Stylet unit for human organ perforation and ascites drainage tube-delivering medical device including same

The stylet unit with a perforation prevention member and perforation member, combined with a guide wire and pushing device, addresses the challenges of safe and precise ascites drainage by preventing unintended perforations and ensuring efficient catheter insertion, thereby improving medical service quality.

WO2025178229A1PCT designated stage Publication Date: 2025-08-28WABE TREE CO LTD
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Patent Information

Application Number
PCT/KR2024/095370
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-02-19
Publication Date
2025-08-28

AI Technical Summary

Technical Problem

Existing medical procedures for draining ascites through repeated paracentesis cause discomfort, risk of intestinal perforation, and complications like bleeding and infection due to unintentional perforation of non-target sites during abdominal puncture, and there is a need for a device that can smoothly insert catheters to the bladder wall for effective drainage.

Method used

A stylet unit with a perforation prevention member and a perforation member, featuring a blunt tip and elastic support, ensures precise and safe perforation of the target site, followed by a guide wire and pushing device to insert an ascites drainage tube safely and efficiently.

Benefits of technology

The solution prevents unintended perforations, enabling accurate and safe perforation of the target site, enhancing procedure safety and convenience, and allowing for high-quality medical services by ensuring quick and precise drainage tube insertion.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a stylet unit for human organ perforation, in which the tip of a perforation prevention member is positioned in front of the tip of a perforating member before the perforation prevention member is brought into proximity and applies pressure to a human organ, thus making it possible to prevent unexpected perforation, and after pressure is applied to the organ by the perforation prevention member, a spring moves together with the perforation prevention member so that the tip of the perforating member is positioned in front of the perforation prevention member when the reaction force generated by the pressure is greater than the elastic force applied to a movement regulating member, thus making it possible to perforate the human organ. Therefore, the present invention can prevent procedural complications caused by unexpected perforation of sites other than a target site during human organ perforation, and enable even those who are not experienced specialists to accurately and safely perforate a target site, thus having the effects of improving the convenience and satisfaction of medical procedures and making it possible to provide high-quality medical services.
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Description

Stylet unit for perforating human organs and medical device for delivering ascites drainage tubes including the same

[0001] The present invention relates to a stylet unit for perforating a human organ and a medical device for delivering ascites drainage tubes including the same, and more particularly, to a stylet unit for perforating a human organ having an improved structure so as to prevent side effects from occurring due to unexpected perforation of a site other than a target site during perforation of a human organ and to enable accurate and safe perforation of a target site, and to a medical device for delivering ascites drainage tubes including the same.

[0002] In cases of liver cirrhosis or peritoneal disseminated disease (peritoneal metastasis of cancer, peritoneal carcinomatosis: when cancer metastasizes to the peritoneum from stomach / colon / pancreatic cancer / ovarian cancer, etc.), ascites, which is fluid accumulation inside the peritoneal cavity, occurs. When ascites symptoms worsen, patients experience discomfort, pain, and difficulty moving due to abdominal distension. In these cases, as well as shown in Figures 1 and 2, repeated paracentesis (a procedure to repeatedly puncture the abdomen with a needle to drain ascites outside the abdomen) is required to improve symptoms. However, since the duration of symptom improvement is not long, patients undergo repeated paracentesis at daily intervals (approximately 2 to 3 liters of ascites are cultured per procedure).

[0003] This procedure requires puncturing the abdomen with a thick needle deep into the peritoneum, causing a lot of discomfort such as pain. Repeated paracentesis can cause intestinal perforation by puncturing the intestines as the number of times increases, or it can cause many complications such as bleeding and infection due to the procedure.

[0004] Therefore, in cases where a part of a human organ must be perforated for a procedure, it has become necessary to develop a product that can prevent unintentional perforation of a part other than the target area.

[0005] In addition, after perforation of a human organ, a catheter insertion procedure is performed in which a catheter is placed on the bladder wall dividing the area between the abdominal cavity and the bladder to drain ascites through the bladder. The applicant of the present invention has developed various abdominal-connected catheters used in catheter insertion procedures, such as those disclosed in Patent Publication No. 10-2020-0126046, Patent Publication No. 10-2020-0126047, and Patent Registration No. 10-2161349. Therefore, there is a need for the development of a product that can smoothly move such a novel abdominal-connected catheter to the bladder wall, which is the standard for dividing the area between the abdominal cavity and the bladder.

[0006] As for prior art, there is Republic of Korea Patent Publication No. 10-2020-0126046.

[0007] The present invention was conceived in response to the above-described need, and the purpose of the present invention is to provide a stylet unit for perforating a human organ, which enables accurate and safe perforation of a target area when perforating a human organ.

[0008] Another object of the present invention is to provide a medical device for delivering an ascites drainage tube that can smoothly move the ascites drainage tube, which allows ascites in the abdominal cavity to be discharged as urine through the bladder, to the bladder wall, which is the standard for dividing the area between the abdominal cavity and the bladder.

[0009] The problems solved by the present invention are not limited to those mentioned above, and other problems not mentioned can be clearly understood by those skilled in the art from the description below.

[0010] In order to achieve the above object, the stylet unit for perforating a human organ according to the present invention is for moving through an endoscope channel inserted into a human body to form a hole in one side of a human organ, and comprises: a perforation prevention member having a non-pointed but blunt tip shape, a tubular shape to allow a guide wire to pass through, and communication holes formed at the tip and rear ends to allow exposure of the guide wire; a perforation member having a tip end formed to be sharp and positioned in a manner that surrounds the perforation prevention member so that the perforation prevention member is positioned inside, and is positioned rearward of the tip end of the perforation prevention member to enable perforation of a bladder wall; and a space forming part provided at the rear end of the tip end and having a moving space formed to allow relative movement of the perforation prevention member; And an elastic member installed in the space-forming part of the perforation member to elastically support the rear end of the perforation prevention member; including, before the perforation prevention member is brought close to the human organ and pressure is applied, the front end of the perforation prevention member is positioned further forward than the front end of the perforation member, thereby preventing unexpected perforation, and after the perforation prevention member is brought into contact with the organ, when a pressure greater than the elastic force of the elastic member is applied, the perforation prevention member retreats and the pointed front end of the perforation member is positioned further forward than the perforation prevention member, thereby allowing the human organ to be perforated.

[0011] It is preferable that the above-mentioned puncture prevention member include a tubular puncture prevention member having a bluntly formed tip, and a sliding member that is coupled to the rear end of the puncture prevention member and is elastically pressed against an elastic member installed in the moving space of the puncture member.

[0012] It is preferable that the space expansion portion of the above-mentioned perforation member includes a first portion that surrounds the perforation prevention member, and a second portion that is screw-connected to the first portion, supports one end of the elastic member, and through which the sliding portion passes.

[0013] In order to achieve the above object, the medical device for delivering a drainage tube according to the present invention comprises a stylet unit as described above, and is characterized by including a guide wire passing through a communication hole formed at the front and rear ends of the perforation prevention member to move a peritoneal-bladder connecting catheter (hereinafter referred to as an “ascites drainage tube”) for fluidically connecting the abdominal cavity and the bladder to the bladder wall, which is a reference for dividing the area between the abdominal cavity and the bladder; and a pushing device for positioning an ascites drainage tube between the guide wire and a cystoscope channel while the front end of the guide wire sequentially passes through the rear end of the perforation member and the front end of the perforation prevention member and is positioned on the abdominal cavity side, and then pushing the ascites drainage tube toward the portion perforated by the stylet.

[0014] The stylet unit for perforating a human organ according to the present invention having the configuration described above prevents unexpected perforation by positioning the tip of the perforation prevention member further forward than the tip of the perforation member before applying pressure by bringing the perforation prevention member closer to the human organ, and when a pressure greater than the elastic force of the elastic member is applied after bringing the perforation prevention member into contact with the organ, the pointed tip of the perforation member is positioned further forward than the perforation prevention member to perforate the human organ, thereby preventing the occurrence of side effects of the procedure due to unexpected perforation of a part other than the target part during perforation of the human organ, and enabling even a non-experienced specialist to accurately and safely perforate the target part, ultimately resulting in the effect of increasing convenience and satisfaction of the procedure and enabling the provision of high-quality medical services.

[0015] According to an embodiment of the present invention, a medical device for delivering a drainage tube having a configuration as described above uses a stylet unit including a perforation prevention member and a perforation member to precisely and safely perforate a perforation target site of a bladder wall, and then uses a guide wire and a pushing device to smoothly insert an ascites drainage tube into the tip site, thereby enabling a drainage tube insertion procedure to be performed quickly and precisely in a safe manner, thereby ultimately enhancing the reliability of medical services due to improved procedure safety, and thereby producing the effect of enabling the provision of patient-tailored medical services due to improved procedure convenience.

[0016] FIG. 1 is a cross-sectional view showing an endoscope channel inserted into the urethra during a procedure using a stylet unit for perforating a human organ according to one embodiment of the present invention.

[0017] Figure 2 is a cross-sectional view showing an embodiment of the present invention and an endoscope channel separated.

[0018] Figure 3 is a cross-sectional view for explaining the configuration and operation process of one embodiment of the present invention.

[0019] FIG. 4 is a drawing for explaining the organic coupling relationship between a stylet unit and a guide wire employed in a medical device for delivering multiple drainage tubes according to one embodiment of the present invention.

[0020] FIG. 5 is a drawing for explaining the organic coupling relationship between a guide wire and a dilator employed in one embodiment of the present invention.

[0021] FIG. 6 is a drawing for explaining the organic coupling relationship between the guide wire and the pushing device employed in one embodiment of the present invention.

[0022] To ensure a clear understanding of the present invention, descriptions of known techniques related to the features of the present invention will be omitted in the following description. The following examples are provided as detailed descriptions to aid understanding of the present invention and should not be construed as limiting the scope of the invention. Therefore, equivalent inventions that perform the same functions as the present invention will also fall within the scope of the invention.

[0023] In the following description, identical identifiers denote identical configurations, and unnecessary redundant descriptions and descriptions of known technologies will be omitted. Furthermore, descriptions of each embodiment of the present invention below that overlap with the description of the technology underlying the invention will also be omitted.

[0024] Hereinafter, a stylet unit for perforating a human organ according to an embodiment of the present invention will be described in detail with reference to the attached drawings.

[0025] FIG. 1 is a cross-sectional view showing an endoscope channel inserted into the urethra during a procedure using a stylet unit for perforating a human organ according to an embodiment of the present invention, FIG. 2 is a cross-sectional view showing an endoscope channel separated from an embodiment of the present invention, and FIG. 3 is a cross-sectional view for explaining the configuration and operation process of an embodiment of the present invention.

[0026] As shown in these drawings, a stylet unit (2) for perforating a human organ according to one embodiment of the present invention is configured to move through an endoscope channel (1; see FIG. 1) inserted into a human body to form a hole on one side of a human organ, and includes a perforation prevention member (21), a perforation member (22), and an elastic member (23).

[0027] As well illustrated in (a) of FIGS. 2 and 3, the above-mentioned perforation prevention member (21) is intended to prevent unexpected perforation of a part other than the perforation target part of a human body organ, and is formed in a blunt shape, for example, such as a curved surface, with a tip shape that is not sharp, and is formed in a tubular shape so that a guide wire (3) can pass through, and communication holes (211a)(212a) that enable exposure of the guide wire (3) are formed at the tip and the rear ends, respectively.

[0028] As shown in (b) of FIGS. 2 and 3, the above-mentioned perforation member (22) is capable of perforating a target area of ​​a human organ for perforation, in contrast to the above-mentioned perforation prevention member (21), and includes a tip portion (221) and a space-forming portion (222), and is combined in a form that surrounds the perforation prevention member (21) so that the perforation prevention member (21) is positioned on the inside.

[0029] The above-mentioned tip (221) is formed with a sharp tip to enable perforation of the bladder wall (B1) and is positioned behind the tip of the perforation prevention member (21), and the space forming member (222) has a movement space formed therein to allow relative movement of the perforation prevention member (21).

[0030] The above elastic member (23) is installed in the space forming part (222) of the above perforation member (22) and serves to elastically support the rear end of the above perforation prevention member (21).

[0031] According to an embodiment of the present invention having such a configuration, the stylet unit for perforating a human organ is configured so that, before applying pressure by bringing the perforation prevention member (21) close to the human organ, the tip of the perforation prevention member (21) is positioned further forward than the tip of the perforation member (22), as shown in (a) of FIG. 3, so as to prevent unexpected perforation, and when a pressure greater than the elastic force of the elastic member (23) is applied after bringing the perforation prevention member (21) into contact with the organ, the pointed tip of the perforation member (22) is positioned further forward than the perforation prevention member (21), so as to perforate the human organ, thereby preventing the occurrence of side effects of the procedure due to unexpected perforation of a part other than the target part when perforating the human organ, and enabling even a non-experienced specialist to accurately and safely perforate the target part. Therefore, it has the advantage of ultimately increasing the convenience and satisfaction of the procedure and enabling the provision of high-quality medical services.

[0032] Meanwhile, the anti-perforation member (21) can be formed integrally with a single material, but in this embodiment, for ease of manufacturing, a structure was adopted in which the anti-perforation member (211) having a communication hole (211a) formed at the front end and the sliding member (212) having a communication hole (212a) formed at the rear end were manufactured separately and then joined together.

[0033] The above-mentioned puncture prevention part (211) has a tubular structure with a bluntly formed tip, and the sliding part (212) is coupled to the rear end of the puncture prevention part (211) and is elastically pressed against an elastic member (23) installed in the moving space of the puncture member (22), so that when no external force is applied, the tip of the puncture prevention part (211) can be positioned further forward than the tip (221), as shown in (a) of FIG. 3.

[0034] In addition, the space-forming part (222) of the perforated member (22) can be formed integrally with a single material, but in this embodiment, a structure in which the first part (222a) and the second part (222b) are manufactured separately and then joined together is adopted so that the elastic member (23) can be easily installed inside the space-forming part (222) of the perforated member (22).

[0035] The first part (222a) above is a part that surrounds the sliding part (212) of the anti-perforation member (21), and the second part (222b) is a part that forms a moving space in which the sliding part (212) can move together with the first part (222a), and is screw-connected to the first part (222a), one end of the elastic member (23) is supported, and a part of the sliding part (212) passes through it.

[0036] This embodiment having such a configuration has the advantage of allowing the elastic member (23) for elastically pressing the rear end of the puncture prevention member (21) to be easily installed on the inside of the puncture member (22) by placing the elastic member (23) on the inside of the second part (222b) while the first part (222a) is arranged to surround the sliding part (212), and then allowing the sliding part (212) to pass without interference in the process of bringing the second part (222b) closer to the first part (222a), and screw-connecting the first part (222a) and the second part (222b) after the sliding part (212) passes, thereby enabling the elastic member (23) for elastically pressing the rear end of the puncture prevention member (21) to be easily installed on the inside of the puncture member (22).

[0037] Hereinafter, a medical device for transmitting multiple drainage tubes according to one embodiment of the present invention will be described in detail with reference to FIGS. 4 to 6.

[0038] FIG. 4 is a drawing for explaining an organic coupling relationship between a stylet unit and a guide wire employed in a medical device for delivering a multiple drainage tube according to one embodiment of the present invention, FIG. 5 is a drawing for explaining an organic coupling relationship between a guide wire and a dilatator employed in one embodiment of the present invention, and FIG. 6 is a drawing for explaining an organic coupling relationship between a guide wire and a pushing device employed in one embodiment of the present invention.

[0039] As well illustrated in FIGS. 4 and 6, the medical device for delivering a drainage tube employed in this embodiment comprises the stylet unit (2) described above, the guide wire (3) described below, and the pusher (8), so as to move the abdominal cavity-bladder connecting catheter (hereinafter referred to as 'drainage tube (7)') for fluidically connecting the abdominal cavity (A) and the bladder (B) to the bladder wall (B1), which is the reference for dividing the area between the abdominal cavity (A) and the bladder (B).

[0040] The above guide wire (3) is inserted into the perforation site by sequentially passing through the communication holes (212a) (211a) formed at the rear and front ends of the perforation prevention member (21) after a portion of the bladder wall (B1) is perforated using the stylet unit (2) described above, as shown in (a) of FIG. 4, and serves to guide a dilator (5, see FIG. 5) for expanding the perforation site and a drainage tube (7, see FIG. 6) providing a drainage path for multiple drains, etc., to the perforation site. During the procedure, after the front end of the guide wire (3) is positioned in the abdominal cavity (A) as shown in (a) of FIG. 4, the stylet unit (2) is removed as shown in (b) of FIG. 4.

[0041] The dilator (5) employed in this embodiment is intended to further enlarge the hole of the perforated bladder wall (B1) by utilizing the stylet unit (2), and is guided along the guide wire (3) as shown in (a) of Fig. 5 to enlarge the hole of the bladder wall (B1), and then removed as shown in (b) of Fig. 5.

[0042] The above pusher (8) positions the ascites drainage tube (7) between the guide wire (3) and the endoscope channel (1) as shown in (b) of FIG. 6, with the tip of the guide wire (3) penetrating the perforation prevention member and positioned on the abdominal cavity (A) side as shown in (a) of FIG. 6, and then pushes the ascites drainage tube (7) toward the perforation site by the stylet so that it can be inserted into the perforation site. Thereafter, when the guide wire (3) is removed as shown in (c) of FIG. 6, the ascites drainage tube (7) is prevented from coming off from the bladder wall (B1) as the ends of the ascites drainage tube (7) are rolled to provide a fixing force.

[0043] According to an embodiment of the present invention, a medical device for delivering a drainage tube having such a configuration uses a stylet unit (2) including a perforation prevention member (21) and a perforation member (22) to precisely and safely perforate a target perforation site of a bladder wall (B1), and then uses a guide wire (3) and a pushing device (8) to smoothly insert a drainage tube (7) into the perforation site, thereby enabling a drainage tube insertion procedure to be performed quickly and precisely in a safe manner, thereby ultimately increasing the reliability of medical services due to improved procedure safety, and has the advantage of being able to provide customized medical services to patients due to improved procedure convenience.

[0044] Although various embodiments of the present invention have been described above, the embodiments and the drawings attached to the present specification only clearly show a part of the technical idea included in the present invention, and it will be obvious that all modified examples and specific embodiments that can be easily inferred by a person skilled in the art within the scope of the technical idea included in the specification and drawings of the present invention are included in the scope of the rights of the present invention.

Claims

1. It is intended to move through an endoscopic channel inserted into the human body and create a hole in one side of the human organ. A perforation prevention member having a tubular shape so that a guide wire can pass through it, with a leading end and a trailing end having communication holes formed therein to allow the guide wire to be exposed; A perforation member having a tip end formed to be pointed and positioned behind the tip end of the perforation prevention member so that the perforation prevention member is positioned inside, and a space forming part formed at the rear end of the tip end and having a moving space that allows relative movement of the perforation prevention member; and Including an elastic member installed in the space forming part of the above perforation member to elastically support the rear end of the above perforation prevention member; A stylet unit for perforating a human organ, characterized in that before applying pressure to the perforation prevention member by bringing the perforation prevention member closer to the human organ, the tip of the perforation prevention member is positioned further forward than the tip of the perforation member, thereby preventing unexpected perforation, and after bringing the perforation prevention member into contact with the organ, when a pressure greater than the elastic force of the elastic member is applied, the perforation prevention member retreats, thereby allowing the pointed tip of the perforation member to be positioned further forward than the perforation prevention member, thereby allowing the human organ to be perforated.

2. In paragraph 1, A stylet unit for perforating a human organ, characterized in that the above-mentioned perforation prevention member includes a tubular perforation prevention member having a bluntly formed tip, and a sliding member that is coupled to the rear end of the perforation prevention member and is elastically pressed against an elastic member installed in a moving space of the perforation member.

3. In paragraph 2, A stylet unit for perforating a human organ, characterized in that the space expansion part of the perforation member includes a first part that surrounds the perforation prevention member, and a second part that is screw-connected to the first part, supports one end of the elastic member, and passes through the sliding part.

4. Including the stylet unit of paragraph 1 or 2, the abdominal cavity-bladder connecting catheter (hereinafter referred to as “ascites drainage tube”) for fluidly connecting the abdominal cavity and bladder is moved to the bladder wall, which is the standard for dividing the area between the abdominal cavity and the bladder. A guide wire passing through a communication hole formed at the front and rear ends of the above-mentioned perforation prevention member; and A medical device for delivering a drainage tube, characterized in that it includes a pushing device that positions a drainage tube between the guide wire and the cystoscope channel while the tip of the guide wire sequentially penetrates the communication holes of the perforation prevention member and is positioned on the abdominal cavity side, and then pushes the drainage tube toward the portion perforated by the stylet.

Citation Information

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