Venous bridge vessel dilating device

Abstract

The application discloses a kind of venous bridge blood vessel dilating devices and methods, setting is made so that the venous bridge blood vessel implanted in human body is dilated, including dilating balloon, inflation pump, pressure sensor and controller;Dilating balloon has shrinkage state and fullness state, dilating balloon is suitable for the radial expansion of venous bridge blood vessel when fullness state;Pressure sensor is set to be suitable for detecting the intimal pressure signal of venous bridge blood vessel, inflation pump is communicated with dilating balloon and is used to inflate or deflate dilating balloon;Controller is electrically connected with pressure sensor and inflation pump, and responds to the intimal pressure signal output by pressure sensor to control inflation pump to execute inflation action or deflation action.This venous bridge blood vessel dilating mode is compared with the mode of using syringe to control pressure in prior art, and the pressure control effect is better, the venous bridge blood vessel can be efficiently, conveniently and safely dilated under stable ideal pressure, the integrity of the intimal function of the venous bridge blood vessel is protected, and the patency rate is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of coronary artery bypass grafting surgery, in particular to a vein bridge blood vessel dilating device and method. BACKGROUND

[0002] The acquisition and preparation of great saphenous vein bridge blood vessels is an important link in coronary artery bypass grafting surgery. At present, the great saphenous vein is still used as a bridge blood vessel material in most CABG (coronary artery bypass grafting) surgeries, which is due to the fact that the length of the great saphenous vein meets the sequential anastomosis requirement and the blood vessel is easy to obtain.

[0003] However, the patency rate of the vein bridge blood vessel is not ideal, and the patency rate within 1 year after the surgery is only 80%, and the patency rate can be reduced to about 50% after about 5 years. The development of vein bridge blood vessel restenosis mainly includes three stages. In the early stage, the endothelial injury of the vein is caused by the operation damage and blood flow pressure in the process of acquiring the great saphenous vein, which causes platelet aggregation, inflammatory reaction and accelerates the formation of acute thrombus. In the middle stage, the intimal hyperplasia is mainly caused by the hyperplasia and migration of vascular smooth muscle cells, and in the late stage, the characteristic is atherosclerotic plaque formation. In the process of acquiring the great saphenous vein, the lumen of the great saphenous vein needs to be dilated to meet the anastomosis requirement of the surgery, and the branch bleeding is checked at the same time.

[0004] The existing great saphenous vein dilating method mainly clamps the distal end of the acquired great saphenous vein, and manually injects heparin saline into the lumen by using a syringe at the proximal end. However, in the process of manually dilating the blood vessel by using the syringe, the pressure in the lumen can be as high as 600 mmHg, which can easily damage the integrity of the endothelium in the lumen and activate the inflammatory reaction. At the same time, the high pressure makes the great saphenous vein lose the function of smooth muscle relaxation and contraction, promotes the intimal hyperplasia, and seriously affects the patency rate of the bridge blood vessel.

[0005] The existing vein protection device mainly places a pressure limiting valve in front of the syringe. This method provides unstable pressure and poor lumen dilating effect, which cannot meet the needs of the surgery, and due to the insensitive pressure monitoring, the instantaneous pressure can be higher than the limited value, which can damage the endothelium of the vein. Therefore, a new type of vein bridge blood vessel dilating device is needed to dilate the lumen under the stable ideal pressure in the laminar flow mode, so as to protect the integrity of the intima and the function of the smooth muscle, which is the exploration direction to improve the patency rate of the vein bridge blood vessel. SUMMARY

[0006] Therefore, the technical problem to be solved by the present application is to overcome the defects of the existing technology, that is, the vein protection device uses a pressure limiting valve to control the dilating pressure to limit the pressure in the lumen, which is not accurate in pressure detection and poor in vein dilating effect, so as to provide a vein bridge blood vessel dilating device and method.

[0007] To solve the above technical problems, the technical scheme of the present application is as follows:

[0008] A venous bridge blood vessel dilating device is provided to dilate a venous bridge blood vessel implanted in a human body, comprising a dilating balloon, an inflation pump, a pressure sensor and a controller; the dilating balloon has a contracted state and a full state, the dilating balloon is adapted to be implanted in the inner cavity of the venous bridge blood vessel in the contracted state, and the dilating balloon is adapted to dilate the venous bridge blood vessel radially in the full state; the pressure sensor is adapted to detect the intimal pressure signal of the venous bridge blood vessel, the inflation pump is in communication with the dilating balloon and is used to inflate or deflate the dilating balloon; the controller is electrically connected with the pressure sensor and the inflation pump, and controls the inflation pump to perform inflation or deflation action in response to the intimal pressure signal output by the pressure sensor.

[0009] Further, the dilating balloon is fixed at the distal end of a push tube and is configured to be inserted into the venous bridge blood vessel using the push tube.

[0010] Further, the distal end of the dilating balloon is provided with a tapered tip, and the tip blocks the distal end of the push tube.

[0011] Further, a guide wire is arranged in the push tube, the distal end edge of the guide wire protrudes beyond the tip of the dilating balloon, and the pressure sensor is integrated at the distal end of the guide wire.

[0012] Further, a channel is arranged in the interior of the push tube, and a wire connected between the pressure sensor and the controller is arranged in the channel in the interior of the push tube.

[0013] Further, a stress-constrained tube is connected at the proximal end of the dilating balloon, the proximal end of the stress-constrained tube is connected with a catheter seat, the inner cavity of the catheter seat is in communication with the inflation pump, and the proximal end of the push tube is connected with the catheter seat.

[0014] Further, the dilating balloon is a semi-compliant or compliant balloon, the material of the dilating balloon is one of nylon, polyether block polyamide, thermoplastic polyurethane elastomer rubber and polyethylene, and the shape of the dilating balloon in the full state is cylindrical or ellipsoidal.

[0015] Further, a drug coating is arranged on the dilating balloon, and the drug coating is a mixture of one or more of paclitaxel, rapamycin, zotarolimus and everolimus.

[0016] A venous bridge blood vessel dilating method is provided, which adopts the venous bridge blood vessel dilating device described above and comprises the following steps:

[0017] S1, insert the push tube integrated with the pressure sensor and the expansion balloon into the lumen of the venous bridging blood vessel;

[0018] S2, the controller controls the inflation pump to inflate the expansion balloon, and simultaneously collects the intimal pressure signal of the venous bridging blood vessel by using the pressure sensor;

[0019] S3, judge whether the size of the collected intimal pressure signal of the venous bridging blood vessel reaches the size of the set pressure signal, if the judgment result is no, the controller controls the inflation pump to continue inflating the expansion balloon, when the size of the intimal pressure signal of the venous bridging blood vessel detected by the pressure sensor is equal to the size of the set pressure signal, the controller controls the inflation pump to stop the inflation action;

[0020] S4, collect the intimal pressure signal of the venous bridging blood vessel by using the pressure sensor again, judge whether the acquired intimal pressure signal of the venous bridging blood vessel is greater than the set pressure signal, if the judgment result is yes, the controller controls the inflation pump to execute the deflation action to extract the gas in the expansion balloon, when the size of the intimal pressure signal of the venous bridging blood vessel detected by the pressure sensor is equal to the size of the set pressure signal, the controller controls the inflation pump to stop the deflation action;

[0021] S5, the controller controls the inflation pump to execute the inflation action to expand the venous bridging blood vessel.

[0022] The technical scheme of the present application has the following advantages:

[0023] 1. The venous bridging blood vessel expansion device provided by the present application adopts a pressure sensor implanted in the venous bridging blood vessel to collect the intimal pressure signal of the venous bridging blood vessel, and a controller controls the inflation pump to execute the inflation action to inflate the expansion balloon or execute the deflation action to deflate the expansion balloon, so that the pressure in the venous bridging blood vessel can be controlled during the inflation and deflation of the expansion balloon. Compared with the pressure control method using a syringe in the prior art, the pressure control effect is better, the venous bridging blood vessel can be expanded in a laminar flow mode under stable ideal pressure, which is efficient, convenient and safe, and can protect the integrity of the intima and the smooth muscle function of the venous bridging blood vessel, thereby improving the patency rate of the venous bridging blood vessel. Moreover, this control method can realize intelligent program control, and can obtain accurate values and change curves of the intimal pressure signal of the venous bridging blood vessel in real time.

[0024] 2. The method for expanding the venous bridge blood vessel, in the inflation process before the formal expansion of the venous bridge blood vessel by the expansion balloon, the intima pressure signal of the venous bridge blood vessel is collected by the pressure sensor inserted into the venous bridge blood vessel in real time until the size of the collected intima pressure signal of the venous bridge blood vessel reaches the size of the set pressure signal, the controller controls the inflation pump to stop the inflation action, if the inflation action of the formal expansion of the venous bridge blood vessel is directly performed at this time, the intima pressure of the venous bridge blood vessel will be further increased, which will cause the intima tissue of the venous bridge blood vessel to be damaged, at this time, the inflation pump is controlled by the controller to perform the deflation action, when the intima pressure signal of the venous bridge blood vessel decreases to meet the set condition, finally, the inflation pump inflates the expansion balloon to perform the formal expansion action on the venous bridge blood vessel, the venous bridge blood vessel expansion method has better pressure control effect, the venous bridge blood vessel can be expanded in the laminar flow mode under the stable ideal pressure, the lumen of the venous bridge blood vessel is efficiently, conveniently and safely expanded, the integrity of the intima and the smooth muscle function of the venous bridge blood vessel are protected, and the patency rate of the venous bridge blood vessel is improved. BRIEF DESCRIPTION OF DRAWINGS

[0025] In order to more clearly illustrate the technical solutions in the specific embodiments or the prior art, the following will briefly introduce the drawings needed to be used in the specific embodiments or the prior art description. Obviously, the drawings in the following description are some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0026] Figure 1 The implementation principle diagram of the venous bridge blood vessel expansion device provided by the embodiment of the present application is shown in the figure.

[0027] Figure 2 The implementation flowchart of the venous bridge blood vessel expansion method provided by the embodiment of the present application is shown in the figure.

[0028] The figure mark explanation: 1, expansion balloon; 2, push tube; 3, sharp end; 4, guide wire; 5, stress constraint tube; 6, catheter seat. DETAILED DESCRIPTION

[0029] The technical solutions of the present application will be described in detail below with reference to the drawings, obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor belong to the protection scope of the present application.

[0030] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second", "third" are only for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0031] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting" should be understood in a broad sense, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0032] In addition, the technical features involved in the different embodiments of the application described below can be combined with each other as long as there is no conflict.

[0033] As Figure 1 shown in a kind of venous bridge blood vessel dilatation device, including dilatation balloon 1, inflation pump, pressure sensor and controller;Wherein, dilatation balloon 1 has shrinkage state and fullness state, dilatation balloon 1 is suitable for implanting in the lumen of venous bridge blood vessel when in shrinkage state, dilatation balloon 1 is suitable for the radial expansion of venous bridge blood vessel when in fullness state;Pressure sensor is set to be suitable for detecting intimal pressure signal of venous bridge blood vessel, inflation pump is communicated with dilatation balloon 1 and is used to inflate or deflate dilatation balloon 1;Controller is electrically connected with pressure sensor and inflation pump, and controls inflation pump to execute inflation action or deflation action in response to intimal pressure signal output by pressure sensor.

[0034] Specifically, dilatation balloon 1 is fixed at the distal end of a push tube 2, and is configured to be inserted into the venous bridge blood vessel using the push tube 2. The distal end of the dilatation balloon 1 is provided with a tapered tip 3, and the tip 3 blocks the distal end of the push tube 2. A guide wire 4 is provided in the push tube 2, and the distal edge of the guide wire 4 protrudes beyond the tip 3 of the balloon. The pressure sensor is integrated on the part of the guide wire 4 that protrudes beyond the balloon. The push tube 2 has a channel inside, and the connecting wire between the pressure sensor and the controller is arranged in the channel inside the push tube 2.

[0035] In the embodiment, the proximal end of the expanding balloon 1 is connected with a stress constraint tube 5, the proximal end of the stress constraint tube 5 is connected with a catheter seat 6, the inner cavity of the catheter seat 6 is communicated with the inflation pump, and the proximal end of the push tube 2 is connected with the catheter seat 6.

[0036] In the embodiment, the expanding balloon 1 is a semi-compliant or compliant balloon, and the material of the expanding balloon 1 is one of nylon, polyether block polyamide, thermoplastic polyurethane elastomer rubber and polyethylene, and the shape of the expanding balloon 1 in the inflated state is a cylindrical shape or an ellipsoidal shape.

[0037] The venous bridge blood vessel expanding device provided by the application adopts a pressure sensor implanted in the venous bridge blood vessel to collect the intimal pressure signal of the venous bridge blood vessel, and a controller controls the inflation pump to perform an inflation action to inflate the expanding balloon 1 or perform a deflation action to deflate the expanding balloon 1, so that the pressure in the venous bridge blood vessel can be controlled in the process of inflation and deflation of the expanding balloon 1. Compared with the pressure control mode of the prior art using a syringe, the pressure control effect is better, the venous bridge blood vessel can be expanded in a laminar flow mode under stable ideal pressure, and the lumen of the venous bridge blood vessel is efficiently, conveniently and safely expanded to protect the integrity of the intima and the smooth muscle function of the venous bridge blood vessel, which is beneficial to improving the patency rate of the venous bridge blood vessel. Moreover, the control mode can realize intelligent control of the program, and the accurate value and change curve of the intimal pressure signal of the venous bridge blood vessel can be obtained in real time.

[0038] In the embodiment, a drug coating is arranged on the expanding balloon, and the drug coating is a mixture of one or more of paclitaxel, rapamycin, zotarolimus and everolimus. For example, the drug coating is paclitaxel, paclitaxel+rapamycin, zotarolimus+everolimus.

[0039] As shown in Figure 2 The embodiment of the application also provides a venous bridge blood vessel expanding method, which adopts the venous bridge blood vessel expanding device described above and specifically includes the following steps.

[0040] S1, inserting the push tube 2 integrated with the pressure sensor and the expanding balloon 1 into the lumen of the venous bridge blood vessel;

[0041] S2, controlling the inflation pump to inflate the expanding balloon 1, and collecting the intimal pressure signal of the venous bridge blood vessel by using the pressure sensor;

[0042] S3, judging whether the size of the collected intimal pressure signal of the venous bridge blood vessel reaches the size of the set pressure signal, if the judgment result is no, the controller controls the inflation pump to continue inflating the expanding balloon 1, and when the size of the intimal pressure signal of the venous bridge blood vessel detected by the pressure sensor is equal to the size of the set pressure signal, the controller controls the inflation pump to stop the inflation action;

[0043] S4, the pressure sensor is used again to collect the intima pressure signal of the venous bridging vessel, and it is judged whether the collected intima pressure signal of the venous bridging vessel is greater than the set pressure signal, if the judgment result is yes, the controller controls the inflation pump to execute the deflation action to extract the gas in the expansion balloon 1, when the intima pressure signal of the venous bridging vessel detected by the pressure sensor is equal to the size of the set pressure signal, the controller controls the inflation pump to stop the deflation action;

[0044] S5, the controller controls the inflation pump to execute the inflation action to expand the venous bridging vessel.

[0045] The venous bridging vessel expansion method, in the inflation process before the expansion balloon 1 formally expands the venous bridging vessel, the pressure sensor inserted into the venous bridging vessel is used to collect the intima pressure signal of the venous bridging vessel in real time, until the size of the collected intima pressure signal of the venous bridging vessel reaches the size of the set pressure signal, the controller controls the inflation pump to stop the inflation action, if the inflation action of formally expanding the venous bridging vessel is directly executed at this time, the intima pressure of the venous bridging vessel will be further increased, which will cause the intima tissue of the venous bridging vessel to be damaged, at this time, the controller is used again to control the inflation pump to execute the deflation action, when the intima pressure signal of the venous bridging vessel decreases to meet the set condition, finally the inflation pump inflates the expansion balloon 1 to execute the formal expansion action on the venous bridging vessel, the venous bridging vessel expansion method, the pressure control effect is better, the venous bridging vessel can be expanded in the laminar flow mode under the stable ideal pressure, which is efficient, convenient and safe to expand the lumen of the venous bridging vessel, to protect the integrity of the intima and the smooth muscle function of the venous bridging vessel, which is beneficial to improve the patency rate of the venous bridging vessel.

[0046] Obviously, the above embodiments are only examples for clearly illustrating, but not limiting the embodiments. For those skilled in the art, other different forms of changes or variations can be made on the basis of the above description. Here, all the embodiments need not and cannot be exhausted. The obvious changes or variations derived therefrom are still within the protection scope of the present application.

Claims

1. A venous graft dilation device, configured to dilate venous graft vessels, thereby realizing the preparation of venous graft vessels in coronary artery bypass grafting, characterized in that, The device includes an inflatable balloon (1), an inflation pump, a pressure sensor, and a controller. The inflatable balloon (1) has a contracted state and an inflated state. When the inflatable balloon (1) is contracted, it is suitable for implantation into the lumen of a venous graft. When the inflatable balloon (1) is inflated, it is suitable for radial expansion of the venous graft. The pressure sensor is configured to detect the intimal pressure signal of the venous graft. The inflation pump is connected to the inflatable balloon (1) and is used to inflate or deflate the inflatable balloon (1). The controller is electrically connected to the pressure sensor and the inflation pump and controls the inflation pump to perform inflation or deflation actions in response to the intimal pressure signal output by the pressure sensor.

2. The venous graft vasodilator according to claim 1, characterized in that, The dilating balloon (1) is fixed to the distal end of a push tube (2) and is configured to be inserted into the venous graft vessel using the push tube (2).

3. The venous graft vasodilator according to claim 2, characterized in that, The distal end of the dilating balloon (1) is provided with a conical tip (3), which blocks the distal end of the push tube (2).

4. The venous graft vasodilator according to claim 3, characterized in that, The push tube (2) is provided with a guide wire (4), the distal edge of the guide wire (4) protrudes beyond the tip (3) of the balloon, and the pressure sensor is integrated at the distal end of the guide wire (4).

5. The venous graft vasodilator according to claim 4, characterized in that, The push tube (2) has a channel inside, and the wire connecting the pressure sensor and the controller is arranged in the channel inside the push tube (2).

6. The venous graft vasodilator according to claim 2, characterized in that, The proximal end of the dilatation balloon (1) is connected to a stress restraint tube (5), and the proximal end of the stress restraint tube (5) is connected to a catheter seat (6). The inner lumen of the catheter seat (6) is connected to the inflation pump, and the proximal end of the push tube (2) is connected to the catheter seat (6).

7. The venous graft vasodilator according to claim 1, characterized in that, The expandable balloon (1) is a semi-compliant or compliant balloon. The expandable balloon (1) is made of one of the following materials: nylon, polyether block polyamide, thermoplastic polyurethane elastomer rubber, and polyethylene. The expandable balloon (1) is cylindrical or ellipsoidal in its inflated state.

8. The venous graft vasodilator according to claim 1, characterized in that, The dilating balloon (1) is provided with a drug coating, which is one or a mixture of paclitaxel, rapamycin, zotamoxetine, and everolimus.

9. A method for dilating venous grafts, using the venous graft dilator according to any one of claims 1-8, characterized in that, Includes the following steps: S1. Insert the push tube (2) integrating the pressure sensor and the dilation balloon (1) into the lumen of the venous graft. S2, The controller controls the inflation pump to inflate the dilation balloon (1), and at the same time uses the pressure sensor to collect the intima pressure signal of the venous graft. S3. Determine whether the magnitude of the collected intima pressure signal of the venous graft vessel reaches the magnitude of the set pressure signal. If the determination result is no, the controller controls the inflation pump to continue to inflate the dilation balloon (1). When the magnitude of the intima pressure signal of the venous graft vessel detected by the pressure sensor is equal to the magnitude of the set pressure signal, the controller controls the inflation pump to stop the inflation action. S4. The pressure sensor is used again to collect the intima pressure signal of the venous graft vessel. It is determined whether the obtained intima pressure signal of the venous graft vessel is greater than the set pressure signal. If the determination result is yes, the controller controls the inflation pump to perform the deflation action to extract the gas in the dilation balloon (1). When the magnitude of the intima pressure signal of the venous graft vessel detected by the pressure sensor is equal to the magnitude of the set pressure signal, the controller controls the inflation pump to stop the deflation action. S5. The controller controls the air pump to perform an inflation action to expand the venous graft vessels, thereby realizing the preparation of venous graft vessels in coronary artery bypass grafting.

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