Ultrasonic surgical equipment and its processing and assembly method

Abstract

The present invention provides an ultrasonic surgical instrument that includes an ultrasonic scalpel holder (1) for transmitting ultrasonic energy, and a sleeve assembly (2) that is coaxially attached to the outside of the ultrasonic scalpel holder (1), and that has a clamp (3) at the distal end of the sleeve assembly (2) and a handle portion (4) at the proximal end thereof, and that is easy to assemble the sleeve assembly (2). The sleeve assembly (2) has an integrated structure and is connected to the handle portion (4) via a connection mechanism. This integrated sleeve assembly can reduce the number of assembly steps, simplify the mounting structure, reduce the complex structure, and generally reduce the manufacturing cost of the instrument and ease the burden on the patient.

Description

[Technical Field]

[0001] The present invention relates to the field of surgical medical instruments, and is applied to surgical instruments, and more particularly to ultrasonic surgical instruments and processing and assembly methods. [Background technology]

[0002] With the spread of minimally invasive surgery, ultrasonic scalpels have become a common surgical tool. Using an ultrasonic frequency generator, ultrasonic scalpels mechanically vibrate a scalpel holder at a specific ultrasonic frequency, evaporating water molecules in tissue, breaking protein hydrogen bonds, and fracturing cells, thereby cutting or coagulating tissue and closing blood vessels. Ultrasonic scalpels can simultaneously cut tissue and stop bleeding while minimizing lateral thermal damage. Clinical use of this device allows for lesion resection at low temperatures with minimal bleeding and minimizes lateral thermal damage to tissue, making ultrasonic scalpels increasingly popular.

[0003] An ultrasonic scalpel is primarily composed of an ultrasonic frequency generator, a transducer, and a surgical instrument. The ultrasonic generator generates an oscillating electrical signal, and the transducer converts the oscillating electrical signal into mechanical vibrations. The surgical instrument uses the transducer's mechanical vibrations to cut tissue and stop bleeding. The surgical instrument typically consists of a scalpel holder, a clamp that forms a clamping structure with the scalpel holder, a sleeve assembly surrounding the scalpel holder, and a handle. The scalpel holder transmits the mechanical vibrations of the transducer to the scalpel holder. The scalpel holder and the clamp cooperate to clamp tissue to achieve cutting and hemostasis. The sleeve assembly consists of an outer sleeve and an inner sleeve. The scalpel holder is located inside the inner sleeve. The sleeve assembly isolates the scalpel holder from the outside, protecting and supporting it, and forms a connecting mechanism with the clamp to open and close the clamp. The handle, which is held by the surgeon's hand, controls the opening and closing of the clamp and has a switch that controls the ultrasonic frequency generator to start or stop the output of the oscillating electrical signal.

[0004] Conventional ultrasonic scalpels have a relatively complex structure for the scalpel holder assembly, which results in high manufacturing costs and inconvenient assembly. The assembly of the inner and outer sleeves requires processes such as tube expansion and rotary groove machining, which makes it difficult to keep costs down. Furthermore, the complex structure of the inner and outer sleeves results in high costs and low processing efficiency.

[0005] As shown in FIG. 9, the sealing between the inner and outer sleeves of a conventional ultrasonic scalpel is generally achieved by forming a flared groove structure. The ultrasonic scalpel shown in FIG. 9 includes an outer sleeve assembly 21', an inner sleeve assembly 22', a knob outer ring 23', and a seal ring 24'. The knob outer ring 23', the outer sleeve assembly 21', and the inner sleeve assembly 22' form a structure distributed sequentially from the outside to the inside. The seal ring 24' is located between the outer sleeve body 211' of the outer sleeve assembly 21' and the inner sleeve body 221' of the inner sleeve assembly 22'. Both the outer sleeve body 211' of the outer sleeve assembly 21' and the inner sleeve body 221' of the inner sleeve assembly 22' have complex concave-convex structures, which enable sealing between the inner and outer sleeves. In other words, to achieve sealing by forming a flared groove structure, the sleeve must be molded into a special structure. However, such sleeves are expensive due to their complex structure and complex processing.

[0006] Therefore, there is a need in the art for an ultrasonic surgical instrument (ultrasonic scalpel) that can overcome or at least mitigate all or some of the above-mentioned deficiencies present in the prior art. Summary of the Invention

[0007] To address at least one of the above deficiencies in the prior art, the present invention provides a reusable and easy-to-assemble ultrasonic surgical instrument, which has a simpler overall structure and significantly reduces the cost of sleeve assembly.

[0008] Furthermore, the present invention reduces assembly man-hours through the use of a one-piece molding process. The components obtained through the one-piece molding process (co-injection) have high integrity, and the sealing between the inner and outer sleeves can be achieved without the need to design complex structural components (such as a flared groove structure) for the sleeve. The flared groove structure of the sleeve can be omitted or simplified, significantly improving the overall performance of the ultrasonic surgical instrument, allowing it to be used in more precise surgeries.

[0009] According to one aspect of the present invention, there is provided an ultrasonic surgical instrument including a scalpel holder, a clamp, a sleeve assembly, and a handle portion. The clamp and the distal end of the scalpel holder form a clamping structure, and the scalpel holder is an ultrasonic scalpel holder for transmitting ultrasonic energy. The sleeve assembly and the scalpel holder are coaxially arranged, the clamp is provided at the distal end portion of the sleeve assembly, and the handle portion is provided at the proximal end portion of the sleeve assembly. The sleeve assembly includes an outer sleeve assembly, a sleeve assembly, and a knob outer ring, and the outer sleeve assembly and the inner sleeve assembly are all integrally formed (integral structures) and connected to the handle portion via a connecting mechanism. The ultrasonic surgical instrument further includes a knob outer ring, which is coaxially attached to the outside of the outer sleeve assembly, and the knob outer ring and the outer sleeve assembly cannot rotate relative to each other. The sleeve assembly is rotatably connected to the handle portion. The rotational connection between the outer sleeve assembly and the handle portion is non-detachable and limits axial movement. The connecting structure of the sleeve assembly that rotates coaxially with the handle portion is provided on the outer sleeve assembly or the knob outer ring. A detent boss is provided on the outer sleeve assembly along the axial direction, and a detent groove is provided on the knob outer ring, with the detent boss fitted into the detent groove. Alternatively, a detent groove is provided on the outer sleeve assembly along the axial direction, and a detent boss is provided on the knob outer ring, with the detent boss fitted into the detent groove. A first detent boss is provided on the outer sleeve assembly along the axial direction, and a second detent boss is provided on the knob outer ring, with the outer sleeve assembly and the knob outer ring assembled by engaging the first detent boss of the outer sleeve assembly with the second detent boss of the knob outer ring. The knob outer ring and the outer sleeve assembly are assembled by, but not limited to, an interference fit or adhesive to prevent relative rotation between the knob outer ring and the outer sleeve assembly.

[0010] The ultrasonic surgical instrument of the present invention uses an integrated sleeve assembly and does not have (is omitted from) a protruding structure within the sleeve assembly, thereby simplifying the structure of the ultrasonic surgical instrument, making it easier to assemble, and reducing costs.

[0011] According to another aspect of the present invention, there is provided a method for assembling an ultrasonic surgical instrument, the ultrasonic surgical instrument including a scalpel holder, a clamp, a sleeve assembly, and a handle portion, the clamp and the distal end of the scalpel holder forming a clamping structure, and the sleeve assembly including an outer sleeve assembly and an inner sleeve assembly. Outer sleeve body and outer sleeve base and assembling the above components by a co-injection molding process, a welding process, or an adhesive process to form an integrated outer sleeve assembly; Inner sleeve body and inner sleeve base forming an integrated inner sleeve assembly by a co-injection molding process, a welding process, or an adhesive process; simultaneously attaching the outer sleeve assembly and the inner sleeve assembly to obtain a sleeve assembly; assembling the sleeve assembly, scalpel holder, clamp, and handle portion to obtain an ultrasonic surgical instrument; Includes:

[0012] The ultrasonic surgical instrument and the processing and assembly method provided in the embodiments of the present invention provide the following beneficial effects.

[0013] Since the outer sleeve assembly and the inner sleeve assembly are both one-piece structures, sealing between the inner and outer sleeves can be achieved without the need to design a complex configuration for the sleeves, and the protruding structure of the sleeve portion can be omitted or simplified, making the overall structure simpler and optimizing performance. [Brief explanation of the drawings]

[0014] The drawings described in this specification are intended to further understand the embodiments of the present invention and constitute a part of the present invention. The schematic embodiments of the present invention and their descriptions are intended to help understand the present invention and are not intended to unduly limit the present invention.

[0015] [Figure 1] 1 is an overall schematic diagram of an ultrasonic surgical instrument according to the present invention. [Figure 2] FIG. 2 is an exploded view of the sleeve assembly of the present invention. [Figure 3] 1 is an assembly schematic diagram of a sleeve assembly of the present invention. [Figure 4] FIG. 2 is a structural schematic diagram of the knob outer ring of the present invention. [Figure 5] FIG. 2 is a schematic diagram of an outer sleeve assembly of the present invention. [Figure 6] FIG. 2 is a schematic diagram of an inner sleeve assembly of the present invention. [Figure 7] 1 is a schematic diagram of a sleeve assembly of the present invention installed in place. [Figure 8] FIG. 8 is an enlarged view of part A in FIG. 7. [Figure 9] FIG. 1 is a schematic diagram of the prior art.

[0016] Explanation of symbols 1 female holder; 2 sleeve assembly; 3 clamp; 4 handle portion; 21 outer sleeve assembly; 22 inner sleeve assembly; 23 knob outer ring; 24 seal ring; 25 first installation direction; 26 second installation direction; 211 outer sleeve body; 212 outer sleeve base 213 First retaining boss; 214 Anti-rotation boss; 215 Connection structure; 221 Inner sleeve body; 222 Inner sleeve base ;231 second retaining boss;232 anti-rotation groove;21' outer sleeve assembly;22' inner sleeve assembly;23' knob outer ring;24' seal ring;211' outer sleeve body;212' outer sleeve base. DETAILED DESCRIPTION OF THE INVENTION

[0017] In order to clarify the purpose, technical means and advantages of the present invention, the following provides a clear and complete description of the technical means of the present invention through specific embodiments of the present invention and corresponding drawings. It is obvious that the following embodiments are only a part of the embodiments of the present invention, and are not all of the embodiments. Based on the embodiments of the present invention, any other embodiments that can be obtained by those skilled in the art without creative efforts are all included in the protection scope of the present invention.

[0018] In the prior art, a Chinese application with application number CN201220588716.4 (publication number CN202908803U) discloses a disposable ultrasonic scalpel including a blade and a holder, the blade including an inner blade tube, an outer blade tube, and a blade body, the holder including an inner holder tube, an outer holder tube, and a holder body, the blade, the inner holder tube, the outer holder tube, and the body being detachably connected together. The blade of this ultrasonic scalpel can only be used once, i.e., it is discarded after one use, resulting in high usage costs.

[0019] A Chinese application with application number CN201921215696.4 (publication number CN211187447U) discloses a scissors-type integrated ultrasonic scalpel and surgical instrument. The scissors-type integrated ultrasonic scalpel includes an ultrasonic driving rod and a scissors-type handle. The ultrasonic driving rod includes a scalpel holder and an ultrasonic transducer. The scissors-type handle includes a first handle and a second handle. The ultrasonic driving rod is permanently attached to the first handle. The ultrasonic driving rod includes a position restricting structure. The position restricting structure is located inside the first handle and is used to restrict movement of the ultrasonic driving rod. The ultrasonic scalpel according to this invention is also a completely disposable sterile instrument and cannot be used multiple times.

[0020] A Chinese application with application number CN201810130712.3 discloses a reusable ultrasonic scalpel. The ultrasonic scalpel includes a blade, a holder assembly, and a functional assembly. The blade, holder assembly, and functional assembly are connected in sequence. The holder assembly includes a holder and an inner sleeve and an outer sleeve that are fitted onto the holder from the inside out. The inner sleeve is divided into a clamp head end inner sleeve and a rotary handle end inner sleeve. The outer sleeve is divided into a clamp head end outer sleeve and a rotary handle end outer sleeve. The clamp head end inner sleeve and the rotary handle end inner sleeve are engaged by an L-shaped engagement structure. The clamp head end outer sleeve and the rotary handle end outer sleeve are also engaged by an L-shaped engagement structure.

[0021] The Chinese application with application number CN201810871843.7 (publication number CN109009330A) discloses an ultrasonic scalpel including a casing, a holder assembly and a sleeve unit penetrating the casing, and a trigger assembly movably connected to the sleeve unit, the holder assembly including a tip holder unit and a handle unit, the sleeve unit including an outer sleeve, an inner sleeve, two opposing inner casings and an outer casing, a rotary operating tool, and a fixing device, an axial positioning device being provided between the inner casing and the inner sleeve, the fixing device being provided between the outer sleeve and the rotary operating tool, and the pin shaft unit being located in a first strip groove of the outer sleeve and a third strip groove of the inner sleeve.

[0022] The Chinese application with application number CN201811114966.2 (publication number CN108969058A) discloses a reusable ultrasonic scalpel including a casing, a handle, a holder assembly, a universal wheel, and a moving mechanism, the holder assembly passing through the casing, a handle portion located on the casing and connected to the holder assembly, the universal wheel fitted onto the holder assembly, the holder assembly including a tip holder, an inner sleeve, and an outer sleeve, the tip holder passing through the inner sleeve and the outer sleeve fitted onto the outside of the inner sleeve, the tip holder being fixed to the handle in the axial direction and connected to the outer sleeve via an axial pin so that its position is restricted in the radial direction, the moving mechanism being located within the casing and connected to the inner sleeve, a notch formed in an end of the universal wheel facing the outer sleeve, a silicone plug provided in the notch, and a cleaning opening formed at the connection portion, the silicone plug sealing the cleaning opening.

[0023] A Chinese application with application number CN201910752035.3 (publication number CN110448357A) discloses a reusable ultrasonic scalpel, which includes a handle assembly and an ultrasonic scalpel holder extending from the distal end of the handle assembly for transmitting ultrasonic mechanical energy, a sleeve assembly disposed around the ultrasonic scalpel holder, and the sleeve assembly detachably connected to the handle assembly via a quick connection mechanism.

[0024] In conventional ultrasonic scalpels, the scalpel holder assembly structure is relatively complex, resulting in high manufacturing costs and inconvenient assembly. The assembly of the inner and outer sleeves requires processes such as tube expansion and rotary groove machining, which makes it difficult to control costs. In addition, the complex structure of the inner and outer sleeves results in high costs and low processing efficiency.

[0025] Hereinafter, the technical solutions provided in the embodiments of the present invention will be described in detail with reference to the drawings.

[0026] Unless otherwise specified, the terms used herein are consistent with the common meaning of various scientific and technical terms in the art and the meaning of technical terms as defined in various technical dictionaries, textbooks, etc.

[0027] In this specification, when describing a direction and position, the operator is generally used as the reference, and a position relatively close to the operator is referred to as the “near end,” and a position relatively far from the operator is referred to as the “far end.” Furthermore, in this specification, the longitudinal direction of the ultrasonic scalpel may be referred to as the axial direction.

[0028] 1 shows an ultrasonic surgical instrument according to one embodiment of the present invention. This surgical instrument generally includes a scalpel holder 1, a clamp 3, a sleeve assembly 2, and a handle portion 4. The clamp 3 and the distal end of the scalpel holder 1 form a clamping structure. The sleeve assembly 2 surrounds the exterior of the scalpel holder 1.

[0029] The scalpel holder 1 is an ultrasonic scalpel holder for transmitting ultrasonic energy. The sleeve assembly 2 is arranged coaxially with the scalpel holder 1. The clamp 3 is provided at a distal end portion of the sleeve assembly 2. The handle portion 4 is provided at a proximal end portion of the sleeve assembly 2. The sleeve assembly 2 has an integrated structure and is connected to the handle portion 4 via a connection mechanism.

[0030] During surgery, a surgeon can manually grasp the handle 4 to open or close the clamp 3, and can use a switch to control the ultrasonic frequency generator to start or stop the output of an oscillating electrical signal. The oscillating electrical signal is converted into mechanical vibrations by a transducer. The scalpel holder 1 transmits the mechanical vibrations of the transducer to the scalpel holder. The scalpel holder and clamp 3 cooperate to clamp tissue, performing ultrasonic cutting and hemostasis on the clamped tissue.

[0031] The sleeve assembly 2 serves to isolate the scalpel holder 1 from the outside and protect the scalpel holder, and at the far end thereof forms a link mechanism with the clamp 3 to open and close the clamp 3.

[0032] 2 is an exploded view of a sleeve assembly 2 of an ultrasonic surgical instrument according to the present invention. The sleeve assembly 2 includes an outer sleeve assembly 21, an inner sleeve assembly 22, and a knob outer ring 23.

[0033] The outer sleeve assembly 21, the inner sleeve assembly 22, and the scalpel holder 1 are arranged coaxially. The inner sleeve assembly 22 is located between the outer sleeve assembly 21 and the scalpel holder 1, that is, the structural order from outside to inside is the outer sleeve assembly 21, the inner sleeve assembly 22, and the scalpel holder 1.

[0034] 3 is a schematic diagram of the installation of the sleeve assembly 2 of the ultrasonic surgical instrument according to the present invention. The ultrasonic surgical instrument further includes a knob outer ring 23. The inner sleeve assembly 22 and the outer sleeve assembly 21 are coaxially attached, i.e., attached along a first attachment direction 25 in the figure. The inner sleeve assembly 22 is inserted into the proximal end of the outer sleeve assembly 21 from the distal end. Furthermore, the knob outer ring 23 is also coaxially attached to the outer sleeve assembly 21, i.e., attached along a second attachment direction 26 in the figure. Specifically, the knob outer ring 23 is inserted onto the outer sleeve assembly 21 from the distal end.

[0035] The knob outer ring 23 and the outer sleeve assembly 21 cannot rotate relative to each other.

[0036] Preferably, the rotational connection between the outer sleeve assembly 2 and the handle portion 4 is non-detachable and limits axial movement.

[0037] The outer sleeve assembly 21 is generally obtained by assembling the outer sleeve body 211 and the outer sleeve base 212 by a coinjection molding process, a welding process, or an adhesive process. The inner sleeve assembly 22 is generally obtained by assembling the inner sleeve body 221 and the inner sleeve base 222 by a coinjection molding process, a welding process, or an adhesive process.

[0038] The assembled sleeve assembly 2 is attached to the handle portion 4, and then the inner sleeve assembly 22 of the sleeve assembly 2 is moved by a transmission assembly in the handle portion 4, and the relative movement of the inner sleeve assembly 22 and the outer sleeve assembly 21 realizes opening and closing of the clamp 3 and the scalpel holder 1.

[0039] The circumferential rotation of the knob outer ring 23 allows the sleeve assembly 2, scalpel holder 1, and clamp 3 to be rotated, which is convenient for the doctor to adjust the appropriate cutting angle and hemostasis angle.

[0040] 5, the outer sleeve assembly 21 is comprised of an outer sleeve body 211 and an outer sleeve base 212. The outer sleeve body 211 and the sleeve base 212 are provided as a unitary structure.

[0041] As an optional process, the outer sleeve body 211 and the outer sleeve base 212 are integrally molded by co-injection molding technology. The integrated structure formed by co-injection molding technology has no gaps in the connection, which makes it excellent in integrity and convenient to use.

[0042] As a further alternative process, the outer sleeve body 211 and the outer sleeve base 212 may be integrally formed by welding or adhesive bonding. The outer sleeve assembly 21 thus formed has the advantages of excellent integrity and ease of use.

[0043] To facilitate assembly with the knob outer ring 23, the outer sleeve assembly 21 is provided with first retaining bosses 213 and anti-rotation bosses 214. The number of first retaining bosses 213 and anti-rotation bosses 214 may be the same or different. The first retaining bosses 213 and anti-rotation bosses 214 may be arranged one by one on the circumference, or may be arranged in multiple evenly or unevenly. Preferably, two first retaining bosses 213 and two anti-rotation bosses 214 are provided, with the two first retaining bosses 213 arranged symmetrically on the circumference and the two anti-rotation bosses 214 arranged symmetrically on the circumference. This facilitates installation because the orientation does not matter.

[0044] In contrast, as shown in FIG. 4, second retaining bosses 231 and anti-rotation grooves 232 are provided on the knob outer ring 23. The number of second retaining bosses 231 and anti-rotation grooves 232 may be the same or different. The second retaining bosses 231 and anti-rotation grooves 232 may be arranged one by one on the circumference, or multiple second retaining bosses 231 and anti-rotation grooves 232 may be arranged evenly or unevenly. Preferably, two second retaining bosses 231 and two anti-rotation grooves 232 are provided, with the two second retaining bosses 231 arranged symmetrically on the circumference and the two anti-rotation grooves 232 arranged symmetrically on the circumference. This facilitates installation because the orientation does not matter.

[0045] When the knob outer ring 23 and the outer sleeve assembly 21 are attached, the anti-rotation boss 214 and the first anti-removal boss 213 on the outer sleeve assembly 21 fit into the anti-rotation groove 232 and the second anti-removal boss 231 of the knob outer ring, respectively. 231 The mutual engagement of the anti-rotation boss 214 and the anti-rotation groove 232 fixes the relative positions of the knob outer ring 23 and the outer sleeve assembly 21, and the knob outer ring 23 cannot come off the outer sleeve assembly 21 at the distal end. The engagement of the anti-rotation boss 214 and the anti-rotation groove 232 limits relative rotation between the knob outer ring 23 and the outer sleeve assembly 21.

[0046] Preferably, when attaching the knob outer ring 23 and the outer sleeve assembly 21, the anti-rotation boss 214 on the outer sleeve assembly 21 enters the anti-rotation groove 232 of the knob outer ring 23 to confirm the attachment position, and then the first anti-removal boss 213 on the outer sleeve assembly 21 engages with the second anti-removal boss 231 of the knob outer ring 23, and the first anti-removal boss 213 and the second anti-removal boss 231 The mutual engagement action of the knob outer ring 23 and the outer sleeve assembly 21 fixes their relative positions.

[0047] Preferably, the detent boss 214 and the detent groove 232 are secured by an interference fit or adhesive.

[0048] Preferably, the sleeve assembly 2 and handle portion 4 are provided with a coaxially rotating connection structure 215 for limiting axial movement. The coaxially rotating connection structure 215 may be coaxially connected to the handle at the outer sleeve base 212. The coaxially rotating connection structure 215 may be coaxially connected to the handle on the knob outer ring 23.

[0049] Preferably, the coaxially rotating connecting structure 215 is provided on the outer sleeve assembly 21 , and the connecting structure 215 is connected to the handle portion 4 .

[0050] 6, the inner sleeve assembly 22 is comprised of an inner sleeve body 221 and an inner sleeve base 222. The inner sleeve body 221 and base 222 are assembled into a unitary structure.

[0051] As an optional process, the inner sleeve body 221 and the inner sleeve base 222 are integrally molded by co-injection technology. The integrated structure formed by co-injection technology has no gaps in the connection, which makes it excellent in integrity and convenient to use.

[0052] As a further optional process, the inner sleeve body 221 and the inner sleeve base 222 may be integrally formed by welding or bonding. The inner sleeve assembly 22 thus formed also has the advantages of excellent integrity and convenience in use.

[0053] In a preferred embodiment, the outer sleeve assembly 21 of Outer sleeve base 212 and the inner sleeve assembly 22 Inner Sleeve base 222 A sealing structure is provided between the handle and the handle, which prevents fine tissue or blood generated during surgery from entering the handle and contaminating it, making it impossible to reuse.

[0054] Specifically, as shown in FIGS. 2 and 8, the outer sleeve assembly 21 of Outer sleeve base 212 and the inner sleeve assembly 22 Inner Sleeve base 222 A seal ring 24 may be provided between the seal ring 24 and the Outer sleeve base 212 and Inner sleeve base 222 This seals the gap between the handle portion 4 and the cavity, preventing fine tissue or blood from entering the cavity by capillary action and preventing the handle portion 4 from being contaminated.

[0055] 7 is a schematic diagram of the assembled ultrasonic surgical instrument according to the present invention. The sleeve assembly 22 and the outer sleeve assembly 21 are coaxially assembled, and the knob outer ring 23 is coaxially mounted on the outside of the outer sleeve assembly 21. The specific mounting process is as follows: Step A: assembling the outer sleeve body 211 and the outer sleeve base 212 by a co-injection molding process, a welding process, or an adhesive process to form an integrated outer sleeve assembly 21; Step B: assembling the inner sleeve body 221 and the inner sleeve base 222 by a co-injection molding process, a welding process, or an adhesive process to form an integrated inner sleeve assembly 22; Step C of coaxially mounting the outer sleeve assembly 21 and the inner sleeve assembly 22 to obtain a sleeve assembly 2; Step D: assembling the sleeve assembly 2, the scalpel holder 1, the clamp 3, and the handle portion 4 to obtain an ultrasonic surgical instrument; Includes:

[0056] The order of steps A and B can be changed. That is, step B may be performed first, followed by step A.

[0057] Step A further includes assembling the outer sleeve body 211 and the outer sleeve base 212 by a co-injection molding process to form an integrated outer sleeve assembly 21 .

[0058] Step B involves assembling the inner sleeve body 221 and the inner sleeve base 222 by a co-injection molding process to form the integrated inner sleeve assembly 22.

[0059] Further, step C includes coaxially mounting the seal ring 24 to the inner sleeve assembly 22 and coaxially mounting the outer sleeve assembly 21 to the inner sleeve assembly 22. That is, the seal ring 24 is mounted between the outer sleeve base 212 and the inner sleeve base 222.

[0060] Furthermore, the ultrasonic surgical instrument includes a knob outer ring 23. Step D includes assembling the sleeve assembly 2, scalpel holder 1, clamp 3, handle portion 4, and knob outer ring 23 to obtain the ultrasonic surgical instrument.

[0061] Furthermore, the knob outer ring 23 and the outer sleeve assembly 21 cannot rotate relative to each other.

[0062] Furthermore, the scalpel holder 1 is an ultrasonic scalpel holder for transmitting ultrasonic energy. The sleeve assembly 2 is coaxially attached to the outside of the scalpel holder 1. The clamp 3 is provided at a distal end portion of the sleeve assembly 2. The handle portion 4 is provided at a proximal end portion of the sleeve assembly 2.

[0063] Furthermore, the outer sleeve assembly 21 is provided with a first retaining boss 213 and a rotation-preventing boss 214. The knob outer ring 23 is provided with a second retaining boss 231 and a rotation-preventing groove 232.

[0064] Furthermore, when the knob outer ring 23 and the outer sleeve assembly 21 are attached, the anti-rotation boss 214 and the first anti-detachment boss 213 on the outer sleeve assembly 21 fit into the anti-rotation groove 232 and the second anti-detachment boss 231 of the knob outer ring 23, respectively, so that the knob outer ring 23 cannot fall off the outer sleeve assembly 21 at the distal end.

[0065] When the ultrasonic surgical instrument of the present invention is used, the clamp 3 is opened and closed by moving the inner sleeve assembly 22 via the transmission assembly in the handle portion 4, thereby causing the clamp 3 and the distal end of the scalpel holder 1 to be in an open or closed state.

[0066] During use, the sleeve assembly 2, the knife holder 1, and the clamp 3 are rotated by the circumferential rotation of the knob outer ring 23.

[0067] The ultrasonic surgical instrument provided in the embodiment of the present invention provides the following beneficial effects.

[0068] 1. The sleeve assembly is formed by coinjection technology, welding process or adhesive process, and then processed and assembled to obtain the ultrasonic surgical instrument, thereby reducing the assembly man-hours.

[0069] 2. The components obtained by co-injection, welding or bonding have excellent integrity, and the sealing between the inner and outer sleeves can be achieved without the need to design a complex sleeve structure. The protruding structure of the sleeve can be omitted or simplified, making the overall structure simpler and optimizing the performance.

[0070] 3. The ultrasonic surgical instrument of the present invention has low manufacturing costs due to the use of an integrated sleeve assembly.

[0071] 4. This surgical ultrasonic surgical instrument has a simple structure, is convenient to assemble, disassemble, clean and disinfect.

[0072] 5. The sealing structure between the inner sleeve assembly and the outer sleeve assembly can prevent minute tissues or blood generated during surgery from entering the handle and causing contamination.

[0073] 6. The ultrasonic surgical instrument of the present invention can be applied to more precise surgeries.

[0074] Figure 9 is an assembly diagram of the prior art, which shows that a complex overhang structure needs to be designed between the inner sleeve portion and the outer sleeve portion, resulting in a complex structure and poor performance.

[0075] It should be noted that the embodiments in the drawings are relatively representative examples of the present invention, intended to help those skilled in the art better understand the present invention. The scope of protection of the present invention is not limited to the embodiments in the drawings. Any combinations, modifications and variations of the embodiments in the drawings are included within the scope of protection of the present invention.

[0076] It should be noted that, as used herein, the terms "comprise," "contain," or any variation thereof, are intended to be non-exclusive inclusive, such that a process, method, article, or facility that includes a set of elements includes not only those elements but also other elements not expressly listed or that are inherent in such process, method, article, or facility. Unless further qualified, elements qualified by the term "comprises" do not exclude the presence of other identical elements in a process, method, article, or facility that includes said elements.

[0077] Finally, the above examples are merely for illustrating the technical means of the present invention, and are not intended to limit the present invention. Although the present invention has been described in detail through the above examples, it is still possible to modify the technical means described in each of the above examples, or to replace some of the technical features therein with equivalent features, and it is obvious to those skilled in the art that such modifications or replacements do not deviate the essence of the corresponding technical means from the spirit and scope of the technical means of each of the embodiments of the present invention.

Claims

1. An ultrasonic surgical instrument including a scalpel holder, a clamp, a sleeve assembly, and a handle portion, the scalpel holder is an ultrasonic scalpel holder for transmitting ultrasonic energy, the sleeve assembly is arranged coaxially with the scalpel holder, the clamp is provided at a distal end portion of the sleeve assembly, and the handle portion is provided at a proximal end portion of the sleeve assembly; the sleeve assembly includes an outer sleeve assembly, an inner sleeve assembly, and a knob outer ring, the outer sleeve assembly being a one-piece structure, and the inner sleeve assembly also being a one-piece structure, and the outer sleeve assembly and the inner sleeve assembly are assemblable; the sleeve assembly is rotatably connected to the handle portion; the knob outer ring is coaxially attached to the outside of the outer sleeve assembly, and the knob outer ring and the outer sleeve assembly cannot rotate relative to each other; the knob outer ring is coaxially fitted to the outer peripheral surface of the outer sleeve assembly, the outer peripheral surface of the outer sleeve assembly is provided with a detent boss along the axial direction, the knob outer ring is provided with a detent groove on its inner peripheral surface facing the outer sleeve assembly, and the detent boss is fitted into the detent groove; or an anti-rotation groove is provided on an outer peripheral surface of the outer sleeve assembly along the axial direction, and an anti-rotation boss is provided on an inner peripheral surface of the knob outer ring facing the outer sleeve assembly, and the anti-rotation boss is fitted into the anti-rotation groove; the knob outer ring is coaxially fitted to the outer peripheral surface of the outer sleeve assembly, a first retaining boss is provided on the outer peripheral surface of the outer sleeve assembly along the axial direction, and a second retaining boss is provided on the knob outer ring on the inner peripheral surface facing the outer sleeve assembly, and the outer sleeve assembly and the knob outer ring are assembled by engaging the first retaining boss with the second retaining boss, two first retaining bosses and two anti-rotation bosses are provided, the two first retaining bosses are arranged symmetrically on a circle, and the two anti-rotation bosses are arranged symmetrically on a circle; An ultrasonic surgical instrument characterized by:

2. 10. The ultrasonic surgical instrument of claim 1, wherein the rotatable connection between the outer sleeve assembly and the handle portion is non-detachable and limits axial movement.

3. 2. The ultrasonic surgical instrument of claim 1, wherein the sleeve assembly includes a coaxially rotating connection structure, the connection structure being coaxially connected to the handle at a base of the outer sleeve assembly or coaxially connected to the handle portion at a knob outer ring.

4. 2. The ultrasonic surgical instrument of claim 1, wherein the knob outer ring and the outer sleeve assembly are assembled by, but not limited to, an interference fit or adhesive to prevent the knob outer ring and the outer sleeve assembly from rotating relative to each other.

5. 2. The ultrasonic surgical instrument according to claim 1, wherein the clamp and the distal end of the scalpel holder form a clamping structure, the outer sleeve assembly and the inner sleeve assembly are assembled coaxially, the inner sleeve assembly is located between the scalpel holder and the outer sleeve assembly, and the clamp is opened or closed by moving the inner sleeve assembly using a transmission assembly of the handle portion, thereby opening and closing the clamp and the distal end of the clamp and scalpel holder.

6. The ultrasonic surgical instrument of claim 1, wherein the outer sleeve assembly includes an outer sleeve body and an outer sleeve base, and the outer sleeve body and the outer sleeve base are assembled and integrated by a coinjection molding process, an adhesive process, or a welding process.

7. The ultrasonic surgical instrument of claim 1, wherein the inner sleeve assembly includes an inner sleeve body and an inner sleeve base, and the inner sleeve body and the inner sleeve base are assembled and integrated by a coinjection molding process, an adhesive process, or a welding process.

8. An ultrasonic surgical instrument as described in claim 1, characterized in that a sealing structure is provided between the outer sleeve base of the outer sleeve assembly and the inner sleeve base of the inner sleeve assembly, and the sealing structure is a seal ring.

9. 2. A method for processing and assembling an ultrasonic surgical instrument according to claim 1, comprising: The ultrasonic surgical instrument includes a scalpel holder, a clamp, a sleeve assembly, and a handle portion, the clamp and the distal end of the scalpel holder forming a clamping structure, the sleeve assembly including an outer sleeve assembly, an inner sleeve assembly, and a knob outer ring, and the processing and assembling method includes: assembling the outer sleeve body and the outer sleeve base by a co-injection molding process, a welding process, or an adhesive process to form an integrated outer sleeve assembly; assembling the inner sleeve body and the inner sleeve base by a co-injection molding process, a welding process, or an adhesive process to form an integrated inner sleeve assembly; coaxially mounting the outer sleeve assembly and the inner sleeve assembly to obtain a sleeve assembly; assembling the sleeve assembly, scalpel holder, clamp, and handle portion to obtain an ultrasonic surgical instrument; Including, The knob outer ring and the outer sleeve assembly of the sleeve assembly cannot rotate relative to each other, the knob outer ring is coaxially fitted to an outer peripheral surface of the outer sleeve assembly, an anti-rotation boss is provided on the outer peripheral surface of the outer sleeve assembly along the axial direction, and an anti-rotation groove is provided on the knob outer ring on an inner peripheral surface facing the outer sleeve assembly, and the processing and assembling method includes fitting the anti-rotation boss into the anti-rotation groove, the knob outer ring is coaxially fitted to the outer peripheral surface of the outer sleeve assembly, a first retaining boss is provided on the outer peripheral surface of the outer sleeve assembly along the axial direction, and a second retaining boss is provided on the knob outer ring on an inner peripheral surface relative to the outer sleeve assembly, and the processing and assembling method includes assembling the outer sleeve assembly and the knob outer ring by engaging the first retaining boss with the second retaining boss, Here, two of each of the first retaining bosses and the anti-rotation bosses are provided, the two first retaining bosses are arranged symmetrically on a circle, and the two anti-rotation bosses are arranged symmetrically on a circle.

1. A method for processing and assembling an ultrasonic surgical instrument, comprising:

10. 10. The method for processing and assembling an ultrasonic surgical instrument according to claim 9, wherein the rotatable connection between the outer sleeve assembly and the handle portion is non-detachable and limits axial movement, and the sleeve assembly includes a coaxially rotating connection structure, which is coaxially connected to the handle at a base of the outer sleeve assembly or coaxially connected to the handle portion at a knob outer ring.

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