Ultrasonic surgical instrument

Abstract

The invention discloses an ultrasonic surgical instrument, and belongs to the field of medical instruments. Comprising a central rod which is provided with a longitudinal axis; the tail end executing part extends from the far end of the center rod, a channel is formed in at least one part of the area of the tail end executing part, the channel extends from the far end face of the tail end executing part to the near side, and at least one part of the channel penetrates through the circumferential side wall of the tail end executing part. The ultrasonic surgical instrument disclosed by the invention can be used for performing various surgical operations such as ultrasonic suction, cutting and hemostasis.

Description

Technical Field

[0001] The present invention relates to the field of surgical instruments, and in particular to an ultrasonic surgical instrument. Background Art

[0002] The application of ultrasound in medicine is mainly divided into two categories: diagnostic ultrasound and therapeutic ultrasound. Diagnostic ultrasound is mainly used to diagnose diseases, such as B-ultrasound imaging, ultrasonic Doppler blood flow analysis, ultrasonic bone testing, etc.; therapeutic ultrasound is mainly used to treat diseases, such as ultrasonic drug permeation therapy, physical therapy, extracorporeal lithotripsy, dental treatment, surgical operations, and cancer treatment. In ultrasonic therapy, ultrasound acting on the human body will produce a series of physiological effects, which are mainly manifested as cavitation effect, mechanical effect, thermal effect, thixotropic effect, and diffusion effect. In ultrasonic therapy, one or several unique effects of ultrasound on biological tissues are often used. Based on the different physiological effects on tissues, ultrasonic surgical instruments are divided into many types. One of the ultrasonic surgical instruments, also known as ultrasonic soft tissue cutting / hemostasis instruments or ultrasonic surgical scalpels, is constructed to use the mechanical effects of ultrasonic therapy to achieve tissue cutting and coagulation in surgical operations. Another type of ultrasonic surgical instrument, also known as an ultrasonic aspirator or CUSA, has a hollow tool at the end of the instrument that radiates high-amplitude ultrasound waves. It uses the cavitation effect of ultrasound therapy to crush and emulsify tumors and other tissues, and then aspirates surgical debris by applying negative pressure. The advantage of ultrasonic aspirators is that they use different cavitation thresholds of different biological tissues to achieve the purpose of selective fragmentation and emulsification. In liver and brain tumor removal surgeries, ultrasonic aspirators can remove tumors while protecting blood vessels and nerves from damage.

[0003] Liver resection is a commonly used surgical method in liver surgery and is currently the preferred treatment for liver space-occupying lesions, especially liver cancer. With the widespread development of laparoscopic liver surgery, it has gradually developed from local resection of lesions at the edge and superficial part of the liver to precise resection of anatomical hemiliver and liver segments. Since the liver is a solid organ with extremely rich blood supply, how to control bleeding is the top priority during the separation of liver parenchyma. Although currently Figure 1 The ultrasonic surgical scalpel shown is generally capable of cutting blood vessels that are less than 3-5mm in size. However, during the process of cutting and dissecting the liver parenchyma, the phenomenon of tissue adhesion to the blade is relatively serious, resulting in an increase in the working temperature of the blade, which affects the working performance of the ultrasonic surgical scalpel. The use of an ultrasonic suction knife (CUSA) can only cut the liver parenchyma and expose the intrahepatic blood vessels and bile duct, and other surgical instruments are required to complete the cutting of blood vessels and bile duct, which not only increases the cost of the operation, but also prolongs the operation time. For this reason, proposing an ultrasonic instrument that can simultaneously perform ultrasonic suction, cutting, and hemostasis has become a technical problem that needs to be solved urgently by those skilled in the art. Summary of the invention

[0004] To this end, the present invention proposes a multifunctional ultrasonic surgical instrument capable of performing surgical operations such as ultrasonic aspiration, cutting, and hemostasis.

[0005] In view of the above technical problems, the present invention provides the following technical solutions:

[0006] An ultrasonic surgical instrument comprises: a central rod having a longitudinal axis; and an end effector extending from the distal end of the central rod, wherein at least a portion of the end effector is provided with a channel, the channel extending from the distal end of the end effector toward the proximal side, and at least a portion of the channel passes through a circumferential side wall of the end effector.

[0007] In some embodiments of the present invention, a first opening is provided on the circumferential side wall on the proximal side of the end effector, and the first opening is configured as the proximal end of the channel; a second opening is provided at the farthest end of the end effector, and the second opening is configured as the distal end of the channel.

[0008] In some embodiments of the present invention, the channel includes a proximal channel portion and a distal channel portion, the distal channel portion extends proximally from the second opening along the longitudinal axis, and the proximal channel portion extends from the first opening and smoothly engages with the distal channel portion.

[0009] In some embodiments of the present invention, the proximal channel portion includes a proximal channel curved surface to provide a smooth transition from the first opening to the distal channel portion.

[0010] In some embodiments of the present invention, the outer contour of the distal channel portion and the end effector portion in the area where the distal channel portion is located are non-coaxially arranged.

[0011] In some embodiments of the present invention, the first opening is configured as at least a portion of an ellipse or a long waist shape.

[0012] In some embodiments of the present invention, the second opening is configured as at least a portion of a circle or an ellipse.

[0013] In some embodiments of the present invention, the distal channel portion is configured as a cylindrical or conical hole.

[0014] In some embodiments of the present invention, the channel is a channel extending along the longitudinal axis of the end effector and having a notch on one side.

[0015] In some embodiments of the present invention, the end effector includes a transition section and a distal section extending distally along the transition section, the outer contour of the distal section is configured as a teardrop shape, and the outer contour of the transition section is configured as a circle or an ellipse.

[0016] In some embodiments of the present invention, an outer contour of the transition segment is smoothly connected to an outer contour of the distal segment.

[0017] In some embodiments of the present invention, the transition section of the end effector gradually tapers from the proximal side to the distal side along the longitudinal axis.

[0018] In some embodiments of the present invention, the end effector gradually tapers from the proximal side to the distal side along the longitudinal axis.

[0019] In some embodiments of the present invention, the distal segment includes a first surface and a second surface extending distally from the distal end of the transition segment, the first surface and the second surface meet on one side of the end execution portion to form a cutting edge, and the cutting edge extends distally along the longitudinal axis.

[0020] In some implementation modes of the present invention, the cutting edge is processed to form a cutting surface, and the cutting surface smoothly transitions with the first surface and the second surface.

[0021] In some embodiments of the present invention, the first surface includes multiple curved segments with smooth transitions; the second surface includes multiple curved segments with smooth transitions; the first surface and the second surface are joined in a smooth transition form on the other side of the end execution portion opposite to the cutting edge.

[0022] In some embodiments of the present invention, the first surface includes multiple curved segments with smooth transitions; the second surface includes multiple curved segments with smooth transitions; the first surface and the second surface are transitionally joined through a third surface on the other side of the end execution portion opposite to the cutting edge.

[0023] In some embodiments of the present invention, the third surface is configured as a curved surface joining the first surface and the second surface, and a curvature radius of the curved surface is greater than or equal to a curvature radius of the first surface or the second surface.

[0024] In some embodiments of the present invention, the third surface is configured as a plane joining the first surface and the second surface.

[0025] In some embodiments of the present invention, the first surface and the second surface are constructed to be symmetrical with each other, the first surface includes a concave curved section and a convex curved section that smoothly transitions from the concave curved section; the second surface includes a concave curved section and a convex curved section that smoothly transitions from the concave curved section; the concave curved section of the first surface and the concave curved section of the second surface are joined to define the cutting edge.

[0026] In some embodiments of the present invention, the angle between the first surface and the second surface where the cutting edge or cutting surface is formed is between 30° and 110°.

[0027] In some embodiments of the present invention, the angle between the first surface and the second surface where the cutting edge or cutting surface is formed is about 60°.

[0028] In some embodiments of the present invention, the curved section of the first surface and the curved section of the second surface adjacent to the cutting edge or cutting surface are convex curved sections.

[0029] In some embodiments of the present invention, the curved section of the first surface and the curved section of the second surface adjacent to the cutting edge or cutting surface are concave curved sections.

[0030] In some embodiments of the present invention, a portion of the first surface and a portion of the second surface adjacent to the cutting edge or cutting surface are planar.

[0031] In some embodiments of the present invention, the end effector further includes a cylindrical section, and the cylindrical section is disposed between the conical surface adjacent to the farthest node point of the central rod and the transition section.

[0032] Some embodiments of the present invention further include a tubular component suitable for adapting to a suction device or an irrigation device, and at least a portion of the tubular component is disposed in the channel.

[0033] Some embodiments of the present invention further include a sleeve, in which at least a portion of the central rod is located; the proximal portion of the tubular component is located in the sleeve, and the distal portion extends out of the sleeve and is placed in the channel of the end execution part through the first opening.

[0034] Some embodiments of the present invention further include a clamping member, wherein the clamping member includes a clamping arm, and the clamping arm is suitable for selectively engaging with a portion of the end effector.

[0035] In some embodiments of the present invention, the clamping arm is pivotally supported adjacent to the end effector and pivots between an open position and a closed position, wherein the clamping arm is spaced apart from the end effector in the open position and the clamping arm is capable of pressing tissue against a third surface of the end effector in the closed position.

[0036] In some embodiments of the present invention, the clamping member further comprises a pad mounted on the clamping arm for pressing the tissue against the end effector.

[0037] The present invention also provides an ultrasonic surgical instrument, comprising: a handle assembly, on which an opening suitable for adapting a suction device or a flushing device is provided; a center rod extending from the handle assembly to the distal end, the center rod having a longitudinal axis; an end execution part extending from the distal end of the center rod, at least a portion of the end execution part is provided with a channel, the channel extends from the distal end of the end execution part to the proximal side, and at least a portion of the channel passes through the circumferential side wall of the end execution part; a tubular assembly, the proximal portion of the tubular assembly is connected to the suction device or the flushing device through the opening of the handle assembly, and the distal portion is placed in the channel of the end execution part through a first opening provided on the circumferential side wall of the end execution part.

[0038] Some embodiments of the present invention further include a clamping member, which includes a supporting sleeve and a clamping arm. The clamping arm is pivotally mounted to the distal end of the supporting sleeve so as to be pivotally movable relative to the end effector.

[0039] In some embodiments of the present invention, the proximal portion of the tubular component is disposed within the supporting sleeve, and the distal portion of the tubular component extends out of the supporting sleeve.

[0040] The technical solution of the present invention has the following technical effects compared with the prior art:

[0041] In the ultrasonic surgical instrument provided by the present invention, the end effector includes a distal effector and a proximal effector connected in sequence from the distal end to the proximal end, the distal effector forms a hollow cylinder, and the proximal effector is a solid structure. When the ultrasonic transducer is supplied with energy, since the distal effector itself is far away from the vibration node and is formed into a hollow cylinder with a small wall thickness, its amplitude is large. When the amplitude of the distal effector reaches more than 100 microns, it can act on the tissue to implement the crushing and emulsification of the tissue; and the proximal effector is a solid structure, which can move longitudinally within the range of about 20 microns to 90 microns, and it can realize the operation of tissue coagulation alone, and can realize the operation of tissue cutting and coagulation in conjunction with the clamping arm. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings, which will help to understand the objects and advantages of the present invention, wherein:

[0043] Figure 1 It is a structural schematic diagram of an ultrasonic surgical instrument in the prior art;

[0044] Figure 2 It is a structural schematic diagram of a specific embodiment of the ultrasonic surgical instrument of the present invention;

[0045] Figure 3A schematic diagram of a host and an ultrasonic transducer used in conjunction with the ultrasonic surgical instrument of the present invention;

[0046] Figure 4 A top view of a specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0047] Figure 5 A top view of another specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0048] Figure 6 A three-dimensional diagram of a specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0049] Figure 7 Another stereoscopic view of a specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0050] Figure 8 A three-dimensional diagram of a specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0051] Fig. 9 for Figure 8 A cross-sectional view of section 5-5;

[0052] Fig.10 It is a front view of a specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0053] Fig.11 for Fig. 9 Sectional view of part 2-2;

[0054] Fig.12 for Fig. 9 Sectional view of part 3-3;

[0055] Fig.13 A three-dimensional diagram of a specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0056] Fig.14 for Fig.13 Sectional view of part 4-4;

[0057] Fig.15 A cross-sectional view of a specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0058] Fig.16 is a cross-sectional view of another specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0059] Fig.17 It is a schematic diagram of a specific embodiment of the end effector of the present invention having a suction assembly;

[0060] Fig.18 It is a schematic diagram of the structure of the flushing or suction component in the handheld ultrasonic surgical instrument of the present invention;

[0061] Fig.19 is a schematic diagram of a specific embodiment of the ultrasonic surgical instrument of the present invention;

[0062] Fig. 20 It is a structural schematic diagram of another specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention;

[0063] Fig.21 It is a schematic structural diagram of another specific embodiment of the end effector of the ultrasonic surgical instrument of the present invention. DETAILED DESCRIPTION

[0064] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0065] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0066] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0067] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0068] In various embodiments of the present invention, the “distal end / side” refers to the end of the ultrasonic surgical instrument that is away from the operator when being operated, and the “proximal end / side” refers to the end / side that is close to the operator when being operated.

[0069] The present application generally relates to a medical instrument, and more particularly to an ultrasonic surgical instrument that can be used to cut tissue, crush emulsify tissue, coagulate tissue and / or clamp tissue during a surgical procedure.

[0070] Figure 2 1 is a partial cross-sectional view of an embodiment of an ultrasonic surgical instrument 10, which includes an elongated central rod 31 and an end effector 40 (also commonly referred to as a blade head). In a specific embodiment, the ultrasonic surgical instrument 10 further includes a cannula assembly, which includes a hollow cylindrical cannula 60 and a cannula connector 70 disposed at the proximal end of the cannula 60. In other embodiments, the cannula assembly is omitted.

[0071] exist Figure 2 In the embodiment shown in , the center rod 31 is disposed in the sleeve 60 and the sleeve connector 70. However, the sleeve assembly is not directly fixedly connected to the center rod 31. Instead, as described in detail below, the center rod 31 is operably connected to the ultrasonic transducer at its proximal end, and the sleeve connector 70 is fixedly connected to the transducer housing. However, it is understood that the center rod 31 can also be fixed to the sleeve assembly (i.e., fixed to the sleeve 60 and / or the sleeve connector 70), for example, by welding, bonding, or other methods known in the art.

[0072] The center rod 31 includes a connecting portion 14 with an internal thread disposed at its proximal end, and a plurality of flat surfaces 16 connected to the connecting portion 14 and arranged circumferentially around the center rod 31. The flat surfaces 16 form a prismatic structure on the center rod 31 for tightening the center rod to the transducer. Although the center rod 31 is depicted as an integral structure, in an alternative embodiment, the center rod 31 may include two or more parts that are engaged with each other (e.g., attached by threads). For example, in another embodiment, the connecting portion 14 and the flat surfaces 16 are an integral structure and are connected to the proximal end of the center rod 31 by threads (e.g., the two parts of the center rod 31 are connected by a hole with an internal thread and a stud matching it).

[0073] Similarly, although the end effector 40 is depicted as an integrated structure with the central rod 31 , as an alternative embodiment, the end effector 40 and the central rod 31 are separate structures, for example, the end effector 40 is connected to the distal end of the central rod 31 by threads.

[0074] Figure 3An example of a host 80 and an ultrasonic transducer 82 that can be used with an ultrasonic surgical instrument 10 is shown. It is understood that the host 80 and the ultrasonic transducer 82 are merely exemplary, as the ultrasonic surgical instrument 10 can be used with different hosts and transducers. The transducer 82 includes a housing 84 that is configured to be easily grasped and operated by a medical practitioner. The proximal end of the housing 84 includes an electrical connector (e.g., a plug or a socket) to be operably connected to the host 80 through a docking connector 81, which is disposed at one end of a cable that is connected to the host 80 in a similar manner. Therefore, an electrical drive signal (including alternating current having an ultrasonic frequency) is provided to the transducer 82 from the host 80 via the cable and the docking connector 81. The transducer 82 converts the drive signal into an ultrasonic vibration standing wave in the transducer, including a distal portion 85 of a transducer horn (or speed transformer, not shown) extending from the distal end of the housing 84. The transducer housing 84 also includes a threaded extension 89 disposed at its distal end and connected to the distal portion 85 of the transducer horn. A threaded mounting stud 88 is fixed to the distal portion 85 of the transducer horn, for example, by being screwed into and adhesively fixed in a threaded hole (not shown) in the distal portion 85. Therefore, the threaded mounting stud 88 extends distally from the distal wall 86 of the distal portion 85. It should also be noted that the distal wall 86 of the distal portion 85 of the transducer horn is located at the antinode of the vibration standing wave generated by the transducer 82. As an example, the host 80 and the transducer 82 of the embodiment shown in the drawings are configured to generate a vibration standing wave with a vibration frequency of about 55kHz. However, other ultrasonic frequencies may also be used, such as a vibration frequency of about 48kHz, or a frequency between about 20kHz and about 120kHz, for example.

[0075] The ultrasonic surgical instrument 10 can be operably connected to the transducer 82 in a variety of ways. In the illustrated embodiment, the connecting portion 14 at the proximal end of the center rod 31 includes a threaded hole 17 that extends inwardly (i.e., distally) from the proximal wall 15 of the connecting portion 14. The threaded hole 17 is designed to receive the mounting stud 88 of the transducer 82 so as to operably thread the center rod 31 to the transducer 82. When the connecting portion 14 is threaded onto the mounting stud 88 of the transducer 82, the proximal wall 15 of the connecting portion 14 abuts the distal wall 86 of the distal portion 85 of the transducer 82. When connected in this manner, the vibration standing wave generated in the transducer propagates along the length of the center rod 31. The flat surface 16 is used to further tighten the center rod 31 to the distal end of the transducer 82, and a torque wrench (not shown) can be used to ensure that the center rod is not over-tightened.

[0076] Further, the cannula assembly includes a cylindrical cannula 60 and a cannula connector 70, which are connected to each other as shown in the figure. The cannula 60 can be connected to the cannula connector 70 in a variety of ways, such as by welding, bonding and / or swaging. When the central rod 31 is assembled in the cannula 60, at least a portion of the end effector 40 extends beyond the distal wall 62 of the cannula 60. In other words, in some embodiments, the proximal portion of the end effector 40 is located in the cannula 60, and the distal portion of the end effector 40 extends beyond the distal wall 62 of the cannula 60. In general, the end effector 40 should extend beyond the distal end of the cannula 60 by a sufficient length to ensure that the end effector 40 is long enough to be visible, contact tissue, and operable during emulsification, cutting, separation, and coagulation operations, while at the same time not exposing the end effector 40 too much, otherwise there is a high risk of unintentional contact between the end effector 40 and the tissue.

[0077] In some embodiments, an elastic ring 17A, 17B, including, for example, a silicone ring, is disposed outside the center rod 31. Since the amplitude of the longitudinal vibration of the center rod 31 at the driving frequency is 0 at the node of the standing wave during use, the elastic ring is disposed at or near the vibration node of the center rod 31 to limit the attenuation of the standing wave. The elastic ring can also attenuate vibrations with other frequencies, because the vibration nodes of other frequencies are usually not consistent with the position of the vibration nodes with the driving frequency.

[0078] As known to those skilled in the art, the center rod 31 may also include a number of other features. For example, Figure 2 The central rod 31 shown in the figure includes multiple sections of different diameters to adjust the amplitude and / or frequency of the vibration wave propagating along the length of the central rod 31. In some embodiments, the multiple sections can be further provided with tapered surfaces 18A, 18B, 18C to provide a smooth transition between sections of different diameters.

[0079] The center rod 31 can be made of a variety of materials, especially a variety of medically or surgically acceptable metal materials, such as titanium, titanium alloys (such as Ti6Al4V), aluminum, aluminum alloys or stainless steel. In some embodiments, such as the embodiment shown in the drawings, the end effector 40 and the center rod 31 are integrally formed, such as milling from a metal rod to provide desired features.

[0080] It is also understood that the ultrasonic surgical instrument including the center rod 31 and the end effector 40 can be used without a sleeve assembly, simply by operatively connecting the proximal end of the center rod 31 to the transducer (e.g., by a threaded mounting stud). However, the sleeve 60 not only protects the center rod 31, but also prevents inadvertent contact between the center rod 31 and the patient, medical personnel, or surgical environment. Such inadvertent contact not only attenuates the vibration of the center rod 31, but it may also cause harm to the patient or medical personnel because the center rod 31 is in ultrasonic vibration.

[0081] Specifically, Figure 4 As shown, a top view of the end effector 40 of the ultrasonic surgical instrument described in a specific embodiment of the present application is shown. The end effector 40 includes a transition section 41a and a distal section 41b extending distally from the distal end of the center rod 31. The transition section 41a is configured to be generally cylindrical. For example, in some specific embodiments, the transition section 41a is configured to be a cylinder with a substantially constant outer diameter along the length direction of the end effector 40, or the transition section 41a can also be configured to be a cone with an outer diameter gradually decreasing from the proximal side to the distal side along the length direction of the end effector 40, that is, the transition section 41a gradually tapers in the distal direction. In another specific embodiment, the transition section 41a is configured to first gradually taper in the distal direction and then remain unchanged, or first remain unchanged and then gradually taper.

[0082] In an alternative embodiment, if Figure 5As shown, the end effector 40 also includes a cylindrical section 42, which is arranged between the conical surface 32 adjacent to the farthest node of the center rod 31 and the transition section 41b. In other embodiments, especially when the conical surface is not arranged at the farthest node (that is, when there is no conical surface between the farthest node and the cutter head), the end effector includes a cylindrical section arranged between the farthest node and multiple faces of the center rod. In addition, in another embodiment, such a cylindrical section is not included on the proximal end of the end effector. It is understood that the transition section 41a, the distal section 41b and / or the cylindrical section 42 can also be combined and connected together in a conventional manner, rather than necessarily in an integrally formed form. The distal section 41b extends distally from the distal end of the transition section 41a, and the distal section 41b is constructed as a hollow structure, for example, as a hollow cylindrical structure. The farthest end 47 of the distal section 41b corresponds to the vibration antinode point of the ultrasonic standing wave, that is, the position where the longitudinal amplitude is the largest. By setting a channel in at least a part of the area of ​​the end effector 40, the physical mass of the end effector, especially the distal segment, is reduced, so that the distal end 47 thereof can output an amplitude greater than 100 microns, stimulating the cavitation effect of ultrasonic vibration to implement pulverization and emulsification of tissue. Specifically, the channel is constructed to extend from the distal end of the end effector to the proximal side, and at least a part of the channel passes through the circumferential side wall of the end effector. It is understandable that the channel can be set to an open or semi-open structure. A detailed description will be given below in conjunction with the accompanying drawings.

[0083] Figure 6 An embodiment of the end effector is shown, the end effector 40 comprises a channel 50, the proximal end of the channel 50 starts from the side wall of the transition section 41a, and the distal end of the channel 50 ends at the distal end 47 of the distal section 41b, thereby forming the hollow structure of the distal section 41b. Figure 6 As shown, a first opening 51 is provided on the side wall of the transition section 41a, and the first opening 51 is configured as a proximal port of the channel 50. A second opening 52 is provided at the most distal end 47 of the distal section 41b, and the second opening 52 is configured as a distal port of the channel 50. More specifically, the first opening 51 provided on the side wall of the transition section 41a can be configured in a variety of suitable shapes, for example, the first opening 51 can be configured in a variety of shapes such as an ellipse, a long waist, etc. Fig. 9 and Fig.10The figure shows a cross-sectional view of the end effector 40 along the longitudinal axis, wherein the channel 50 includes a proximal channel portion 53 disposed in the transition section 41a and a distal channel portion 54 disposed in the distal section 41b, wherein the proximal channel portion 53 provides a smooth transition from the first opening 51 to the distal channel portion 54. For example, in some embodiments, the proximal channel portion 53 includes a proximal channel surface 55, and the proximal channel surface 55 is configured to provide a curved surface that smoothly transitions from the first opening 51 of the transition section 41a to the distal channel portion 54. The provision of the channel 50 reduces the solid material mass of the distal section 41b and the transition section 41a of the end effector 40, thereby increasing the ultrasonic longitudinal amplitude provided by the distal section 41b, and enabling the distalmost end 47 of the distal section 41b to provide a longitudinal amplitude that achieves an ultrasonic cavitation effect, for example, providing an ultrasonic longitudinal amplitude greater than 100 microns.

[0084] In some embodiments, the distal channel portion 54 of the channel 50 is a cylindrical hole with a diameter that remains substantially constant from the proximal side to the distal side; of course, it is understandable that the distal channel portion 54 of the channel 50 can also be configured as a hole with a diameter that gradually decreases from the proximal side to the distal side; or other special-shaped holes with non-circular cross-sections, such as holes with elliptical cross-sections, as long as it can reduce the mass of the solid material of the distal segment 41b of the end effector 40 and enable its most distal end 47 to achieve the longitudinal amplitude for realizing the ultrasonic cavitation effect after being driven.

[0085] Furthermore, in order to better balance the mass of the cutter head, in some embodiments, the channel 50 is configured to be non-coaxial with the end effector 40. Specifically, generally, the end effector 40 of the ultrasonic surgical instrument 10 can be made of any turning material, and the turning material includes not only cylindrical materials or conical materials, but also elliptical cylindrical materials or elliptical conical materials. Here, cylindrical materials are taken as an example to describe the non-coaxial structure of the distal channel portion 54 of the channel 50 and the distal segment 41b. For other forms such as conical materials, elliptical conical materials, etc., similar eccentric or non-coaxial structures can also be used. Reference Fig.11 ,as well as Fig.12 , showing the cross-sectional view of the distal segment 41b along 3-3 and 2-2. Fig.11 and Fig.12 As shown, the dotted circle shows the cross section of the cylindrical material used for milling the distal section 41b. The axis O5 of the distal channel portion 54 of the channel 50 is arranged non-concentrically with the axis O4 of the cylindrical material. Fig.12In the illustrated embodiment, the distal channel portion 54 is eccentric downward by a distance d relative to the cylindrical material constituting the distal segment 41b. The distal channel portion 54 of the channel 50 is configured as an eccentric structure relative to the cylindrical material constituting the distal segment 41b, so as to better balance the end effector 40 and adjust the center of mass position of the distal segment 41b to improve the ultrasonic vibration performance of the end effector 40. It is understood that the axis of the distal channel portion 54 of the channel 50 can be configured to be parallel to the axis of the cylindrical material forming the distal segment 41b, or it can be non-parallel.

[0086] In an alternative embodiment, if Fig. 20 As shown, at least a portion of the end effector 400 is provided with a channel 450, which can be constructed as an open channel or a notch. The channel 450 starts from a semi-open first opening 451 located on the proximal circumferential side wall of the end effector 400, that is, the distal end of the first opening 451 extends all the way to the distal end surface 447 of the end effector 400, so that the channel 450 forms a channel with a C-shaped cross section. At the same time, the thickness of the side wall of the end effector 400 having the channel 450 is different along the circumferential direction, specifically, the thickness of the side wall close to the notch side gradually becomes thinner, so that sharper cutting edges are formed on both sides thereof, thereby utilizing the tissue cutting effect of ultrasonic vibration to provide faster tissue cutting performance.

[0087] In another embodiment, Fig.21 As shown, at least part of the end effector 500 is provided with a channel 550, and the channel 450 can be constructed as an open channel or notch. Similar to the end effector 400, the channel 550 starts from a semi-open first opening 551 located on the proximal circumferential side wall of the end effector 500, that is, the distal end of the first opening 551 extends all the way to the distal end face 547 of the end effector 500, so that the channel 550 forms a channel with a C-shaped cross section. At the same time, the thickness of the side wall of the end effector 500 with the channel 450 is consistent along the circumferential direction, so that blunt cutting surfaces are formed on both sides of the notch to avoid accidental injury to blood vessels or tissues due to excessive sharpness. For further reference Figure 6 and Figure 7 The distal segment 41b is constructed to have an outer contour with a cross-section approximately in the shape of a teardrop, that is, a portion of the circumferential side wall of the distal segment 41b protrudes outward and forms a relatively sharp area to construct a cutting edge suitable for cutting tissue; the other end opposite to the cutting edge is formed into a relatively blunt outer surface such as an arc or a plane, so that the overall cross-section forms a shape approximately in the shape of a dripping teardrop.

[0088] Specifically, the distal segment 41b includes a first surface 43 and a second surface 44 extending distally from the outer surface of the transition segment 41a, and the intersection of the first surface 43 and the second surface 44 on one side of the end effector 40 defines a cutting edge 45, which extends along at least a portion of the length portion or the longitudinal axis C of the end effector 40, so as to provide medical workers with the option of quickly cutting tissue. The first surface 43 and / or the second surface 44 include a plurality of curved segments, and the plurality of curved segments transition smoothly, and the curvature of the curved segments of the first surface 43 and the second surface 44 may be positive and / or negative.

[0089] For example, in some embodiments, Fig.14 As shown, the first face 43 and the second face 44 are constructed to be symmetrical with respect to the axis AA, the first face 43 includes a concave curved section 43a, and a convex curved section 43b smoothly joined and transitioned from the concave curved section 43a, and correspondingly, the second face 44 also includes a concave curved section 44a, and a convex curved section 44b smoothly joined and transitioned from the concave curved section 44a. It can be understood that the concave curved section refers to a curved surface with a negative curvature or a radius of curvature, and the convex curved section refers to a curved surface with a positive curvature or a radius of curvature. The concave curved section 43a of the first face 43 and the concave curved section 44a of the second face 44 meet on one side of the distal section 41b, defining a cutting edge 45, thereby utilizing the tissue cutting effect of ultrasonic vibration to provide faster tissue cutting performance. In some embodiments, the angle between the first face 43 and the second face 44 at which the cutting edge 45 is formed is between 30° and 110°. In other embodiments, the angle between the first face 43 and the second face 44 at which the cutting edge is formed is about 60°. If necessary, the cutting edge 45 can be polished or ground to make the edge blunt or sharper. Figure 4 and Figure 5 In some embodiments, the cutting edge 45 is smoothed to make it more blunt to avoid being too sharp and accidentally damaging blood vessels or tissues. Further, the convex curved section 43b of the first surface 43 and / or the convex curved section 44b of the second surface 44 can be a part of the cylindrical material constituting the distal section 41b, or can be made on the basis of the cylindrical material through machining processes such as cutting and milling.

[0090] It is understandable that, in some alternative embodiments, the first surface 43 and / or the second surface 44 include a plurality of smoothly transitioned convex curved segments, and the first convex curved segment of the first surface 43 and the first convex curved segment of the second surface 44 meet at one side of the distal segment 41b to define a cutting edge; or, in some other embodiments, the first surface 43 and / or the second surface 44 include a plane and a convex curved segment smoothly transitioning with the plane, and the planes of the first surface 43 and the second surface 44 meet at one side of the distal segment to define a cutting edge. Of course, setting the portion of the first surface 43 and the second surface 44 used to define the cutting edge as a concave curved segment can provide the doctor with a better field of view for observing the distal tip of the end effector 40 during surgery.

[0091] Further, the first surface 43 and the second surface 44 are joined in a smooth transition form on the other side of the end effector 40 opposite to the cutting edge 45, or form a smoothly transitioned third surface 46. In other words, the third surface 46 can be a portion of the first surface 43 and the second surface 44 on the side opposite to the cutting edge 45 (for example, Fig.14 The third surface 46 may be a single surface that joins the first surface 43 and the second surface 44. Moreover, the proximal side of the third surface 46 smoothly transitions with the outer surface of the transition section 41a. In some embodiments, the third surface 46 is configured as a curved surface that joins the first surface 43 and the second surface 44, or a flatter surface. This joining may be in the form of a smooth transition, or may form a certain angle with the first surface 43 or the second surface 44, so as to further define the edge that can be used to cut tissue (for example, as Fig.15 Of course, the third surface 46 can also be configured to be a plane or a nearly plane that joins the first surface 43 and the second surface 44, respectively (for example, as shown in FIG. Fig.16 As shown). The third surface 46 can be configured as a coagulation surface because it is smoother and blunter than the cutting edge 45. For example, the third surface 46 can be used alone or in conjunction with the clamping member to perform coagulation and cutting operations. In some embodiments, the third surface 43 has the same radius of curvature as the convex curved section 43b of the first surface 43 and the convex curved section 44b of the second surface 44, or the convex curved section 43b of the first surface 43 and the convex curved section 44b of the second surface 44b have the same radius of curvature, and the convex curved section 43b and the convex curved section 44b constitute a part of a cylindrical surface.

[0092] Alternatively, in an alternative embodiment, the third surface 43 has a larger radius of curvature than the convex curved section 43b of the first surface 43 and / or the convex curved section 44b of the second surface 44; or, the third surface 43 is configured as a plane to perform a coagulation operation on tissues or blood vessels as required. Similarly, if necessary, the third surface 46 can also be polished or ground to improve its tissue and blood vessel coagulation performance. In addition, if necessary, the entire end effector 40 can also be polished to improve the surface finish, extend the service life of the blade (to prevent fatigue wear) and / or adjust the cutting speed.

[0093] In order to further increase the amplitude of the tip or the most distal end of the end effector 40, the distal segment 41b is configured to taper from the proximal side to the distal side along its length direction or along the longitudinal axis. Alternatively, in some other embodiments, the distal segment 41b includes a proximal portion that tapers from the proximal side to the distal side along the length direction or along the longitudinal axis, and a distal portion whose outer diameter is substantially constant along the length direction.

[0094] When the end effector 40 of the ultrasonic surgical instrument described in the above embodiment is used to crush and emulsify soft tissue, especially liver parenchymal tissue, the channel 50 can provide a channel for cleaning and suctioning the crushed tissue residue. For example, the ultrasonic surgical instrument described in the embodiment of the present application also includes a tubular component suitable for adapting to a medical suction device or a flushing device, and at least a portion of the tubular component is disposed in the channel. In some embodiments, such as Fig.17 As shown, the tubular component is specifically configured as a suction component 63, which is suitable for matching with a medical suction device (not shown in the figure). In some embodiments, at least a portion of the suction component 63 is constructed as a tubular structure. The distal portion of the suction component 63 extends distally from the distal end of the sleeve 60, and is inserted into the channel 50 of the end effector 40 through the first opening 51, until its distal end. More specifically, the portion of the suction component 63 that enters the first opening 51 distally is configured to be curved to adapt to the proximal channel portion 53 of the channel 50, so that the distal portion of the suction component 63 can smoothly and smoothly enter the channel 50. Accordingly, the proximal channel surface 55 of the proximal channel portion 53 provides guidance and support for the distal portion of the suction component 63 to enter the channel 50 from the first opening 51. Therefore, the proximal channel surface 55 is designed to have a certain curvature according to the needs, such as the thickness of the suction tube 63 and the hardness and softness of the material, so as to provide guidance and / or support for the distal part of the suction assembly 63 and further balance the end effector 40. More specifically, the suction assembly 63 is a deformable hose made of a sterilizable plastic material.

[0095] When in use, the end effector 40 of the ultrasonic surgical instrument is used to crush and emulsify the tissue, and at the same time or subsequently, the suction device is controlled to start, so that the suction assembly 63 sucks the crushed tissue. Of course, it can be understood that in other embodiments, the suction assembly 63 can also be constructed to be independent of the end effector 40 and extend to the distal end of the end effector 40.

[0096] It is understandable that, based on a similar design, the channel 50 can also provide an intraoperative irrigation channel. For example, a irrigation tube is placed in the channel 50 in a manner similar to the suction assembly, and the irrigation tube is connected to the irrigation device to provide an irrigation function during surgery. Fig.18 As shown, on the handle assembly, corresponding openings 62A, 62B, 62C can be set at different positions of the handle assembly according to specific usage scenarios to connect to compatible medical suction or flushing equipment.

[0097] On the other hand, the present application also provides Fig.19The ultrasonic surgical instrument 100 shown (configured as ultrasonic surgical scissors) includes a handle assembly 20, a clamping member 30, and a center rod 31 in which all parts are located in the clamping member 30 except that the end effector 40 partially or completely extends out of the distal end of the clamping member 30. The handle assembly 20 includes a main housing 21 and a handle 22, and the handle 22 extends downward from the main housing 21. The handle assembly 20, especially the handle 22 of the handle assembly 20, is suitable for being held by a medical practitioner during surgery to facilitate the grasping and operation of the surgical instrument, while isolating the medical practitioner from ultrasonic vibrations. The trigger 23 is mounted on the handle assembly 20, and is suitable for pivoting relative to the handle 22 to cause the clamping arm 36 located at the distal end of the clamping member 30 to pivot. As an alternative embodiment of the gun-type handle structure shown in the drawings, the handle assembly 20 is designed in a variety of other alternative forms, such as a scissor-type handle. The proximal end of the main housing 21 is open so that the distal end of the transducer 82 can be inserted into the interior of the main housing 21. The clamp arm 36 is adapted to selectively engage with a surface of the end effector 40, for example, the third surface 46 of the end effector 40, so that the tissue to be operated is pressed against the surface of the end effector 40 by the clamp arm 36. The clamp arm 36 includes a pad 37 mounted on the clamp arm 36 for pressing the tissue against the surface or edge of the end effector 40 to facilitate cutting of the tissue and coagulation. The pad 37 is formed of a polymer material or other flexible material, and when the clamp arm 36 is pivoted to its fully closed position, the pad 37 is against the third surface 46 of the end effector 40. The pad 37 can be made of a material such as PTFE or polyimide (PI), with or without the addition of filler materials such as glass, metal and / or carbon. In some embodiments, the material of the pad 37 includes a high temperature resistant material. And, the pad 37 is attached to the clamp arm 36 by means such as bonding or mechanical fastening. In addition, the pad 37 can be provided with a non-smooth surface (e.g., a serrated structure) to enhance the clamping of tissue in combination with the end effector 40. The serrated structure or teeth can provide traction that resists the movement of the knife. The teeth can also provide opposite traction to the movement of the end effector 40 and the clamping arm 36. As will be appreciated by those skilled in the art, the serrated structure is only one example of a variety of tissue engaging surfaces for preventing movement of tissue relative to the end effector 40. Other exemplary embodiments include protrusions, cross-shaped patterns, tread patterns, shot peening or sand blasting surfaces, etc.

[0098] Further, the clamping member 30 includes an outer sleeve 33, an inner sleeve 32 and the clamping arm 36. The outer sleeve 33 is sleeved on the outside of the inner sleeve 32, and the central rod 31 is arranged in the inner sleeve 32. The outer sleeve 33 is fixedly connected to the handle assembly 20. The proximal end of the clamping arm 36 is pivotally mounted on the outer sleeve 33 through a pivot pin 34. The inner sleeve 32 can move along the longitudinal axis of the outer sleeve 33, and the clamping arm 36 further engages the distal end of the inner sleeve 32 through a pivot pin 35, whereby the reciprocating motion of the inner sleeve 32 relative to the outer sleeve 33 causes the clamping arm 36 to pivot relative to the end effector 40, that is, the reciprocating motion of the inner sleeve 32 drives the clamping arm 36 to open or close. The central rod 31, the outer sleeve 33 and the inner sleeve 32 are connected to each other by a bayonet connector assembly 36, so that they can be rotated as a whole with the ultrasonic transducer relative to the handle assembly 20 by means of a knob 37, and the central rod 31 extends into the main housing 21 of the handle assembly 20 through the knob 37. During use, the outer sleeve 33 and the central rod 31 can be rotated by means of the knob 37, thereby adjusting the end effector 40 and the clamping member 30 connected thereto to a desired direction.

[0099] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. However, the obvious changes or modifications derived therefrom are still within the scope of protection of the present invention.

Claims

1. An ultrasonic surgical instrument, include: a center rod having a longitudinal axis; as well as An end effector extends from the distal end of the central rod, wherein at least a portion of the end effector is provided with a channel, the channel extends from the distal end of the end effector toward the proximal side, and at least a portion of the channel penetrates through a circumferential side wall of the end effector.

2. The ultrasonic surgical instrument according to claim 1, It is characterized in that A first opening is provided on the circumferential side wall at the proximal side of the end effector, and the first opening is configured as the proximal end of the channel; a second opening is provided at the distal end of the end effector, and the second opening is configured as the distal end of the channel.

3. The ultrasonic surgical instrument according to claim 2, It is characterized in that The channel includes a proximal channel portion and a distal channel portion, the distal channel portion extending proximally from the second opening along the longitudinal axis, the proximal channel portion extending from the first opening and smoothly joined to the distal channel portion.

4. The ultrasonic surgical instrument according to claim 3, It is characterized in that The proximal channel portion includes a proximal channel curve to provide a smooth transition from the first opening to the distal channel portion.

5. The ultrasonic surgical instrument according to claim 2, It is characterized in that The outer contour of the distal channel portion and the end effector portion in the area where it is located are non-coaxially arranged.

6. The ultrasonic surgical instrument according to claim 2, It is characterized in that The first opening is configured as at least a portion of an oval shape or a long waist shape.

7. The ultrasonic surgical instrument according to claim 2, It is characterized in that The second opening is configured as at least a portion of a circle or an ellipse.

8. The ultrasonic surgical instrument according to claim 3, It is characterized in that The distal channel portion is configured as a cylindrical or conical hole.

9. The ultrasonic surgical instrument according to claim 1, It is characterized in that The channel is a channel extending along the longitudinal axis of the end effector and having a notch on one side.

10. The ultrasonic surgical instrument according to claim 1, It is characterized in that The end effector comprises a transition section and a distal section extending distally along the transition section, wherein an outer contour of the distal section is configured in a teardrop shape, and an outer contour of the transition section is configured in a circular or elliptical shape.

11. The ultrasonic surgical instrument according to claim 10, It is characterized in that The outer contour of the transition section smoothly joins the outer contour of the distal section.

12. The ultrasonic surgical instrument according to claim 10, It is characterized in that The transition section of the end effector gradually tapers from the proximal side to the distal side along the longitudinal axis.

13. The ultrasonic surgical instrument according to claim 1, It is characterized in that The end effector gradually tapers from the proximal side to the distal side along the longitudinal axis.

14. The ultrasonic surgical instrument according to claim 10, It is characterized in that The distal section includes a first surface and a second surface extending distally from a distal end of the transition section, wherein the first surface and the second surface meet at one side of the end effector to form a cutting edge, and the cutting edge extends distally along the longitudinal axis.

15. The ultrasonic surgical instrument according to claim 14, It is characterized in that The cutting edge is processed to form a cutting surface, and the cutting surface smoothly transitions with the first surface and the second surface.

16. The ultrasonic surgical instrument according to claim 14, It is characterized in that The first surface includes a plurality of curved segments with smooth transition; the second surface includes a plurality of curved segments with smooth transition; the first surface and the second surface are joined in a smooth transition form on the other side of the end execution portion opposite to the cutting edge.

17. The ultrasonic surgical instrument according to claim 14, It is characterized in that The first surface includes a plurality of curved segments with smooth transition; the second surface includes a plurality of curved segments with smooth transition; the first surface and the second surface are transitionally joined via a third surface at the other side of the end execution portion opposite to the cutting edge.

18. The ultrasonic surgical instrument according to claim 17, It is characterized in that The third surface is configured as a curved surface joining the first surface and the second surface, and a curvature radius of the curved surface is greater than or equal to a curvature radius of the first surface or the second surface.

19. The ultrasonic surgical instrument according to claim 17, It is characterized in that The third surface is configured as a plane joining the first surface and the second surface.

20. The ultrasonic surgical instrument according to claim 14, It is characterized in that The first surface and the second surface are constructed to be symmetrical to each other, the first surface includes a concave curved section and a convex curved section that smoothly transitions from the concave curved section; the second surface includes a concave curved section and a convex curved section that smoothly transitions from the concave curved section; the concave curved section of the first surface and the concave curved section of the second surface are joined to define the cutting edge.

21. The ultrasonic surgical instrument according to claim 14, It is characterized in that The included angle between the first surface and the second surface where a cutting edge or a cutting surface is formed is between 30° and 110°.

22. The ultrasonic surgical instrument according to claim 14, It is characterized in that The angle between the first surface and the second surface where a cutting edge or a cutting surface is formed is about 60°.

23. The ultrasonic surgical instrument according to claim 14 or 15, It is characterized in that The curved section of the first face and the curved section of the second face adjacent to the cutting edge or cutting face are convex curved sections.

24. The ultrasonic surgical instrument according to claim 14 or 15, It is characterized in that The curved section of the first face and the curved section of the second face adjacent to the cutting edge or cutting face are concave curved sections.

25. The ultrasonic surgical instrument according to claim 14 or 15, It is characterized in that Portions of the first face and portions of the second face adjacent to the cutting edge or face are planar.

26. The ultrasonic surgical instrument according to claim 10, It is characterized in that The end execution part also includes a cylindrical section, which is arranged between the conical surface adjacent to the farthest node of the central rod and the transition section.

27. The ultrasonic surgical instrument according to claim 1, It is characterized in that Also included is a tubular assembly adapted to fit a suction device or an irrigation device, at least a portion of the tubular assembly being disposed within the passageway.

28. The ultrasonic surgical instrument according to claim 27, Characterized in that, It further includes a sleeve, at least a part of the central rod is located within the sleeve; the proximal part of the tubular assembly is located within the sleeve, and the distal part extends out of the sleeve and is inserted into the channel of the end effector through a first opening.

29. The ultrasonic surgical instrument according to any one of the preceding claims, Characterized in that, It further includes a clamping member, the clamping member includes a clamping arm, and the clamping arm is adapted to selectively engage with a part of the end effector.

30. The ultrasonic surgical instrument according to claim 29, Characterized in that, The clamping arm is pivotally supported adjacent to the end effector and pivots between an open position and a closed position. In the open position, the clamping arm is spaced apart from the end effector; in the closed position, the clamping arm can press the tissue against the third surface of the end effector.

31. The ultrasonic surgical instrument according to claim 29, Characterized in that, The clamping member further includes a gasket mounted on the clamping arm for pressing the tissue against the end effector.

32. An ultrasonic surgical instrument, Comprising: A handle assembly, on which there is an opening adapted to fit a suction device or a flushing device; A central rod extending distally from the handle assembly, the central rod having a longitudinal axis; An end effector extending distally from the distal end of the central rod, at least a part of the end effector is provided with a channel, the channel extends proximally from the distal end surface of the end effector, and at least a part of the channel penetrates the circumferential side wall of the end effector; A tubular assembly, the proximal part of the tubular assembly communicates with a suction device or a flushing device through the opening of the handle assembly, and the distal part is inserted into the channel of the end effector through a first opening provided on the circumferential side wall of the end effector.

33. The ultrasonic surgical instrument according to claim 32, Characterized in that, It further includes a clamping member, the clamping member includes a support sleeve and a clamping arm, and the clamping arm is pivotally mounted to the distal end of the support sleeve to pivot relative to the end effector.

34. The ultrasonic surgical instrument according to claim 33, Characterized in that, The proximal part of the tubular assembly is arranged within the support sleeve, and the distal part of the tubular assembly extends out of the support sleeve.

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