Medical device for sleeve gastrectomy

Abstract

A medical device for sleeve gastrectomy is disclosed. The medical device for sleeve gastrectomy according to one aspect of the present invention may include: a catheter to be inserted into the stomach; a plurality of balloons attached to the catheter at intervals from one another and expandable by inflow of saline solution; and a plurality of electrode pairs, each pair disposed inside each of the plurality of balloons into which saline solution has been introduced, for measuring the internal impedance of each of the plurality of balloons.

Description

Medical device for sleeve gastrectomy

[0001] The present invention relates to a medical device for sleeve gastrectomy.

[0002] The digestive tract includes the oral cavity, pharynx, esophagus, stomach, small intestine, and large intestine. In the medical field, catheters inserted into the digestive tract are flexible, thin, and long tube-shaped medical devices widely used for procedures such as sleeve gastrectomy, treatment of esophageal obstruction, removal of foreign bodies from the esophagus, examinations, procedures, irrigation, and nutritional support.

[0003] Catheters are primarily used in sleeve gastrectomy. The catheter used in sleeve gastrectomy is also referred to as a buoy.

[0004] Sleeve gastrectomy is a laparoscopic surgery in which, in addition to a catheter, special tools such as an observation camera, stapler, and traction device are used to cut the stomach, leaving only a thin, uniform diameter portion of the stomach with a volume of 100-150 mL.

[0005] The degree of resection is crucial in sleeve gastrectomy. The ideal resection is to leave a stomach that is long, slender, and has a uniform cross-sectional area (a sleeve or tube-shaped stomach).

[0006] However, if part or all of the stomach is excessively resected beyond the appropriate level, it can obstruct the movement of food. In this case, it increases the risk of nutritional deficiencies and nutritional diseases, and may lead to complications such as acute or chronic esophageal inflammation, gastrointestinal bleeding, and obstruction.

[0007] Conversely, if the stomach is not sufficiently resected, resulting in an excessively large cross-sectional area or volume of the remaining stomach, the weight loss effect may be insufficient, making it difficult to achieve the surgical goal.

[0008] Therefore, surgical decisions must be appropriately adjusted according to the patient's condition and goals.

[0009] However, since the criteria for determining the appropriate amount for sleeve gastrectomy are unclear, it relies heavily on the surgeon's subjective judgment. Consequently, sleeve gastrectomy is a very difficult surgery for inexperienced physicians, and because it is performed by viewing only the outside of the stomach via laparoscopy, it is by no means an easy procedure even for those with sufficient experience.

[0010] The present invention aims to solve the aforementioned problems, and the objective of the present invention is to provide a medical device for sleeve gastrectomy configured to facilitate the easy performance of sleeve gastrectomy.

[0011] The problems of the present invention are not limited to those mentioned above, and other unmentioned problems will be clearly understood by a person skilled in the art to which the present invention pertains from the description below.

[0012] According to one aspect of the present invention, a medical device for sleeve gastrectomy is provided, comprising: a catheter inserted into the stomach; a plurality of balloons attached to the catheter at a distance from one another and inflatable by the inflow of saline solution; and a plurality of electrode pairs disposed inside each of the plurality of balloons into which saline solution has been introduced and for measuring the internal impedance of each of the plurality of balloons.

[0013] At this time, the catheter may be extended to a predetermined length and made of a soluble material.

[0014] Meanwhile, each of the above electrode pairs may include a positive electrode and a negative electrode.

[0015] At this time, each electrode pair may be configured such that the electrodes facing each other among the two adjacent electrode pairs have the same polarity.

[0016] Meanwhile, the medical device for sleeve gastrectomy may further include a saline supply line for supplying saline to each of the balloons; and a saline discharge line for discharging saline from each of the balloons.

[0017] At this time, the catheter has a hollow tube shape, and each pair of electrodes can be connected to the outside by a connecting line extending through the interior of the catheter.

[0018] Meanwhile, each of the above balloons may be configured to have a maximum inflation size that is the same as or different from that of other balloons, and each of the above electrode pairs may be configured to have a distance between electrodes that is the same as or different from that of other electrode pairs.

[0019] Meanwhile, the medical device for gastric sleeve surgery may further include a cross-sectional area calculator that is electrically connected to each electrode pair and calculates the cross-sectional area of ​​each balloon based on an impedance signal received from each electrode pair.

[0020] At this time, the cross-sectional area calculator may include: a voltage application unit that applies a voltage between the positive electrode and the negative electrode of each electrode pair; an impedance calculation unit that receives an impedance signal from the positive electrode and the negative electrode of each electrode pair and calculates the impedance; and a cross-sectional area conversion unit that converts the impedance calculated by the impedance calculation unit into the cross-sectional area of ​​each balloon.

[0021] At this time, the cross-sectional area calculator may further include a display unit that displays the cross-sectional area of ​​each balloon generated by the cross-sectional area conversion unit.

[0022] According to the above configuration, a medical device for gastric sleeve surgery according to one aspect of the present invention can measure the impedance inside a plurality of balloons through a plurality of electrode pairs. In this case, based on the measured impedance, the cross-sectional area of ​​each balloon can be calculated and monitored in real time through an impedance area measurement method, thereby enabling easy, precise, and accurate gastric sleeve surgery.

[0023] The effects of the present invention are not limited to the effects described above, and should be understood to include all effects that can be inferred from the configuration of the invention described in the detailed description or claims of the present invention.

[0024] FIG. 1 is a drawing showing a medical device for sleeve gastrectomy according to one embodiment of the present invention.

[0025] Figure 2 is an enlarged cross-sectional view of a part of the medical device for sleeve gastrectomy shown in Figure 1.

[0026] Figure 3 is a diagram showing the configuration of a cross-sectional area calculator of a medical device for sleeve gastrectomy shown in Figure 1.

[0027] FIGS. 4 to 7 are drawings for explaining a sleeve gastrectomy using a medical device for sleeve gastrectomy according to an embodiment of the present invention.

[0028] Hereinafter, embodiments of the present invention are described in detail with reference to the attached drawings so that those skilled in the art can easily implement the present invention. The present invention may be embodied in various different forms and is not limited to the embodiments described herein. To clearly explain the present invention, parts unrelated to the description in the drawings have been omitted, and the same reference numerals have been used throughout the specification for identical or similar components.

[0029] The words and terms used in this specification and claims are not limited to their ordinary or dictionary meanings, but should be interpreted in a meaning and concept consistent with the technical spirit of the invention in accordance with the principles by which the inventor defines terms and concepts to best describe his invention.

[0030] Therefore, the embodiments described in this specification and the configurations illustrated in the drawings correspond to preferred embodiments of the present invention and do not represent all technical concepts of the present invention; thus, various equivalents and modifications that may replace such configurations may exist at the time of filing the present invention.

[0031] In this specification, terms such as “comprising” or “having” are intended to describe the existence of the features, numbers, steps, actions, components, parts, or combinations thereof described in the specification, and should not be understood as precluding the existence or addition of one or more other features, numbers, steps, actions, components, parts, or combinations thereof.

[0032] The statement that a component is "in front," "rear," "upper," or "lower" of another component includes, unless there are special circumstances, not only being positioned "in front," "rear," "upper," or "lower" in direct contact with the other component, but also cases where another component is positioned in between. Furthermore, the statement that a component is "connected" to another component includes, unless there are special circumstances, not only being directly connected to each other, but also being indirectly connected to each other.

[0033] FIG. 1 is a drawing showing a medical device for gastric sleeve surgery according to one embodiment of the present invention, FIG. 2 is an enlarged cross-sectional view of a part of the medical device for gastric sleeve surgery shown in FIG. 1, and FIG. 3 is a drawing showing the configuration of a cross-sectional area calculator of the medical device for gastric sleeve surgery shown in FIG. 1.

[0034] Referring to FIGS. 1 to 3, a medical device (10) for sleeve gastrectomy (hereinafter referred to as the medical device (10)) includes a catheter (100), a plurality of balloons (300), a plurality of electrode pairs (500), and a cross-sectional area calculator (700).

[0035] The catheter (100) is extended to a predetermined length. The catheter (100) has a tube shape. At this time, the catheter (100) may have a hollow tube shape as shown in FIG. 2. However, although not shown, the catheter may have a solid tube shape.

[0036] The catheter (100) is inserted into the stomach through the patient's oral or nasal cavity. The catheter (100) is made of a flexible material such as silicone or synthetic resin, so that its shape can be varied. Accordingly, the catheter (100) can be inserted into the stomach more smoothly and can be bent or curved to correspond to the curvature and shape of the stomach.

[0037] A plurality of balloons (300) are attached to the catheter (100) at spaced intervals. A plurality of balloons (300) are attached at spaced intervals in the extension direction of the catheter (100). A plurality of balloons (300) are attached to the area located inside the stomach of the entire area of ​​the catheter (100).

[0038] A plurality of balloons (300) are configured to be inflated by the inflow of saline solution (401). Each balloon (300) may be configured to cover a predetermined area in the extension direction of the catheter (100) when inflated. At this time, each balloon (300) may be attached to the catheter (100) in a manner that surrounds a predetermined area in the extension direction of the catheter (100) when inflated.

[0039] The inflation size of each balloon (300) can be determined according to the amount of saline solution (401) filled in each balloon (300).

[0040] Referring to FIG. 2, a plurality of saline supply lines (410) may be used to supply saline (401) to a plurality of balloons (300). The plurality of saline supply lines (410) are connected to a plurality of balloons (300). At this time, the plurality of saline supply lines (410) may be connected to a plurality of balloons (300) through the interior of a catheter (100).

[0041] A plurality of saline supply lines (410) are connected to a saline storage tank (not shown), and saline (401) from the saline storage tank is supplied to a plurality of balloons (300) through the plurality of saline supply lines (410) via a supply pump (not shown). At this time, a valve (not shown) is installed in each of the plurality of saline supply lines (410). The amount of saline supplied to each balloon (300) can be controlled by controlling the operation of the valve and the supply pump.

[0042] Multiple saline discharge lines (420) may be used to discharge saline (401) from multiple balloons (300). Multiple saline discharge lines (420) are connected to multiple balloons (300). At this time, multiple saline discharge lines (420) may be connected to multiple balloons (300) through the interior of a catheter (100).

[0043] A plurality of saline discharge lines (420) are connected to a saline recovery tank (not shown), and saline (401) filled in a plurality of balloons (300) is recovered to the saline recovery tank through the plurality of saline discharge lines (420) by a discharge pump (not shown). At this time, a valve (not shown) is installed in each of the plurality of saline discharge lines (420). The amount of saline discharged from each balloon (300) can be controlled by controlling the operation of the valve and the discharge pump.

[0044] A plurality of electrode pairs (500) are each placed inside a plurality of balloons (300) into which saline solution (401) is introduced. Each electrode pair (500) acts as a sensor to measure the internal impedance of each balloon (300) that is inflated by the introduction of saline solution (401).

[0045] Each electrode pair (500) includes a positive electrode and a negative electrode. The positive and negative electrodes of each electrode pair (500) may be spaced apart in the extension direction of the catheter (100) and attached to the outer surface of the catheter (100).

[0046] The positive electrode (510) and negative electrode (520) of each electrode pair (500) can be connected to a cross-sectional area calculator (not shown) by a connecting line (610, 620). The connecting line (610, 620) can be extended through the interior of the catheter (100) to be connected to the positive electrode (510) and negative electrode (520) of each electrode pair (500).

[0047] The cross-sectional area of ​​each balloon (300) can be calculated using an impedance area measurement method based on the internal impedance value of each balloon (300) measured by each electrode pair (500).

[0048] At this time, the user can determine the original size of the stomach before resection based on the calculated cross-sectional area of ​​each balloon (300). The user can also adjust the degree of inflation of each balloon (300) based on the calculated cross-sectional area of ​​each balloon (300) so that each balloon (300) has a size corresponding to the desired stomach shape through surgery.

[0049] Referring to FIGS. 1 to 3, the cross-sectional area calculator (700) calculates the cross-sectional area of ​​each balloon (300) using an impedance area measurement method. The cross-sectional area calculator (700) may include a voltage application unit (710), an impedance calculation unit (730), and a cross-sectional area conversion unit (750).

[0050] The voltage application unit (710) applies voltage between the positive electrode (510) and the negative electrode (520) of each electrode pair (500).

[0051] The impedance calculation unit (730) calculates the impedance by receiving an impedance signal from the positive electrode (510) and the negative electrode (520) after a voltage is applied between the positive electrode (510) and the negative electrode (520) of each electrode pair (500).

[0052] For example, when a voltage is applied between the positive electrode (510) and the negative electrode (520), a current is generated along the positive electrode (510), the saline solution (401), and the negative electrode (520). At this time, the impedance can be calculated through the voltage applied between the positive electrode (510) and the negative electrode (520) and the current generated between the positive electrode (510) and the negative electrode (520). Here, the current generated between the positive electrode (510) and the negative electrode (520) may be an impedance signal.

[0053] The impedance inside each balloon (300) depends on the amount of saline solution (401) filled inside each balloon (300).

[0054] The cross-sectional area conversion unit converts the calculated impedance value into the cross-sectional area of ​​each balloon (300). At this time, the cross-sectional area conversion unit can convert the cross-sectional area of ​​each balloon (300) by comparing the calculated impedance value with the previously stored impedance data for each balloon cross-sectional area.

[0055] Here, the impedance data for each balloon cross-sectional area is data organized by matching the impedances measured for each cross-sectional area of ​​the balloon inflated by saline solution (401) through prior experiment or numerical analysis.

[0056] The cross-sectional area calculator (700) may further include a display unit (770). The display unit (770) displays the cross-sectional area of ​​each balloon (300) generated by the cross-sectional area conversion unit (750). The user can check and monitor the cross-sectional area of ​​each balloon (300) through the display unit (770).

[0057] The medical device (10) configured as described above allows the user to easily check the cross-sectional area of ​​each balloon (300) that is placed inside the stomach and is not visible, and to easily check the portion of the stomach to be resected and the degree of resection based on the cross-sectional area of ​​each balloon (300) that is checked, thereby enabling the performance of a precise and effective sleeve gastrectomy.

[0058] In one embodiment of the present invention, a plurality of electrode pairs (500) may be formed such that the electrodes facing each other among two adjacent electrode pairs (500) have the same polarity. For example, in FIG. 2, the positive electrodes of two adjacent electrode pairs (500) are positioned facing each other.

[0059] In other words, the positive electrode (510) constituting each electrode pair (500) is positioned adjacent to the positive electrode (510) constituting another electrode pair (500), or the negative electrode (520) constituting each electrode pair (500) is positioned adjacent to the negative electrode (520) constituting another electrode pair (500).

[0060] In this case, signal interference or noise generation between adjacent electrode pairs (500) can be effectively reduced. In this case, the internal impedance of each balloon (300) can be precisely measured, allowing the cross-sectional area of ​​each balloon (300) to be precisely calculated. By utilizing the calculated cross-sectional area of ​​each balloon (300), sleeve gastrectomy can be easily performed, and surgical accuracy can be increased.

[0061] In one embodiment of the present invention, each balloon (300) may be configured to have a maximum inflation size that is the same as or different from that of another balloon (300), and each electrode pair (500) may be configured to have a distance between electrodes that is the same as or different from that of another electrode pair (500).

[0062] Here, the distance between electrodes of each electrode pair (500) refers to the distance between the positive electrode (510) and the negative electrode (520) constituting each electrode pair (500).

[0063] In this case, the maximum inflation size of each balloon (300) and the distance between the electrodes of each electrode pair (500) can be configured differently in response to stomachs of various shapes and sizes. In this case, the size of stomachs of various shapes and sizes can be accurately measured, and accurate surgery can be performed based on this.

[0064] FIGS. 4 to 7 are drawings for explaining a sleeve gastrectomy using a medical device for sleeve gastrectomy according to an embodiment of the present invention. Hereinafter, a method of using the medical device for sleeve gastrectomy according to an embodiment of the present invention will be described with reference to FIGS. 4 to 7.

[0065] First, referring to FIG. 4, the user inserts a catheter (100) constituting the medical device (10) into the stomach (S). At this time, a plurality of balloons (300) attached to the catheter (100) are placed inside the stomach (S).

[0066] Afterward, as shown in FIG. 5, saline solution is supplied to a plurality of balloons (300) placed inside the stomach (S). At this time, the user observes the outside of the stomach (S) through an endoscope via a laparoscope to check whether the stomach (S) is expanding. When the part of the stomach (S) corresponding to each balloon (300) begins to expand, it is considered that each balloon (300) is in close contact with the stomach (S), and the supply of saline solution to each balloon (300) is stopped.

[0067] Subsequently, the cross-sectional area of ​​each balloon (300) is calculated using the impedance area measurement method. Specifically, the internal impedance of each balloon (300) is measured in real time through each pair of electrodes (500) that are placed in contact with saline solution inside each balloon (300), and the cross-sectional area of ​​each balloon (300) is calculated based on this. In this case, the size of the stomach (S) before surgery can be determined through the cross-sectional area of ​​each balloon (300).

[0068] Afterward, as shown in FIG. 7, the user cuts the stomach (S) while adjusting the size of each balloon (300). At this time, the user sequentially adjusts the size of each balloon (300) so that the stomach (S) is cut into the desired shape while monitoring the cross-sectional area of ​​each balloon (300) in real time through the impedance area measurement method.

[0069] The user can use an automatic stapler (not shown) to resect the stomach (S) and suture the resected portion with a stapler. The automatic stapler is a known device capable of resecting tissue and suturing it with a stapler.

[0070] However, during the excision process, the size of each balloon (300) is not adjusted sequentially in real time, and the size of each balloon (300) is adjusted in advance so that each balloon (300) has a size corresponding to the desired stomach (S) shape, and then the excision can be started.

[0071] Afterwards, the gastrectomy (S) is completed as shown in Fig. 7. At this time, the resected portion of the gastrectomy (S) is expelled from the body.

[0072] The medical device (10) for gastric sleeve surgery according to one embodiment of the present invention described above can measure the impedance inside a plurality of balloons (300) through a plurality of electrode pairs (500). In this case, based on the measured impedance, the cross-sectional area of ​​each balloon (300) can be calculated and monitored in real time through an impedance area measurement method, thereby enabling easy, precise, and accurate gastric sleeve surgery.

[0073] Although embodiments of the present invention have been described, the spirit of the present invention is not limited by the embodiments presented in this specification. Those skilled in the art who understand the spirit of the present invention may easily propose other embodiments within the scope of the same spirit by adding, changing, deleting, or adding components, and such are also to be considered to fall within the scope of the spirit of the present invention.

[0074]

[0075] For reference, the present invention was developed as part of the execution of the following national project.

[0076] [Project ID] 2710002520

[0077] [Assignment No.] 00252244

[0078] [Ministry Name] Ministry of Science and ICT

[0079] [Project Management (Specialized) Agency Name] Pan-Governmental Medical Device Research & Development Project Group

[0080] [Research Project Name] Pan-Governmental Full-Cycle Medical Device Research and Development (Ministry of Science and ICT)

[0081] [Research Project Title] Gastric Sleeve Resection (Obesity Surgery) Intelligence Using Pressure-Sensing Balloon Catheter

[0082] Development of a guide system

[0083] [Names of Performing Organizations] CHA University Industry-Academic Cooperation Foundation, Ajou University Industry-Academic Cooperation Foundation, Daegu Gyeongbuk Institute of Science and Technology Industry-Academic Cooperation Foundation, Soonchunhyang University Industry-Academic Cooperation Foundation, Gayoung Medical Co., Ltd.

[0084] [Research Period] 2023.04.01 ~ 2025.12.31

Claims

1. A catheter inserted into the stomach; A plurality of balloons attached to the above catheter spaced apart from one another and capable of being inflated by the inflow of saline solution; and A medical device for sleeve gastrectomy comprising a plurality of electrode pairs disposed inside each of the plurality of balloons into which saline solution is introduced, and for measuring the internal impedance of each of the plurality of balloons.

2. In Paragraph 1, The above catheter is a medical device for sleeve gastrectomy, which is extended to a predetermined length and made of a soluble material.

3. In Paragraph 1, A medical device for sleeve gastrectomy, wherein each of the above electrode pairs includes a positive electrode and a negative electrode.

4. In Paragraph 2, A medical device for sleeve gastrectomy, wherein each of the above electrode pairs is configured such that the electrodes positioned facing each other among two adjacent electrode pairs have the same polarity.

5. In Paragraph 1, A saline supply line for supplying saline to each of the above balloons; and A medical device for sleeve gastrectomy comprising a saline drainage line for draining saline from each of the above balloons.

6. In Paragraph 1, The above catheter has a hollow tube shape, and A medical device for sleeve gastrectomy, wherein each of the above electrode pairs is connected to the outside by a connecting line extending through the inside of the catheter.

7. In Paragraph 1, Each of the above balloons is configured to have a maximum inflation size that is the same as or different from that of other balloons, and A medical device for sleeve gastrectomy, wherein each of the above electrode pairs is configured such that the distance between the electrodes is the same or different from that of other electrode pairs.

8. In Paragraph 1, A medical device for sleeve gastrectomy, further comprising a cross-sectional area calculator electrically connected to each of the above electrode pairs and calculating the cross-sectional area of ​​each balloon based on an impedance signal received from each of the above electrode pairs.

9. In Paragraph 8, The above cross-sectional area calculator is, A voltage application unit that applies a voltage between the positive and negative electrodes of each of the above electrode pairs; An impedance calculation unit that receives impedance signals from the positive and negative electrodes of each electrode pair and calculates the impedance; and A medical device for sleeve gastrectomy comprising a cross-sectional area conversion unit that converts the impedance calculated by the impedance calculation unit into the cross-sectional area of ​​each balloon.

10. In Paragraph 9, The above cross-sectional area calculator is, A medical device for sleeve gastrectomy, further comprising a display unit for displaying the cross-sectional area of ​​each balloon generated by the cross-sectional area conversion unit.

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