JP4425782B2 - Ultrasound system for soft tissue cutting and coagulation - Google Patents

Description

  The present invention relates to an ultrasound system for soft tissue cutting and coagulation.

  Surgical ultrasonic instruments have been used for many years to cut and coagulate soft tissue. Ultrasonic equipment includes an ultrasonic transducer that converts electrical energy supplied by the generator into ultrasonic vibration energy applicable to the patient's tissue. The ultrasonic transducer is typically housed inside a handpiece or transducer exterior. Surgical ultrasound instruments use relatively high power and low frequency vibration energy, typically in the range of about 20 kHz to about 100 kHz.

  Generally, an ultrasonic system for cutting and coagulating soft tissue includes an ultrasonic vibration member that is connected to an ultrasonic transducer and vibrates at an ultrasonic frequency. An ultrasonic vibration member such as an ultrasonic blade, an ultrasonic probe, or an ultrasonic horn is brought into contact with the tissue, the ultrasonic output is propagated to the contacted tissue, and thus the tissue that is in contact with the ultrasonic vibration member is cut or coagulated. . Surgical ultrasound instruments have many advantages over conventional surgical systems, such as reduced bleeding and trauma.

  The mechanism of interaction between the ultrasonic vibration member and tissue, that is, the physics of soft tissue cutting and coagulation by ultrasound has not been fully elucidated, but researchers have proposed various theories so far. Such theories include explanations based on mechanical and thermal effects. The mechanical effect is that sufficient force and pressure are generated within a short distance from the tip of the ultrasonic vibration member to remove tissue cells and destroy tissue structure. The forces assumed to break the tissue layer are caused by different types of forces, for example, the impact force generated when the tip of the vibrating member is in direct contact with the tissue or the force across the tissue boundary. Shear force. Some of the energy can be reduced by frictional heat or heat generated by the tissue absorbing acoustic energy.

  The thermal effect may include frictional heat that is generated from the tip of the ultrasonic vibration member and is sufficient to melt a portion of the tissue in contact with the tip. Alternatively, the vibrational energy absorbed by the tissue may be changed to heat. The heat thus generated can be used, for example, to clot blood. Another effect assumed to explain the interaction between the probe and the tissue is the cavitation effect. This is because when ultrasonic power is applied to the tissue, the tissue is hollowed out, that is, cavities or bubbles filled with gas or vapor are formed in the tissue, and these cavities or bubbles cause vibration and propagation. is there. The combination of mechanical and thermal effects and cavitation effects can produce the desired surgical outcome, for example cutting and coagulation.

  In the past, a number of ultrasound systems for soft tissue cutting and coagulation have been disclosed. For example, on June 21, 1994, T.W. W. There is US Pat. No. 5,322,055 (hereinafter also referred to as “'055 patent”) entitled “Clamp Coagulator / Cutting System For Ultrasonic Surgical Instruments” issued to Davidson et al. And assigned to Ultrasonic.

  The "'055 patent" has a non-vibrating clamp for pressing tissue against an ultrasonically oscillating ultrasonic blade to cut, coagulate and blunt the tissue. A handpiece containing the ultrasonic transducer is coupled to the ultrasonic blade. An ultrasonic blade activated by ultrasonic waves produces a vibration mode in the longitudinal direction parallel to the ultrasonic blade edge. A clamp accessory including a clamp member is releasably connected to the handpiece and an ultrasonic blade is used in conjunction with the clamp member to apply a compressive force to the tissue in a direction orthogonal to the direction of vibration.

On March 14, 2000, R.C. US Patent No. 6,036,667 (hereinafter also referred to as “'667 patent”) entitled “Ultrasonic Disposition and Coagulation System” issued to Manna et al. And assigned to US Surgical Corporation and Misison Incorporated. .
The '667 patent discloses an ultrasonic cutting and coagulation system for surgical use. The system includes a housing and an elongated body extending from the housing. The housing houses an ultrasonic transducer that is operatively coupled to the cutting ultrasonic blade by a vibrating coupler. The cutting ultrasonic blade has a cutting plane perpendicular to the longitudinal axis of the elongated body, i.e. to the axis of ultrasonic vibration. The clamping member that clamps the tissue together with the ultrasonic cutting blade has a working surface that approaches the cutting surface of the ultrasonic cutting blade from an open position where the active surface of the clamping member is separated from the cutting surface of the ultrasonic cutting blade. They are aligned in a juxtaposed state and are movable to a clamping position for clamping the tissue between them.

On May 2, 2000, M.M. There is US Pat. No. 6,056,735 (hereinafter also referred to as the “'735 patent”) entitled “Ultrasound Treatment System” issued to Okada et al. And assigned to Olympus Optical Co., Ltd.
The '735 patent relates to an sonication system that includes an endoscopic system and a suction system for processing live tissue. This patent features an ultrasonic processing system having a handpiece that houses an ultrasonic transducer and an ultrasonic probe coupled to the ultrasonic transducer and acting as an ultrasonic output conducting member. The processing unit of the ultrasonic processing system includes a fixed far member where ultrasonic vibration is conducted by the ultrasonic probe and a movable holding member. The retaining member clamps the living tissue together with the fixed distal member. A scissors-like operating means operates the processing unit to clamp or unclamp the living tissue. In a preferred embodiment, a turning mechanism is provided for turning the processing unit with respect to the operating means about the axial direction of the transducer.

The design shape of the ultrasonic vibration member and the design shape of the clamp member used for grasping the tissue together with the ultrasonic vibration member greatly influence the interaction between the surgical ultrasonic system and the tissue.
The above-described conventional ultrasonic system includes an ultrasonic vibration member and / or clamp having a curved shape that ensures that the ultrasonic power is delivered substantially uniformly to tissue in contact with the working surface of the ultrasonic vibration member. The member is not disclosed. In the conventional ultrasonic system described above, it is necessary to fix the ultrasonic vibration member with respect to a clamp or other holding member. In the conventional apparatus, the ultrasonic vibration member needs to cooperate with the clamp or the jaw member in order to grasp the tissue to be processed. In a conventional ultrasonic system, the vibration of the ultrasonic vibration element (receives ultrasonic energy and sends the received ultrasonic energy to the tissue) is in the longitudinal vibration mode, that is, the mode parallel to the longitudinal axis of the ultrasonic vibration element. It is limited to. In fact, there are several conventional patents that intentionally suppress the transverse vibration mode.

  In conventional surgical ultrasound systems, components such as ultrasound transducers, transducer sheaths, ultrasound conducting couplers, surgical ultrasound blades are generally precision cut and are therefore not disposable or replaceable . For example, these components are used to place the vibration node (or anti-node) of an ultrasonic device at a desired or required position along the ultrasonic device, i.e., to reduce the vibration of the ultrasonic device to a desired frequency. Can be precision cut to tune. By using these precision cut components, the surgical system can have the desired features (e.g., the desired ultrasonic vibration frequency) limited to the particular surgical procedure or specific tissue being used. It can be incorporated. However, the use of precision-cut components increases manufacturing costs and assembly costs for surgical ultrasonic instruments.

US Pat. No. 5,322,055 US Pat. No. 6,036,667 US Pat. No. 6,056,735

The problem to be solved is to improve the coupling of ultrasonic power to soft tissue by providing a surgical ultrasonic system that can treat soft tissue uniformly across the contact surface.
Another problem to be solved is to provide a surgical ultrasound system in which soft tissue can be treated with ultrasound output that is spatially distributed as desired across the contact surface. The movable ultrasonic vibrating member can also achieve a variety of surgical effects.
Another problem to be solved is a surgical ultrasound that has an ultrasonic blade / jaw member assembly, where the ultrasonic vibrating member operates (in combination with the jaw member) without performing its own gripping function. Is to provide a system. It would also be desirable to provide a multi-wavelength probe that can simultaneously vibrate a remote probe in multiple modes.

Other problems to be solved include non-longitudinal vibration modes, such as vibration modes including transverse, rotational, or flexural vibration modes, so that a wide variety of surgical effects can be achieved. It is to provide a surgical ultrasound system having a receiving vibration element. Specifically, the transverse and rotational vibration modes are induced so that the vibration element causes movement in a direction perpendicular to the longitudinal axis of the ultrasonic probe.
Another challenge to be solved is an economically manufactured that meets the demand for low-cost equipment made from inexpensive, disposable and replaceable components that can be used for ultrasonic energy And providing an improved surgical ultrasound system that houses one or more components that can be used and discarded after use.

  The present invention relates to an ultrasonic blade member for cutting and / or coagulating tissue, and a clamp member facing the ultrasonic blade member that can be used in combination with the ultrasonic blade member to compress / clamp the tissue to be processed. And an ultrasonic system for cutting and / or coagulating tissue. At least one of the ultrasonic blade member and the clamp member has a substantially curved shape. This curve shape can be optimized to improve the coupling of the ultrasonic power to the tissue to be processed.

  A surgical ultrasonic instrument according to one embodiment of the present invention includes one or more ultrasonic transducers for generating ultrasonic vibrations. An elongated, ultrasonic conducting coupler includes a proximal end and a distal end and is coupled to the ultrasonic transducer at the proximal end location. The ultrasonic conducting coupler receives ultrasonic vibration from the ultrasonic transducer and conducts the received ultrasonic vibration from the near end to the far end.

  A surgical ultrasound assembly is coupled to the distal end of the elongated ultrasound conducting coupler. In one embodiment, the ultrasonic assembly includes an ultrasonic blade member and a clamp member, the ultrasonic blade member and the clamp member are connected in a movable state and cooperate to engage tissue between each working surface. In one embodiment, the ultrasonic blade member is acoustically coupled to an ultrasonic conducting coupler and receives ultrasonic output from the ultrasonic conducting coupler. When the ultrasonic blade member receives an ultrasonic output, the ultrasonic blade member receives a vibration operation. Thus, the ultrasonic blade member can deliver ultrasonic power to the contacted tissue to achieve the desired surgical effect such as cutting and / or coagulation.

In another embodiment of the present invention, the clamp member is also acoustically coupled to the ultrasonic conducting coupler and produces an oscillating action upon receiving the ultrasonic output. In this embodiment, the ultrasonic blade member and / or the clamp member can be vibrated by ultrasonic waves.
In the present invention, at least one of the ultrasonic blade member and the clamp member is characterized by being substantially curved. In one embodiment of the invention, the ultrasonic blade member and / or clamp member may have a curved configuration so that the ultrasonic power can be delivered to the tissue substantially uniformly in a direction transverse to the longitudinal direction of the contact surface. In another embodiment of the invention, the curvilinear form allows delivery of ultrasonic power according to a desired spatial distribution.

In one embodiment of the invention, the ultrasonic blade member is rigidly attached to the ultrasonic conducting coupler, and the clamp member is movably attached to the ultrasonic conducting coupler. In this embodiment, the clamp member is movable from an open position where the ultrasonic blade member and the clamp member are separated to a closed position where the ultrasonic blade member and the clamp member are engaged and the tissue is gripped therebetween. In another form of the invention, the clamp member is rigidly attached to the ultrasonic conducting coupler, and the ultrasonic blade member is movably attached to the ultrasonic conducting coupler and is movable from the open position to the closed position. In yet another embodiment, a scissor-like ultrasonic blade-clamp assembly for a surgical ultrasonic system has a movable ultrasonic blade member and a movable clamp member, and the opposing transverse sides of each of these members. direction surface is adapted to mutual interference by an angle that is responsive to relative movement therebetween portion.

  In another embodiment of the invention, an ultrasonic system for soft tissue cutting and coagulation includes a movable ultrasonic probe member coupled to a fixed clamp jaw member, and an ultrasonic transducer for generating ultrasonic vibrations. A surgical ultrasonic instrument having The ultrasonic probe member is coupled to the ultrasonic transducer and receives ultrasonic vibration from the ultrasonic transducer. The clamp jaw member has a tissue engaging surface, and the ultrasonic probe member is movably connected to the clamp jaw member. The ultrasonic probe member has an open position separated from the tissue engaging surface of the clamp jaw member, the ultrasonic probe member moves toward the tissue engaging surface, and a tissue between the ultrasonic probe member and the tissue engaging surface. It is movable between the clamp position that captures. When cutting tissue using a surgical ultrasound instrument, the ultrasound probe member may include a cutting surface.

  In yet another embodiment, a surgical ultrasound system is provided that includes a retractable grasping device, the grasping device comprising: a grasping jaw member movable in a direction orthogonal to the primary vibration mode of the ultrasound blade member; Including a clamp member. The jaw member is pressed against the ultrasonic blade member in a direction substantially parallel to the vibration direction of the ultrasonic blade member or element. As a result, the tissue is grasped between the jaw member and the ultrasonic blade member. According to this gripping device, the ultrasonic blade member can be used without the need for the ultrasonic blade member itself to perform a gripping function.

  In yet another embodiment, an ultrasonic system for soft tissue cutting or coagulation is provided that can harmonize the vibration of an ultrasonic member by using multiple vibration modes simultaneously. In this embodiment, the ultrasonic element is in a non-longitudinal vibration mode, i.e. at least one component whose vibrational motion direction is not parallel to the longitudinal axis of the vibration element, for soft tissue cutting or coagulation. It also aims at sound wave systems.

  A surgical ultrasonic instrument configured in accordance with a preferred embodiment of the present invention includes an ultrasonic transducer for generating ultrasonic vibrations. An ultrasonic coupler in which an elongated ultrasonic coupler is extended along the axis of the ultrasonic coupler has a proximal end coupled to an ultrasonic transducer and receiving ultrasonic vibration from an ultrasonic transducer, and a far end. Have. The ultrasonic coupler conducts ultrasonic vibration received at the position of the near end to the far end. The far end is connected to a vibration element that generates ultrasonic motion by receiving ultrasonic vibration from the ultrasonic coupler.

The vibration element is in one form flexible and is made of a flexible material, for example a polymer. In one embodiment of the invention, the vibration element has a substantially curvilinear form.
In one embodiment of the invention, the vibration element is configured such that the direction of vibration movement of the vibration element includes at least one component that is non-parallel with respect to the longitudinal axis.
In one embodiment of the present invention, the vibration element is in a harmonic mode, where the vibrational motion of the vibration element can be all excited by a single vibration mode source, superimposing simultaneous multiple vibration modes. It is set as such a form.
In one embodiment of the present invention, the vibration modes of the vibration element include, but are not limited to, a transverse vibration mode, a rotational vibration mode, a stretching vibration mode, a bending vibration mode, and a bending vibration. Modes can be included.

In one embodiment of the present invention, the vibration element is configured to generate an extension direction vibration mode and a bending direction vibration mode, both excited by an external source. According to this form, the trajectory of each mass point along the action edge of the ultrasonic probe member is an elliptical trajectory. In this form, the booster part of the motion profile, ie the base curve equation, is:
r = 0.0625 + 0.002 (e ^695x-6.45 -1).
Here, 0.5 ≦ x ≦ 1.0, r is the inch radius of the base, and x is the inch distance from the tip.

In one embodiment of the present invention, the vibrating element is periodically subjected to a vibrating motion from a substantially compressed first state to a decompressed second state and from a substantially expanded second state. Move on.
Another embodiment of the present invention is directed to a surgical ultrasound system that is inexpensive to manufacture and use, and that includes at least one disposable and replaceable component. The manufacturing and use costs associated with this surgical ultrasound system are reduced by not using precision cutting components.

  The surgical ultrasonic system according to the present invention includes an ultrasonic transducer for converting an electrical signal into ultrasonic vibration, and an ultrasonic wave coupled to the ultrasonic transducer and receiving ultrasonic vibration from the ultrasonic transducer. Conductive couplers. The ultrasonic conducting coupler is preferably elongate and is adapted to conduct ultrasonic vibrations from its proximal end to its distal end. An ultrasonic vibration element is connected to the far end of the ultrasonic conducting coupler. The ultrasonic vibrating element can be, for example, a surgical ultrasonic blade.

The surgical ultrasound system can include an ultrasound transducer sheath that houses the ultrasound transducer. The ultrasonic conducting coupler can be housed inside an elongated tubular sheath.
In the present invention, at least one of the ultrasonic transducer, the ultrasonic conductive coupler, the ultrasonic vibration element, the ultrasonic transducer sheath, and the elongated tubular sheath for housing the ultrasonic conductive coupler is disposable. Is.
In one embodiment of the present invention, the surgical ultrasound system is entirely disposable, formed only by disposable components.
A surgical ultrasound system can be characterized by a resonant frequency. Disposable components can be made of a material with a constant cross-sectional area and can be varied in length so that the desired resonant frequency can be achieved in the finished surgical ultrasound system. The

Suitable materials for the disposable ultrasonic transducer may include, but are not limited to, piezoelectric materials, piezoceramic materials, nickel. Suitable materials for disposable ultrasonic vibrating elements (eg, disposable surgical ultrasonic blades) include, but are not limited to, plastics, ceramics, polymers, polycarbonates, metals, plastics Metal alloys can be included.
The surgical ultrasound system may include a control unit for controlling the magnitude of ultrasound vibrations generated by the surgical ultrasound system. The control unit may also control the frequency and / or duration of the ultrasonic vibration. The control unit is preferably a manual control unit and is disposable.

  FIG. 1 generally illustrates an ultrasonic system 100 for soft tissue cutting and coagulation having a configuration according to one embodiment of the present invention. The ultrasound system includes a handpiece 102 that houses one or more ultrasound transducers 104. The handpiece 102 is coupled with an ultrasonic generator for supplying electric energy, that is, electric power. The ultrasonic transducer 104 converts the supplied electrical energy into vibration energy having an ultrasonic frequency. The operating frequency range of the ultrasound system 100 is typically between about 20 kHz and 100 kHz, and the electrical energy supplied by the ultrasound generator is typically about 100 W to about 150 W. However, other frequencies and power levels can be used. The ultrasonic transducer 104 can be made from a piezoelectric material or other material that can convert electrical energy into vibrational energy, such as nickel. The handpiece 102 can also house an amplifier, such as an acoustic horn, that amplifies the mechanical vibrations generated by the ultrasonic transducer 104.

  An elongated ultrasonic conducting coupler 106 is coupled to the handpiece 102. In one embodiment, the ultrasonic conducting coupler 106 has a proximal end 108 and a distal end 109 and is coupled to the handpiece 102 at the location of the proximal end 108. The ultrasonic conducting coupler 106 conducts ultrasonic vibration energy from the ultrasonic transducer 104 received at the position of the near end 108 to the far end 109.

  In the illustrated embodiment, the surgical ultrasound assembly 110 is coupled to the distal end 109 of the elongated ultrasound conductive coupler 106 and includes an ultrasound blade member 112 and a clamp member 114. In a preferred embodiment, the ultrasonic blade member 112 and the clamp member 114 are movably connected to each other and cooperate to engage tissue between their respective working surfaces. In the illustrated embodiment, the ultrasonic blade member 112 is acoustically coupled to the ultrasonic conducting coupler 106 and the ultrasonic output is conducted to and carried by the ultrasonic blade member 112. The ultrasonic blade member 112 receives ultrasonic vibration from one or a plurality of ultrasonic transducers 104 and vibrates to deliver an ultrasonic output to the contacting tissue. Thus, the desired surgical effect such as cutting and / or coagulation can be achieved.

In another embodiment not shown, the clamp member 114 is acoustically coupled to the ultrasonic conducting coupler 106, and thus the ultrasonic output can be conducted to and carried by the clamp member 114. In this embodiment, either or both of the ultrasonic blade member 112 and the clamp member 114 can be ultrasonically vibrated.
The ultrasonic blade member 112 and the clamp member 114 can be pivotally attached to the end position of the elongated ultrasonic conducting coupler 106 around the pivot point or the pivot point 116, but in another embodiment (for example, FIG. 8). Example), other mechanisms for linking the ultrasonic blade member 112 and the clamp member 114 in a movable state can be used. In the embodiment illustrated in FIG. 1, the surgical ultrasound assembly 110 is activated by a scissor-like clamp actuation mechanism 118.

  The ultrasound system 100 is generally characterized by a resonant frequency determined primarily by the assembly length of the component. The most effective vibration is when the ultrasound system 100 including the handpiece 102, the ultrasound conducting coupler 106, and the surgical ultrasound assembly 110 is vibrated under the intended resonant frequency in the ultrasound system. To occur. In that case, the vibration motion becomes maximum at the position of the tip 120 of the ultrasonic blade member 112.

  The design shape of the clamp member 114 as well as the ultrasonic blade member 112 has a significant effect on the interaction of the surgical ultrasound system 100 with the tissue. In the present invention, at least one of the ultrasonic blade member 112 and the clamp member 114 has a substantially curved shape. The ultrasonic blade member 112 and the clamp member 114 are an open position where the ultrasonic blade member 112 and the clamp member 114 are separated from each other, and the ultrasonic blade member 112 and the clamp member 114 are engaged with each other between the respective working surfaces. Relatively movable between a closed position for capturing tissue.

  In the preferred embodiment of the present invention, the working surfaces of the ultrasonic blade member 112 and the clamp member 114 are not curvilinear and dissimilar to each other. In other words, at least a portion of the ultrasonic blade member 112 and the clamp member 114 are characterized by being substantially different in their radii of curvature. The spacing between each working surface is not uniform and can vary in some or all parts between one end and the other end of the surgical ultrasound assembly 110. In this specification, that is, “dissimilar” in this specification means that, as explained in a textbook of geometry, two polygons are formed when two corresponding angles match and the corresponding sides are proportional. Used to mean “dissimilar” as an antonym when defining “similar”.

  The ultrasonic blade member 112 and the clamp member 114 have a curvilinear and dissimilar shape, so that compared to a conventional ultrasonic system having a linear and / or parallel ultrasonic blade member 112 and clamp member 114, The ultrasound system 100 of the present invention has several beneficial features. For example, the curved form of the ultrasonic blade member 112 and the clamp member 114 may be optimized to distribute the ultrasonic vibration energy substantially uniformly in a direction across the working surface of the ultrasonic blade member 112. Thereby, energy for cutting and / or coagulation can be delivered substantially uniformly along the longitudinal direction of the contact surface with the tissue. The curvilinear form can also be optimized to achieve the desired spatial distribution of ultrasound output along the length of the contact surface in contact with the tissue. Also, in some forms of the invention, the curved clamp member 114 that is offset from the ultrasonic blade member 112 and dissimilar to the ultrasonic blade member 112 may be a linear or parallel clamp known in the art. It has a much higher tissue grasping ability compared to the member.

  FIG. 2 shows the velocity distribution, bonding force distribution, and curves obtained by the ultrasonic blade member and the clamp member in the shape and the dissimilar shape optimized so that the ultrasonic power can be delivered to the tissue substantially uniformly. 6 schematically shows an ultrasonic output distribution. In the illustrated embodiment, the ultrasonic blade member 10 and the clamp member 20 are pivotally mounted about the pivot point 12. In this embodiment, the ultrasonic vibration of the ultrasonic blade member 10 is characterized by the resonance frequency at which the maximum vibrational motion occurs at the position of the tip 22 of the ultrasonic blade member 10 and the vibration node occurs at the position of the pivot point 12. Thus, the distance between the tip 22 position and the pivot point 12 position is given by (1/4) (λ). λ represents the wavelength of ultrasonic vibration.

  In FIG. 2, curves A and B schematically represent the curved geometric shapes of the working surfaces of the ultrasonic blade member 10 and the clamp member 20. A curve V (x) in FIG. 2 schematically shows a spatial variation in the transverse speed of the ultrasonic blade member 10 along the working surface. A curve C (x) in FIG. 2 schematically shows the coupling of ultrasonic waves to the tissue to be processed, that is, the mechanical compression force exerted on the tissue by the respective working surfaces of the ultrasonic blade member 10 and the clamp member 20. It is a thing. As shown in FIG. 2, the coupling force of the curve C (x) is maximum at the position of the pivot point 12 (ie, the vibration node), while the velocity of the ultrasonic blade member 10 is the pivot point 12 in the curve V (x). Is the minimum at the position and the maximum at the position of the tip 22.

  In the present invention, the changes in the geometrical forms A and B of the working surfaces of the ultrasonic blade member 10 and the clamp member 20 are in a curve V (x) along the longitudinal direction of the working surface of the ultrasonic blade member 10. It can be controlled based on the velocity distribution in the transverse direction. Specifically, in the illustrated embodiment, the working surfaces of the ultrasonic blade member 10 and the clamp member 20 are ultrasonic waves at all points x along the contact surface between the ultrasonic blade member 10 and the tissue. The product of the transverse speed V (x) of the blade member 10 and the mechanical coupling force C (x) is controlled to be constant. As a result, the ultrasonic power is substantially uniform along the entire length of the ultrasonic blade member 10, and the spatial distribution of the ultrasonic power delivered to the tissue with which the ultrasonic blade member contacts is the curve E (x). As shown schematically in FIG.

In other embodiments not shown, the geometrical changes of the working surfaces of the ultrasonic blade member and the clamp member are determined by the transverse velocity V of the ultrasonic blade member along the contact surface between the ultrasonic blade member and the tissue. The product of (x) and binding force C (x) has the desired and predetermined spatial dependence, i.e.
Control can be performed so that (velocity V (x) of the ultrasonic blade member) × (binding force C (x)) = f _E (x).
Here, f _E (x) represents the spatial distribution of the ultrasonic output sent to the tissue.

  In FIGS. 3A-D, an ultrasonic blade member and a clamp member that receives the ultrasonic blade member both have a working surface characterized by a curved configuration. Examples are given. FIG. 3A shows a side view of the surgical ultrasound assembly and FIG. 3B shows an end view thereof. In the illustrated embodiment, the clamp member is mounted to pivot about the pivot point at the end position of the tubular support structure. The pivot point is shown in a state of being arranged at a position far from the tip of the ultrasonic blade member. In order to activate the pivoted ultrasonic blade member and clamp member, a clamp activation device, shown schematically in block diagram in FIG. 3A, can be provided.

  In the surgical ultrasound assembly illustrated in FIGS. 3A-D, FIG. 3C illustrates an open clamp configuration and FIG. 3D illustrates a closed clamp configuration. As shown in FIGS. 3C to 3D, the ultrasonic blade member and the clamp member are movably connected. Specifically, in the illustrated embodiment, the ultrasonic blade member is fixed, and the clamp member is moved from the open position of FIG. 3C where the clamp member is separated from the ultrasonic blade member. Are movable to the closed position shown in FIG. 3D.

  4A-C, the ultrasonic blade member has a curved convex working surface that is substantially convex and the clamping member has a curved concave working surface that is substantially concave. A sonic assembly is illustrated. As shown in FIGS. 3A to 3C, the ultrasonic blade member is fixed and the clamp member is movable. FIG. 4A shows the surgical ultrasound assembly in a neutral position. That is, in this position, the clamp member is not spaced apart to the maximum, is not closed, and engages the ultrasonic blade member. In FIG. 4B, the movable clamp member is in the open position, and the clamp member is positioned at a position away from the ultrasonic blade member. In FIG. 4C, the clamp member is closed and tissue can be grasped between the working surfaces of the ultrasonic blade member and the clamp member.

In some surgical processes, it may be desirable for some sections of tissue to receive higher energy compared to other sections of tissue. The ultrasonic vibration mode along the working surface of the convex ultrasonic blade member illustrated in FIGS. 4A to 4C is more uniform than the ultrasonic mode along the working surface of the linear ultrasonic blade member. Is low. Thus, the ultrasonic vibration mode with a convex ultrasonic blade member may be such that one or more sections of the working surface of the ultrasonic blade member have a high energy region that maximizes the surgical effect. . As discussed in connection with FIG. 2, this represents the geometric change of each working surface of the ultrasonic blade member and the clamp member as follows:
V (x) × C (x) = f _E (x)
Can be achieved by controlling so that
Here, V (x) is the velocity distribution in the transverse direction along the working surface of the ultrasonic blade member, C (x) is the ultrasonic bonding force distribution, f _E (x) is the tissue, A desired spatial distribution of ultrasonic power along the length of the contact surface with the working surface of the sonic blade member.

  5A-C illustrate a surgical ultrasound assembly having an ultrasonic blade member that is substantially curvilinear and has a working surface that is dissimilar to the working surface of a curvilinear clamping member. As in the embodiment illustrated in FIGS. 3A-C, the ultrasonic blade member has a substantially convex working surface and the clamping member has a substantially concave working surface.

  However, in the illustrated embodiment, the clamping member is fixed and not movable, in contrast to the embodiment illustrated in FIGS. 3A-C and 4A-C. The ultrasonic blade member is movable between the open position of FIG. 4A, the neutral position of FIG. 4B, and the closed position of FIG. 4C, in which the clamping member engages tissue between the working surfaces. Cooperate with.

In FIGS. 6A-6D, the opposing lateral surfaces of the movable ultrasonic blade member and the movable clamp member interfere with each other at an angle depending on the relative motion of these lateral surfaces. ultrasonic surgical assembly has become to so that is illustrated. In the illustrated embodiment, both the ultrasonic blade member and the clamp member have a curved working surface.
In FIG. 6A, the movable ultrasonic blade member and the movable clamp member are shown in the open position, and the clamp member is shown in a position spaced from the ultrasonic blade member, while FIG. 6B shows the end face in this state. A figure is shown.
FIG. 6C illustrates a closed position of the movable ultrasonic blade member and the movable clamp member where the tissue can be grasped between the clamp member and the ultrasonic blade member, while FIG. 6D illustrates this state. An end view at is shown.

  FIG. 7 illustrates a surgical ultrasonic assembly having a corrugated configuration in which the working surfaces of the ultrasonic blade member and the clamp member are serrated. In this embodiment, the working surface of the ultrasonic blade member is characterized by a substantially sinusoidal form represented by the first sine wave function f1 (x). Similarly, the tissue engaging surface of the clamp member may be characterized by having a substantially sinusoidal form represented by the second sinusoidal function f2 (x). The first and second sinusoidal functions can be selected such that the ultrasound power can be delivered to the tissue substantially uniformly or according to a desired spatial distribution.

The Figure 8 each working surface of the blade member and the clamp member, is a sine function representing the geometrical change having a serrated form as discussed in connection with FIG. 7 is shown schematically. In FIG. 8, curve A represents f1 (x), a sinusoidally changing geometry at the working surface of the ultrasonic blade member, and curve B represents f2 (x), a sinusoidal at the working surface of the clamping member. Represents a changing geometric form. In this embodiment, f1 (x) and f2 (x) are, for example, the following equations:
f1 (x) = sin (aωx) + sin (ωx),
f2 (x) = [sin (aωx) + sin (ωx)] × sin (bωx). Where ω represents the angular frequency of the sinusoidal change in f1 (x) and f2 (x), and a and b are one end of the surgical ultrasonic assembly between the working surfaces of the ultrasonic blade member and the clamp member. This is a parameter that represents the distance in the transverse direction at the selected position along the distance x measured from the other end to the other end. By varying these parameters a and b, the geometry of each serrated working surface on the ultrasonic blade member and the clamp member can be optimized to achieve the desired energy distribution profile.

  FIG. 9 shows an embodiment of the present invention, in which the ultrasonic blade member 212 and the clamp member 214 are not pivotably mounted around the pivot point, and are also provided by a scissor-like clamp activation mechanism. It is connected in a movable state without having to be activated. In the illustrated embodiment, the ultrasonic blade member 212 and the clamp member 214 are relatively movable in a direction parallel to the ultrasonic vibration direction in the longitudinal direction of the ultrasonic blade member 212. Specifically, the movable ultrasonic blade member 212 is coupled to the fixed clamp member 214, the ultrasonic blade member 212 is moved in the longitudinal vibration direction, and the ultrasonic blade member 212 is aligned with the clamp member 214 in contact with the clamp member 214. To do. As a result, the tissue disposed between the movable ultrasonic blade member 212 and the fixed clamp member 214 is compressed when the ultrasonic blade member 212 moves in the direction of the clamp member 214, and the ultrasonic blade member 212 and the clamp are compressed. Each opposing working surface 222 and 224 of member 214 can be used to grasp tissue between each of these working surfaces. As in the previously discussed embodiment, each working surface 222 and 224 is substantially curved and dissimilar, and at least a portion of each working surface is characterized by a substantially different curvature. .

In the illustrated embodiment, the ultrasonic blade member 212 is movable and the clamp member 214 is fixed, but in other embodiments not shown, the ultrasonic blade member 212 is fixed and the clamp member 214 is subjected to longitudinal ultrasonic vibration. It can be movable along the direction.
In short, a substantially curvilinear and morphologically dissimilar ultrasonic blade member and a clamp member facing the ultrasonic blade member are provided, whereby the soft tissue can be brought into contact with the surface according to the present invention. Can be processed evenly across or according to the desired energy distribution profile, thus improving the coupling of the ultrasound output to the tissue.

  FIG. 10 generally illustrates an ultrasonic system 230 for soft tissue cutting and coagulation configured in accordance with the present invention. The ultrasonic system 230 is coupled to a handpiece 232, an ultrasonic energy conducting guide (or horn) 238 covered by a sheath 239, and an ultrasonic probe-jaw member assembly (shown in FIGS. 11-15). A tip assembly 240 extending from piece 232 is included. An ultrasonic generator for supplying electric energy is connected to the handpiece 232. The handpiece 232 houses one or more ultrasonic transducers 234 that convert the supplied electrical energy into vibrational energy at ultrasonic frequencies. The ultrasonic frequency range over which the ultrasonic system operates is typically between about 20 kHz and about 100 kHz, and the power supplied by the ultrasonic generator is typically between about 100 W and 150 W. The ultrasonic transducer 234 can be made from a piezoelectric material, or can be made of other materials, such as nickel, that can convert electrical energy into vibrational energy. The handpiece 232 typically also contains an amplifier such as an acoustic horn that amplifies the mechanical vibrations generated by the ultrasonic transducer, for example. The amplified ultrasonic energy is conducted to the tip assembly 240 by the ultrasonic energy conduction guide 238.

The ultrasound system of the present invention is generally characterized by a resonant frequency determined primarily by the length of each component assembled. Most effective frequencies occur when the handpiece-probe assembly vibrates at its intended resonant frequency, where the maximum vibrational motion occurs at the probe tip position.
In a preferred embodiment of the present invention, the ultrasound system produces a longitudinal oscillating motion, i.e., the oscillating motion occurs along an axis through the ultrasound transducer, amplifier and ultrasound probe member. The design shape of the ultrasonic probe member greatly affects the interaction between the ultrasonic system and the tissue.

In one embodiment, the ultrasound system includes a clamp assembly for clamping tissue between the clamp jaw member and the horn member. Specifically, the present invention relates to a clamp assembly in which the ultrasonic probe member is movable and the clamp jaw member is fixed, in contrast to the conventional case where the ultrasonic probe member is fixed to the movable clamp jaw member. It is characterized by being.
In one embodiment, the clamp jaw member is pivotally mounted at the end of the elongated tube and is activated by a scissor-like clamp activation mechanism.

  11A-D illustrate a probe jaw member assembly for a surgical ultrasound system configured in accordance with one embodiment of the present invention and having a substantially convex working surface with respect to a longitudinal axis (“LA”). A movable ultrasound probe member having a clamping jaw member having a substantially concave working surface with respect to a longitudinal axis ("LA"), wherein the substantially concave working surface of the clamping jaw member is When the ultrasonic probe member is in the closed position, the substantially convex working surface of the ultrasonic probe member is received. In the illustrated embodiment, a pivot point is provided for the ultrasonic probe member. The pivot point is arranged at a position spaced from the tip of the ultrasonic probe member.

  In FIG. 11A, the movable ultrasonic probe member is shown in an open position where the ultrasonic probe member is positioned away from the clamp jaw member, and in FIG. 11B, the ultrasonic probe member is not maximally spaced. In FIG. 11C, the ultrasonic probe member and the clamp jaw member are shown in a closed position where tissue can be grasped between their respective working surfaces.

  FIG. 11D illustrates the situation where the clamp jaw member has an engagement surface that engages tissue. The ultrasonic probe member is movable and is pivotally connected to the clamp jaw member. The ultrasonic probe member is moved away from the tissue engaging surface of the clamp jaw member, and the ultrasonic probe member moves toward the tissue engaging surface of the clamp jaw member. It is movable between the closed position to capture the. When used as a cutting device, the ultrasonic probe member includes a cutting surface that moves toward the tissue engaging surface of the clamp jaw member on the fixed side and can grasp tissue between the tissue engaging surface. obtain.

  12A-D illustrate another embodiment of a probe jaw member assembly for a surgical ultrasound system, which is movable with a working surface that is substantially concave with respect to a longitudinal axis ("LA"). An ultrasonic probe member and a clamping jaw member having a working surface substantially convex with respect to a longitudinal axis ("LA"), wherein the substantially concave working surface of the ultrasonic probe member is ultrasonic When the probe member is in the closed position, it receives the substantially convex working surface of the ultrasonic probe member.

  In FIG. 12A, the movable ultrasonic probe member is shown in an open position where the ultrasonic probe member is positioned at a position spaced from the clamp jaw member, and FIG. 12B shows an end view in the state of FIG. 12A. In FIG. 12C, the ultrasonic probe member and the clamp jaw member are shown in a closed position where tissue can be grasped between their respective working surfaces, and FIG. 12D shows an end view in the state of FIG. 12C.

  FIG. 13 illustrates a probe jaw member assembly for a surgical ultrasound system configured in accordance with another embodiment of the present invention, where the ultrasound probe member is parallel to the longitudinal vibration direction of the ultrasound probe member. It is movable in the direction. The ultrasonic probe member is clamped so that when the ultrasonic probe member moves in the longitudinal vibration direction, the ultrasonic probe member is aligned with the clamp jaw member while being pressed against the fixed clamp jaw member. It is fixed to the jaw member. Accordingly, when the ultrasonic probe member is moved toward the clamp jaw member, the tissue disposed between the movable ultrasonic probe member and the fixed clamp jaw member is compressed.

  FIG. 14 illustrates a probe jaw member assembly for a surgical ultrasound system configured in accordance with another embodiment of the present invention so that the ultrasound probe member can be rotationally moved relative to a fixed clamp jaw member. It has become. In this embodiment, the clamp jaw member is fixed, but is rotatable between a plurality of different positions. After rotating the clamp jaw member to a desired position, the ultrasonic probe member can be moved forward beyond the tip of the clamp jaw member. The ultrasonic probe member can be rotated around the clamp jaw member.

  FIG. 15 illustrates a probe jaw member assembly for a surgical ultrasound system configured in accordance with another embodiment of the present invention to move the ultrasound probe member through a matching orifice in a fixed clamp jaw member. It is possible. As in the embodiment illustrated in FIG. 13, the ultrasonic probe member is movable in a direction parallel to the longitudinal vibration direction of the ultrasonic probe member, and thus the movable ultrasonic probe member and the fixed clamp jaw member are fixed. The tissue disposed therebetween is compressed when the ultrasonic probe member is moved toward the clamp jaw member. In the embodiment of FIG. 15, the receiving clamp jaw member is provided with a matching orifice, and the movable ultrasonic probe member can move through the orifice as it moves toward the clamp jaw member. It is said.

By providing a movable ultrasound probe member with respect to a fixed clamping jaw member, the present invention provides a flexible tissue cutting and coagulation ultrasound system that is much more versatile than conventional systems. For example, a much wider range of ultrasonic vibration frequencies can be achieved to achieve more diverse surgical effects.
In another aspect, the present invention provides a surgical ultrasound system having a retractable gripping device that allows an ultrasonic vibrating member to operate with a clamping jaw member without the need for the ultrasonic vibrating member itself to have a gripping function. It is oriented.

  FIG. 16 generally illustrates an ultrasound system 300 for soft tissue cutting and coagulation configured in accordance with one embodiment of the present invention. The ultrasound system 300 includes a handpiece 302 that houses one or more ultrasound transducers 304, to which is coupled an ultrasound generator that supplies electrical energy. The ultrasonic transducer 304 converts electrical energy into ultrasonic vibration energy. The operating frequency range of the ultrasound system 300 is between about 20 kHz and about 100 kHz, and the electrical energy supplied by the ultrasound generator is typically between about 100 W and 150 W. However, other frequencies and power levels can be used. The ultrasonic transducer 304 can be made from a piezoelectric material, or can be made of other materials, such as nickel, that can convert electrical energy into vibrational energy. The handpiece 302 also houses an amplifier such as an acoustic horn that amplifies mechanical vibrations generated by the ultrasonic transducer 304, for example.

  An elongated ultrasonic conducting coupler 306 is coupled to the handpiece 302. In one embodiment, the ultrasonic conducting coupler 306 has a proximal end 308 and a distal end 309 that are coupled to the handpiece at the proximal end 308. The ultrasonic conducting coupler 306 conducts the ultrasonic vibration energy received from the ultrasonic transducer 304 from the proximal end 308 to the far end 309. In one embodiment, the sheath 390 may enclose the ultrasonic conducting coupler 306.

  In the illustrated embodiment, the surgical ultrasound assembly 310 is coupled to the distal end 309 of the ultrasound conducting coupler 306 and includes an ultrasound blade member 312 and a retractable grasping device 313. The ultrasonic blade member 312 preferably includes an elongated ultrasonic blade edge 397. The ultrasonic blade member 312 is acoustically coupled to the ultrasonic conducting coupler 306 such that ultrasonic energy is conducted to and carried by the ultrasonic blade member.

  The ultrasonic blade member 312 vibrates upon receiving ultrasonic vibration from the ultrasonic transducer (s) 304 and delivers ultrasonic energy to the contacting tissue, thus providing the desired surgical, such as cutting and / or coagulation. An effect can be achieved. In one form of the invention, the ultrasonic blade member undergoes ultrasonic vibrations characterized by at least one primary vibration mode. This primary vibration mode may be along a longitudinal direction substantially parallel to the edge of the ultrasonic blade member in one embodiment. The retractable gripping device 313 includes a gripping jaw member that operates to engage tissue between each working surface by closing in contact with the ultrasonic blade member 312.

  In one embodiment, the present invention comprises an ultrasonic transducer for generating ultrasonic vibrations, and an elongated ultrasonic conductive coupler coupled to the ultrasonic transducer and receiving ultrasonic vibrations from the ultrasonic transducer. It is aimed at accessories for surgical ultrasound instruments. The accessory includes a clamp assembly coupled to an ultrasonic transducer. The clamp assembly includes an ultrasonic blade member and a clamp jaw member that is movable and retractable with respect to the ultrasonic blade member. The clamp jaw member is movable from its extended position to a closed position where the ultrasonic blade member and the clamp jaw member engage and engage the tissue between them. The clamp jaw member is further movable to a retracted position suitable for storing the accessory.

17A-C illustrate a gripping device 313 configured in accordance with one embodiment of the present invention. The gripping device 313 is retractable and extensible. That is, the gripping jaw member 314 is movable from the extended position to a closed position where the ultrasonic blade member and the gripping jaw member engage with each other and capture the tissue between them. It is supposed to be movable.
FIG. 17A shows the retracted position. If the ultrasound system 300 is not used, the gripping device 313 can be stored in the retracted position. The gripping device 313 is illustrated in an expanded state in FIG. 17B, with the gripping jaw member 314 positioned along a horizontal direction substantially parallel to the longitudinal primary vibration mode of the ultrasonic blade member.

  Preferably, a jaw member activation mechanism is provided for moving the gripping jaw member relative to the ultrasonic blade member, and the gripping jaw member is moved from its extended open position to the closed position and to the retracted position. In one embodiment, the jaw member activation mechanism is a hinge. In this embodiment, the gripping jaw member is hinged, that is, the gripping jaw member closes in contact with the ultrasonic blade member from the open position around the pivot point 396, and the tissue between the ultrasonic blade member is closed. Is pivotable to a closed position for gripping and then to a retracted position for storage. In the extended state, the pivot point 396 is preferably aligned with the elongate ultrasonic blade edge 397 of the ultrasonic blade member, and the gripping jaw member 314 preferably extends beyond the elongate edge along the horizontal direction.

  The gripping jaw member 314 is movable from the extended open position described above to the closed position illustrated in FIG. 17C in a direction substantially perpendicular to the primary vibration mode of the ultrasonic blade member. FIG. 17C shows a grasping jaw member that is hinged and closed with respect to the ultrasonic blade member, thus grasping the tissue. As shown in FIG. 17C, the gripping jaw member closes in contact with the ultrasonic blade member in a direction substantially parallel to the direction of the ultrasonic blade member. As a result, the tissue to be processed is gripped between the gripping jaw member and the ultrasonic blade member, and thus the tissue can be gripped without the need for the ultrasonic blade member itself to exhibit a gripping function.

  In another embodiment of the present invention, a “multi-frequency” type ultrasonic probe member is characterized, and the ultrasonic probe member generates a vibration mode in which a plurality of different vibration modes are superimposed. Thus, multiple vibration modes can be activated simultaneously. Specifically, in this embodiment, vibration induction in a direction orthogonal to the longitudinal axis of the ultrasonic probe member is intended. The total vibration amount of the ultrasonic probe member is intentionally amplified by inducing vibration in the transverse direction mode and / or the rotational direction mode.

  FIG. 18 generally illustrates a surgical ultrasound system 400 configured in accordance with the present invention. The ultrasound system 400 includes at least one ultrasound transducer 404 that is coupled to an ultrasound generator that supplies electrical energy. The ultrasonic transducer 404 converts the supplied electric energy into vibration energy having an ultrasonic frequency. The operating frequency range of the ultrasound system is between about 20 kHz and about 100 kHz, and the electrical energy supplied by the ultrasound generator is typically between about 100 W and 150 W. However, other frequencies and power levels can be used. The ultrasonic transducer 404 can be made from a piezoelectric material, or can be made of other materials, such as nickel, that can convert electrical energy into vibrational energy. The ultrasound system also houses an amplifier (such as an acoustic horn) that amplifies the mechanical vibrations generated by the ultrasound transducer.

  The ultrasound system also includes an ultrasound conducting coupler 406. Ultrasonic conducting coupler 406 extends along its coupler axis and has a proximal end 408 and a distal end 409. The ultrasonic conducting coupler 406 is connected to the ultrasonic transducer 404 at the position of the proximal end 408 and receives ultrasonic vibration from the ultrasonic transducer 404. The ultrasonic conducting coupler 406 conducts the ultrasonic vibration received at the position of the near end 408 to the far end 409.

A vibration element 420 is coupled to the far end of the ultrasonic conductive coupler 406, and when it receives ultrasonic vibration from the ultrasonic conductive coupler 406, it vibrates. When using the vibrating element 420 to cut tissue, the vibrating element 420 is in the form of an ultrasonic blade, preferably having an ultrasonic blade edge 422 parallel to the axis of the ultrasonic conducting coupler 406. In one embodiment of the invention, the vibrating element is formed from a flexible material, such as a polymer. Flexible materials that can be used to make the vibrating element include, but are not limited to, polymeric materials.
In one embodiment of the invention, the vibration element is substantially in the form of a curve.

  In the present invention, the vibration element 420 is configured such that the vibration operation of the vibration element is a combination of a plurality of vibration modes. In a preferred embodiment, the vibration element 420 is configured such that multiple vibration modes can be used simultaneously to cause the vibration element 420 to harmonize. In one embodiment of the present invention, such multiple vibration modes can be excited by a single vibration mode source. Structurally independent vibration modes may be included, such as, but not limited to, stretching, bending, bending, transverse, and rotational vibration modes. .

Preferably, the vibration element 420 includes at least one vibration component whose direction of vibration motion of the vibration element 420 is parallel to the axis of the ultrasonic conducting coupler 406, that is, the vibration mode of the vibration element is non-longitudinal. It is configured to include a vibration mode.
In a preferred embodiment, a transverse vibration mode and / or a rotational vibration mode is induced. In other words, the plurality of vibration modes forming a composite vibration mode of the vibration element include 1) at least one transverse vibration mode generated by the ultrasonic probe member operating in a direction orthogonal to its longitudinal axis. And 2) at least one rotational vibration mode generated by rotational movement about the longitudinal axis.

  19A and 19B illustrate surgical ultrasound systems 500 and 501 configured in accordance with a preferred embodiment of the present invention. In the illustrated embodiment, the vibrating elements 520 and 521 are configured to amplify the total amount of vibration through transverse and / or rotational movement. In other words, in this embodiment, the vibration element moves in a direction perpendicular to the longitudinal axis (indicated by reference numeral 530 in FIGS. 19A and B) of the ultrasonic systems 500 and 501, or rotates around the axis 530. Is deliberately induced.

  The form of the vibration element illustrated in FIGS. 19A and 19B is intended to generate an extension direction vibration mode coupled with a bending direction vibration mode. Either vibration mode can be induced by a single vibration mode source, ie, a stretching direction vibration mode source. In the illustrated embodiment, the wavelength of the bending direction vibration mode is not the same as the wavelength of the stretching direction vibration mode, but the design shape shown in the illustrated embodiment that is consistent with the wavelength of the stretching direction vibration mode is finite. This is by iterative improvement using elemental mode analysis. In another embodiment of the present invention, the design shape of the vibration element can be realized by trial and error methods or tests. As shown in FIGS. 19A and B, the material from which the surgical ultrasound systems 400 and 401 are made is a titanium-aluminum alloy, specifically Ti6AL-4VELI.

The vibration element 520 has a tip 550, the vibration element 521 has a tip 551, and each vibration element has at least one working edge 552 or 553 along at least one side thereof. Yes. In the illustrated embodiment, the formula for the curve for the booster portion or base of the motion profile is as follows:
r = 0.0625 + 0.002 (e ^6.95x-6.45 -1),
0.5 ≦ x ≦ 1.0
Where r is the radius of the base and x is the inch distance from the tip.
The trajectories of the mass points generated along the action edges 552 and 553 of the vibration element 520 and the vibration element 521 are elliptical orbits.

  As shown in FIGS. 19A and B, the distance measured from the position of the proximal end 508 of the ultrasonic conducting coupler 506 of the ultrasonic systems 500 and 501 to the distal end of the vibrating element is about 2800 inches (about 7.1 cm). ). The vibration element 520 of the ultrasound system 500 has a base radius of 0.044 inches (about 0.1 cm) and the distal end position of the vibration element is chamfered at an angle of 45 °. The width of the vibrating element is 0.038 inches. The vibration element 521 of the ultrasonic system 501 has a shape similar to a knife tooth. The tapered portion of the vibrating element 521 has a length of 0.239 inches (about 0.06 cm). The base radius of the ultrasound system 501 is 0.277 inches.

In the illustrated embodiment, each vibration mode in the transverse direction and / or rotational direction is induced, and a velocity vector in multiple dimensions is developed at the working edge of the vibration element. This velocity vector varies with time and varies as a function of position along the working edge, thus producing a velocity profile based on time and position.
FIG. 20 illustrates the surface velocity and bias profile of an example vibration element that produces a vibration motion in which the stretching direction vibration mode and the bending direction vibration mode are superimposed as described with reference to FIG. Each curve shown in FIG. 20 is determined by finite element analysis performed at a frequency of 75856 Hz.

  A solid curve 600 shown in FIG. 20 illustrates an instantaneous longitudinal deviation profile, and thus the velocity profile of the surface of the vibrating element indicated by the number 521 in FIGS. 19A and B is shown. The instantaneous longitudinal deflection (not to scale) is shown as a function of inch distance from the distal end of the ultrasound probe member. In FIG. 20, the instantaneous transverse deflection of the surface of the vibrating element 521 is also indicated by the dotted curve 601 as a function of inch distance from the distal end of the ultrasound probe member. The instantaneous deviation for the vibration element obtained by combining the solid line curve 600 and the dotted line curve 601 is indicated by a curve 602 indicated by a dashed line in FIG. This complex surface deviation curve (ie, the curve 602 shown in dashed lines) is also shown as a function of inch distance from the distal end of the ultrasound probe member. As discussed in connection with FIGS. 19A and B, the trajectory of each mass point that occurs along the working edge of the vibrating element is an elliptical trajectory.

In FIGS. 21A-E, for ultrasonic vibrations conducted through an ultrasonic conducting coupler, the vibrating element changes from a substantially compressed state to an uncompressed state (or depressurized state) and the vibrating element substantially Another embodiment of the present invention is illustrated which produces an oscillating motion characterized by a periodic change to a stretching state.
FIG. 21A illustrates an initial substantially compressed state of the vibration element in the embodiment illustrated in FIGS. FIG. 21B illustrates a vibration element that is subsequently depressurized, FIG. 21D illustrates a vibration element that has returned to an unstretched, uncompressed state, and FIG. The final state where the vibration element is substantially compressed is illustrated.

  Each vibration mode illustrated in FIGS. 21A-E can be formed by combining a longitudinal vibration mode with a torsional vibration mode in one embodiment of the present invention. Alternatively, each illustrated vibration mode can be formed by combining a longitudinal vibration mode with a flexural vibration mode. Alternatively, each illustrated vibration mode can be generated by combining a longitudinal vibration mode and a rotational vibration mode.

When subjected to a longitudinal vibration mode, the vibrating element moves back and forth along a longitudinal axis parallel to the axis of the ultrasonic conducting coupler. When the longitudinal vibration mode is combined with the torsional or rotational vibration modes, the vibration element creates a trajectory as schematically shown in FIGS. 21A-E, from the substantially compressed state to the compressed state, and then substantially Move to a fully stretched state, and then return to a substantially compressed state.
FIG. 22 illustrates another example of a vibrating element in which a curved tip 622 is adjusted for ultrasonic conduction. The curve of the tip 622 is preferably adjusted to conduct vibrations that are amplified to the maximum at the position of the tip 622.

  Another embodiment of the invention is a surgical ultrasound system characterized in that it includes at least one disposable component. Disposable components include, but are not limited to, ultrasonic transducers, ultrasonic conducting couplers, ultrasonic vibrating elements (e.g., surgical ultrasonic blades), and ultrasonic transducer sheaths. obtain. By using disposable components that can be replaced after use and are not precision cut, the surgical ultrasound system of the present invention is much more economical to manufacture compared to conventional surgical ultrasound systems. Yes and useful.

  FIG. 23 illustrates a surgical ultrasound system 700 configured in accordance with one embodiment of the present invention. The ultrasound system 700 includes an ultrasound transducer sheath 702 that encloses one or more ultrasound transducers 704. An ultrasonic generator for supplying electric energy is coupled to the ultrasonic transducer sheath 702. The ultrasonic transducer 704 converts the supplied electric energy into vibration energy having an ultrasonic frequency. The operating frequency range of the ultrasound system 700 is between about 20 kHz and about 100 kHz, and the electrical energy supplied by the ultrasound generator is typically between about 100 W and 150 W. However, other frequencies and power levels can be used. The ultrasonic transducer 704 can be made from a piezoelectric material, or it can be made of other materials, such as nickel, that can convert electrical energy into vibrational energy. The ultrasound system also contains an amplifier, such as an acoustic horn, that amplifies the mechanical vibrations generated by the ultrasound transducer 704.

  A surrounding ultrasonic conducting coupler 706 is coupled to the ultrasonic transducer sheath 702. In one embodiment, the ultrasonic conducting coupler 706 has a proximal end 708 and a distal end 709 that are coupled to the ultrasonic transducer sheath 702 at the proximal end location. The ultrasonic conducting coupler 706 conducts the ultrasonic vibration received from the ultrasonic transducer 704 from the proximal end 708 to the far end 709. In one embodiment, a tubular sheath 790 houses the ultrasonic conducting coupler 706.

  In the illustrated embodiment, an ultrasonic vibrating element 710 is coupled to the distal end 709 of the elongated ultrasonic conducting coupler 706. The ultrasonic vibration element 710 has the form and shape of an ultrasonic vibration blade, but may be of other shapes and forms in other embodiments of the invention. The ultrasonic vibration element 710 is acoustically coupled to the ultrasonic conducting coupler 706 so that ultrasonic energy is conducted and carried by the ultrasonic vibration element 710. When receiving the ultrasonic vibration from the ultrasonic transducer 704, the ultrasonic vibration element 710 generates a vibration motion. This allows the ultrasonic vibrating element 710 to deliver ultrasonic energy to the contacting tissue, thus achieving the desired surgical effect such as cutting and / or coagulation.

  In this embodiment, at least one of the ultrasonic transducer 704, the ultrasonic conductive coupler 706, and the ultrasonic vibration element 710 is disposable. By using inexpensive, disposable components, the surgical ultrasound system 700 of the present invention is much less costly to manufacture and use compared to conventional surgical ultrasound systems.

  In some embodiments of the present invention, the ultrasonic transducer sheath and the tubular sheath that houses the ultrasonic conducting coupler are also disposable. In one embodiment, the entire surgical ultrasound system 700 is disposable and is composed entirely of disposable parts. In this embodiment, each of the ultrasonic transducer 704, the ultrasonic conductive coupler 706, the ultrasonic vibration element 710, and the tubular sheath is assumed to be disposable.

  In order to produce a disposable component, it is necessary to select an appropriate material for each component. In embodiments where the ultrasonic system 700 includes a disposable ultrasonic transducer, the ultrasonic transducer may be made from one of a piezoelectric material, a piezoceramic material, and nickel. In embodiments where the ultrasonic system 700 includes a disposable ultrasonic vibrating element, such as a disposable surgical ultrasonic blade, the materials that form such a disposable ultrasonic vibrating element include plastic, ceramics, Polymers, polycarbonates, metals, plastic-metal alloys may be included.

  In the present invention, the disposable component is not precisely cut. These disposable components are, instead, pressed together or “ballistically engaged” to form the final surgical ultrasound assembly. For example, in embodiments where the surgical ultrasound system includes an ultrasound transducer sheath and a disposable ultrasound transducer, the ultrasound transducer is adapted to be press fit within the ultrasound transducer sheath. Yes. Similarly, in embodiments where the surgical ultrasound system includes a tubular sheath containing an ultrasound transducer conducting coupler, the ultrasound transducer conducting coupler is adapted to be press fit within the tubular sheath.

Or each component which has disposable property has a thread groove, and can be screwed to a to-be-connected element. Alternatively, the components of the surgical ultrasound system are connected to each other via a spring mechanism.
Because each component is disposable and not precision cut, the surgical ultrasound system of the present invention accepts a much wider tolerance compared to a surgical ultrasound system having a precision cut component. It is possible. Roughly speaking, the tolerance range can be received.

  The ultrasonic system as described with reference to FIG. 23 has a resonance frequency mainly determined by the assembly length of each component. However, the surgical ultrasound system 700, which can be considered to form an acoustic assembly, can be vibrated under most any frequency, but is effective and only when the acoustic assembly vibrates under its intended resonant frequency. Produces beneficial vibrations. In this case, the maximum vibration movement occurs at the position of the tip of the vibration element under a state where the electric power input from the ultrasonic generator is relatively small.

  In the present invention, the resonant frequency of the ultrasound system can be adjusted by changing the length of the disposable component until the desired resonant frequency is generated. FIG. 24 illustrates a surgical ultrasound system that can adjust the resonant frequency by changing the length of one or more disposable components.

  In order to keep costs low, certain features (eg, specific vibration frequencies desired) that result from precision cutting of each component are not incorporated. Rather, a material with a constant cross-section is selected that is suitable for a component having disposable properties, and then the ultrasound system is adjusted until the desired resonant frequency for the ultrasound system is achieved. The

The surgical ultrasound system of the present invention may include a control unit for controlling the magnitude of ultrasound vibration. The control unit is preferably manually controllable, i.e. a manual control unit. The control unit can also control the frequency and / or duration of the ultrasonic vibration. FIG. 25 schematically illustrates a surgical ultrasound system having a control unit for controlling the duration and / or frequency and / or magnitude of ultrasound vibration. As shown in FIG. 25, the control unit is coupled to an ultrasonic transducer. In one embodiment, the control unit is also disposable.
In summary, the present invention features an inexpensive surgical ultrasound system that includes one or more disposable and replaceable components that can be assembled by press-fitting each.
Although the present invention has been described with reference to the embodiments, it should be understood that various modifications can be made within the present invention.

1 is an overall schematic view of a surgical ultrasound system having a configuration according to the present invention. Shows a curvilinear and dissimilar distribution of velocity distribution and binding force that occurs in an ultrasonically oscillating blade member whose geometry has been optimized so that the ultrasonic power is delivered to the tissue substantially uniformly. FIG. 1A-D are schematic views of one embodiment of a surgical ultrasound assembly in which an ultrasound blade member and a receiving clamp member have a working surface characterized by a curved configuration. FIGS. 1A to 1C are schematic views of a surgical ultrasound assembly in which a stationary ultrasound blade member has a substantially convex working surface. FIGS. 1A to 1C are schematic views of a surgical ultrasound assembly in which a movable ultrasound blade member has a substantially convex working surface. A~D Each lateral surface opposite to the blade member and the movable clamp member of the movable interferes at an angle that is in accordance with the relative movement of the respective lateral surface, ultrasonic surgical system FIG. 3 is an exemplary view of a scissors-like ultrasonic blade-clamp assembly for; 1 is an exemplary view of a surgical ultrasonic system in which an ultrasonic blade member and a clamp member have a sawtooth shape. FIG. It is the schematic of the sine function showing the geometrical change in each action surface of the ultrasonic blade member which has a sawtooth form, and a clamp member. Overview of a surgical ultrasonic assembly according to one embodiment of the present invention, wherein the ultrasonic blade member is movable toward a clamping member parallel to the longitudinal vibration direction of the ultrasonic blade member and thus does not require a scissor-like mechanism. FIG. 1 is an overall schematic view of a surgical ultrasound system according to the present invention. AD, the ultrasonic probe member has a substantially convex working surface with respect to the longitudinal axis of the ultrasonic probe member, and the clamping jaw member is substantially concave with respect to the longitudinal axis of the clamping jaw member. 1 is an overall schematic view of a surgical ultrasound system according to one embodiment of the present invention having an active surface. FIG. A to D, the ultrasonic probe member has a substantially concave working surface with respect to the longitudinal axis of the ultrasonic probe member, and the clamp jaw member has a substantially convex shape with respect to the longitudinal axis of the clamp jaw member. 1 is an overall schematic view of a surgical ultrasound system according to one embodiment of the present invention having an active surface. FIG. FIG. 6 is an overall schematic view of a surgical ultrasound system according to another embodiment of the present invention, wherein the ultrasound probe member is movable in a direction parallel to the longitudinal vibration direction. FIG. 6 is an overall schematic view of a surgical ultrasound system according to another embodiment of the present invention in which the ultrasound probe member is rotatable with respect to a fixed jaw member. FIG. 6 is an overall schematic view of a surgical ultrasound system according to another embodiment of the present invention in which an ultrasound probe member is movable through a matching orifice in a fixed jaw member. 1 is an overall schematic view of a surgical ultrasound system according to the present invention. A is an illustration of a grip portion in one embodiment of the present invention represented by the retracted state, B is an illustration of a grip portion in one embodiment of the present invention to indicate in a state of being stretched a gripping device, C is an illustrative view of a gripping apparatus according to an embodiment of the closed hinged operated toward the ultrasonic blade, the present invention be shown in a state of gripping the tissue. 1 is an overall schematic view of a surgical ultrasound system according to the present invention. A and B are exemplary views of a surgical ultrasound assembly having a vibrating element configured to allow a vibration mode including a combined mode of stretching mode and bending mode. FIG . 19B is an exemplary view of an instantaneous bias profile by finite element analysis in the longitudinal direction of the vibration element shown in FIGS . 19A and 19B . A is an illustration of an oscillating element subjected to an oscillating motion characterized by periodic fluctuations, substantially under compression fluctuations, and B is an uncompressed, oscillating element subject to an oscillating movement characterized by periodic fluctuations. FIG. 2 is an exemplary diagram under fluctuation, C is an exemplary diagram under a substantially expansion fluctuation of a vibration element that receives vibration motion characterized by periodic fluctuation, and D is a vibration movement characterized by periodic fluctuation. FIG. 5 is an exemplary view of a vibration element subjected to vibration under a second uncompressed variation, and E is an exemplary view of a vibration element subjected to a vibration motion characterized by periodic variation under a second expansion variation. FIG. 6 is an illustration of another example of a vibrating element showing a curved tip adjusted for ultrasonic conduction. 1 is an overall schematic view of a surgical ultrasound system according to the present invention. FIG. 6 is an illustration of a surgical ultrasound system that can change the resonant frequency by changing the length of one or more of the disposable components. 1 is an illustration of a surgical ultrasound system having a manually controllable control unit for controlling the duration and / or frequency and / or magnitude of ultrasound vibration. FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Ultrasonic blade member 12 Pivot point 20 Clamp member 22 Tip part 102 Hand piece 104 Ultrasonic transducer 106 Ultrasonic conduction coupler 108 Proximal end 109 Distant end 110 Surgical ultrasonic assembly 112 Ultrasonic blade member 114 Clamp member 116 Pivot point 118 Scissor-like Clamp Acting Mechanism 120 Tip 212 Ultrasonic Blade Member 214 Clamp Member 222, 224 Working Surface 230 Ultrasonic System 232 Handpiece 234 Ultrasonic Transducer 239 Sheath 238 Ultrasonic Energy Conduction Guide 240 Tip Assembly 300 Ultrasonic System 302 handpiece
304 Ultrasonic Transducer 306 Ultrasonic Conducting Coupler 308 Proximal End 309 Far End 390 Sheath 310 Surgical Ultrasound Assembly 312 Ultrasonic Blade Member 313 Grasping Device 396 Pivot Point 397 Ultrasonic Blade Edge 400 Surgical Ultrasound System 404 Ultrasound Transducer 406 Ultrasonic conducting coupler 408 Proximal end 409 Distal end 420 Vibrating element 422 Ultrasonic blade edge 500, 501 Surgical ultrasound system 506 Ultrasonic conducting coupler 508 Proximal end 520, 521 Vibrating element 530 Longitudinal axis 552, 553 Working edge 600 Solid curve 601 Dotted curve 622 Tip 700 Surgical ultrasound system 702 Ultrasonic transducer sheath 704 Ultrasonic transducer 706 Ultrasonic conducting coupler 08 proximal end 709 distal end 710 ultrasonic vibrating element

Claims (7)

A surgical ultrasonic instrument,
a. An ultrasonic transducer for generating ultrasonic vibrations;
b. A long and narrow ultrasonic conducting coupler, which has a proximal end and a far end, is connected to an ultrasonic transducer at the near end position, receives ultrasonic vibration at the near end position, and conducts the received ultrasonic vibration to the far end An ultrasonic conducting coupler that
c. A surgical ultrasonic assembly coupled to a distal end of an ultrasonic conducting coupler includes a blade member and a clamp member, the blade member and the clamp member engaging each other with an open position spaced apart from each other. A surgical ultrasound assembly movable between a closed position to capture tissue in a portion therebetween,
Including
At least one blade member and the clamp member have a substantially curved form, includes a working surface having a substantially sinusoidal form blade member is represented by a first sinusoidal function, the clamp member, An ultrasonic instrument comprising a working surface having a substantially sine wave form represented by a second sine wave function .   A blade member is acoustically coupled to the ultrasonic conducting coupler to receive ultrasonic vibrations from the ultrasonic conducting coupler, which enables delivery of the received ultrasonic vibrations to tissue in contact with the blade member. The ultrasonic device according to claim 1.   The blade member is rigidly attached to the ultrasonic conduction coupler, and the clamp member is movably attached to the ultrasonic conduction coupler and is engaged with the blade member from an open position where the blade member is separated from the blade member, and a tissue is formed between the blade member. The ultrasonic device according to claim 1, wherein the ultrasonic device is movable toward a closed position for capturing an object.   The clamp member is rigidly attached to the ultrasonic conduction coupler, and the blade member is movably attached to the ultrasonic conduction coupler and is engaged with the clamp member from an open position where the blade member is movably attached to the ultrasonic conduction coupler. The ultrasonic device according to claim 1, wherein the ultrasonic device is movable toward a closed position where the sound is captured.   The ultrasonic device according to claim 1, wherein the blade member has a working surface having a first curvature, and the clamp member has a working surface having a second curvature.   The ultrasonic device according to claim 5, wherein the first curvature and the second curvature are substantially different. Blade member and opposite each lateral surface of the clamping member, the blade member and the ultrasonic instrument of claim 1, an angle that is in accordance with the relative movement of the clamp member has become so that to interfere with each other.

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