A self-sealing bladder puncture and fistula creation assembly

Abstract

The present invention provides a self-sealing bladder puncture and fistula creation assembly, belonging to the technical field of medical auxiliary instruments. A self-sealing bladder puncture and fistula creation assembly includes a tearable sheath, a stylet, and a self-sealing mechanism. The tearable sheath is sleeved outside the stylet. The self-sealing mechanism includes a needle cap, a control button, a compression spring, a urine drainage hole, a distal cavity of the needle cap, and a proximal cavity of the needle cap. The control button can move up and down within the needle cap. When the puncture needle successfully punctures into the bladder and contacts urine, it can instantaneously drain urine to remind the operator that the puncture is in place, without the need to rely on other devices or multiple punctures, preventing secondary injuries. When at rest, it is tightly sealed by the compression spring to prevent urine from flowing out. The structure of the present invention is simple, the cost is low, and the operation is convenient at the same time.

Description

Technical Field

[0001] The present invention relates to the field of medical auxiliary devices, and particularly to a self-sealing bladder puncture and fistula forming assembly. Background Art

[0002] Clinically, bladder puncture and fistula forming is a common surgical procedure, often used to treat patients with neurogenic bladder or urinary retention. For bladder fistula forming, relatively quick puncture and fistula forming is mostly selected. Puncture and fistula forming needles are also divided into traditional surgical kits that are disinfected, sterilized and reused, and disposable bladder puncture and fistula forming assemblies. For the convenience of use and to avoid cross-infection, disposable puncture and fistula forming assemblies have gradually become the mainstream. Chinese Patent (Application No.: CN201120156121.7, Application Date: May 7, 2011) proposed a combined puncture and fistula forming assembly composed of an inner core and an outer sheath; Chinese Patent (Application No.: CN201320345218.1, Application Date: June 17, 2013) and Chinese Patent (Application No.: CN201621241522.1, Application Date: November 10, 2016) changed the outer sheath to a tearable sheath, thus meeting the clinical requirement of disposable use.

[0003] The existing bladder puncture mainly has the following difficulties: 1. Since the puncture needle is too sharp, it may penetrate too deep during the operation, damaging the posterior wall of the bladder or surrounding organ tissues, which is mainly seen in the sharp inner cores such as traditional reusable surgical kits; 2. In order to mark the puncture into the bladder during the operation, almost all inner cores of puncture and fistula forming tubes have a urine drainage cavity. During the puncture process, urine in the bladder will quickly spray upward along the urine drainage cavity, thus contaminating the operating table, and the puncture channel may be lost due to the rapid retraction of the bladder, resulting in surgical failure. Especially when young doctors are not fully prepared before the operation, they will be in an embarrassing situation of being flustered during the operation. For doctors, it is difficult to prevent urine backflow and perform the next surgical preparation at the same time.

[0004] In order to make the puncture smooth during the operation and reduce secondary injuries, Chinese Patent (Application No.: CN201821295955.4, Application Date: August 13, 2018) proposed a puncture inner core with a retractable blade; in order to prevent complications caused by the rapid leakage of urine in the bladder during the operation, Chinese Invention Patent Application (Application No.: CN201911226184.2, Application Date: December 4, 2019) proposed a puncture cannula with a cross-shaped flap, but this method is not stable and cannot effectively solve this problem.

[0005] However, some of the above patents are not suitable for making disposable puncture and fistula tubes. Some have a puncture inner core that is too sharp and prone to causing secondary injuries. Some do not solve the complication of intraoperative urine leakage. Some have an outer sheath that is prone to damaging the catheter water sac and leading to surgical failure. Some solve one of these problems, but the overall effect is less than ideal.

[0006] Therefore, those skilled in the art are committed to researching a bladder puncture and fistula assembly that solves the complication of urine leakage. Summary of the Invention

[0007] 1. Technical Problems to be Solved by the Invention

[0008] The purpose of the present invention is to overcome the problem of rapid urine leakage after puncture with a traditional bladder puncture and fistula needle, and provides a self-sealing bladder puncture and fistula assembly. When the puncture needle successfully punctures into the bladder and contacts urine, it can instantaneously drain urine to remind the operator that the puncture is in place. When at rest, it forms a seal under the pressure of a compression spring to prevent urine from flowing out.

[0009] 2. Technical Solution

[0010] To achieve the above purpose, the technical solution provided by the present invention is as follows:

[0011] A self-sealing bladder puncture and fistula assembly includes a tearable sheath and a needle core, and the tearable sheath is sleeved outside the needle core;

[0012] It further includes a self-sealing mechanism, and the self-sealing mechanism includes a needle cap, a control button, and a compression spring;

[0013] The upper part of the needle cap has a proximal cavity of the needle cap, and the lower part of the needle cap has a distal cavity of the needle cap. The needle cap is also provided with a urine drainage hole communicating with the proximal cavity of the needle cap; the urine inlet hole at the distal end of the needle core communicates with the distal cavity of the needle cap through the cavity inside the needle core;

[0014] The control button is accommodated in the needle cap and can move up and down inside the needle cap; the compression spring abuts against the control button upward, the lower end of the compression spring abuts against the bottom of the proximal cavity of the needle cap, and the lower end of the control button forms a seal between the distal cavity of the needle cap and the proximal cavity of the needle cap, isolating the distal cavity of the needle cap from the proximal cavity of the needle cap;

[0015] When the control button is pressed downward, the seal formed by the lower end of the control button is released, and the distal cavity of the needle cap communicates with the proximal cavity of the needle cap; when pressing the control button stops, the control button is pushed back by the compression spring and the seal is restored.

[0016] The structure of the present invention is simple, with low cost, and is convenient to operate. When the puncture needle successfully punctures into the bladder and contacts the urine, it can instantaneously drain the urine to remind the operator that the puncture is in place. At the same time, when the operator stops applying external force, due to the activation of the self-sealing mechanism, the occurrence of urine leakage can be effectively prevented, allowing the operator to have sufficient time to prepare the next surgical instrument materials after the puncture is successful.

[0017] As a further improvement of the present invention, the control button is in the shape of a "work" character, and the control button is stuck in the cavity of the needle cap. The proximal end of the control button is large and the distal end is small. The proximal end of the control button is located in the proximal cavity of the needle cap, and the distal end of the control button is located in the distal cavity of the needle cap. Under the action of the compression spring, the upper edge of the distal end of the control button abuts against the upper wall surface of the distal cavity of the needle cap to form a seal. The control button can be fixed inside the needle cap and can move up and down at the same time. Pressing the control button will separate the upper edge of the distal end of the control button from the upper wall surface of the distal cavity of the needle cap. The "work" character structure is not easy to fall off from the cavity. At the same time, using the horizontal part of the "work" character to abut against the upper wall surface of the distal cavity makes the seal more airtight.

[0018] As a further improvement of the present invention, a seal is formed between the distal cavity and the proximal cavity of the needle cap, and a sealing ring is provided at the corresponding position at the lower end of the control button. The sealing ring can improve the sealing effect and prevent urine reflux during isolation.

[0019] As a further improvement of the present invention, it further includes a waterproof ring. The waterproof ring is in a circular ring shape and is fixed in the groove on the outer periphery of the proximal end of the control button. Although the tight contact between the control button and the proximal cavity is used to avoid urine leakage, the waterproof ring can better prevent urine leakage from the proximal cavity of the needle cap.

[0020] As a further improvement of the present invention, it includes a plurality of waterproof rings arranged in parallel, and the plurality of waterproof rings are arranged in a plurality of corresponding grooves at the proximal end of the control button. Further improve the sealing effect.

[0021] As a further improvement of the present invention, the compression spring is sleeved on the middle section of the control button, or includes a plurality of compression springs, which are respectively located outside the middle section of the control button.

[0022] As a further improvement of the present invention, the tearable sheath is in a round tube shape, the proximal end of the tearable sheath is folded back, tearable notches are provided at symmetrical positions on both sides of the proximal end of the tearable sheath, and the folded ends on both sides of the notch are respectively locked and fixed by locking parts to form 2 tear handles. The distal end of the tearable sheath shrinks obliquely inward to form a distal slope. It can not only make the sheath body close to the inner core to ensure smooth sheath insertion, but also reduce the damage to the surrounding tissues during sheath insertion.

[0023] As a further improvement of the present invention, the tip of the stylet is sharp, and the head end of the stylet is conical; there are tissue stripping flanks covering both sides of the head end of the stylet; a circular urine inlet hole is opened near the end of the head end of the stylet, and the urine inlet hole is connected to the stylet lumen inside the stylet body, and the proximal end of the stylet body is integrally connected with the needle cap. The edges of the tissue stripping flanks are sharp, facilitating the further penetration of the stylet into the bladder.

[0024] As a further improvement of the present invention, the stylet is made of 304 steel or other metals or polycarbonate (PC), acrylonitrile-butadiene-styrene (ABS) or other rigid plastics; and / or, the tearable sheath is made of polytetrafluoroethylene (PTFE) or other plastic materials. Metals or rigid plastics can ensure the rigidity and force conduction during puncture, prevent damage and ensure puncture accuracy; the soft tearable sheath can also avoid the surgical failure caused by the secondary damage of the sharp outer sheath to the catheter balloon.

[0025] As a further improvement of the present invention, scale lines are marked on the outer side of the tearable sheath; and / or, X-ray imaging lines are provided on the sheath body of the tearable sheath, which are made of a mixture of polytetrafluoroethylene (PTFE) and barium sulfate (BaSO4). The scale lines can indicate the depth of sheath insertion; when the position of the tearable sheath is uncertain during the operation, bedside X-ray fluoroscopy can be performed, and the imaging lines on the tearable sheath can be imaged to show the position of its front end, assisting the operator to judge.

[0026] 3. Beneficial effects

[0027] Adopting the technical solution provided by the present invention, compared with the prior art, it has the following beneficial effects:

[0028] A self-sealing bladder puncture and fistula forming assembly of the present invention includes a tearable sheath, a stylet, and a self-sealing mechanism. The tearable sheath is sleeved outside the stylet: the self-sealing mechanism includes a needle cap, a control button, a compression spring, a urine drainage hole, a distal cavity of the needle cap, and a proximal cavity of the needle cap. When the puncture needle successfully punctures into the bladder and contacts urine, it can instantaneously drain urine to remind the operator that the puncture is in place, without the need to rely on other equipment or multiple punctures, preventing secondary injuries. At rest, it is tightly sealed by the compression spring to prevent urine from flowing out, allowing the operator to have sufficient time to prepare the next surgical instrument materials after successful puncture. Using a soft tearable sheath can avoid damaging the catheter balloon. The edges of the tissue stripping flanks at the distal end of the stylet are sharp, facilitating the further penetration of the stylet into the bladder and reducing secondary damage to tissues. The structure of the present invention is simple, low in cost, and convenient to operate. Description of the drawings

[0029] Figure 1 It is a schematic diagram of the overall structure of the present invention;

[0030] Figure 1a It is a cross-sectional view of the overall structure of the present invention;

[0031] Figure 2Schematic diagram of the tearable sheath structure;

[0032] Figure 2a Cross-sectional view of the tearable sheath;

[0033] Figure 3a Schematic diagram of the structure of the puncture needle core;

[0034] Figure 3b High-definition schematic diagram of the head end of the needle core;

[0035] Figure 4a Schematic diagram of the cooperation of the needle cap, compression spring and control button (before pressing);

[0036] Figure 4b Schematic diagram of the cooperation of the needle cap, compression spring and control button (after pressing);

[0037] Figure 5 High-definition partial schematic diagram of the sealing ring and waterproof ring;

[0038] Figure 6 Schematic diagram of the urine flow channel;

[0039] Figure 7 Schematic diagram of inserting a urinary catheter after successful puncture;

[0040] Figure 8 Schematic diagram of tearing the tearable sheath.

[0041] Explanation of the labels in the schematic diagram:

[0042] 1. Tearable sheath; 101. Proximal fold; 102. Tear handle; 103. Locking member; 104. Distal bevel; 105. Notch;

[0043] 2. Needle core; 201. Head end of the needle core; 202. Needle tip; 203. Tissue stripping flank; 204. Urine inlet hole; 205. Needle core body; 206. Needle core lumen;

[0044] 3. Self-sealing mechanism; 301. Needle cap; 302. Control button; 303. Waterproof ring; 304. Compression spring; 305. Sealing ring; 306. Urinary catheterization hole; 307. Distal cavity of the needle cap; 308. Proximal cavity of the needle cap;

[0045] 4. Urinary catheter. Detailed implementation manners

[0046] To further understand the content of the present invention, the present invention will be described in detail in combination with the accompanying drawings and embodiments.

[0047] The structures, proportions, sizes, etc. shown in the accompanying drawings of this specification are only used to cooperate with the content disclosed in the specification for those familiar with this technology to understand and read, and are not used to limit the limiting conditions under which the present invention can be implemented. Therefore, they do not have a substantial technical meaning. Any modification of the structure, change in the proportional relationship, or adjustment of the size, without affecting the effects that the present invention can produce and the purposes that can be achieved, should still fall within the scope covered by the technical content disclosed in the present invention. At the same time, terms such as "upper", "lower", "left", "right", "middle", etc. cited in this specification are only for the convenience of clear narration and are not used to limit the scope of implementation. The change or adjustment of their relative relationship, without substantial change in the technical content, should also be regarded as the scope in which the present invention can be implemented.

[0048] Specifically, the terms "distal end", "front end" or "head end" refer to the position close to or entering the patient, while the terms "proximal end", "tail end" or "end" refer to the position close to the operator. Other directional terms can be understood according to the accompanying drawings and the following description.

[0049] Please refer to Figure 1 、 1a 、 Figure 2 、 2a 、 Figure 3a and Figure 3b , a self-sealing bladder puncture and fistula creation assembly according to this embodiment includes a tearable sheath 1, a stylet 2, and a self-sealing mechanism 3. The tearable sheath 1 is sleeved outside the stylet 2. The stylet 2 has a hollow structure, and the stylet head end 201 of the stylet 2 is in the shape of a slope or a cone, which is convenient for piercing into the bladder. The overall shape of the stylet 2 is a straight tube, and the piercing process can minimize the occurrence of secondary injuries as much as possible. The self-sealing mechanism 3 includes a needle cap 301, a control button 302, a compression spring 304, a urine drainage hole 306, a distal cavity 307 of the needle cap, and a proximal cavity 308 of the needle cap. The needle cap 301 is a ring-shaped structure, and the control button 302 is accommodated in the needle cap 301. The control button 302 can move up and down inside the needle cap 301. A compression spring 304 is sleeved outside the control button 302. When the control button 302 is not under force, it is pushed out of the upper end of the needle cap 301 by the compression spring 304. Please refer to Figure 4a and Figure 4bThe needle cap 301 is divided into an upper part and a lower part. The upper part of the needle cap 301 is provided with a needle cap proximal cavity 308, and the lower part of the needle cap 301 is provided with a needle cap distal cavity 307. The control button 302 is buckled in the needle cap, and the upper end of the control button 302 is located at the top of the needle cap proximal cavity 308, and the lower end of the control button 302 is located in the needle cap distal cavity 307. When the control button 302 is not subjected to force, the compression spring 304 presses the control button 302 upward, and the lower end of the compression spring 304 presses against the bottom of the needle cap proximal cavity 308, and the lower end of the control button 302 forms a seal between the needle cap proximal cavity and the needle cap distal cavity 307; when the control button 302 is subjected to downward pressure, the compression spring 304 is compressed, the control button 302 moves downward, the seal is released, and a channel is formed between the needle cap distal cavity 307 and the needle cap proximal cavity 308; after the force is removed, the seal is formed again. A urinary catheter hole 306 is provided on one side of the needle cap 301, and the urinary catheter hole 306 is connected to the proximal cavity 308 of the needle cap. When the puncture needle successfully punctures the bladder and contacts urine, urine can be drained instantly, reminding the operator that the puncture is in place. The internal cavity of the needle core 2 is connected to the distal cavity 307 of the needle cap.

[0050] See also Figure 5 Preferably, the needle cap 301 is made of plastic materials such as polycarbonate (PC), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene (ABS), etc., and is in the shape of a disc or a flat cube, with smooth chamfered edges and protruding toward the proximal end and the distal end in the middle, so as to facilitate the operator to hold during the operation. The upper part of the needle cap 301 is consistent with the shape of the needle cap 301 and has a smooth surface.

[0051] See also Figure 5 Preferably, the control button 302 is in the shape of an I-shaped letter, and is buckled into the cavity of the needle cap 301. The proximal end of the control button 302 is large and the distal end is small. The proximal end of the control button 302 is located in the proximal cavity 308 of the needle cap, and the distal end of the control button 302 is located in the distal cavity 307 of the needle cap. When the control button is in a resting state, the distal upper edge of the I-shaped control button abuts against the upper wall of the distal cavity of the needle cap to form a seal.

[0052] It should be noted that the control button can also adopt a T-shaped structure, with the distal end of the T-shaped vertical part being wide and the proximal end being narrow. The distal end of the T-shaped vertical part is used to form a seal between the distal cavity of the needle cap and the proximal cavity of the needle cap. When the distal end is pushed into the distal cavity of the needle cap, the narrower part of the vertical part reaches the sealing part and cannot play a sealing role, so the proximal cavity of the needle cap and the distal cavity of the needle cap are connected.

[0053] See also Figure 5, preferably, it further includes a sealing ring 305. The sealing ring 305 is arranged at the distal end of the control button 302. Preferably, a groove is formed at the distal end of the control button 302, and the sealing ring 305 is arranged in the groove. At rest, the sealing ring 305 forms a seal between the distal end of the control button 302 and the distal cavity 307 of the needle cap, which can prevent urine reflux. The sealing ring 305 is made of soft plastics such as silica gel, latex, and rubber to form a soft pad, improving the sealing effect and extending the service life of the device.

[0054] Please refer to Figure 5 , preferably, it further includes a waterproof ring 303. The waterproof ring 303 is annular and fixed in the proximal groove of the "I"-shaped control button 302, and is connected to the proximal cavity 308 of the needle cap, which can prevent urine from leaking out of the proximal cavity 308 of the needle cap during the operation. Preferably, two or more horizontal grooves are arranged at the proximal end of the control button 302. Correspondingly, two or more waterproof rings 303 are arranged in the grooves, which can further improve the sealing effect.

[0055] The proximal end of the compression spring 304 is connected to the control button, and the distal end is connected to the bottom of the proximal cavity 308 of the needle cap. The compression spring 304 can be a single spring, which is sleeved on the middle section of the "I"-shaped control button. Multiple compression springs 304 can also be arranged, which are respectively located on the outside of the middle section of the control button 302. Preferably, the multiple springs are equidistantly distributed.

[0056] Preferably, 2 compression springs 304 are arranged, which are respectively located on both sides of the middle section of the control button 302. 4 compression springs 304 can also be arranged, which are respectively located on the four sides of the middle section of the control button 302.

[0057] Please refer to Figure 2 , preferably, the tearable sheath 1 is in a tubular shape. The tearable sheath 1 is made of plastic materials such as polytetrafluoroethylene (PTFE). The proximal end of the tearable sheath 1 is turned over to form a proximal fold 101. At symmetric positions on both sides of the proximal end of the tearable sheath 1, there are tearable notches 105. The folded ends on both sides of the notch are respectively locked and fixed by locking members 103 to form two tearing handles 102 for the operator to hold when tearing. The sheath body of the tearable sheath 1 is provided with X-ray imaging lines, which are made of a mixture of polytetrafluoroethylene (PTFE) and barium sulfate (BaSO4). Scale lines are marked on the outer side of the sheath body of the tearable sheath 1, which can indicate the depth of sheath insertion. The distal end of the tearable sheath 1 is inclined and shrinks inward to form a distal slope 104, which can not only make the sheath body closely adhere to the inner core to ensure smooth sheath insertion, but also reduce the damage to the surrounding tissues during sheath insertion.

[0058] Preferably, the needle core 2 is made of metals such as 304 steel or hard plastics such as polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS), which can ensure the rigidity and force transmission during puncture. Please refer to Figure 3a and Figure 3b, the tip end 201 of the stylet 2 is made of plastic material, the tip 202 is sharp, the tip end 201 of the stylet is conical and slightly flattened, and there are tissue splitting flanks 203 covered on both sides of the tip end 201 of the stylet, with sharp edges. A circular urine inlet hole 204 is opened near the end of the tip end 201 of the stylet 2. Preferably, one urine inlet hole 204 is opened on each side, or multiple urine inlet holes 204 can be opened. The main body part of the stylet 2 is the stylet body 205, and inside the stylet body 205 is the stylet inner cavity 206. The urine inlet hole 204 is connected to the stylet inner cavity 206. The proximal end of the stylet body 205 is inserted into the distal cavity 307 of the needle cap. The stylet body 205 is in the shape of a long cylinder, with a smooth surface, can conduct urine during the operation, and is integrally connected with the needle cap 301 at the proximal end.

[0059] Please refer to Figure 7 , it also includes a urinary catheter 4, and a water sac is provided on the outer side of the distal end of the urinary catheter 4. After the stylet 2 is pulled out by driving the needle cap 301, only the tearable sheath 1 remains in the patient's body. At this time, the urinary catheter 4 is inserted into the tearable sheath 1, and the water sac of the urinary catheter 4 expands to clamp the inside of the bladder. After removing the tearable sheath 1, the urinary catheter 4 is set in place.

[0060] A self-sealing bladder puncture and fistula forming assembly of this embodiment is used for patients with clinical urinary retention or inability to urinate independently. The patient is routinely disinfected, covered with a sterile drape, and as much normal saline as possible is injected into the bladder; two transverse fingers above the pubis are taken. After successful local anesthesia, the syringe is used to puncture the bladder and urine is seen successfully.

[0061] The present invention operates the bladder puncture and fistula formation through the following steps.

[0062] Please refer to Figure 1 , Figure 2 , Figure 3a and Figure 4a , take the stylet 2 of the bladder puncture and fistula forming needle. At this time, the compression spring 304 is in a straight state, the control button 302 is at the proximal end of the needle cap 301 and protrudes from the surface of the needle cap 301; the sealing ring 305 is buckled at the proximal end of the distal cavity 307 of the needle cap, and the waterproof ring 303 is at the proximal end of the proximal cavity 308 of the needle cap along with the control button 302. The stylet 2 is inserted into the tearable sheath 1, and the tip end 201 of the stylet needs to expose the distal end of the tearable sheath 1. The proximal end of the tearable sheath 1 is connected to the needle cap 301; it is prepared for puncture and fistula formation.

[0063] Please refer to Figure 1 , Figure 3b , Figure 4b and Figure 5, the operator holds the end of the needle cap 301 with the right hand (or the left hand, determined according to the operator's usage habit, the same below), pinches the needle core body 205 and the tearable sheath 1 outside it with the thumb, index finger and middle finger, uses the thenar and hypothenar to push the control button 302 forward, compresses the compression spring 304 to displace distally, and drives the distal structure of the control button 302 away from the distal cavity 307 of the needle cap. Align the tip 202 with the puncture site to be punctured, insert the needle vertically, and the operator holds the needle core 2 of the suprapubic cystostomy needle and pushes it downward in a spiral manner. At this time, the tip 202 and the tissue stripping flank 203 penetrate into the tissue space under the action of external force and perform a combined sharp and blunt separation of the tissue until the anterior wall of the bladder.

[0064] Please refer to Figure 3b , Figure 4b and Figure 6 , the operator further punctures the anterior wall of the bladder, the head end 201 of the needle core enters the bladder and contacts the urine. At this time, the operator will feel a sense of falling, indicating that the head end 201 of the needle core has entered the bladder. At this time, the urine in the bladder enters through the urine inlet hole 204, enters the distal cavity 307 of the needle cap through the inner cavity 206 of the needle core, and enters the proximal cavity 308 of the needle cap through the gap between the control button 302 and the needle cap 301 because the sealing ring 305 is separated from the distal cavity 307 of the needle cap. Because the proximal cavity 308 of the needle cap communicates with the outside through the urine drainage hole 306, the operator can see the urine flowing out from the urine drainage hole 306. Because there is a waterproof ring 303 around the needle cap 301 for protection, the urine will not ooze out from the gap between the needle cap 301 and the proximal cavity 308 of the needle cap. Continue to apply external force to push the suprapubic cystostomy needle forward by 2 - 3 cm to ensure that the distal part of the tearable sheath 1 on the needle core body 205 enters the bladder and does not slip off. Generally, it is necessary to keep the distal inclined plane 104 part enter the bladder cavity by 1 - 2 cm. The operator can release the right hand. As Figure 4a shown, at this time, the compression spring 304 returns to the straight state, the proximal push control button 302 is at the proximal end of the needle cap 301 and protrudes from the surface of the needle cap 301; the sealing ring 305 is buckled at the proximal end of the distal cavity 307 of the needle cap to isolate the urine and prevent it from flowing back continuously, and the waterproof ring 303 is at the proximal end of the proximal cavity 308 of the needle cap along with the control button 302. Because the urine no longer flows back, the operator has sufficient time to prepare the next surgical supplies.

[0065] Before inserting the urinary catheter 4, the operator can press the control button 302 to observe the water outflow situation of the urine drainage hole 306. If the water outflow is smooth, it indicates that the suprapubic cystostomy needle has not shifted. Otherwise, it is necessary to push the needle core 2 forward by a certain distance again to ensure that it is in the bladder cavity; if it is uncertain, or the urine in the bladder is not much, at this time, bedside X-ray fluoroscopy can be performed, and the imaging line on the tearable sheath 1 can be imaged to show the position of its front end, assisting the operator to judge. Please refer to Figure 7 and Figure 8, remove the stylet 2, leaving only the tearable sheath 1 in the patient's body. The operator can quickly hold the proximal fold 101 of the tearable sheath 1 with the thumb to prevent urine leakage. The assistant inserts the urinary catheter 4 downward along the tearable sheath 1 until most of it is located in the bladder cavity. Inject the water balloon of the urinary catheter 4 and connect it to the external drainage urine bag. Pull the urinary catheter 4 upward to make the water balloon press against the anterior wall of the bladder; slowly lift the tearable sheath 1 upward along the periphery of the urinary catheter 4, and at the same time pull the tear handle 102 to both sides until the entire sheath body is completely torn; finally, suture and fix the urinary catheter 4, and the operation is completed.

[0066] It should be noted that the tearable sheath and the stylet in the above embodiments adopt a separable structure, and the tearable sheath and the stylet need to be combined first during the surgical use, or they can also be combined during production.

[0067] The present invention and its implementation manners have been described schematically above. The description is not restrictive. What is shown in the drawings is only one of the implementation manners of the present invention, and the actual structure is not limited thereto. Therefore, if those of ordinary skill in the art are inspired by it and design similar structural manners and embodiments to the technical solution without creative efforts without departing from the gist of the present invention, they shall fall within the protection scope of the present invention.

Claims

1. A self-sealing bladder puncture and fistula component, comprising a tearable sheath and a stylet, wherein the tearable sheath is sleeved outside the stylet, and is characterized in that: It further comprises a self-sealing mechanism, and the self-sealing mechanism includes a needle cap, a control button, and a compression spring; The upper part of the needle cap is provided with a proximal cavity of the needle cap, and the lower part of the needle cap is provided with a distal cavity of the needle cap. The needle cap is also provided with a urine drainage hole communicated with the proximal cavity of the needle cap; the urine inlet hole at the distal end of the stylet is communicated with the distal cavity of the needle cap through the cavity inside the stylet; The control button is accommodated in the needle cap, and the control button can move up and down inside the needle cap; the compression spring abuts against the control button upwards, the lower end of the compression spring abuts against the bottom of the proximal cavity of the needle cap, and the lower end of the control button forms a seal between the distal cavity of the needle cap and the proximal cavity of the needle cap, isolating the distal cavity of the needle cap from the proximal cavity of the needle cap; When the control button is pressed downwards, the seal formed by the lower end of the control button is released, and the distal cavity of the needle cap is communicated with the proximal cavity of the needle cap; when pressing the control button stops, the control button is pushed back by the compression spring and the seal is restored.

2. The self-sealing bladder puncture and fistula component according to claim 1, characterized in that: The control button is in an "I" shape, and the control button is stuck in the cavity of the needle cap. Among them, the proximal end of the control button is located in the proximal cavity of the needle cap, and the distal end of the control button is located in the distal cavity of the needle cap. Under the action of the compression spring, the upper edge of the distal end of the control button abuts against the upper wall surface of the distal cavity of the needle cap to form a seal.

3. The self-sealing bladder puncture and fistula creation assembly according to claim 1, wherein: At the position where a seal is formed between the distal cavity of the needle cap and the proximal cavity of the needle cap, a sealing ring is provided at the corresponding position of the lower end of the control button.

4. The self-sealing bladder puncture and fistula creation assembly according to claim 1, wherein: It further comprises a waterproof ring, and the waterproof ring is in a circular ring shape and is fixed in a groove on the outer periphery of the proximal end of the control button.

5. The self-sealing bladder puncture and fistula component according to claim 4, characterized in that: It includes a plurality of waterproof rings arranged in parallel, and the plurality of waterproof rings are arranged in a plurality of corresponding grooves at the proximal end of the control button.

6. The self-sealing bladder puncture and fistula creation assembly according to claim 1, wherein: The compression spring is sleeved on the middle section of the control button, or includes a plurality of compression springs, which are respectively located outside the middle section of the control button.

7. The self-sealing bladder puncture and fistula creation assembly according to claim 1, wherein: The tearable sheath is in a circular tube shape, the proximal end of the tearable sheath is folded back, and tearable notches are provided at symmetric positions on both sides of the proximal end of the tearable sheath. The folded ends on both sides of the notch are respectively locked and fixed by a locking member to form 2 tearing handles. The distal end of the tearable sheath is contracted obliquely inward to form a distal slope.

8. The self-sealing bladder puncture and fistula creation assembly according to claim 1, wherein: The head end of the stylet is conical; both sides of the head end of the stylet are covered with tissue stripping flanks.

9. The self-sealing bladder puncture and fistula creation assembly according to any one of claims 1-8, characterized in that: The stylet is made of metal or hard plastic; and / or, the tearable sheath is made of soft plastic material.

10. The self-sealing bladder puncture and fistula creation assembly according to any one of claims 1-8, characterized in that: Scale lines are marked on the outside of the tearable sheath; and / or, X-ray imaging lines are provided on the sheath body of the tearable sheath.

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