Visualized pressure regulating catheter

Abstract

The present invention discloses a visualized pressure-regulating catheter, comprising a catheter body, a water pressure expansion balloon and a pressure regulating handle arranged on the catheter body; an endoscope pressure-regulating cavity and an expansion fluid perfusion cavity are formed inside the catheter body; the expansion fluid perfusion cavity is communicated with the water pressure expansion balloon; a perfusion port and a pressure regulating port are arranged on the pressure regulating handle; the perfusion port and the pressure regulating port are respectively communicated with the expansion fluid perfusion cavity and the endoscope pressure-regulating cavity; an observation channel is arranged on the endoscope pressure-regulating cavity at a position opposite to the axial direction of the water pressure expansion balloon; a camera located at the front end of the endoscope passes through the pressure regulating port, the endoscope pressure regulating cavity and the observation channel in sequence and extends into the water pressure expansion balloon; and an operating rod located at the end of the endoscope is slidably and sealedly connected with the pressure regulating port.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and further to a visualized pressure-regulating catheter, and in particular to a catheter that cooperates with an endoscope and is used to precisely regulate a balloon expansion position and expansion pressure during organ tissue cavity and vascular dilation treatment. Background Art

[0002] At present, it is becoming more and more common to dilate and treat various diseases by introducing a balloon catheter into the patient's blood vessels or other tissue cavities (for example, the vagina, urinary tract, airway, intestine, bile duct or esophagus, etc.). The basic principle of the application of the above-mentioned balloon catheter is to treat the lesion by transmitting mechanical dilation pressure to the lesion through the dilation balloon. After the balloon catheter is dilated, the balloon is withdrawn to reduce pressure. While the decompressed balloon reduces the mechanical pressure on the lesion tissue, the outer diameter of the balloon will also shrink significantly due to the reduction in pressure. The conventional clinical dilation treatment operation process mainly relies on angiography, B-ultrasound and other equipment to assist in determining the dilation site and dilation pressure during the operation. Since the auxiliary images are not intuitive images, the operation process is greatly affected by the operator's experience.

[0003] In the prior art, the use of endoscopes for medical diagnosis has been widely used in the medical field. Endoscopes can enter the natural cavities of the human body and provide intuitive images to examine the internal structure of the cavities. They are an important means of diagnosis. Matching surgical instruments can also perform fine treatments on the cavities, making the surgical process safer and more effective. Therefore, the use of endoscope-assisted balloon catheters to dilate lesions in cavities is becoming more and more widespread in clinical practice, such as in the esophagus, intestines, or urinary tract. There are two main ways to perform endoscope-assisted balloon dilation surgeries. One is to deliver the surgical instruments to the lesion site through the endoscopic instrument cavity, and the other is to push the endoscope and surgical instruments in parallel to the lesion site. Since the balloon catheter and the endoscope are relatively independent, both methods have the following defects:

[0004] 1. During the surgical process, due to the compression of the cavity, the balloon catheter and the endoscope affect each other, making the surgical operation inconvenient. It is often impossible to observe the condition of the instruments, and the operation is basically in a completely blind or semi-blind state.

[0005] Second, the balloon catheter and the endoscope are in the front-to-back position, and the endoscope cannot accurately observe the balloon positioning and expansion process, and cannot adjust the expansion site and expansion pressure in real time, which brings great inconvenience to the operation.

[0006] Currently, no effective solution has been given to the problem that balloon catheters and endoscopes are inconvenient to use in conjunction with each other and have poor effects.

[0007] Therefore, the inventor, relying on his many years of experience and practice in related industries, proposes a visualized pressure regulating catheter to overcome the defects of the prior art. Summary of the invention

[0008] The purpose of the present invention is to provide a visualized pressure-regulating catheter, which is easy to operate and greatly improves the positioning efficiency of the endoscope through guidance. It can cooperate with the endoscope to adjust the balloon positioning and expansion. The balloon expansion process can be observed in real time through the endoscope to observe the expanded lesion site, thereby preventing the expansion treatment from failing due to balloon sliding during the expansion process.

[0009] Another object of the present invention is to provide a visualized pressure-regulating catheter, which can observe tissue changes during the expansion process in real time through an endoscope, and accurately adjust the expansion pressure of the balloon by adjusting the position of the endoscope in the pressure-regulating cavity, thereby greatly improving the efficiency and effect of the operation.

[0010] Another object of the present invention is to provide a visualized pressure-regulating catheter that can provide local linear pressure to the lesion site when the balloon is fully expanded, thereby dividing the severely proliferative and narrow lesion tissue into multiple lesion areas, reducing the ability of the lesion site to rebound after expansion, and improving the surgical treatment effect.

[0011] The purpose of the present invention can be achieved by adopting the following technical solutions:

[0012] The present invention provides a visualized pressure-regulating catheter, which comprises a catheter body, a water pressure expansion balloon and a pressure regulating handle arranged on the catheter body, an endoscope pressure-regulating cavity and an expansion liquid perfusion cavity are formed inside the catheter body along the extension direction of the catheter body, the expansion liquid perfusion cavity is connected with the water pressure expansion balloon, and a perfusion port and a pressure regulating port are arranged on the pressure regulating handle, the perfusion port and the pressure regulating port are respectively connected with the expansion liquid perfusion cavity and the endoscope pressure regulating cavity;

[0013] An observation channel is provided on the endoscope pressure regulating cavity at a position axially opposite to the water pressure expansion balloon. A camera located at the front end of the endoscope passes through the pressure regulating port, the endoscope pressure regulating cavity and the observation channel in sequence and extends into the water pressure expansion balloon. An operating rod located at the end of the endoscope is slidably and sealedly connected to the pressure regulating port.

[0014] In a preferred embodiment of the present invention, the pressure regulating handle is disposed at one end of the catheter body, a conical sealing head is disposed at the other end of the catheter body, and the water pressure expansion balloon is disposed close to the sealing head.

[0015] In a preferred embodiment of the present invention, a pressure regulating valve is provided on the pressure regulating handle, and the pressure regulating port is located on the pressure regulating valve.

[0016] In a preferred embodiment of the present invention, a steering guide is provided at the observation channel away from the pressure regulating handle, and the steering guide is provided with an arc-shaped edge inclined toward the outside of the endoscope pressure regulating cavity to guide the camera at the front end of the endoscope to extend from the observation channel.

[0017] In a preferred embodiment of the present invention, the endoscope pressure regulating lumen is coaxially arranged with the expansion fluid perfusion lumen, and the expansion fluid perfusion lumen is annularly arranged outside the endoscope pressure regulating lumen.

[0018] In a preferred embodiment of the present invention, the catheter body includes an inner tube body and an outer tube body sleeved on the outside of the inner tube body, so as to form the endoscope pressure regulating cavity inside the inner tube body, and form the expansion fluid perfusion cavity between the inner tube body and the outer tube body, the end of the water pressure expansion balloon away from the pressure regulating handle is connected to the inner tube body, and the end of the water pressure expansion balloon close to the pressure regulating handle is connected to the outer tube body, and the observation channel passes through the inner tube body and the outer tube body in sequence and is connected to the interior of the water pressure expansion balloon.

[0019] In a preferred embodiment of the present invention, the central axis of the endoscope pressure regulating lumen is arranged parallel to the central axis of the expansion fluid perfusion lumen, the endoscope pressure regulating lumen is located at the axial center of the catheter body, and the cross-sectional area of ​​the endoscope pressure regulating lumen is larger than the cross-sectional area of ​​the expansion fluid perfusion lumen, both ends of the water pressure expansion balloon are connected to the catheter body, and the observation channel runs through the catheter body and is connected to the interior of the water pressure expansion balloon.

[0020] In a preferred embodiment of the present invention, the endoscope pressure regulating channel and the expansion fluid perfusion channel are the same common channel.

[0021] In a preferred embodiment of the present invention, a blocking balloon is provided on the catheter body near the water pressure expansion balloon, and an expansion liquid filling tube is provided inside the catheter body, and the expansion liquid filling tube is connected to the inside of the blocking balloon.

[0022] In a preferred embodiment of the present invention, at least one developing ring is provided on the catheter body at a position axially opposite to the hydraulic dilatation balloon.

[0023] In a preferred embodiment of the present invention, a guide tube is provided on one end of the catheter body away from the pressure regulating handle, one end of the guide tube is sealed, and the other end of the guide tube is integrally connected to the catheter body.

[0024] In a preferred embodiment of the present invention, a local pressure reinforcement rib is provided on the outside of the water pressure expansion balloon, one end of the local pressure reinforcement rib is sealed and connected to the catheter body, and the other end of the local pressure reinforcement rib extends away from the pressure regulating handle to the end of the catheter body and is sealed and connected to the catheter body.

[0025] In a preferred embodiment of the present invention, the number of the water pressure expansion balloon is one or a plurality of water pressure expansion balloons are continuously arranged along the axial direction of the catheter body, and the water pressure expansion balloon is made of a transparent material.

[0026] As described above, the characteristics and advantages of the visualized pressure regulating catheter of the present invention are:

[0027] An endoscope pressure regulating cavity and an expansion fluid perfusion cavity are formed inside the catheter body, the expansion fluid perfusion cavity is connected to the water pressure expansion balloon, the pressure regulating handle is provided with a perfusion port connected to the expansion fluid perfusion cavity and a pressure regulating port connected to the endoscope pressure regulating cavity, and an observation channel is opened on the endoscope pressure regulating cavity, and liquid is transported into the expansion fluid perfusion cavity through the perfusion port to control the expansion of the water pressure expansion balloon, so as to achieve the purpose of treating the lesion; in addition, the pressure regulating port can be used as an insertion port for the endoscope, and the camera at the front end of the endoscope passes through the pressure regulating port, the endoscope pressure regulating cavity and the observation channel in turn and extends into the water pressure expansion balloon. During use, the endoscope can not only observe the situation in the cavity in real time, but also can observe and confirm the position of the balloon in real time throughout the process of water pressure expansion balloon expansion treatment, so as to prevent the failure of expansion treatment due to sliding of the water pressure expansion balloon, and ensure the smooth progress of expansion treatment.

[0028] When the endoscope is inserted into the interior of the catheter body, a sliding seal is adopted between the operating rod at the end of the endoscope and the pressure regulating port, so that a closed chamber is formed inside the catheter body. During use, the pressure in the closed chamber can be adjusted by adjusting the volume of the endoscope entering the catheter body and the position of the endoscope, and the expansion pressure of the water pressure expansion balloon can be accurately adjusted. This process does not require the injection or extraction of liquid into the water pressure expansion balloon through the expansion fluid injection cavity, thereby avoiding the problem of poor treatment effect caused by insufficient or excessive expansion of the water pressure expansion balloon, thereby improving the treatment effect on the lesion.

[0029] Local pressure reinforcement ribs are arranged on the outside of the water pressure expansion balloon, which can provide local linear pressure to the diseased area when the water pressure expansion balloon is fully expanded. The diseased area can be expanded and divided into multiple areas for treatment without significantly increasing the expansion pressure of the water pressure expansion balloon, thereby significantly reducing the rebound of the diseased tissue after expansion treatment, especially for severely proliferative and stenotic diseased tissue that is not well treated by simple balloon expansion. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The following drawings are only intended to illustrate and explain the present invention, and are not intended to limit the scope of the present invention.

[0031] in:

[0032] Figure 1 : It is a structural schematic diagram of the visualized pressure regulating conduit of the present invention.

[0033] Figure 2 : It is a structural schematic diagram of the steering guide vane in the visualized pressure regulating conduit of the present invention.

[0034] Figure 3 : It is one of the cross-sectional schematic diagrams of the catheter body in one embodiment of the visualized pressure regulating catheter of the present invention.

[0035] Figure 4 : This is the second cross-sectional schematic diagram of the catheter body in an embodiment of a visualized pressure-regulating catheter of the present invention.

[0036] Figure 5 : It is one of the cross-sectional schematic diagrams of the catheter body in another embodiment of the visualized pressure-regulating catheter of the present invention.

[0037] Figure 6 : This is the second schematic cross-sectional view of the catheter body in another embodiment of the visualized pressure-regulating catheter of the present invention.

[0038] Figure 7 : It is a schematic diagram of the installation position of the developing ring in the visual pressure regulating duct of the present invention.

[0039] Figure 8 : It is a schematic diagram of the installation position of the guide tube in the visual pressure regulating catheter of the present invention.

[0040] Fig. 9 : It is a schematic diagram of the setting position of the blocking balloon and the expansion fluid filling tube in the visual pressure regulating catheter of the present invention.

[0041] Fig.10 : It is one of the cross-sectional schematic diagrams of the setting position of the expansion fluid filling tube in the visual pressure regulating catheter of the present invention.

[0042] Fig.11 : This is the second cross-sectional schematic diagram of the setting position of the expansion fluid filling tube in the visualized pressure regulating catheter of the present invention.

[0043] Fig.12 : It is a schematic diagram of the setting position of the local pressure reinforcement ribs in the visual pressure regulating conduit of the present invention.

[0044] Fig.13 : It is a schematic diagram of the structure of the water pressure expansion balloon in the first embodiment of the visualized pressure regulating catheter of the present invention.

[0045] Fig.14 : It is a schematic diagram of the structure of the water pressure expansion balloon in the second embodiment of the visualized pressure regulating catheter of the present invention.

[0046] Fig.15 : It is a schematic diagram of the structure of the water pressure expansion balloon in the third embodiment of the visualized pressure regulating catheter of the present invention.

[0047] Fig.16 : It is a schematic diagram of the structure of the water pressure expansion balloon in the fourth embodiment of the visualized pressure regulating catheter of the present invention.

[0048] Fig.17 : It is a schematic diagram of the structure of the water pressure expansion balloon in the fifth embodiment of the visualized pressure regulating catheter of the present invention.

[0049] The accompanying drawings in the present invention are:

[0050] 1. catheter body; 101. outer tube body;

[0051] 102. inner tube body; 103. sealing head;

[0052] 2. Water pressure expansion balloon; 3. Pressure regulating handle;

[0053] 301. Infusion port; 4. Observation channel;

[0054] 5. Endoscope pressure regulating channel; 6. Expansion fluid perfusion channel;

[0055] 7. Pressure regulating valve; 701. Pressure regulating port;

[0056] 8. Steering guide; 9. Developing ring;

[0057] 10. Occluding balloon; 11. Dilating fluid filling tube;

[0058] 12. Guide tube; 13. Local pressure reinforcement ribs. DETAILED DESCRIPTION

[0059] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, specific embodiments of the present invention are now described with reference to the accompanying drawings.

[0060] like Figures 1 to 16As shown, the present invention provides a visualized pressure-regulating catheter, which comprises a catheter body 1, a water pressure expansion balloon 2 and a pressure regulating handle 3 arranged on the catheter body 1, an endoscope pressure-regulating cavity 5 and an expansion liquid perfusion cavity 6 are formed inside the catheter body 1 along the extension direction of the catheter body 1, the expansion liquid perfusion cavity 6 is connected with the inside of the water pressure expansion balloon 2, a perfusion port 301 and a pressure regulating valve 7 are arranged on the pressure regulating handle 3, a pressure regulating port 701 is arranged on the pressure regulating valve 7, the perfusion port 301 is connected with the expansion liquid perfusion cavity 6, and the pressure regulating port 701 is connected with the endoscope pressure-regulating cavity 5; a position on the endoscope pressure-regulating cavity 5 opposite to the axial direction of the water pressure expansion balloon 2 is opened An observation channel 4 is provided, and a camera located at the front end of the endoscope passes through the pressure regulating port 701, the endoscope pressure regulating cavity 5 and the observation channel 4 in sequence and extends into the water pressure expansion balloon 2. The operating rod located at the end of the endoscope is slidingly and sealingly connected to the pressure regulating port 701, so that the endoscope pressure regulating cavity 5, the expansion liquid perfusion cavity 6 and the interior of the water pressure expansion balloon 2 form a closed chamber with a fixed volume. By pulling or pushing the operating rod part of the endoscope outside the pressure regulating port 701, the endoscope part located in the closed chamber can be controlled to move, so as to change the space occupied by the endoscope in the closed chamber, thereby being able to flexibly and precisely adjust the expansion pressure of the water pressure expansion balloon 2.

[0061] During use of the present invention, liquid can be transported into the expansion liquid infusion cavity 6 through the infusion port 301 to control the expansion of the water pressure expansion balloon 2, thereby achieving the purpose of treating the lesion site; in addition, the pressure regulating port 701 can be used as an insertion port for an endoscope, and the camera at the front end of the endoscope passes through the pressure regulating port 701, the endoscope pressure regulating cavity 5 and the observation channel 4 in sequence and extends into the water pressure expansion balloon 2. During this process, the endoscope can not only observe the situation in the cavity in real time, but also can observe and confirm the position of the water pressure expansion balloon 2 in real time throughout the expansion treatment process of the water pressure expansion balloon 2, thereby preventing the failure of the expansion treatment due to the sliding of the water pressure expansion balloon 2, and ensuring the smooth progress of the expansion treatment. Since the operating rod at the end of the endoscope is connected to the pressure regulating port 701 by a sliding seal, a closed chamber is formed inside the catheter body 1. During use, the pressure in the closed chamber can be adjusted by adjusting the volume of the endoscope entering the catheter body 1 and the position of the endoscope, and the expansion pressure of the water pressure expansion balloon 2 can be accurately adjusted. This process does not require the injection or extraction of liquid into the water pressure expansion balloon 2 through the expansion liquid injection channel 6, thereby avoiding the problem of poor treatment effect caused by insufficient expansion or excessive expansion of the water pressure expansion balloon 2, thereby improving the treatment effect on the lesion site.

[0062] Furthermore, the infusion port 301 may be a Luer connector but is not limited to one.

[0063] Furthermore, the length of the catheter body 1 is 10 cm to 250 cm, and the outer diameter of the catheter body 1 is 0.1 cm to 1.5 cm.

[0064] Furthermore, when the water pressure expansion balloon 2 is in a fully expanded state, the axial length of the contact position between the water pressure expansion balloon 2 and the diseased part (i.e., the effective working section length of the water pressure expansion balloon 2) is 1mm to 300mm, and the diameter of the water pressure expansion balloon 2 (effective expansion diameter) is 1mm to 100mm.

[0065] Furthermore, the axial length of the observation channel 4 in the endoscope pressure regulating cavity 5 is 3 mm to 50 mm.

[0066] In an optional embodiment of the present invention, Figure 1 As shown, the pressure regulating handle 3 is arranged at one end of the catheter body 1, and a conical sealing head 103 is arranged at the other end of the catheter body 1, and the water pressure expansion balloon 2 is arranged close to the sealing head 103. The conical sealing head 103 plays a guiding role, which facilitates the delivery of the water pressure expansion balloon 2 to the patient's lesion site.

[0067] Furthermore, the catheter body 1 and the sealing head 103 are both made of plastic material. Preferably, the catheter body 1 and the sealing head 103 are both made of transparent plastic material.

[0068] In an optional embodiment of the present invention, Figure 2 As shown, a steering guide 8 is provided on the side of the observation channel 4 away from the pressure regulating handle 3, and the steering guide 8 is provided with an arc-shaped edge inclined toward the outside of the endoscope pressure regulating cavity 5. When the endoscope is transported to the observation channel 4 through the endoscope pressure regulating cavity 5, the steering guide 8 uses its arc-shaped edge to guide the endoscope, thereby assisting the endoscope to turn and extend into the interior of the water pressure expansion balloon 2.

[0069] In an optional embodiment of the present invention, Figure 3 , Figure 4 As shown, the endoscope pressure regulating lumen 5 and the expansion liquid perfusion lumen 6 are coaxially arranged (i.e., the interior of the catheter body 1 is a coaxial double-lumen structure), and the expansion liquid perfusion lumen 6 is arranged in a ring outside the endoscope pressure regulating lumen 5. The cross section of the endoscope pressure regulating lumen 5 is circular or square; the cross section of the expansion liquid perfusion lumen 6 is circular or crescent-shaped.

[0070] Specifically, Figure 1 , Figure 3 , Figure 4As shown, the catheter body 1 includes an inner tube body 102 and an outer tube body 101 sleeved on the outer side of the inner tube body 102, so as to form an endoscope pressure regulating lumen 5 inside the inner tube body 102, and an expansion liquid perfusion lumen 6 between the inner tube body 102 and the outer tube body 101, the end of the hydraulic expansion balloon 2 away from the pressure regulating handle 3 is integrally connected to the inner tube body 102, and the end of the hydraulic expansion balloon 2 close to the pressure regulating handle 3 is integrally connected to the outer tube body 101, and the observation channel 4 sequentially penetrates the inner tube body 102 and the outer tube body 101 and is connected to the inside of the hydraulic expansion balloon 2. In addition, the inner tube body 102 can be used as a reinforcing rib of the outer tube body 101, and the arrangement of the inner tube body 102 can enhance the anti-bending ability and pushing control performance of the catheter body 1.

[0071] Furthermore, the diameter of the inner tube body 102 gradually decreases from the end close to the pressure regulating handle 3 to the end far from the pressure regulating handle 3, which can allow the water pressure expansion balloon 2 to have a larger retraction space when it is retracted and folded. After the water pressure expansion balloon 2 is folded, it has a smaller radial dimension, which is beneficial to improve the passing ability of the water pressure expansion balloon 2 in the narrow lesion area.

[0072] In an optional embodiment of the present invention, Figure 5 , Figure 6 As shown, the central axis of the endoscope pressure regulating lumen 5 is arranged parallel to the central axis of the expansion liquid perfusion lumen 6 (that is, the interior of the catheter body 1 is a non-coaxial double-lumen structure), the endoscope pressure regulating lumen 5 is located at the axial center of the catheter body 1, and the cross-sectional area of ​​the endoscope pressure regulating lumen 5 is larger than the cross-sectional area of ​​the expansion liquid perfusion lumen 6, both ends of the water pressure expansion balloon 2 are connected to the catheter body 1, and the observation channel 4 runs through the catheter body 1 and is connected to the interior of the water pressure expansion balloon 2. The cross section of the endoscope pressure regulating lumen 5 is circular; the cross section of the expansion liquid perfusion lumen 6 is circular or crescent-shaped.

[0073] In an optional embodiment of the present invention, the endoscope pressure regulating lumen 5 and the expansion fluid perfusion lumen 6 may be the same common lumen (ie, the interior of the catheter body 1 is a single-lumen structure), and the cross-section of the common lumen is circular, diamond-shaped or square.

[0074] In an optional embodiment of the present invention, Fig. 9As shown, a blocking balloon 10 is provided on the catheter body 1 near the hydraulic expansion balloon 2, and an expansion liquid filling tube 11 is provided inside the catheter body 1, and the expansion liquid filling tube 11 is connected to the inside of the blocking balloon 10. Liquid is injected into the blocking balloon 10 through the expansion liquid filling tube 11 to expand the blocking balloon 10. The expansion state of the blocking balloon 10 is used for expansion treatment while blocking the contaminated body fluids from both sides of the hydraulic expansion balloon 2 in the patient's cavity, so that the hydraulic expansion balloon 2 can obtain a better treatment effect. The blocking balloon 10 can be located on the left or right side of the hydraulic expansion balloon 2, which can be adjusted according to clinical treatment needs. If the catheter body 1 is a coaxial double-lumen structure, the expansion liquid filling tube 11 is arranged in the expansion liquid perfusion cavity 6, and passes through the expansion liquid perfusion cavity 6 to be connected to the inside of the blocking balloon 10; if the catheter body 1 is a non-coaxial double-lumen structure, such as Figure 5 , Figure 6 As shown, the expansion fluid filling tube 11 is arranged in the catheter body 1, and the expansion fluid filling tube 11 and the expansion fluid perfusion channel 6 are symmetrically arranged on both sides of the endoscope pressure regulating channel 5, and the size and shape of the cross section of the expansion fluid filling tube 11 are the same as the size and shape of the cross section of the expansion fluid perfusion channel 6.

[0075] Furthermore, the cross-sectional shape of the expansion liquid filling tube 11 may be, but is not limited to, circular or crescent-shaped.

[0076] In an optional embodiment of the present invention, Figure 7 As shown, at least one developing ring 9 is provided on the catheter body 1 at a position axially opposite to the water pressure expansion balloon 2. The developing ring 9 can increase the developing property of the visualized pressure regulating catheter of the present invention under X-rays and improve the positioning performance of the visualized pressure regulating catheter of the present invention. If the catheter body 1 is a coaxial double-lumen structure, the developing ring 9 is provided inside the water pressure expansion balloon 2 and located on the outer surface of the inner tube body 102; if the catheter body 1 is a non-coaxial double-lumen structure, the developing ring 9 is provided inside the water pressure expansion balloon 2 and located on the outer surface of the catheter body 1.

[0077] Specifically, there are two developing rings 9 , which are respectively located on both sides of the water pressure expansion balloon 2 .

[0078] In an optional embodiment of the present invention, Figure 8 As shown, a guide tube 12 is provided at one end of the catheter body 1 away from the pressure regulating handle 3, one end of the guide tube 12 is sealed, and the other end of the guide tube 12 is integrally connected to the catheter body 1. The guide tube 12 can play a guiding role (similar to the role of a guide wire), which is beneficial for the catheter to pass through a narrow area without the guidance of a guide wire during delivery.

[0079] In an optional embodiment of the present invention, Fig.12As shown, a local pressure reinforcing rib 13 is provided on the outside of the water pressure expansion balloon 2, one end of the local pressure reinforcing rib 13 is sealed and connected to the catheter body 1, and the other end of the local pressure reinforcing rib 13 extends away from the pressure regulating handle 3 to the end of the catheter body 1 and is sealed and connected to the catheter body 1. The local pressure reinforcing rib 13 can be an integral connection structure with the catheter body 1. Of course, the local pressure reinforcing rib 13 can also extend to the position of the pressure regulating handle 3 and be integrally connected to the catheter body 1 or integrally connected to the pressure regulating handle 3, ensuring that the local pressure reinforcing rib 13 can cover the outer surface of the water pressure expansion balloon 2 in the axial direction of the water pressure expansion balloon 2. By setting the local pressure reinforcement rib 13, local linear pressure can be provided to the lesion site when the water pressure expansion balloon 2 is fully expanded. Without significantly increasing the expansion pressure of the water pressure expansion balloon 2, the lesion site can be expanded and divided into multiple areas for treatment, thereby significantly reducing the rebound of the lesion tissue (such as: severe hyperplastic stenosis lesion tissue, which has a large density and the tissue as a whole has a large resilience) after expansion treatment, especially for severe hyperplastic stenosis lesion tissue that is not well treated by simple balloon expansion. In addition, during the use of the visualized pressure regulating catheter of the present invention, the segmentation of the lesion tissue can be observed through an endoscope. When it is necessary to fine-tune and increase the pressure, the expansion pressure of the water pressure expansion balloon 2 can be accurately regulated by the pressure regulating valve 7 without increasing the liquid in the water pressure expansion balloon 2, thereby improving the treatment effect.

[0080] Further, the number of local pressure reinforcing ribs 13 may be, but not limited to, 1 to 7, the extension direction of each local pressure reinforcing rib 13 is parallel to the axial direction of the water pressure expansion balloon 2 (i.e., the direction of movement of the water pressure expansion balloon 2 when working), and each local pressure reinforcing rib 13 is distributed along the circumference of the water pressure expansion balloon 2 on the outer surface of the water pressure expansion balloon 2, and the cross section of each local pressure reinforcing rib 13 is an arc, triangle, diamond or square structure, and the height of the local pressure reinforcing rib 13 (i.e., the contact distance of the local pressure reinforcing rib 13 with the lesion) can be adjusted according to the actual lesion, so that the outer surface of the local pressure reinforcing rib 13 can divide the lesion into multiple areas for treatment. When the cross section of the local pressure reinforcing rib 13 is a triangle, diamond or square, the sharp outer edge of the local pressure reinforcing rib 13 (wherein the sharp outer edge is only located at the position where the local pressure reinforcing rib 13 is axially opposite to the water pressure expansion balloon 2, or only located at a part of the position where the local pressure reinforcing rib 13 is axially opposite to the water pressure expansion balloon 2) divides the lesion.

[0081] Furthermore, the local pressure reinforcement ribs 13 may be made of, but not limited to, metal or hard plastic.

[0082] In an optional embodiment of the present invention, the number of the water pressure expansion balloon 2 can be one or a plurality of water pressure expansion balloons 2 continuously arranged along the axial direction of the catheter body 1, and the water pressure expansion balloon 2 is made of a transparent material.

[0083] Furthermore, the water pressure expansion balloon 2 can be made of a single-layer material, and the single-layer material is any one of polyvinyl chloride, polyurethane, nylon or polyether block amide; the water pressure expansion balloon 2 can be made of a multi-layer material, and each layer of material can be any one of polyvinyl chloride, polyurethane, nylon or polyether block amide.

[0084] Further, such as Figures 13 to 17 As shown, the shape of the water pressure expansion balloon 2 can be, but is not limited to, an ellipse or a cylinder. Of course, the water pressure expansion balloon 2 can also be a special-shaped columnar structure (such as a dumbbell-shaped structure with large diameters at both ends and a small diameter in the middle; a cone-shaped structure with a large diameter in the middle and gradually reduced diameters at both ends; a wedge-shaped structure with a large diameter at one end and a small diameter at the other end).

[0085] Since the visualized pressure regulating catheter of the present invention is provided with an endoscopic pressure regulating lumen 5, other instruments can be arranged in the catheter through the endoscopic pressure regulating lumen 5 to cooperate with the water pressure expansion balloon 2. Preferably, the other instruments include an ultrasonic probe, a radiotherapy catheter or a laser device.

[0086] The working process of the present invention is: connect the external balloon expansion pump to the infusion port 301 on the pressure regulating handle 3, and sequentially inject liquid into the water pressure expansion balloon 2 through the infusion port 301 and the expansion liquid infusion channel 6 to expand the water pressure expansion balloon 2. Since the pressure regulating port 701 is also the insertion port of the endoscope, during operation, the endoscope is inserted from the pressure regulating port 701, and sequentially enters the preset position in the water pressure expansion balloon 2 through the endoscope pressure regulating channel 5 and the observation channel 4. By rotating or pressing the pressure regulating valve 7, the operating rod of the endoscope can be tightly fitted with the inner wall of the pressure regulating valve 7. At this time, water is injected and pressurized through the infusion port 301. Under the condition of ensuring that the water pressure expansion balloon 2 is fully expanded, the pressure regulating port 701 can withstand water pressure above 3atm without leakage.

[0087] The characteristics and advantages of the visualized pressure regulating catheter of the present invention are:

[0088] 1. The visualized pressure-regulating catheter is provided with an expansion fluid perfusion channel 6 and an endoscope pressure-regulating channel 5. The endoscope can be used in conjunction with the water pressure expansion balloon 2. During the process of delivering liquid to the water pressure expansion balloon 2 and positioning the water pressure expansion balloon 2, the endoscope can synchronously observe the situation in the channel in real time, thereby simplifying the operational difficulty caused by the independent setting of the position of the endoscope and the balloon catheter in the prior art, and improving the efficiency and effect of catheter delivery and positioning.

[0089] 2. In the visualized pressure-regulating catheter, the operating rod at the end of the endoscope is slidably and sealingly connected to the pressure regulating port 701. During the process of the water pressure expansion balloon 2 performing expansion treatment on the lesion site, the endoscope can observe and confirm the action position of the water pressure expansion balloon 2 in real time throughout the process to prevent the failure of the expansion treatment due to the sliding of the water pressure expansion balloon 2. In addition, the volume of the endoscope entering the catheter body 1 and the position of the endoscope can be adjusted by pushing or pulling the operating rod of the endoscope inward or outward, so as to adjust the pressure in the closed chamber, and accurately adjust the expansion pressure of the water pressure expansion balloon 2 in real time to avoid the poor treatment effect due to insufficient or excessive expansion of the water pressure expansion balloon 2.

[0090] 3. The visualized pressure-regulating catheter can be used in conjunction with a variety of commonly used clinical instruments according to clinical treatment needs. It is easy to operate, avoids complications caused by cavity damage due to instrument switching, and effectively improves clinical treatment effects.

[0091] Fourth, in the visualized pressure-regulating catheter, a local pressure reinforcement rib 13 is provided on the outside of the water pressure expansion balloon 2, which can provide local linear pressure to the lesion site when the water pressure expansion balloon 2 is fully expanded. Without significantly increasing the expansion pressure of the water pressure expansion balloon 2, the lesion site can be expanded and divided into multiple areas for treatment, thereby significantly reducing the rebound of the lesion tissue after expansion treatment, especially for severely proliferative and stenotic lesions that are poorly treated with simple balloon expansion.

[0092] The above description is only an illustrative embodiment of the present invention and is not intended to limit the scope of the present invention. Any equivalent changes and modifications made by any person skilled in the art without departing from the concept and principle of the present invention shall fall within the scope of protection of the present invention.

Claims

1. A visual pressure regulating catheter, characterized in that: The visualized pressure-regulating catheter comprises a catheter body, a water pressure expansion balloon and a pressure regulating handle arranged on the catheter body, an endoscope pressure-regulating cavity and an expansion liquid perfusion cavity are formed inside the catheter body along the extension direction of the catheter body, the expansion liquid perfusion cavity is connected with the water pressure expansion balloon, and a perfusion port and a pressure regulating port are arranged on the pressure regulating handle, the perfusion port and the pressure regulating port are respectively connected with the expansion liquid perfusion cavity and the endoscope pressure regulating cavity; An observation channel is provided on the endoscope pressure regulating channel at a position axially opposite to the water pressure expansion balloon. A camera located at the front end of the endoscope passes through the pressure regulating port, the endoscope pressure regulating channel and the observation channel in sequence and extends into the water pressure expansion balloon. An operating rod located at the end of the endoscope is slidingly and sealingly connected to the pressure regulating port, so that the endoscope pressure regulating channel, the expansion fluid perfusion channel and the interior of the water pressure expansion balloon form a closed chamber with a fixed volume. The operating rod part of the endoscope outside the pressure regulating port is pulled outward or pushed inward to control the movement of the endoscope part located in the closed chamber, thereby changing the space occupation of the endoscope in the closed chamber to adjust the expansion pressure of the water pressure expansion balloon.

2. The visualized pressure regulating catheter according to claim 1, characterized in that: The pressure regulating handle is arranged at one end of the catheter body, a conical sealing head is arranged at the other end of the catheter body, and the water pressure expansion balloon is arranged close to the sealing head.

3. The visualized pressure regulating catheter according to claim 1 or 2, characterized in that: The pressure regulating handle is provided with a pressure regulating valve, and the pressure regulating port is located on the pressure regulating valve.

4. The visualized pressure regulating catheter according to claim 1, characterized in that: A steering guide is provided at the observation channel on the side away from the pressure regulating handle, and the steering guide is provided with an arc-shaped edge inclined toward the outside of the endoscope pressure regulating cavity to guide the camera at the front end of the endoscope to extend from the observation channel.

5. The visualized pressure regulating catheter according to claim 1, characterized in that: The endoscope pressure regulating lumen is coaxially arranged with the expansion fluid perfusion lumen, and the expansion fluid perfusion lumen is annularly arranged outside the endoscope pressure regulating lumen.

6. The visualized pressure-regulating catheter according to claim 5, characterized in that: The catheter body includes an inner tube body and an outer tube body sleeved on the outer side of the inner tube body, so as to form the endoscope pressure regulating cavity inside the inner tube body and form the expansion fluid perfusion cavity between the inner tube body and the outer tube body. The end of the water pressure expansion balloon away from the pressure regulating handle is connected to the inner tube body, and the end of the water pressure expansion balloon close to the pressure regulating handle is connected to the outer tube body. The observation channel passes through the inner tube body and the outer tube body in sequence and is connected to the interior of the water pressure expansion balloon.

7. The visualized pressure-regulating catheter according to claim 1, characterized in that: The central axis of the endoscope pressure regulating channel is arranged parallel to the central axis of the expansion fluid perfusion channel, the endoscope pressure regulating channel is located at the axial center position of the catheter body, and the cross-sectional area of ​​the endoscope pressure regulating channel is larger than the cross-sectional area of ​​the expansion fluid perfusion channel, both ends of the water pressure expansion balloon are connected to the catheter body, and the observation channel runs through the catheter body and is connected to the interior of the water pressure expansion balloon.

8. The visualized pressure-regulating catheter according to claim 1, characterized in that: The endoscope pressure regulating channel and the expansion fluid perfusion channel are the same common channel.

9. The visualized pressure-regulating catheter according to claim 1, characterized in that: A blocking balloon is arranged on the catheter body near the water pressure expansion balloon, and an expansion liquid filling tube is arranged inside the catheter body, and the expansion liquid filling tube is connected with the inside of the blocking balloon.

10. The visualized pressure-regulating catheter according to claim 1, characterized in that: At least one developing ring is arranged on the catheter body at a position axially opposite to the water pressure expansion balloon.

11. The visualized pressure-regulating catheter according to claim 1, characterized in that: A guide tube is arranged on one end of the catheter body away from the pressure regulating handle, one end of the guide tube is sealed, and the other end of the guide tube is integrally connected with the catheter body.

12. The visualized pressure-regulating catheter according to claim 1, characterized in that: A local pressure reinforcement rib is arranged on the outside of the water pressure expansion balloon, one end of the local pressure reinforcement rib is sealed and connected to the catheter body, and the other end of the local pressure reinforcement rib extends away from the pressure regulating handle to the end of the catheter body and is sealed and connected to the catheter body.

13. The visualized pressure-regulating catheter according to claim 1, characterized in that: The number of the water pressure expansion balloon is one or a plurality of balloons continuously arranged along the axial direction of the catheter body, and the water pressure expansion balloon is made of a transparent material.

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