CN218961031U - Embolic protection and remote monitoring coaxial exchange device for intracranial small blood vessel - Google Patents

Abstract

The application discloses an embolic protection and remote monitoring coaxial exchange device for intracranial small blood vessels, which comprises a tubular exchange guide wire, a remote hollow net tubular protector and a remote sensor; the tubular protector is provided with a tubular exchange guide wire, is in a tubular network shape, has self-expansion property, is folded at the head end and is provided with a protective wire, and a developing ring is arranged in the middle of the tubular exchange guide wire. The distal hollow net tubular protector provided by the application can capture emboli and stabilize the fixed position in the blood vessel, and can prevent the movement and damage of the distal intracranial blood vessel during coaxial exchange. The remote sensor monitors the intra-cavity pressure in real time, and provides more accurate information reference for the treatment in the doctor operation.

Description

Embolic protection and remote monitoring coaxial exchange device for intracranial small blood vessel

Technical Field

The application relates to an embolic protection and distal monitoring coaxial exchange device for intracranial small blood vessels, which belongs to the technical field of medical appliances, is used for preventing a distal embolic event when performing intracranial vascular occlusion opening or intracranial stenosis angioplasty, and is used for safely and stably reserving a channel as an exchange guide wire for providing support and monitoring the pressure and blood flow in a distal cavity during coaxial exchange.

Background

Intracranial nerve interventional instruments are widely used in the field of medical instruments. The guidewire is capable of extending in tortuous and serpentine nerve vessels, guiding catheters and other therapeutic devices, and performing intra-operative procedures on stenosed or aneurysmal lesion areas for therapeutic purposes. For the forming operation of opening an occlusion lesion or a stenosis, more schemes are used in the current clinic, namely, after a conventional guide wire is matched with a micro-catheter to reach a distal end through a lesion vessel, a long bare rod exchange guide wire is replaced to maintain a channel, and other instruments in an intracranial nerve vessel, such as the micro-catheter, a balloon, a stent and the like, are further replaced through the bare rod exchange guide wire. The function of the device is single, the remote end is easy to shift in the exchange process to cause vascular injury, and an operator needs to replace the device for multiple times in order to realize different purposes such as coaxial exchange and remote end monitoring in the operation, so that the problems of prolonged operation time, increased operation risk and the like are caused. In addition, in the occlusion opening operation and the narrow forming operation of unstable plaque, the remote embolism event is easily caused by embolic escape, and the existing exchange guide wire can not realize the function of protecting the remote embolism of the intracranial small blood vessel.

At present, in carotid interventional operation, there is a supporting guide wire with a protective umbrella at the far end, and the structure comprises the protective umbrella, the supporting guide wire, a feeding catheter, a recovery catheter and other parts, but the product has a too thick appearance and poor flexibility, and cannot be used for intracranial small blood vessels. Such a structure consists of an umbrella structure and a 300cm, 0.014 inch diameter exchange guidewire coaxially connected thereto. The connection mode is a structure that the protective umbrella is fixed on the guide wire itself or the protective umbrella is arranged on the guide wire in a thin middle and thick at two ends. The defects are mainly that: 1. the hardness and size of extracranial products cannot meet the needs of tortuous, tiny, fragile intracranial surgery; 2. additional conveying and recovery devices are required; 3. the protective umbrella structure only has the most expanded circle of edge contacted with the blood vessel, the position is not easy to be stable, and the vasospasm is easy to be caused.

Disclosure of Invention

The purpose of the application is to provide a stable coaxial exchange device capable of realizing distal blood flow and pressure measurement and distal embolic protection.

In order to achieve the aim, the technical scheme of the application is to provide an embolic protection and remote monitoring coaxial exchange device for intracranial small blood vessels, which comprises a tubular exchange guide wire, a remote hollow net tubular protector and a remote sensor; the tubular protector is provided with a tubular pipe network and has self-expansion.

Preferably, the distal hollow mesh tubular protector comprises three sections in one piece: the device comprises a furling closing section positioned in the distal end direction, a middle section and an opening section connected with a tubular exchange guide wire, wherein the basic shape of the middle section is a cylindrical tube shape, and the distal end of the furling closing section is closed.

Preferably, the mesh density of the furling closing section is greater than the mesh density of the middle section; the opening section is provided with an elliptic opening and is connected with the tubular exchange guide wire.

Preferably, the closed end of the furling closing section is connected with a flexible guide wire pointing to the far end; and the middle section is provided with a developing ring for prompting an open state.

Preferably, the distal end of the tubular exchange guide wire is connected with a distal hollow net tubular protector, and three to four sections with different softness are arranged from the proximal end to the distal end of the tubular exchange guide wire, and the tubular exchange guide wire is sequentially softer from the proximal end to the distal end.

Preferably, the distal sensor is a piezoelectric sensor for measuring pressure in the cavity, and comprises a main body piezoelectric sheet, a piezoelectric positive electrode and a piezoelectric negative electrode which are connected with the main body piezoelectric sheet, wherein the piezoelectric positive electrode and the piezoelectric negative electrode are connected to the proximal end of the tubular exchange guide wire through a sensor circuit arranged in the tubular exchange guide wire, and the proximal end of the tubular exchange guide wire is provided with a connector for connecting a data acquisition upper computer.

Preferably, the main structure of the tubular exchange guide wire is a tubular structure, and comprises an outer tube, an inner core and an insulating layer between the outer tube and the inner core; the outer tube is set to be connected with a negative circuit of the piezoelectric negative electrode, and the inner core is set to be connected with a positive circuit of the piezoelectric positive electrode.

Preferably, the main structure of the tubular exchange guide wire is a tubular structure and comprises an outer tube, two inner cores and an insulating layer for isolating the outer tube and each inner core; the outer tube is set as the reference electrode of the sensor circuit, one inner core is set as the negative electrode circuit connected with the piezoelectric negative electrode, and the other inner core is set as the positive electrode circuit connected with the piezoelectric positive electrode.

The application provides a distal end hollow network tubular protector can both catch the embolus, can anchor in the fixed position of blood vessel safely again, can prevent to remove and harm distal end intracranial blood vessel when coaxial exchange to can help the microcatheter to put in place, the loop that breaks. The flexibility of the tubular exchange guide wire near the far end ensures that the device can easily pass through the intracranial tortuous blood vessel to realize in-place far-end protection when performing intracranial operation and opening the occluded blood vessel. The remote sensor monitors the intra-cavity pressure in real time, and provides more accurate information reference for the treatment in the doctor operation. The lengthened tubular exchange guide wire is convenient to complete coaxial exchange operation when being matched with the existing widely used longer intermediate catheter.

Drawings

Fig. 1 is a schematic diagram of a coaxial switching device provided in an embodiment;

FIG. 2 is a schematic diagram of a distal hollow mesh tubular protector provided in an embodiment;

FIG. 3 is a schematic illustration of a tubular exchange guidewire structure provided in an embodiment;

fig. 4 is a partial cross-sectional view of a distal sensor provided in an embodiment.

Detailed Description

The utility model is described in further detail below with reference to the drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the utility model and are not limiting thereof. It should be further noted that, for convenience of description, only some, but not all of the structures related to the present utility model are shown in the drawings.

In the description of the present utility model, unless explicitly stated and limited otherwise, the terms "connected," "connected," and "fixed" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art.

In the present utility model, unless expressly stated or limited otherwise, a first feature "above" or "below" a second feature may include both the first and second features being in direct contact, as well as the first and second features not being in direct contact but being in contact with each other through additional features therebetween. Moreover, a first feature being "above," "over" and "on" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature includes the first feature being directly under and obliquely below the second feature, or simply means that the first feature is less level than the second feature.

In the description of the present embodiment, the terms "upper", "lower", "right", etc. orientation or positional relationship are based on the orientation or positional relationship shown in the drawings, and are merely for convenience of description and simplicity of operation, and do not indicate or imply that the apparatus or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the utility model. Furthermore, the terms "first," "second," and the like, are used merely for distinguishing between descriptions and not for distinguishing between them.

In the description of this embodiment, "proximal" refers to the end proximal to the operator and "distal" refers to the end extending into the blood vessel.

Referring to fig. 1, the embodiment provides an embolic protection and distal monitoring coaxial exchange device for intracranial small blood vessels, which specifically comprises a proximal sensor joint 1, a tubular exchange guide wire 2, a distal hollow net tubular protector 3 and a distal sensor 4.

In relation to the first aspect provided by the present embodiment, the distal hollow-mesh tubular protector 3 is for housing emboli escaping along the arterial vessel to the distal branch. Referring to fig. 2, in the present embodiment, a distal hollow mesh protector 3 is connected to a distal end position of a tubular exchange guidewire 2, the distal hollow mesh protector 3 is woven or cut from a memory alloy such as a nickel-titanium alloy, has a self-expansion property, can be smoothly pushed forward by the tubular exchange guidewire 2 when compressed and folded in a catheter, and when reaching a desired release vascular position, stabilizes the distal hollow mesh protector 3 and retreats the catheter, and the distal hollow mesh protector 3 expands under the self-expansion property and anchors on an intracranial vascular wall. Specifically, the surface of the far-end hollow net tubular protector 3 is provided with an array of meshes, and the meshes are distributed near, far and close from the tubular exchange guide wire 2 to the tubular exchange guide wire 2. The far-end hollow net tubular protector 3 comprises three sections, namely a furling closing section, a middle section and an opening section connected with the tubular exchange guide wire 2, wherein the furling closing section, the middle section and the opening section are of an integrated structure, and the furling closing section and the opening section are respectively positioned at two sides of the middle section. The closed end of the closing section is connected with a flexible guide wire 31 pointing to the far end, and when the far-end hollow net tubular protector 3 is released, the flexible guide wire 31 is firstly released into the blood vessel, so that the function of avoiding the damage of the blood vessel is achieved. The middle section is basically cylindrical, the distal hollow net tubular protector 3 is unfolded and leaned against the vascular wall under the self-expansion characteristic after being released, the distal hollow net tubular protector 3 is relatively anchored at the release position, and the distal hollow net tubular protector 3 and the tubular exchange guide wire 2 can be kept stable under the contact limiting effect with the vascular wall. The developing ring 32 is arranged on the middle section, and after the distal hollow net tubular protector 3 is released, the releasing state can be judged by observing whether the developing ring 32 is restored to the annular state. The mesh density of the furling closing section is greater than that of the middle section, the furling closing section is positioned in the distal end direction of the middle section, the meshes of the furling closing section can enable blood flow to normally flow, but thrombus with a certain size can be blocked by the dense mesh, so that the thrombus can be prevented from escaping to the distal nerve blood vessel at the farther end to cause the blood vessel blockage. The opening section is an oval opening and is used for being connected with the tubular exchange guide wire 2. In the neurointerventional operation, because of the treatment operation, thrombus with different degrees can escape from arterial blood vessels in an occlusion or stenosis section, and flow into thinner intracranial blood vessels along the direction of arterial blood flow, a plurality of instruments are required to be arranged in the same catheter to prevent the occurrence of the situation according to the traditional treatment means, but the effect of the exchange guide wire with the protector provided by the embodiment at the moment is particularly important under the limitation of conditions. Meanwhile, the radial supporting force of the middle section provided by the embodiment keeps the stability of the far-end hollow net tubular protector 3 and the tubular exchange guide wire 2, and the far-end hollow net tubular protector 3 has a certain expansion effect on a narrow vessel while not damaging the elastic intracranial arterial vessel under the self-expansion characteristic of the far-end hollow net tubular protector 3.

In relation to the second aspect provided by this embodiment, the core part that functions as an exchange function is a tubular exchange guidewire 2, the length of the tubular exchange guidewire 2 is set to 330-340cm, and the diameter dimension is set to 0.014 inches. The distal end of the tubular exchange guide wire 2 is connected with a distal hollow net tubular protector 3. The tubular exchange guidewire 2 is provided with three to four sections of different softness from the proximal end to the distal end, which in turn become more flexible from the proximal end to the distal end in order to better adapt to the conditions of intracranial vascular tortuosity. In particular, the main structure of the tubular exchange guidewire 2 is a tubular structure, see fig. 3, comprising an outer tube 21 and an inner core 22, and an insulating layer 23 therebetween. Both the outer tube 21 and the inner core 22 are made of medical materials such as stainless steel or titanium alloy, and the insulating layer 23 may be made of high-resistance polymer materials such as polyimide. Embodiment one: the outer tube 21 and the inner core 22 respectively provide a negative electrode channel and a positive electrode channel for the remote sensor module 4 to form a sensor circuit; embodiment one: two separate cores 22 provide negative and positive channels, respectively, for the distal sensor module 4, forming a sensor circuit. As one possible sensor circuit transmission connection mode, a proximal sensor joint 1 for connecting data acquisition equipment is arranged at the proximal end of a tubular exchange guide wire 2, the joint comprises an outer metal tube and an inner metal tube, the outer metal tube is connected with a negative electrode circuit of the sensor circuit, and the inner metal tube is connected with a positive electrode circuit of the sensor circuit; the outer metal tube and the inner metal tube are separated by an insulating layer. The length of the inner metal tube is longer than that of the outer metal tube, and the anode and the cathode exposed outside can be conveniently inserted into a data acquisition upper computer, so that acquisition data transmission of the sensor is realized.

Concerning the third aspect provided by the present embodiment, the distal sensor 4 provided by the present embodiment relates to the technology of installing a microminiature sensor on an exchange guide wire. The distal sensor 4 is essentially a microminiature blood flow and pressure monitoring sensor, specifically a piezoelectric sensor, for measuring the pressure in a blood vessel cavity at a location, and referring to fig. 4, the distal sensor comprises a main piezoelectric sheet 41, a piezoelectric positive electrode 42 and a piezoelectric negative electrode 43 connected with the main piezoelectric sheet, an electrode wire connecting the piezoelectric positive electrode 42 and the piezoelectric negative electrode 43, and a packaging structure for packaging the sensor. The main piezoelectric sheet 41 includes, but is not limited to, various PZT (such as a flexible thin film piezoelectric sensor of model LEAN STAR YD-SF 2513) and the like, and realizes real-time monitoring of blood pressure, and the upper surface of the main piezoelectric sheet is exposed to blood flow through a reserved window of the packaging structure, so that blood pressure can be dynamically monitored. Specifically, the piezoelectric positive electrode 42 and the piezoelectric negative electrode 43 are prepared to the upper surface of the main body piezoelectric sheet, made of a metal material having excellent biocompatibility, and are bonded with the main body piezoelectric sheet 41 by a strong bonding force. Embodiment one: the electrical signals generated from the piezoelectric positive electrode 42 and the piezoelectric negative electrode 43 are connected by electrode wires to the positive and negative electrodes, i.e., the inner core and the outer tube, respectively, of the tubular exchange guidewire 2; embodiment two: referring to fig. 4, the number of the inner cores of the tubular exchange guide wire 2 is two or more, the positive and negative electrodes of the distal sensor 4 are respectively connected to different inner cores, the electric signal generated by the distal sensor 4 is transmitted through the inner cores, and the outer tube is used as a reference electrode. The position of the distal sensor 4 is arranged at the junction between the distal hollow-mesh tubular protector 3 and the tubular exchange guidewire 2, which can be measured far enough and is not affected by the distal hollow-mesh tubular protector 3 on blood flow, and at which the clinician judges the circulation state of the blood vessel and other pathological conditions by means of real-time transmitted intra-luminal pressure information, providing more information for the treatment in surgery for better treatment.

In relation to the fourth aspect provided in this embodiment, this embodiment provides a data acquisition handle for acquiring sensor measurement data, where the data acquisition handle is a schematic structure for connecting to a sensor circuit provided in this embodiment, and is used as a switching structure for switching a data acquisition host computer, and is not an essential structure of this embodiment. Specifically, the handle structure is in a shape of a hand-held thin handle, and the center of the handle structure is provided with a rod-shaped hollow structure into which a connector can be inserted. From the structure, when the joint inserts in the handle, the metal shrapnel that sets up in different positions in the handle is connected with the anodal that exposes on the joint, negative pole, reference pole, then the signal processing is carried out in the signal processing that gets into the collection chip after the signal transmission to the metal shrapnel on, after signal processing such as amplification, filtering, exports the host computer through the signal output line on the handle, then the operator of being convenient for observes and judges. Since the apparatus of the blood pressure signal display end has already been mature in the cardiovascular field, the device in this embodiment is designed to adapt to the existing signal processing and display device, which is not described herein in detail, and does not limit the scope of the application.

The use process of the device is as follows:

when the device is used for opening an occlusion blood vessel, a common microcatheter is firstly used for finding a passage, the microcatheter is arranged on a normal blood vessel at the distal end of the occlusion, and then the passage is sent into the device through the microcatheter.

The device is opened and kept, the micro catheter is withdrawn, the hollow net tubular protector 3 at the far end of the device is anchored on the inner wall of the blood vessel after being expanded, and the position of the tubular exchange guide wire 2 is kept.

At this location, the clinician determines the flow status of the blood vessel and other pathological conditions from intra-luminal pressure information measured in real time by the remote sensor 4, providing more information for the intraoperative therapy for better treatment. The device plays a role of exchanging guide wires in the operation process, and can be introduced into a balloon and a bracket according to operation requirements, and the far-end hollow net tubular protector 3 plays a role in preventing thrombus from flowing to a far-end peripheral nerve vessel to cause vessel stenosis and blockage in the whole process.

After the operation is finished, the microcatheter (the diameter is the same as the previous one or the diameter specification can be increased) is replaced, the distal hollow net tubular protector 3 is recovered, and the outside of the body is withdrawn. During which the balloon catheter may be used upstream to block blood flow or negative pressure aspiration may be used.

The application has the advantages that: the tubular protector 3 of the far-end hollow net can capture emboli and safely and stably fix the position in the blood vessel, and can prevent the far-end intracranial blood vessel from moving and being damaged during coaxial exchange. The flexibility of the tubular exchange guide wire 2 near the far end ensures that the device can easily pass through the intracranial tortuous blood vessel to realize in-place far-end protection when performing intracranial operation and opening the occluded blood vessel. The remote sensor 4 monitors the intra-cavity pressure in real time, and provides more accurate information reference for the treatment in the doctor operation. The lengthened tubular exchange guide wire is convenient to complete coaxial exchange operation when being matched with the existing widely used longer intermediate catheter.

Claims (9)

1. The coaxial exchange device for the embolic protection and the remote monitoring of the intracranial small blood vessel is characterized by comprising a tubular exchange guide wire (2), a remote hollow net tubular protector (3) and a remote sensor (4); the tubular protector (3) of the far-end hollow net is arranged at the far end of the tubular exchange guide wire (2), and the tubular protector (3) of the far-end hollow net is in a net shape and has self-expansion.

2. The embolic protection, distal monitoring coaxial exchange device for intracranial small vessels according to claim 1, characterized in that the distal hollow-mesh tubular protector (3) comprises three segments in one piece: the tubular exchange guide wire comprises a furling closing section positioned in the distal end direction, a middle section and an opening section connected with the tubular exchange guide wire (2), wherein the basic shape of the middle section is a cylindrical tube shape, and the distal end of the furling closing section is closed.

3. The embolic protection, distal monitoring coaxial exchange device for intracranial small vessels of claim 2, wherein the collapsed closing section has a greater mesh density than the middle section; the opening section is provided with an elliptic opening and is connected with the tubular exchange guide wire (2).

4. The embolic protection, distal monitoring coaxial exchange device for intracranial small vessels as in claim 2, wherein a distally directed flexible guide wire (31) is attached to the closed end of the collapsed closing section.

5. The embolic protection, distal monitoring coaxial exchange device for intracranial small vessels as in claim 2, wherein the intermediate section is provided with a visualization ring (32) prompting an open condition.

6. The embolic protection, distal monitoring coaxial exchange device for intracranial small vessels according to claim 1, wherein the tubular exchange guidewire (2) is distally connected to a distal hollow-mesh tubular protector (3), the tubular exchange guidewire (2) is provided with three to four sections of different softness from proximal to distal, and sequentially softer from proximal to distal.

7. The embolic protection, distal monitoring coaxial exchange device for intracranial small vessels according to claim 1, wherein the distal sensor (4) is configured as a piezoelectric sensor for measuring blood flow pressure, comprising a main body piezoelectric plate (41), a piezoelectric positive electrode (42) and a piezoelectric negative electrode (43) connected to the main body piezoelectric plate, the piezoelectric positive electrode (42) and the piezoelectric negative electrode (43) being connected to the proximal end of the tubular exchange wire (2) via a sensor circuit provided in the tubular exchange wire (2), the proximal end of the tubular exchange wire (2) being provided with a connector for connecting to a data acquisition host computer.

8. The embolic protection, distal monitoring coaxial exchange device for intracranial small vessels according to claim 7, wherein the main structure of the tubular exchange guidewire (2) is provided as a tubular structure comprising an outer tube (21) and an inner core (22), and an insulating layer (23) therebetween; the outer tube (21) is provided with a negative electrode circuit connected with a piezoelectric negative electrode (43), and the inner core (22) is provided with a positive electrode circuit connected with a piezoelectric positive electrode (42).

9. The embolic protection, distal monitoring coaxial exchange device for intracranial small vessels according to claim 7, characterized in that the main structure of the tubular exchange guidewire (2) is provided as a tubular structure comprising an outer tube (21), two inner cores (22), and an insulating layer (23) for insulating the outer tube (21), the respective inner cores (22); the outer tube (21) is used as a reference electrode of a sensor circuit, one inner core (22) is used as a negative electrode circuit connected with a piezoelectric negative electrode (43), and the other inner core (22) is used as a positive electrode circuit connected with a piezoelectric positive electrode (42).

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