CN116942993A - Hardness-adjustable shaping catheter capable of self-adapting to shape of blood vessel and application method thereof - Google Patents

Abstract

The application discloses a hardness-adjustable shaping catheter capable of conforming to a blood vessel shape, a use method and a manufacturing method thereof; the distal end of the main pipe body is provided with a soft section; the soft section is provided with a first inner liner layer, a first winding spring layer and a fastening layer, and an adjusting cavity is formed between the first winding spring layer and the fastening layer; the catheter seat is arranged at the proximal end of the main pipe body and is provided with a first channel and a second channel, and the first channel is connected with a pipeline inner cavity formed by the first lining layer; the second channel is communicated with the adjusting cavity and is used for being connected with a negative pressure device; the negative pressure device provides suction force, the second channel acts on the adjusting cavity, the fastening layer is tightly held by the reed winding tube under the action of the suction force, the angle of the first reed winding layer is fixed, and meanwhile, the hardness of the soft section is improved. The application can simplify the operation process without multi-system operation, and realize the effect of single-tube treatment.

Description

Hardness-adjustable shaping catheter capable of self-adapting to shape of blood vessel and application method thereof

Technical Field

The application relates to the technical field of medical catheters, in particular to a hardness-adjustable shaping catheter capable of self-adapting to the shape of a blood vessel and a use method thereof.

Background

The first report of stranding by Bierman et al in 1951 since the time of arterial catheterization of the cerebral angiography, femoral artery access has been considered a conventional access for cerebral angiographic treatment. However, the femoral artery is used as a classical approach way for the intervention of cerebrovascular diseases, and has certain defects such as hematoma at puncture, arteriovenous leakage, long-time bedridden after operation and the like. Therefore, many scholars begin to try other approaches, radial access being the most valuable research direction.

Percutaneous access cardiography was first introduced in 1989 and is used to reduce complications at the puncture site and to increase patient comfort. After successful radial artery access cerebrovascular angiography was reported by Matsumoto et al in 2000, many researchers began to try radial artery access cerebrovascular angiography and radial artery access cerebrovascular therapy developed gradually as radial artery access cerebrovascular angiography developed. The transradial approach has the added advantage of reducing surgical complications and increasing patient comfort over the transfemoral approach. If the radial artery is superficial, the risk of nerve injury and arteriovenous leakage caused by puncture is obviously less than that of the femoral artery; the anti-platelet and anticoagulant therapy is not required to be interrupted in the examination process; pre-operation does not need perineum skin preparation, postoperative bed-free and the like. However, with clinical application of transradial cerebrovascular intervention, it has been gradually found that it has greater difficulty than transfemoral approach, such as difficulty in radial puncture than femoral artery, complicated selective catheterization procedure, difficult catheter manipulation, low success rate of selective catheterization of secondary blood vessels on aortic arch, longer learning time required for the operator, more radiation exposure to the operator during the operation than femoral approach, etc.

Considering the advantages of reducing complications of the radial artery access and increasing comfort level of patients, the radial artery access proportion in the cerebrovascular interventional therapy is gradually increased clinically, the pain point of the radial artery access is solved, and the introduction of a more novel, simple, rapid and convenient treatment mode is more important. The better instrument can more simply assist the doctor to complete the operation and becomes a 'sharp tool' in the hands of the operator.

The defects of the existing radial artery access cerebral vascular interventional operation are mainly the problems of in-place difficulty, weak support, easy folding, difficult operation, instability and the like caused by the limitation of special instruments, so that the operation needs multiple instruments and multiple systems to be performed in a coaxial or exchange manner under the condition of more complicated blood paths of the radial artery, the operation process is complicated, the operation time is long, and the learning curve of new people is long.

Disclosure of Invention

In order to overcome the defects of the prior art, the application provides the hardness-adjustable shaping catheter capable of self-adapting to the shape of the blood vessel and the use method thereof, which are designed aiming at the blood path condition of radial artery, can achieve the effects of simplifying the operation process, needing no multi-system operation and realizing single-tube treatment.

A first aspect of the present application is to provide a stiffness adjustable sizing catheter that conforms to a vessel shape, comprising a main catheter body and a catheter hub;

the two ends of the main pipe body respectively form a distal end and a proximal end, the main pipe body is provided with a soft section, and the soft section is arranged close to the distal end; the soft section is provided with a first inner liner layer, a first spring winding layer and a fastening layer from inside to outside, the first spring winding layer is formed by winding a plurality of strands of metal wires on the surface of the first inner liner layer, and an adjusting cavity is formed between the first spring winding layer and the fastening layer;

the catheter seat is arranged at the proximal end of the main pipe body and is provided with a first channel and a second channel, and the first channel is connected with a pipeline inner cavity formed by the first lining layer and is used for a working passage; the second channel is communicated with the adjusting cavity and is used for being connected with a negative pressure device;

the negative pressure device provides suction force, the second channel acts on the adjusting cavity, the fastening layer is tightly held by the reed winding tube under the action of the suction force, the angle of the first reed winding layer is fixed, and meanwhile, the hardness of the soft section is improved.

In a first aspect of the present application, as a preferred embodiment, the surface of the wire of the first wrap spring layer is provided with a reinforcing structure for increasing friction between the wire of the first wrap spring layer and the fastening layer.

In a first aspect of the present application, as a preferred embodiment, the reinforcement structure is a clad tube, the clad tube is a tube body made of PTFF, and the clad tube is sleeved on the surface of the wire of the first spring winding layer.

In a first aspect of the present application, as a preferred embodiment, the soft segment further comprises a coated tube, the coated tube being a tube body made of TPU, the surface of which is coated with a hydrophilic coating; the coating pipe is sleeved on the surface of the fastening layer.

In a first aspect of the present application, as a preferred embodiment, the main tubular body further comprises a support section, the support section being disposed near the proximal end; the supporting section is sequentially provided with a second inner liner layer, a second spring winding layer, a braiding layer and an outer tube from inside to outside; the braided layer is a net structure formed by braiding a plurality of strands of metal wires, the metal wires of the braided layer are flat wires, the braided layer is provided with a density gradient section, and the density range of the braided layer is 60-110 ppi.

In the first aspect of the present application, as a preferred embodiment, the wire pitch of the first spring winding layer ranges from 0.05 to 0.2mm; the size range of the metal wire spacing of the second winding spring layer is 0.1-0.3 mm.

In the first aspect of the present application, as a preferred embodiment, the outer tube has a plurality of segments having different hardness, the segments having progressively smaller hardness in a proximal-to-distal direction; the outer tube is internally provided with a cavity channel which is used for communicating the adjusting cavity and the second channel.

In the first aspect of the present application, as a preferred embodiment, the main tube body distal end is provided with a developing ring; a stress release tube is arranged between the main tube body and the catheter seat; the primary tubular body surface is coated with a hydrophilic coating.

In a second aspect, the present application provides a method of using a stiffness adjustable sizing catheter that conforms to a shape of a blood vessel, comprising the steps of:

providing a stiffness adjustable sizing catheter compliant with the shape of a blood vessel according to any of the first aspect of the application;

flushing the inner cavity of the hardness-adjustable shaping catheter by heparin physiological saline, immersing the distal end into the heparin physiological saline, and soaking the hydrophilic coating;

providing an introduction means by which the hardness-adjustable sizing catheter is introduced into the vascular system;

under the monitoring of radiographic perspective, advancing the hardness-adjustable shaping catheter until reaching a target position;

connecting the second channel to a negative pressure device, sucking the adjusting cavity through the second channel, compressing the space of the adjusting cavity, enabling the fastening layer to hold the reed winding tube tightly, fixing the angle of the first reed winding layer, completing the shaping and the hardness improvement of the adjustable shaping catheter, maintaining a negative pressure state, and completing the establishment of a working channel;

and performing operation through the first channel entering the working channel.

In a third aspect, the present application provides a method of manufacturing a catheter with adjustable durometer that conforms to a shape of a blood vessel, comprising the steps of:

providing a cladding pipe and a metal wire, and sleeving the cladding pipe on the surface of the metal wire;

providing a lining pipe and a developing ring, and fixing the developing ring at the end part of the lining pipe; winding a metal wire sleeved with a cladding tube on the surface of the lining tube to form a spring winding layer, wherein the end part of the metal wire is fixedly connected with the developing ring;

providing a fastening layer to cover the surface of the spring winding layer at a position 10-50cm close to the far-end port; providing a coating pipe sleeved on the surface of the fastening pipe;

providing a plurality of metal flat wires, and braiding the metal flat wires on the surface, close to the proximal end, of the spring winding layer to form a braiding layer;

providing segments with different hardness, mutually connecting the segments according to the hardness order to form an outer tube, sleeving the outer tube on the surface of the braiding layer, and rheologically integrating the outer tube, the braiding layer, the spring winding layer and the inner liner layer into a whole; a cavity is formed in the outer tube;

coating hydrophilic coatings on the surfaces of the coating pipe and the outer pipe;

a catheter hub and a stress relief tube are provided and mounted to the proximal end of the main body.

Compared with the prior art, the application has the beneficial effects that:

1. the flexible section of the self-adaptive vessel conformal hardness-adjustable shaping catheter is in a flexible state in a natural state, so that the catheter can better conform to the vessel and can be used in place in the cerebral vessel.

2. The soft section of the self-adaptive vessel conformal hardness-adjustable shaping catheter can be subjected to hardness adjustment. The soft section is internally provided with an adjusting cavity, when the soft section is suitable for the bending type of the blood vessel, the negative pressure device is connected to the first channel port of the catheter seat for sucking, the adjusting cavity contracts and holds the hardness of the blood vessel to be increased, the soft section is fixed, and the current bending type compliance shaping of the blood vessel is realized.

3. The self-adaptive vascular compliance hardness adjustable shaping catheter has high-in-place and strong support and realizes single-tube treatment. The hardness of the product can be adjusted, the product has the characteristics of the middle catheter and the guiding catheter, and the coaxial multitube treatment mode of passing the middle catheter in the guiding catheter in the clinic is not needed, so that all problems are solved by one catheter.

4. The hardness-adjustable shaping catheter capable of self-adapting to the shape of the blood vessel has the advantages of no need of pre-shaping and better stability. The hardness of the catheter is improved and the catheter is shaped after the catheter is compliant with the bending of the blood vessel. This means that the catheter does not need to be pre-shaped and the soft tip can easily pass through any complex blood path. After shaping, the soft section is well attached to the blood vessel, so that the device is stable and motionless when the intermediate instrument treatment operation is performed, and the phenomenon that the conventional catheter is dropped on the bow is avoided.

Drawings

FIG. 1 is a perspective view of a stiffness adjustable sizing catheter of the present application adaptable to a vascular compliance;

FIG. 2 is a front view of an adaptable vascular conformable, hardness-adjustable sizing catheter of the present application;

FIG. 3 is a cross-sectional view of a stiffness adjustable sizing catheter of the present application that is adaptable to a vascular compliance;

FIG. 4 is a partial schematic view of section A of the adaptable vaso-compliant adjustable durometer catheter of the present application;

FIG. 5 is a partial schematic view of a portion B of an adaptable, vaso-compliant, hardness-adjustable sizing catheter of the present application;

FIG. 6 is a schematic view showing the use state of the hardness-adjustable sizing catheter capable of adapting to the shape of a blood vessel according to the application.

In the figure: 100. a main pipe body; 110. a soft section; 111. a first liner layer; 112. a first winding layer; 1121. a regulating chamber; 113. a fastening layer; 114. a cladding tube; 115. coating a pipe; 120. a support section; 121. a second liner layer; 122. a second wrap spring layer; 123. a braiding layer; 124. an outer tube; 1241. 200, a catheter seat; 210. a first channel; 220. a second channel; 300. and a developing ring.

Detailed Description

The application will be further described with reference to the drawings and the detailed description, wherein it should be noted that, on the premise of no conflict, the embodiments or technical features described below can be arbitrarily combined to form new embodiments. Materials and equipment used in this example are commercially available, except as specifically noted. Examples of embodiments are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements throughout or elements having like or similar functionality. The embodiments described below by referring to the drawings are exemplary only for explaining the present application and are not to be construed as limiting the present application.

In the description of the present application, it should be understood that the terms "upper," "lower," "front," "rear," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like indicate or are based on the orientation or positional relationship shown in the drawings, merely to facilitate description of the present application and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present application. In the description of the present application, the meaning of "a plurality" is two or more, unless specifically stated otherwise.

In the description of the present application, it should be noted that, unless explicitly stated or limited otherwise, the terms "connected," "connected," and "connected" are to be construed broadly, and may be fixedly connected, or may be connected through an intermediary, or may be connected between two elements or may be an interaction relationship between two elements. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances.

The terms first, second and the like in the description and in the claims and in the above-described figures, are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.

Example 1

Referring to fig. 1-6, the present embodiment provides a catheter with adjustable hardness that can conform to the shape of a blood vessel, comprising a main catheter body 100 and a catheter hub 200;

the two ends of the main pipe body 100 respectively form a distal end and a proximal end, the main pipe body 100 is provided with a soft section 110 and a supporting section 120, the soft section 110 is arranged near the distal end, and the supporting section 120 is arranged near the proximal end;

the effective length of the main pipe body 100 is 90-150 cm, the length of the soft section 110 is 10-50cm, the length capable of adjusting the hardness is 10-50cm, the outer surface of the main pipe body 100 is coated with a hydrophilic coating, the coating length is 20-100 cm, the inner diameter of the main pipe body 100 is 1.00-2.64 mm, and the outer diameter is 1.15-3.10 mm, so that the main pipe body is suitable for the radial artery access characteristics, and the operation requirement of an operation is met to the greatest extent.

The soft section 110 is provided with a first inner liner layer 111, a first spring winding layer 112 and a fastening layer 113 from inside to outside, wherein the first inner liner layer 111 is made of PTFE (polytetrafluoroethylene), so that the inner cavity of the catheter is flat and has high lubricity, and the passage of other instruments is facilitated; the end of the main tube body 100 is provided with a developing ring 300, the developing ring 300 is made of platinum iridium alloy, and is fixed at a position 1mm away from the head end (flat head end) of the main tube body 100, and is used for displaying the position of the head end of the catheter under rays, so that clinical judgment and use are facilitated;

the first spring winding layer 112 is a plurality of strands of metal wires wound on the surface of the first inner liner 111, the metal wires are generally stainless steel round wires, the pitch between the metal wires is 0.05-0.2 mm and is gradually changed, and the tail ends of the metal wires are fixed on the developing ring 300 through welding;

the fastening layer 113 is made of TPU (polyurethane) and is used for holding the metal wire of the first winding spring layer 112 under negative pressure, and an adjusting cavity 1121 is formed between the first winding spring layer 112 and the fastening layer 113;

the catheter seat 200 is arranged at the proximal end of the main pipe body 100, and a stress release pipe is arranged at the joint of the catheter seat 200 and the main pipe body 100; the stress relief cuff is attached to catheter hub 200 at the proximal end of the catheter for ease of catheter control during intraoperative handling by the operator and to avoid breakage of the stress concentrating catheter.

The catheter seat 200 is in a Y-shaped dual-channel form made of PC (polycarbonate), both ends of the channel are standard luer connectors, a first channel 210 and a second channel 220 are formed inside the catheter seat 200, and the first channel 210 is connected with a pipeline inner cavity formed by the first lining layer 111 to serve as a conventional catheter working channel; the second channel 220 is communicated with the adjusting cavity 1121, and is connected with a negative pressure device outside the negative pressure suction channel, so as to complete the hardness adjustment and the compliance shaping of the control catheter.

The flexible section 110 of the self-adaptive vessel conformal hardness-adjustable shaping catheter is in a flexible state in a natural state (namely when negative pressure suction is not performed), so that the self-adaptive vessel conformal hardness-adjustable shaping catheter can better conform to a vessel and can be used in place in a cerebral vessel. After the flexible section adapts to the bending of the blood vessel, the negative pressure device provides a suction force, and the suction force acts on the adjusting cavity 1121 through the second channel 220, so that the fastening layer 113 tightly holds the reed pipe under the action of the suction force, and the angle in the axial section direction formed by the first reed layer 112 due to the shape of the blood vessel is limited to realize shaping and hardness adjustment, thereby realizing the current bending type compliance shaping of the blood vessel.

In some preferred embodiments, the wire surface of the first wrap spring layer 112 is provided with a reinforcing structure for increasing friction between the wire of the first wrap spring layer 112 and the fastening layer 113. The reinforcing structure of this embodiment is a coated tube 114, the coated tube 114 being a tube body made of PTFF (polytetrafluoroethylene), the metal wire is sleeved on the surface of the first winding spring layer 112, so that the first winding spring layer 112 is conveniently fixed, and the friction force between the first winding spring layer and the fastening layer 113 during shaping is increased. In other embodiments, the reinforcing structure may be a frosted structure etched on the surface of the wire, or the like.

The soft section also comprises a coating pipe 115, wherein the coating pipe 115 is a pipe body made of TPU, and the surface of the coating pipe is coated with a hydrophilic coating; the coating pipe 115 is sleeved on the surface of the fastening layer 113, smoothness of the hardness-adjustable shaping catheter in the blood vessel is enhanced by arranging the coating pipe 115, and meanwhile, the coating pipe 115 can also shrink and hug tightly under negative pressure adjustment, so that the fastening pipe is assisted to realize blood vessel compliance shaping and hardness adjustment to a certain extent.

Specifically, the support section 120 is provided with a second inner liner 121, a second spring winding layer 122, a braiding layer 123 and an outer tube 124 in sequence from inside to outside;

the second inner liner layer 121 is identical to the first inner liner layer 111 in structure, the second wrap spring layer 122 is identical to the first wrap spring layer 112 in structure, and the pitches between the metal wires of the second wrap spring layer 122 are 0.05-0.2 mm in gradual change arrangement.

The braiding layer 123 is a net structure formed by braiding a plurality of strands of metal wires, and the metal wires of the braiding layer 123 are preferably stainless steel flat wires; the knitting layer 123 is provided with a density gradient section, the density range of the knitting layer 123 is 60-110 ppi, the supporting section 120 is reinforced by arranging the knitting layer 123, and the supporting and deformation resistance in the using process is improved.

The outer tube 124 is a tube body made of PA (polyamide) and Pebax (block polyether amide resin), the outer tube 124 has segments with different hardness, and the hardness of the segments gradually decreases from the proximal end to the distal end; by alternating the hardness, the gradual transition of the product hardness is realized, the operation transmission of the main pipe body 100 in the blood vessel is enhanced, and the bending and the folding in the practical process are avoided. The surface of the outer tube 124 is coated with a hydrophilic coating, a cavity 1241 is arranged inside the outer tube 124, and the cavity 1241 is communicated with the adjusting cavity 1121 and the second channel 220 for controlling the hardness adjustment of the catheter and adapting to shaping. The lumen 1241 may be a separate port within the outer tube 124, or may be provided with multiple ports to enhance pumping efficiency. The mode of the pore canal can reduce the influence of suction force on deformation and the like of the outer tube, and can avoid suction failure caused by blockage or extrusion.

The embodiment is suitable for the hardness-adjustable shaping catheter which can conform to the shape of a blood vessel in radial artery interventional operation, has high in-place performance and strong support, and can realize single-tube treatment; the product can carry out hardness adjustment, has the characteristics of the middle catheter and the guiding catheter, optimizes the coaxial multitube treatment mode of the middle catheter passing through the guiding catheter at present, and realizes one catheter to solve all problems. Meanwhile, the catheter has the advantages of no need of pre-shaping and better stability, and the hardness of the catheter is improved and shaped after the catheter is compliant with the bending of the blood vessel, so that the catheter does not need to be pre-shaped, and the soft head end can easily pass through any complicated blood path. After shaping, the soft section is well attached to the blood vessel, so that the device is stable and motionless when the intermediate instrument treatment operation is performed, and the phenomenon that the conventional catheter is dropped on the bow is avoided.

Example 2

On the basis of the embodiment 1, the application method of the hardness-adjustable shaping catheter which can conform to the shape of a blood vessel comprises the following steps:

step S11: providing a stiffness adjustable sizing catheter that is conformable to a vessel shape as described in example 1; opening the hardness-adjustable sizing catheter package, taking the hardness-adjustable sizing catheter out carefully;

step S12: immediately check if the hardness adjustable sizing catheter is damaged. Care is taken not to use a hardness adjustable sizing catheter that has been damaged. If damage is detected, replacing another new undamaged adjustable hardness sizing catheter;

step S13: before use, the inner cavity of the hardness-adjustable shaping catheter is washed by heparin physiological saline, the distal end is immersed in the heparin physiological saline, and the hydrophilic coating is soaked;

step S14: providing an introducing sheath and a catheter sheath, and inserting the hardness-adjustable shaping catheter through the introducing sheath in an auxiliary way so as to enable the hardness-adjustable shaping catheter to pass through the catheter sheath;

step S15: a hardness-adjustable sizing catheter is introduced into the vasculature via a guidewire through a catheter sheath using a selected percutaneous technique.

Step S16: the heparin physiological saline is used for continuous flushing through a rotary hemostatic valve side arm on the luer connector locking device. A continuous flushing with heparin saline is maintained between the catheter and any instruments that pass coaxially through the lumen of the catheter.

Step S17: under the monitoring of radiographic perspective, advancing the hardness-adjustable shaping catheter until reaching a target position;

step S18: connecting the second channel 220 to a negative pressure device, sucking the adjusting cavity 1121 through the second channel 220, compressing the space of the adjusting cavity 1121 to enable the fastening layer 113 to hold the reed winding tube tightly, fixing the angle of the first reed winding layer 112, completing the shaping and the hardness improvement of the adjustable shaping catheter, maintaining a negative pressure state, and completing the establishment of a working channel;

step S19: the over-selected catheter or guidewire is removed prior to introduction of other intravascular devices or perfusion of contrast.

Step S110: after the working channel is established, other products are conveyed;

step S111: after the operation is completed, the catheter is taken out from the patient

Example 3

The present embodiment provides a method for manufacturing a catheter with adjustable hardness, which is mainly used for manufacturing the catheter with adjustable hardness, which is capable of conforming to the shape of a blood vessel and is described in embodiment 1, and specifically comprises the following steps:

step S21: providing a cladding tube 114 and a metal wire, and sleeving the cladding tube 114 on the surface of the metal wire;

step S22: providing a lining pipe and a developing ring 300, and fixing the developing ring 300 at the end of the lining pipe; winding a metal wire sleeved with a cladding pipe 114 on the surface of the lining pipe to form a spring winding layer, wherein the end part of the metal wire is fixedly connected with the developing ring 300;

step S23: providing a fastening layer 113 to cover the surface of the spring winding layer at a position 10-50cm close to the distal end port; providing a coating tube 115 sleeved on the surface of the fastening tube;

step S24: providing a plurality of metal flat wires, and braiding the metal flat wires on the surface of the spring winding layer close to the proximal end to form a braiding layer 123;

step S25: providing segments with different hardness, mutually connecting the segments according to the hardness order to form an outer tube 124, sleeving the outer tube 124 on the surface of the braiding layer 123, and rheologically integrating the outer tube 124, the braiding layer 123, the second spring winding layer 122 and the second inner liner 121; and a channel is machined into the outer tube 124;

step S26: coating a hydrophilic coating on the surfaces of the coating tube 115 and the outer tube 124;

step S27: a catheter hub 200 and stress relief tube are provided, and the catheter hub 200 and stress relief tube are mounted to the proximal end of the main body 100.

The hardness-adjustable shaping catheter capable of conforming to the shape of a blood vessel, and the use method and the manufacturing method thereof, provided by the application, enable the catheter to have the high-reaching capacity of the middle catheter and the strong supporting capacity of the guiding catheter through two forms of switching, thereby realizing single-tube treatment; the application range is enlarged, the bleeding nerve intervention treatment and the ischemia nerve intervention treatment can be applied, and the current situation that the two fields cannot be commonly used nowadays is changed; the use of an intermediate catheter is omitted, so that the treatment cost of a patient is saved; the operation of operators is simplified, multiple systems are not needed, and the operation mode is simple; the emergency treatment device can better cope with emergency such as emergency treatment, shortens treatment time, is beneficial to treating golden time and improves operation efficiency; the hardness and the shape of the blood vessel can be adjusted, the use of the instrument is stabilized, the damage in the blood vessel is reduced, and the operation risk is low and safer; widening a new mode of radial artery interventional therapy, and being worthy of great popularization and use.

The above embodiments are only preferred embodiments of the present application, and the scope of the present application is not limited thereto, but any insubstantial changes and substitutions made by those skilled in the art on the basis of the present application are intended to be within the scope of the present application as claimed.

Claims (10)

1. A hardness-adjustable shaping catheter capable of conforming to the shape of a blood vessel, which is characterized by comprising a main catheter body and a catheter seat;

the two ends of the main pipe body respectively form a distal end and a proximal end, the main pipe body is provided with a soft section, and the soft section is arranged close to the distal end; the soft section is provided with a first inner liner layer, a first spring winding layer and a fastening layer from inside to outside, the first spring winding layer is formed by winding a plurality of strands of metal wires on the surface of the first inner liner layer, and an adjusting cavity is formed between the first spring winding layer and the fastening layer;

the catheter seat is arranged at the proximal end of the main pipe body and is provided with a first channel and a second channel, and the first channel is connected with a pipeline inner cavity formed by the first lining layer and is used for a working passage; the second channel is communicated with the adjusting cavity and is used for being connected with a negative pressure device;

the negative pressure device provides suction force, the second channel acts on the adjusting cavity, the fastening layer is tightly held by the reed winding tube under the action of the suction force, the angle of the first reed winding layer is fixed, and meanwhile, the hardness of the soft section is improved.

2. The adjustable durometer catheter of claim 1, wherein the wire surface of the first wrap spring layer is provided with a reinforcing structure for increasing friction between the wire of the first wrap spring layer and the fastening layer.

3. The adjustable durometer catheter of claim 2, wherein the reinforcement structure is a covered tube, the covered tube is a tube made of PTFF, and the covered tube is sleeved on the wire surface of the first wrap spring layer.

4. The adjustable durometer catheter of claim 1, wherein the flexible section further comprises a coated tube, the coated tube being a tube made of TPU, coated with a hydrophilic coating; the coating pipe is sleeved on the surface of the fastening layer.

5. The adjustable durometer catheter of claim 1, wherein the main tubular body further comprises a support section, the support section disposed proximally; the supporting section is sequentially provided with a second inner liner layer, a second spring winding layer, a braiding layer and an outer tube from inside to outside;

the braided layer is a net structure formed by braiding a plurality of strands of metal wires, the metal wires of the braided layer are flat wires, the braided layer is provided with a density gradient section, and the density range of the braided layer is 60-110 ppi.

6. The adjustable-hardness sizing catheter capable of conforming to the shape of a blood vessel according to claim 5, wherein the wire spacing of the first wrap spring layer is in the range of 0.05-0.2 mm; the size range of the metal wire spacing of the second winding spring layer is 0.1-0.3 mm.

7. The adjustable durometer catheter of claim 5, wherein the outer tube has segments of differing durometer, the segments being progressively less stiff from proximal to distal; the outer tube is internally provided with a cavity channel which is used for communicating the adjusting cavity and the second channel.

8. The adjustable durometer catheter of claim 7, wherein the main body distal tip is provided with a visualization ring; a stress release tube is arranged between the main tube body and the catheter seat; the primary tubular body surface is coated with a hydrophilic coating.

9. A method of using a catheter with adjustable durometer that conforms to the shape of a blood vessel, comprising the steps of:

providing a stiffness adjustable sizing catheter compliant with a vascular shape according to any of claims 1-8;

flushing the inner cavity of the hardness-adjustable shaping catheter by heparin physiological saline, immersing the distal end into the heparin physiological saline, and soaking the hydrophilic coating;

providing an introduction means by which the hardness-adjustable sizing catheter is introduced into the vascular system;

under the monitoring of radiographic perspective, advancing the hardness-adjustable shaping catheter until reaching a target position;

connecting the second channel to a negative pressure device, sucking the adjusting cavity through the second channel, compressing the space of the adjusting cavity, enabling the fastening layer to hold the reed winding tube tightly, fixing the angle of the first reed winding layer, completing the shaping and the hardness improvement of the adjustable shaping catheter, maintaining a negative pressure state, and completing the establishment of a working channel;

and performing operation through the first channel entering the working channel.

10. A method of manufacturing a catheter with adjustable durometer capable of conforming to a shape of a blood vessel, comprising the steps of:

providing a cladding pipe and a metal wire, and sleeving the cladding pipe on the surface of the metal wire;

providing a lining pipe and a developing ring, and fixing the developing ring at the end part of the lining pipe; winding a metal wire sleeved with a cladding tube on the surface of the lining tube to form a spring winding layer, wherein the end part of the metal wire is fixedly connected with the developing ring;

providing a fastening layer to cover the surface of the spring winding layer at a position 10-50cm close to the far-end port; providing a coating pipe sleeved on the surface of the fastening pipe;

providing a plurality of metal flat wires, and braiding the metal flat wires on the surface, close to the proximal end, of the spring winding layer to form a braiding layer;

providing segments with different hardness, mutually connecting the segments according to the hardness order to form an outer tube, sleeving the outer tube on the surface of the braiding layer, and rheologically integrating the outer tube, the braiding layer, the spring winding layer and the inner liner layer into a whole; a cavity is formed in the outer tube;

coating hydrophilic coatings on the surfaces of the coating pipe and the outer pipe;

a catheter hub and a stress relief tube are provided and mounted to the proximal end of the main body.