Balloon sheath catheter

Abstract

A balloon sheath catheter (100), comprising: a sheath catheter main body (110), which is provided with a main cavity (111), a filling cavity (112) and a perfusion cavity (113) that are not in communication with each other, wherein a distal end of the main cavity (111) penetrates through a distal end of the sheath catheter main body (110), at least one first side hole (114) and at least one second side hole (115) are formed on a side wall of the sheath catheter main body (110), and the first side hole (114) is in communication with the perfusion cavity (113) and an external space of the sheath catheter main body (110); and a balloon (120), which is arranged near a distal end of the balloon sheath catheter (100), wherein the second side hole (115) is in communication with the balloon (120) and the filling cavity (112), and the first side hole (114) is formed on a proximal end side of the balloon (120). The balloon (120) of the balloon sheath catheter (100) is used for occluding a blood vessel, and the first side hole (114) formed on the proximal end side of the balloon (120) and the perfusion cavity (113) in communication with the first side hole (114) are used for perfusion of a contrast agent. The contrast agent can show whether the blood vessel is completely occluded by the balloon (120), without the need to insert an additional angiographic catheter from another part of the blood vessel.

Description

A balloon sheath 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 therapy has experienced rapid development. Sheaths play a crucial role in establishing access for surgical instruments. Many vascular interventional procedures require blood flow occlusion, leading to the development of balloon sheaths.

[0003] Current balloon sheaths typically feature a filling chamber within the sheath wall to inflate the balloon. Their primary function is to occlude blood vessels and block blood flow. To monitor blood pressure behind the balloon or determine if the occlusion is complete, an angiographic catheter must be inserted through another vessel.

[0004] In summary, in order to optimize the existing balloon sheath, it is particularly important to develop an angiographic balloon sheath.

[0005] Summary of the Invention

[0006] Based on this, it is necessary to provide a balloon sheath that can be imaged.

[0007] The present invention provides a balloon sheath tube, comprising:

[0008] The sheath tube body comprises a main lumen, a filling lumen, and an infusion lumen that are not interconnected; the distal end of the main lumen passes through the distal end of the sheath tube 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 infusion lumen and the external space of the sheath tube body;

[0009] The balloon is arranged near the distal end of the balloon sheath, the second side hole communicates with the balloon and the filling cavity; and the first side hole is arranged on the proximal side of the balloon.

[0010] In one embodiment, the diameter of the first side hole gradually decreases from inside to outside along the radial direction of the sheath tube body.

[0011] 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;

[0012] 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 braided to form the support layer.

[0013] In one embodiment, the filling cavity and / or the perfusion cavity are embedded in the outer layer.

[0014] 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 and the filling cavity.

[0015] In one embodiment, a valve body is provided 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.

[0016] In one embodiment, a plurality of valve bodies are provided 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.

[0017] In one embodiment, the valve body is disposed near the proximal end of the perfusion chamber.

[0018] In one embodiment, the outer layer includes at least one transparent segment, and a projection of the valve body along the radial direction of the sheath body falls on the transparent segment, so that the valve body can be observed through the transparent segment.

[0019] In one embodiment, the balloon sheath further includes a first angiographic connector and a second angiographic connector; the first angiographic connector is disposed on the proximal side of the sheath body and is connected to the main cavity; the second angiographic connector is disposed on the proximal side of the sheath body and is connected to the perfusion cavity.

[0020] The balloon of the balloon sheath of the present invention is used to occlude blood vessels. A first side hole provided at the proximal end of the balloon and a perfusion chamber connected to the first side hole are used to perfuse contrast agent. The contrast agent can indicate whether the blood vessel is completely occluded by the balloon, eliminating the need to insert an additional angiographic catheter from other locations within the vessel. Furthermore, the perfusion chamber can also be used to perfuse a medical solution for localized treatment of the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG1 is a partial axial cross-sectional view of the balloon sheath in Example 1 of the present invention;

[0022] FIG2 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;

[0023] FIG3 is a schematic structural diagram of the balloon sheath tube in Example 1 of the present invention;

[0024] Figure 4 is an enlarged view of point A in Figure 1;

[0025] FIG5 is a partial schematic diagram of the first side hole in another embodiment of the present invention;

[0026] FIG6 is a radial cross-sectional view of the balloon sheath in Example 1 of the present invention;

[0027] FIG7 is a schematic structural diagram of the valve body in Example 1 of the present invention;

[0028] FIG8 is a schematic structural diagram of a valve body in a closed state in another embodiment of the present invention;

[0029] FIG9 is a schematic structural diagram of a valve body in an open state in another embodiment of the present invention;

[0030] FIG10 is a partial axial cross-sectional view of the balloon sheath in Example 2 of the present invention;

[0031] FIG11 is a schematic structural diagram of a support layer in Example 3 of the present invention;

[0032] FIG12 is a partial axial cross-sectional view of the balloon sheath in Example 4 of the present invention. DETAILED DESCRIPTION

[0033] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below with reference to 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.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used in this specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0035] To more clearly describe the structure of this application, the terms "proximal" and "distal" are defined herein as commonly used in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical procedure, "proximal" refers to the end closer to the operator during the surgical procedure, "axial" refers to the length direction, and "radial" refers to the direction perpendicular to the "axial" direction.

[0036] Example 1

[0037] As shown in FIG1 , this embodiment provides a balloon sheath 100, comprising: a sheath body 110 having a main lumen 111, a filling lumen 112, and an infusion lumen 113 that are not interconnected; the distal end of the main lumen 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 infusion lumen 113 and the external space of the sheath body 110;

[0038] The balloon 120 is disposed near the distal end of the balloon sheath 100 , and the second side hole 115 connects the balloon 120 and the filling cavity 112 ; and the first side hole 114 is disposed on the proximal side of the balloon 120 .

[0039] The balloon 120 of the balloon sheath 100 of the present invention is used to occlude blood vessels. A first side hole 114 provided at the proximal end of the balloon 120 and a perfusion chamber 113 connected to the first side hole 114 are used to perfuse contrast agent. This contrast agent can indicate whether the blood vessel is completely blocked by the balloon 120, eliminating the need to insert an additional angiographic catheter into other locations within the vessel. Furthermore, the perfusion chamber 113 can also be used to perfuse other fluids (such as saline or other medications) for localized treatment of the blood vessel.

[0040] This embodiment is illustrated by taking carotid artery intervention surgery as an example. As shown in FIG2 , the carotid artery reverse flow system for carotid artery intervention 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 that needs 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 flow starts 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 carotid artery is connected through the intracranial circle of Willis. After the balloon sheath 100 occludes the left common carotid artery 01, the left common carotid artery 01 experiences insufficient blood supply. Due to the pressure differential between arterial and venous blood, arterial blood from the right common carotid artery flows back into the left common carotid artery 01 and is re-infused into the human body through the balloon sheath 100, the shunt device 20, and the venous sheath 30. As the stent system 40 enters the left common carotid artery 01 along the balloon sheath 100 and releases the stent, blood clots in the bloodstream flow into the shunt device 20 and are filtered, preventing them from entering cerebral blood vessels.

[0041] In this embodiment, the balloon sheath 100 further includes a first angiographic connector 130 and a second angiographic connector 140; the first angiographic connector 130 is disposed on the proximal side of the sheath body 110 and communicates with the main lumen 111; the second angiographic connector 140 is disposed on the proximal side of the sheath body 110 and communicates with the perfusion lumen 113. During surgery, after the balloon sheath 100 is placed into the left common carotid artery 01, a contrast medium is first injected into the main lumen 111 through the first angiographic connector 130, and the contrast medium diffuses from the distal end of the sheath body 110 along the direction of blood flow into the left common carotid artery 01. The lesion condition 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 medium, thereby adjusting the balloon sheath 100 to a suitable position. Then, a filling medium (such as saline) is injected through the filling chamber 112 to fill the balloon 120. After filling, the balloon 120 occludes 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 lumen 111 of the sheath body 110, and then flows back to the patient's femoral vein 02 through the main lumen 111 and the venous sheath 30 connected to the main lumen 111. Then, contrast fluid is injected into the perfusion chamber through the second contrast connector 140. DSA images can be used to observe 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 has successfully blocked the blood vessel, ensuring that thrombus detached from the carotid artery wall during the operation will not enter the cerebral blood vessels along the carotid artery.

[0042] In this embodiment, as shown in Figures 1 and 4 , the diameter of the first side hole 114 gradually decreases from the inside to the outside along the radial direction of the sheath tube body 110. Because the flow rate of a liquid increases as the flow area decreases under the same pressure, when the developer or other medical liquid enters the blood vessel through the first side hole 114, the flow rate of the developer or other medical liquid increases, and the developer or other medical liquid flows out of the first side hole 114 in a jet-like manner, quickly diffusing within the blood vessel, which helps to reduce the development and observation time.

[0043] In other embodiments, a plurality of first side holes 114 are provided on the side wall of the sheath tube body 110, for example, two or three. As shown in the partial enlarged view of the first side hole in FIG5 , two first side holes 114 are provided on the sheath tube body 110, and the two side holes 114 are arranged along the axial direction of the sheath tube body 110, so as to facilitate the rapid diffusion of the developer or other liquid medicine along the axial direction of the sheath tube body 110.

[0044] In other embodiments, the sidewall of the sheath body is provided with a plurality of perfusion cavities and a plurality of first side holes, each of the perfusion cavities being connected to at least one of the first side holes. The plurality of perfusion cavities are spaced apart along the circumference of the sheath body, and the proximal ends of the plurality of perfusion cavities are connected by a conduit. When a drug or developer is introduced through the conduit, the drug or developer flows along the plurality of perfusion cavities to the plurality of first side holes, thereby enabling the drug or developer to diffuse rapidly along the circumference of the sheath body.

[0045] As shown in Figures 1 and 6, the sheath body comprises an inner layer 116, a support layer 117, and an outer layer 118 arranged radially from the inside out. The support layer 117 includes at least one support rod 1171, which extends helically along the axial direction of the sheath body. In other embodiments, the support rods are braided to form the support layer. The inner layer is formed of a PTFE inner membrane, and the outer layer is made of a PEBAX tube.

[0046] 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, embedding the filling cavity 112 and / or the perfusion cavity 113 in the outer layer 118 can reduce the overall diameter of the sheath body 110, thereby facilitating the passage of the balloon sheath 100 within the blood vessel. In other embodiments, the filling cavity 112 and / or the perfusion cavity 113 are disposed between the inner layer 116 and the support layer 117 or between the support layer 117 and the outer layer 118.

[0047] 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 placed in 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 placed in 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 placed in 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.

[0048] For easier observation, the valve body 130 is positioned near the proximal end of the perfusion lumen 113. When the distal end of the balloon sheath 100 reaches the lesion, the valve body 130 is located outside the patient's body. Furthermore, in this embodiment, the outer layer 118 is made of transparent PEBAX tubing, allowing the operator to observe the valve body 130 within the perfusion lumen 113 through the outer layer. Alternatively, the outer layer 118 includes at least one transparent section made of transparent PEBAX tubing, within which the valve body 130 is positioned.

[0049] Specifically, as shown in Figure 7 , the valve body 130 in this embodiment includes a flow passage 131 and a connecting portion 132. The flow passage 131 is provided with a slit 133. The connecting portion 132 surrounds the flow passage 131 and connects the flow passage 131 to the inner wall of the perfusion chamber 113. The flow passage 131 is thinner than the connecting portion 132. When the flow passage 131 is subjected to blood pressure that exceeds the preset pressure of the valve body 130, the flow passage 131 deforms, causing the slit 133 to open, allowing blood to pass through the valve body 130 via the slit 133.

[0050] When manufacturing the balloon sheath 100 of this embodiment, the outer layer 118 can be directly cut to allow the valve body 130 to be placed into the perfusion cavity 113. After the valve body 130 is fixed to the inner wall of the perfusion cavity 113 using an adhesive or hot melt method, the cut in the outer layer is closed using an adhesive or hot melt method. This method allows the valve body 130 to be accurately placed in the perfusion cavity 113, ensuring that the valve body 130 is located outside the human body after the balloon sheath 100 is inserted into the human body.

[0051] In other embodiments, as shown in FIG8 , the circumferential edge of the valve body 130 includes a connecting segment 134 and a movable segment 135. The connecting segment 134 is fixedly connected to the inner wall of the perfusion chamber 113, and the movable segment 135 is movable relative to the inner wall of the perfusion chamber 113. When the valve body 130 is subjected to blood pressure that is greater than a preset pressure of the valve body 130, the valve body 130 deforms, causing the movable segment 135 to move away from the inner wall of the perfusion chamber 113. Blood then flows through the valve body 130 through the gap between the movable segment 135 and the inner wall of the perfusion chamber 113.

[0052] Example 2

[0053] The main difference between Example 2 and the balloon sheath tube 100 disclosed in Example 1 is that, as shown in FIG10 , the support rod of the balloon sheath tube 200 in Example 2 is a hollow tube, the lumen of which forms at least one of the perfusion cavity 213 or the filling cavity 212. The support rod not only improves the support strength of the balloon sheath tube 200, but also provides the perfusion cavity and / or filling cavity, reducing the space occupied by the perfusion cavity and / or filling cavity on the balloon sheath tube, thereby further reducing the diameter of the balloon sheath tube.

[0054] In this embodiment, the support layer 217 of the balloon sheath 200 includes a first support rod 2171 and a second support rod 2172. The first support rod 2171 and the first support rod 2172 both extend spirally along the axial direction of the balloon sheath 200, and the spiral rings of the first support rod 2171 and the spiral rings 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, since the distal end of the balloon sheath 200 only has the first support rod 2172, it has lower strength and better flexibility, thereby preventing the distal end of the balloon sheath 200 from causing damage to the blood vessel.

[0055] The first support rod 2171 includes a straight section 21711, which is disposed at the proximal end of the balloon sheath 200 and extends axially along the balloon sheath 200. The valve body 230 is disposed within the straight section 21700. The first support rod 2171 is made of a material such as polyethylene (PE) or nylon, and at least a portion of the straight section 21711 is made of a transparent material such as PE or nylon. Preferably, the entire first support rod 2171 is made of a transparent material such as PE or nylon.

[0056] Example 3

[0057] The primary difference between the balloon sheath disclosed in Example 3 and Example 2 is that, as shown in FIG11 , the support layer 317 includes at least one first support rod 3171 and at least one second support rod 3172, which are woven together 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. The second support rod 3172 connects to the balloon of the balloon sheath and is used to inflate the balloon. The first support rod 3171 is used to inject medication or developer into a blood vessel. Because 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 in the side wall of the balloon sheath. The medication or developer flows along the three first support rods 3171 to reach the three first side holes, allowing the medication or developer to diffuse rapidly along the circumference of the sheath body.

[0058] 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. The operator injects the developer or medicine through the second angiography connector.

[0059] Example 4

[0060] The main difference between Example 4 and the balloon sheath 100 disclosed in Example 1 is that, as shown in Figure 12, a plurality of valve bodies 430 are provided in the perfusion cavity 413 of the balloon sheath 400 in Example 4, and the preset pressures of the plurality of valve bodies 430 gradually increase from the distal end to the proximal end of the sheath body 410.

[0061] The multiple valve bodies 430 are all arranged at the proximal end of the balloon sheath 400, and during the operation, the multiple valve bodies 430 are located outside the patient's body and visible through the balloon sheath 400. When the balloon sheath 400 is placed in a blood vessel, the patient's current blood pressure can be monitored in real time by determining 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 caused by stress-induced hypertension, which can easily lead to various complications such as cerebral hemorrhage and heart failure, requiring timely intervention to lower blood pressure; a sudden decrease in the patient's blood pressure may be caused by blood vessel rupture or excessive blood loss, which can easily lead to various complications such as insufficient circulating blood volume and multiple organ dysfunction, requiring timely intervention to increase blood pressure).

[0062] If angiography or thrombolysis is required during the operation, contrast fluid or liquid medicine can be injected into the perfusion chamber 413 at a pressure greater than the current blood pressure, and blood pressure monitoring is temporarily stopped. After the injection is stopped, blood flows back to the perfusion chamber, and the blood pressure monitoring function is restored.

[0063] In this embodiment, the balloon sheath 400 includes three valve bodies 430. The preset pressures of the three valve bodies 430 are 20 mmHg, 40 mmHg, and 60 mmHg, respectively. The three valve bodies 430 are spaced from small to large along the distal end to the proximal end of the balloon sheath 400 according to the preset pressures. The valve bodies 430 are made of rubber or silicone, and their preset pressures are proportional to their thickness. For example, the thickness of a valve body with a preset pressure of 40 mmHg is twice the thickness of a valve body with a preset pressure of 20 mmHg.

[0064] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned 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.

[0065] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended 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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