WO2023090488A1

WO2023090488A1 - Tissue resection device

Info

Publication number: WO2023090488A1
Application number: PCT/KR2021/017032
Authority: WO
Inventors: 원영재; 김기섭
Original assignee: 주식회사 인텍메디
Priority date: 2021-11-18
Filing date: 2021-11-18
Publication date: 2023-05-25

Abstract

Disclosed in an embodiment is a tissue resection device comprising: a shaft extending in the lengthwise direction; and a clamp arm that is rotatable with respect to the shaft, wherein the shaft includes a first region overlapping the clamp arm in the vertical direction, and a second region not overlapping the clamp arm in the vertical direction, and the outside of the shaft includes a recess in the second region.

Description

tissue resection device

The embodiment relates to a tissue ablation device.

In medical terms, surgery refers to the treatment of diseases by cutting, cutting, or manipulating skin, mucous membranes, or other tissues using medical machines. Among these operations, open surgery corresponds to surgery to open the abdominal cavity or the skin of the face and treat, shape, or remove internal organs and the like.

When such open surgery is performed, the skin is incised so that a predetermined space is formed between the skin and tissue, and then the surgical action is performed through the space, so there is a problem that a lot of wounds are formed and healing is slow after surgery. However, recently, laparoscopic surgery has been attracting attention as an alternative to this.

Laparoscopic surgery is a method in which a small hole is drilled in a patient's surgical site and a laparoscope is inserted through the hole to perform surgery while observing the surgical site in the abdominal cavity. Laparoscopic surgery has developed rapidly since cholecystectomy in 1990 because of its many advantages, such as shorter recovery period, smaller scars, reduced pain and risk of infection, compared to conventional open surgery.

Currently, it is applied to almost all areas of surgery, such as colorectal cancer surgery, gastric cancer surgery, hernia, liver resection, and thyroid surgery, and accounts for about 20-40% of all surgeries, and in the future, it will account for 80% of all surgeries. is expected to

A laparoscope is one of the equipment for diagnosing images of the internal organs of the body, and is configured so that a device equipped with a small camera is inserted into the body to observe image information detected by the small camera through an external monitor.

In laparoscopic surgery, the location and size of the blood vessels inside the tissue to be excised vary greatly depending on the patient, and the information is also unknown. Therefore, there is a high possibility of unintentional vascular ablation during tissue ablation.

When a blood vessel is cut during laparoscopic surgery, considerable time and effort are consumed to prevent bleeding, which can worsen the condition of the patient and doctor. there is.

Various studies have been conducted to solve this problem, but rather than research to prevent unintentional vascular ablation itself during laparoscopic tissue resection, it is more focused on developing workarounds to reduce problems by hemostasis with energy such as ultrasound after vascular ablation. it's stopping

In addition, since the location of blood vessels passing through the tissue differs from patient to patient and the size varies greatly, information on the presence or absence and size of blood vessels inside the tissue cannot be accurately represented only by information on the intensity of the light signal passing through the tissue. However, if the device malfunctions, it can pose a significant risk to the patient during surgery. In actual surgical procedures, the probability of unintentional vascular ablation is approximately 3%, and the probability of fatal damage is approximately 18%. situation is becoming.

Furthermore, this tissue ablation shaft cuts and seals tissue by ultrasonic vibration. At this time, the tissue ablation shaft needs a space for further arranging an additional member for more easily performing tissue ablation.

However, since the tissue ablation shaft has a groove, for example, a space for an additional member, there is a problem in that noise due to ultrasonic vibration is generated and energy transfer interference occurs due to an additional space or shape.

Embodiments provide a tissue ablation device having space for an additional member to facilitate tissue ablation and sealing.

In addition, a tissue ablation apparatus having a space for placing an additional member and suppressing noise generation is provided.

In addition, a tissue ablation apparatus having a space for placing an additional member and minimizing energy interference due to ultrasonic vibration is provided.

In addition, a tissue ablation device that prevents damage due to unintended vascular ablation during various types of surgeries such as laparoscopic surgery, thoracoscopic surgery, robotic surgery, or laparotomy is provided.

The problem to be solved in the embodiment is not limited thereto, and it will be said that the solution to the problem described below or the purpose or effect that can be grasped from the embodiment is also included.

A tissue ablation device according to an embodiment of the present invention includes a shaft extending in a longitudinal direction; and a clamp arm rotatable with respect to the shaft, wherein the shaft includes a first region overlapping the clamp arm in a vertical direction; and a second area that does not overlap with the clamp arm in the vertical direction, wherein an outer surface of the shaft includes a groove in the second area.

The groove may have a length of 2.0 mm or less in the vertical direction.

The ratio of the length of the groove in the vertical direction to the minimum diameter in the second region of the shaft may be 1:1.7 or more.

The groove may be disposed on an imaginary line bisecting the shaft in a vertical direction.

The first region may include a 1-1 region having a curvature distally; and a 1-2 region disposed proximal to the 1-1 region.

The curvature of the side of the shaft in the first-first region may be greater than the curvature of the side in the first-second region.

The shaft includes the first side surface and a second side surface opposite to the first side surface in the 1-1 region, the radius of curvature of the first side surface is smaller than the radius of curvature of the second side surface, The groove may be disposed closer to the second side surface than to the first side surface.

The groove may be disposed on an imaginary line parallel to the vertical direction and bisecting the shaft.

The shaft may include an upper surface of the shaft facing the clamp arm, and the groove may be spaced apart from the upper surface of the shaft.

The shaft includes an upper surface of the shaft facing the clamp arm, the groove is spaced apart from the upper surface of the shaft, and the clamp arm includes a pad groove disposed on a surface facing the shaft, wherein the A clamp pad seated in the pad groove may be further included.

a first rod coupled to the clamp arm; a second rod disposed outside the first rod; and a protective member disposed between the shaft and an inner surface of the first rod, wherein the shaft may be disposed inside the first rod.

According to embodiments, a tissue ablation device having a space for an additional member to facilitate tissue ablation and sealing may be implemented.

In addition, it is possible to manufacture a tissue ablation device having a space for placing an additional member and suppressing noise generation.

In addition, it is possible to implement a tissue ablation apparatus having a space for placing an additional member and minimizing energy interference due to ultrasonic vibration.

In addition, it is possible to manufacture a tissue ablation device that prevents damage due to unintentional vascular ablation during various types of surgeries such as laparoscopic surgery, thoracoscopic surgery, robotic surgery, or open surgery.

Various advantageous advantages and effects of the present invention are not limited to the above description, and will be more easily understood in the process of describing specific embodiments of the present invention.

1 is a block diagram of a tissue ablation system according to an embodiment;

2 is a conceptual diagram of a tissue ablation device according to an embodiment;

3 is an exploded perspective view of an ablation device according to an embodiment;

4 is a perspective view of an ablation device according to an embodiment;

5 and 6 are diagrams for explaining the operation of the ablation device according to the embodiment,

7 is a perspective view of a shaft and a protective member of an ablation device according to an embodiment;

8 is a bottom view of a shaft of an ablation device according to an embodiment;

9A is a top view of a shaft of an ablation device according to an embodiment;

9B is a top view of a shaft of an ablation device according to another embodiment;

10 is a perspective view of a shaft of an ablation device according to an embodiment;

11 is a side view of a shaft of an ablation device according to an embodiment;

12 is a cross-sectional view taken along line AA' in FIG. 11;

13 is an exploded view of a clamp arm, a clamp pad, and a first rod of an ablation device according to an embodiment;

14 is a diagram explaining operations of a clamp arm, a clamp pad, and a first rod of an ablation device according to an embodiment;

15 is a perspective view of a second rod of an ablation device according to an embodiment;

16 is a perspective view of a second rod and a clamp arm of the ablation device according to the embodiment.

Since the present invention can make various changes and have various embodiments, specific embodiments are illustrated and described in the drawings. However, this is not intended to limit the present invention to specific embodiments, and should be understood to include all modifications, equivalents, and substitutes included in the spirit and scope of the present invention.

Terms including ordinal numbers such as second and first may be used to describe various components, but the components are not limited by the terms. These terms are only used for the purpose of distinguishing one component from another. For example, a second element may be termed a first element, and similarly, a first element may be termed a second element, without departing from the scope of the present invention. The terms and/or include any combination of a plurality of related recited items or any of a plurality of related recited items.

It is understood that when an element is referred to as being "connected" or "connected" to another element, it may be directly connected or connected to the other element, but other elements may exist in the middle. It should be. On the other hand, when an element is referred to as “directly connected” or “directly connected” to another element, it should be understood that no other element exists in the middle.

Terms used in this application are only used to describe specific embodiments, and are not intended to limit the present invention. Singular expressions include plural expressions unless the context clearly dictates otherwise. In this application, the terms "include" or "have" are intended to designate that there is a feature, number, step, operation, component, part, or combination thereof described in the specification, but one or more other features It should be understood that the presence or addition of numbers, steps, operations, components, parts, or combinations thereof is not precluded.

Unless defined otherwise, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which the present invention belongs. Terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with the meaning in the context of the related art, and unless explicitly defined in the present application, they should not be interpreted in an ideal or excessively formal meaning. don't

Hereinafter, the embodiments will be described in detail with reference to the accompanying drawings, but the same or corresponding components regardless of reference numerals are given the same reference numerals, and overlapping descriptions thereof will be omitted.

1 is a block diagram of a tissue ablation system according to an embodiment, and FIG. 2 is a conceptual diagram of a tissue ablation device according to an embodiment.

Referring to FIGS. 1 and 2 , a tissue ablation device 1000 according to an embodiment may include a ablation device 100 , a conversion unit 200 and a manipulation unit 300 .

First, the ablation device 100 is a device for ablating a desired part of a tissue, and may include a shaft, a clamp arm, a first rod, a second rod, a clamp pad, and a protective member. This will be described later.

The converter 200 may be connected to the ablation device 100 . In particular, the conversion unit 200 may be disposed at the rear end of the shaft of the ablation device 100 and coupled with the shaft. The conversion unit 200 may be connected to an external device to receive power. Also, the conversion unit 200 may change the supplied power into predetermined vibration energy. For example, the conversion unit 200 may generate ultrasonic vibration using electric power. Also, ultrasonic vibration may be performed on the shaft connected to the conversion unit 200 . Accordingly, mechanical movement occurs in the shaft, and proteins of tissues in contact with the shaft are denatured, so that coagulation and incision or ablation may be performed. More specifically, the shaft moves according to the ultrasonic vibration, and the ultrasonic vibration or energy is converted into thermal energy in the tissue in contact with the shaft. That is, the temperature may rise with the tissue distal to the shaft in contact with the tissue. Thus, tissue ablation, dissection, coagulation, and the like can be performed. That is, the conversion unit may convert electrical energy into ultrasonic vibration energy and may be positioned within the manipulation unit 300 .

The manipulation unit 300 may manipulate the operation of the ablation device 100 . For example, the manipulation unit 300 may perform opening and closing (or opening and closing) by manipulating rotation of a shaft or a clamp arm by the ablation device 100, and through this, grip or ablate tissue. That is, the manipulation unit 300 may come into contact with the user's arm in order to easily perform cutting and sealing of a tissue desired by a user such as a doctor. For example, the manipulation unit 300 may be formed in various shapes for the user's convenience, and may be equipped with various additional functions necessary for surgery.

Also, the tissue ablation system according to the embodiment may include a tissue ablation apparatus 1000 , an image generator 2000 and a display unit 3000 .

In an embodiment, when the tissue ablation system inserts the front end of the tissue ablation device 1000 into a human body, the tissue ablation device 1000 is removed from the tissue held by the ablation device of the tissue ablation device 1000, and the ablation site, which is an abnormal tissue, and the normal tissue It is a system that images the non-surgical area to be distinguished. Through this, the user can easily perform ablation or sealing of the tissue using the image.

Since the tissue ablation device 1000 has the above-described structure and function, description of the tissue ablation device 1000 will be omitted below.

The image generator 2000 may include a signal generator (not shown) and an image signal calculator. A signal generator (not shown) may provide a signal toward tissue through the tissue ablation device. The signal generator may be applied with various light sources that emit light signals and the like.

The image signal calculator may interfere with a signal reflected from tissue to output an image signal and transmit the output image signal to the display unit 3000 . Here, the image signal may be a signal obtained by optically interfering a signal provided through the signal generator with a signal reflected from one surface of the tissue. As an embodiment, since the user can perform ablation by easily determining, for example, a portion with a rapid change in slope on the graph as an ablation tissue and a portion with a gradual change in slope as a non-ablative tissue, tissue ablation according to the embodiment The system can improve the convenience of surgery and the accuracy of surgery. In addition, the image signal calculator may include, for example, an optical coherence optical system to which optical coherence tomography (OCT) technology is applied to the optical signal.

The display unit 3000 may be connected to the image generator 2000 to image a signal (eg, an optically interfered signal) output from the image generator 2000 . At this time, the display unit 3000 may provide images of the ablated and non-ablated areas of the tissue to the user. At this time, since the light generated from the signal generating unit is emitted toward the tissue from the lower surface of the shaft or the side of the shaft, the user visually checks the position of the ablated tissue on one side and simultaneously checks the presence or absence of blood vessels inside the tissue by viewing an image. Through this, you can make a correct judgment on whether or not to resect. Accordingly, it is possible to prevent accidents such as unintentional vascular ablation. In addition, the tissue ablation system according to the embodiment can provide an image capable of easily distinguishing an ablation site/non-ablation site without a photographing device such as a camera.

In addition, in addition to ultrasonic ablation or radiofrequency ablation, various types of components used to ablate micro-tissues such as blood vessels in various surgeries such as laparoscopic surgery, thoracoscopic surgery, or robotic surgery are ablated within the scope apparent to those skilled in the art. It should be understood that it may be mounted on a device.

FIG. 3 is an exploded perspective view of an ablation device according to an embodiment, FIG. 4 is a perspective view of an ablation device according to an embodiment, and FIGS. 5 and 6 are diagrams illustrating operations of the ablation device according to the embodiment.

3 to 6, the ablation device 100 according to the embodiment includes a shaft 110, a clamp arm 120, a first rod 130, a second rod 140, a clamp pad PD and A protective member (PE) may be included.

Shaft 110 may extend in the longitudinal direction. Here, the longitudinal direction is mixed with the first direction (X-axis direction), and the first direction (X-axis direction) is the longitudinal direction of the shaft 110 and may be the same as the extension line of the first rod 130 to be described later, Hereinafter, it may be used interchangeably with 'longitudinal direction' and 'extension direction'. The second direction (Y-axis direction) is a direction perpendicular to the first direction (X-axis direction). The second direction (Y-axis direction) may be a direction from the shaft toward the clamp arm or clamp pad. The second direction (Y-axis direction) may be used interchangeably with the 'vertical direction'. The third direction (Z-axis direction) may be a direction perpendicular to the first direction (X-axis direction) and the second direction (Y-axis direction).

The shaft 110 extends in the longitudinal direction and may be positioned below the ablation device 100 . In addition, the shaft 110 may be located within the first rod 130 and the second rod 140, which are partially described later. Also, a portion of the shaft 110 may have a curvature at a distal end. In particular, it may have a curvature in a 1-1 region to be described later. With this configuration, the user's view of the tissue can be easily secured during tissue excision and sealing. A description of this will be given later.

Further, the shaft 110 may be connected to the transducer at the proximal end as described above. Accordingly, the shaft 110 may vibrate ultrasonically by receiving mechanical vibration energy of the converting unit, that is, ultrasonic vibration energy. For example, shaft 110 may move distally or proximally along its longitudinal direction. In the present specification, proximal is an area or direction from the shaft toward the conversion unit or manipulation unit, and distal is an area or direction opposite to the proximal, which may correspond to an area or direction in contact with tissue.

The clamp arm 120 may be positioned above the shaft 110 . The clamp arm 120 may be coupled to the first rod 130 so as to be rotatable with respect to the first rod 130 . Accordingly, the clamp arm 120 may tilt or rotate in a vertical direction with respect to the shaft 110 . For example, when the user moves (M1) the first rod 130 in the longitudinal direction through the manipulation unit, the clamp arm 120 is moved in the vertical direction with respect to the shaft 110 by the movement (M1) of the first rod 130. can rotate (T). For example, when the first rod 130 is moved to the rear end or proximal side, the distance between the clamp arm 120 and the shaft 110 may be reduced. Through this, the ablation device 100 may hold or grip tissue through the clamp arm 120 and the shaft 110 . Also, when the shaft 110 moves in the longitudinal direction (M2) as described above, the tissue in contact with the shaft 110 may be ablated or sealed by the above-described thermal energy. Conversely, when the user moves the first rod 130 toward the front end or the distal side, the distance between the clamp arm 120 and the shaft 110 may increase. Through this, the ablation device 100 may place tissue between the clamp arm 120 and the shaft 110 . Accordingly, the user can perform excision and sealing only on a desired region or tissue.

In an embodiment, the shaft 110 or the clamp arm 120 may rotate and move. Hereinafter, the rotation of the clamp arm 120 will be described as a standard.

The first rod 130 may be a hollow tube or tube. The first rod 130 extends in the longitudinal direction, and the shaft 110 may be disposed in a hole therein. The shaft 110 may move along the longitudinal direction as described above inside the first rod 130 . Thus, the first rod 130 may support the shaft.

In addition, the first rod 130 may partially overlap the shaft 110 in a vertical direction. In an embodiment, the distal portion of the shaft 110 may not overlap in the vertical direction. Thus, sealing and excision may be performed by gripping the tissue at the distal end of the shaft 110 .

Like the first rod 130, the second rod 140 may be a hollow tube or tube. The second rod 140 may be disposed outside the first rod 130 . Accordingly, the shaft 110, the protective member PE, and the first rod 130 may be positioned inside the second rod 140. Accordingly, the diameter of the second rod 140 may be greater than that of the first rod 130 .

The second rod 140 may be disposed outside the first rod 130 to protect the first rod 130 and maintain the position of the clamp arm 120 . Accordingly, the ablation device 100 can accurately grip the tissue.

The clamp pad PD may be seated in a pad groove formed in the clamp arm 120 . The pad groove may be located on a surface of the clamp arm 120 facing the shaft 110 . For example, the pad groove may be located on the lower surface of the clamp arm 120 .

The clamp pad PD may be combined with the clamp arm 120 in various ways such as sliding in the pad groove. In addition, the clamp pad PD is a part in contact with tissue and may be made of a material having high thermal durability.

Also, the clamp pad PD may have a plurality of protrusions or an inclined structure on its lower surface. Accordingly, heat generation to tissues can be easily achieved by the protruding or inclined structure. That is, tissue resection can be easily performed.

The protection member PE may be disposed between the shaft 110 and the first rod 130 . In an embodiment, the protective member PE may come into contact with the inner surface of the first rod 130 and the outer surface of the shaft 110 between the inner surface of the first rod 130 and the outer surface of the shaft 110. . The protective member PE may be made of a silicon material or the like to protect the inner surface of the first rod 130 while the shaft 110 moves in the longitudinal direction. In addition, by reducing friction with the first rod 130 with respect to the movement of the shaft 110, it is possible to reduce noise due to friction and suppress reliability deterioration of the shaft 110 or the first rod 9130 due to friction. .

7 is a perspective view of a shaft and a protective member of an ablation device according to an embodiment, FIG. 8 is a bottom view of a shaft of the ablation device according to an embodiment, and FIG. 9A is a top view of a shaft of the ablation device according to an embodiment. FIG. 9B is a top view of a shaft of an ablation device according to another embodiment, FIG. 10 is a perspective view of a shaft of an ablation device according to an embodiment, and FIG. 11 is a view of a shaft of an ablation device according to an embodiment. It is a side view, and FIG. 12 is a cross-sectional view taken along line AA' in FIG. 11 .

7 to 12 , in the ablation device according to the embodiment, the shaft 110 may include a first region S1 and a second region S2.

In an embodiment, the first region S1 may overlap the clamp arm in a vertical direction. The second region S2 is a proximal region from the first region S1 and may be a region that does not overlap with the clamp arm in the vertical direction.

Accordingly, the first region S1 is a region in which the clamp arm 120 rotates, and in the first region S1, the distance between the shaft 110 and the clamp pad decreases or increases due to the rotation of the clamp arm 120. can That is, the tissue may be ablated in the first region S1. The shaft 110 may have a circular shape in the cross section YZ in the second region S2. In addition, the shaft 110 may be curved to one side in the first region S1 and a top surface or a surface in contact with the clamp arm may be flat.

In an embodiment, the first region S1 may have a curvature in some or all of the region. For example, the first region S1 may include a 1-1 region S1-1 and a 1-2 region S1-2. The 1-1st region S1-1 may have a curvature on its side. Unlike this, the side of the first-second region S1-2 may extend in the longitudinal direction and be flat. For example, the curvature of the side in the 1-1st region S1-1 may be greater than the curvature of the side in the 1-2nd region S1-2.

Also, the 1-1 region S1-1 may come into contact with the tissue by the rotation of the clamp arm. That is, tissue cutting and sealing may be performed on the 1-1 region S1-1. Accordingly, the shaft 110 is curved in the second direction or in a direction opposite to the second direction in the 1-1 region S1-1, so that the user's view of the tissue can be easily secured. In addition, it is possible to prevent damage to peripheral organs or the like caused by the shaft 110 .

In addition, the shaft 110 may include a first side surface 110SS1 , a second side surface 110SS2 , an upper surface 110US1 , and a lower surface 110BS in the first region S1 .

The first side surface 110SS1 and the second side surface 110SS2 may be bent in the second direction or in a direction opposite to the second direction. That is, as described above, the first side surface 110SS1 and the second side surface 110SS2 may have a predetermined radius of curvature due to a shape curved in the third direction or the opposite direction thereof. The first side surface 110SS1 may be disposed opposite to the second side surface 110SS2 . The radius of curvature of the first side surface 110SS1 may be smaller than the radius of curvature of the second side surface 110SS2 .

Further, the groove 110H may be disposed adjacent to the second side surface 110SS2 having a large radius of curvature. For example, the groove 110H may be located closer to the second side surface 110SS2 than the first side surface 110SS1 .

The top surface 110US1 may include the first top surface 110US1-1 in the 1-1 area S1-1 and the second top surface 110US1-2 in the 1-1 area S1-2. there is. The first upper surface 110US1 - 1 is disposed distal to the second upper surface 110US1 - 2 and may be bent in a second direction relative to the second upper surface 110US1 - 2 . That is, a part of the distal end of the first upper surface 110US1 - 1 may be spaced apart from the distal end of the second upper surface 110US1 - 2 in the second direction. The upper surface 110US1 may be spaced apart from a groove 110H to be described later in the longitudinal direction. Furthermore, the second upper surface 110US1 - 2 may overlap the first groove 110H in at least a portion of the extension direction (X-axis direction). Also, the upper surface 110US1 may face the clamp arm. Alternatively, the upper surface 110US1 may face the clamp pad. Further, the upper surface 110US1 may be brought closer to or farther from the clamp arm or the clamp pad by the rotation of the clamp arm. That is, the tissue may be seated on the upper surface 110US1, and the tissue may be excised and sealed by the rotation of the clamp arm and the movement of the shaft in the extending direction.

A recess RS may be present in the lower surface 110BS. As a result, it is possible to improve the field of view of the tissue. In addition, the ablated part can be easily moved to the outside.

In addition, the shaft 110 may include a groove 110H in the second region S2. The home is used interchangeably with the 'shaft home' below. This groove 110H may be located on the outer surface 110OS in the second region S2 of the shaft 110 . Accordingly, the groove 110H may not overlap the clamp pad and the clamp arm in the vertical direction. Also, the groove 110H may be spaced apart from the clamp pad and the clamp arm in the longitudinal direction.

As an example, the groove 110H may be located on the outer surface 110OS in the second area S2 of the shaft 110 .

The groove 110H according to the embodiment may extend along the longitudinal direction (X-axis direction). The groove 110H may extend adjacent to the manipulation unit 300 . In an embodiment, the length of the groove 110H relative to the entire length of the shaft 110 in the shaft 110 may be 1:0.8 to 1:0.9. When the ratio is less than 1:0.8, it is difficult for the additional member disposed in the groove to connect to the manipulation unit, and when the ratio is greater than 1:0.9, it may be difficult to secure a space for tissue ablation in the first region.

In addition, in the second region S2 of the shaft 110 according to the embodiment, the shaft 110 may be bisected in the vertical direction (Y-axis direction) and disposed on a line parallel to the extension direction (X-axis direction). That is, in the second region S2 of the shaft 110 according to the embodiment, the groove 110H may be disposed at a position that halves the shaft 110 in the vertical direction.

Further, the grooves 110H may have the same distance apart from the center C in the second region S2 of the shaft 110.

As an example, the diameter of the shaft 110 may change along the extension direction (X-axis direction). Accordingly, the depth (length in the third direction in this embodiment) of the groove 110H may also vary along the extension direction (X-axis direction). However, the distance between the groove 110H and the center C of the shaft 110 may be maintained the same. In this specification, radius and diameter mean the distance from the center (C) of the shaft (110). And the center (C) may mean the origin and the center of gravity on the cross section (YZ plane).

For example, the radius DR1 of the shaft 110 in the first-second region S1-1 may be smaller than the radii DR2 and DR3 of the shaft 110 in some regions of the second region S2.

In the second region S2 , distances dd1 and dd2 between the groove 110H of the shaft 110 and the center C may be the same. Accordingly, the depth of the groove 110H may vary according to the diameter of the shaft 110 in the second region S2. For example, when the diameter of the shaft 110 increases in the second region S2 , the depth of the groove 110H also increases, and when the diameter of the shaft 110 decreases, the depth of the groove 110H may also decrease.

Accordingly, a hole or an opening may exist between the shaft 110 and the protection member PE by the groove 110H. As a result, a space in which an additional member is disposed adjacent to the shaft 110 or within the first rod may be provided. For example, a fluid injection unit LD may be disposed in the groove 110H. Accordingly, the user's field of view can be secured by reducing heat generated at the distal end of the shaft 110 through the sprayed fluid or removing smoke generated during tissue ablation through the fluid spray. In addition, residues of tissue ablation on the shaft 110 may be easily removed through fluid injection. In addition, by arranging the fluid injection unit LD through the groove 110H on the shaft 110, the ablation device and thus the tissue ablation device can be made compact.

Furthermore, the groove 110H may be located on the side opposite to the direction in which the end faces in the 1-1 region S1-1 of the shaft. For example, when the end faces the right side in the 1-1 region S1-1 of the shaft, the groove 110H may be located on the left side of the shaft. With this configuration, when the user performs tissue ablation with the left side of the shaft in the field of view, the fluid ejected from the fluid ejection unit can easily remove smoke or the like (by heat) generated from the tissue during ablation or sealing. there is. That is, it is possible to easily secure a view of the tissue from the side of the shaft.

Furthermore, the number of grooves 110H may be plural. For example, the groove 110H may be variously present on the outer surface of the shaft 110 in the second region S2.

In an embodiment, the depth H1 of the groove 110H may be smaller than the minimum diameter R1 in the second region S2 of the shaft 110 . In an embodiment, the groove 110H may have a length of 2 mm or less in a vertical direction. Furthermore, the ratio of the length of the groove 110H in the vertical direction to the minimum diameter in the second region of the shaft may be greater than or equal to 1:1.7.

Hereinafter, the contents of the experiment on the length of the groove 110H in the vertical direction are described. The minimum diameter of the shaft is 3.4mm. And a shaft without a groove (Comparative Example 1), a shaft with a groove (2 mm) (Example 1), a shaft with a groove (2.2 mm) (Comparative Example 2) and a shaft with a groove (2.4 mm) (Comparative Example 3 ), the conversion unit was connected, the entire distal end of the shaft was placed in a water bath, and ultrasonically driven. The ultrasonic operation time was set to a minimum of 3 seconds (min(3)) and a maximum of 5 seconds (max(5)) because it was performed within 5 seconds during surgery. The results for this are shown in Table 1 below. (Hereinafter, P means pass, F means Fail, and the experiment was conducted based on the presence or absence of noise and non-operation of audible frequencies. In the case of noise and non-operation, enter Fail)

구분division	동작 시간operating time	시료sample
구분division	동작 시간operating time	1One	22	33	44	55	66	77	88	99	1010
실험예 1 Experimental Example 1	min (3)min (3)	PP	PP	PP	PP	PP	PP	PP	PP	PP	PP
실험예 1 Experimental Example 1	max (5)max (5)	PP	PP	PP	PP	PP	PP	PP	PP	PP	PP
실시예Example	min (3)min (3)	min (3)min (3)	PP	PP	PP	PP	--	--	--	--	--
실시예Example	max (5)max (5)	max (5)max (5)	PP	PP	PP	PP	--	--	--	--	--
실험예 2 Experimental Example 2	min (3)min (3)	min (3)min (3)	PP	F (동작 X)F (action X)	PP	F (강한소음)F (strong noise)	--	--	--	--	--
실험예 2 Experimental Example 2	max (5)max (5)	max (5)max (5)	F (강한소음)F (strong noise)	F (동작 X)F (action X)	F (강한소음)F (strong noise)	F (강한소음)F (strong noise)	--	--	--	--	--
실험예 3 Experimental Example 3	min (3)min (3)	min (3)min (3)	PP	FF	--	--	--	--	--	--	--
실험예 3 Experimental Example 3	max (5)max (5)	max (5)max (5)	FF	FF	--	--	--	--	--	--	--

In addition, the conversion unit is connected to the shaft with groove (2 mm) (Example 1), the shaft with groove (2.2 mm) (Comparative Example 2) and the shaft with groove (2.4 mm) (Comparative Example 3), and the shaft circle It was ultrasonically driven in contact with a silicon pad on top. The ultrasonic operation time was set to a minimum of 3 seconds (min(3)) and a maximum of 5 seconds (max(5)) because it was performed within 5 seconds during surgery. The results for this are shown in Table 2 below. (Hereinafter, P means pass and F means Fail)

구분division	동작 시간operating time	시료sample
구분division	동작 시간operating time	1One	22	33	44
실시예Example	min (3)min (3)	PP	PP	PP	PP
실시예Example	max (5)max (5)	PP	PP	PP	PP
실험예 2 Experimental Example 2	min (3)min (3)	F (약소음)F (weak noise)	F (동작 X)F (action X)	F (약소음)F (weak noise)	F (강한소음)F (strong noise)
실험예 2 Experimental Example 2	max (5)max (5)	F (강한소음)F (strong noise)	F (동작 X)F (action X)	F (강한소음)F (strong noise)	F (강한소음)F (strong noise)
실험예 3 Experimental Example 3	min (3)min (3)	F (강한소음)F (strong noise)	F (강한소음)F (strong noise)	--	--
실험예 3 Experimental Example 3	max (5)max (5)	FF	FF	--	--

As in the above experiment, when the length in the vertical direction of the groove 110H is greater than 2 mm, or when the ratio of the length in the vertical direction of the groove 110H to the minimum diameter in the second region of the shaft is 1:1.7 or less, noise generation increases. do. Furthermore, there is a problem that not only noise generation but also heat generation by ultrasonic vibration is not achieved because the crest point is damaged due to interference between nodes and antinodes for ultrasonic vibration. (110H') may be located on an imaginary line (VL1) parallel to the vertical direction (eg, parallel) and bisecting the shaft 110. That is, the groove 110H' may be positioned on the virtual line VL1. Furthermore, the groove 110H' may be bisected by an imaginary line. In other words, the groove 110H' may be located on the uppermost surface (or point) or the lowermost surface (or point) of the second region S2 of the shaft 110. Due to this configuration, when the shaft 110 moves in the longitudinal direction, the weight of the shaft 110 can be balanced with respect to the imaginary line VL1. Accordingly, temperature imbalance may not occur at the distal end of the shaft 110 due to the groove 110H. That is, deterioration in ablation performance can be prevented. In addition, noise generation can be reduced due to the weight imbalance of the shaft along the groove 110H'.

In addition, the protective member PE may be disposed outside the shaft 110 to cover the shaft 110 . At this time, the protective member PE may be disposed to correspond to an antinode or ship of the shaft 110 . That is, the protective member PE may be positioned to at least partially overlap an antinode of the shaft 110 in a vertical direction. With this configuration, noise suppression according to ultrasonic vibration can be easily achieved even if the output according to ultrasonic vibration is increased at the antinode.

13 is an exploded view of a clamp arm, a clamp pad, and a first rod of an ablation device according to an embodiment, and FIG. 14 illustrates operations of the clamp arm, clamp pad, and first rod of the ablation device according to an embodiment. it is a drawing

Referring to FIGS. 13 and 14 , the clamp arm 120 of the ablation device according to the embodiment may be located at a distal side of the ablation device. As described above, the clamp arm 120 is rotatable (T). For this rotation, the clamp arm 120 may include an arm protrusion 120p. The arm protrusion 120p may extend inward from an inner surface of the clamp arm 120 . The female protrusion 120p may be accommodated in the first rod hole 130h of the first rod 130 to be described later. With this configuration, the clamp arm 120 can rotate with the arm protrusion 120p as a reference axis. In addition, when the clamp arm 120 is coupled to the first rod 130 through the arm protrusion 120p and the first rod 130 moves along the longitudinal direction (M1) according to the user's manipulation, the clamp arm 120 ) can rotate (T). This is a structure for the embodiment of the present invention, and for rotation of the clamp arm 120, the clamp arm 120 and the first rod 130 may have various structures. For example, the positions of the female protrusion 120p and the first rod hole 130h may be changed. That is, the clamp arm 120 may have a groove, and the first rod 130 may have a protrusion.

Also, as described above, a pad groove 120h may exist on the bottom surface of the clamp arm 120 . The clamp pad PD may be used for the pad groove 120h. Accordingly, the clamp pad PD may face the upper surface of the shaft, particularly the upper surface of the first region.

The diameter or radius R3 of the first rod 130 may be greater than the diameter or radius of the shaft. Thus, the shaft may be located inside the first rod 130 .

The first rod 130 may include a first opening 1300 disposed on the distal side. A space for rotation of the clamp arm 120 may be easily secured by the first opening 1300. In other words, the first opening 1300 may be a space for rotation of the clamp arm 120 .

15 is a perspective view of the second rod of the ablation device according to the embodiment, and FIG. 16 is a perspective view of the second rod and the clamp of the ablation device according to the embodiment.

Referring to FIGS. 15 and 16 , the second rod 140 may include a distal second opening. Since the first opening is located in a region distal and superior to the first rod, a second opening may exist corresponding to the first opening. Through this, space for rotation of the clamp arm can be easily secured.

Furthermore, the second rod 140 may include a second rod hole 140h disposed on the distal side. The second rod hole 140h may be coupled with the protrusion of the clamp arm. In this way, the radius or posture of the rotation of the clamp arm can be maintained. That is, the accuracy of rotation of the clamp arm can be improved. Furthermore, the reliability of the clamp arm can also be improved. The second rod hole 140h may be positioned proximal to the first rod hole. In accordance with this, it is possible to improve the rotation radius by reducing spatial restrictions on rotation of the clamp arm.

Unlike the first rod 130, the second rod 140 does not move in the longitudinal direction by the user. Thus, unlike the first rod hole, the second rod hole 140h may not be a rotation axis for the rotation of the clamp arm.

Also, the diameter or radius of the second rod 140 may be larger than that of the first rod. Thus, the second rod 140 can easily accommodate the first rod, the shaft, and the protective member.

The tissue ablation device or system including the same according to the present invention has a structure that is detachably connected to an external device for imaging tissues, so that when the tissue ablation device is damaged, it can be easily replaced and immediately retaken, so that laparoscopic It can increase the efficiency of surgery.

In addition, as described above, the tissue ablation device or a system including the same can easily observe the presence or absence of blood vessels and their size with the naked eye through an image of the internal structure of a tissue to be excised, and thus unintended blood vessel ablation during surgery. damage can be minimized.

That is, the present invention uses a tissue ablation apparatus to which an internal tissue imaging module is applied to determine the presence or absence of blood vessels inside the resected tissue during laparoscopic surgery. It protects vascular resection and allows for safe tissue resection.

The term '~unit' used in this embodiment means software or a hardware component such as a field-programmable gate array (FPGA) or ASIC, and '~unit' performs certain roles. However, '~ part' is not limited to software or hardware. '~bu' may be configured to be in an addressable storage medium and may be configured to reproduce one or more processors. Therefore, as an example, '~unit' refers to components such as software components, object-oriented software components, class components, and task components, processes, functions, properties, and procedures. , subroutines, segments of program code, drivers, firmware, microcode, circuitry, data, databases, data structures, tables, arrays, and variables. Functions provided within components and '~units' may be combined into smaller numbers of components and '~units' or further separated into additional components and '~units'. In addition, components and '~units' may be implemented to play one or more CPUs in a device or a secure multimedia card.

Although the above has been described with reference to the embodiments, this is only an example and does not limit the present invention, and those skilled in the art to which the present invention belongs will not deviate from the essential characteristics of the present embodiment. It will be appreciated that various variations and applications are possible. For example, each component specifically shown in the embodiment can be modified and implemented. And differences related to these modifications and applications should be construed as being included in the scope of the present invention as defined in the appended claims.

Claims

a shaft extending in the longitudinal direction; and

Including; clamp arm rotatable with respect to the shaft,

The shaft may include a first region overlapping the clamp arm in a vertical direction; And a second region that does not overlap with the clamp arm in the vertical direction; includes,

An outer surface of the shaft includes a groove in the second region.
According to claim 1,

The groove is a tissue ablation device having a length of 2.0 mm or less in the vertical direction.
According to claim 1,

The tissue ablation device of claim 1 , wherein the length of the groove in the vertical direction is 1:1.7 or greater in ratio to the minimum diameter in the second region of the shaft.
According to claim 1,

The groove is a tissue ablation device disposed on an imaginary line bisecting the shaft in a vertical direction.
According to claim 4,

The first region may include a 1-1 region having a curvature distally; and a 1-2 area disposed proximal to the 1-1 area.
According to claim 5,

The tissue excision apparatus of claim 1 , wherein the curvature of the side of the shaft in the 1-1 region is greater than the curvature of the side in the 1-2 region.
According to claim 6,

The shaft includes a first side surface and a second side surface opposite to the first side surface in the 1-1 region,

The radius of curvature of the first side surface is smaller than the radius of curvature of the second side surface,

The tissue ablation device of claim 1 , wherein the groove is disposed closer to the second side surface than to the first side surface.
According to claim 1,

The groove is disposed on an imaginary line parallel to the vertical direction and bisecting the shaft.
According to claim 1,

The shaft includes an upper surface of the shaft facing the clamp arm,

The groove is disposed spaced apart from the upper surface of the shaft,

The clamp arm includes a pad groove disposed on a surface facing the shaft,

Tissue ablation device further comprising; a clamp pad seated in the pad groove.
According to claim 1,

a first rod coupled to the clamp arm;

a second rod disposed outside the first rod; and

Further comprising a protective member disposed between the shaft and the inner surface of the first rod,

The tissue ablation device of claim 1 , wherein the shaft is disposed inside the first rod.