Balloon sheath tube

Abstract

The invention provides a balloon sheathing canal, which comprises a sheathing canal main body, which is provided with a main cavity, a filling cavity and a perfusion cavity which are not communicated with each other; the far end of the main cavity penetrates through the far end of the sheathing canal main body; at least one first side hole and at least one second side hole are formed in the side wall of the sheathing canal main body; the first side hole is communicated with the perfusion cavity and the external space of the sheathing canal main body; the balloon is arranged close to the far end of the balloon sheath tube, and the second side hole is communicated with the balloon and the filling cavity; and the first side hole is formed in the near end side of the balloon. According to the balloon sheath tube, the balloon is used for blocking the blood vessel, the first side hole formed in the near end side of the balloon and the perfusion cavity communicated with the first side hole are used for perfusing the developing agent, the developing agent can display whether the blood vessel is completely blocked by the balloon or not, and an angiographic catheter does not need to be additionally arranged from other parts of the blood vessel.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a balloon sheath. Background Art

[0002] From the 1970s to today, vascular interventional treatment technology has developed rapidly. Sheaths play an important role in establishing surgical instrument access. Many vascular interventional surgeries require blood flow occlusion, so balloon sheaths came into being.

[0003] As for the current balloon sheaths, most of them have a filling cavity in the sheath wall to fill the balloon. And their function is mostly to block blood vessels and block blood flow. If you want to monitor the blood pressure at the rear end of the balloon or determine whether the balloon is completely blocked, you need to insert an additional angiography catheter from other blood vessels.

[0004] In summary, in order to optimize the existing balloon sheath, it is particularly important to develop a balloon sheath that can be used for imaging. Summary of the invention

[0005] Based on this, it is necessary to provide a balloon sheath that can be imaged.

[0006] The present invention provides a balloon sheath tube, comprising:

[0007] The sheath tube body comprises a main cavity, a filling cavity and a perfusion cavity which are not connected to each other; the distal end of the main cavity passes through the distal end of the sheath tube body; at least one first side hole and at least one second side hole are arranged on the side wall of the sheath tube body; the first side hole communicates with the perfusion cavity and the external space of the sheath tube body;

[0008] The balloon is arranged near the distal end of the balloon sheath, the second side hole connects the balloon and the filling cavity; and the first side hole is arranged at the proximal side of the balloon.

[0009] In one embodiment, the diameter of the first side hole gradually decreases from inside to outside along the radial direction of the sheath body.

[0010] In one embodiment, the sheath body includes an inner layer, a support layer and an outer layer arranged radially from the inside to the outside;

[0011] The support layer includes at least one support rod, and the support rod spirally extends along the axial direction of the sheath tube body, or the support tube is woven to form the support layer.

[0012] In one embodiment, the filling cavity and / or the perfusion cavity are embedded in the outer layer.

[0013] In one embodiment, the support rod is a hollow tube, and the lumen of the support rod forms at least one of the perfusion cavity or the filling cavity.

[0014] In one embodiment, a valve body is disposed in the perfusion cavity. When the fluid pressure in the perfusion cavity is greater than a preset pressure of the valve body, the valve body opens to allow the fluid to flow from the distal end to the proximal end of the sheath body.

[0015] In one embodiment, a plurality of valve bodies are disposed in the perfusion cavity, and the preset pressures of the plurality of valve bodies gradually increase from the distal end to the proximal end of the sheath body.

[0016] In one embodiment, the valve body is disposed near the proximal end of the perfusion chamber.

[0017] In one embodiment, the outer layer includes at least one transparent section, and the projection of the valve body along the radial direction of the sheath body falls on the transparent section, so that the valve body can be observed through the transparent section.

[0018] In one embodiment, the balloon sheath further includes a first angiography connector and a second angiography connector; the first angiography connector is disposed on the proximal side of the sheath body and is connected to the main cavity; the second angiography connector is disposed on the proximal side of the sheath body and is connected to the perfusion cavity.

[0019] The balloon of the balloon sheath of the present invention is used to block a blood vessel, and the first side hole provided on the proximal side of the balloon and the perfusion cavity connected to the first side hole are used to perfuse a contrast agent, which can show whether the blood vessel is completely blocked by the balloon without inserting an additional angiography catheter from other parts of the blood vessel. In addition, the perfusion cavity can also be used to perfuse a liquid medicine to perform local treatment on the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a partial axial cross-sectional view of the balloon sheath tube in Example 1 of the present invention;

[0021] Figure 2 This is a schematic diagram of the structural connection of the balloon sheath tube in Example 1 of the present invention when used in a carotid artery reverse flow system;

[0022] Figure 3 This is a schematic diagram of the structure of the balloon sheath tube in Example 1 of the present invention;

[0023] Figure 4 for Figure 1 The enlarged view of point A in the middle;

[0024] Figure 5 It is a partial schematic diagram of the first side hole in other embodiments of the present invention;

[0025] Figure 6 is a radial cross-sectional view of the balloon sheath tube in Example 1 of the present invention;

[0026] Figure 7 This is a schematic diagram of the structure of the valve body in Example 1 of the present invention;

[0027] Figure 8 It is a structural schematic diagram of the valve body in a closed state in other embodiments of the present invention;

[0028] Fig. 9 It is a structural schematic diagram of the valve body in the open state in other embodiments of the present invention;

[0029] Fig.10 It is a partial axial cross-sectional view of the balloon sheath tube in Example 2 of the present invention;

[0030] Fig.11 Schematic diagram of the structure of the support layer in Example 3 of the present invention;

[0031] Fig.12 It is a partial axial cross-sectional view of the balloon sheath tube in Example 4 of the present invention. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0033] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0034] In order to more clearly describe the structure of the present application, the terms "proximal end" and "distal end" are defined herein as commonly used terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, "proximal end" refers to the end close to the operator during the surgical operation, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.

[0035] Example 1

[0036] like Figure 1As shown, this embodiment provides a balloon sheath 100, comprising: a sheath body 110, which has a main cavity 111, a filling cavity 112 and a perfusion cavity 113 that are not connected to each other; the distal end of the main cavity 111 passes through the distal end of the sheath body 110; at least one first side hole 114 and at least one second side hole 115 are provided on the side wall of the sheath body 110; the first side hole 114 communicates with the perfusion cavity 113 and the external space of the sheath body 110;

[0037] The balloon 120 is disposed near the distal end of the balloon sheath 100 , the second side hole 115 connects the balloon 120 and the filling cavity 112 ; and the first side hole 114 is disposed at the proximal side of the balloon 120 .

[0038] The balloon 120 of the balloon sheath 100 of the present invention is used to block a blood vessel, and the first side hole 114 provided on the proximal side of the balloon 120 and the perfusion cavity 113 connected to the first side hole 114 are used to perfuse a developer, which can show whether the blood vessel is completely blocked by the balloon 120, without the need to insert an additional angiography catheter from other parts of the blood vessel. In addition, the perfusion cavity 113 can also be used to perfuse other liquids (such as saline, liquid medicine, etc.) to perform local treatment on the blood vessel.

[0039] This embodiment takes carotid artery intervention surgery as an example. Figure 2 As shown, the carotid artery reverse flow system for carotid artery interventional surgery includes the balloon sheath 100, the shunt device 20, the venous sheath 30 and the stent system 40. The balloon sheath 100, the shunt device 20 and the venous sheath 30 are connected in sequence, the distal end of the balloon sheath 100 is inserted into the common carotid artery to be treated (hereinafter illustrated by the left common carotid artery 01), and the venous sheath is inserted into the patient's vein (hereinafter illustrated by the femoral vein 02). Under normal circumstances, arterial blood flows from the aortic arch, flows to the left common carotid artery and the right common carotid artery respectively, and then flows into the skull, and the blood of the left common carotid artery and the right common carotid artery is connected through the intracranial Willis circle. After the balloon sheath 100 blocks the left common carotid artery 01, the left common carotid artery 01 is insufficiently supplied with blood. Under the pressure difference between arterial blood and venous blood, arterial blood from the right common carotid artery flows back into the left common carotid artery 01 and is returned to the human body through the balloon sheath 100, the shunt device 20, and the venous sheath 30. When the stent system 40 enters the left common carotid artery 01 along the balloon sheath 100 and releases the stent, the thrombus in the blood flow enters the shunt device 20 with the blood flow and is filtered, which can prevent the thrombus from entering the cerebral blood vessels.

[0040] In this embodiment, the balloon sheath 100 further includes a first contrast connector 130 and a second contrast connector 140; the first contrast connector 130 is disposed on the proximal side of the sheath body 110 and communicated with the main cavity 111; the second contrast connector 140 is disposed on the proximal side of the sheath body 110 and communicated with the perfusion cavity 113. During the operation, after the balloon sheath 100 is placed into the left common carotid artery 01, contrast fluid is first injected into the main cavity 111 through the first contrast connector 130, and the contrast fluid diffuses from the distal end of the sheath body 110 into the left common carotid artery 01 along the direction of blood flow. The lesion in the left common carotid artery 01 can be determined by DSA imaging, and the distal position of the balloon sheath 100 can be determined by observing the diffusion position of the contrast fluid, so that the balloon sheath 100 is adjusted to a suitable position. Then, a filling medium (such as saline solution, etc.) is injected through the filling chamber 112 to fill the balloon 120. After the filling is completed, the balloon 120 blocks the left common carotid artery 01. Under the pressure difference between the artery and the vein, the blood flow at the distal end of the balloon 120 flows reversely into the main chamber 111 of the sheath body 110, and flows back to the patient's femoral vein 02 through the main chamber 111 and the venous sheath 30 connected to the main chamber 111. Then, contrast fluid is injected into the perfusion chamber through the second contrast connector 140. Through DSA imaging, it can be observed whether the contrast fluid flows from the proximal side of the balloon 120 to the distal side of the balloon 120. If the contrast fluid does not flow from the proximal side of the balloon 120 to the distal side of the balloon 120, the balloon 120 blocks the blood vessel, ensuring that the thrombus that falls off from the carotid artery wall during the operation will not enter the cerebral blood vessels along the carotid artery.

[0041] In this embodiment, if Figure 1 and Figure 4 As shown, the aperture of the first side hole 114 gradually decreases from the inside to the outside along the radial direction of the sheath body 110. Since the flow rate of the liquid increases with the decrease of the flow area under the same pressure, when the developer or other liquid medicine enters the blood vessel through the first side hole 114, the flow rate of the developer or other liquid medicine increases, and the developer or other liquid medicine flows out of the first side hole 114 in a jet shape and diffuses rapidly in the blood vessel, which is conducive to reducing the development observation time.

[0042] In other embodiments, the side wall of the sheath body 110 is provided with a plurality of first side holes 114, for example, two or three. Figure 5 In the partial enlarged view of the first side hole shown, two first side holes 114 are provided on the sheath body 110 , and the two side holes 114 are arranged along the axial direction of the sheath body 110 to facilitate the rapid diffusion of developer or other liquid medicine along the axial direction of the sheath body 110 .

[0043] In other embodiments, a plurality of perfusion cavities and a plurality of first side holes are provided on the side wall of the sheath body, and each of the perfusion cavities is connected to at least one of the first side holes. The plurality of perfusion cavities are arranged at intervals along the circumference of the sheath body, and the proximal ends of the plurality of perfusion cavities are connected through pipelines. When the drug or developer is input from the pipeline, the drug or developer reaches the plurality of first side holes along the plurality of perfusion cavities, so that the drug or developer can diffuse rapidly along the circumference of the sheath body.

[0044] like Figure 1 and Figure 6 As shown, the sheath body includes an inner layer 116, a support layer 117 and an outer layer 118 arranged radially from the inside to the outside; the support layer 117 includes at least one support rod 1171, and the support rod 1171 extends spirally along the axial direction of the sheath body. In other embodiments, the support rods are woven to form the support layer. The inner layer is formed by a PTEF inner membrane, and the outer layer is made of a PEBAX tube.

[0045] The filling cavity 112 and / or the perfusion cavity 113 are embedded in the outer layer 118. Specifically, the pore size of the filling cavity 112 or the perfusion cavity 113 is smaller than the thickness of the outer layer 118. Since the outer layer 118 itself has a certain thickness, the filling cavity 112 and / or the perfusion cavity 113 are embedded in the outer layer 118, which can reduce the overall diameter of the sheath body 110 and facilitate the passage of the balloon sheath 100 in the blood vessel. In other embodiments, the filling cavity 112 and / or the perfusion cavity 113 are arranged between the inner layer 116 and the support layer 117 or between the support layer 117 and the outer layer 118.

[0046] A valve body 130 is provided in the perfusion cavity. When the fluid pressure in the perfusion cavity 113 is greater than the preset pressure of the valve body 130, the valve body 130 opens to allow the fluid to flow from the distal end to the proximal end along the sheath body 110. In this embodiment, the preset pressure of the valve body 130 is greater than the venous blood flow pressure and less than the arterial blood flow pressure. When the distal end of the balloon sheath tube 100 is inserted into the patient's blood vessel, if the blood can pass through the valve body 130 smoothly, it means that the distal end of the balloon sheath tube 100 is inserted into the patient's artery; if the blood cannot pass through the valve body 130, it means that the distal end of the balloon sheath tube 100 is inserted into the patient's vein. Therefore, the balloon sheath tube 100 in this embodiment can assist the operator to quickly determine whether the position of the balloon sheath tube 100 is correct.

[0047] For easy observation, the valve body 130 is arranged near the proximal end of the perfusion cavity 113. When the distal end of the balloon sheath 100 reaches the lesion, the valve body 130 is located outside the patient's body. In addition, in this embodiment, the outer layer 118 is made of a transparent PEBAX tube so that the operator can observe the valve body 130 located in the perfusion cavity 113 through the outer layer. Alternatively, the outer layer 118 has at least one transparent section, which is made of a transparent PEBAX tube, and the valve body 130 is arranged in the transparent section.

[0048] Specifically, Figure 7 As shown, the valve body 130 in this embodiment has a circulation portion 131 and a connecting portion 132. The circulation portion 131 is provided with a slit 133. The connecting portion 132 is provided around the circulation portion 131, and the connecting portion 132 is used to connect the circulation portion 131 and the inner wall of the perfusion chamber 113. The thickness of the circulation portion 131 is smaller than the thickness of the connecting portion 132. When the circulation portion 131 is subjected to the pressure of the blood and the pressure of the blood is greater than the preset pressure of the valve body 130, the circulation portion 131 is deformed to open the slit 133, and the blood passes through the valve body 130 from the slit 133.

[0049] When manufacturing the balloon sheath tube 100 of this embodiment, the outer layer 118 can be directly cut open so that the valve body 130 can be placed in the perfusion cavity 113. After the valve body 130 is fixed to the inner wall of the perfusion cavity 113 by using an adhesive or hot melt, the cut on the outer layer is closed by using an adhesive or hot melt. In the above manner, the valve body 130 can be accurately placed in the perfusion cavity 113, ensuring that the valve body 130 is located outside the human body after the balloon sheath tube 100 is placed in the human body.

[0050] In other embodiments, Figure 8 As shown, the circumferential edge of the valve body 130 includes a connecting section 134 and a movable section 135, wherein the connecting section 134 is fixedly connected to the inner wall surface of the perfusion chamber 113, and the movable section 135 can move relative to the inner wall surface of the perfusion chamber 113. When the valve body 130 is subjected to the pressure of the blood and the pressure of the blood is greater than the preset pressure of the valve body 130, the valve body 130 is deformed to make the movable section 135 away from the inner wall surface of the perfusion chamber 113, and the blood passes through the valve body 130 from the gap between the movable section 135 and the inner wall surface of the perfusion chamber 113.

[0051] Example 2

[0052] The main difference between the balloon sheath tube 100 disclosed in Example 2 and Example 1 is that Fig.10As shown, the support rod of the balloon sheath tube 200 in Example 2 is a hollow tube, and the lumen of the support rod forms at least one of the perfusion cavity 213 and the filling cavity 212. The support rod can not only improve the support strength of the balloon sheath tube 200, but also provide the perfusion cavity and / or the filling cavity, thereby reducing the space occupied by the perfusion cavity and / or the filling cavity on the balloon sheath tube, which is conducive to further reducing the diameter of the balloon sheath tube.

[0053] In this embodiment, the support layer 217 of the balloon sheath tube 200 includes a first support rod 2171 and a second support rod 2172, both of which extend spirally along the axial direction of the balloon sheath tube 200, and the spiral ring of the first support rod 2171 and the spiral ring of the first support rod 2172 are arranged alternately. The inner cavity of the first support rod 2171 forms the perfusion cavity 213, and the inner cavity of the first support rod 2172 forms the filling cavity 212. The distal end of the first support rod 2171 extends to the first side hole 214, and the distal end of the first support rod 2172 extends to the second side hole 215. Therefore, the distal end of the balloon sheath tube 200 has only the first support rod 2172, so the strength is lower and the flexibility is better, which prevents the distal end of the balloon sheath tube 200 from causing damage to the blood vessel.

[0054] The first support rod 2171 includes a straight section 21711, which is arranged at the proximal end of the balloon sheath tube 200 and extends along the axial direction of the balloon sheath tube 200, and the valve body 230 is arranged in the straight section 21700. The first support rod 2171 is made of polyethylene (PE), nylon and other materials, and at least part of the straight section 21711 is made of transparent PE, nylon and other materials. Preferably, the first support rod 2171 is made of transparent PE, nylon and other materials as a whole.

[0055] Example 3

[0056] The main difference between the balloon sheath tube disclosed in Example 3 and Example 2 is that Fig.11As shown, the support layer 317 includes at least one first support rod 3171 and at least one second support rod 3172, and the at least one first support rod 3171 and the at least one second support rod 3172 are woven to form the support layer 317. In this embodiment, the support layer 317 includes three first support rods 3171 and one second support rod 3172, and the second support rod 3172 is connected to the balloon of the balloon sheath tube for filling the balloon. The first support rod 3171 is used to inject medicine or developer into the blood vessel. Since the support layer 317 in this embodiment includes three first support rods 3171, the distal end of each first support rod 3171 corresponds to a first side hole formed on the side wall of the balloon sheath tube, and the medicine or developer reaches the three first side holes along the three first support rods 3171, so the medicine or developer can quickly diffuse along the circumferential direction of the sheath tube body.

[0057] The proximal ends of the three first support rods 3171 are connected through a fan-shaped pipe 3173, and the pipe 3173 is connected to the second angiography connector of the balloon sheath tube. The operator injects the developer or the drug through the second angiography connector.

[0058] Example 4

[0059] The main difference between the balloon sheath tube 100 disclosed in Example 4 and Example 1 is that Fig.12 As shown, a plurality of valve bodies 430 are disposed in the perfusion cavity 413 of the balloon sheath tube 400 in Example 4, and the preset pressures of the plurality of valve bodies 430 gradually increase in the direction from the distal end to the proximal end of the sheath tube body 410 .

[0060] The multiple valve bodies 430 are all arranged at the proximal end of the balloon sheath tube 400, and during the operation, the multiple valve bodies 430 are located outside the patient's body and visible through the balloon sheath tube 400. When the balloon sheath tube 400 is placed in a blood vessel, the current patient's blood pressure can be monitored in real time by which valve body 430 the blood flows back to, thereby avoiding the occurrence of dangerous situations (for example, a sudden increase in the patient's blood pressure may be stress-induced hypertension, which can easily lead to various complications such as cerebral hemorrhage and heart failure, and requires timely intervention to reduce blood pressure; a sudden decrease in the patient's blood pressure may be due to ruptured blood vessels or excessive blood loss, which can easily lead to various complications such as insufficient circulating blood volume and multiple organ dysfunction, and requires timely intervention to increase blood pressure).

[0061] If contrast or thrombolysis is required during the operation, contrast solution or liquid medicine can be injected into the perfusion cavity 413 at a pressure greater than the current blood pressure, and blood pressure monitoring is temporarily stopped at this time. After the injection is stopped, blood flows back to the perfusion cavity, and the function of monitoring blood pressure is restored.

[0062] In this embodiment, the balloon sheath tube 400 includes three valve bodies 430, the preset pressures of the three valve bodies 430 are 20 mmHg, 40 mmHg and 60 mmHg respectively, and the three valve bodies 430 are arranged from small to large intervals along the distal end to the proximal end of the balloon sheath tube 400 according to the magnitude of the preset pressure. The valve body 430 is made of rubber or silicone, and its preset pressure is proportional to its thickness. For example, the thickness of the valve body with a preset pressure of 40 mmHg is twice the thickness of the valve body with a preset pressure of 20 mmHg.

[0063] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0064] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A balloon sheath, characterized in that: include: A sheath body having a main lumen, a filling lumen and an irrigation lumen which are not communicated with each other; The distal end of the main lumen passes through the distal end of the sheath body; At least one first side hole and at least one second side hole are provided on the side wall of the sheath tube body; the first side hole communicates with the perfusion cavity and the external space of the sheath tube body; The balloon is arranged near the distal end of the balloon sheath, the second side hole connects the balloon and the filling cavity; and the first side hole is arranged at the proximal side of the balloon.

2. The balloon sheath according to claim 1, characterized in that: The aperture of the first side hole gradually decreases from inside to outside along the radial direction of the sheath tube body.

3. The balloon sheath according to claim 1, characterized in that: The sheath tube body comprises an inner layer, a support layer and an outer layer which are arranged radially from the inside to the outside; The support layer includes at least one support rod, and the support rod spirally extends along the axial direction of the sheath tube body, or the support rods are woven to form the support layer.

4. The balloon sheath according to claim 3, characterized in that: The filling cavity and / or the perfusion cavity are embedded in the outer layer.

5. The balloon sheath according to claim 3, characterized in that: The support rod is a hollow tube, and the lumen of the support rod at least forms one of the perfusion cavity or the filling cavity.

6. The balloon sheath according to claim 3, characterized in that: A valve body is arranged in the perfusion cavity. When the fluid pressure in the perfusion cavity is greater than the preset pressure of the valve body, the valve body opens to allow the fluid to flow from the distal end to the proximal end of the sheath body.

7. The balloon sheath according to claim 6, characterized in that: A plurality of valve bodies are arranged in the perfusion cavity, and the preset pressures of the plurality of valve bodies gradually increase along the direction from the distal end to the proximal end of the sheath tube body.

8. The balloon sheath according to claim 6, characterized in that: The valve body is arranged close to the proximal end of the perfusion chamber.

9. The balloon sheath according to claim 6, characterized in that: The outer layer includes at least one transparent section, and the projection of the valve body along the radial direction of the sheath tube body falls on the transparent section, so that the valve body can be observed through the transparent section.

10. The balloon sheath according to claim 1, characterized in that: The balloon sheath also includes a first angiography connector and a second angiography connector; the first angiography connector is arranged on the proximal side of the sheath body and communicates with the main cavity; the second angiography connector is arranged on the proximal side of the sheath body and communicates with the perfusion cavity.

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