Patent Description:
Compared with ordinary scalpels and other energy surgical instruments, ultrasonic hemostasis and cutting systems have advantages such as easy operation, small surgical trauma area, no smoke, less amount of bleeding, high precision of surgery, and quick postoperative recovery, and have been widely used in surgery.

During coagulation or cutting, microscopic temperature uniformity of the ultrasonic hemostasis and cutting systems mainly depends on the temperature diffusion rate inside tissues and the uniformity of frictional heat generation caused by ultrasonic vibrations. Ultrasonic scalpel tips of existing ultrasonic hemostasis and cutting systems are straight cutters, and the ultrasonic scalpel bits only produce longitudinal vibrations. When the ultrasonic scalpel tip is in a balanced position, a gap between the ultrasonic scalpel tip and a clamping arm is at the minimum, and the clamping pressure of the ultrasonic scalpel tip and the clamping arm on a biological tissue is maximized, as shown in <FIG>. According to the principle of longitudinal ultrasonic vibration, the further away from the ultrasonic scalpel tip, the smaller the longitudinal amplitude. When the ultrasonic scalpel is used to cut the biological tissue, the clamping pressure of the scalpel tip and the end of the scalpel on the tissue will also vary with the thickness of the clamped tissue, the change in the position where the tissue is clamped by the ultrasonic scalpel bit, and the change in the elasticity of the tissue after heating and denaturation. As a result, the heat generated by the ultrasonic vibration differs a lot, and the temperature inside the tissue being cut or coagulated is not uniform, so that there is a relatively large difference in the coagulation and cutting effects of the ultrasonic scalpel bit at different positions. For example, when hemostasis or cutting is performed on a biological tissue such as a large-diameter blood vessel, there is a condition in which the hemostasis or cutting has been done at the position being cut by the scalpel tip, but the hemostasis has not yet done at the remaining positions. In this case, if the cutting operation is still continued, the tissue at the position being cut by the scalpel tip may be overheated to cause adverse effects such as high-temperature carbonization, which may endanger the safety of a patient.

<CIT> discloses an ophthalmologic cutting device having a base support section and a tip with a blade section. The blade section has upper and lower edges, and a forward aspiration free edge extending between them, with the upper edge having a shorter longitudinal length compared with the lower edge and where the forward edge slopes down from a distal end of the upper edge to a distal end of the lower edge.

<CIT> discloses an apparatus for generating torsional-mode ultrasonic vibrations to activate an ultrasonically-vibratable tool. A horn is mounted coaxially to a distal face of a first transducer unit. A thin, elongate, cylindrical waveguide extends from the horn to an end effector at a distal tip of the tool. There are a series of nodes along the waveguide.

<CIT> discloses an ultrasonic surgical device including an elongate waveguide having a longitudinal axis and a distal end, and a blade extending away from the distal end of the waveguide, the blade including a curved portion that has at least five faces extending lengthwise along at least a portion of the length of the blade.

<CIT> discloses a surgical instrument comprising an ultrasonic oscillation mechanism for generating an ultrasonic vibration, a horn coupled with the ultrasonic oscillation mechanism for amplifying the vibration transmitted from the ultrasonic oscillation mechanism, a vibration conversion mechanism for converting the vibration transmitted from the ultrasonic oscillation mechanism into a composite vibration.

<CIT> discloses an ultrasonic tissue dissection system providing combined longitudinal and torsional motion of tips, together with irrigation and aspiration, for improved cutting of resistant biological tissue.

The present disclosure provides an ultrasonic vibration propagation assembly, and an ultrasonic hemostasis and cutting system, in order to solve the problem of poor cutting and hemostasis effects on biological tissues such as large blood vessels in the prior art.

The objective of the present invention may be achieved by the subject matters according to the independent claim.

In a first aspect, the present disclosure provides an ultrasonic vibration propagation assembly according to claim <NUM>.

Further, the vibration guide groove may be configured as a beveled groove, which advances spirally along an ultrasound axis, and pitch of which is uniform or non-uniform.

Further, the ratio of the pitch of the vibration guide groove to the wavelength of an ultrasonic vibration may be <NUM> ~ <NUM>.

Further, the beveled groove may be in the shape of a trapezoid, a semi-circle or a triangle.

Further, a plurality of beveled grooves may be provided.

Further, the beveled grooves may be arranged on the ultrasonic scalpel bit at equal intervals.

Further, the ultrasonic scalpel tip may be a gradually-varying width in addition to being laterally bent at the pointed end thereof.

Further, the gradually-varying width may be a trapezoidal gradually-varying width. Further, the support structure of the ultrasonic vibration propagation assembly may further comprise an outer sleeve, an inner sleeve and a lubrication cylinder, wherein the ultrasonic scalpel bit is located inside the lubrication cylinder.

Further, the lubrication cylinder may be a polytetrafluoroethylene casing.

In a second aspect, the present disclosure further provides an ultrasonic hemostasis and cutting system according to claim <NUM>.

Further, the ultrasonic hemostasis and cutting system may further comprise a host, a handle, an ultrasonic transducer and a foot switch or a button, wherein the handle comprises a clamping switch, the ultrasonic scalpel bit of the ultrasonic vibration propagation assembly is removably connected to the ultrasonic transducer via a connection portion at a rear end of the ultrasonic scalpel bit, and the host is electrically connected to the ultrasonic transducer via a cable.

In the present disclosure, by designing the bit of the ultrasonic hemostasis and cutting system in a bent shape and converting a longitudinal ultrasonic vibration into a longitudinal-torsional composite vibration, on the one hand, the dependence of the temperature uniformity inside the tissue on the vibration direction is reduced, and the effective length of the vibration friction is increased; and on the other hand, when the ultrasonic scalpel bit in the bent shape is subjected to a torsional vibration, the clamping pressures of the clamping arm are different at positions with different distances from the scalpel tip. The clamping pressure is greatly reduced in an area near the scalpel tip, whereas the pressure is reduced less in an area remote from the scalpel tip. Therefore, the temperature uniformity inside the tissue being cut or coagulated is improved, thereby improving the efficiency and safety of cutting and hemostasis.

In the present disclosure, the frictional heat generation effect between the vibration guide groove and the lubrication cylinder is further reduced by providing the vibration guide groove at the rear end of the ultrasonic scalpel tip. In addition, the assembly process is simplified by designing a polytetrafluoroethylene casing in the support structure of the ultrasonic vibration propagation assembly, thereby reducing assembly time.

In the present disclosure, the mass distribution law of the ultrasonic scalpel tip along a vibration axis is changed by making the ultrasonic scalpel bit have a gradually-varying width, such that the amplitude and pressure distribution characteristics of the ultrasonic scalpel tip along the vibration axis are improved, further improving the temperature uniformity of the ultrasonic scalpel tip during coagulation or cutting of the biological tissue, thereby improving the hemostasis effect.

In the following embodiments, the detailed description and the drawings illustrate in conjunction how the disclosed embodiments are implemented. It is to be understood that other embodiments are feasible, and the embodiments may be modified structurally or logically without departing from the scope of the appended claims.

An ultrasonic scalpel bit <NUM> is shown, the structure of which is as shown in <FIG>, <FIG>, comprising an ultrasonic scalpel tip <NUM>, a waveguide <NUM>, a connection portion <NUM> and vibration node bosses <NUM>, wherein the ultrasonic scalpel tip <NUM> is arranged in front of the waveguide <NUM>, the connection portion <NUM> is arranged behind the waveguide <NUM>, the vibration node bosses <NUM> are arranged on the waveguide <NUM>, the ultrasonic scalpel tip <NUM> is laterally bent at a pointed end thereof, and a vibration guide groove <NUM> is provided on the waveguide <NUM>. Among the above components, the ultrasonic scalpel tip <NUM> is used to perform cutting and hemostasis operations on a biological tissue <NUM>; the vibration guide groove <NUM> is used to convert a longitudinal vibration of an ultrasonic transducer into a longitudinal-torsional composite vibration; the connection portion <NUM> is used to connect the ultrasonic scalpel bit to the ultrasonic transducer to achieve continuous propagation of ultrasonic vibration, which is convenient for a surgeon to perform cleaning and disinfection operations, and the connection portion <NUM> may be connection threads; the vibration node bosses <NUM> are used to support the ultrasonic scalpel bit <NUM> and reduce the friction between the ultrasonic scalpel bit <NUM> and the support structure during vibration, and the number of vibration node bosses is not limited; and the waveguide <NUM> is used to propagate the ultrasonic vibration. The vibration guide groove <NUM> may be provided between two vibration node bosses <NUM> of the waveguide <NUM>, or may be provided at another location on the waveguide <NUM>.

Further, as shown in <FIG>, the ultrasonic vibration guide groove <NUM> is configured as beveled groove which advances spirally along an ultrasound axis, and the shape of the beveled groove may be a trapezoid, a semi-circle or a triangle, as shown in <FIG>. Pitch may be uniform or non-uniform. Preferably, the ratio of the pitch of the guide groove to the wavelength of the ultrasonic vibration is <NUM> ~ <NUM>. The number of the guide grooves is at least one. Preferably, the guide grooves are arranged at equal intervals in a circumferential direction of the ultrasonic scalpel bit.

Further, as shown in <FIG> and <FIG>, an ultrasonic vibration propagation assembly is further disclosed in this embodiment, which comprises an ultrasonic scalpel bit <NUM>, a support structure and a clamping arm <NUM>. The clamping arm <NUM> is located at a front end of the support structure. The support structure comprises an outer sleeve <NUM>, an inner sleeve <NUM>, and a lubrication cylinder <NUM>. A rear end of the ultrasonic scalpel bit <NUM> is located inside the lubrication cylinder <NUM>. The inner sleeve <NUM> and the outer sleeve <NUM> are sheathed outside the lubrication cylinder <NUM>. The vibration node bosses <NUM> can form a support for the ultrasonic scalpel bit together with the lubrication cylinder <NUM>, the inner sleeve <NUM> and the outer sleeve <NUM>, and can also reduce the heat generation caused by the friction between the ultrasonic scalpel bit and the support member during vibration. In addition, the lubrication cylinder <NUM> may also be made of a low-friction-coefficient material such as a polytetrafluoroethylene casing, to further reduce the friction. At the same time, the use of a polytetrafluoroethylene casing can simplify the assembly process and reduce the time taken for assembly compared to the prior art in which each vibration node boss <NUM> is provided with a collar.

In addition, as shown in <FIG>, this embodiment further comprises an ultrasonic hemostasis and cutting system, comprising a host <NUM>, an ultrasonic vibration propagation assembly <NUM>, a handle <NUM>, an ultrasonic transducer <NUM>, and a foot switch or a button <NUM>, wherein the handle <NUM> comprises a clamping switch <NUM>, the host <NUM> is connected to the ultrasonic transducer <NUM> via a cable <NUM>, and the ultrasonic scalpel bit <NUM> of the ultrasonic vibration propagation assembly <NUM> is removably connected to the ultrasonic transducer <NUM> via a connection portion <NUM> at a rear end of the ultrasonic scalpel bit. The ultrasonic transducer <NUM> is used to convert a high-voltage electrical signal into an ultrasound vibration to drive the ultrasonic scalpel bit to operate. The host <NUM> is used to detect the access of the ultrasonic handle, control and adjust an ultrasonic driving signal so that the ultrasonic system can operate at the optimal resonance frequency, and also identify and detect the vibration state of the handle, such as identifying current, voltage and phase parameters of the ultrasonic driving signal, and detecting whether the driving signal is over-current, open-circuit or short-circuit. The host <NUM> can enable a user to perform the starting, stopping and other operations by means of the foot switch or the button <NUM>, to control the output and stop of ultrasound, and can also achieve the functions such as the setting of the output power of the ultrasonic hemostatic scalpel, fault diagnosis and warning by means of a user's operation interface. The surgeon manipulates the clamping switch <NUM>, driving the clamping arm <NUM> of the ultrasonic vibration propagation assembly <NUM> to rotate via the outer sleeve <NUM> and the inner sleeve <NUM>. The clamping arm <NUM> and the ultrasonic scalpel tip <NUM> together perform the clamping operation on the biological tissue <NUM>, as shown in <FIG>.

In this embodiment, by providing the vibration guide groove <NUM> on the ultrasonic scalpel bit <NUM>, the longitudinal vibration of the ultrasonic transducer can be converted into the longitudinal-torsional composite vibration, so that the ultrasonic scalpel bit is longitudinally vibrated and twisted at the same time, to form a composite vibration, as shown in <FIG>. At the same time, since the ultrasonic scalpel tip <NUM> is laterally bent at the pointed end portion thereof, the size of the gap between the ultrasonic scalpel tip <NUM> and the clamping arm <NUM> varies periodically with the change of the vibration and torsion when the bent ultrasonic scalpel tip in this embodiment is used to cooperate with the longitudinal-torsional composite vibration. When the torsional vibration reaches the maximum displacement, the gap between the ultrasonic scalpel tip <NUM> and the clamping arm <NUM> is the largest, as shown in <FIG>, at which time the clamping pressure of the ultrasonic scalpel tip <NUM> and the clamping arm <NUM> on the biological tissue is minimized, and the difference in the clamping strength between the scalpel tip portion and the other portions of the bit is reduced compared to the prior art ultrasonic scalpel which uses a straight bit and does not generate a torsional vibration. As a result, the difference in the amount of the generated heat is reduced, and the temperature inside the tissue being cut or coagulated is more uniform, which is conducive to closing the biological tissue such as a large blood vessel.

As shown in <FIG>, different from Embodiment <NUM> in which the vibration guide groove is provided on the waveguide <NUM>, in this embodiment, the ultrasound guide groove <NUM> of the ultrasonic scalpel bit <NUM> is provided on the ultrasonic scalpel tip <NUM>, and is located at a rear end of the ultrasonic scalpel tip <NUM>. The frictional heat generation effect between the vibration guide groove <NUM> and the lubrication cylinder <NUM> can be further reduced by means of the above arrangement.

This embodiment further defines the shape of the ultrasonic scalpel tip <NUM> of the ultrasonic scalpel bit <NUM> on the basis of Embodiment <NUM> or <NUM>. That is, the ultrasonic scalpel tip <NUM> comprises a gradually-varying width in addition to being laterally bent at the pointed end thereof. For example, the gradually-varying width may be a trapezoidal gradually-varying width, a top view of which is as shown in <FIG> in which the front end of the ultrasonic scalpel tip <NUM> has a width larger than that of the rear end thereof, and a side view of which is as shown in <FIG>. With the above design, the mass distribution law of the ultrasonic scalpel tip <NUM> along a vibration axis can be changed, such that the amplitude and pressure distribution characteristics of the ultrasonic scalpel tip <NUM> along the vibration axis are improved, further improving the temperature uniformity of the ultrasonic scalpel tip <NUM> during coagulation or cutting of the biological tissue <NUM>, thereby improving the hemostasis effect.

Claim 1:
An ultrasonic vibration propagation assembly (<NUM>), comprising:
a support structure;
a clamping arm (<NUM>) located at a front end of the support structure; and
an ultrasonic scalpel bit (<NUM>), a portion of the ultrasonic scalpel bit (<NUM>) being located in the support structure, the ultrasonic scalpel bit (<NUM>) comprising an ultrasonic scalpel tip (<NUM>) for performing operations on biological tissue and configured to perform a clamping operation together with the clamping arm (<NUM>), a connection portion (<NUM>), and a waveguide (<NUM>), wherein the ultrasonic scalpel tip (<NUM>) is arranged in front of the waveguide (<NUM>), and the connection portion (<NUM>) is arranged behind the waveguide (<NUM>),
characterized in that the ultrasonic scalpel bit further comprises vibration node bosses (<NUM>), wherein the vibration node bosses (<NUM>) are arranged on the waveguide (<NUM>), wherein the ultrasonic scalpel tip (<NUM>) is laterally bent at a pointed end thereof with respect to the clamping arm, and wherein a vibration guide groove (<NUM>) is further provided on the ultrasonic scalpel bit (<NUM>), and
wherein the vibration guide groove (<NUM>) is located on the ultrasonic scalpel tip (<NUM>), at a rear end of the ultrasonic scalpel tip (<NUM>), or the vibration guide groove is provided on the waveguide (<NUM>) and is located between two vibration node bosses (<NUM>).