WO2020045882A1 - Lesion marking system for laparoscopic surgery - Google Patents

Abstract

The present invention relates to a lesion marking system for a laparoscopic surgery and, more specifically, to a technology regarding a lesion marking system for a laparoscopic surgery, wherein the system comprises an indicator clip having an electronic tag (RFID) mounted thereon, through application of an existing hemostatic clip, and an applier for fixing the indicator clip to a lesion area in order to mark the lesion, and when used, the applier is mounted on an endoscopic device or a surgical device while being loaded with the indicator clip, and then driven to fix the loaded indicator clip to the lesion area. [Representative drawing] figure 1

Description

Laparoscopic lesion marking system

The present invention relates to a lesion marking system for laparoscopic surgery, and more particularly, by applying an existing hemostatic clip to fix a marker clip on which an electronic tag (RFID) is mounted and to fix the marker clip to a site of a lesion. Consists of an applier, and in use, the applier is mounted on an endoscope instrument or a surgical instrument with the marker clip loaded, thereby driving the loaded marker clip to be fixed to the lesion site. A description of marking systems.

Conventional abdominal surgery has been followed by laparotomy with open abdomen. Laparotomy is a traditional surgical technique that is still used frequently in modern medicine. However, laparotomy has disadvantages such as risk of wound infection, slow recovery after surgery, and deterioration of cosmetic satisfaction due to scarring. As an alternative, Laparoscopic gastrectomy, first introduced by Kitano in 1994 for gastric cancer, attempted to overcome the above-mentioned shortcomings of laparotomy by inserting a surgical tool into the abdomen instead of the abdomen. With the development of laparoscopic surgery instruments and surgical techniques and the increasing interest of patients and doctors about the quality of life, the surgical trend of gastrointestinal cancer has recently shifted from laparotomy to laparoscopic surgery. Laparoscopic surgery has already been recognized as a standard operation in early gastric cancer, and many researchers have reported excellent laparoscopy for advanced gastric cancer. Laparoscopic surgery has several advantages over laparotomy, including less postoperative pain, faster recovery, and better cosmetic results. However, it is difficult to palpate the lesion by hand during surgery, and it may be difficult to determine the exact location of the lesion because of the use of instruments. In particular, early lesions or benign lesions growing into the lumen of the intestine may not be marked by the tabernacle, so it may be difficult to determine the location of the appropriate resection margin.

In the case of gastrectomy, endoscopy during surgery or X-ray imaging method was introduced, but it is not widely used in clinical practice due to the complexity of the process and collaboration with other departments, and colorectal resection is also injected into the mucosa. Although the tattoo method was used to mark lesions, there was an economic problem due to the patient's discomfort and additional procedures because the endoscopy had to be done one more time before surgery, and especially since the dye spreads rapidly, The more quickly the effect falls. These problems led to unmet demand for new medical technologies for identifying lesions. Although there are some differences in opinion about the safety margin of gastric cancer, Japanese medical community recommends cutting the stomach with a margin of about 20mm to 50mm, and the domestic medical community generally follows these standards. However, in order to improve the quality of life after surgery, interest in minimally invasive surgery has recently increased, and the demand for technology development for realizing this has been continued.

Previously, there have been cases of using various methods to determine the location of lesions during laparoscopic surgery.

In 2005, Hyung WJ and two others introduced a method to identify lesions using laparoscopic ultrasound during gastric submucosal tumors growing into the lumen, which can be easily and safely performed. It has a limitation that it can fail to identify the lesion because of the small size of the clip. In a 2011 report, Kim HI and two others presented a method to detect preoperatively installed abdominal X-rays in 80 early gastric cancer patients.In 2014, Kim BS and three others used Radio-Opaque Gauze. We reported a method to identify lesions after X-ray. Various methods through gastroscopy were also introduced. Jeong O. et al. Reported a self-transfusion tattoo method in which blood was collected from the patient in 2012 and injected into the lower mucosa of the gastric mucosa with a preoperative gastroscope. In addition, the method was used to identify the location of the lesion on the gastrointestinal mucosa by injecting a dye under the gastric mucosa through an endoscope during surgery without installing a clip before surgery.

[Non-Patent Documents]

(1) Hyung W. J, Lim J, et al., "Intraoperative tumor localization using laparoscopic ultrasonography in laparoscopic-assisted gastrectomy" Surgical Endoscopy And Other Interventional Techniques, 2005, 19: 1353-1357.

(2) Kim H. I, Hyung W. J, et al., "Intraoperative portable abdominal radiograph for tumor localization: a simple and accurate method for laparoscopic gastrectomy" Surgical Endoscopy, 2011, 25: 958-963.

(3) Kim B. Su, Yook J. H, et al., "A simplified technique for tumor localization using preoperative endoscopic clipping and radio-opaque markers during totally laparoscopic gastrectomy" The American Surgeon 2014, 80: 1266-1270.

(4) Jeong O, Cho S. B, et al., "Novel technique for intraoperative tumor localization during totally laparoscopic distal gastrectomy: endoscopic autologous blood tattooing" Surgical Endoscopy, 2012, 26: 1778-1783.

(5) Xuan Y, Hur H, et al., "Efficacy of intraoperative gastroscopy for tumor localization in totally laparoscopic distal gastrectomy for cancer in the middle third of the stomach" Surgical Endoscopy, 2013, 27: 4364-4370.

As can be seen from the research results of the non-patent documents 1 to 5, such operations are not actually utilized in the clinical field due to problems such as skill, reliability, and persistence of the operator. Therefore, there is a need to develop a technology for overcoming these shortcomings and marking the location of lesions that can be used in actual clinical settings.

 The present invention is composed of a marker clip of the form of the addition of an electronic tag (RFID) and a clip detector for fixing it to the site of the lesion, the laparoscopic surgical lesion marking system that can determine the location of the lesion without the operator in palpation during laparoscopic surgery To provide.

In addition, the present invention is to provide a laparoscopic surgical lesion marking system comprising a sleeve that moves so that the loaded marker clip is fixed to the lesion site while protecting the electronic tag is fixed to the marker clip.

In addition, the present invention is to provide a laparoscopic surgical lesion marking system is formed so that the angle of the two wires of the marker clip is changed by the applier as the sleeve moves to pinch the lesion site.

The problem to be solved by the present invention is not limited to the above-mentioned problem, another problem to be solved by the present invention not mentioned herein is to those of ordinary skill in the art from the following description It will be clearly understood.

Laparoscopic lesion marking system according to the present invention, an electronic tag (RFID) is mounted on the marker clip so that the location of the lesion in a non-contact manner; And an applier for fixing the marker clip to the site of the lesion, and in use, the applier is mounted on an endoscope instrument or a surgical instrument with the marker clip loaded, and the loaded marker clip is mounted. It is characterized in that the drive to be fixed to the lesion site.

In addition, in the laparoscopic lesion marking system according to the present invention, the marker clip, two wires crossing each other; And a sleeve configured to surround the two wires so as to move forward, wherein the two wires are fixed to a portion of the lesion by varying an angle formed by the two wires as the sleeve moves. Characterized in that can be.

In addition, in the laparoscopic lesion marking system according to the present invention, the marker clip is characterized in that it is formed so that the electronic tag is wound around the point corresponding to the intersection of the two wires.

In addition, in the laparoscopic lesion marking system according to the present invention, the appliar, the sleeve support which can support the rear end of the sleeve; And a clip pulling unit configured to be caught by the two wire rear ends and pulled backward while the rear end of the sleeve is supported by the sleeve supporting unit, wherein the clip pulling unit includes a rear end of the two wires. And a catching part for catching; when the clip is pulled by the clip pulling part, if a force exceeding a reference range is caught by the catching part, the catching part is deformed or broken so that the marker clip can be separated from the applier. It features.

In addition, in the laparoscopic lesion marking system according to the present invention, the applier further comprises a hollow outer surface forming an appearance, the sleeve support and the clip pulling portion in the interior of the outer sequential Is inserted into, the opposite end of the portion of the outer surface to which the marker clip is mounted, connected to the sleeve support portion, the operation support portion exposed to the outside for the user to grip; And a pulling member connected to the clip pulling unit to allow a user to pull in a state in which the manipulation support unit is gripped.

By the means for solving the above problems, the laparoscopic lesion marking system of the present invention is a conventional laparoscopic operation of the perforation-endoscope insertion-lesion confirmation using endoscope and detection needle-endoscope in the process of lesion resection using a resection instrument, etc. Since it is a type added to the insertion process, it can be used without difficulty even for an operator who is familiar with the existing surgical method.

In addition, the laparoscopic lesion marking system of the present invention has the effect that the operator can finish all the procedures alone without manipulating the patient during surgery or cooperating with others and can also save a lot of surgery time.

1 is a view showing a lesion marking system for laparoscopic surgery of the present invention.

Figure 2 is a perspective view of the marker clip of the laparoscopic lesion marking system of the present invention.

3 is a view showing embodiments of the engaging portion of the applier according to the present invention.

4 is a view showing the overall appearance of the applier according to the present invention.

5 is a view showing a state in which the marker clip is loaded on the applier according to the present invention.

6 is a view showing a state in which an applier loaded with a marker clip according to the present invention is pushed.

7 and 8 are views showing a state in which the marker clip is extruded from the applier loaded with the marker clip according to the present invention.

9 and 10 are views showing a state in which the marker clip is separated from the applier loaded with the marker clip according to the present invention.

Specific matters including the problem to be solved, the means for solving the problem, and the effects of the present invention as described above are included in the following embodiments and the drawings. Advantages and features of the present invention, and methods for achieving them will be apparent with reference to the embodiments described below in detail in conjunction with the accompanying drawings.

Laparoscopic lesion marking system according to an embodiment of the present invention, as shown in Figure 1, the marker clip 10 is equipped with an electronic tag (RFID) 13 so that the location of the lesion in a non-contact manner ; And an applier 20 for fixing the marker clip 10 to the site of the lesion.

In the laparoscopic surgery lesion marking system of the present invention, the applier 20 in the state where the marker clip is loaded at the actual laparoscopic surgery site is mounted on an endoscope instrument or a surgical instrument, and the loaded marker clip is It is driven to anchor to the lesion site.

This is a conventional laparoscopic procedure of the perforation-endoscope insertion-endoscope and detection of the lesion using the detection needle-during the lesion resection step using the resection instrument, the endoscope insertion step using the applier (10) the marker clip ( It is also suitable for the surgeon who is familiar with the existing surgical method because it is a type of simply adding a laparoscopic lesion marking system for fixing 10) to the site of the lesion. In addition, compared with the conventional laparoscopic marking method, the existing method is affected by the skill of the operator, or the method is too complicated and requires a lot of cooperation. Therefore, the laparoscopic lesion marking system of the present invention has been developed in such a way as to reduce the dependence of the operator's skill level as much as possible, the burden on the patient's body, and the reliability are increased while simplifying.

The marker clip 10 includes two wires 11 crossing each other and a sleeve 20 configured to surround the two wires 11 and provided to move forward. At this time, as the sleeve 20 moves, the angle formed by the two wires 11 enclosing is changed so that the two wires 11 may be fixed to a portion of the lesion.

As shown in FIG. 2, the two wires 11 are divided into two wire front ends 111 and two wire rear ends 112.

The two wire front ends 111 may vary in an angle formed by the two wire front ends 111 based on a point where the wire 11 intersects when the sleeve 20 moves forward. As the width narrows, the site of the lesion is fixed in the form of being pinched.

In addition, the two wire front end 111 is formed with a hook portion at the end, it may be configured to prevent the departure from the site of the lesion.

The two wire rear ends 112 are formed to be bent and connected in a direction close to each other, so that the two wires based on the point where the wire 11 crosses when the sleeve 20 moves forward. As the angle formed by the rear end 112 is varied, the width of the sleeve 20 is inserted into the narrow portion 121.

On the other hand, the marker clip 10, as shown in Figure 2, is formed so that the electronic tag 13 is wound around the point corresponding to the intersection of the two wires (11). To this end, the two wire front ends 111 are bent to have a gentle inclination relative to the point where the wires 11 intersect, so that the sleeve 20 moves forward to the two wire front ends 111. Even if the width of N is narrowed, the electronic tag 13 may be fixed so as not to move forward.

The sleeve 12 is formed in a hollow shape, a shear accommodating portion 121 having an inner diameter greater than or equal to the maximum separation distance between the two wire rear ends 112 and the maximum separation between the two wire rear ends 112. A rear end receiving portion 122 formed to have an inner diameter less than a distance, and connecting the front end receiving portion 121 and the rear end receiving portion 122, the front end receiving portion 121 and the rear end receiving portion 122 Including a middle receiving portion 123 having an inner peripheral surface inclined according to the difference in the inner diameter.

Therefore, when the sleeve 12 having the above-described structure moves forward, the two wire rear ends 112 are positioned as the rear end accommodation portions 122, and the two wire front ends 111 are moved to the sleeve ( 12) The angle formed by the two wire front ends 111 is variable while being inserted into the inside.

That is, the sleeve 12 not only serves as a cap to protect the electronic tag 13 from inside the body, but also changes the angle formed by the two wires 11 of the marker clip 10 to change the lesion site. It serves to fix it.

On the other hand, the marker clip 10 may be formed of STS304 material.

When designing the marker clip 10, the stomach, the inside of the colon is high humidity and high acidity, so resistant to moisture resistance and oxidation, high tensile strength was selected as an excellent STS301 and STS304 candidate, In order to determine the final tensile strength, yield strength, Poisson's ratio to compare the results are shown in Table 1 below.

Material name	STS304	STS301
Tensile Strength (Mpa)	752	862
Yield strength (Gpa)	376	517
Poisson's ratio	0.55	0.29

In the case of the tensile strength, the tensile strength of the STS304 and STS301 material is similar within a difference of about 15%, but in the case of the yield strength, the yield strength of the STS304 material is as small as 20%. Both the clip clip 10 and the applier 20 are expected to be less deformed in the state of the product because the situation is less subject to external forces, but because the yield strength is advantageous in the processing step is formed of STS304 material It would be desirable.

The two wires of the applier 20 may be supported by a sleeve support 21 in which a rear end of the sleeve 12 may be supported, and a rear end of the sleeve 12 supported by the sleeve support 21. It includes a clip pull unit 22 configured to be caught by the rear end 112 and pulled backward.

The sleeve support portion 21 is provided with a plurality of incision lines 211 in which a portion of the sleeve 12 is in contact with the incision, and is configured such that the sleeve 12 can be inserted only to a necessary portion therein. The sleeve 12 can be stably supported at insertion.

The clip pulling portion 22 includes a catching portion 221 for catching the two wire rear ends 112. When the marker clip 10 is loaded on the applier 20, the two wire rear ends 112 are caught by the catching part 221. In this state, when the marker clip 10 is pulled by the clip pulling portion 22, if a force greater than or equal to a reference range is caught by the catching portion 221, the catching portion 221 is deformed or broken so that The marker clip 10 can be separated from the applier 20.

As shown in FIG. 3, the locking portion 221 may be formed in an annular shape (a), a forceps type (b), or a circular annular shape (c).

Preferably, the engaging portion 221 may be formed in a ring (a). The structure of the annular (a) is simpler than the forceps (b) or the circular annular (c), and can be deformed or broken, and may fall out of the annulus when the clip is rotated and fixed. The problem is also a part that can sufficiently solve the above problems by adjusting the properties of the material, such as rigidity.

In addition, the applier 20 further includes a hollow outer surface 23 forming an exterior, as shown in FIG. 4, and the sleeve support 21 and the inside of the outer surface 23. The clip pulling unit 22 is inserted in sequence.

On the opposite end portion of the outer surface body 23 to which the marker clip 10 is mounted, the operation support part 24 and the clip puller which are connected to the sleeve support part 21 and exposed to the outside for the user to grip A pulling member 25 is connected to the unit 22 to allow the user to pull in a state in which the manipulation supporter 24 is gripped. That is, after the user supports the manipulation supporter 24 with a palm, the user pulls the pull member 25 with a finger to separate the marker clip 10.

Hereinafter, the principle of fixing the marker clip 10 to the site of the lesion in the laparoscopic lesion marking system according to the present invention.

First, as shown in FIG. 5, before attaching the applier 20 to an endoscope instrument or a surgical instrument, the marker clip 10 is press-inserted into the outer surface 23, so that the sleeve 12 is pressed. ) Is inserted into the sleeve support 21, and the two wire rear ends 112 are loaded onto the latching portion 221 to load the marker clip 10 to the applier 20. At this time, the sleeve support portion 21 and the clip pulling portion 22 is inserted in a form that does not protrude out of the outer surface 23 due to the force of the user pressure, the rear end receiving portion 122 of the sleeve ) Is located inside the sleeve support 21.

Next, as illustrated in FIG. 6, the structures inserted into the outer surface 23 are moved forward by pressing. For this reason, the sleeve support 21 and the clip pulling portion 22 is positioned to the front maximum, and the two wire rear ends 112 are still caught by the catching portion 221.

Next, as shown in FIG. 7, the user mounts the applier 20 loaded with the marker clip 10 on an endoscope instrument or a surgical instrument, and locates it near the lesion site. ), The pulling member 25 is pulled while holding. As a result, the clip pulling portion 22 connected to the pulling member 25 moves rearward, and thus the sleeve support 21 also moves rearward. At this time, the two wire rear ends 112 press the locking portion 221 to the front side by a pulling force, and the marker clip 10 is changed into a state in which it is extruded. In addition, the sleeve 12 is moved to the rear relative to the two wires 11 by the pulling force, so that the angle formed by the two wire front end portion 111 becomes small. This process is performed until the locking portion 221 is completely inserted into the outer surface 23, as shown in FIG.

Next, as illustrated in FIGS. 9 and 10, when the force applied to the locking portion 221 is greater than or equal to the reference, the locking portion 221 is deformed or broken so that the two wire rear ends 112 are closed. The marker clip 10 is separated from the locking portion 221. In this case as well, the sleeve 12 is continuously moved backward by a pulling force, so that the angle formed by the two wire front end portions 111 is minimized, and the site of the lesion is picked up and fixed by this driving. .

It will be understood by those skilled in the art that the above-described technical configuration of the present invention can be implemented in other specific forms without changing the technical spirit or essential features of the present invention.

Therefore, the above-described embodiments are to be understood in all respects as illustrative and not restrictive, and the scope of the present invention is indicated by the appended claims rather than the detailed description, and the meaning and scope of the claims and their All changes or modifications derived from an equivalent concept should be construed as being included in the scope of the present invention.

[Description of the code]

10: Marker clip

11: 2 wires

111: two wire front ends

112: two wire rear ends

12: sleeve

121: shear accommodating part

122: rear end accommodating part

123: intermediate accommodation

13: electronic tag

20: Applier

21: sleeve support

211: incision

22: clip pulling unit

221: catching part

23: icosahedron

24: operation support

25: pulling member

Claims (5)

1. Marker clip equipped with an electronic tag (RFID) so that the location of the lesion in a non-contact manner; And

   And an applier for fixing the marker clip to the site of the lesion.

   In use, the appliator is mounted on an endoscope instrument or a surgical instrument with the marker clip loaded, thereby driving the loaded marker clip to be fixed to the lesion site.
2. The method of claim 1,

   The marker clip,

   Two wires crossing each other; And

   A sleeve configured to surround the two wires and provided to move forwards;

   Laparoscopic lesion marking system, characterized in that the two wires can be fixed to the site of the lesion by changing the angle formed by the two wires as the sleeve moves.
3. The method of claim 2,

   The marker clip is a laparoscopic surgical lesion marking system, characterized in that the electronic tag is wound around the point corresponding to the intersection of the two wires are formed.
4. The method of claim 2,

   The applier,

   A sleeve support portion capable of supporting a rear end portion of the sleeve; And

   And a clip puller configured to be hooked to the rear end of the two wires and pulled rearward while the rear end of the sleeve is supported by the sleeve support part.

   The clip pulling unit,

   Includes; engaging portion for catching the rear end of the two wires,

   Laparoscopic lesion marking system, characterized in that when the force is pulled by the clip pull portion, if the force over the reference range is caught by the locking portion, the locking portion is deformed or broken so that the marker clip can be separated from the applier. .
5. The method of claim 4, wherein

   The applier further includes a hollow outer surface forming an appearance;

   The sleeve support part and the clip pulling part are sequentially inserted into the outer surface body,

   At the opposite end of the portion in which the marker clip is mounted on the outer surface,

   An operation support part connected to the sleeve support part and exposed to the outside to be gripped by a user; And

   Laparoscopic surgical lesion marking system, characterized in that provided; is connected to the clip pulling unit for pulling the user in the state holding the operation support.

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