WO2020000548A1

WO2020000548A1 - Flow-reducing device and system for preventing perfusion hemorrhage

Info

Publication number: WO2020000548A1
Application number: PCT/CN2018/096662
Authority: WO
Inventors: 沈碧峰; 朱大伟; 付亮辉
Original assignee: 依奈德医疗技术（上海）有限公司
Priority date: 2018-06-26
Filing date: 2018-07-23
Publication date: 2020-01-02
Also published as: CN108744232B; CN108744232A

Abstract

Provided are a flow-reducing device and system for preventing perfusion hemorrhage (1), specifically, the flow-reducing device comprises n flow-limiting elements (2), wherein, 1≤n≤5, and the flow-limiting elements (2) are arranged at the remote end of the flow-reducing device. A main body (3): n liquid channels (7) are arranged on the wall (6) of the main body (3), the flow-limiting elements (2) are arranged at the remote end on the main body (3), and communicate with the liquid channels (7), wherein the flow-limiting elements (2) and the liquid channels (7) are in one-to-one corresponding communication; n liquid injection ports (4) are arranged on the proximal end of the flow-reducing device, fixed on the main body (3), and communicate with the liquid channels (7), wherein the liquid injection ports (4) and the liquid channels (7) are in one-to-one corresponding communication. The flow-reducing device can be provided with a pressure measuring wire (11). The flow-limiting elements (2) serve as a blocking device, the blood in blood vessels can be reduced in a controllable and adjustable mode by controlling the filling of the flow-limiting elements (2).

Description

Reducing device and system for preventing perfusion bleeding

Technical field

The present invention relates to the field of medical equipment, and more particularly to a flow reduction device and system for preventing perfusion bleeding after carotid artery stenosis or cerebral artery stenosis after angioplasty.

Background technique

In recent years, there are many clinical conditions of cerebral artery stenosis or carotid artery stenosis. In order to solve the pain and improve the quality of life for these patients, angiofilling or stenting is usually performed.

Angioplasty can restore narrow blood vessels to the same size as the original blood vessel, thereby restoring blood flow to the original stenosis. However, as blood flow to the carotid or cerebral arteries is restored, new problems or complications will arise. One of the more important symptoms is hyperperfusion.

Cerebral Hyper-fusion Syndrome (CHS) is a serious complication caused by the original increase in cerebral blood flow in the hypoperfusion area significantly over the metabolic needs of the brain tissue. Common risk factors for CHS are: over 75 years of age, history of stroke, long history of hypertension, severe stenosis of the ipsilateral internal carotid artery, insufficient establishment of collateral circulation, and preoperative TCD (transcranial Doppler ultrasound) suggesting the affected brain The middle arterial blood flow velocity was more than 40% below normal, and the contralateral internal carotid artery was severely narrowed or occluded.

At present, clinical angioplasty is sometimes used to achieve a small and slow expansion of the cross-sectional area of a narrowed area in each operation to slowly increase blood perfusion in the blood vessel. However, multiple angioplasty increases the cost of surgery and surgery. Difficulty, psychologically, it will increase the pressure on the patient and the patient's family members, which will psychologically resist multiple operations. Sometimes, blood pressure-lowering drugs are used to reduce the patient's blood pressure, thereby reducing blood perfusion after angioplasty. However, when antihypertensive drugs are used to lower blood pressure, it is difficult and ineffective to control blood pressure stability from high pressure to required blood pressure.

Therefore, there is still a lack of a medical device that can effectively prevent hyperperfusion bleeding in clinic.

Summary of the invention

The purpose of the present invention is to provide a flow reduction device and system for preventing perfusion bleeding. The flow reduction device of the present invention is provided with n (1≤n≤5) flow limiting elements, and the blood vessels can be adjusted by adjusting the filling of the flow limiting elements. Controlled and adjustable blood flow reduction.

The present invention provides a flow reduction device for preventing perfusion hemorrhage, characterized in that the flow reduction device includes n flow limitation elements, wherein 1≤n≤5, and the flow limitation element is located in the flow reduction The distal end of the device; the main body, wherein the main body is provided with n liquid channels, the current limiting element is disposed at the distal end of the main body and is in communication with the liquid channel, the current limiting element and the liquid channel Are in one-to-one correspondence; and n liquid injection ports, which are located at the proximal end of the flow reduction device, are fixed at the proximal end of the main body, and are in communication with the liquid channel, the liquid injection The inlet and the liquid passage are in one-to-one correspondence.

In another preferred example, the outer diameter of the flow-restricting element is d, and the inner diameter of the blood vessel is D, where d <D.

In another preferred example, the hollow channel of the main body is a central channel.

In another preferred example, the main body is a hollow long tube.

In another preferred example, the length of the main body is 1 and the diameter is r, wherein 1 / r ≧ 20.

In another preferred example, the current-limiting element may have various regular or irregular shapes such as a fusiform shape, a cylindrical shape, a spherical shape (for example, an ellipsoidal shape, a spherical shape, etc.), an apple shape, and a winter melon shape.

It should be noted that the "winter melon shape" refers to a shape in which the middle section of the current limiting element is cylindrical, and both ends of the current limiting element are hemispherical; the "apple shape" refers to two parts of the current limiting element The end is hemispherical, the diameter of the hemispheric at one end is larger, and the diameter of the other hemispherical is smaller. The middle section of the current-limiting element is dome-shaped, and the middle section connects the hemispherical structures at both ends to form a whole.

In another preferred example, when the middle section of the current-limiting element is cylindrical, its two ends are hemispherical or truncated cone-shaped.

In another preferred example, n (2 ≦ n ≦ 5) of the current limiting elements may be the same shape or different in shape.

In another preferred example, when the shapes of the plurality of current limiting elements are the same, the plurality of current limiting elements may be the same size or different sizes.

In another preferred example, according to actual requirements, n (when 2 ≦ n ≦ 5) of the current limiting elements may be used in whole or in part.

In another preferred example, the central channel of the main body can be passed by a guide wire.

In another preferred example, the surface of the current-limiting element is coated with an anticoagulant drug, such as heparin.

In another preferred example, when there are multiple current limiting elements, the adjacent current limiting elements are spaced a certain distance apart.

In another preferred example, when there are a plurality of current-limiting elements, the current-limiting elements are disposed on the main body at equal intervals in sequence.

In another preferred example, the diameters of the n current-limiting elements after filling are the same.

In another preferred example, the diameters of the n current-limiting elements after filling are sequentially reduced from the proximal end to the distal end of the flow reduction device.

In another preferred example, a central channel is provided in the center of the main body for the guide wire to pass through, and the liquid channel is evenly distributed on the periphery of the central channel.

In another preferred example, the eccentric channel is located on one side of the cross section of the main body for the guide wire to pass through, and the liquid channel is located on the other side of the eccentric channel.

In another preferred example, when there is one current limiting element, the current limiting element is a compliant current limiting element; when there are two to five current limiting elements, the current limiting element is compliant, non- One or more of a compliant or semi-compliant current limiting element.

In another preferred example, the shrinking operation is performed on the current-limiting element after filling, and the shrinking operation is performed in multiple stages. For the flow-reducing device having only one of the current-limiting elements, only A part of the volume of the current-limiting element, and the interval between the two shrinking operations is 0.5-5h; preferably, 2-4h; more preferably, 2.5-3.5h; Device, shrinking only one of said current-limiting elements at a time, with an interval of 0.5-5h between two shrinking operations; preferably, 2-4h; more preferably, 2.5-3.5h.

In another preferred example, the flow reduction device includes a guide catheter.

In another preferred example, the flow reducing device can control the blood flow in the blood vessel in a controllable manner, so as to limit the blood flow and gradually increase the blood flow. Regardless of whether it is a single said current-limiting element or a plurality of said current-limiting elements, the flow-reducing device adjusts the blood flow incrementally in multiple steps. That is, the blood flow is initially adjusted to a small value, and then it is increased several times, and finally increases to be equal to the blood flow when there is no obstruction in the blood vessel.

In another preferred example, when the flow-reducing device regulates the intravascular flow rate, the blood flow adjustment amount in each stage may be a fixed value or may fluctuate within a certain range. The amount of blood flow regulation in each stage can be different due to the number of stages divided. For example, the greater the number of stages, the less the regulation of blood flow in adjacent stages; when the number of stages is the same, the blood flow of each stage The amount of regulation can also be different, such as the blood flow regulation in each stage is equivalent, the blood flow regulation in each stage increases linearly, the blood flow regulation in each stage increases non-linearly, the blood flow regulation in each stage decreases linearly, and the blood flow regulation in each stage Non-linear reduction, irregularities in blood flow regulation at each stage, etc.

In another preferred example, the material of the current limiting element of the flow reduction device is an elastomer material, and the elastomer material is selected from the group consisting of silicone, latex, TPU, and TPE.

In a second aspect of the present invention, there is provided a flow reduction system for preventing perfusion bleeding, the flow reduction system comprises a balloon for dilating blood vessels; a flow-restricting element, the flow-restricting element is located at The distal end of the flow-reducing system is located at a farther end of the flow-reducing system than the balloon flow-restricting element, the flow-restricting element is used to reduce blood flow in a blood vessel; a subject, the subject A liquid passage is provided on the wall, the flow-restricting element is disposed on the body, and is in communication with the liquid passage, and the flow-restricting element and the liquid passage are connected one to one correspondingly; and a liquid injection port, The liquid injection port is located at the proximal end of the flow reduction system, is fixed on the main body, and is in communication with the liquid channel, and the liquid injection port and the liquid channel correspond one-to-one.

In another preferred example, the diameter of the balloon in the expanded state is greater than or equal to the diameter of the blood vessel.

In another preferred example, the balloon is disposed at the distal end of a balloon catheter.

In another preferred example, the guide catheter of the flow reduction device is used to guide the balloon catheter into a blood vessel.

In another preferred example, the balloon catheter enters the guide catheter, and the distal end of the balloon catheter extends out of the guide catheter into the blood vessel, and the balloon located at the distal end of the balloon catheter also enters the blood vessel. And swell and expand the blood vessel.

In another preferred example, after the expansion is completed, the balloon is contracted, and the balloon is withdrawn from the body with the balloon catheter.

In another preferred example, after the balloon is expanded and expanded, the flow-restricting element starts to work.

In another preferred example, after the expansion is completed, the balloon is contracted, the balloon is retracted into the catheter channel, the balloon catheter is left in the main body, and finally the entire flow reduction system is together Withdraw blood vessels.

In another preferred example, the balloon is disposed at a distal end of the main body, a balloon channel is provided on the main body, the balloon is in communication with the balloon channel, and the balloon passes through the balloon. The balloon channel is inflated.

In another preferred example, the balloon is inflated and expanded by injecting liquid.

In another preferred example, the surface of the balloon is coated with an anticoagulant drug.

In another preferred example, the balloon is inflated by injecting liquid through the balloon channel, thereby expanding the blood vessel.

In another preferred example, after the blood vessel is dilated, the balloon is decompressed, and the blood flow of the blood vessel is controlled by the flow limiting element.

In another preferred example, the flow reducing device is provided with a pressure measuring wire.

In another preferred example, the flow reduction system is provided with a pressure measuring wire.

In another preferred example, the pressure measuring wire passes through the guide wire cavity inside the flow reducing device, a pressure sensor is provided at the distal end of the pressure measuring wire, a pressure monitoring device is provided at the proximal end, and a pressure display screen on the pressure monitoring device displays instant pressure, It can play the role of real-time monitoring of the blood pressure at the distal end of the current-limiting element. At the same time, the pressure measuring wire can be used as the guide wire of the flow reducing device to transport the flow reducing element to the required position. The pressure measuring wire and the flow reducing device are two parts, which can be separated and are separated.

It should be noted. The guide wire cavity is the central channel or the eccentric channel.

In another preferred example, the pressure measuring wire is embedded in the flow reducing device, a pressure sensor is provided at the distal end of the pressure measuring wire, and a pressure monitoring device is provided at the proximal end. The pressure display on the monitoring device displays the real-time pressure, which can perform real-time monitoring. The role of distal blood pressure in the current-limiting element. At the same time, the pressure-measuring wire can be used as a built-in support wire of the flow-reducing device to enhance the pushing force when the flow-reducing element is transported to the position to be reached. At the same time, the pressure-measuring wire can be used as the guide wire of the flow-reducing device to transport the flow-reducing element to Position, the pressure measuring wire and the flow reducing device are integral, cannot be separated, and are integrated.

In another preferred example, the material of the pressure measuring wire is selected from the group consisting of stainless steel, nickel titanium, platinum, iridium, and a polymer (such as PTFE, Pebax, Nylon, etc.).

In another preferred example, the outer diameter of the pressure measuring wire is 0.005-0.05 inches, more preferably 0.01-0.04 inches, and most preferably 0.010-0.038 inches; the outer diameter may be a certain value or may vary.

In another preferred example, the length of the pressure measuring wire is 500-5000 mm, more preferably 1000-3500 mm, and most preferably 1200-3000 mm.

It should be understood that, within the scope of the present invention, the above technical features of the present invention and the technical features specifically described in the following (such as the embodiments) can be combined with each other to form a new or preferred technical solution. Due to space limitations, I will not repeat them here.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly explain the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are merely These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without paying creative labor.

FIG. 1 is a schematic structural view of a flow-reducing system having three shuttle-shaped flow-restricting elements with the same maximum outer diameter and a balloon also on its main body in an example of the present invention.

FIG. 2 is a schematic structural diagram of a flow reduction system having three shuttle-shaped flow-restricting elements with different maximum diameters and a balloon also on its main body in an example of the present invention.

Fig. 3 is a cross-sectional view taken along a line A-A in Fig. 1 and / or Fig. 2.

Fig. 4 is another cross-sectional view of the A-A cross section in Fig. 1 and / or Fig. 2.

FIG. 5 is a schematic structural diagram of a flow reduction system having three ellipsoidal current-limiting elements with the same maximum outer diameter and a balloon also on its main body in an example of the present invention.

FIG. 6 is a schematic structural diagram of a flow reduction system having three ellipsoidal current-limiting elements with different maximum outer diameters and a balloon on its main body in an example of the present invention.

FIG. 7 is a schematic structural diagram of a flow reduction system having three melon-shaped flow-restricting elements with the same maximum outer diameter and a balloon on its body in an example of the present invention.

FIG. 8 is a schematic structural diagram of a flow reduction system with a melon-shaped flow-restricting element having three different maximum outer diameters and a balloon also on its main body in an example of the present invention.

FIG. 9 is a schematic structural diagram of a flow-reducing system with a shuttle-shaped current-limiting element and a balloon on its main body in an example of the present invention.

FIG. 10 is a schematic structural diagram of a flow reduction system having an ellipsoidal current-limiting element and a balloon on its body in an example of the present invention.

FIG. 11 is a schematic structural view of a flow reduction system having a melon-shaped flow-restricting element and a balloon also on its main body in an example of the present invention.

Fig. 12 is a cross-sectional view taken along a line B-B in any one of Figs. 9, 10, 11 and 17;

Fig. 13 is another cross-sectional view taken along the line B-B of any one of Figs. 9, 10, 11 and 17.

FIG. 14 is a schematic structural diagram of an embodiment of the present invention having three shuttle-shaped flow-restricting elements with the same maximum outer diameter and a balloon flow-reducing system as a whole received in a guide catheter.

Figure 15 is an example of the present invention with three shuttle-shaped flow-restricting elements with the same maximum outer diameter and the three flow-restricting elements of the flow-reduction system with the balloon also on its body, and the balloon all extend out of the guide catheter and are filled Schematic diagram of the structure.

Figure 16 is a flow reduction system with three shuttle-shaped flow-restricting elements with the same maximum outer diameter and a balloon on its body in an example of the present invention, with two flow-restricting elements at its distal end extending out of the guide catheter and filling Schematic diagram of the structure.

FIG. 17 is a schematic structural view of a flow reduction system having a cylindrical flow-restricting element and a balloon also on its body in an example of the present invention.

18 is a schematic structural view of a flow reduction system having a shuttle-shaped flow-restricting element and a balloon independently on a balloon catheter in an example of the present invention.

FIG. 19 is a schematic structural view of a flow reduction system having a cylindrical flow-restricting element and a balloon independently on a balloon catheter in an example of the present invention.

20 is a schematic structural view of a flow reduction system having an elliptical flow-restricting element and a balloon independently on a balloon catheter in an example of the present invention.

FIG. 21 is a schematic structural diagram of a flow reduction system having a gourd-shaped flow-restricting element and a balloon independently on a balloon catheter in an example of the present invention.

Fig. 22 is a cross-sectional view taken along a line C-C in any one of Figs. 18, 19, 20, and 21;

Fig. 23 is another sectional view taken along the line C-C of any of Figs. 18, 19, 20, and 21.

It should be noted that the cross-sectional views of the DD section in any of FIG. 19, FIG. 20, and FIG. 21 can also be configured as the structure in FIG. 22 or FIG. 23, except that 8 indicates the central channel or eccentricity of the balloon catheter. The channel, 7 indicates the liquid channel of the balloon catheter, and 6 indicates the outer wall of the balloon catheter.

FIG. 24 is a schematic structural diagram of a flow reduction system having a shuttle-shaped flow-restricting element and a balloon independently on a balloon catheter, and a pressure-measuring wire separated from the flow-reduction device in an example of the present invention.

25 is a schematic structural diagram of a flow reduction system having a shuttle-shaped flow-restricting element and a balloon independently on a balloon catheter, and a pressure-measuring wire integrated with the flow-reduction device and integrated therein.

In the drawings, they are marked as follows:

1-flow reduction system;

2- current limiting element;

3-subject;

4- liquid injection port;

5-guide catheter;

6- the outer wall of the main body;

7-liquid channel;

8-center channel or eccentric channel;

9-balloon;

10-balloon catheter;

11-Measuring wire.

detailed description

After extensive and in-depth research, the inventor has developed a flow reduction device and system for preventing perfusion bleeding for the first time through a large number of screenings. The flow reduction device of the present invention is used as a protection device for carotid artery surgery. The flow device includes one or more flow-restricting elements. When in use, the flow-reducing device is placed in a blood vessel, and the flow is reduced by filling the flow-restricting element (the filling-adjusting flow-restricting element serves as a blocking device). The purpose of reducing blood flow and thus reducing perfusion is achieved, and the present invention is completed on the basis of this.

the term

As used herein, the term "compliance" refers to the change in the volume of the current-limiting element every time a unit pressure is changed, usually: non-compliant current-limiting element when the compliance is not greater than 1.1; and 1.3-1.8 when the compliance is It is a semi-compliant current limiting element; when the compliance is greater than 2, it is a compliant current limiting element.

The invention provides a flow reduction device for preventing perfusion bleeding, which is a flow reduction device with a specific structure.

Typically, the flow reduction device of the present invention is used as a protection device for carotid artery surgery, and specifically includes a main body, a flow restriction element, and a liquid injection port. The center of the main body is a central channel. The main body is provided with n liquid channels. One end of the liquid channel is in communication with the flow restricting element and the other end is in communication with the liquid injection port. The flow restricting element is fixed at the distal end of the main body and the liquid injection port. Fixed to the proximal end of the body, the number of flow-restricting elements is n, where 1≤n≤5. After the flow-reducing device is placed in a blood vessel, blood is reduced by adjusting and filling the flow-restricting element.

It should be noted that the “plurality” described herein means two or more.

In addition, the current-limiting element can be contracted to a small size, and can be filled to a certain size in the lumen of a blood vessel. The flow restricting element can be filled under the external force (applied pressure), and the external force (unloading pressure) can be removed and returned to the original small size through a hollow tube (guiding catheter).

The contraction of the flow restricting element can be assisted by a guide catheter. After the pressure restricting element is depressurized, the process of drawing the current restricting element into the lumen of the guide catheter is the process of contracting the current restricting element. The element is filled with liquid to fill it.

The single current-limiting element may be fusiform, cylindrical, spherical or other shapes in appearance. When the current-limiting element is a cylinder, the two ends of the current-limiting element are hemispherical or truncated cone. The entire current-limiting element is a polymer material.

The space between the flow-restricting element and the blood vessel wall can allow blood flow to pass through. In this way, the flow-restricting element in the filling state has a blocking effect on the transportation of blood and reduces the blood flow. When the product has only a single current-limiting element, the change in blood flow is controlled by the change of the cross-section of the current-limiting element; when the product has multiple current-limiting elements, multiple current-limiting elements have multiple barriers and are reduced step by step multiple times. Blood flow. The diameters of different current limiting elements can be the same or different.

When the product has multiple flow-restricting elements, when the multiple flow-restricting elements in the blood vessel function in the filling state, they can work simultaneously, or one or more of them can work. Different numbers of flow limiting elements will have different blocking reduction effects on blood flow. Adjacent current limiting elements are spaced a certain distance apart. Among them, the distance between the barriers is 5-50 mm; preferably, 10-30 mm; more preferably, 15-30 mm.

When the product has only a single flow-restricting element, a single flow-restricting element functions in the vascular filling state. When the flow-restricting element transitions from one cross-section to another, it should stay in the state of the previous cross-section for a period of time. The purpose is to make the cerebral blood flow in the patient's original hypoperfusion area slowly increase and have a slow adaptation process for each increase in blood flow, instead of a transient large amount of blood flow into the original hypoperfusion area. When the product has multiple flow-restricting elements, during the process of multiple flow-restricting elements functioning in the vascular filling state, each flow-restricting element must stay in a certain state in the blood flow state before the current-restricting element contracts. Time, the purpose is also to slowly increase the cerebral blood flow in the patient's original hypoperfusion area and have a slow adaptation process for each increase in blood flow, rather than a transient large amount of blood flow into the original hypoperfusion area. In this way, the brain tissue metabolism in the original hypoperfusion zone slowly increased and increased, and the blood flow demand also became greater. It was not easy for the situation of hyperperfusion hemorrhage because the brain blood flow in the original hypoperfusion zone increased significantly over the brain tissue metabolism needs.

Operation process of the flow reducing device of the present invention:

a) Carotid artery stenosis is identified by medical imaging;

b) Under medical imaging, the flow-reducing device that relieves hyperperfusion hemorrhage is delivered to the carotid artery through the guide catheter and passes through the carotid stenosis. The flow-reducing device protrudes from the front end of the guide catheter and sends the restrictive element outside the guide catheter , Inject liquid into the current limiting element to make the current limiting element full;

c) Under medical imaging, deliver a carotid angioplasty device (such as a stent system) to a narrow carotid artery and perform angioplasty on the carotid artery to fill the narrow carotid artery;

d) At this time, the blood flow at the filled original stenotic carotid artery increases. When the blood flows to the filled current limiting element, the blood flow is gradually reduced by the effect of the filled current limiting element. The blood flow at the distal end of the flow restriction element is smaller than the blood flow at the proximal end of the flow restriction element;

e) After a certain time after angioplasty (such as 3 hours):

For those with only one flow-restricting element, reduce the volume of the liquid injected into the flow-restricting element to reduce its volume. At this time, the cross-section is also reduced, and the blood flow in the blood vessel is increased. Keep the volume of the flow-restricting element at the above-mentioned volume. After a period of time, the volume of the liquid injected into the flow-restricting element continues to decrease, and the volume of the flow-restricting element is reduced to a smaller value again. At this time, the cross section is also reduced to a smaller value, and the blood flow in the blood vessel continues to increase. ; Keep the volume of the current-limiting element at the above-mentioned volume for a period of time, continue to reduce the volume of liquid injected into the current-limiting element, the volume of the current-limiting element is reduced again to a smaller value, and the cross section is also reduced to a smaller value again , The blood flow in the blood vessel continues to change greatly; and so on until the current-limiting element is fully contracted, and the blood flow in the blood vessel is equivalent to the original blood flow (blood flow when there is no obstruction in the blood vessel), and the flow reducing device exits the human body; If there are multiple current-limiting elements, the first current-limiting element at the proximal end is contracted. At this time, the blood flow in the blood vessel at the distal end of the current-limiting element device becomes larger; after the first current-limiting element at the proximal end is contracted, Hold the blood flow state for a period of time (for example, 3 hours), and then continue to contract the next (proximal second) current limiting element; and so on, you must stay for a period of time before each contraction of a current limiting element, until all the limit The flow elements are all contracted, and the flow reducing device exits the human body.

In addition, in particular, the blood flow in the intracranial blood vessel is monitored using a manometer wire at any time before the filling of the current-limiting element of the present invention, during filling, and after filling. The monitoring method of the pressure measuring wire can not only quickly and timely understand the blood flow condition of the blood vessel in the diseased area of the patient, but also use the measured blood flow result to feedback the blood flow control status of the flow reduction device of the present invention.

The main advantages of the invention include:

(a) In the present invention, a shuttle-shaped, cylinder-shaped, spherical, ellipsoidal, or other shape partition device is placed in a blood vessel to reduce blood flow, thereby reducing the blood flow and thereby reducing perfusion.

(b) In the present invention, one or more shuttle-shaped, cylindrical-shaped, or spherical or other-shaped blocking devices are placed in a blood vessel to reduce blood flow, so that the blood flow can be controlled and adjustable in different proportions to reduce perfusion. The patient slowly adapts to the purpose of blood perfusion.

(c) The blocking device in the present invention may be made of a compliant, non-compliant or semi-compliant flow limiting element, and the volume is stable and controllable, and the blood flow is accurately controlled by adjusting the filling state of the flow limiting element in a blood vessel.

The present invention will be further described below with reference to specific embodiments. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, the drawings are schematic diagrams, so the apparatus and equipment of the present invention are not limited by the size or ratio of the schematic diagrams.

It should be noted that in the claims and description of this patent, relational terms such as first and second are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or Imply any such actual relationship or order between these entities or operations. Moreover, the terms "including", "comprising", or any other variation thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or device that includes a series of elements includes not only those elements but also those that are not explicitly listed Or other elements inherent to such a process, method, article, or device. Without more restrictions, an element limited by the phrase "including one" does not exclude that there are other identical elements in the process, method, article, or device that includes the element.

Example 1

The flow reduction system for preventing hyperperfusion bleeding in this embodiment is shown in FIGS. 1 and 3. The flow reduction system 1 includes a main body 3, a flow restricting element 2, a balloon 9, and a liquid injection port 4. The central channel 8 of the main body 3 is provided with four liquid channels 7 on the outer wall 6 of the main body. The liquid channels 7 are symmetrically distributed in the outer wall 6 of the main body. One end of the liquid channel 7 communicates with the flow restricting element 2 or the balloon 9 and the other end It is in communication with the liquid injection port 4, wherein the flow restriction element 2 and the balloon 9 are fixed to the distal end of the main body 3, the liquid injection port 4 is fixed to the proximal end of the main body 3, and the number of the flow restriction elements 2 is three, and three The current limiting elements 2 are arranged at equal intervals, and the diameters of the current limiting elements after filling are the same, and the number of the balloons 9 is one.

As shown in Figure 14-16, the flow reduction system 1 is incorporated into the guide catheter 5, the flow reduction system 1 enters the blood vessel through the guide catheter 5, and the flow reduction system 1 is gradually pushed out of the guide catheter 5 to the limited flow element 2, the balloon 9 The guide catheter 5 is pushed out, the balloon 9 is injected with liquid to dilate the narrowed blood vessels, and the flow-restricting element 2 is adjusted and filled to reduce blood flow.

When the three flow-restricting elements 2 of the flow reduction system 1 enter the blood vessel from the guide catheter 5, when the three flow-restricting elements in the blood are filled, the blood flow is only about 25% of the blood flow when the flow-restricting elements are not full ( 15% -35%), when the proximal-most restrictive element is contracted and withdrawn into the guide catheter 5, the blood flow becomes large to about 50% (40% -60%) of the blood flow when the restrictive element is not full, When the two closest current-limiting elements are contracted and retracted into the guide catheter 5, the blood flow increases to about 75% (65% -85%) of the blood flow when the current-limiting element is not full, and when all of them are contracted ( (3) When the current-limiting element is used, the blood flow becomes large and is equivalent to that when the current-limiting element is not full.

The flow-reducing system of this embodiment can reduce blood flow in different proportions, and can be controlled and adjusted to reduce the perfusion and allow the patient to slowly adapt to the blood perfusion.

Example 2

The flow reduction system for preventing hyperperfusion bleeding in this embodiment is shown in FIGS. 2 and 3. The flow-reducing system of this embodiment is similar to Embodiment 1, except that the diameters of the three flow-restricting elements 2 of this embodiment after filling are different, and from the distal end to the proximal end of the flow-reducing system 1, The diameter of the current-limiting element 2 after filling is increased in sequence.

When the diameters of the flow-restricting elements after filling are the same, the cross-sections of the flow-restricting elements are the same, and the amount of blood flow reduction in the blood vessel is the same for each flow-restricting element; The cross-sections of the flow-restricting elements are different, and each flow-restricting element has a different reduction in blood flow in a blood vessel. The diameter of the flow-restricting element is gradually changed, and the reduction of blood flow in a blood vessel can be controlled by different amounts.

Example 3

The flow reduction system for preventing hyperperfusion bleeding in this embodiment is shown in FIGS. 1 and 4. The flow reduction system of this embodiment is similar to that of Embodiment 1. The difference is that the eccentric channel 8 of this embodiment is located on one side of the cross section of the catheter, and the liquid channel 7 is located on the other side of the cross section of the catheter, making the guide wire difficult to contact with the liquid. The channels are intertwined.

Example 4

The flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 1, except that the number of flow limiting elements in this embodiment is two, the number of balloons 9 is one, and the corresponding liquid is The number of channels is also three, and the number of corresponding liquid injection ports is also three.

When the two flow-restricting elements of the flow reduction system enter the blood vessel from the guide catheter, when the two flow-restricting elements in the blood are filled, the blood flow is only about 30% (20%) of the blood flow when the flow-restricting element is not full. -40%), when one of the current-limiting elements is contracted, the blood flow becomes large to about 65% (55% -75%) of the blood flow when the current-limiting element is not full, and when all (two) of them are contracted When the element is flowed, the blood flow becomes large and is comparable to that when the current-limiting element is not full.

Example 5

As shown in FIG. 5, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 1, except that the shape of the current-limiting element in this embodiment is ellipsoidal in a filled state.

Example 6

As shown in FIG. 6, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 2, except that the shape of the flow-restricting element 2 in this embodiment in the filling state is ellipsoidal.

Example 7

As shown in FIG. 7, the flow reduction system for preventing hyperperfusion hemorrhage in this embodiment is similar to that in Embodiment 1, except that the shape of the current-limiting element 2 in this embodiment in a filled state is a winter melon shape.

Example 8

As shown in FIG. 8, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 2, except that the shape of the flow-restricting element 2 in this embodiment in a filled state is a winter melon shape.

Example 9

As shown in FIG. 9, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 1, except that the number of flow restricting elements 2 in this embodiment is one, and that of the balloon 9 The number is also one, and the number of corresponding liquid channels 7 is also two. The number of corresponding liquid injection ports 4 is also two. Among them, the eccentric channel 8 is located on one side of the main body section, and the liquid channel 7 is located on the side of the catheter section. The other side. The cross-sectional shape of the liquid channel 7 may be a pea shape as shown in FIG. 12 or a circular shape as shown in FIG. 13. There is no specific limitation on the cross-sectional shape of the liquid channel 7 as long as the liquid channel can pass the flow-restricting element. 3. The balloon can be injected with liquid. When the product has only one current-limiting element 2, the size of the current-limiting element 2 during the filling process is especially controllable, and the size (cross-section) of the current-limiting element 2 is controlled by controlling the liquid entering the current-limiting element 2.

For example, the volume of the current limiting element 2 is adjusted by controlling the liquid injected into the current limiting element 2. For example, the volume of the current limiting element 2 is adjusted by adjusting the volume of the liquid injected into the current limiting element 2. When the volume of the current limiting element 2 increases, its cross section also increases.

By filling the flow-restricting element 2 to increase its cross-section, the blood flow in the blood vessel can be reduced. When in use, the amount of liquid injected can be adjusted, first increasing the volume of the flow restricting element 2 to a larger value, and also increasing the cross section to a larger value. At this time, due to the blockage of the flow restricting element 2, the The blood flow changes to about 25% (15% -35%) of the original blood flow (blood flow when there is no obstruction in the blood vessel); keep the volume of the flow-restricting element 2 at the above-mentioned volume for a period of time (for example, 3 hours) ), The volume of the flow-restricting element 2 is reduced to a relatively intermediate value, and the cross-section is also reduced to a relatively intermediate value. At this time, due to the blockage of the flow-restricting element 2, the blood flow in the blood vessel becomes approximately About 50% (40% -60%) of the original blood flow (blood flow when there is no obstruction in the blood vessel); keep the volume of the restrictive element 2 after the above-mentioned volume for a period of time (for example, 3 hours), and continue at this time By reducing the amount of liquid in the current limiting element 2, the volume of the filling current limiting element 2 is reduced again to a smaller value, and the cross section is also reduced to a smaller value. At this time, due to the blocking of the current limiting element 2, The blood flow in the blood vessel changes to about the original blood flow (blood when there is no obstruction in the blood vessel Volume) is about 75% (65% -85%); keep the volume of the current-limiting element 2 after the above-mentioned volume for a period of time (for example, 3 hours), and then continue to reduce the amount of liquid in the current-limiting element 2 to limit the flow The volume of element 2 is reduced to the minimum, and the cross section is also reduced to the minimum. At this time, the blood flow in the blood vessel is equivalent to the original blood flow (the blood flow when there is no obstruction in the blood vessel).

Example 10

As shown in FIG. 10, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 9, except that the shape of the current-limiting element in this embodiment is ellipsoidal.

Example 11

As shown in FIG. 11, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 9, except that the shape of the current-limiting element in this embodiment is a winter melon shape.

Example 12

As shown in FIG. 17, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 9, except that the shape of the flow-restricting element in this embodiment is cylindrical.

Example 13

As shown in FIG. 18, the reducing flow system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 1, except that the number of balloons 9 in this embodiment is also one, but the balloons Independently on the body of the flow reduction system, the balloon 9 is at the distal end of a separate balloon catheter 10.

Example 14

As shown in FIG. 19, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 13, except that the shape of the flow-restricting element in this embodiment is cylindrical.

Example 15

As shown in FIG. 20, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 13, except that the shape of the flow-restricting element in this embodiment is oval.

Example 16

As shown in FIG. 21, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 13, except that the shape of the current-limiting element in this embodiment is a winter melon shape.

Example 17

As shown in FIG. 24, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 13, except that there is a pressure measuring wire in this embodiment, and the pressure measuring wire is independent and not reducing. On the flow device, the pressure measuring wire and the flow reducing device are two parts, which can be separated and separated. The pressure measuring wire passes through the guide wire cavity (that is, the center hole 8 or the eccentric hole 8 of the flow reducing device) inside the flow reducing device. There is a pressure sensor at the far end of the pressure measuring wire, and a pressure monitoring device at the near end. The pressure display on the monitoring device shows the real-time pressure, which can play a role of real-time monitoring of the blood pressure at the far end of the current-limiting element. At the same time, the pressure measuring wire can be used as the guide wire of the flow reducing device, and the flow reducing element is transported to the required position.

Example 18

As shown in FIG. 25, the flow reduction system for preventing hyperperfusion bleeding in this embodiment is similar to that in Embodiment 13, except that there is a pressure measuring wire in this embodiment, which is embedded in the flow reducing Inside the device, the pressure-measuring wire and the flow-reducing device are integral and cannot be separated and are integrated. There is a pressure sensor at the far end of the pressure measuring wire, and a pressure monitoring device at the near end. The pressure display on the monitoring device shows the real-time pressure, which can play a role of real-time monitoring of the blood pressure at the far end of the current-limiting element. At the same time, the pressure measuring wire can be used as a built-in support wire of the flow reducing device to enhance the pushing force when the flow reducing element is transported to the position that needs to be reached. To the location.

All documents mentioned in the present invention are incorporated by reference in this application, as if each document was individually incorporated by reference. In addition, it should be understood that after reading the above teaching content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of the present application.

Claims

A flow reduction device for preventing perfusion bleeding, characterized in that the flow reduction device includes

n current limiting elements, wherein 1≤n≤5, the current limiting element is located at a distal end of the flow reducing device, and the current limiting element is used to reduce blood flow of a blood vessel;

A main body, wherein n liquid channels are provided on a wall of the main body, the current limiting element is disposed at a distal end of the main body and is in communication with the liquid channel, and the current limiting element and the liquid channel are one by one Correspondingly connected; and

n liquid injection ports, which are located at the proximal end of the flow reduction device, are fixed on the main body, and are in communication with the liquid channel, and the liquid injection ports and the liquid channel have a one-to-one correspondence Connected.
The flow reduction device according to claim 1, wherein an outer diameter of the flow restricting element is d, and an inner diameter of the blood vessel is D, wherein d <D.
The flow-reducing device according to claim 1, wherein the surface of the current-limiting element is coated with an anticoagulant drug.
The flow-reducing device according to claim 1, wherein the diameters of the n current-limiting elements after filling are the same; or

The diameters of the n current-limiting elements after filling are sequentially reduced from the proximal end to the distal end of the flow reduction device.
The flow reduction device according to claim 1, wherein the main body is provided with a central channel or an eccentric channel through which a guide wire passes;

The central channel is located in the center of the main body, the liquid channel is located in the wall of the main body, and is evenly distributed on the periphery of the central channel;

The eccentric channel is located on one side of the main body section, the eccentric channel is for the guide wire to pass through, and the liquid channel is located on the other side of the main body section.
The flow reducing device according to claim 1, wherein the flow reducing device is provided with a pressure measuring wire.
The flow reducing device according to claim 1, wherein when there is one current limiting element, the current limiting element is a compliant current limiting element; or

When there are 2-5 current limiting elements, the current limiting elements are one or more of compliant, non-compliant or semi-compliant current limiting elements.
The flow-reducing device according to claim 1, wherein a shrinking operation is performed on the current-limiting element after filling, and the shrinking operation is performed in multiple stages. A flow reducing device, which only shrinks a part of the volume of the current limiting element at a time, and the interval between the two shrinking operations is 0.5-5h;

For the flow reducing device having a plurality of the current limiting elements, only one of the current limiting elements is contracted at a time, and the interval between the two contraction operations is 0.5-5h.
The flow reducing device according to claim 1, wherein the material of the current limiting element of the flow reducing device is an elastomer material, and the elastomer material is selected from the group consisting of silicone, latex, TPU, and TPE.
A reduced flow system for preventing perfusion bleeding, characterized in that the reduced flow system includes

A balloon for dilating blood vessels;

A flow-restricting element, which is located at the distal end of the flow-reducing system, the flow-restricting element is used to reduce blood flow in a blood vessel, and the balloon is disposed near the proximal end of the flow-restricting element when in use ;

A main body, a liquid passage is provided on a wall of the main body, the current limiting element is disposed on the main body and is in communication with the liquid passage, and the current limiting element and the liquid passage are connected one to one correspondingly; as well as

A liquid injection port, which is located at the proximal end of the flow reduction system, is fixed on the main body, and is in communication with the liquid channel, and the liquid injection port and the liquid channel have a one-to-one correspondence.