CN219323765U - Interventional catheter - Google Patents

Abstract

The utility model provides an interventional catheter, which comprises a catheter seat, a stress release piece and a catheter body which are sequentially connected, wherein the catheter body comprises a proximal end supporting part, a middle transition part and a distal end soft part which are sequentially connected along the axial direction; the pipe body is of a cavity structure, and a lubricating inner layer, an adhesive layer, a reinforcing layer and an outer layer are arranged from inside to outside in the radial direction; wherein, the thickness of the outer layer of the proximal support part of the tube body is larger than that of the outer layer of the distal soft part, and the tube body is in smooth transition. The utility model has simple structure and easy processing, utilizes the flexible distal end of the composite catheter to establish a vascular access, the distal end of the catheter body can pass through a tortuous blood vessel with flexible compliance, and the proximal end can provide stronger proximal end support and is not easy to slide.

Description

Interventional catheter

Technical Field

The utility model relates to the field of medical instruments, in particular to a catheter instrument for interventional therapy.

Background

In the treatment of stroke, the catheter-like device for interventional therapy needs to be as close to the vascular access of the lesion site as possible, so that the subsequent thrombus removing device or other therapeutic devices can reach the lesion site rapidly for corresponding treatment. In general, the distal end of the vascular access device needs to be compliant to pass through tortuous vessels, while the proximal end needs to be relatively stiff to provide a strong support for the subsequent device to ensure that it is in place successfully. While most vascular access devices are sufficiently flexible at the distal end, the proximal end does not provide adequate support; or the proximal end may provide sufficient support that the distal end is too stiff to be successfully placed in position through tortuous vessels. It is therefore necessary to design a catheter with a distal end that is flexible enough to be in place and a proximal end that is rigid enough to provide strong support.

Disclosure of Invention

The technical problem to be solved by the utility model is to provide the interventional catheter with simple structure and strong support property aiming at the defects.

The utility model is realized by the following technical scheme:

an interventional catheter comprises a catheter seat, a stress release piece and a catheter body which are sequentially connected, wherein the catheter body comprises a proximal supporting part, a middle transition part and a distal soft part which are sequentially connected along the axial direction;

the pipe body is of a cavity structure, and a lubricating inner layer, an adhesive layer, a reinforcing layer and an outer layer are arranged from inside to outside in the radial direction;

wherein, the thickness of the outer layer of the proximal support part of the tube body is larger than that of the outer layer of the distal soft part, and the tube body is in smooth transition.

Further, the reinforcement layer comprises a spiral braid adjacent to the adhesive layer and a cross braid adjacent to the outer layer.

Further, in the interventional catheter, the spiral braid and the cross braid are super-elastic wire braid with shape memory, the pitch of the spiral braid is between 0.02 and 0.10mm, and the density of the cross braid is between 60 and 150 PPI.

Further, in the interventional catheter, the adhesive layer and the outer layer are adhered to each other.

Further, in the interventional catheter, the adhesive layer has a thickness of no more than 0.0001 inches.

Further, in the interventional catheter, the outer layer is of a segmented structure, and the Shore hardness difference of the adjacent segments is not more than 20D.

Further, in the interventional catheter, the thickness of the outer layer of the proximal support section is 2-10 times the thickness of the outer layer of the distal soft section.

Further, in the interventional catheter, a hydrophilic coating is further arranged on the surface of the outer layer of the distal soft part.

Further, in the interventional catheter, a developing mark which does not project light is arranged at the end part of the distal soft part, and the developing mark is embedded between the outer layer and the reinforcing layer.

Further, in the interventional catheter, the developing mark is open-loop or closed-loop.

The utility model has the advantages and effects that:

1. the utility model has simple integral structure and easy processing, utilizes the flexible distal end of the composite catheter to establish a vascular access, the distal end of the catheter can pass through a tortuous blood vessel with flexible compliance, and the proximal end can provide stronger proximal end support and is not easy to slide.

2. The catheter outer layers with different thicknesses are arranged, particularly the wall thickness of the outer layer of the proximal support part is large, the wall thickness of the outer layer of the distal soft part is small, and extremely strong proximal support can be provided on the premise of considering the in-place performance of distal softness.

3. The catheter is provided with double-layer metal braiding layers, namely a spiral braiding layer and a cross braiding layer, so that multidirectional reinforcement is provided, meanwhile, a high polymer material bonding layer and an outer layer are arranged outside the braiding layers, the bonding layer and the outer layer made of the same material are bonded into a whole after penetrating through gaps between the two layers of metal braiding layers, and the reinforced braiding layers are tightly wrapped in the reinforced braiding layers to form an integrated structure. The structural design can reduce the axial elongation of the catheter, ensure the strength requirement of the catheter, and further optimize the operation performance of the catheter.

Drawings

FIG. 1 shows a schematic structural view of an interventional catheter according to an embodiment of the present utility model;

FIG. 2 shows a schematic structural view of a distal soft portion of an embodiment provided by the present utility model;

FIG. 3 shows a schematic structural view of a mid-section transition section of an embodiment provided by the present utility model;

fig. 4 shows a schematic structural view of a proximal support portion of an embodiment provided by the present utility model.

Reference numerals: a 1-catheter hub, a 2-stress relief, a 3-catheter body, a 4-annular development mark, a 5-distal soft portion outer layer, a 5-1-middle transition portion outer layer, a 5-2-proximal support portion outer layer, a 6-cross-braid, a 7-spiral braid, an 8-adhesive layer, and a 9-lubricious inner layer.

Detailed Description

In order to make the purposes, technical solutions and advantages of the implementation of the present utility model more clear, the technical solutions in the embodiments of the present utility model are described in more detail below with reference to the accompanying drawings in the embodiments of the present utility model. The described embodiments are some, but not all, embodiments of the utility model. The embodiments described below by referring to the drawings are illustrative and intended to explain the present utility model and should not be construed as limiting the utility model. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to fall within the scope of the utility model. Embodiments of the present utility model will be described in detail below with reference to the attached drawings:

in the description of the present utility model, it is to be understood that, unless otherwise indicated, the meaning of "a plurality" is two or more; the terms "center," "longitudinal," "transverse," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used for convenience in describing and simplifying the description based on the orientation or positional relationship shown in the drawings, and do not denote or imply that the devices or elements being referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the scope of the utility model. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In the description of the present utility model, it should also be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the above terms in the present utility model can be understood as appropriate by those of ordinary skill in the art.

In this specification, the term "proximal" generally refers to an end that is proximal to the operator of the medical device, and "distal" generally refers to an end that is distal from the operator of the medical device, typically the end that enters the human body first. "Shore hardness" refers to a reading of a value measured with a Shore durometer in degrees (D). PPI is the unit of pixel density, which in the present utility model represents the number of cross-woven meshes per inch.

Aiming at the problems in the prior art, the utility model provides a catheter type medical instrument for quickly establishing a vascular access when an interventional operation is completed. The catheter body of the interventional catheter is divided into three sections, namely a distal soft part, a middle transition part and a proximal support part. The whole tube body is composed of a plurality of layers of gradual change composite materials, and the main function of the far-end soft part is to provide a soft part catheter, so that the catheter can approach a lesion part infinitely through a tortuous blood vessel in the in-place process of the instrument; the proximal support portion is more rigid and the primary function of this portion is to provide strong support; the intermediate transition portion serves primarily as a gradual transition between the distal soft portion and the proximal support portion. The outer layer of the distal soft portion is coated with a hydrophilic coating to increase lubrication and reduce friction as it passes through the vessel; the outer layer of the proximal support portion is not coated with a hydrophilic coating so that it does not slide easily while providing support.

As shown in fig. 1 to 4, the specific structure of the catheter in this embodiment is:

the interventional catheter comprises a catheter seat 1, astress release element 2 and a catheter body 3 which are arranged in sequence from the proximal end to the distal end. The tube body 3 comprises a proximal support portion, a middle transition portion and a distal soft portion in this order from the proximal end to the distal end in the axial direction. The pipe body 3 is of a cavity structure, and the pipe body 3 is provided with a lubricating inner layer 9, an adhesive layer 8, a reinforcing layer and an outer layer from inside to outside along the radial direction.

The thickness of the outer layer 5-2 of the proximal supporting part of the tube body 3 is larger than that of the outer layer 5 of the distal soft part, and the two layers are connected in a smooth transition way through the outer layer 5-1 of the middle transition part. The thickness of the outer layer of the proximal support portion is 2-10 times the thickness of the outer layer of the distal soft portion. Specifically, the outer layer adopts a segmented structure, the outer layer is divided into at least five sections, the sections are connected in a thermal butt joint mode, and the difference value of the Shore hardness of the adjacent sections is not more than 20D. The outer layer is processed on the reinforcing layer by adopting a hot compress process, and the outer layer is mutually adhered with the adhesive layer, so that the distal catheter is reinforced to ensure that the whole body is not layered.

The reinforcement layer is a wire braid comprising a spiral braid 7 and a cross braid 6. The spiral braid 7 is adjacent to the adhesive layer 8 and the cross braid is adjacent to the outer layer. Specifically, the spiral braiding layers and the cross braiding layers are made of super-elastic metal wires with shape memory, the pitch of the spiral braiding layers is 0.02-0.10mm, and the cross braiding density is 60-150 PPI.

The end of the distal soft part is provided with a developing mark 4 which does not project light, the developing mark 4 is fixedly embedded between the outer layer and the reinforcing layer, the developing mark is of an annular structure, can be open-loop or closed-loop, and is used for facilitating a doctor to accurately convey a catheter to a designated position of a blood vessel under X-rays.

The inner lubricating layer 9 can be made of PTFE or HDPE, including but not limited to other materials with lubricating property, and has the functions of improving the lubricity of the inner cavity of the catheter, reducing the friction force of other instruments when passing through, and facilitating the pushing of the therapeutic instruments. The lubricant inner layer 9 is coated with an adhesive layer 8 having a thickness of not more than 0.0001 inch, and the adhesive layer 8 may be made of polyamide, polyether amide, polyurethane, or the like. The reinforcing layer can be made of 304 stainless steel wire, nickel-titanium alloy wire, etc. with shape memory super-elasticity. The outer layer can be an elastic resin material such as polyamide, polyether amide and polyurethane. The outer layer is added with developing materials such as barium sulfate or bismuth sulfate, etc., so that a doctor can see the shape of the whole catheter under X-ray. The outer periphery of the flexible portion of the distal end is also provided with a hydrophilic coating (not shown in the figures) which can significantly enhance the lubrication of the catheter within the blood vessel so that the catheter can be more smooth within the blood vessel.

In some embodiments, the utility model may be modified as follows:

1. the spiral braiding layers in the same pipe body or the same or gradual screw pitches are selected according to the use scene and the reinforcing degree.

2. The cross braiding layers in the pipe body or different braiding modes or different braiding densities are selected according to the use scene and the reinforcing degree.

3. The diameter of the tube body is 0.5mm-2mm so as to adapt to blood vessels with different diameters.

In addition, one processing mode of the tube body of the interventional catheter of the utility model is as follows:

1) The lubricant coating of the inner layer may be processed using a variable-size mandrel, such as a silver-plated copper shaft, including but not limited to a silver-plated copper shaft;

2) After the lubricating coating is coated, an adhesive layer is coated, wherein the adhesive layer is made of materials such as polyamide, polyether amide, polyurethane and the like, including but not limited to the materials, and the thickness of the adhesive layer is not more than 0.0001 inch;

3) Weaving a super-elastic wire with shape memory on the coated mandrel according to a parameter range of 0.02-0.10 of pitch;

4) Cross-braiding shape memory superelastic metal wires on another stainless steel mandrel according to a parameter range of 60-150, wherein the size of the stainless steel mandrel is smaller than or equal to the outer diameter of the spiral braided variable-size mandrel;

5) Blowing the whole woven stainless steel mandrel by using a high-temperature spray gun;

6) Removing the woven mesh tube from the stainless steel mandrel;

7) Penetrating a woven mesh tube from one end of a spiral woven mandrel;

8) Loading the developing ring to the head end of the far-end woven net pipe and compacting;

9) Sleeving the outer layer tube into a woven mesh tube, wherein the outer layer tube is divided into at least 5 sections, and the hardness difference between two adjacent sections is not more than 20D;

10 Penetrating the heat shrinkage pipe body into the outer layer pipe;

11 Blowing the heat shrinkage tube by heat radiation or stable hot air equipment with the temperature of 200-450 ℃ and ensuring that each section can be passed at a stable speed;

12 A section with thin wall of the outer layer pipe should be blown at a higher speed, and a section with thick wall of the outer layer pipe should be blown at a lower speed to achieve a better bonding effect;

13 Using a core drawing device to thin the variable-size mandrel to be smaller than the size of the lubricating coating pipe, and drawing the mandrel out;

14 Cutting the two ends of the tube body to make the two ends flat.

The above embodiments are only for illustrating the technical solution of the present utility model, and are not intended to limit the implementation scope of the present utility model. All equivalent changes and modifications within the scope of the present utility model should be considered as falling within the scope of the present utility model.

Claims (10)

1. An interventional catheter, includes catheter holder, stress relief spare and body that connect gradually, its characterized in that:

the tube body (3) comprises a proximal end supporting part, a middle transition part and a distal end soft part which are sequentially connected along the axial direction;

the pipe body (3) is of a cavity structure, and a lubricating inner layer (9), an adhesive layer (8), a reinforcing layer and an outer layer are arranged outside the pipe body from inside to outside in the radial direction;

wherein the thickness of the outer layer (5-2) of the proximal supporting part of the tube body (3) is larger than that of the outer layer (5) of the distal soft part, and the tube body is in smooth transition.

2. An interventional catheter according to claim 1, wherein: the reinforcement layer comprises a spiral braid (7) adjacent to the adhesive layer, and a cross braid (6) adjacent to the outer layer.

3. An interventional catheter according to claim 2, wherein: the spiral braiding layers (7) and the cross braiding layers (6) are super-elastic metal wire braiding layers with shape memory, the screw pitch of the spiral braiding layers (7) is between 0.02 and 0.10mm, and the density of the cross braiding layers (6) is between 60 and 150 PPI.

4. An interventional catheter according to any one of claims 1 to 3, wherein: the adhesive layer (8) and the outer layer are adhered to each other.

5. An interventional catheter according to any one of claims 1 to 3, wherein: the adhesive layer (8) has a thickness of no more than 0.0001 inches.

6. An interventional catheter according to any one of claims 1 to 3, wherein: the outer layer is of a segmented structure, and the Shore hardness difference of the adjacent segments is not more than 20D.

7. An interventional catheter according to any one of claims 1 to 3, wherein: the thickness of the outer layer (5-2) of the proximal support portion is 2-10 times the thickness of the outer layer (5) of the distal soft portion.

8. An interventional catheter according to any one of claims 1 to 3, wherein: the surface of the outer layer (5) of the distal soft part is also provided with a hydrophilic coating.

9. An interventional catheter according to any one of claims 1 to 3, wherein: the end of the distal soft part is provided with a developing mark (4) which does not project light, and the developing mark (4) is embedded between the outer layer and the reinforcing layer.

10. An interventional catheter according to claim 9, wherein: the developing mark (4) is open-loop or closed-loop.

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