A variable blood flow aortic balloon catheter

Abstract

The present invention relates to the technical field of medical devices, and in particular to a variable blood flow aortic balloon catheter, comprising: a catheter seat; a stress relief tube; an outer catheter provided with a guidewire cavity and a filling cavity; a balloon portion comprising an inner tube, a balloon, a wire restraint unit and a plurality of developing marker rings; a catheter tip arranged at the top of the balloon portion away from the outer catheter; an injection pump connected to a second input channel; a data acquisition module comprising an ultrasonic imaging unit for acquiring a blood vessel image and a blood flow rate and a blood oxygen acquisition unit for acquiring human blood oxygen parameters; a control module for reducing the balloon pressure when determining that the blockage of a blood vessel does not meet a preset standard according to a characteristic coefficient of blood vessel wall expansion, or for verifying whether the blockage of a blood vessel meets the preset standard according to a blood oxygen change rate, and for increasing the balloon pressure under the condition that the blockage of the blood vessel does not meet the preset standard, thereby realizing precise regulation of aortic blood flow.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a variable blood flow aortic balloon catheter. Background Art

[0002] Hemorrhagic shock caused by severe trauma is a disease with a very high mortality rate. According to statistics, non-compressible torso hemorrhage (NCTH) is the main cause of severe hemorrhagic shock, with a mortality rate of up to 45%, most of which occurred before surgery or interventional treatment. The latest treatment option - resuscitative endovascular balloon occlusion of the aorta (REBOA) came into being. During REBOA surgery, a balloon is placed in the aorta and expanded to block blood flow, thereby alleviating non-compressible torso hemorrhage. When the balloon is working, it is necessary to ensure that the balloon can effectively control excessive blood loss from the aorta without completely blocking blood flow, thereby avoiding a series of serious complications, such as cardiac arrest, renal failure and other problems.

[0003] Chinese Patent Publication No.: CN116459433A, discloses a balloon catheter, including a balloon body and a coating film, the balloon body having a filling cavity, the filling cavity being used to contain a filling agent so that the balloon body is filled; the cross-section of the balloon body in a filled state includes peaks and valleys alternately arranged along the circumference of the balloon body; the coating film is coated on the circumferential surface of the balloon body and connected to the peaks, a fluid flow channel is formed between the coating film and the valley, and the fluid channel is isolated from the filling cavity. The balloon body of the balloon catheter can be introduced into a blood vessel and expand the blood vessel, and it will not block the blood flow in the blood vessel, so as to allow the balloon body to maintain a longer expansion time and improve the treatment effect. It can be seen that the above technical solution does not take into account the different requirements for balloon pressure at different pre-blocking points of the blood vessel, which leads to inaccurate balloon pressure adjustment. Summary of the invention

[0004] To this end, the present invention provides a variable blood flow aortic balloon catheter to overcome the problem in the prior art that different pre-occlusion points of the blood vessels have different requirements for balloon pressure, thereby causing inaccurate balloon pressure adjustment.

[0005] To achieve the above object, the present invention provides a variable blood flow aortic balloon catheter, comprising:

[0006] Catheter hub;

[0007] A stress relief tube, which is arranged at the output end of the catheter seat;

[0008] An outer catheter, which passes through the stress relief tube and is arranged at the output end of the stress relief tube, wherein a guidewire cavity for conveying a guidewire and a filling cavity arranged outside the guidewire cavity for conveying an expansion medium are arranged inside the outer catheter;

[0009] A balloon part is arranged at the output end of the outer catheter, and the balloon part includes an inner tube, a balloon, a wire constraint unit and a plurality of development marker rings; the inner tube is communicated with the guide wire cavity, the balloon is circumferentially wrapped around the outer wall of the inner tube, the balloon is communicated with the filling cavity, the wire constraint unit is circumferentially wrapped around the outer wall of the balloon, one end of the wire constraint unit is connected to the outer catheter of the balloon close to the stress relief tube, and the development marker ring is arranged between the inner wall of the balloon and the outer wall of the inner tube;

[0010] A catheter tip, which is arranged at the top of the balloon portion away from the outer catheter, and the other end of the wire restraint unit is connected to the catheter tip;

[0011] a syringe pump connected to the catheter adapter and used to pump the expansion medium;

[0012] A data acquisition module, comprising an ultrasonic imaging unit for acquiring a blood vessel image at a pre-blocking point and a blood flow velocity at the pre-blocking point, and a blood oxygen acquisition unit for acquiring blood oxygen parameters of a human body;

[0013] A control module is connected to the data acquisition module and the injection pump, respectively, and is used to reduce the balloon pressure when it is determined that the blockage of the blood vessel does not meet the preset standard according to the blood vessel wall expansion characteristic coefficient, or to verify whether the blockage of the blood vessel meets the preset standard according to the blood oxygen change rate, and to increase the balloon pressure under the condition that the blockage of the blood vessel does not meet the preset standard.

[0014] Furthermore, the metal wire restraint unit is a plurality of bridge-shaped metal wires arranged at equal angles along the outer wall of the balloon, and the bridge-shaped metal wires include a first bridge segment, a second bridge segment and a third bridge segment; the left side of the first bridge segment is connected to the catheter end, the second bridge segment is connected to the right side of the first bridge segment, the second bridge segment is parallel to the center of the inner tube, and the left side of the third bridge segment is connected to the second bridge segment, and the right side of the third bridge segment is connected to the outer catheter of the balloon close to the stress relief tube.

[0015] Furthermore, the metal wire restraint unit is a spring-shaped metal wire arranged around the outer wall of the balloon; the pitches of the spring-shaped metal wires are the same.

[0016] Further, the filling cavity is annularly arranged on the outer side wall of the guide wire cavity, or the guide wire cavity and the filling cavity are arranged in parallel.

[0017] Furthermore, the catheter seat is a three-way structure, which includes a first input channel for introducing a guide wire, a second input channel for injecting an expansion medium, a connecting output channel and a Luer interface; the connecting output channel is connected to the stress relief tube, the outer catheter is fixed in the connecting output channel, and the Luer interface respectively connects the outer catheter, the first input channel and the second input channel.

[0018] Furthermore, the control module determines the shape of the metal wire restraint unit according to the blood flow rate at the pre-blocking point, wherein:

[0019] If the blood flow rate is less than a preset blood flow rate, the metal wire restraint unit uses a bridge-shaped metal wire;

[0020] If the blood flow rate is greater than or equal to the preset blood flow rate, the metal wire restraining unit uses a spring-shaped metal wire;

[0021] The blood flow velocity is acquired by the ultrasonic imaging unit.

[0022] Furthermore, the control module preliminarily determines whether the blockage of the blood vessel meets a preset standard according to the characteristic coefficient of blood vessel wall expansion under the first preset condition, wherein:

[0023] If the blood vessel wall expansion characteristic coefficient is less than the first preset blood vessel wall expansion characteristic coefficient, the control module preliminarily determines that the blockage of the blood vessel meets the preset standard;

[0024] If the blood vessel wall expansion characteristic coefficient is greater than or equal to the first preset blood vessel wall expansion characteristic coefficient and less than the second preset blood vessel wall expansion characteristic coefficient, the control module preliminarily determines that the blockage of the blood vessel does not meet the preset standard, and verifies whether the blockage of the blood vessel meets the preset standard according to the blood oxygen change parameter;

[0025] If the blood vessel wall expansion characteristic coefficient is greater than or equal to the second preset blood vessel wall expansion characteristic coefficient, the control module preliminarily determines that the blockage of the blood vessel does not meet the preset standard, and reduces the balloon pressure according to the difference between the blood vessel wall expansion characteristic coefficient and the second preset blood vessel wall expansion characteristic coefficient;

[0026] The vascular wall expansion characteristic coefficient is determined based on the inner cavity diameter and wall thickness of the vascular occlusion point;

[0027] The first preset condition is that the balloon completes blocking of the blood vessel and the outflow rate of the blood vessel after blocking is greater than the first preset outflow rate and less than the second preset outflow rate.

[0028] Furthermore, the control module checks whether the blockage of the blood vessel meets a preset standard according to the blood oxygen change rate, wherein:

[0029] If the blood oxygen change rate is less than a preset blood oxygen change rate, the control module verifies that the blockage of the blood vessel meets a preset standard;

[0030] If the blood oxygen change rate is greater than or equal to the preset blood oxygen change rate, the control module verifies that the blockage of the blood vessel does not meet the preset standard, and increases the balloon pressure according to the difference between the blood oxygen change rate and the preset blood oxygen change rate.

[0031] Furthermore, the increase amplitude of the balloon pressure is positively correlated with the blood oxygen difference, wherein the blood oxygen difference is the difference between the blood oxygen change rate and the preset blood oxygen change rate.

[0032] Furthermore, under a second preset condition, the control module is provided with several correction methods for correcting the balloon pressure, and each correction method has a different correction amplitude for the balloon pressure; the second preset condition is that the control module completes the adjustment of the increase of the balloon pressure and the outflow rate of the blood vessel after the adjustment is greater than the second preset outflow rate.

[0033] Compared with the prior art, the beneficial effects of the present invention are as follows: the present invention blocks the aortic blood flow by inflating the balloon, and at the same time, the inflated balloon forms a channel under the constraint of the metal wire circumferentially wrapped around the outer wall of the balloon, allowing blood to circulate; the shape of the metal wire constraint unit is adjusted by the blood flow rate, so that the balloon can expand smoothly and maintain a stable shape under different blood flow rates; the effect of the balloon blocking blood is tested by the blood vessel wall expansion characteristic coefficient and the blood oxygen change rate and a corresponding balloon air pressure adjustment strategy is adopted, thereby realizing real-time monitoring of the balloon blocking process, thereby realizing precise regulation of the aortic blood flow.

[0034] Furthermore, the present invention realizes marking of the balloon position by providing a developing marking ring.

[0035] Furthermore, the present invention achieves blood diversion by providing a metal wire restraint unit circumferentially wrapped around the outer wall of the balloon.

[0036] Furthermore, the present invention arranges wire constraint units of different forms, including spring-shaped wires and bridge-shaped wires. During the expansion process of the balloon, the path length of the spring-shaped wire is longer than the path length of the bridge-shaped wire, thereby making the blood flow evenly in the blood vessel, thereby avoiding erosion of the blood vessel wall caused by excessively fast blood flow velocity.

[0037] Furthermore, the present invention arranges the filling cavity in an annular shape on the side wall of the guidewire cavity, or arranges the guidewire cavity and the filling cavity side by side, so that it is easier to control the advancement of the catheter and the filling of the balloon, thereby improving the convenience of surgical operation.

[0038] Furthermore, the present invention improves the blocking effect on aortic blood by providing a control module to determine whether the blocking of the blood vessel meets the preset standard according to the characteristic coefficient of blood vessel wall expansion.

[0039] Furthermore, the present invention is provided with a control module to verify whether the blockage of the blood vessel meets the preset standard according to the blood oxygen change rate, and to monitor in real time the rate at which the ratio of oxygenated hemoglobin to reduced hemoglobin in the blood changes over time, thereby improving the reliability of the evaluation of the effect of aortic blood blockage.

[0040] Furthermore, the present invention achieves precise control of the balloon pressure by setting the increase amplitude of the balloon pressure to be positively correlated with the blood oxygen difference, wherein the blood oxygen difference is the difference between the blood oxygen change rate and the preset blood oxygen change rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 It is a schematic structural diagram of a variable blood flow aortic balloon catheter according to an embodiment of the present invention;

[0042] Figure 2 This is a schematic structural diagram of a spring-shaped metal wire used as a metal wire restraint unit in a variable blood flow aortic balloon catheter according to an embodiment of the present invention;

[0043] Figure 3A It is a schematic diagram of the three-dimensional structure of the balloon in the filled state and the spring-shaped metal wire in the embodiment of the present invention;

[0044] Figure 3B It is a schematic diagram of the three-dimensional structure of the balloon and the bridge-shaped metal wire in the filled state according to an embodiment of the present invention;

[0045] Figure 4 For the embodiment of the present invention Figure 1 A front cross-sectional view of the filling cavity inside the outer catheter along the AA plane being annularly arranged on the side wall of the guidewire cavity;

[0046] Figure 5 For the embodiment of the present invention Figure 1 A front cross-sectional view of the guidewire cavity and the filling cavity inside the outer catheter arranged side by side along the AA plane;

[0047] Figure 6 This is a schematic diagram of module connection of a variable blood flow aortic balloon catheter according to an embodiment of the present invention;

[0048] Figure 7 This is a flow chart of an embodiment of the present invention for preliminarily determining whether the blockage of the blood vessel meets the preset standard according to the characteristic coefficient of blood vessel wall expansion;

[0049] In the figure: 1. catheter seat; 11. first input channel; 12. second input channel; 13. connecting output channel; 14. Luer interface; 2. stress relief tube; 3. outer catheter; 31. guide wire cavity; 32. filling cavity; 41. inner tube; 42. balloon; 431. bridge-shaped metal wire; 432. spring-shaped metal wire; 46. developing marker ring; 5. catheter tip; 6. injection pump; 71. spiral blood flow channel; 72. linear blood flow channel. DETAILED DESCRIPTION

[0050] In order to make the objects and advantages of the present invention more clearly understood, the present invention is further described below in conjunction with embodiments; it should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0051] It should be pointed out that the data in this embodiment are obtained by comprehensive analysis and evaluation of the historical test data and the corresponding historical test results of the present invention in the three months before this test. It can be understood by those skilled in the art that the determination method of the system of the present invention for the above-mentioned single parameter can be to select the value with the highest proportion as the preset standard parameter according to the data distribution, use weighted summation to use the obtained value as the preset standard parameter, substitute each historical data into a specific formula and use the value obtained by the formula as the preset standard parameter or other selection methods, as long as the system of the present invention can clearly define the different specific situations in the single determination process through the obtained values.

[0052] The preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood by those skilled in the art that these embodiments are only used to explain the technical principles of the present invention and are not intended to limit the protection scope of the present invention.

[0053] See also Figure 1 , Figure 2 , Figure 3A , Figure 3B , Figure 4 , Figure 5 , Figure 6 as well as Figure 7 As shown, they are respectively a schematic diagram of the structure of the variable blood flow aortic balloon catheter according to an embodiment of the present invention; a schematic diagram of the structure of the metal wire constraint unit in the variable blood flow aortic balloon catheter according to an embodiment of the present invention using a spring-shaped metal wire; a schematic diagram of the three-dimensional structure of the balloon in a filled state and the spring-shaped metal wire in cooperation with the embodiment of the present invention; a schematic diagram of the three-dimensional structure of the balloon in a filled state and the bridge-shaped metal wire in cooperation with the embodiment of the present invention; Figure 1 A front cross-sectional view of the filling cavity inside the outer catheter along the AA plane being arranged in an annular manner on the side wall of the guidewire cavity; an embodiment of the present invention Figure 1A front cross-sectional view of the guidewire cavity and the filling cavity inside the outer catheter along the AA plane, which are arranged side by side; a schematic diagram of the module connection of the variable blood flow aortic balloon catheter according to an embodiment of the present invention; a flow chart of the embodiment of the present invention for preliminarily determining whether the blockage of the blood vessel meets the preset standard based on the characteristic coefficient of the blood vessel wall expansion.

[0054] The embodiment of the present invention provides a variable blood flow aortic balloon catheter, comprising:

[0055] Catheter seat 1;

[0056] A stress relief tube 2, which is arranged at the output end of the catheter seat 1;

[0057] An outer catheter 3, which passes through the stress relief tube 2 and is arranged at the output end of the stress relief tube 2, wherein a guidewire cavity 31 for conveying a guidewire and a filling cavity 32 arranged outside the guidewire cavity 31 for conveying an expansion medium are arranged inside the outer catheter 3;

[0058] The balloon part is arranged at the output end of the outer catheter 3, and the balloon part includes an inner tube 41, a balloon 42, a wire constraint unit and a plurality of development marker rings 46; the inner tube 41 is communicated with the guide wire cavity 31, the balloon 42 is circumferentially wrapped around the outer wall of the inner tube 41, the balloon 42 is communicated with the filling cavity 32, the wire constraint unit is circumferentially wrapped around the outer wall of the balloon 42, one end of the wire constraint unit is connected to the outer catheter 3 of the balloon 42 close to the stress relief tube 2, the development marker ring 46 is arranged between the inner wall of the balloon 42 and the outer wall of the inner tube 41, and two development marker rings 46 are arranged in this embodiment, and the material of the development marker ring 46 is platinum;

[0059] A catheter tip 5 is arranged at the top of the balloon portion away from the outer catheter 3, and the other end of the wire restraint unit is connected to the catheter tip 5;

[0060] A syringe pump 6, connected to the catheter adapter 1, for pumping the expansion medium;

[0061] A data acquisition module, which includes an ultrasonic imaging unit for acquiring a blood vessel image at a pre-blocking point and a blood flow velocity at the pre-blocking point, and a blood oxygen acquisition unit for acquiring blood oxygen parameters of a human body;

[0062] A control module is connected to the data acquisition module and the injection pump 6, respectively, and is used to reduce the balloon pressure when it is determined that the blockage of the blood vessel does not meet the preset standard according to the blood vessel wall expansion characteristic coefficient, or to verify whether the blockage of the blood vessel meets the preset standard according to the blood oxygen change rate, and to increase the balloon pressure under the condition that the blockage of the blood vessel does not meet the preset standard.

[0063] In this embodiment, one end of the wire constraint unit can be connected to the outer catheter 3 of the balloon 42 close to the stress relief tube 2 by gluing, and the other end of the wire constraint unit is also connected to the catheter end 5 by gluing, without specific limitation.

[0064] In this embodiment, Figure 1 and Figure 2 The balloons 42 in the figure are all in an unexpanded state.

[0065] Specifically, the expansion medium is a mixed solution of 50% saline and 50% contrast agent, which can clearly observe the position and shape of the balloon 42 through X-ray angiography when the balloon 42 is expanded. At the same time, the characteristic of saline as an isotonic solution is used to reduce stimulation and damage to the inner wall of the blood vessel.

[0066] In this embodiment, the injection pump 6 is connected to the second input channel 12 of the catheter seat 1 to provide balloon pressure and inject expansion medium into the balloon 42 through the second input channel 12. It can be understood that the injection pump 6 can be a dLSP510 / 520 injection pump or a TYD03-01 injection pump. There is no specific limitation, as long as the requirement of injecting expansion medium into the balloon 42 can be met.

[0067] In this embodiment, the specific structure of the control module is not limited, and the control module itself and each unit therein can be composed of logic components, and the logic components include field programmable components, computers or microprocessors in computers.

[0068] In this embodiment, the ultrasonic imaging unit is a Doppler ultrasonic diagnostic instrument, and the blood oxygen acquisition unit is a blood oximeter.

[0069] In this embodiment, the material of the balloon 42 is silicone, thermoplastic elastomer or a mixture thereof.

[0070] Specifically, the metal wire constraint unit is a plurality of bridge-shaped metal wires 431 arranged at equal angles along the outer wall of the balloon 42, and the bridge-shaped metal wires 431 include a first bridge segment, a second bridge segment and a third bridge segment; the left side of the first bridge segment is connected to the catheter end 5, the second bridge segment is connected to the right side of the first bridge segment, the second bridge segment is parallel to the center of the inner tube 41, and the left side of the third bridge segment is connected to the second bridge segment, and the right side of the third bridge segment is connected to the outer catheter 3 of the balloon 42 close to the stress relief tube 2.

[0071] Specifically, the metal wire restraint unit is a spring-shaped metal wire 432 arranged around the outer wall of the balloon 42; the pitch of the spring-shaped metal wire 432 is the same as 4.5 mm.

[0072] In this embodiment, the material of the metal restraint wire of the present invention is one of stainless steel or nickel-titanium alloy, and is not specifically limited thereto, as long as it meets the blood guidance requirements.

[0073] In this embodiment, the balloon 42 in the filled state cooperates with the spring-shaped metal wire 432 to form a spiral blood flow channel 71 on the surface of the balloon 42, such as Figure 3A As shown, blood flows out through the blood channel to ensure continuous blood circulation, thereby partially blocking the blood flow in the blood vessel;

[0074] Furthermore, the balloon 42 in the filled state cooperates with the bridge-shaped metal wire 431 to form a linear blood flow channel 72 on the surface of the balloon 42, such as Figure 3B As shown, blood flows out through the blood channel to ensure continuous blood circulation, thereby partially blocking the blood flow in the blood vessel.

[0075] Specifically, the filling cavity 32 is annularly arranged on the outer wall of the guide wire cavity 31, or the guide wire cavity 31 and the filling cavity 32 are arranged in parallel.

[0076] Specifically, the catheter seat 1 is a three-way structure, which includes a first input channel 11 for introducing a guide wire, a second input channel 12 for injecting an expansion medium, a connecting output channel 13 and a Luer interface 14; the connecting output channel 13 is connected to the stress relief tube 2, and the external catheter 3 is fixed in the connecting output channel 13, and the Luer interface 14 connects the external catheter 3, the first input channel 11 and the second input channel 12 respectively.

[0077] In this embodiment, the Luer interface 14 is composed of three interconnected pipes, one of which is a main pipe and the other two are branch pipes. This structure allows fluid connection and control in three directions.

[0078] Specifically, the control module determines the shape of the wire restraint unit according to the blood flow rate at the pre-blocking point, wherein:

[0079] If the blood flow velocity is less than the preset blood flow velocity of 1.84 m / s, the metal wire restraint unit uses the bridge-shaped metal wire 431;

[0080] If the blood flow rate is greater than or equal to the preset blood flow rate, the wire restraining unit uses a spring-shaped wire 432;

[0081] The blood flow velocity is acquired by the ultrasonic imaging unit.

[0082] In this embodiment, the preset blood flow velocity is selected within the range of [1.71 m / s, 1.91 m / s]. Preferably, the preset blood flow velocity is selected as 1.84 m / s.

[0083] In this embodiment, the specific structure of the control module is not limited. The control module itself and each unit therein can be composed of logic components, and the logic components include field programmable components, computers or microprocessors in computers.

[0084] Specifically, the control module determines whether the blockage of the blood vessel meets the preset standard according to the blood vessel wall expansion characteristic coefficient under the first preset condition, wherein:

[0085] If the blood vessel wall expansion characteristic coefficient is less than the first preset blood vessel wall expansion characteristic coefficient of 1.21, the control module preliminarily determines that the blockage of the blood vessel meets the preset standard;

[0086] If the blood vessel wall expansion characteristic coefficient is greater than or equal to the first preset blood vessel wall expansion characteristic coefficient and less than the second preset blood vessel wall expansion characteristic coefficient 1.46, the control module preliminarily determines that the blockage of the blood vessel does not meet the preset standard, and verifies whether the blockage of the blood vessel meets the preset standard according to the blood oxygen change parameter;

[0087] If the blood vessel wall expansion characteristic coefficient is greater than or equal to the second preset blood vessel wall expansion characteristic coefficient, the control module preliminarily determines that the blockage of the blood vessel does not meet the preset standard, and reduces the balloon pressure according to the difference between the blood vessel wall expansion characteristic coefficient and the second preset blood vessel wall expansion characteristic coefficient; the first preset condition is that the balloon 42 completes the blockage of the blood vessel and the outflow rate of the blood vessel after the blockage is greater than the first preset outflow rate of 0.89 m / s and less than the second preset outflow rate of 1.75 m / s;

[0088] The vascular wall expansion characteristic coefficient is calculated by the following formula:

[0089] In the formula, P represents the characteristic coefficient of vascular wall expansion; represents the first evaluation coefficient, =0.47; represents the second evaluation coefficient, =0.91; D0 represents the inner cavity diameter of the vascular blocking point before expansion; D1 represents the inner cavity diameter of the vascular blocking point after expansion; T0 represents the average wall thickness of the vascular blocking point before expansion; T1 represents the average wall thickness of the vascular blocking point after expansion; the inner cavity diameter and average wall thickness of the vascular blocking point before and after expansion are both acquired by the ultrasonic imaging unit.

[0090] In this embodiment, the outflow rate of the blood vessel is acquired by the ultrasonic imaging unit.

[0091] In this embodiment, the first preset vascular wall expansion characteristic coefficient is selected within the range of [1.15, 1.25], and the second preset vascular wall expansion characteristic coefficient is selected within the range of [1.36, 1.56]. Preferably, the first preset vascular wall expansion characteristic coefficient is selected as 1.21, and the second preset vascular wall expansion characteristic coefficient is selected as 1.46.

[0092] Specifically, the control module checks whether the blockage of the blood vessel meets the preset standard according to the blood oxygen change rate, wherein:

[0093] If the blood oxygen change rate is less than a preset blood oxygen change rate of 3.5%, the control module verifies that the blockage of the blood vessel meets a preset standard;

[0094] If the blood oxygen change rate is greater than or equal to the preset blood oxygen change rate, the control module verifies that the blockage of the blood vessel does not meet the preset standard, and increases the balloon pressure according to the difference between the blood oxygen change rate and the preset blood oxygen change rate.

[0095] In this embodiment, the blood oxygen change rate is the magnitude of the decrease in blood oxygen saturation of the aorta at the pre-blocking point at the time node 2 minutes after blocking.

[0096] In this embodiment, the preset blood oxygen change rate is selected within the range of [2%, 4%]. Preferably, the preset blood oxygen change rate is selected as 3.5%.

[0097] Specifically, the increase amplitude of the balloon pressure is positively correlated with the blood oxygen difference, wherein the positive correlation is, for example, a linear positive correlation or a nonlinear positive correlation, and the linear slope of the linear positive correlation is not specifically limited. It can be understood that the larger the blood oxygen difference is, the larger the increase amplitude of the balloon pressure is; the blood oxygen difference is the difference between the blood oxygen change rate and the preset blood oxygen change rate.

[0098] Specifically, under the second preset condition, the control module is provided with several correction methods for correcting the balloon pressure, wherein:

[0099] If the correction difference is less than the first preset correction difference of 1.06 m / s, the balloon pressure is corrected to a corresponding value using a first correction coefficient of 0.98;

[0100] If the correction difference is greater than or equal to the first preset correction difference and less than the second preset correction difference of 1.33 m / s, the balloon pressure is corrected to a corresponding value using a second correction coefficient of 0.96;

[0101] If the correction difference is greater than or equal to the second preset correction difference, the balloon pressure is corrected to a corresponding value using a third correction coefficient of 0.94;

[0102] The second preset condition is that the control module completes the adjustment of the increase of the balloon pressure and the outflow rate of the blood vessel after the adjustment is greater than the second preset outflow rate; the correction difference is the difference between the outflow rate of the blood vessel and the second preset outflow rate.

[0103] In this embodiment, the reduction of the balloon pressure is achieved by reducing the injection amount of the expansion medium injected into the balloon 42 ; and the increase of the balloon pressure is achieved by increasing the injection amount of the expansion medium injected into the balloon 42 . Embodiment 1:

[0104] The method for using the variable blood flow aortic balloon catheter of this embodiment is as follows: using a Doppler ultrasound diagnostic instrument to obtain the blood flow velocity at the pre-blocking point, determining the use form of the metal wire constraint unit according to the blood flow velocity at the pre-blocking point, and determining that the metal wire constraint unit uses a bridge-shaped metal wire when the Doppler ultrasound diagnostic instrument monitors that the blood flow velocity at the pre-blocking point is 1.76 m / s and less than 1.84 m / s;

[0105] Assembling a catheter seat, a stress relief tube, an outer catheter, an inner tube, a balloon, a metal wire restraint unit, a development marker ring, a catheter tip and an injection pump to form a variable blood flow aortic balloon catheter;

[0106] The variable blood flow aortic balloon catheter is introduced to the pre-blocking point; before the balloon is filled, the inner cavity diameter and average wall thickness of the pre-blocking point are measured using a Doppler ultrasound diagnostic instrument, and the blood oxygen content is measured using an oximeter; an expansion medium is injected into the balloon using a syringe pump to expand the balloon so that the balloon is in a filled state, and a bridge-shaped metal wire squeezes the balloon surface so that a linear blood flow channel is formed on the balloon surface;

[0107] The inner cavity diameter and average wall thickness of the blood vessel blocking point before and after expansion are measured by using a Doppler ultrasound diagnostic instrument. In this embodiment, the inner cavity diameter of the blood vessel blocking point before expansion is 280 mm, and the average wall thickness before expansion is 2.50 mm. The inner cavity diameter of the blood vessel blocking point after expansion is 295 mm, and the average wall thickness after expansion is 2.39 mm. The blood vessel wall expansion characteristic coefficient is 1.316 after being substituted into the calculation formula of the blood vessel wall expansion characteristic coefficient. The blood vessel wall expansion characteristic coefficient is compared with the first preset blood vessel wall expansion characteristic coefficient and the second preset blood vessel wall expansion characteristic coefficient respectively. The blood vessel wall expansion characteristic coefficient is 1.316. The first preset blood vessel wall expansion characteristic coefficient is selected between 1.21 and the second preset blood vessel wall expansion characteristic coefficient is selected between 1.46. The balloon catheter is preliminarily verified to be up to standard for blood vessel blockage, and the blood vessel blockage is verified to meet the preset standard according to the blood oxygen change parameter;

[0108] When the balloon was inflated, an oximeter was used to measure the blood oxygen content, and the blood oxygen change rate was found to be 2.6%. The blood oxygen change rate was compared with the preset blood oxygen change rate to verify that the balloon catheter had met the standard for blocking the blood vessels.

[0109] So far, the technical solutions of the present invention have been described in conjunction with the preferred embodiments shown in the accompanying drawings. However, it is easy for those skilled in the art to understand that the protection scope of the present invention is obviously not limited to these specific embodiments. Without departing from the principle of the present invention, those skilled in the art can make equivalent changes or substitutions to the relevant technical features, and the technical solutions after these changes or substitutions will fall within the protection scope of the present invention.

[0110] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A variable blood flow aortic balloon catheter, characterized in that: include: Catheter hub; A stress relief tube, which is arranged at the output end of the catheter seat; An outer catheter, which passes through the stress relief tube and is arranged at the output end of the stress relief tube, wherein a guidewire cavity for conveying a guidewire and a filling cavity arranged outside the guidewire cavity for conveying an expansion medium are arranged inside the outer catheter; A balloon part is arranged at the output end of the outer catheter, and the balloon part includes an inner tube, a balloon, a wire constraint unit and a plurality of development marker rings; the inner tube is communicated with the guide wire cavity, the balloon is circumferentially wrapped around the outer wall of the inner tube, the balloon is communicated with the filling cavity, the wire constraint unit is circumferentially wrapped around the outer wall of the balloon, one end of the wire constraint unit is connected to the outer catheter of the balloon close to the stress relief tube, and the development marker ring is arranged between the inner wall of the balloon and the outer wall of the inner tube; A catheter tip, which is arranged at the top of the balloon portion away from the outer catheter, and the other end of the wire restraint unit is connected to the catheter tip; a syringe pump connected to the catheter adapter and used to pump the expansion medium; A data acquisition module, which includes an ultrasonic imaging unit for acquiring a blood vessel image at a pre-blocking point and a blood flow velocity at the pre-blocking point, and a blood oxygen acquisition unit for acquiring blood oxygen parameters of a human body; a control module, which is connected to the data acquisition module and the injection pump, respectively, and is used to reduce the balloon pressure when it is determined that the blockage of the blood vessel does not meet the preset standard according to the blood vessel wall expansion characteristic coefficient, or to check whether the blockage of the blood vessel meets the preset standard according to the blood oxygen change rate, and to increase the balloon pressure under the condition that the blockage of the blood vessel does not meet the preset standard; The control module determines the shape of the wire restraint unit according to the blood flow rate at the pre-blocking point, wherein: If the blood flow rate is less than a preset blood flow rate, the metal wire restraining unit uses a bridge-shaped metal wire; If the blood flow rate is greater than or equal to the preset blood flow rate, the metal wire restraining unit uses a spring-shaped metal wire; The blood flow velocity is obtained by the ultrasonic imaging unit; The control module preliminarily determines whether the blockage of the blood vessel meets the preset standard according to the characteristic coefficient of the blood vessel wall expansion under the first preset condition, wherein: If the blood vessel wall expansion characteristic coefficient is less than the first preset blood vessel wall expansion characteristic coefficient, the control module preliminarily determines that the blockage of the blood vessel meets the preset standard; If the blood vessel wall expansion characteristic coefficient is greater than or equal to the first preset blood vessel wall expansion characteristic coefficient and less than the second preset blood vessel wall expansion characteristic coefficient, the control module preliminarily determines that the blockage of the blood vessel does not meet the preset standard, and verifies whether the blockage of the blood vessel meets the preset standard according to the blood oxygen change parameter; If the blood vessel wall expansion characteristic coefficient is greater than or equal to the second preset blood vessel wall expansion characteristic coefficient, the control module preliminarily determines that the blockage of the blood vessel does not meet the preset standard, and reduces the balloon pressure according to the difference between the blood vessel wall expansion characteristic coefficient and the second preset blood vessel wall expansion characteristic coefficient; The vascular wall expansion characteristic coefficient is determined based on the inner cavity diameter and wall thickness of the vascular occlusion point; The first preset condition is that the balloon completes the blocking of the blood vessel and the outflow rate of the blood vessel after blocking is greater than the first preset outflow rate and less than the second preset outflow rate; The vascular wall expansion characteristic coefficient is calculated by the following formula: In the formula, P represents the characteristic coefficient of vascular wall expansion; represents the first evaluation coefficient, ; represents the second evaluation coefficient, ; D0 represents the inner diameter of the vascular blocking point before expansion; D1 represents the inner diameter of the vascular blocking point after expansion; T0 represents the average wall thickness of the vascular blocking point before expansion; T1 represents the average wall thickness of the vascular blocking point after expansion; the inner diameter and average wall thickness of the vascular blocking point before and after expansion are both acquired by the ultrasonic imaging unit.

2. The variable blood flow aortic balloon catheter according to claim 1, characterized in that: The metal wire restraint unit is a plurality of bridge-shaped metal wires arranged at equal angles along the outer wall of the balloon, and the bridge-shaped metal wires include a first bridge segment, a second bridge segment and a third bridge segment; the left side of the first bridge segment is connected to the catheter end, the second bridge segment is connected to the right side of the first bridge segment, the second bridge segment is parallel to the center of the inner tube, and the left side of the third bridge segment is connected to the second bridge segment, and the right side of the third bridge segment is connected to the outer catheter of the balloon close to the stress relief tube.

3. The variable blood flow aortic balloon catheter according to claim 1, characterized in that: The metal wire restraint unit is a spring-shaped metal wire arranged around the outer wall of the balloon; the pitches of the spring-shaped metal wires are the same.

4. The variable blood flow aortic balloon catheter according to claim 1, characterized in that: The filling cavity is annularly arranged on the outer side wall of the guide wire cavity, or the guide wire cavity and the filling cavity are arranged in parallel.

5. The variable blood flow aortic balloon catheter according to claim 1, characterized in that: The catheter seat is a three-way structure, which includes a first input channel for introducing a guide wire, a second input channel for injecting an expansion medium, a connecting output channel and a Luer interface; The connecting output channel is connected to the stress relief tube, the outer catheter is fixed in the connecting output channel, and the Luer interface is respectively connected to the outer catheter, the first input channel and the second input channel.

6. The variable blood flow aortic balloon catheter according to claim 5, characterized in that: The control module verifies whether the blockage of the blood vessel meets the preset standard according to the blood oxygen change rate, wherein: If the blood oxygen change rate is less than a preset blood oxygen change rate, the control module verifies that the blockage of the blood vessel meets a preset standard; If the blood oxygen change rate is greater than or equal to the preset blood oxygen change rate, the control module verifies that the blockage of the blood vessel does not meet the preset standard, and increases the balloon pressure according to the difference between the blood oxygen change rate and the preset blood oxygen change rate.

7. The variable blood flow aortic balloon catheter according to claim 6, characterized in that: The increase amplitude of the balloon pressure is positively correlated with the blood oxygen difference, wherein the blood oxygen difference is the difference between the blood oxygen change rate and the preset blood oxygen change rate.

8. The variable blood flow aortic balloon catheter according to claim 7, characterized in that: Under the second preset condition, the control module is provided with several correction methods for correcting the balloon pressure, and each correction method has a different correction amplitude for the balloon pressure; The second preset condition is that the control module completes the adjustment of the increase of the balloon pressure and the outflow rate of the blood vessel after the adjustment is greater than the second preset outflow rate.

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