabilizing part 22 at the proximal end of the torsion part 21, the transmission of torsional vibration to the connecting part 1 is effectively eliminated, thereby avoiding the traditional compound vibration (longitudinal vibration + torsional vibration) of the cutter head, resulting in the connection
  • the connection between the connecting part 1 and the ultrasonic handle is unstable, causing the problem of looseness between the connecting part 1 and the ultrasonic handle.
  • the setting of the stabilizing part prevents the connecting part from being affected by the torsional vibration of the torsional part, so that the position of the connecting part does not need to be increased or decreased at 1/2 the torsional vibration wavelength of the torsional part, and can be freely adjusted according to specific needs.
  • Setting the length of the connecting part makes it easier to select a surgical operating distance suitable for the user; during the cutting process at the end of the cutting part, the maximum torsional stress position is designed to be between the stable part and the torsional part, thereby reducing the impact of stress on the cutting part to ensure The cutting part is not easily affected by stress and breaks, improving its stability and reliability in use.
  • the third aspect of the embodiment of the present application also provides an ultrasonic scalpel.
  • the ultrasonic scalpel includes a connecting part 1.
  • the proximal end of the connecting part 1 is coupled to an ultrasonic handle.
  • the ultrasonic scalpel also includes an ultrasonic scalpel.
  • the cutting part for the ultrasonic scalpel provided in the first aspect of the embodiment of the application also includes the transition part for the ultrasonic scalpel provided by the second aspect of the embodiment of the application.
  • the connecting part 1 is also provided with a wrench position 6.
  • the wrench position 6 is used to facilitate the application of torque when the connecting part 1 is coupled with the handle.
  • the embodiment of the present application provides a cutting part, a transition part and an ultrasonic scalpel.
  • the end of the cutting part 3 is provided with a plurality of cutting teeth 5.
  • the cutting teeth 5 There is a first cutting edge 51 and a second cutting edge 52 connected at the tooth top.
  • the first cutting edge 51 and the second cutting edge 52 are located on the outer circumferential surface of the cutting part 3; that is, the first cutting edge 51 and the second cutting edge 52 are located on the outer circumferential surface of the cutting part 3;
  • One cutting edge 51 and the second cutting edge 52 are located within the minimum outer diameter coverage range of the end of the cutting part 3, thereby ensuring the accuracy of the cutting range and ensuring that they are outside the minimum outer diameter range of the end of the cutting part 3 tissue safety, thereby improving the safety of tissue ablation and/or resection procedures.
  • the cutting tooth 5 is also provided with a third cutting edge 53 connected with the first cutting edge 51 and the second cutting edge 52 at the tooth top; the third cutting edge 53 gradually moves toward the distal end from the proximal end.
  • the axes of the cutting portion 3 are close to each other. That is, through the structural design of the third cutting edge 53, the cutting teeth 5 form a structure with a small distal end and a large proximal end. In the actual working process, by setting the cutting teeth 5 to be small in the far end and large in the near end. The shape ensures the overall strength of the cutting teeth 5 and conforms to the cutting habits of the cutting teeth 5. When performing shallow tissue removal, the relatively sharp parts closer to the ends of the cutting teeth 5 can be completed more quickly. Tissue resection; when performing deep tissue removal, the sharper part near the end of the cutting teeth 5 is responsible for opening up the cutting path to ensure that the tissue is broken and segmented relatively far away from the end. The cutting teeth 5 are thicker far away from the end.
  • the part provides stable support to ensure the overall strength and smoothness of cutting of the cutting teeth 5.
  • the edge of the tissue is crushed through the third cutting edge 53, making it easier for the cutting teeth 5 to penetrate into the tissue and ensuring that the removed tissue is The block is within the center hole of the instrument.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mechanical Engineering (AREA)
  • Biomedical Technology (AREA)
  • Dentistry (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne une partie de coupe (3) et une partie de transition (2) pour un scalpel à ultrasons, et un scalpel à ultrasons. Une pluralité de dents de coupe (5) sont disposées sur une partie d'extrémité de la partie de coupe (3). Un premier bord de coupe (51) et un second bord de coupe (52) des dents de coupe (5) sont situés dans une une plage de couverture de diamètre externe minimal de la partie d'extrémité de la partie de coupe (3), ce qui assure la sécurité des tissus situés à l'extérieur de la plage de diamètre externe minimal de la partie d'extrémité de la partie de coupe (3), ce qui permet d'améliorer la sécurité des opérations d'ablation et/ou de résection de tissu. De plus, au moyen du réglage des dents de coupe (5) pour qu'elles soient en forme de petite au niveau de l'extrémité distale et étant grandes à l'extrémité proximale, la résistance globale des dents de coupe (5) est assurée. Lors d'un retrait superficiel des tissus, une partie relativement pointue sur les dents de coupe (5) plus près de la partie d'extrémité peut rapidement achever la résection de tissu. Lors d'un retrait profond des tissus, une partie relativement pointue sur les dents de coupe (5) à proximité de la partie d'extrémité est responsable de la fourniture d'un trajet de coupe, ce qui permet d'assurer que le tissu est broyé et segmenté par la partie relativement éloignée de la partie d'extrémité. Une partie relativement épaisse et solide sur les dents de coupe (5) à l'opposé de la partie d'extrémité fournit un support stable, ce qui permet d'assurer la résistance globale et le lissé de coupe des dents de coupe (5).
PCT/CN2023/078380 2022-09-13 2023-02-27 Partie de coupe et partie de transition pour scalpel à ultrasons, et scalpel à ultrasons WO2024055527A1 (fr)

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