Tearable sheath for percutaneous renal puncture operation

Abstract

The utility model belongs to the technical field of medical instruments, and discloses a tearable sheath for percutaneous renal puncture surgery, which comprises a sheath tube, a non-degradable balloon component is mounted on the sheath tube, the sheath tube comprises a tearable hard tube and a tearable soft tube, the tearable soft tube is arranged on the inner side of the tearable hard tube, and the tearable soft tube is connected with the tearable hard tube. The inner wall of the tearing hard tube is coated with a chitosan coating, the outer surface of the tearing hard tube is coated with a hyaluronic acid coating, a special material with hemostasis and anti-adhesion functions and a surface treatment process are adopted, in the operation process, once bleeding occurs, the hemostasis effect can be achieved in time, the bleeding amount is reduced, the operation risk is reduced, and meanwhile the operation efficiency is improved. After the operation, the adhesion of tissues and the sheathing canal can be effectively prevented, the pain of a patient is relieved, the postoperative recovery is promoted, the balloon filling degree, the supporting force, the drug release rate and the like can be flexibly adjusted according to the operation process and requirements, the ability of the operation to deal with complex conditions is improved, and the operation safety and effect are guaranteed.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the technical field of medical apparatus and instruments, and particularly relates to a tearable sheath for percutaneous nephrostomy operation. BACKGROUND

[0002] The conventional percutaneous nephrostomy tearable sheath has single function and is difficult to meet the modern operation requirement, and the main function is only to construct a channel, and lacks active hemostasis, anti-adhesion and local drug treatment functions, once bleeding occurs during the operation, additional operation is needed for hemostasis, which not only prolongs the operation time, increases the operation risk and operation difficulty, but also may affect the operation visual field due to untimely hemostasis, and further affect the operation effect; postoperative tissue adhesion problems frequently occur, which easily causes pain, infection, ureteral obstruction and various complications, and seriously affects the rehabilitation process and life quality of the patient; and since there is no drug release function, drugs cannot be directly released at the operation site to prevent infection or reduce inflammatory reaction, which is not conducive to the postoperative recovery of the patient.

[0003] The prior art also has obvious deficiencies, the conventional invisible sheath material is mostly ordinary medical plastic, and the doctor cannot observe the position and state of the sheath tube in the body during the operation, and can only operate by experience and hand feeling, so that the puncture is easy to be too shallow or too deep, the puncture is too shallow, and the nephroscope and dilator need to be repeatedly replaced, which increases the operation time and the pain of the patient; the puncture is too deep, and may cause kidney perforation, and cause serious bleeding, renal pelvis mucosa perforation and other complications, although the product of the patent CN202011606313 solves the problem of visualization, the structure is complex, is composed of multiple components and needs to be separately assembled, which undoubtedly increases the preparation work and operation difficulty of the medical staff, and the connection between the components is not tight enough or not smooth enough, which may also affect the smoothness of the operation, and the minimally invasive dilatation drainage kit of the patent CN2022234454816 focuses on the hardness and puncture force of the dilatation tube, but does not involve the hemostasis function during the puncture process and the prevention of postoperative tissue adhesion, and the overall structure of the kit is relatively complex, contains multiple components that cooperate with each other, and increases the use cost and maintenance difficulty. UTILITY MODEL CONTENTS

[0004] To solve the problems in the background art, the utility model provides a tearable sheath for percutaneous nephrostomy operation, which has the advantages of providing support and drug release function during the operation, and can perform hemostasis and prevent adhesion.

[0005] To achieve the above-mentioned purpose, the utility model provides the following technical scheme: a tearable sheath for percutaneous nephrostomy operation, comprising a sheath tube, a non-degradable balloon assembly is installed on the sheath tube;

[0006] The sheath pipe comprises a tearable hard pipe and a tearable soft pipe, the tearable soft pipe is arranged inside the tearable hard pipe, the inner wall of the tearable hard pipe is coated with a chitosan coating, and the outer surface of the tearable hard pipe is coated with a hyaluronic acid coating.

[0007] The non-degradable balloon assembly comprises a balloon, a slow-release drug is arranged in the balloon, a gas guide port is communicated with the balloon lumen, the gas guide port is connected with a filling interface through a gas guide pipeline, and the filling interface is arranged at the pipe seat position of the sheath pipe.

[0008] Preferably, the pipe seat position of the sheath pipe is provided with two correspondingly arranged tearable structures.

[0009] Preferably, the balloon is connected to the outer wall of the sheath pipe through a cyanoacrylate adhesive.

[0010] Preferably, the outer side of the connection position of the balloon and the sheath pipe is provided with a biocompatible sealant, and the inner side of the connection position of the balloon and the sheath pipe is provided with a medical rubber sealing ring.

[0011] Preferably, a flow regulating valve is mounted on the pipeline of the filling interface.

[0012] Preferably, a pressure sensor is mounted on the inner wall of the balloon.

[0013] Compared with the prior art, the beneficial effects of the utility model are as follows:

[0014] 1. The utility model adopts special materials and surface treatment processes with hemostatic and anti-adhesion functions. In the surgical process, once bleeding occurs, the hemostatic effect can be exerted in time to reduce the amount of bleeding and reduce the risk of surgery. At the same time, after the operation, the organization can be effectively prevented from adhering to the sheath pipe, the pain of the patient is reduced, and the postoperative recovery is promoted.

[0015] 2. The utility model can flexibly adjust the balloon filling degree, supporting force and drug release rate according to the operation process and demand, improve the ability of the operation to cope with complex situations, and guarantee the safety and effect of the operation. BRIEF DESCRIPTION OF DRAWINGS

[0016] Figure 1 It is a whole structure schematic view of the utility model;

[0017] Figure 2 It is a structure schematic view of the sheath pipe of the utility model;

[0018] Figure 3 It is a structure schematic view of the gas guide pipeline of the utility model;

[0019] Figure 4 It is a structure schematic view of the balloon of the utility model;

[0020] Figure 5 It is a whole structure schematic view of the utility modelFigure 4 Enlarged structure schematic diagram at middle A.

[0021] Figure: 1, sheath tube; 101, tear hard tube; 102, tear soft tube;

[0022] 2, non-degradable balloon assembly; 201, balloon; 202, slow-release drug; 203, air guide; 204, air guide pipe; 205, filling interface;

[0023] 3, chitosan coating; 4, hyaluronic acid coating; 5, tearable structure; 6, cyanoacrylate adhesive; 7, biocompatible sealant; 8, medical rubber seal ring; 9, flow regulating valve; 10, pressure sensor. DETAILED DESCRIPTION

[0024] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0025] As shown in Figures 1 to 5 The present application provides a tearable sheath for percutaneous renal puncture surgery, which comprises a sheath tube 1, and a non-degradable balloon assembly 2 is installed on the sheath tube 1;

[0026] The sheath 1 comprises a tearable hard tube 101 and a tearable soft tube 102, the tearable soft tube 102 is arranged inside the tearable hard tube 101, the inner wall of the tearable hard tube 101 is coated with a chitosan coating 3, the outer surface of the tearable hard tube 101 is coated with a hyaluronic acid coating 4, the tearable hard tube 101 is made of medical polyether ether ketone (PEEK) material, which has the characteristics of high strength, low friction coefficient and good biocompatibility, the chitosan coating 3 coated on the inner wall of the tearable hard tube 101 is the key to hemostasis, chitosan has good biocompatibility and carries a positive charge, when the surgical instruments move in the tearable hard tube 101 or blood vessels are damaged during the operation to cause bleeding, red blood cells and platelets in the blood carry a negative charge, the chitosan coating 3 can quickly adsorb red blood cells and platelets through electrostatic action, activate blood clotting factors and promote platelet aggregation, thereby accelerating the blood clotting process, forming a blood clot at the bleeding site quickly, effectively reducing bleeding and keeping the surgical field clear, providing a strong guarantee for the smooth progress of the operation, the tearable soft tube 102 is mainly made of medical silicone material, which is soft and has good flexibility and biocompatibility, the outer surface is wrapped with a hyaluronic acid coating 4 which has high hydrophilicity and lubricity, during the operation, when the tearable soft tube 102 contacts the kidney tissue, the hyaluronic acid coating 4 can adsorb water from the surrounding tissue to form a layer of hydrated gel, this gel layer can significantly reduce the direct contact area between the tissue and the tearable soft tube 102, reduce the friction, at the same time, hyaluronic acid can inhibit the proliferation of fibroblasts and the deposition of collagen, thereby effectively preventing the adhesion between the tissue and the tearable soft tube 102, when the tearable sheath is removed after the operation, this anti-adhesion function can minimize the pulling injury to the kidney tissue and surrounding blood vessels and nerves, which is beneficial to the rapid recovery of the patient after the operation;

[0027] The non-degradable balloon assembly 2 comprises a balloon 201, the balloon 201 is provided with a slow-release drug 202, the balloon 201 is connected with a gas guide port 203, the gas guide port 203 is connected with a filling interface 205 through a gas guide pipe 204, the filling interface 205 is arranged at the tube seat position of the sheath tube 1, the balloon 201 is made of medical polyurethane material, which has excellent elasticity, good biocompatibility and excellent wear resistance, and can maintain stable physical and chemical properties in the body for a long time, the slow-release drug 202 is an antibiotic such as cefuroxime and an anti-inflammatory drug such as dexamethasone, the antibiotic such as cefuroxime and the anti-inflammatory drug such as dexamethasone are loaded into the balloon 201 by immersion method, the drug molecules are uniformly distributed in the pores of the balloon 201 material and attached to the inner surface of the balloon 201, when the balloon 201 starts to fill, for example, physiological saline is injected into the balloon 201 using a syringe, the balloon 201 wall will be stretched, the pressure in the balloon 201 will rise, this change destroys the interaction between the drug molecules and the balloon 201 material, at the same time, a drug concentration gradient is formed inside and outside the balloon 201, the drug molecules begin to diffuse to the surrounding tissue along this gradient, the microporous structure of the balloon 201 wall plays a key role in the drug release process, the micropore size is in the nanometer to micrometer range, the drug molecules are released from the balloon 201 to the surrounding tissue through these micropores, the size and density of the micropores accurately determine the diffusion path and resistance of the drug, thereby effectively controlling the release rate of the drug and ensuring that the drug can continuously and stably play a role during the operation, such as continuously preventing infection and reducing inflammation, the balloon 201 is in a filled state, the internal pressure can be maintained within a stable range, this pressure can make the balloon 201 expand outward and tightly contact the inner wall of the renal collecting system, the elastic material of the balloon 201 can effectively resist the peristalsis of the renal tissue and various disturbances caused by external operation, and the supporting effect is mainly to provide a stable position for the tearable sheath in the kidney, when the surgical instrument passes through the tearable sheath to enter the kidney, the balloon 201 acts as a reliable "support" to prevent the tearable sheath from shifting or deforming, and ensures that the surgical instrument can accurately reach the stone position or the lesion site for operation, greatly improving the accuracy and stability of the operation.

[0028] Specifically, the tube seat position of the sheath tube 1 is provided with two corresponding tearable structures 5 for tearing the sheath tube 1.

[0029] Further, the balloon 201 is connected to the outer wall of the sheath tube 1 by a cyanoacrylate adhesive 6.

[0030] Further, a biocompatible sealant 7 is arranged outside the connection position of the balloon 201 and the sheath 1 to further fill the gap at the connection position and form a secondary sealing and reinforcement, so as to ensure that the drug cannot seep out and external liquid cannot enter. A medical rubber sealing ring 8 is arranged inside the connection position of the balloon 201 and the sheath 1 to play a buffering and preliminary sealing role, which can effectively reduce the impact on the connection position when the balloon 201 is inflated or the instrument is operated, and prevent the drug from leaking.

[0031] It is worth noting that a flow regulating valve 9 is arranged on the pipeline of the inflation interface 205, which can accurately control the flow of liquid in and out of the balloon 201. When the balloon 201 needs to be inflated, the flow regulating valve 9 is adjusted to an appropriate opening degree to allow the liquid in the syringe to flow into the balloon 201. When the inflated state of the balloon 201 needs to be maintained, the flow regulating valve 9 is closed to prevent the liquid from entering or leaving.

[0032] It is worth noting that a pressure sensor 10 is arranged on the inner wall of the balloon 201, which can monitor the pressure inside the balloon 201 in real time and transmit the pressure data to the monitoring device at the bedside of the operating bed. Medical staff can adjust the flow regulating valve 9 more accurately according to the pressure value displayed on the monitoring device to realize accurate control of the inflation and deflation of the balloon 201, and ensure that the state of the balloon 201 during the operation always meets the operation requirements.

[0033] Working principle and process: During the operation, the stable support of the balloon 201 provides a reliable foundation for the tearable hard tube 101, enabling it to play a more stable role in dealing with bleeding. When the blood vessel is injured and bleeding, the chitosan coating 3 on the inner wall of the tearable hard tube 101 can more accurately adsorb platelets and promote blood coagulation under the support of the balloon 201, because the support of the balloon 201 prevents the displacement of the tearable hard tube 101 caused by bleeding impact or instrument operation, thereby ensuring the maximization of hemostatic effect. At the same time, the anti-adhesion function of the tearable soft tube 102 is further optimized in the presence of the balloon 201. The inflated state of the balloon 201 makes the position of the tearable soft tube 102 relatively fixed in the kidney tissue, reducing unnecessary friction between the soft tube and the tissue, while the hyaluronic acid coating 4 of the tearable soft tube 102 reduces the risk of tissue adhesion, both of which work together to effectively protect the kidney tissue from injury and reduce the incidence of postoperative complications. In addition, the balloon 201, combined with the tearable sheath, also has the new function of dynamically adjusting the surgical environment. As the operation progresses, the balloon 201 can adjust the inflation degree as needed, thereby changing the support strength of the tearable sheath and the release rate of the drug. For example, when the operation is more intense or encounters greater resistance, the inflation pressure of the balloon 201 can be appropriately increased to enhance the support of the tearable sheath and ensure the stability of the surgical channel. At the same time, the increase in pressure will also accelerate the release of the drug to a certain extent, in order to better cope with the risk of infection or inflammation that may be caused by surgical operation. During the relatively stable stage of the operation, the pressure of the balloon 201 can be appropriately reduced to maintain the basic support and drug release function, reduce the sustained pressure on the kidney tissue, and reduce the possibility of tissue damage. This dynamic adjustment function is a unique innovation of the balloon 201 combined with the tearable sheath, which can be flexibly adjusted according to the real-time needs of the operation, greatly improving the safety and effectiveness of the operation, and providing more comprehensive protection for the surgical treatment and postoperative rehabilitation of patients.

[0034] It should be noted that in this text, relational terms such as first and second are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "contain" or any other variant thereof are intended to cover non-exclusive inclusion, so that the process, method, article or equipment including a series of elements not only includes those elements, but also includes other elements not explicitly listed or inherent to such process, method, article or equipment.

[0035] Although the embodiments of the present application have been shown and described, it is to be understood that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present application, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A tearable sheath for percutaneous nephrostomy procedures comprising a sheath tube (1) characterised in that: The sheath (1) is provided with a non-degradable balloon assembly (2); The sheath (1) comprises a tearable hard tube (101) and a tearable soft tube (102), the tearable soft tube (102) is arranged inside the tearable hard tube (101), the inner wall of the tearable hard tube (101) is coated with a chitosan coating (3), and the outer surface of the tearable hard tube (101) is coated with a hyaluronic acid coating (4); The non-degradable balloon assembly (2) comprises a balloon (201), the balloon (201) is provided with a sustained-release drug (202) inside, the balloon (201) is provided with a gas guide port (203) in communication with the inner cavity of the balloon (201), the gas guide port (203) is connected with a filling interface (205) through a gas guide pipeline (204), and the filling interface (205) is arranged at the tube seat position of the sheath (1).

2. A tearable sheath for percutaneous nephrolithotomy procedures as defined in claim 1, wherein: The tube seat position of the sheath (1) is provided with two corresponding tearable structures (5).

3. A tearable sheath for percutaneous nephrolithotomy procedures as defined in claim 1, wherein: The balloon (201) is connected to the outer wall of the sheath (1) through a cyanoacrylate adhesive (6).

4. A tearable sheath for percutaneous nephrolithotomy procedures as defined in claim 3, wherein: The outer side of the connection position of the balloon (201) and the sheath (1) is provided with a biocompatible sealant (7), and the inner side of the connection position of the balloon (201) and the sheath (1) is provided with a medical rubber sealing ring (8).

5. The tearable sheath for percutaneous nephrolithotomy procedures of claim 1, wherein: The pipeline of the filling interface (205) is provided with a flow regulating valve (9).

6. The tearable sheath for percutaneous nephrolithotomy procedures of claim 1, wherein: The inner wall of the balloon (201) is provided with a pressure sensor (10).

Images