CN114432031A - An intravascular hypothermia system - Google Patents

Abstract

An intravascular cryogenic system relates to the field of medical devices and comprises: the low-temperature conduit is provided with a sensing module for sensing temperature and dynamic pressure; and the low-temperature generation control device is connected with the low-temperature conduit through a cold source joint and is configured to control the working state of the intravascular low-temperature system based on the temperature value and the dynamic pressure value sensed by the sensing module. The intravascular low-temperature system can be used for local or whole body, realizes low-temperature treatment of different target organs, and can detect hemodynamics and temperature states in real time for feedback regulation.

Description

An intravascular hypothermia system

technical field

The invention relates to the field of medical devices, in particular to an intravascular hypothermia system.

Background technique

Ischemic disease is an important disease affecting human health at present. In the treatment of acute ischemic disease, timely opening of culprit vessels and improving blood supply to ischemic organs are the main treatment methods at present. At present, such diseases mainly include acute myocardial infarction, acute cerebral infarction, and acute limb ischemia. The following is an example of acute myocardial infarction.

Acute myocardial infarction is an important disease that seriously endangers human health. Reperfusion therapy is currently the most effective way to treat myocardial infarction. Emergency percutaneous coronary intervention is currently the preferred treatment method, which can effectively improve the ischemic state and improve patient outcomes. survival rate. However, in acute myocardial infarction, 20-50% of myocardial damage is caused by ischemia-reperfusion injury. There are a lot of studies related to ischemia-reperfusion injury, such as ischemia preconditioning, postconditioning, various drugs, adjuvant therapy, etc. , There are a large number of effective treatment methods in animal experiments, but there is currently no effective way to be used in clinical practice.

Mild hypothermia therapy is the application of physical or pharmaceutical methods to lower the core temperature of the human body to 32°C-35°C. Hypothermia therapy can protect myocardial function, promote cell survival, and inhibit and reduce apoptosis. Previous studies have shown that, within a certain range, the decrease in myocardial temperature is linearly related to the size of myocardial infarction (each 1 °C reduction in myocardial infarction risk area can reduce by 8%). Animal studies have shown that therapeutic mild hypothermia plays an important role in reducing myocardial infarction size, reperfusion injury, no-reflow, improving myocardial remodeling, and maintaining cardiac function. Therefore, the research on the treatment of myocardial infarction with mild hypothermia is also being explored clinically. The current research methods include: ice blanket directly contacting the body, inferior vena cava hypothermic cooling device, hypothermic device for peritoneal lavage, intracoronary injection of hypothermic saline OTW balloon device. These devices have shown a certain therapeutic effect in animal tests, but their own characteristics and side effects were found in clinical research, which limited their wide application. Among them, the previous whole body cryogenic device requires a certain operation time, which affects the ischemia time, and has systemic side effects such as tremor and anesthesia. Intracoronary OTW can act locally, but a short-term intracoronary infusion of normal saline will increase the cardiac load. Therefore, it is necessary to develop a hypothermic device that can quickly act locally without increasing the burden on the heart.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide an intravascular hypothermia system to solve the above problems.

Embodiments of the present invention are implemented as follows:

An aspect of the embodiments of the present invention provides an intravascular hypothermia system, comprising:

The cryogenic catheter is equipped with a sensing module for sensing temperature and dynamic pressure;

A low temperature generation control device is connected to the cryogenic catheter through a cold source joint, and the low temperature generation control device is configured to control the intravascular cryogenic system based on the temperature value and the dynamic pressure value sensed by the sensing module. working status.

Optionally, the sensing module includes a temperature sensor and a dynamic pressure sensor.

Optionally, the temperature sensor is arranged at the distal end of the cryogenic catheter, and the dynamic pressure sensor is arranged at the proximal, middle and distal end of the surface of the cryogenic catheter.

Optionally, the low temperature generation control device includes a control module, a human-computer interaction module and a cooling medium module electrically connected to the control module, respectively.

Optionally, the cryogenic catheter comprises a flexible connecting tube, a handle and an elongated shaft of the catheter; the proximal end of the flexible connecting tube is connected with the distal end of the cold source joint, and the distal end of the flexible connecting tube and the The proximal end of the handle is connected, and the distal end of the handle is connected with the proximal end of the elongated shaft of the catheter.

Optionally, the distal end of the elongated shaft of the catheter has a low temperature region.

Optionally, the length of the low temperature region is 30-60 mm.

Optionally, the handle has a compression-resistant and heat-insulating function.

The intravascular hypothermia system provided by the present invention can be used locally or whole body to realize hypothermia treatment of different target organs, and can detect the hemodynamics and temperature state in real time for feedback adjustment.

Description of drawings

In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the following briefly introduces the accompanying drawings used in the embodiments. It should be understood that the following drawings only show some embodiments of the present invention, and therefore do not It should be regarded as a limitation of the scope, and for those of ordinary skill in the art, other related drawings can also be obtained according to these drawings without any creative effort.

FIG. 1 is a block diagram of an intravascular hypothermia system according to an embodiment of the present invention;

FIG. 2 is a block diagram of the low temperature generation control device of the intravascular low temperature system in FIG. 1;

FIG. 3 is a block diagram of a cryogenic catheter of the intravascular cryogenic system of FIG. 1 .

Detailed ways

In order to make the purposes, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments These are some embodiments of the present invention, but not all embodiments. The components of the embodiments of the invention generally described and illustrated in the drawings herein may be arranged and designed in a variety of different configurations.

Thus, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the invention as claimed, but is merely representative of selected embodiments of the invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

It should be noted that like numerals and letters refer to like items in the following figures, so once an item is defined in one figure, it does not require further definition and explanation in subsequent figures.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. The indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship that the product of the invention is usually placed in use, only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying The device or element referred to must have a particular orientation, be constructed and operate in a particular orientation, and therefore should not be construed as limiting the invention. Furthermore, the terms "first", "second", "third", etc. are only used to differentiate the description and should not be construed as indicating or implying relative importance.

Furthermore, the terms "horizontal", "vertical" and the like do not imply that a component is required to be absolutely horizontal or overhang, but rather may be slightly inclined. For example, "horizontal" only means that its direction is more horizontal than "vertical", it does not mean that the structure must be completely horizontal, but can be slightly inclined.

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

Please refer to FIG. 1 to FIG. 3 , this embodiment provides a cryogenic catheter system for detecting blood temperature and blood flow state. The generation control device 1 includes a human-computer interaction module 11, a control module 12 and a cooling medium module 13, the human-computer interaction module 11 is electrically connected to the control module 12, the control module 12 is electrically connected to the cooling medium module 13, and the cryogenic catheter 2 includes a flexible connection pipe 21. The handle 22, the elongated shaft of the catheter 23 and the low temperature area at the distal end of the elongated shaft of the catheter 23, the proximal end of the flexible connecting tube 21 is connected to the distal end of the cold source joint 3, and the distal end of the flexible connecting tube 21 is connected to the handle 22 The proximal end is connected, the distal end of the handle 22 is connected with the proximal end of the slender shaft 23 of the catheter, the distal end of the cryogenic catheter 2 is provided with a temperature sensor 4, the proximal, middle and distal ends of the surface of the cryogenic catheter 2 are provided with a dynamic pressure sensor 5, and the temperature sensor 4 and the dynamic pressure sensor 5 are electrically connected to the control module 12 .

During operation, the system detects the blood temperature and dynamic pressure according to the temperature of the temperature sensor 4 and the installation position of the dynamic pressure sensor 5, so as to efficiently and directly detect the blood temperature and blood flow state of the blood perfused tissue.

The intravascular hypothermia system can reduce the intracoronary temperature by 3-6 degrees Celsius in the preliminary test. The intravascular hypothermia system is a three-lumen structure, and the three lumens are respectively denoted as lumen 1, lumen 2 and lumen 3. Lumen 1 is used to pass a guide wire, lumen 2 is a medium for passing low temperature, and lumen 3 is a return low temperature medium; the catheter; The low temperature area in the front section is 30-60mm, and has the function of transferring temperature; the low temperature medium of cavity 2 is connected with the front section of cryocatheter 2, and the front section of cryocatheter 2 is connected with cavity 3, which are all single-valve links; There is a temperature sensor 4; there are dynamic pressure receptors before and after the low temperature area in the front section of the catheter, which is also the identification point of the low temperature area; the handle 22 is designed with pressure resistance and heat insulation; cavity 2 is connected to the interface of low temperature medium, and cavity 3 is connected to a medium recovery device; The pressure sensor and temperature sensor are connected to the control panel; the outer diameter of the catheter is 1.7-7.0F.

Hypothermia has a protective effect on ischemia-reperfusion, and the current device is unreasonable. The current hypothermia-related technologies include ice blankets that directly contact the body, inferior vena cava cryogenic cooling devices, cryogenic devices for peritoneal lavage, and OTW balloon devices for intracoronary injection of cryogenic saline. Hypothermia can be achieved by ice blankets, intravascular ice saline, and intracoronary perfusion of hypothermic saline. The current cryogenic devices include whole-body cryogenic devices. As mentioned above, the previous whole-body cryogenic devices require a certain operation time, which affects the ischemia time, and has systemic side effects such as tremors and anesthesia. Intracoronary OTW can act locally, but intracoronary infusion of normal saline for a short time will increase the cardiac load. The intravascular hypothermia system has minimally invasive treatment, local action, does not increase ischemia time, and does not increase systemic side effects.

The intravascular hypothermia system is used as follows. Taking acute myocardial infarction as an example, when the patient undergoes emergency PCI, the guide wire passes through the lesion to the distal end of the culprit vessel, and the balloon is pre-expanded to restore blood flow. Immediately use the hypothermia system for treatment. The cryogenic catheter 2 is sent to the culprit blood vessel by wire, and the cryogenic system is turned on. The blood flushing the cryogenic catheter system can reduce the temperature and reach the distal end. At the same time, the temperature sensor at the distal end of the catheter can sense the temperature decrease and observe the cooling effect. The pressure sensor in the low temperature area transmits pressure. data to see if there is blood flow through. According to the temperature and pressure values, the conveying pressure of the low-temperature medium is adjusted in real time, and the low-temperature medium is closed and circulated in the system to achieve the effect of continuous cooling. After the low temperature is over, the cryogenic medium delivery system is closed, and the cryogenic catheter 2 is withdrawn for further operations.

The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims (8)

1. An intravascular cryogenic system comprising:

the low-temperature conduit is provided with a sensing module for sensing temperature and dynamic pressure;

and the low-temperature generation control device is connected with the low-temperature conduit through a cold source joint and is configured to control the working state of the intravascular low-temperature system based on the temperature value and the dynamic pressure value sensed by the sensing module.

2. The intravascular cryogenic system of claim 1 wherein the sensing module comprises a temperature sensor and a dynamic pressure sensor.

3. The intravascular cryogenic system of claim 2 wherein the temperature sensor is disposed at a distal end of the cryogenic catheter and the dynamic pressure sensor is disposed at a mesial distal end of a surface of the cryogenic catheter.

4. The intravascular cryogenic system of claim 1 wherein the cryogenically-generated control device includes a control module and a human-machine interaction module and a cooling medium module electrically connected to the control module, respectively.

5. The intravascular cryogenic system of claim 4 wherein the cryogenic catheter comprises a flexible connecting tube, a handle, and a catheter elongated shaft; the near end of the flexible connecting pipe is connected with the far end of the cold source joint, the far end of the flexible connecting pipe is connected with the near end of the handle, and the far end of the handle is connected with the near end of the slender shaft of the catheter.

6. The endovascular cryogenic system of claim 5, wherein the distal end of the catheter elongate shaft has a cryogenic region.

7. The intravascular cryogenic system of claim 6 wherein the cryogenic region has a length of 30-60 mm.

8. The endovascular cryogenic system of claim 5, wherein the handle has a pressure resistant thermal insulation function.

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