Shape-forming component and catheter shaping device for interventional surgery catheter

Abstract

The shaping component for interventional surgical catheters of the present application includes a heating sleeve and a universal tube. A heating wire is provided in the heating sleeve. The universal tube is formed by a plurality of universal joints connected in sequence. Two adjacent universal joints are connected in sequence and can rotate relative to each other. A longitudinally through heating tube cavity is formed in the universal tube. The heating sleeve is arranged in the heating tube cavity. A longitudinally through catheter cavity is provided in the heating sleeve. The shaping device of the present application includes the shaping component and a heating controller electrically connected to the heating wire. The catheter shaping component of the present application adopts a universal joint structure, which is flexible, adaptable to various shaping needs, and very convenient to operate; the shaping device can set different heating parameters for catheters of different specifications and brands, which is convenient for doctors to adjust, improves applicability, and has good plastic effect and consistency under the same parameters.

Description

[Technical field]

[0001] The present application relates to the field of medical devices, and in particular to a catheter shaping device and a shaping component for a catheter in an interventional surgery. [Background technology]

[0002] Blood vessels are an important part of the human circulatory system. If embolism or lesions occur, it will have a serious impact on the human body. For example, intracranial aneurysms are mostly abnormal bulges on the walls of intracranial arteries. They are the leading cause of subarachnoid hemorrhage. Among cerebrovascular accidents, the incidence rate is second only to cerebral thrombosis and hypertensive cerebral hemorrhage, ranking third. After the first rupture of an aneurysm, the mortality rate is as high as 20-30%, half of whom die within 48 hours of onset. Even if the patient survives, 1 / 3 of the patients may bleed again. Survivors may also have a variety of sequelae such as hemiplegia and aphasia.

[0003] Intravascular embolization therapy technology is to place certain embolic materials including various types of detachable coils, balloons, non-adhesive liquid embolic agents or coated stents in the intracranial aneurysm cavity through microcatheter technology to achieve the purpose of occluding the aneurysm. Embolization using microcatheter technology is currently the most common treatment method. The stability of the microcatheter in the blood vessel is crucial for interventional surgery and is also the key and difficulty of the operation. However, there are some very obvious disadvantages during the operation. In the past, doctors could only manually shape the catheter to basically match the patient's blood vessels, but this shaping method has high technical requirements for doctors, and each patient's brain blood vessel morphology is different. For patients with complex blood vessels, there are certain risks during the operation, which will also delay some of the operation time; doctors have clinical demands for manual plasticization of catheters for patients with different types of blood vessels. At present, plasticization is mostly done by hand-held or clamped catheters using hot steam to thermoplasticize the catheter, and guide wires or other tools are required for assistance. This method has problems such as difficulty in quantifying plasticity standards, difficulty in unifying plasticity effects, inability to plasticize multiple twists and turns at one time, cumbersome operation, and burns caused by misoperation. Although some microcatheters can be shaped using vascular models, insertion and fixation are very troublesome, and inserting the microcatheter into the model cannot be well shaped using hot steam, and the operation is also very inconvenient.

[0004] Therefore, it is necessary to design a shaping device that can make the shaping operation more flexible, convenient, quick and simple, with good shaping effect and adapt to various complex shaping requirements for interventional surgical catheters. [Summary of the invention]

[0005] The purpose of the present application is to provide a catheter shaping device and a shaping component for interventional surgical catheters that are more flexible and convenient to operate and have a good shaping effect.

[0006] In order to achieve the purpose of this application, the following technical solutions are provided:

[0007] The present application provides a shaping component for an interventional surgical catheter, which includes a heating sleeve and a universal tube. A heating wire is arranged in the heating sleeve. The universal tube is formed by a plurality of universal joints which are connected in sequence. Two adjacent universal joints are connected in sequence and can rotate relatively. A longitudinally through-going heating tube cavity is formed in the universal tube. The heating sleeve is arranged in the heating tube cavity. A longitudinally through-going catheter cavity is arranged in the heating sleeve.

[0008] The surgical microcatheter that needs to be shaped can be heated and shaped in the heating sleeve to obtain the desired shaping effect, and the heating and shaping component can be reused after being sterilized.

[0009] In some embodiments, the heating sleeve is connected to the first universal joint at the proximal end. In a specific embodiment, the connection can be fixed by bonding or other methods, and the connection part can be matched and fixed at the outer wall of the heating sleeve and the inner wall of the first universal joint. In some other embodiments, the heating sleeve can also be connected to the first universal joint by means of a buckle or other methods.

[0010] In some embodiments, at least one heating wire is provided and extends longitudinally along the tube body of the heating sleeve, or the heating wire is provided along the tube body of the heating sleeve and extends longitudinally spirally around the catheter cavity.

[0011] In some embodiments, the universal joint includes a socket and a ball head connected to each other, the socket is nested with the ball head of another adjacent universal joint, and each independent universal joint can rotate within a certain spatial angle after nesting. The ball head is extended from the socket, or the two can be integrally formed.

[0012] In some embodiments, the universal joint has a longitudinally extending sleeve cavity and tube cavity, the sleeve cavity is located in the sleeve seat to accommodate the ball head of an adjacent universal joint, the tube cavity is connected to the sleeve cavity and extends longitudinally to the ball head end of the universal joint, and the sleeve cavities and tube cavities of multiple universal joints of the universal tube are connected and penetrated to form the heating tube cavity.

[0013] In some embodiments, two or more lumens are provided in the universal joint, into which two or more corresponding heating sleeves can be placed.

[0014] In a specific implementation manner, the cross-sectional shape of the tube cavity is circular, square, triangular, polygonal or irregular, and can be specifically designed according to the cross-sectional shape of the heating tube.

[0015] In some embodiments, the sleeve cavity is a spherical cavity, the diameter of the sleeve seat end opening is smaller than the diameter of the universal joint ball head, and the maximum diameter inside the sleeve cavity is equal to or greater than the diameter of the universal joint ball head. When the ball head of a universal joint is sleeved in the sleeve seat of another adjacent universal joint, since the diameter of the sleeve cavity at the sleeve seat end opening is smaller than the diameter of the universal joint ball head, the sleeves of the two universal joints are locked in a certain range of movement and will not fall off; since the maximum diameter inside the sleeve cavity is equal to or greater than the diameter of the universal joint ball head, the sleeves of the two universal joints have a relatively rotatable activity space, and the sleeve seat and the ball head can rotate relative to each other in all directions on the spherical surface of the sleeve range. In some embodiments where the sleeve diameters are relatively close, a certain rotational friction can be generated, which is convenient for rotation control and positioning.

[0016] In some implementations, the heating sleeve is made of 200° C. resistant heat-insulating plastic or rubber.

[0017] In some implementations, the heating wire is made of nickel-chromium alloy.

[0018] The present application also provides a catheter shaping device, which includes a heating controller and a shaping component for an interventional surgical catheter as described above, wherein both ends of the heating wire are electrically connected to the heating controller to form a heating circuit. The heating controller can control the current waveform and size of the current flowing through the resistance wire and other process conditions to control the power of the tool and the heating time to ensure the effectiveness and safety of the heating plasticity.

[0019] In some embodiments, two or more heating circuits are provided.

[0020] Compared with the prior art, this application has the following advantages:

[0021] The catheter shaping device used for interventional surgical catheters in this application can set different heating parameters for catheters of different specifications and brands, which is convenient for doctors to adjust and improves applicability. The doctor can use the shaping component to be sleeved on the surgical catheter to be shaped, perform bending plasticity in advance, and perform complex bending plasticity at one time, and have good plasticity effect and consistency under the same parameters; it can be bent manually. The shaping component adopts a universal joint structure, which is flexible, adaptable to various shaping needs, and very convenient to operate. The heating sleeve material is made of 200°C heat-insulating plastic, rubber or other soft materials, and will not decompose toxic and harmful substances under high temperature conditions. The heating wire uses nickel-chromium alloy or other resistance materials, which is convenient for electric heat conversion and has a long service life.

Brief Description of the Drawings

[0022] Figure 1 This is a schematic diagram of the connection between the heating wire and the controller of the shaping component embodiment of the present application;

[0023] Figure 2 This is a schematic diagram of the connection between the heating sleeve and the heating wire and the controller of the shaping component embodiment of the present application;

[0024] Figure 3 This is a cross-sectional schematic diagram of an embodiment of the shaping device of the present application;

[0025] Figure 4 This is a schematic diagram of the appearance of an embodiment of the shaping device of the present application;

[0026] Figure 5 This is a schematic diagram of the appearance of a universal joint of an embodiment of a shaping component of the present application;

[0027] Figure 6 This is a schematic cross-sectional view of a universal joint of an embodiment of a shaping component of the present application;

[0028] Figure 7 A schematic diagram of bending and shaping of an embodiment of the shaping device of the present application;

[0029] Figure 8 A schematic diagram of a microcatheter after being bent and shaped by the shaping device of the present application;

[0030] Fig. 9 A cross-sectional view of a universal joint according to another embodiment of the shaping component of the present application. [Specific implementation method]

[0031] The exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present application are shown in the accompanying drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

[0032] It should be understood that the terms used herein are only for the purpose of describing specific example embodiments and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not interpreted as necessarily requiring them to be performed in the specific order described or illustrated, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0033] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0034] For ease of description, spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", "front end", "rear side", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, the element described as "below other elements or features" or "below other elements or features" will then be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0035] In the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end". Based on this principle, the "proximal end" and "distal end" of any component of the medical device are defined. In some practices, the "proximal end" and "distal end" may also be referred to as the "tail end" and "head end" respectively, with the first intervention end of the device being referred to as the "head end". These terms do not define the features of the technical solution of this application, but are only used to distinguish the components for description. "Axial" in this application should be understood to mean the direction in which the device is pushed, and the direction perpendicular to the "axial direction" is defined as the "radial direction", and the "length direction" should be understood as the direction in which the device has the longest physical dimension.

[0036] See also Figures 1 to 4The shaping component embodiment of the present application for an interventional surgical catheter includes a heating sleeve 200 and a universal tube 100. The heating sleeve 200 is provided with a heating wire 300. The universal tube 100 includes a plurality of universal joints 500. The plurality of universal joints 500 are sequentially sleeved to form the universal tube 100. Specifically, two adjacent universal joints 500 are sequentially sleeved and can rotate relative to each other. A longitudinally through-going heating tube cavity is formed in the universal tube 100. The heating sleeve 200 is arranged in the heating tube cavity and connected to the first section of the universal joint 500. A longitudinally through-going catheter cavity is provided in the heating sleeve 200. Specifically, the universal tube 100 is composed of 10-20 sections of universal joints 500. Adjacent universal joints 500 can be nested with each other. After nesting, each independent universal joint 500 can rotate within a certain spatial angle.

[0037] At least one heating wire 300 is provided and is arranged in the tube body of the heating sleeve 200. Specifically, the heating wire 300 can be arranged to extend longitudinally along the tube body / tube wall of the heating sleeve 200, or the heating wire 300 is arranged along the tube body of the heating sleeve 200 and spirally extends longitudinally around the catheter cavity. Both ends of the heating wire 300 are electrically connected to the heating controller, and one or more heating wire 300 loops can be set.

[0038] Please refer to Figures 5 to 8 The universal joint 500 includes a connected socket 510 and a ball head 520, and the socket 510 is nested and connected with the ball head 520 of another adjacent universal joint 500. Specifically, the ball head 520 is formed by extending the socket 510, and the two can also be integrally formed.

[0039] The universal joint 500 has a sleeve cavity 530 and a tube cavity 540 that penetrate longitudinally. The sleeve cavity 530 is located in the sleeve seat 510 to accommodate the ball head 520 of the adjacent universal joint 500. The tube cavity 540 is connected to the sleeve cavity 530 and extends longitudinally to the end of the ball head 520 of the universal joint 500. The sleeve cavities 530 and tube cavities 540 of multiple universal joints 500 of the universal tube 100 are connected and penetrated to form the heating tube cavity. The cross-sectional shape of the tube cavity 540 is circular, square, triangular, polygonal or other special shapes, and the specific shape can be adjusted according to the actual situation of the heating sleeve.

[0040] In a specific embodiment, the sleeve cavity 530 is a spherical cavity, and the diameter d2 of the opening at the end face of the sleeve seat 510 is smaller than the diameter D of the ball head 520 of the universal joint 500, and the maximum internal diameter d2 of the sleeve cavity 530 is equal to or greater than the diameter D of the ball head 520 of the universal joint 500.

[0041] When the ball head of a universal joint is inserted into the socket of another adjacent universal joint, since the diameter of the socket cavity at the opening of the socket end face is smaller than the diameter of the universal joint ball head, the sockets of the two universal joints are locked in a certain range of motion and will not fall off; since the maximum diameter inside the socket cavity is equal to or greater than the diameter of the universal joint ball head, the sockets of the two universal joints have a relatively rotatable activity space, and the socket and the ball head can rotate relative to each other in all directions on the spherical surface of the socket range. In some embodiments where the socket diameters are relatively close, a certain rotational friction force can be generated, which is convenient for rotation regulation and positioning. In some embodiments, the transition from the maximum diameter inside the socket cavity to the cavity surface of the socket cavity at the opening of the socket end face can be designed to be slightly retracted inward, so that the socket fit between the universal joints has a certain friction resistance when the shaping component is bent, and will not easily change shape again.

[0042] In a specific embodiment, the heating sleeve 200 is made of 200° C. heat-insulating plastic or rubber. The heating wire is made of nickel-chromium alloy.

[0043] In the embodiment of the catheter shaping device for an interventional surgical catheter of the present application, both ends of the heating wire 300 are electrically connected to the heating controller to form a heating circuit. The heating circuit may be provided with two or more. The controller may control the heating time and power of the heating wire 300. Figure 7 and Figure 8 As shown, the catheter shaping device of the present application is applied to the surgical microcatheter to be bent and shaped according to actual needs, and the following can be obtained: Figure 8 The microcatheter 600 shown has been shaped to meet surgical requirements, is flexible and convenient to operate, and has more precise shaping and high consistency.

[0044] In other embodiments, there are two or more lumens in the middle of the universal joint. Fig. 9 In this embodiment, the universal joint 501 is provided with two tube cavities 541 connected to the sleeve cavity 531 in the sleeve seat 511, and the two tube cavities 541 are both connected to the end surface of the ball head 521. After multiple universal joints are sleeved together, two heating tube cavities are formed, and two corresponding heating sleeves can be placed.

[0045] The above description is only a preferred embodiment of the present application, and the protection scope of the present application is not limited thereto. Any equivalent transformation based on the technical solution of the present application belongs to the protection scope of the present application.

Claims

1. A shaping component for an interventional surgical catheter, characterized in that: It includes a heating sleeve and a universal tube. A heating wire is arranged in the heating sleeve. The universal tube is formed by a plurality of universal joints which are connected in sequence. Two adjacent universal joints are connected in sequence and can rotate relatively. A longitudinally through heating tube cavity is formed in the universal tube. The heating sleeve is arranged in the heating tube cavity. A longitudinally through catheter cavity is arranged in the heating sleeve.

2. The shaping component for an interventional surgical catheter according to claim 1, characterized in that: At least one heating wire is provided, which is longitudinally extended along the tube body of the heating sleeve, or the heating wire is arranged along the tube body of the heating sleeve and spirally extended longitudinally around the catheter cavity.

3. The shaping component for an interventional surgical catheter according to claim 1 or 2, characterized in that: The universal joint comprises a sleeve seat and a ball head which are connected to each other. The sleeve seat is nested and connected with the ball head of another adjacent universal joint.

4. The shaping component for an interventional surgical catheter according to claim 3, characterized in that: The universal joint has a longitudinally connected sleeve cavity and a tube cavity. The sleeve cavity is located in the sleeve seat to accommodate the ball head of an adjacent universal joint. The tube cavity is connected to the sleeve cavity and extends longitudinally to the ball head end of the universal joint. The sleeve cavities and tube cavities of multiple universal joints of the universal tube are connected and connected to form the heating tube cavity.

5. The shaping component for an interventional surgical catheter according to claim 4, characterized in that: The cross-sectional shape of the lumen is circular, polygonal or irregular.

6. The shaping component for an interventional surgical catheter according to claim 4, characterized in that: The sleeve cavity is a spherical cavity, the diameter of the opening at the end face of the sleeve seat is smaller than the diameter of the universal joint ball head, and the maximum diameter inside the sleeve cavity is greater than or equal to the diameter of the universal joint ball head.

7. The shaping component for an interventional surgical catheter according to claim 1, characterized in that: The heating sleeve is made of 200°C resistant heat insulating plastic or rubber.

8. The shaping component for an interventional surgical catheter according to claim 1, characterized in that: The heating wire is made of nickel-chromium alloy.

9. A catheter shaping device, characterized in that: It comprises a heating controller and a shaping component for an interventional surgical catheter as claimed in any one of claims 1 to 8, wherein both ends of the heating wire are electrically connected to the heating controller to form a heating circuit.

10. The catheter shaping device according to claim 9, characterized in that Two or more heating circuits are provided.

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