CN114431921A

CN114431921A - Ultrasonic scalpel and scalpel head thereof

Info

Publication number: CN114431921A
Application number: CN202210102850.7A
Authority: CN
Inventors: 王磊; 郑少腾; 刘柯; 颜忠余; 骆威
Original assignee: Innolcon Medical Technology Suzhou Co Ltd
Current assignee: Innolcon Medical Technology Suzhou Co Ltd
Priority date: 2022-01-27
Filing date: 2022-01-27
Publication date: 2022-05-06
Also published as: WO2023142525A1

Abstract

The invention discloses an ultrasonic scalpel and a scalpel head thereof, wherein the ultrasonic scalpel comprises a cylindrical main body, the near end of the main body is provided with a connecting structure, the far end of the main body is provided with the scalpel head, the scalpel head comprises a blade positioned at the far end and a sawtooth row at least positioned at one side of the blade and extending along the axis of the main body, the sawtooth row is two rows side by side, each row of sawtooth row is formed by arranging one row of sawteeth, and the tooth tips of the two rows of sawteeth face to opposite directions. The double-row reversely-arranged hook tooth structure design ensures that enough cutting force exists in the whole period, can improve the cutting efficiency in multiples on the premise of not increasing the stress value, and reduces the power output requirement on a host; the tool bit can carry out the coupling with the load well in the cutting process, and the operator only need hold the cutter and cut can, has improved the comfortable degree of use.

Description

Ultrasonic scalpel and scalpel head thereof

Technical Field

The invention relates to the technical field of surgical instruments, in particular to an ultrasonic scalpel and a scalpel head thereof.

Background

With the rapid development of modern medicine, ultrasonic surgical instruments are increasingly applied to clinical surgical operation treatment, ultrasonic energy is applied to surgical operation, and the ultrasonic surgical instrument has the characteristics of fine cutting, safety, tissue selectivity, low-temperature hemostasis and the like, greatly enriches the means of the surgical operation, improves the quality of the surgical operation, and relieves the pain of patients to a certain extent. Wherein, the ultrasonic scalpel is an ultrasonic surgical instrument with specific application functions.

The prior art ultrasonic surgical blade generally has two types, for example, an ultrasonic surgical blade disclosed in US8343178, and the working head at the distal end has a smooth blade structure, i.e., the part disclosed by reference numerals 20, 22 and 24 in the patent, the blade structure comprises a distal blade and lateral blades at both sides thereof, and the distal blade and the lateral blades are smoothly transited. This type of blade structure is not efficient in cutting.

Thus, U.S. patent USD667117 discloses another blade configuration for an ultrasonic surgical blade wherein the distal blade is in the form of a blade and the sides of the blade are in the form of regular triangular serrations. Therefore, the surgical use scene of the ultrasonic scalpel can be increased, and the regular triangle saw teeth can cut relatively hard bones or other tissues. However, due to the existence of high internal stress generated by ultrasonic high-frequency oscillation, the shape of the sawtooth cannot be made rapidly as in the traditional industry, and the tooth shape is deep and sharp. In order to coordinate the stress in the serrations and the cutting efficiency, european patent EP3586774 discloses a cutting blade of another ultrasonic surgical blade.

Disclosure of Invention

The invention aims to overcome the defects in the prior art and provide an ultrasonic scalpel capable of cutting efficiently and a scalpel head thereof.

The purpose of the invention is realized by the following technical scheme:

the utility model provides an ultrasonic scalpel, includes the columniform main part, the near-end of main part is a connection structure, and the distal end is provided with the tool bit, the tool bit is including the cutting edge that is located the most distal end and the sawtooth row that is located its one side at least and extends the setting along the main part axis, the sawtooth row is two side by side, and every row of sawtooth is arranged and is formed by a sawtooth arrangement, two the orientation of the prong of sawtooth row is opposite.

Preferably, the rake angle γ of the serrations is a positive rake angle.

Preferably, the rake angle γ of the serrations is 15 ° ± 5 °.

Preferably, the relief angle α of the serrations is 20 ° ± 10 °.

Preferably, the tip angle β of the saw tooth is not less than 45 °.

Preferably, the spacing between the saw teeth of the saw tooth rows is between 1.3mm and 1.7 mm.

Preferably, the tooth roots of the corresponding saw teeth in the two rows of the saw teeth are in a mutual overlapped common-tooth-bottom structure in the thickness direction of the ultrasonic scalpel.

Preferably, the ultrasonic scalpel is provided with two end faces in the thickness direction, and at least one end face is provided with a groove.

Preferably, the blade is at least one of a cutting edge blade, a blunt edge blade, and a serrated edge blade.

Preferably, the cutter head comprises a cutting edge positioned at the most far end and two saw tooth rows symmetrically arranged on two sides of the cutting edge and extending along the axis of the main body.

Preferably, the blade includes a distal-most edge and a row of serrations extending along the axis of the body on one side thereof, and a cutting edge on the other side of symmetry thereof.

The invention also discloses a cutter head of the ultrasonic scalpel, which comprises a cutting edge positioned at the most distal end and a saw tooth row which is positioned at least on one side of the cutting edge and extends along the axis of the main body, wherein the saw tooth row comprises saw teeth, the saw teeth are tortoise back teeth, the front angle gamma of the saw teeth is 15 degrees +/-5 degrees, and the back angle alpha of the saw teeth is 20 degrees +/-10 degrees.

Preferably, the sawtooth rows are two rows side by side, each row of sawtooth rows is formed by arranging one row of sawteeth, and the tooth tops of the two rows of sawtooth rows face in opposite directions.

Preferably, the tip angle β of the saw tooth is not less than 45 °.

Preferably, the blade is at least one of a cutting blade, a blunt blade, and a serrated blade.

The invention has the following beneficial effects:

the design of the double-row reverse layout hook tooth structure ensures that enough cutting force exists in the whole period, the cutting efficiency can be improved in multiples on the premise of not increasing the stress value, and the power output requirement on a host machine is reduced;

the cutter head can be well coupled with the load in the cutting process, an operator only needs to hold the cutter to cut, and the comfort degree in the use process is improved;

one side of the cutter head is provided with a sawtooth row, and the other symmetrical side of the cutter head is provided with a cutting edge, so that an operator can selectively choose the sawtooth row or the cutting edge to cut, and the use scene of the invention is enlarged.

Drawings

The technical scheme of the invention is further explained by combining the accompanying drawings as follows:

FIG. 1: a schematic view of a preferred embodiment of the ultrasonic surgical blade of the present invention;

FIG. 2: an enlarged view of portion a in fig. 1;

FIG. 3: the front view of fig. 2;

FIG. 4: FIG. 2 is a top view;

FIG. 5: a characteristic diagram of the ultrasonic wave;

FIG. 6: the cutting force of three tooth forms is compared and shown schematically;

FIG. 7: a graph comparing the rake angle with the cutting force;

FIG. 8: schematic comparison of two tooth back shapes;

FIG. 9: the arrangement of the tortoise back teeth of the preferred embodiment of the invention is shown schematically;

FIG. 10: a schematic view of a blade head of a second embodiment of the ultrasonic surgical blade of the present invention;

FIG. 11: a schematic view of a blade head of a third embodiment of the ultrasonic surgical blade of the present invention;

FIG. 12: a schematic view of another direction of the cutter head of the third embodiment of the ultrasonic surgical knife of the invention;

FIG. 13: a schematic view of a blade of a fourth embodiment of the ultrasonic surgical blade of the present invention;

FIG. 14: a schematic view of a blade head of a fifth embodiment of the ultrasonic surgical blade of the present invention;

FIG. 15: a schematic view of a blade of a sixth embodiment of the ultrasonic surgical blade of the present invention.

Detailed Description

The present invention will be described in detail below with reference to specific embodiments shown in the drawings. These embodiments are not intended to limit the present invention, and structural, methodical, or functional changes that may be made by one of ordinary skill in the art in light of these embodiments are intended to be within the scope of the present invention.

In the description of the schemes, it should be noted that the terms "center", "upper", "lower", "left", "right", "front", "rear", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In the description of the embodiment, the operator is used as a reference, and the direction close to the operator is a proximal end, and the direction away from the operator is a distal end.

As shown in FIG. 1, the present invention discloses an ultrasonic surgical blade including a cylindrical body 111. The body 111 may be a cylinder of the same diameter or may be a multi-segmented cylinder of different diameters that accommodates the transmission of ultrasonic energy.

The near end of the main body 111 is a connecting structure 112, and the connecting structure 112 may be an internal thread, an external thread, a bonding or ultrasonic welding mode, and the like, and is connected with the ultrasonic generator.

The distal end of the body 111 is provided with a cutting head 113. As shown in fig. 2 to 4 in particular, the cutting head 113 comprises a blade 101 at the most distal end and a row of teeth 102 extending along the axis of the body at least on one side thereof. As is well known to those skilled in the art, the rows of teeth 102 may be disposed on either side of the cutting head 113, but may be two rows of teeth 102 symmetrically disposed on either side of the cutting edge 101 as shown in fig. 2.

The cutting head 113 is the design point of the present invention, and as shown in fig. 1 to fig. 4, in a preferred embodiment, the cutting edge 101 of the cutting head 113 is a thin-sheet type gradually-changing cutting edge, specifically: the projection is arc-shaped along the thickness direction of the ultrasonic scalpel, and the projection is triangular 110 along the width direction of the ultrasonic scalpel. The knife edge 101 is in semicircular structural design along the thickness direction, the structure is smooth, when the knife edge is in contact with fragile tissues such as blood vessels and nerves, the fragile tissues cannot be scratched, the fragile tissues can be pushed away under the action of ultrasound, and the heat effect can be reduced by matching with enough cooling water, so that a good protection effect can be generated on the tissues. The cutting tool is designed to be triangular along the width direction, the tip part can be provided with a small plane or a circular arc surface, and when the cutting tool contacts cancellous bone and thinner cortical bone, the sharp top at an acute angle can cut the tissues more effectively.

The two side ends of the semicircular arc top of the blade 101 are respectively provided with a tooth tip, and the tooth tips are formed by intersecting two arc sections to form a first tooth tip 114. The first tooth point 114 is formed by combining a tip outer circle R3mm and an inner circle R1.5mm, a tangent line is made along the tooth point, so that the tooth belongs to a negative rake angle of-15 degrees +/-5 degrees, the whole cutting edge 101 is ensured to belong to a tip surface which is assisted by cutting and mainly safe, the requirement on the operation precision of a doctor in the operation is reduced, and important tissues are better protected.

The sawtooth rows 102 are two rows side by side, each sawtooth row 102 is formed by arranging one row of sawteeth 103, and the sawteeth 103 of the two sawtooth rows 102 are identical in the preferred embodiment.

For the sawtooth 103, its motion trajectory is ideally simple harmonic, starting from the equilibrium position zero as shown in fig. 5, and for the positive half cycle, the tip of the tooth travels towards the distal end of the cutter head; for the negative half-cycle, travel is toward the proximal end of the blade. To ensure that the cutting head has a similar cutting effect on both the positive and negative halves, the

tips

104, 105 of the two rows 102 of teeth of the present invention are oriented in opposite directions.

For a sawtooth shape, there are three important parameters, respectively:

γ: rake angle 122, the angle of the cutting rake face from the vertical plane;

α: a relief angle 120, the angle of the cutting face to the horizontal;

beta: cusp 121, the rake face and the relief face form an angle.

Three tooth forms shown in fig. 6 are a normal tooth 117 (front angle of 0 °), a blunt tooth 118 (front angle of-15 ° ± 5 °), and a hook tooth 119 (front angle of +15 ° ± 5 °). The conventional saw tooth has an isosceles triangle tooth shape, and the rake angle γ is negative and belongs to the blunt tooth 118. Although the same effect is achieved in both the positive and negative half cycles of movement; but the disadvantages are also equally evident, and the cutting efficiency is insufficient.

With particular reference to fig. 6, the cutting force experienced by the tool during the cutting run is analyzed. It can be seen that the cutting force of the blunt tooth 118 is greatest and the cutting force of the hook tooth 119 is least, but the blunt tooth has a greater force Fz away from the cutting face, while the hook tooth force Fz away from the cutting face is negative. The conventional isosceles triangle saw teeth generate large advancing cutting force in the use process, but the cutter head is easy to bounce off in the cutting process, and enough pressing force is needed to stabilize the cutter head. In the present invention, the hook tooth 119 is used, i.e., the rake angle γ 122 of the sawtooth 103 is a positive rake angle. Although the advancing cutting force is only about 68% of that of the blunt tooth, the obvious cutting effect is better for the load with the same difficulty; and the force Fz deviating from the cutting surface is a negative value, which indicates that the cutter head can be well coupled with the load in the cutting process, and an operator only needs to hold the cutter to cut, thereby improving the comfort degree in the use process.

In order to determine the angle of the positive rake angle, as shown in fig. 7, the present invention uniformly sets 7 kinds of angles of the positive rake angle from 0 degree to 30 degrees, respectively, and it was found that as the angle of the positive rake angle increases, the advancing cutting force gradually decreases, and a negative pressing force Fz starts to appear at 10 °. And the cutting force is gradually reduced along with the increase of the angle of the front angle. And then carrying out modal analysis on the 7 groups of tooth-shaped cutter heads, analyzing and counting the numerical value of the maximum stress at the designed working frequency, wherein the whole stress change is smaller, but the stress value can also be seen to firstly fall and then rise along with the increase of the front angle, and the stress value is the minimum value near the front angle of 10 degrees to 20 degrees +/-10 degrees. Subsequently, the positive rake angle increases and the maximum stress gradually increases. In addition, the increase of the positive rake angle inevitably causes the reduction of the tooth tip angle, the strength of the cutting tooth tip is reduced, and the cutting fatigue is more likely to occur to cause the tooth tip fracture. In view of the foregoing, a positive rake angle design between 10 ° and 20 ° ± 10 ° is suitable, and the present invention employs a positive rake angle γ 122 that is optimally 15 ° ± 5 °.

As shown in fig. 8, according to the shape of the back of the tooth, there are generally straight back teeth 123 and tortoise back teeth 124, and the tortoise back teeth 124 are used in the present invention. Because the back of the turtle tooth can have narrower tooth width under the premise of the same front and back angles, the design of the strength of the tooth tip and the tooth space has obvious advantages. Modeling analysis was performed by the same method as above, we analyzed the magnitude of the clearance angle, set 7 kinds of clearance angle parameters uniformly from 0 ° to 30 ° respectively (neglecting the friction effect between the back and the load), analyzed the cutting force, and we found that the advancing cutting force tends to increase weakly as the clearance angle increases. From the viewpoint of cutting force only, the smaller the clearance angle, the better. However, the smaller the back angle, the easier the tooth back will come into contact with the remaining loaded tissue, increasing resistance and frictional heating; in terms of shape, the smaller the back angle, the larger the tooth pitch, and the smaller the number of teeth that can be placed per unit distance, and the cutting effect is reduced. Taken together, the preferred back angle in the present invention is 20 ° ± 10 °. The angle of the tip angle β 121 of the serration 103 is not less than 45 °. The preferred angle of cusp angle β 121 of the present invention is 55 °.

As shown in FIG. 9, the back-of-the-tortoise teeth designed according to the positive front angle of 15 ° + -5 ° and the back angle of 20 ° + -10 ° have root fillet R of 0.25, tooth height of 0.6mm and shortest tooth spacing of 1.05 mm. On the premise of ensuring that the total cutting length is equivalent as much as possible, the cutting length is determined according to the tooth spacing 125 x the tooth number 126: four different tooth spacings were designed 1.1mm × 13, 1.3mm × 11, 1.5mm × 10, 1.7mm × 8. The maximum high-frequency internal stress is analyzed at the resonance frequency point designed by the invention, the maximum stress is always positioned at the root of the tooth at the nearest end, the maximum stress is gradually reduced along with the increase of the distance, the reduced value of the stress is weaker after the distance is increased to 1.5mm, at this time, the maximum stress is mainly determined by the position of the tooth at the nearest end, and the closer the tooth is to the first node, the higher the stress value is. On the premise of keeping the total length unchanged, 1.3mm to 1.7mm is a reasonable selection interval, wherein the 1.5mm tooth space is a better value.

The double-row reverse layout (i.e. the opposite orientation of the

tooth tips

104, 105 of the two rows of the sawtooth rows 102) hook tooth structure design provided by the invention ensures that enough cutting force is available in the whole cutting cycle of the hard tissue 127, and through simulation analysis, the structure provided by the invention can improve the cutting efficiency in multiples on the premise of not increasing the stress value.

In order to avoid the failure and fracture risks caused by stress concentration due to position staggering, the invention adopts a common-tooth-bottom structure design, as shown in fig. 3, namely, the tooth roots 109 of the corresponding sawteeth 103 in the two rows of saw tooth rows 102 are overlapped with each other in the thickness direction of the ultrasonic scalpel and are in a completely common structure with the tooth height being below approximately half of the tooth height, and the tooth tips are divided into two sides from the arc corner of the tortoise back to the front and the back.

Another problem encountered during the cutting operation is that when a bone with a large cross section and a thick tissue is broken, the ultrasonic scalpel head is inevitably embedded in the bone for a long time. The ultrasonic surgical blade that is mainstream at present is a sheet-shaped structure, and has two end faces 106 with large area in the thickness direction. When the blade is embedded into the tissue, the planar structure can make long-time contact with the resected plane, and a large amount of heat can be generated under the action of ultrasound, so that the secondary temperature rise of the cut wound surface is easily caused to influence the bone healing. And the ultrasonic generator is required to output more energy, and the energy acts on the invalid output, so that higher requirements are put on the output power of hardware. To solve this problem, as shown in fig. 10, in the second embodiment of the present invention, a groove 107 is formed on each end surface 106. In this embodiment, the grooves 107 are shown as racetrack shaped, with the depth of the single-sided grooves being no more than 25% of the total thickness, leaving substantially more than 50% of the total thickness in between, and retaining sufficient mechanical strength. The total length of the groove is greater than the total length of the cutting teeth. Of course, other shapes of the groove 107 are also permissible.

The third embodiment of the present invention as disclosed in fig. 11 and 12 is different from the preferred embodiment in that one side of the cutting head 113 is extended along the axis of the body to be provided with the row of saw teeth 102, and the other side of the symmetry is provided with the cutting edge 108. Thus, the operator can selectively choose the sawtooth row 102 or the cutting edge 108 to cut, and the use scene of the invention is enlarged.

The fourth embodiment of the invention as disclosed in fig. 13, compared to the third embodiment, adds a groove 107 on the end surface 106. This effect is similar to the second embodiment, and is not described in detail herein.

In the fifth and sixth embodiments shown in fig. 14 and 15, the cutting edge 101 of the cutting head 113 is a semicircular blunt cutting edge, compared to the preferred and second embodiments shown in fig. 1 and 10. Therefore, when the ultrasonic wave generated by the ultrasonic generator is transmitted to the blade, a stronger driving-away effect is generated, fragile tissues such as blood vessels and nerves are protected, the fragile tissues are not easily scratched, and a good protection effect can be generated on the tissues. In the sixth embodiment shown in fig. 15, a groove 107 is added on the end surface 106, and the effect is similar to that of the second embodiment, and is not described again. Of course, it will be appreciated by those skilled in the art that the cutting edge 101 of the cutting head 113 may also be of other forms, such as a serrated edge or the like.

It should be understood that although the present description refers to embodiments, not every embodiment contains only a single technical solution, and such description is for clarity only, and those skilled in the art should make the description as a whole, and the technical solutions in the embodiments can also be combined appropriately to form other embodiments understood by those skilled in the art.

The above-listed detailed description is only a specific description of a possible embodiment of the present invention, and they are not intended to limit the scope of the present invention, and equivalent embodiments or modifications made without departing from the technical spirit of the present invention should be included in the scope of the present invention.

Claims

1. An ultrasonic surgical blade characterized in that: including columniform main part (111), the near-end of main part (111) is a connection structure (112), and the distal end is provided with tool bit (113), tool bit (113) are including being located most distal cutting edge (101) and being located at least that one side thereof extends sawtooth row (102) that sets up along the main part axis, sawtooth row (102) are two rows side by side, and every row sawtooth row (102) are formed by arranging a sawtooth (103), two rows the orientation of prong (104, 105) of sawtooth row (102) is opposite.

2. The ultrasonic surgical blade of claim 1, wherein: the rake angle gamma (122) of the saw teeth (103) is a positive rake angle.

3. The ultrasonic surgical blade of claim 2, wherein: the rake angle γ (122) of the serrations (103) is 15 ° ± 5 °.

4. The ultrasonic surgical blade of claim 1, wherein: the relief angle alpha (120) of the saw teeth (103) is 20 DEG + -10 deg.

5. The ultrasonic surgical blade of claim 1, wherein: the tooth tip angle beta (121) of the saw tooth (103) is not less than 45 degrees.

6. The ultrasonic surgical blade of claim 1, wherein: the serration pitch (125) of the serration row (102) is between 1.3mm and 1.7 mm.

7. The ultrasonic surgical blade of claim 1, wherein: the tooth roots (109) of the corresponding saw teeth (103) in the two rows of saw tooth rows (102) are in a mutual overlapped common-tooth-bottom structure in the thickness direction of the ultrasonic scalpel.

8. The ultrasonic surgical blade of claim 1, wherein: the ultrasonic scalpel is provided with two end faces (106) in the thickness direction, and at least one end face (106) is provided with a groove (107).

9. The ultrasonic surgical blade of claim 1, wherein: the cutting edge (101) is at least one of a cutting edge, a blunt edge cutting edge and a sawtooth cutting edge.

10. The ultrasonic surgical blade of any one of claims 1 to 9, wherein: the cutter head (113) comprises a blade (101) positioned at the farthest end and two saw tooth rows (102) which are symmetrically arranged on the two sides of the blade and extend along the axis of the main body.

11. The ultrasonic surgical blade of any one of claims 1 to 9, wherein: the cutting head (113) comprises a cutting edge (101) at the most distal end and a row of saw teeth (102) extending along the axis of the body at one side thereof, and a cutting edge (108) at the other side thereof which is symmetrical.

12. The utility model provides a tool bit of supersound scalpel which characterized in that: the tool bit (113) comprises a cutting edge (101) at the farthest end and a sawtooth row (102) which is at least located on one side of the cutting edge and extends along the axis of the main body, the sawtooth row (102) comprises sawteeth (103), the sawteeth (103) are turtleback teeth, the front angle gamma (122) of the sawtooth is 15 degrees +/-5 degrees, and the rear angle alpha (120) of the sawtooth is 20 degrees +/-10 degrees.

13. The ultrasonic-surgical-blade bit of claim 12, wherein: the sawtooth rows (102) are two rows in parallel, each row of sawtooth rows (102) is formed by arranging one row of sawteeth (103), and the tooth tips (104, 105) of the two rows of sawtooth rows (102) are opposite in direction.

14. The ultrasonic-surgical-blade bit of claim 12, wherein: the tooth tip angle beta (121) of the sawtooth (103) is not less than 45 degrees.

15. The ultrasonic-surgical-blade bit of claim 12, wherein: the tooth spacing (125) of the row of teeth (102) is between 1.3mm and 1.7 mm.

16. The ultrasonic-surgical-blade bit of claim 12, wherein: the tooth roots (109) of the corresponding saw teeth (103) in the two rows of saw teeth (102) are in a mutual overlapped common-tooth-bottom structure in the thickness direction of the ultrasonic scalpel.

17. The ultrasonic-surgical-blade cartridge of claim 12, wherein: the ultrasonic scalpel is provided with two end faces (106) in the thickness direction, and at least one end face (106) is provided with a groove (107).

18. The ultrasonic-surgical-blade cartridge of claim 12, wherein: the cutting edge (101) is at least one of a cutting edge, a blunt edge cutting edge and a sawtooth cutting edge.

19. The ultrasonic-surgical-blade bit of any one of claims 12 to 18, wherein: the cutter head (113) comprises a blade (101) positioned at the farthest end and two sawtooth rows (102) which are symmetrically arranged on the two sides of the blade and extend along the axis of the main body.

20. The ultrasonic-surgical-blade bit of any one of claims 12 to 18, wherein: the cutting head (113) comprises a cutting edge (101) at the most distal end and a row of saw teeth (102) extending along the axis of the body at one side thereof, and a cutting edge (108) at the other side thereof which is symmetrical.