WO2022198810A1

WO2022198810A1 - Guiding catheter and guiding catheter system

Info

Publication number: WO2022198810A1
Application number: PCT/CN2021/100499
Authority: WO
Inventors: 高小龙
Original assignee: 上海苏畅医疗科技有限公司
Priority date: 2021-03-25
Filing date: 2021-06-17
Publication date: 2022-09-29
Also published as: CN113209446A

Abstract

A guiding catheter (100), comprising a catheter main body (110) extending in an axial direction, wherein the catheter main body (110) comprises an inner-layer catheter body (111), an outer-layer catheter body (113), and an intermediate layer (112) located between the inner-layer catheter body (111) and the outer-layer catheter body (113); the intermediate layer (112) is configured to have a relatively high rigidity; the intermediate layer (112) is provided with an opening (300) extending in an axial direction; the inner-layer catheter body (111) is configured to have an inactive extending area (200) extending in a circumferential direction; and the inactive extending area (200) is at least partially accommodated in the opening (300) of the intermediate layer (112). Further provided is a guiding catheter system, comprising the guiding catheter (100). The inactive extending area (200) provided on the inner-layer catheter body (111) enables the outer diameter of the guiding catheter (100) to be less than other guiding catheters of non-expansible inner diameters; and when delivering an instrument with the same specifications, the guiding catheter of the present invention more easily passes through a circuitous blood vessel to reach a designated position during a puncturing and subsequent positioning process, thereby having a smaller delivery resistance, and thus less damage is done to an inner cavity of the blood vessel.

Description

A guiding catheter and guiding catheter system

technical field

The invention relates to the technical field of medical devices, in particular to a guide catheter and a guide catheter system used in neurointerventional medicine.

Background technique

Neurointerventional medicine is interventional neuroradiology, also known as interventional neurosurgery, which refers to the methodology of using interventional radiology to diagnose and treat diseases of the nervous system. The treatment targets are mainly vascular lesions of the brain, meninges, face and neck, eyes, ear, nose and throat, spine and spinal cord, including aneurysms, arteriovenous malformations, arteriovenous fistulas, arterial stenosis, acute cerebral infarction and some head and neck tumors Wait. Interventional neuroradiology treatment avoids complicated and dangerous operations and tissue trauma, and opens up a new treatment approach for some brain and spinal cord vascular diseases that are extremely difficult to perform conventional operations. Small trauma, definite curative effect, few complications, and incomparable advantages of other treatment methods are an important part of minimally invasive medicine in neuroscience.

At present, most cerebral angiography is performed through the femoral artery puncture. In some operations, the radial artery is selected for puncture (the surgical trauma is small). After the puncture, the contrast agent is rapidly injected into the selected arterial high pressure through the catheter. selective imaging. As one of the basic tools for endovascular interventional diagnosis and treatment, the catheter will be guided along the guide wire through the long sheath to the designated site after the puncture is completed, and then selectively enter the branch blood vessel to assist in the delivery of the interventional treatment device, inject the contrast agent, It plays an important role in measuring pressure and determining the status of blood vessels.

As a typical catheter, the guide catheter is mainly responsible for safely and low friction to deliver the device to the distal target site, and is mostly used to deliver interventional devices (such as coils, stents, etc.) and some smaller diameter catheters (such as intermediate catheter and microcatheter). The main features of the guide catheter are thin wall, large lumen and good visibility. At present, the lumen of the commonly used guiding catheter in clinical practice is 6F and the outer diameter is 8F, which needs to pass through the aortic arch to reach the C1 segment. The inside of the guide catheter needs to be compatible with an intermediate catheter with an outer diameter of 6F, and the gap between the two is about 0.2mm. Such a small gap will cause certain problems in the positioning and adaptability of the guide catheter.

1. When radial artery puncture is used in interventional surgery, the guiding catheter will pass through the radial artery, brachial artery, axillary artery and subclavian artery successively, and finally reach the common carotid artery. The blood vessels that the catheter passes through during radial artery puncture are compared with those during femoral artery puncture. The diameter of the blood vessels passing through will be smaller, and the angle between the subclavian artery and the common carotid artery is often an acute angle (<90°), which will make it difficult to place the guide catheter in place.

2. When the radial artery puncture is used clinically, the guiding catheter is limited by the angle between the subclavian artery and the common carotid artery after being in place, the deformation of the lumen is large after bending, and the intermediate catheter is very far away during the delivery process. There is a high probability that it will hit the place where the curvature of the guide catheter is greatest, thus hindering the delivery and positioning of the intermediate catheter.

3. The distal end of some guiding catheters will be rounded by the tip forming process to reduce the damage to the blood vessel when the catheter is bent. This process will make the inner diameter of the distal end of the guiding catheter smaller. During the delivery of the intermediate catheter, the distal end face of the guiding catheter will rub against the outer layer of the intermediate catheter with a larger outer diameter, causing the hydrophilic coating of the intermediate catheter to be scratched, and the fragments of the hydrophilic coating will enter the blood. , which can lead to distal embolism in severe cases.

To sum up, in order to flexibly meet the delivery requirements of various clinical guide catheters and at the same time be compatible with intermediate catheters with more outer diameters, it is necessary to develop a guide catheter with an expandable lumen.

SUMMARY OF THE INVENTION

The present invention provides a guide catheter and a guide catheter system, which can solve the above-mentioned defects in the prior art.

The technical scheme of the present invention is as follows:

A guide catheter, comprising an axially extending catheter body, the catheter body comprising an inner layer tube body, an outer layer tube body and an intermediate layer between the inner layer tube body and the outer layer tube body, the The intermediate layer is configured to have a relatively greater stiffness, wherein the intermediate layer is configured with openings extending in the axial direction, and the inner layer tubular body is configured to have a circumferentially extensible region of inactive extension, the inactive extension The extended region is at least partially received within the opening of the intermediate layer.

In the present invention, the outer diameter of the guiding catheter is smaller than that of other non-expandable inner diameter guiding catheters through the non-active extension area configured in the inner tube body. It is easy to reach the designated position through the tortuous blood vessel, and the delivery resistance is smaller, so the damage to the lumen of the blood vessel is smaller.

In some embodiments, the inactive extension region includes at least one relatively deployable laminate structure. The laminated structure opens easily when passively expanded.

In some embodiments, the laminated structure is configured with at least two, such as three, four, five or more, multiple laminated structures and is uniformly distributed along the circumference of the inner tube body. The greater the number of laminated structures, the further reduction of the radial size of the guide catheter, the smaller the conveying resistance, and the more uniformly distributed laminated structures, the more uniform the pressure, so that the non-active expansion area can be more uniform. It is easy to be unfolded, and the inner tube body will not produce unexpected deformation after expansion.

In some embodiments, the laminated structure extends in a straight line along the axial direction, and the process is relatively simple. In some embodiments, the laminated structure extends in a spiral shape along the inner tube body, and during expansion, one side wall is particularly thin and the other side thick, that is, eccentricity does not occur; Layer structure matching settings.

In some embodiments, the openings of the intermediate layer are matched with the laminated structure, that is, the intermediate layer is configured with a plurality of openings, and each of the laminated structures is respectively accommodated in the corresponding opening of the intermediate layer, which can further Reduce the radial dimension of the guide tube.

In some embodiments, at least one of the laminated structures is completely accommodated in the opening of the intermediate layer, and the remaining laminated structures are configured to closely adhere to the inner wall of the intermediate layer.

In some embodiments, the inner-layer tube body is configured as a closed-loop structure, that is, the inner and outer surfaces of the inner-layer tube body are closed, and during expansion, the laminated structures can be fully unfolded. In some embodiments, the inner layer tube body is configured as an open-loop structure, which has stronger dimensional compatibility, and the process is relatively simple and easy to implement.

In some specific embodiments, the inner tube body includes an open body, the inactive extension region includes a first extension portion and a third extension portion located on both sides, and includes a first extension portion and a third extension portion located on both sides. At least one second extension part between the third extension parts, one end of the first extension part and the third extension part are respectively fixedly connected with the end of the main body, the first extension part and The other ends of the third extending portions are respectively fixedly connected with the ends of the adjacent second extending portions. That is, the inactive extension region is configured as a three-layer or more layered structure, which can effectively reduce the radial dimension of the inner tube body and the entire catheter body, and reduce the transport resistance of the catheter body.

In some embodiments, the inner tube body includes an open body, the inactive extension region includes a first extension portion and a third extension portion, one end of the first extension portion and the third extension portion The first extending portion is at least partially overlapped with the side surface of the third extending portion. Under the same outer diameter, the inner diameter is larger and the size compatibility is stronger.

In some embodiments, the middle layer is configured as a network tube structure with several mesh holes, wherein the middle layer is woven into a network tube structure by using wires, and then cut to form the opening; or, the middle layer is made of The pipe body is cut to form a plurality of the meshes for forming.

In some embodiments, the guide catheter further includes a developing portion at the distal end, the developing portion is configured to have at least one axially extending second opening, the inactive extension region is configured to be received in the In the second opening, such a structure reduces the radial dimension of the distal end of the guide catheter, which is beneficial to reduce the delivery resistance of the catheter and the damage to the blood vessel.

In some embodiments, the developing part includes a plurality of developing segments, the multiple developing segments are arranged in the circumferential direction, and the adjacent developing segments are arranged at intervals; the design of the multi-segment combination of the developing part can significantly reduce the The resistance encountered when the most distal end of the catheter body expands, so that the distal end of the guide catheter can also be expanded. In addition, a plurality of developing segments form a plurality of the second openings, and when the non-actively extending region includes a plurality of stacked structures, the plurality of developing segments can be arranged according to the number of stacked structures, so that each stacked structure can accommodate Placed in a second opening to reduce expansion resistance.

In some embodiments, the guiding catheter is configured to be able to return to its original state after completing the delivery of the device, wherein the inner layer tube body and the outer layer tube body are made of materials with predetermined elasticity, and the middle layer tube body is made of materials with predetermined elasticity. Made of shape memory material.

Specifically, the elastic material of the outer tube body has various hardness gradients, and the hardness decreases sequentially from the proximal end to the distal end.

After the delivery of the device is completed, the middle layer can be controlled to restore the original shape, and the inner layer tube body and the outer layer tube body can be contracted, so that the guide catheter can be restored to the shape before expansion, which is convenient for all The guide catheter was withdrawn.

In some embodiments, the guide catheter further includes a diffusion stress tube and a connecting piece, the diffusion stress tube is connected with the catheter body and the connecting piece, respectively.

A guide catheter system, comprising the guide catheter as described in any of the above, and further comprising at least one dilator.

Compared with the prior art, the beneficial effects of the present invention are as follows:

First, the present invention uses the non-active extension area configured by the inner tube body, so that the outer diameter of the guide catheter will be smaller than that of other non-expandable inner diameter guide catheters. , it is easier to reach the designated position through the tortuous blood vessel, and the delivery resistance is smaller, so the damage to the lumen of the blood vessel is smaller; in addition, after the guide catheter is in place, it can ensure strong support through expansion, and it is also for the device. The delivery provides more space and reduces the delivery resistance of the device.

Second, the developing portion at the distal end of the catheter body of the present invention is configured as an open-loop structure or a multi-segment structure that can conform to the expansion of the inner tube body, and the circumferentially non-closed developing portion enables expansion at the tip of the guide catheter. , the friction between the inner surface of the guide catheter lumen and the outer surface of the intermediate catheter can be reduced, thereby reducing the damage to the hydrophilic coating on the outer surface of the intermediate catheter, thereby reducing the risk of the hydrophilic coating falling off.

Of course, it is not necessary for any product embodying the present invention to achieve all of the above-described advantages simultaneously.

Description of drawings

Fig. 1 is the front view structure schematic diagram of the guide catheter according to Embodiment 1 of the present invention;

Fig. 2 is the partial structural schematic diagram of the catheter main body of the embodiment 1 of the present invention;

3A is a schematic cross-sectional structure diagram of the catheter body according to Embodiment 1 of the present invention;

3B is a schematic cross-sectional structure diagram of the inner layer pipe body according to Embodiment 1 of the present invention;

3C is a partial frontal structural schematic diagram of the inner layer pipe body of Embodiment 1 of the present invention;

3D is a partial frontal structural schematic diagram of another inner layer pipe body according to Embodiment 1 of the present invention;

3E is a partial cross-sectional structural schematic diagram of the catheter body according to Embodiment 1 of the present invention;

Fig. 4 (A, B) is the cross-sectional structure schematic diagram of the inner layer pipe body of the embodiment 1 of the present invention;

5A is a schematic cross-sectional structure diagram of the intermediate layer in Embodiment 1 of the present invention;

5B is a schematic three-dimensional structure diagram of the intermediate layer of Embodiment 1 of the present invention;

5C is a schematic diagram of another intermediate layer in Embodiment 1 of the present invention;

5D is a perspective structural schematic diagram of another intermediate layer according to Embodiment 1 of the present invention;

6 is a schematic cross-sectional structure diagram of the developing portion of Embodiment 1 of the present invention;

7 is another cross-sectional structural schematic diagram of the catheter body according to Embodiment 1 of the present invention;

FIG. 8 is a schematic front view of the structure of the dilator according to Embodiment 1 of the present invention.

Reference numerals: guide catheter 100; catheter main body 110; inner layer tube body 111; intermediate layer 112; outer layer tube body 113; developing part 114; diffusion stress tube 120; extension 210; second extension 220; first end 211; second end 212; third end 221; fourth end 222; third extension 230; fifth end 231; sixth end 232: opening 300; second opening 310; dilator 400; second tip 401; second proximal end 403; straight section 402; body 1110;

Detailed ways

In the description of the present invention, it should be noted that the term "proximal end" generally refers to the end close to the operator, and "distal end" refers to the end away from the operator.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. The indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, which is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the indicated device or element must have a specific orientation or a specific orientation. construction and operation, and therefore should not be construed as limiting the invention. Furthermore, the terms "first", "second", and "third" are used for descriptive purposes only and should not be construed to indicate or imply relative importance.

In the description of the present invention, it should be noted that the terms "installed", "connected" and "connected" should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood in specific situations.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

The present invention will be further described below in conjunction with specific embodiments.

Example 1

This embodiment provides a guide catheter that can provide a passageway guarantee for the delivery of instruments (such as implants and other compatible catheters) in place. For example, when a wide-necked giant aneurysm is clinically treated, the guiding catheter will be punctured through the femoral artery or radial artery to reach the C1 cervical segment of the carotid artery to establish access for the delivery of subsequent intermediate catheters, as well as subsequent catheters and implants. in place to establish a strong support.

The composition of the guiding catheter is shown in FIG. 1 , the guiding catheter 100 includes an axially extending catheter body 110 , a diffusion stress tube 120 and a connecting piece 130 , two ends of the diffusion stress tube 120 are respectively connected to the The conduit body 110 is connected to the connector 130 .

Wherein, the catheter body 110 is usually a multi-layer composite material pipe. As shown in FIG. 2 , the catheter body 110 includes an inner layer pipe body 111 , an outer layer pipe body 113 , and the inner layer pipe body 111 and the outer layer pipe body 113 The middle layer 112 between the outer tube bodies 113, the middle layer 112 is configured to have a relatively greater rigidity; the middle layer 112 is configured with an opening 300 extending in the axial direction, and the inner layer tube body 111 is configured In order to have a circumferentially extensible inactive extension region 200 , the inactive extension region 200 is at least partially accommodated within the opening of the intermediate layer 112 .

The cross section of the catheter body 110 is shown in FIG. 3A , the inactive extension area 200 in the guide catheter of this embodiment is set so that the outer diameter will be smaller than that of other non-expandable inner diameter guide catheters. During the process of puncture and subsequent positioning, it is easier to reach the designated position through the tortuous blood vessel, and the delivery resistance is smaller, so the damage to the lumen of the blood vessel is smaller. In addition, after the guiding catheter is in place, it can ensure strong support while providing more space for the delivery of other instruments through self-expansion, thereby reducing the delivery resistance of other instruments. Wherein, the non-active extension region 200 is accommodated in the opening 300 of the intermediate layer, which can save more space.

In some embodiments, the inactive expansion region 200 includes at least one relatively expandable laminated structure, as shown in FIG. 3A . Wherein, the laminated structure can be a two-layer, three-layer, four-layer or more laminated structure, and the inactive extension area can be determined according to factors such as the thickness of the guide tube, the thickness of the inner layer tube and the middle layer, etc. 200 structure. When the catheter body 110 of this embodiment is formed, the inner layer tube body 111 needs to be expanded by a dilator before it can be expanded, and has a fixed shape when no expansion force is applied.

In some embodiments, the laminated structure extends radially, ie, the multi-layer structures are stacked on each other in a radial direction, and in some embodiments, the laminated structure extends in a circumferential direction, ie, the multi-layer structure extends in a circumferential direction. The directions are stacked on top of each other. After the guide catheter is delivered to the target site, the laminate can be deployed by a dilator to dilate the catheter.

In some embodiments, there are at least two laminated structures, such as three, four, five or more, and a plurality of laminated structures are evenly distributed along the circumference of the inner pipe body, as shown in FIG. 3B shown. The more the inner tube body 111 is constructed with the laminated structure, the more the radial dimension of the guide tube 100 can be further reduced, the conveying resistance is smaller, and the multiple evenly distributed laminated structures can be subjected to more uniform pressure. , dispersion, so that the non-active expansion area can be expanded more easily, and the inner tube body 111 will not produce unexpected deformation after expansion.

In some embodiments, the laminated structure extends in a straight line along the axial direction, as shown in FIG. 3C , and the process is relatively simple.

In some embodiments, the laminated structure extends along the inner tube body in a spiral shape. As shown in FIG. 3D , the inner tube body 111 will not have a particularly thin wall on one side and a thick wall on the other side during expansion, that is, no Eccentricity occurs.

In some embodiments, the openings 300 of the intermediate layer 112 are arranged to match the stacked structure, as shown in FIG. 3E . Matching means that the number of the openings 300 in the intermediate layer 112 matches the number of the stacked structures, and the extension shape of the openings 300 also matches the extension shape of the stacked structure, so that each of the stacked structures can be respectively accommodated in the stacked structure. inside the opening 300 corresponding to the intermediate layer 112 . The radial dimension of the guide catheter can be further reduced.

In some embodiments, at least one of the laminated structures is completely accommodated in the opening of the intermediate layer 112 to reduce the radial size of the guide tube, and the remaining laminated structures are configured to closely adhere to the inner wall of the intermediate layer 112 .

In some embodiments, the inner tube body 111 includes an open body 1110 , the inactive extension region 200 includes a first extension portion 210 and a third extension portion 230 located on both sides, and includes a first extension portion 210 and a third extension portion 230 located on both sides. At least one second extension part 220 between the extension part 210 and the third extension part 230, one end of the first extension part 210 and the third extension part 230 are respectively connected with the end of the body 1110 For fixed connection, the other ends of the first extension part 210 and the third extension part 230 are respectively fixedly connected to the end of the adjacent second extension part 220 .

In the embodiment shown in FIG. 3A , the inactive extension region 200 has a second extension portion 220 , that is, the inactive extension region 200 has a three-layer structure, the first extension portion 210 , the second extension portion 220 and the third extension portion 220 . The three extending portions 230 are stacked in turn radially outward. The first extending portion 210 has a first end portion 211 and a second end portion 212 , the second extending portion 220 has a third end portion 221 and a fourth end portion 222 , and the third extending portion 220 has a third end portion 221 and a fourth end portion 222 The extension portion 230 has a fifth end portion 231 and a sixth end portion 232 : the first end portion 211 of the first extension portion 210 is fixedly connected to one end portion of the body 1110 , and the second end portion 212 of the first extension portion 210 It is fixedly connected to the fourth end 222 of the second extending portion 220 , the third end 221 of the second extending portion 220 is fixedly connected to the fifth end 231 of the third extending portion 230 , and the sixth end of the third extending portion 230 The portion 232 is fixedly connected with the other end of the body 1110 .

Wherein, the non-actively extending region 200 is a continuous structure, the cross section of the inner tube body 110 is a closed-loop structure along the circumferential direction without openings, and the expanded inner-layer tube body is still a closed-loop structure along the circumferential direction. The inner tube body 111 can be folded as shown in FIG. 3A and FIG. 3B to reserve space for the expansion of the inner lumen of the guide catheter.

In some embodiments, when the inactive extension region 200 includes the first extension portion 210 and the third extension portion 230 on both sides, and the second extension portion 220 including two or more layers, the adjacent first extension portion 210 and the third extension portion 230 The ends of the two extending portions 220 are fixedly connected, so that the inactive extending region 200 is configured as a continuous structure.

In some embodiments, the inactive extension region 200 may also be configured as a discontinuous structure, that is, the inner tube body 110 is configured as an open-loop structure. Axially broken (cut or cut), by superimposing the broken side on the other side, space is reserved for the lumen of the guide catheter to expand. The size compatibility is stronger, and the process is relatively simple and easy to implement.

In the embodiment shown in FIG. 4B , the inner tube body 111 includes an open body 1110 , the inactive extension region 200 includes a first extension portion 210 and a third extension portion 230 , the first extension portion 210 and one end of the third extension portion 230 are respectively fixedly connected to the end portion of the body 1110 , wherein the first extension portion 210 at least partially overlaps the side surface of the third extension portion 230 .

Specifically, the circumferential dimension of the first extension portion 210 matches that of the third extension portion 230 , and during molding, the first extension portion 210 and the third extension portion 230 are completely overlapped to form a laminated structure. Of course, in some embodiments, the first extension portion 210 and the third extension portion 230 form a partially overlapping structure.

In some embodiments, the inactive extension region 200 includes a first extension portion 210 and a third extension portion 230 , and further includes a second extension portion, and the second extension portion is disposed on the first extension portion 210 and the third extension portion 230 wherein, one end of the second extension portion is fixedly connected to the first extension portion 210 or the third extension portion 230, and the other end overlaps the extension portion on the side thereof, so that the non-active extension region 200 Constructed as a discontinuous structure. Of course, in some embodiments, the inactive extension region 200 may also be configured with two or more layers of second extension parts 220 , so that the inactive extension region 200 is configured as a multi-layer discontinuous structure.

In this embodiment, the middle layer 112 is configured as a network management structure with several mesh holes, wherein the network management structure is configured with the above-mentioned openings 300; the cross-sectional view is shown in FIG. The network pipe is not completely closed in cross-section, but a certain space is reserved for placing the non-active extension area 200, so that when the inner diameter of the inner layer pipe body 111 expands, the middle layer 112 will also follow the inner diameter of the inner layer 112. The layers 111 expand together.

In a preferred embodiment, the intermediate layer 112 is braided into the mesh tube structure by wire, and then the opening 300 is formed by cutting along the axial direction. Specifically, the intermediate layer 112 is first braided by wire to complete the manufacture of the closed-loop mesh tube structure, and then laser cutting or mechanical cutting is used to cut a cut along the axial direction on the tube body of the braided mesh tube structure to form an opening 300 network management structure. The braided intermediate layer 112 has better flexibility.

In some embodiments, the intermediate layer 112 is formed by cutting the tube body to form a plurality of the mesh holes for forming. Specifically, the opening 300 and a number of holes are cut from the complete metal pipe body along the axial direction to form the intermediate layer 112 as shown in FIG. The cut-and-formed intermediate layer also reserves an opening 300 to place the non-active extension area 200. By processing the surface of the intermediate layer 112 to remove excess material, the rigidity of the network pipe structure can be improved, thereby improving the overall body 110 of the catheter. The flexibility of the intermediate layer 112 is not limited in this patent.

In this embodiment, the guiding catheter further includes a developing portion 114 located at the distal end of the intermediate layer 112 . In order to ensure a good developing effect of the developing part 114, the thickness of the developing part 114 is generally not less than 0.0015 inches.

Further, in order to reduce the resistance caused by the developing portion 114 to the expansion of the inner tube body 111 and ensure that the inner cavity of the guide tube is well opened, in some embodiments, the developing portion 114 is configured to have at least one axially extending A second opening 310 in which the inactive extension region 200 is configured to be received. The developing portion 114 is configured to conform to the non-closed structure extended by the non-active extending region 200 . The developing portion 114 of the non-closed structure enables expansion at the tip of the guide catheter, which can reduce the inner surface of the guide catheter lumen. friction with the outer surface of the intermediate catheter, thereby reducing damage to the hydrophilic coating on the outer surface of the intermediate catheter, thereby reducing the risk of the hydrophilic coating peeling off.

In some embodiments, the developing portion 114 includes a plurality of developing segments 1140 , and the multiple developing segments 1140 are arranged in a circumferential direction, and are arranged at intervals between adjacent developing segments 1140 , thereby forming a multi-segment structure. The design of the multi-segment combination of the developing portion 114 can significantly reduce the resistance encountered when the distal end of the catheter body 110 is expanded. In addition, a plurality of developing segments 1140 form a plurality of the second openings. When the non-active extension region 200 includes a plurality of stacked structures, the plurality of developing segments 1140 may be arranged according to the number of stacked structures, so that each stacked structure The structure can be accommodated in a second opening 310 to reduce expansion resistance.

In the non-limiting embodiment shown in FIG. 6 , the developing portion 114 is composed of four developing segments 1140 with the same wall thickness, inner and outer diameters and widths. When the developing part 114 is assembled at the distal end of the catheter body 110 , the developing part 114 will replace the position of the intermediate layer 112 in space, that is, the distal end of the catheter body 110 is the inner layer tube body 111 and the developing part 114 in order from inside to outside. With the outer tube body 113 , the inactive extension region 200 is accommodated in the second opening 310 between the two developing segments 1140 , as shown in FIG. 7 .

In some embodiments, the developing portion 114 may be configured to have a developing segment, and the developing segment is an open-loop structure having a second opening for accommodating the inactive extending region 200 . Wherein, the number of developing segments can be set according to actual needs.

In a preferred embodiment, the guide catheter 100 is configured to return to its original shape after delivery of the instrument is complete. For example, the inner layer pipe body 111 and the outer layer pipe body 113 are made of elastic material, for example, the inner layer pipe body 111 is made of polytetrafluoroethylene, and the middle layer 112 is made of shape memory material, such as nickel-titanium alloy. After the guiding catheter is expanded and the instrument is delivered in place, the inner layer 111 and the outer layer 113 are contracted by controlling the middle layer 112 to restore the original shape, thereby facilitating the evacuation of the guiding catheter.

Specifically, the elastic material of the outer tube body 113 has various hardness gradients, and the hardness decreases sequentially from the proximal end to the distal end.

As shown in FIGS. 1-3 and 7 , the above-mentioned guiding catheter is a multi-layered single-lumen tube containing multiple materials, and the cross-sectional shape is circular. The inner layer pipe body 111 is generally made of polytetrafluoroethylene (PTFE) or other polymer materials with low friction coefficient, which can be processed and formed by an extrusion process. The middle layer 112 is made of stainless steel or other biocompatible materials without shape memory, which can be prepared by processes such as tube laser cutting and wire weaving, and the rigidity of the middle layer 112 can be improved through a heat treatment process, thereby changing the overall flexibility of the catheter. . The intermediate layer 112 can provide better mechanical properties, flexibility, flexural resistance and compression resistance for the guide catheter, and can realize whole-body development (developing material).

The outer tube body 113 is generally made of thermoplastic polyurethane (TPU), block polyetheramide resin (Pebax), high-density polyethylene (HDPE), nylon (Nylon) and other polymer materials with good elasticity, which can be extruded. The raw material of the pipe is made by the method, and the transition of the rigidity of the pipe is realized by the splicing process. A hydrophilic coating such as polyvinylpyrrolidone (PVP) is usually added to the outer side of the outer tube body 113 to reduce the friction between the tube body and the inner wall of the blood vessel during the delivery of the catheter to the human blood vessel and reduce the use of the catheter. damage to human blood vessels. The outer layer tube body 113 is a closed single-lumen tube, which is invaginated on the inner layer tube body 111 and the middle layer 112 by means of film coating and other processes.

The developing part 114 is generally made of platinum-iridium, platinum-tungsten, platinum-nickel and other metal developing alloy materials or barium sulfate-containing polymer materials. Under X-rays, the developing part will show shadows to mark the position of the distal end of the catheter. The flexibility of the catheter body 110 can be comprehensively adjusted by adjusting the wall thicknesses of the inner tube body 111 and the outer layer tube body 113 , the wire diameter, the braided form and the density of the braided mesh of the intermediate layer 112 . The length of the catheter body 110 can be adjusted according to the conditions and environment of use. In general, the middle layer 112 is a braided mesh tube made of 16-32 braided wires or a metal tube that is cut and formed.

The guiding catheter described in this embodiment is an expandable guiding catheter, wherein the structures of the inner layer tube body 111 , the middle layer 112 and the developing portion 114 are the keys to realize the expansion of the catheter lumen. The expansion of the lumen of the expandable guiding catheter needs to be realized by external force, that is, it is completed by the dilator 400. The dilator 400 is shown in FIG. The straight section 402 between the two proximal ends 403 .

The guide catheter of this embodiment needs to be equipped with dilators of two sizes. When the expandable guide catheter is being punctured, the lumen does not need to be expanded, and the first one whose outer diameter matches the size of the catheter lumen will be used. Dilator for puncture. When the expandable guide catheter reaches the designated position, the lumen of the guide catheter needs to be expanded to deliver the instrument, and a second dilator thicker than the first dilator is used.

The lumen of the guiding catheter of this embodiment has a first inner diameter when it is not expanded, and the lumen of the guiding catheter has a second inner diameter when the inactive expansion region 200 is fully expanded. The outer diameter of the straight section 402 of the second dilator will be larger than the first inner diameter of the guide catheter, and theoretically smaller than the second inner diameter, and the outer diameter of the tip 401 of the second dilator will be smaller than the first inner diameter, so as to facilitate The second dilator can smoothly enter the lumen of the guiding catheter.

As the straight section 402 of the second dilator enters the lumen of the guiding catheter, the inner lumen of the guiding catheter is stretched, the laminated portion of the inactive expansion area 200 of the inner layer tube body 111 decreases continuously, and the middle layer 112 The and developing portion 114 expands in the circumferential direction with the expansion of the inner layer tube body 111, and the outer layer tube body 113 also expands in the circumferential direction due to its own elasticity; when the straight section 402 of the second dilator partially passes through the guide tube At the most distal end, the interior of the lumen will achieve overall expansion.

The above disclosure is only the preferred embodiments of the present invention, and the preferred embodiments do not describe all the details in detail. It should be understood that these embodiments are only used to illustrate the present invention, but not to limit the protection scope of the present invention, and the present invention is only subject to rights Requirements and Limitations of their Full Scope and Equivalents.

This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present invention, so that those skilled in the art can make good use of the present invention. Improvements and adjustments made by those skilled in the art according to the present invention in practical applications still belong to the protection scope of the present invention. The technical features in the different embodiments above can be arbitrarily combined on the premise that there is no conflict with each other.

Claims

A guide catheter is characterized by comprising an axially extending catheter body, the catheter body comprising an inner layer tube body, an outer layer tube body, and a tube located between the inner layer tube body and the outer layer tube body an intermediate layer configured to have a relatively greater stiffness, wherein,

The intermediate layer is configured with an axially extending opening, and the inner layer tubular body is configured with a circumferentially extensible region of inactive expansion that is at least partially received within the opening of the intermediate layer.
The guiding catheter according to claim 1, wherein the inactive expansion region comprises at least one relatively expandable laminated structure.
The guiding tube according to claim 2, wherein there are at least two laminated structures, and they are evenly distributed along the circumference of the inner tube body.
The guiding tube according to claim 2, wherein the laminated structure extends linearly along the axial direction, or the laminated structure extends spirally along the inner tube body.
The guiding catheter according to claim 2, 3 or 4, wherein the opening of the intermediate layer is matched with the laminated structure, and each laminated structure is respectively accommodated in the corresponding opening of the intermediate layer Inside,

Or, at least one of the laminated structures is configured to be completely accommodated in the opening of the intermediate layer, and the remaining laminated structures are closely attached to the inner wall of the intermediate layer.
The guiding catheter according to any one of claims 1-4, wherein the inner layer tube body is configured as a closed-loop structure, or the inner layer tube body is configured as an open-loop structure.
The guiding catheter according to claim 1, wherein the inner pipe body comprises an open body, the inactive extension region comprises a first extension part and a third extension part located on both sides, and includes a first extension part and a third extension part located on both sides. At least one second extension part between the first extension part and the third extension part, one end of the first extension part and the third extension part are respectively fixedly connected with the end of the body , the other ends of the first extension part and the third extension part are respectively fixedly connected with the ends of the adjacent second extension parts.
The guiding catheter according to claim 1, wherein the inner layer tube body comprises an open body, the inactive extension region comprises a first extension part and a third extension part, the first extension part and the One end portion of the third extension portion is respectively fixedly connected with the end portion of the body, wherein the first extension portion at least partially overlaps the side surface of the third extension portion.
The guiding catheter according to claim 1, wherein the intermediate layer is configured as a network management structure with several meshes; wherein,

The middle layer is formed by weaving a wire into a network tube structure, and then cutting to form the opening; or, the middle layer is formed by cutting a tube body to form a plurality of the mesh holes for forming.
The guiding catheter according to any one of claims 1-4 or 7-9, wherein the guiding catheter further comprises a developing portion located at the distal end, and the developing portion is configured to have at least one axially extending portion. A second opening in which the inactive extended region is configured to be received.
The guiding catheter according to claim 10, wherein the developing part comprises a plurality of developing segments, the multiple developing segments are arranged along the circumferential direction, and the adjacent developing segments are arranged at intervals.
The guiding catheter according to claim 1, characterized in that, the guiding catheter is configured to be able to return to its original state after completing the delivery of the instrument, wherein the inner layer tube body and the outer layer tube body are made of a predetermined elasticity. The middle layer is made of shape memory material; preferably, the elastic material of the outer tube body has various hardness gradients, and the hardness decreases sequentially from the proximal end to the distal end.
The guiding catheter according to claim 1, wherein the guiding catheter further comprises a diffusion stress tube and a connecting piece, and the diffusion stress tube is respectively connected with the catheter body and the connecting piece.
A guiding catheter system, characterized by comprising the guiding catheter according to any one of claims 1-13, and further comprising at least one dilator.