Cervical cone radiofrequency ultrasonic knife with dual energy of radiofrequency and ultrasound

Abstract

This invention provides a cervical conical radiofrequency ultrasonic scalpel with dual radiofrequency and ultrasound energy, belonging to the field of medical device technology. The cervical conical radiofrequency ultrasonic scalpel includes a shaft comprising a continuously arranged straight section, a first arc-shaped bending section, a second arc-shaped bending section, and an inclined cutting head. The end of the straight section away from the first arc-shaped bending section is detachably connected to a transducer. The first arc-shaped bending section is curved away from the axis of the straight section, and the second arc-shaped bending section is curved towards the axis of the straight section. The tangent at the second end of the first arc-shaped bending section connected to the second arc-shaped bending section is collinear with the tangent at the third end of the second arc-shaped bending section connected to the first arc-shaped bending section. Through this method, the radiofrequency ultrasonic scalpel provided by this invention can integrate both radiofrequency and ultrasound energy and be applied to cervical conization, simplifying the surgical procedure and effectively reducing thermal damage to tissues while ensuring cutting efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a cervical conical radiofrequency ultrasonic scalpel equipped with both radiofrequency and ultrasonic energy. Background Technology

[0002] Cervical conization is a gynecological surgery performed to remove diseased tissue from the cervix. A portion of the cervical tissue is cut out in a cone shape using a scalpel. This tissue can be used for pathological examination and to remove diseased tissue, making it important for the diagnosis and treatment of cervical diseases.

[0003] During cervical conization, there are requirements for the angle of conization and the size of the cut tissue. If conventional surgical instruments are used, not only is the surgical procedure more complicated, but it is also easy to cause thermal damage to the cervical tissue. Summary of the Invention

[0004] In view of the technical problems existing in the background art, the present invention provides a cervical conical radiofrequency ultrasonic scalpel with dual radiofrequency and ultrasonic energy, which can integrate radiofrequency and ultrasonic energy. Using it for cervical conization can simplify the surgical procedure and effectively reduce thermal damage to tissues while ensuring cutting efficiency.

[0005] This invention provides a cervical conical radiofrequency ultrasonic scalpel with dual radiofrequency and ultrasonic energy. The cervical conical radiofrequency ultrasonic scalpel includes a shaft comprising a straight section, a first arc-shaped bending section, a second arc-shaped bending section, and an inclined blade head, all continuously arranged. The end of the straight section away from the first arc-shaped bending section is detachably connected to a transducer. The first arc-shaped bending section bends in an arc away from the axis of the straight section, and the second arc-shaped bending section bends in an arc close to the axis of the straight section. The tangent of the second end of the first arc-shaped bending section connected to the second arc-shaped bending section is collinear with the tangent of the third end of the second arc-shaped bending section connected to the first arc-shaped bending section. This collinear arrangement helps reduce vibration energy loss and efficiently transmits vibration energy to the inclined blade head. Thus, when applied to cervical conization surgery, the operator can rotate it around the central axis of the straight section to cut the cervical conization sample through the tilted blade. In other words, the cervical conization radiofrequency ultrasonic scalpel of this application can simplify the operation process of traditional cervical conization surgery while ensuring the normal operation of the dual energy of the radiofrequency ultrasonic scalpel.

[0006] In some embodiments, the tangent at the first end of the first arc-shaped bend connecting to the straight section forms a first angle with the axis of the straight section, and the tangent at the fourth end of the second arc-shaped bend connecting to the inclined blade forms a second angle with the tangent at the first end. The ratio of the first angle to the second angle is 0.27 to 0.37. The angle range of each arc-shaped bend should ensure that the cut tissue block meets the ratio of a conical base width of 2-3 cm and a conical height of approximately 2.5 cm. Preferably, the ratio of the first angle to the second angle is 0.275 to 0.35. This invention, by setting the first arc-shaped bending segment at an angle relative to the straight segment and the second arc-shaped bending segment at an angle relative to the first arc-shaped bending segment, and by specifically defining the ratio of the corresponding first and second included angles, allows for more flexible adjustment of the inherent characteristics of the rod body while ensuring that the tilting direction of the tilting head meets the requirements. This enables radio frequency or ultrasonic waves to propagate more efficiently within the rod body, thereby improving the cutting efficiency of the radio frequency ultrasonic scalpel and reducing thermal damage to tissues.

[0007] In some embodiments, the first included angle is 33° to 42°, and / or the second included angle is 115° to 122°. By further optimizing the first and second included angles, the present invention can set the initial bending angle of the first arc-shaped bend segment and the angle between the extension direction of the inclined blade and the extension direction of the straight segment to an angle that satisfies the conization angle requirements and is conducive to improving cutting efficiency and reducing thermal damage. The operator can rotate the ultrasonic scalpel around the central axis of the straight segment to obtain a cervical conization sample that meets the angle requirements through the inclined blade. The operation is convenient and can reduce thermal damage to tissue while improving cutting efficiency. Simultaneously, the dual energy of radiofrequency and ultrasound facilitates hemostasis during cutting, further simplifying hemostasis procedures in cervical conization surgery.

[0008] In some embodiments, the arc length of the first arc-shaped bend is A, the length of the straight segment is B, 0.4 ≤ A / B ≤ 0.45, and the arc length of the second arc-shaped bend is C, 0.45 ≤ C / A ≤ 0.5. This facilitates efficient hemostasis using both radiofrequency and ultrasonic energy. The arc length is calculated as a percentage, i.e., the arc length of the first arc-shaped bend accounts for 40% to 45% of the length of the straight segment, and the arc length of the second arc-shaped bend accounts for 45% to 50% of the arc length of the first arc-shaped bend. Here, arc length refers to the arc length along the central axis, and the length of the straight segment is the length of the central axis of the straight segment.

[0009] In some embodiments, the extension direction of the tilting blade is the same as the tangential direction of the fourth end. This facilitates cutting and hemostasis performed by the working end using both radio frequency and ultrasonic energy.

[0010] In some embodiments, a mounting portion is provided at the end of the straight section away from the first arc-shaped bend section. The mounting portion is provided with a transducer interface, and an interface threaded hole is provided inside the transducer interface. The transducer is detachably connected to the interface threaded hole.

[0011] In some embodiments, the cervical conical radiofrequency ultrasound scalpel also includes a handle, which is connected to the mounting portion.

[0012] In some embodiments, the mounting part is provided with a tool pin hole for mounting the tool pin, and the rod body is connected to the handle through the tool pin.

[0013] The beneficial effects of this invention are:

[0014] The cervical conical radiofrequency ultrasonic scalpel provided by this invention, which incorporates both radiofrequency and ultrasonic energy, is designed with a rod consisting of a straight section, a first arc-shaped bending section, a second arc-shaped bending section, and an inclined cutting head. The end of the straight section furthest from the first arc-shaped bending section is detachably connected to the transducer. The first arc-shaped bending section bends in an arc away from the axis of the straight section, while the second arc-shaped bending section bends in an arc closer to the axis of the straight section. The inclined cutting head is tilted relative to the straight section. This design enables the synergistic output of radiofrequency and ultrasonic energy without the need for additional instrument switching. Combined with the bending structure of the rod (adapted to the physiological curvature of the cervix), this significantly simplifies the surgical procedure, shortens the surgical time, and effectively reduces thermal damage to tissues while ensuring cutting efficiency, thus improving the safety and efficiency of conization.

[0015] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, and in order to make the above and other objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention are described below. Attached Figure Description

[0016] To more clearly illustrate the technical solution of the present invention, the accompanying drawings used in the present invention will be briefly described below. Obviously, the drawings described below are merely some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without any creative effort.

[0017] Figure 1 This is a schematic diagram of the rod body in a cervical conical radiofrequency ultrasonic scalpel equipped with both radiofrequency and ultrasonic energy, provided as an embodiment of the present invention.

[0018] Figure 2 A cross-sectional structural diagram of the transducer interface in a cervical conical radiofrequency ultrasonic scalpel with dual radiofrequency and ultrasonic energy provided in an embodiment of the present invention;

[0019] Figure 3This is a schematic diagram illustrating the working principle of a cervical conical radiofrequency ultrasonic scalpel equipped with both radiofrequency and ultrasonic energy, as provided in an embodiment of the present invention.

[0020] Figure 4 This is a schematic diagram of the cross-section of the tapered cut;

[0021] Explanation of reference numerals in the attached diagram: 1. Transducer interface; 101. Interface threaded hole; 2. Tool pin hole; 3. Straight section; 4. First arc-shaped bend section; 5. Second arc-shaped bend section; 6. Inclined tool head. Detailed Implementation

[0022] The embodiments of the technical solution of the present invention will now be described in detail with reference to the accompanying drawings. These embodiments are merely illustrative of the technical solution of the present invention and are therefore intended to limit the scope of protection of the present invention.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains; the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention; the terms “comprising” and “having”, and any variations thereof, in the specification, claims, and foregoing description of the invention, are intended to cover non-exclusive inclusion.

[0024] In the description of the embodiments of this invention, technical terms such as "first" and "second" are used only to distinguish different objects and should not be construed as indicating or implying relative importance or implicitly specifying the number, specific order, or primary and secondary relationship of the indicated technical features. In the description of the embodiments of this invention, "multiple" means two or more, unless otherwise explicitly defined.

[0025] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of the invention. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0026] In the description of the embodiments of this invention, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship.

[0027] In the description of the embodiments of the present invention, the technical terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of the present invention.

[0028] In the description of the embodiments of the present invention, unless otherwise explicitly specified and limited, the technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of the present invention according to the specific circumstances.

[0029] To address the technical problem of significant thermal damage to tissue caused by existing cervical radiofrequency conization knives, this invention provides a cervical conical radiofrequency ultrasonic knive with dual radiofrequency and ultrasonic energy. On one hand, this cervical conical radiofrequency ultrasonic knive is applicable to cervical conization, filling the gap in the application of existing radiofrequency ultrasonic knives to cervical conization, and facilitating simultaneous cutting and hemostasis during the procedure. On the other hand, this invention improves the shaft, enabling it to maintain high cutting efficiency while effectively reducing thermal damage to tissue under the integrated radiofrequency and ultrasonic energy. The following examples illustrate the cervical conical radiofrequency ultrasonic knive with dual radiofrequency and ultrasonic energy provided by this invention.

[0030] This invention provides a cervical conical radiofrequency ultrasound scalpel with dual radiofrequency and ultrasound energy, including a rod body. A schematic diagram of the rod body is shown below. Figure 1 As shown, the rod body includes a continuously arranged straight section 3, a first arc-shaped bend section 4, a second arc-shaped bend section 5, and an inclined blade head 6. The end of the straight section 3 away from the first arc-shaped bend section 4 is detachably connected to the transducer. The inclined blade head 6 is inclined relative to the straight section 3 and is used for conical cutting of the cervix. The first arc-shaped bend section 4 bends in an arc away from the axis of the straight section 3, and the second arc-shaped bend section 5 bends in an arc close to the axis of the straight section 3.

[0031] The first arc-shaped bending segment 4 includes a first end connected to the straight segment 3 and a second end connected to the second arc-shaped bending segment 5. The second arc-shaped bending segment 5 includes a third end connected to the first arc-shaped bending segment 4 and a fourth end connected to the inclined cutter head 6. The tangent of the second end is collinear with the tangent of the third end.

[0032] In this way, the transducer can receive both radio frequency (RF) and ultrasonic energy and transmit it to the rod. The ultrasonic energy causes the rod to vibrate mechanically, while the RF energy is transmitted through the rod to the tilting blade head 6. Thus, the surgical function is achieved using both RF and ultrasonic energy, allowing for simultaneous cutting and hemostasis during the procedure, thereby improving surgical efficiency. Furthermore, addressing the impact of RF and ultrasonic energy on the rod, this invention simplifies the cervical conization procedure by configuring the rod as a continuous straight section 3, a first arc-shaped bend section 4, a second arc-shaped bend section 5, and a tilting blade head 6, with the tilting blade head 6 tilted relative to the straight section 3. Specifically, by setting the angle between the extension direction of the tilting blade head 6 and the extension direction of the straight section 3 to meet the required conization angle, the operator can rotate the ultrasonic scalpel around the central axis of the straight section to cut the cervical conization sample with the required angle using the tilting blade head 6, making the operation more convenient. Simultaneously, the dual energy of RF and ultrasound facilitates efficient hemostasis during cutting, further simplifying the hemostasis process in cervical conization.

[0033] It should be noted that, in order to enable the ultrasonic and radio frequency signals to propagate efficiently within the rod, this invention also adjusts the natural frequency of the rod by designing its shape. If only the second arc-shaped bend 5 is set to ensure the tilt direction of the inclined blade 6 meets the requirements for the conical cutting angle, the shape of the rod will be significantly limited, making it difficult for the rod's natural frequency to meet the requirements for efficient transmission of radio frequency and ultrasonic signals. Therefore, this invention sets a first arc-shaped bend 4 that is neither parallel to the second arc-shaped bend 5 nor parallel to the straight section 3, and sets both bends to arc shapes. Simultaneously, the bending directions of the first arc-shaped bend 4 and the second arc-shaped bend 5 form an extension trend of first moving away and then moving closer, and the tangents of the second and third ends are collinear. Combined with the tilt setting of the inclined blade 6, this allows for more effective adjustment of the rod's natural frequency while ensuring that the cervical conization sample meets the angle requirements. This enables more efficient propagation of radio frequency energy and ultrasonic vibration within the rod, thereby improving the cutting efficiency of the radio frequency ultrasonic scalpel and reducing thermal damage to tissues.

[0034] Furthermore, in some embodiments, the tangent at the first end forms a first angle with the axis of the straight segment 3, and the tangent at the fourth end forms a second angle with the tangent at the first end, with the ratio of the first angle to the second angle being 0.27 to 0.37. By specifically defining the ratio of the first angle to the second angle, this embodiment of the invention allows for more flexible adjustment of the inherent characteristics of the rod body by utilizing a specific angle ratio between the two arc-shaped bending segments, while ensuring that the tilting direction of the tilting head 6 meets the requirements. This enables more efficient propagation of radio frequency or ultrasound within the rod body, thereby improving the cutting efficiency of the radio frequency ultrasonic scalpel and reducing thermal damage to tissues.

[0035] Furthermore, in some embodiments, the ratio of the first included angle to the second included angle is 0.275 to 0.35. By optimizing the ratio of the first included angle to the second included angle, the present invention can further adjust the inherent frequency of the rod, enabling the rod to transmit radio frequency and ultrasound signals more efficiently, thereby improving the cutting efficiency of the cervical conical radiofrequency ultrasound scalpel and reducing its thermal damage to tissues. Specifically, the ratio of the first included angle to the second included angle can be 0.275, 0.28, 0.29, 0.30, 0.31, 0.32, 0.33, 0.34, 0.35, or any value within the range of 0.275 to 0.35.

[0036] Further, in some embodiments, the first included angle is 33° to 42°, and / or the second included angle is 115° to 122°. While adjusting the ratio of the first included angle to the second included angle, the present invention further optimizes the specific angles of the first and second included angles, which is more conducive to improving the cutting efficiency of the cervical conical radiofrequency ultrasonic scalpel and reducing its thermal damage to tissues compared to other angles. Specifically, the first included angle between the tangent of the first end and the axis of the straight segment 3 can be any value within the range of 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, or 33° to 42°; the second included angle between the tangent of the fourth end and the tangent of the first end can be any value within the range of 115°, 116°, 117°, 118°, 119°, 120°, 121°, 122°, or 115° to 122°, and more preferably 120° to 122°.

[0037] Further, in some embodiments, the arc length of the first arc-shaped bending segment 4 is A, and the length of the straight segment 3 is B, wherein A and B have the same unit, and 0.4 ≤ A / B ≤ 0.45. In percentage terms, the arc length of the first arc-shaped bending segment 4 accounts for 40% to 45% of the length of the straight segment 3. This invention, by optimizing the length ratio between the first arc-shaped bending segment 4 and the straight segment 3, and combining this with the angle between the first end of the first arc-shaped bending segment 4 and the axis of the straight segment 3, can limit the bending of the first arc-shaped bending segment 4, thereby forming an arc segment bent at a specific angle and length. This facilitates tapered cutting while also improving cutting efficiency and reducing thermal damage. Specifically, A / B can be 0.4, 0.41, 0.42, 0.43, 0.44, 0.45, or any value within the range of 0.4 to 0.45.

[0038] Further, in some embodiments, the arc length of the second arc-shaped bending segment 5 is C, where A and C have the same unit, and 0.45 ≤ C / A ≤ 0.5. In percentage terms, the arc length of the second arc-shaped bending segment 5 accounts for 45% to 50% of the arc length of the first arc-shaped bending segment 4. By optimizing the arc length ratio of the second arc-shaped bending segment 5 to the first arc-shaped bending segment 4, and by combining this with the angle between the tangents at both ends of the second arc-shaped bending segment 5 and the two ends of the first arc-shaped bending segment, the bending of the second arc-shaped bending segment 5 can be defined, causing it to bend at a specific angle and length for tapered cutting, thereby improving cutting efficiency and reducing thermal damage. Specifically, C / A can be 0.45, 0.46, 0.47, 0.48, 0.49, 0.5, or any value within the range of 0.45 to 0.5, and more preferably 0.46 to 0.48.

[0039] Furthermore, in some embodiments, the extension direction of the tilting cutter head 6 is the same as the tangential direction of the fourth end. This configuration allows for a smooth connection between the tilting cutter head 6 and the fourth end of the second arc-shaped bend 5, while maintaining the same angle between the tangent of the tilting cutter head 6 and the first end as the angle between the tangent of the fourth end and the tangent of the first end. This allows for control of the angle of the tilting cutter head 6, facilitating cutting and hemostasis at the working ends of both radio frequency and ultrasonic energy sources, improving cutting efficiency, and reducing thermal damage.

[0040] It should be noted that the cervical conical radiofrequency ultrasonic scalpel with dual radiofrequency and ultrasound energy provided by this invention mainly focuses on improving the structure of the rod. This invention designs the rod as a continuous straight section 3, a first arc-shaped bend 4, a second arc-shaped bend 5, and an inclined blade head 6. Furthermore, it optimizes the shape, arc length, and angle of the first and second arc-shaped bend sections 4 and 5. This not only ensures that the cut tissue blocks meet the requirements of a conical base width of approximately 2-3 cm and a conical height of approximately 2.5 cm, thus fulfilling the surgical requirements of cervical conization, but also facilitates the adjustment of the rod's inherent frequency. This allows the cervical conical radiofrequency ultrasonic scalpel to stably and efficiently transmit the received radiofrequency and ultrasound energy to the rod, enabling the rod to undergo stable mechanical vibration at the set ultrasound vibration frequency. Simultaneously, it transmits radiofrequency electrical energy to the inclined blade head 6, preventing rod breakage while maintaining high cutting efficiency and low thermal damage during use. Other structures such as the transducer and handle, and their connection methods, can be configured as needed, and this invention is not limited to these.

[0041] For example, such as Figure 2 As shown, in some embodiments, a mounting portion is provided at the end of the straight section 3 away from the first arc-shaped bend section 4. The mounting portion is provided with a transducer interface 1, and an interface threaded hole 101 is provided in the transducer interface 1. The transducer is detachably connected to the interface threaded hole 101. The transducer is also connected to a radio frequency ultrasound system for receiving both radio frequency and ultrasonic energy. The radio frequency ultrasound system includes an ultrasonic frequency generator and a radio frequency generator connected to the transducer, and its output modes can include ultrasonic mode, radio frequency mode, and radio frequency ultrasound mode to meet different needs. The present invention is not limited thereto.

[0042] In some embodiments, the cervical conical radiofrequency ultrasonic scalpel also includes a handle, which is connected to the mounting part. More specifically, the mounting part is provided with a scalpel pin hole 2 for mounting the scalpel pin, and the handle is provided with a handle pin hole for mounting the scalpel pin. By connecting both ends of the scalpel pin to the scalpel pin hole 2 and the handle pin hole respectively, the scalpel body can be connected to the handle via the scalpel pin. The specific structure of the handle can be selected as needed, and the present invention is not limited thereto.

[0043] Based on the cervical conical radiofrequency ultrasonic scalpel provided by this invention, which incorporates both radio frequency and ultrasound energy, the transducer receives both ultrasound and radio frequency energy and transmits it to the tilting blade head 6 via a rod. By holding the handle and rotating the rod as a whole, the tilting blade head 6 performs a conical cut around its tip. This synergistic use of both radio frequency and ultrasound energy for conical cutting effectively reduces thermal damage to tissue while ensuring high cutting efficiency. For example, as... Figure 3As shown, in some embodiments of the present invention, the rod is made of titanium alloy. Ultrasonic energy enables the rod to vibrate mechanically with an amplitude of 55.5 kHz. Radio frequency energy is transmitted to the tilting cutter head 6 through the titanium alloy rod. By setting an electrode plate at the surgical site and connecting the electrode plate to the radio frequency ultrasound system, a loop of tilting cutter head 6-surgical site-electrode plate is formed, thereby applying both radio frequency and ultrasonic energy to the surgery so as to simultaneously perform cutting and hemostasis, and reduce thermal damage to tissues while ensuring high cutting efficiency.

[0044] To examine the degree of thermal damage to tissue caused by the cervical conical radiofrequency ultrasonic scalpel with dual radiofrequency and ultrasound energy provided by this invention, and to study the influence of different rod structures on the degree of thermal damage, this invention sets up a series of embodiments and comparative examples by changing the structure of the rod, and tests the cutting time and thermal damage under the same detection conditions.

[0045] The testing method used in this invention is as follows: Fresh, isolated porcine cervical tissue is selected as the test material. The target tissue, thoroughly soaked in physiological saline, is immediately retrieved and subjected to a cervical conical radiofrequency ultrasonic scalpel. In radiofrequency ultrasound mode, the tissue is conically dissected at the same output level (ultrasound output frequency of 55.5 kHz, radiofrequency output power of 30 W) each time. The time required for the dissection to be completed is recorded, and a schematic diagram of the cross-section of the resulting conical incision is shown below. Figure 4 As shown. After cutting, the test tissue was placed back into a water bath at a constant temperature of 37°C and immersed in physiological saline to cool and fully infiltrate for 1 minute. The depth of the slightly yellowish-white or white eschar at the cut was measured (i.e., Figure 4 The thickness of the yellow line corresponding to the thermal damage area is used as a characteristic parameter of thermal damage.

[0046] According to the above testing method, the embodiments and comparative examples using different rods were tested. The specific structure of the rods in each embodiment and comparative example and their test results are shown below.

[0047] Example 1

[0048] The rod used in this embodiment includes a continuously arranged straight section 3, a first arc-shaped bend section 4, a second arc-shaped bend section 5, and an inclined blade head 6. The straight section 3 has a mounting portion at the end furthest from the first arc-shaped bend section 4. The mounting portion has a transducer interface 1 and a blade pin hole. The transducer interface 1 has an interface threaded hole 101, allowing the transducer to be detachably connected to the interface threaded hole 101. The blade pin hole 2 is used to install a blade pin, and the rod can be connected to a handle via the blade pin. The inclined blade head 6 is inclined relative to the straight section 3 and is used for conization of the cervix. The first arc-shaped bend section 4 is inclined relative to the straight section 3, and the second arc-shaped bend section 5 is inclined relative to the first arc-shaped bend section 4. The first arc-shaped bend section 4 includes a first end connected to the straight section 3 and a second end connected to the second arc-shaped bend section 5. The second arc-shaped bend section 5 includes a third end connected to the first arc-shaped bend section 4 and a fourth end connected to the inclined blade head 6.

[0049] In this embodiment, both the first arc-shaped bending segment 4 and the second arc-shaped bending segment 5 are arc-shaped. The first arc-shaped bending segment 4 bends away from the axis of the straight segment 3, and the second arc-shaped bending segment 5 bends towards the axis of the straight segment 3. The tangent at the second end is collinear with the tangent at the third end. The first angle between the tangent at the first end and the axis of the straight segment 3 is 37°, and the second angle between the tangent at the fourth end and the tangent at the first end is 120°. The ratio of the first angle to the second angle is approximately 0.308. The ratio (A / B) of the arc length A of the first arc-shaped bending segment 4 to the length B of the straight segment 3 is 0.48. The ratio (C / A) of the arc length C of the second arc-shaped bending segment 5 to the arc length A of the first arc-shaped bending segment 4 is 0.53. The extension direction of the tilting cutter head 6 is the same as the tangent direction at the fourth end.

[0050] The rod body provided in this embodiment is connected to the transducer and the handle to assemble a cervical conical radiofrequency ultrasonic scalpel with dual radiofrequency and ultrasonic energy. The transducer is connected to the radiofrequency ultrasound system and tested according to the above test method. The cutting time is measured to be 1.2s and the thermal damage characteristic parameter is 1.06mm, indicating that it has high cutting efficiency and low thermal damage.

[0051] Example 2

[0052] This embodiment provides a rod body, which differs from Embodiment 1 only in that the arc lengths of the first arc-shaped bend segment 4 and the second arc-shaped bend segment 5 are changed. In this embodiment, the ratio (A / B) of the arc length A of the first arc-shaped bend segment 4 to the length B of the straight segment 3 is 0.42, and the ratio (C / A) of the arc length C of the second arc-shaped bend segment 5 to the arc length A of the first arc-shaped bend segment 4 is 0.465. The remaining structure and parameters are the same as in Embodiment 1, and will not be described again here.

[0053] The rod provided in this embodiment was used to replace the rod in embodiment 1 for testing. The cutting time was measured to be 0.7s and the thermal damage characteristic parameter was 0.68mm. Compared with embodiment 1, the cutting time and thermal damage characteristic parameter were further reduced, showing higher cutting efficiency and lower thermal damage.

[0054] Comparative Examples 1 to 4

[0055] Comparative Examples 1 to 4 each provide a rod body, which differs from the rod body provided in Example 2 only in that the rod body structure has been changed.

[0056] Specifically, the rod in Comparative Example 1 only includes the straight section 3, the first arc-shaped bending section 4, and the inclined cutter head 6 as in Example 2, and does not contain the second arc-shaped bending section 5. The inclined cutter head 6 is directly connected to the first arc-shaped bending section 4. The shape, size, and angle of the straight section 3, the first arc-shaped bending section 4, and the inclined cutter head 6 in Comparative Example 1 are consistent with those in Example 2, and will not be described again here.

[0057] The rod in Comparative Example 2 only includes the straight section 3, the second arc-shaped bend section 5, and the inclined cutter head 6 as in Example 2, and does not include the first arc-shaped bend section 4. The third end of the second arc-shaped bend section 5 is connected to the straight section 3. The shape, size, and angle of the straight section 3, the second arc-shaped bend section 5, and the inclined cutter head 6 in Comparative Example 2 are the same as those in Example 2, and will not be described again here.

[0058] In Comparative Example 3, the first arc-shaped bending segment 4 and the second arc-shaped bending segment 5 in Example 2 are both changed from arc-shaped bends to straight bends. The positions of the two ends of the two bending segments in Comparative Example 3, as well as the shape, size and angle of the straight segment 3 and the inclined cutter head 6, are the same as in Example 2, and will not be described again here.

[0059] In Comparative Example 4, the second arc-shaped bending segment 5 in Example 2 is changed to a straight segment parallel to the straight segment 3. The length of the modified second arc-shaped bending segment 5 is consistent with the arc length of the second arc-shaped bending segment 5 in Example 2. Furthermore, the shape, size, and angle of the straight segment 3, the first arc-shaped bending segment 4, and the inclined cutter head 6 in Comparative Example 4 are consistent with those in Example 2, and will not be described again here.

[0060] The rods provided in Comparative Examples 1 to 4 were used to replace the rods in Example 2 for testing, and the results are shown in Table 1.

[0061] Table 1 Test results of Comparative Examples 1 to 4

[0062]

[0063] Comparing the test results in Table 1 with those in Examples 1 and 2, it can be seen that the cutting time and thermal damage characteristic parameters of Comparative Examples 1 to 4 are significantly worse than those of Examples 1 and 2. This indicates that the rod shape designed in Examples 1 and 2 of this application is more conducive to reducing thermal damage while improving cutting efficiency compared to other rod shapes in Comparative Examples 1 to 4.

[0064] Examples 3 to 9 and Examples 1-1 to 1-5

[0065] Examples 3 to 9 and Examples 1-1 to 1-5 each provide a rod body. Compared with Example 2, the only difference is that the first included angle is changed, and the ratio of the first included angle to the second included angle is also changed accordingly. The rest of the structure and its parameters are the same as those of Example 2, and will not be described again here.

[0066] The rods provided in Examples 3 to 9 and Examples 1-1 to 1-5 were used to replace the rods in Example 2 for testing. The included angle data and test results in each example and comparative example are shown in Table 2.

[0067] Table 2. Angle data and test results for Examples 3 to 9 and Examples 1-1 to 1-5.

[0068]

[0069] As can be seen from Table 2, when the first included angle is in the range of 33° to 42°, the ratio of the first included angle to the second included angle is in the range of 0.275 to 0.35, the cutting time is less than 1.0s, and the thermal damage characteristic parameters are all less than 1.00mm. Compared with the data corresponding to the ratio range of other included angles, it effectively reduces thermal damage while maintaining high cutting efficiency.

[0070] Examples 10 to 13 and Examples 1-6 to 1-10

[0071] Examples 10 to 13 and Examples 1-6 to 1-10 each provide a rod body. Compared with Example 2, the only difference is that the second included angle is changed, and the ratio of the first included angle to the second included angle is also changed accordingly. The rest of the structure and its parameters are the same as those of Example 2, and will not be described again here.

[0072] The rods provided in Examples 10 to 13 and Examples 1-6 to 1-10 were used to replace the rods in Example 2 for testing. The included angle data and test results in each example and comparative example are shown in Table 3.

[0073] Table 3. Angle data and test results for Examples 10 to 13 and Examples 1-6 to 1-10.

[0074]

[0075] As shown in Table 3, when the second included angle is in the range of 100° to 128°, the ratio of the first included angle to the second included angle is in the range of 0.289 to 0.37, and the corresponding cutting time is less than 1.5s, and the thermal damage characteristic parameters are less than 2mm. Compared with the embodiments with the second included angle of 95° and 138°, the cutting efficiency is effectively improved. More preferably, when the second included angle is in the range of 115° to 122°, the cutting time is less than 1.0s, and the thermal damage characteristic parameters are less than 1.5mm. Compared with the data corresponding to other included angle ranges, the cutting efficiency is further improved while the thermal damage is effectively reduced.

[0076] The results in Table 2-3 show that when the ratio of the first included angle to the second included angle is within a similar range, further optimization of the specific angle values ​​of the first and second included angles can more effectively improve cutting efficiency and reduce thermal damage. Specifically, the first included angle is preferably 33° to 42°, and the second included angle is preferably 115° to 122°.

[0077] Examples 14 to 18 and Examples 1-11 to 1-13

[0078] Examples 14 to 18 and Examples 1-11 to 1-13 each provide a rod body. Compared with Example 2, the only difference is that the arc length A of the first arc-shaped bending segment 4 is changed. The ratio of the arc length of the first arc-shaped bending segment 4 to the length of the straight segment 3 is also changed accordingly. The rest of the structure and its parameters are the same as those of Example 2, and will not be described again here.

[0079] The rods provided in Examples 14 to 18 and Examples 1-11 to 1-13 were used to replace the rods in Example 2 for testing. The dimensional data and test results of each example and comparative example are shown in Table 4.

[0080] Table 4. Dimensional data and test results for Examples 14 to 18 and Examples 1-11 to 1-13

[0081]

[0082] As shown in Table 4, when the arc length of the first arc-shaped bending segment 4 is relatively short (A / B is 0.35~0.38), the cutting time is relatively long and the thermal damage is relatively large; when the arc length of the first arc-shaped bending segment 4 is relatively long (A / B is 0.5), the cutting time and thermal damage are also relatively large; when the ratio of the arc length of the first arc-shaped bending segment 4 to the length of the straight segment 3 is 0.4~0.45, the cutting time is less than 1.0s and the thermal damage characteristic parameters are less than 1.00mm. Compared with other embodiments, this method more effectively improves the cutting efficiency and reduces thermal damage.

[0083] Examples 19 to 24 and Examples 1-14 to 1-17

[0084] Examples 19 to 24 and Examples 1-14 to 1-17 each provide a rod body. Compared with Example 2, the only difference is that the arc length C of the second arc-shaped bending segment 5 is changed. The ratio of the arc length of the second arc-shaped bending segment 5 to the arc length of the first arc-shaped bending segment 4 is also changed accordingly. The rest of the structure and its parameters are the same as those of Example 2, and will not be described again here.

[0085] The rods provided in Examples 19 to 24 and Examples 1-14 to 1-17 were used to replace the rods in Example 2 for testing. The dimensional data and test results of each example and comparative example are shown in Table 5.

[0086] Table 5. Dimensional data and test results for Examples 19 to 24 and Examples 1-14 to 1-17

[0087]

[0088] As shown in Table 5, when the arc length of the second arc-shaped bending segment 5 is relatively short (C / A is 0.42~0.44), the cutting time is relatively long and the thermal damage is relatively large; when the arc length of the second arc-shaped bending segment 5 is relatively long (C / A is 0.51~0.55), the cutting time and thermal damage are also relatively large; when the ratio of the arc length of the second arc-shaped bending segment 5 to the arc length of the first arc-shaped bending segment 4 is 0.45~0.5, the cutting time is less than 1.0s and the thermal damage characteristic parameters are less than 1.00mm. Compared with the data corresponding to other ranges, the cutting efficiency is further improved and the thermal damage is further reduced.

[0089] In summary, the cervical conical radiofrequency ultrasonic scalpel provided by this invention, which incorporates both radiofrequency and ultrasonic energy, is designed with a continuous straight section 3, a first arc-shaped bending section 4, a second arc-shaped bending section 5, and an inclined blade head 6. Furthermore, the angle of the inclined blade head 6, as well as the shape, arc length, and angle of the first and second arc-shaped bending sections 4 and 5, are optimized. This facilitates the simplification of the cervical conization procedure while ensuring the efficient and stable propagation of ultrasonic vibration and radiofrequency energy within the section. Consequently, the cervical conical radiofrequency ultrasonic scalpel maintains high cutting efficiency and low thermal damage during use.

[0090] It should be noted that the present invention is not limited to the above-described embodiments. The above embodiments are merely examples, and any embodiments that have the same structure and perform the same effects as the technical concept within the scope of the present invention are included within the scope of the present invention. Furthermore, various modifications that can be conceived by those skilled in the art to the embodiments, and other ways of constructing by combining some of the constituent elements of the embodiments, without departing from the spirit of the present invention, are also included within the scope of the present invention.

Claims

1. A cervical conical radiofrequency ultrasonic scalpel equipped with both radiofrequency and ultrasonic energy, characterized in that, The cervical conical radiofrequency ultrasound knife includes: a rod body, the rod body including a continuously arranged straight section, a first arc-shaped bending section, a second arc-shaped bending section and an inclined blade head; The end of the straight section away from the first arc-shaped bend section is detachably connected to the transducer; The first arc-shaped bend is curved away from the axis of the straight section; The second arc-shaped bend bends in an arc direction toward the axis of the straight section; The tangent at the second end of the first arc-shaped bend segment that connects to the second arc-shaped bend segment is collinear with the tangent at the third end of the second arc-shaped bend segment that connects to the first arc-shaped bend segment; The tangent at the first end of the first arc-shaped bend that connects to the straight section forms a first angle with the axis of the straight section; The tangent at the fourth end of the second arc-shaped bend that connects to the inclined cutter head forms a second angle with the tangent at the first end; The ratio of the first included angle to the second included angle is 0.27 to 0.

37.

2. The cervical conical radiofrequency ultrasound scalpel with dual radiofrequency and ultrasound energy as described in claim 1, characterized in that, The ratio of the first included angle to the second included angle is 0.275 to 0.

35.

3. The cervical conical radiofrequency ultrasound scalpel with dual radiofrequency and ultrasound energy as described in claim 1, characterized in that, At least one of the following conditions must be met: Condition I: The first included angle is between 33° and 42°; Condition II, the second included angle is 115° to 122°.

4. The cervical conical radiofrequency ultrasound scalpel with dual radiofrequency and ultrasound energy as described in claim 1, characterized in that, The arc length of the first curved segment is A, and the length of the straight segment is B, where 0.4 ≤ A / B ≤ 0.

45.

5. The cervical conical radiofrequency ultrasound scalpel with dual radiofrequency and ultrasound energy as described in claim 4, characterized in that, The arc length of the second curved segment is C, and 0.45≤C / A≤0.

5.

6. The cervical conical radiofrequency ultrasound scalpel with dual radiofrequency and ultrasound energy as described in claim 1, characterized in that, The extension direction of the tilting cutter head is the same as the tangential direction of the fourth end.

7. The cervical conical radiofrequency ultrasound scalpel with dual radiofrequency and ultrasound energy as described in claim 1, characterized in that, The straight section is provided with a mounting part at the end away from the first arc-shaped bend section. The mounting part is provided with a transducer interface. The transducer interface is provided with an interface threaded hole. The transducer is detachably connected to the interface threaded hole.

8. The cervical conical radiofrequency ultrasound scalpel with dual radiofrequency and ultrasound energy as described in claim 7, characterized in that, The cervical conical radiofrequency ultrasonic scalpel also includes: a handle; The handle is connected to the mounting part.

9. The cervical conical radiofrequency ultrasound scalpel with dual radiofrequency and ultrasound energy as described in claim 8, characterized in that, The mounting part is provided with a tool pin hole for mounting the tool pin, and the rod body is connected to the handle through the tool pin.

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