Sealing device

Abstract

This application relates to the field of medical device technology and provides an occlusion device. The occlusion device includes a catheter body, an occlusion component, and a multidimensional contact guide. When the multidimensional contact guide enters a vascular dissection or a non-target vessel, the sidewall of the multidimensional contact guide of the occlusion device can form an annular contact area or at least two sub-contact areas with the inner wall of the vessel, thereby encountering resistance and preventing the catheter from being further advanced. This avoids vascular damage caused by the occlusion component filling in branches or non-target vessels. The multidimensional contact guide is used to guide the movement of the catheter body and buffer the elastic deformation force of the distal end of the catheter body when the occlusion component is depressurized. The occlusion device provided by this application can guide the occlusion component into the target occlusion area, avoiding entry into vascular dissection or non-target vessels; and buffer the elastic deformation force of the distal end of the catheter body when the occlusion component is depressurized, preventing the distal end of the occlusion device from puncturing the vessel.

Description

[0001] This application claims priority to patent application No. 202211540185.6, filed on November 30, 2022, entitled "Balloon Catheter". Technical Field

[0002] This application belongs to the field of medical device technology, and more specifically, relates to a sealing device. Background Technology

[0003] Unlike limb injuries, which can be controlled with a tourniquet or by applying direct pressure to a selected arterial pressure point, trunk vascular injuries require surgical exposure and are often difficult to control with forceps. Scenarios that can lead to uncompressible trunk vascular injuries, such as placenta previa, ruptured abdominal / thoracic aortic aneurysms, car accidents, and other disasters, often result in massive bleeding, leading to hypotension, cerebral and cardiac ischemia resulting in neurological death, cardiac arrest, or both. The commonly used method for managing uncompressible trunk bleeding is resuscitation thoracotomy. This requires specialized medical personnel, specialized surgical instruments and lighting, a strictly hygienic medical environment, and general anesthesia. In emergency situations and some emergency facilities, these conditions are often unavailable; therefore, timely resuscitation balloon occlusion is crucial. Resuscitation balloon occlusion involves inserting an occlusion device into the aorta and inflating the balloon with saline to prevent blood from flowing to the distal aorta, reducing active bleeding beyond the occlusion site. Simultaneously, it increases cardiac afterload and proximal aortic pressure, improving perfusion to the heart and brain, ensuring adequate blood supply to the patient's heart and brain, preventing excessive blood loss that could lead to shock or death, and buying more time for further treatment.

[0004] However, since resuscitation balloon occlusion is often used in emergency situations with insufficient medical resources, and there is often no imaging equipment available at the operation site, it can only be performed by "blindly pushing". This can easily lead to the catheter being pushed into a non-target branch vessel or vascular dissection, and the non-target vessel being dilated or occluded by a large-diameter balloon, which will bring great risks to the patient.

[0005] Meanwhile, during balloon occlusion surgery, the catheter undergoes elastic deformation due to increased pressure at the distal end of the balloon. When preparing for subsequent procedures and depressurizing the completely occluded balloon, the sudden drop in pressure at the distal end of the balloon due to blood flow to both ends causes the elastically deformed catheter to suddenly rebound distally. Existing occlusion devices cannot effectively buffer this rebound force, potentially damaging blood vessels. Summary of the Invention

[0006] The purpose of this application is to provide a occlusion device that addresses the technical problem that existing occlusion devices in the prior art are prone to damaging blood vessels at the distal end.

[0007] To achieve the above objectives, according to one aspect of this application, an occlusion device is provided, comprising: a catheter body having a first filling / de-pressure channel within it, the first filling / de-pressure channel forming a first filling port at the proximal end of the catheter body; an occlusion component disposed in the middle of the catheter body and communicating with the first filling / de-pressure channel; and a multidimensional contact guide portion disposed at the distal end of the catheter body, the sidewall of the multidimensional contact guide portion being capable of forming an annular contact area or at least two sub-contact areas with the inner wall of the vascular dissection or a non-target vessel, the multidimensional contact guide portion being used to guide the movement of the catheter body and buffer the elastic deformation force at the distal end of the catheter body when the occlusion component depressurizes.

[0008] Optionally, the occlusion device also includes a pressure measuring channel, which is disposed in the catheter body and forms a pressure measuring device connection port at the proximal end of the catheter body, and forms a pressure measuring port at the distal end of the pressure measuring channel at the distal end of the catheter body.

[0009] Optionally, a second inflation / deflation channel is provided in the catheter body, and the second inflation / deflation channel forms a second filling port at the proximal end of the catheter body. The multidimensional contact guide includes: a first tip balloon, the interior of which is connected to the second inflation / deflation channel, and a pressure measuring port is located between the first tip balloon and the occlusion component. When the occlusion component is depressurized, the sidewall of the first tip balloon can form an annular contact area with the inner wall of the blood vessel.

[0010] Optionally, a third inflation / deflation channel is provided in the catheter body, forming a third inflation port at the proximal end of the catheter body. The multidimensional contact guide includes a second tip balloon, the interior of which communicates with the third inflation / deflation channel, and a pressure measuring port is provided on the distal end of the second tip balloon. The pressure measuring channel penetrates the second tip balloon, and when the occlusion component is depressurized, the sidewall of the second tip balloon can form an annular contact area with the inner wall of the blood vessel.

[0011] Optionally, the multidimensional contact guide includes a main body and an elastic guide structure connected to the main body. The first end of the main body is connected to the distal end of the catheter body. The pressure measuring channel passes through the main body and forms a pressure measuring port at the second end of the main body. When the occlusion component is depressurized, the sidewall of the elastic guide structure can form at least two sub-contact areas with the inner wall of the blood vessel.

[0012] Optionally, the elastic guiding structure consists of at least two arc-shaped bodies, the first end of each arc-shaped body being connected to the second end of the main body, and the second ends of each arc-shaped body being spliced ​​together.

[0013] Optionally, the elastic guiding structure consists of at least two arc-shaped bodies, with the first end of each arc-shaped body hinged to the second end of the main body; or, the elastic guiding structure consists of at least two straight bodies, with the first end of each straight body hinged to the second end of the main body.

[0014] Optionally, the elastic guiding structure consists of at least two rings, one end of each ring being connected to the second end of the main body, and the other ends of each ring being connected to each other.

[0015] Optionally, the sealing device also includes an adjustable latch, which is fitted onto the outside of the conduit body.

[0016] Optionally, the multidimensional contact guide is provided with a imaging mark ring, and the surface of the multidimensional contact guide is coated with a lubricating layer; the catheter body is provided with a scale.

[0017] The beneficial effects of the occlusion device provided in this application are as follows: Compared with the prior art, the occlusion device provided in this application, by setting a multi-dimensional contact guide at the distal end of the catheter body, allows the multi-dimensional contact guide to always move along the extension direction of the blood vessel when the occlusion device is inserted into the blood vessel. This allows the catheter body provided in this application to move to the designated position of the blood vessel under the guidance of the multi-dimensional contact guide and block the blood vessel through the occlusion component. At the same time, when the occlusion component is depressurized, the sidewall of the multi-dimensional contact guide can form an annular contact area or at least two sub-contact areas with the inner wall of the vascular dissection or non-target blood vessel. By increasing the dimension of the contact area through the multi-dimensional contact guide, this application can buffer the elastic deformation force of the distal end of the catheter body when the occlusion component is depressurized, and avoid the distal end of the occlusion device from puncturing the blood vessel. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the sealing device provided in the first embodiment of this application;

[0020] Figure 2 This is a schematic diagram of the sealing device provided in the second embodiment of this application;

[0021] Figure 3 This is a schematic diagram of the sealing device provided in the third embodiment of this application;

[0022] Figure 4 This is a schematic diagram of the structure of the multi-dimensional contact guide provided in the fourth embodiment of this application;

[0023] Figure 5 This is a schematic diagram of the structure of the multi-dimensional contact guide provided in the fifth embodiment of this application;

[0024] Figure 6 A schematic diagram of the structure of the occlusion device using a covered capsule provided in this application during the contraction of the covered capsule;

[0025] Figure 7 This is a schematic diagram of the structure of the sealing device using a covered capsule provided in this application after the covered capsule has expanded.

[0026] The details of the reference numerals used in the above figures are as follows:

[0027] 10. Catheter body; 11. First filling / de-pressure channel; 111. First filling port; 12. Second filling / de-pressure channel; 121. Second filling port; 13. Third filling / de-pressure channel; 131. Third filling port; 14. Pressure measuring chamber; 141. Pressure measuring device connection port; 142. Pressure measuring port; 15. Covered bladder indwelling cavity;

[0028] 20. Blocking components;

[0029] 30. Multidimensional contact guide section; 31. First head balloon; 32. Second head balloon; 33. Main body; 34. Elastic guide structure;

[0030] 40. Adjust the latch;

[0031] 50. Covered capsule; 51. Push tube. Detailed Implementation

[0032] To make the technical problems, technical solutions, and beneficial effects to be solved by this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and are not intended to limit the scope of this application.

[0033] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly or indirectly on that other element. When an element is referred to as being "connected to" another element, it can be directly or indirectly connected to that other element. Unless otherwise specified, the embodiments and features described in this application can be combined with each other. This application will now be described in detail with reference to the accompanying drawings and embodiments.

[0034] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0035] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0036] As described in the background section, currently, non-compressible trunk vascular injuries differ from limb injuries, which can be controlled with tourniquets or by maintaining direct pressure at selected arterial pressure points. Trunk vascular injuries, however, require surgical exposure, and bleeding is often difficult to control with forceps. Scenarios that can lead to non-compressible trunk vascular injuries, such as placenta previa, ruptured abdominal / thoracic aortic aneurysms, car accidents, disasters, and other accidents resulting in massive bleeding, typically lead to hypotension, cerebral and cardiac ischemia leading to neurological death, cardiac arrest, or both. Currently, the commonly used method for treating non-compressible trunk bleeding is resuscitation thoracotomy. Resuscitation thoracotomy requires specialized medical personnel, specialized surgical instruments and lighting equipment, a strictly hygienic medical environment, and general anesthesia. These conditions are often unavailable in emergency situations and some emergency settings; therefore, timely resuscitation balloon occlusion is particularly important. Resuscitation balloon occlusion involves inserting an occlusion device into the aorta and inflating the balloon with saline to stop blood flow to the distal aorta, reducing active bleeding distal to the occlusion site. Simultaneously, it increases cardiac afterload and proximal aortic pressure, improving perfusion to the heart and brain, ensuring adequate blood supply to the patient's heart and brain, preventing excessive blood loss that could lead to shock or death, and buying more time for further treatment. However, because resuscitation balloon occlusion is often performed in emergency situations with limited medical resources, and imaging equipment is often unavailable, it can only be performed blindly. This can easily lead to the catheter being pushed into unintended branch vessels or vascular dissections, or unintended vessels being dilated or occluded by the large-diameter balloon, posing significant risks to the patient. Furthermore, during balloon occlusion, the catheter undergoes elastic deformation due to the increased pressure distal to the balloon. When preparing for subsequent surgery, if the balloon that has been completely blocked needs to be depressurized, the flow of blood at both ends of the balloon will cause the pressure at the distal end of the occlusion balloon to drop suddenly. The catheter, which has undergone elastic deformation, will suddenly rebound distally due to the disappearance of distal pressure. However, the distal end of the existing occlusion device cannot effectively buffer the rebound force of the occlusion device, which can easily damage blood vessels.

[0037] See Figures 1 to 5As shown, in order to solve the above problems, according to one aspect of this application, an embodiment of this application provides an occlusion device, which includes: a catheter body 10, an occlusion component 20, and a multidimensional contact guide 30, wherein the catheter body 10 is provided with a first pressure relief channel 11, and the first pressure relief channel 11 forms a first filling port 111 at the proximal end of the catheter body 10; the occlusion component 20 is disposed in the middle of the catheter body 10 and communicates with the first pressure relief channel 11; the multidimensional contact guide 30 is disposed at the distal end of the catheter body 10, and when the catheter body 10 is in a blood vessel, when the occlusion component depressurizes, the sidewall of the multidimensional contact guide 30 can form an annular contact area or at least two sub-contact areas with the inner wall of the vascular dissection or a non-target blood vessel, and the multidimensional contact guide 30 is used to guide the movement of the catheter body 10 and buffer the elastic deformation force of the distal end of the catheter body 10 when the occlusion component 20 depressurizes. The middle part of the catheter body 10 refers to the area between the distal and proximal ends of the catheter body 10. The occlusion device provided in this embodiment provides a multi-dimensional contact guide 30 at the distal end of the catheter body 10. When the occlusion device is inserted into the blood vessel, the sidewall of the multi-dimensional contact guide 30 allows it to move along the extension direction of the blood vessel. This allows the catheter body 10 to move to the designated position on the blood vessel under the guidance of the multi-dimensional contact guide 30 and block the blood vessel through the occlusion component 20. Simultaneously, when the occlusion component depressurizes, the sidewall of the multi-dimensional contact guide can form an annular contact area or at least two sub-contact areas with the inner wall of the vascular dissection or non-target blood vessel. This embodiment increases the dimensionality of the contact area through the multi-dimensional contact guide 30, which can buffer the elastic deformation force of the distal end of the catheter body 10 when the occlusion component 20 depressurizes, preventing the distal end of the occlusion device from puncturing the blood vessel. In a preferred embodiment, a one-way valve is provided on the first filling port 111 provided in this embodiment.

[0038] In a preferred embodiment, the occlusion component 20 provided in this embodiment is a compliant balloon or a semi-compliant balloon.

[0039] In a preferred embodiment, the occlusion device provided in this embodiment further includes an adjustable latch 40, which is sleeved on the outside of the catheter body 10. The adjustable latch 40 is adjustable in tightness. By sleeved on the outside of the catheter body 10, the operator can measure the required length of the occlusion device externally, and then move the adjustable latch 40 to that length position and fix it to the catheter body 10 to mark the length of the occlusion device.

[0040] In a preferred embodiment, the adjustable latch 40 provided in this embodiment is provided with a fixing structure, which can fix the sealing device to a human body or other fixed object.

[0041] In a preferred embodiment, the fixing structure provided in this embodiment is a fixing hole.

[0042] In a preferred embodiment, the occlusion component 20 provided in this embodiment is provided with fluff, and the fluff provided in this embodiment can be coated with a gel for hemostasis. By providing soft, fluffy protrusions on the occlusion component 20, the occlusion component 20 can make buffered contact with the blood vessel, so that the occlusion component 20 can both block blood flow and reduce damage to the vascular endothelium.

[0043] In a preferred embodiment, the multidimensional contact guide 30 provided in this embodiment is provided with a developing mark ring, and the surface of the multidimensional contact guide 30 is coated with a lubricating layer; the catheter body 10 is provided with a scale.

[0044] In one specific embodiment, by providing a first filling channel within the catheter body 10 provided in this embodiment, and forming a first filling port 111 at the proximal end of the first filling channel, while simultaneously connecting the distal end of the first filling cavity with the occlusion component 20 disposed in the middle of the catheter body 10, the occlusion device provided in this embodiment can fill the occlusion component 20 with an expansion medium through the first filling port 111, thereby causing the occlusion component 20 to expand, thus enabling the occlusion component 20 provided in this embodiment to effectively occlude blood vessels.

[0045] In a preferred embodiment, the diameter of the occlusion component 20 after full expansion is greater than or equal to the diameter of the aorta.

[0046] In a preferred embodiment, the maximum diameter of the blocking component 20 provided in this embodiment is 45 mm.

[0047] In a preferred embodiment, the wall of the catheter body 10 provided in this embodiment has strong axial support performance. By setting the wall of the catheter body 10 to have a certain axial support performance, the occlusion device provided in this embodiment can have better pushing performance, and can be pushed without the use of guide wire, making the operation more convenient.

[0048] In a preferred embodiment, the wall of the catheter body 10 provided in this embodiment is a metal wall.

[0049] In a preferred embodiment, the metal pipe wall material provided in this embodiment is a nickel-titanium alloy. Of course, in other embodiments, the metal pipe wall material provided in this embodiment can also be other metal materials with strong axial support performance.

[0050] To prevent the occlusion device provided in this embodiment from entering a non-target branch vessel or vascular dissection for expansion during the resuscitation balloon occlusion procedure, the occlusion device in this embodiment also includes a pressure measuring channel 14. The pressure measuring channel 14 is disposed within the catheter body 10, and a pressure measuring device connection port 141 is formed at the proximal end of the catheter body 10. A pressure measuring port 142 is formed at the distal end of the pressure measuring channel 14 at the distal end of the catheter body 10. By providing a pressure measuring channel 14 within the catheter body 10 in this embodiment, and forming a pressure measuring device connection port 141 at the proximal end of the pressure measuring channel 14 and a pressure measuring port 142 at the distal end of the catheter body 10, the pressure at the pressure measuring port 142 can be detected in real time through a pressure measuring device connected to the pressure measuring device connection port 141. When the distal end of the occlusion device provided in this embodiment enters a non-target branch vessel or vascular dissection, the pressure at the pressure measuring port 142 will change. This allows the operator to determine whether the occlusion device has entered a non-target branch vessel or vascular dissection based on the pressure change at the pressure measuring port 142, and to promptly withdraw the occlusion device and adjust its position when it enters a non-target branch vessel or vascular dissection, so that the occlusion component 20 can be expanded or occluded in the correct blood vessel.

[0051] See Figure 1 As shown, in the first embodiment of this application, a second inflation / deflation channel 12 is provided inside the catheter body 10. The second inflation / deflation channel 12 forms a second filling port 121 at the proximal end of the catheter body 10. The multidimensional contact guide part 30 includes: a first tip balloon 31, the interior of the first tip balloon 31 is connected to the second inflation / deflation channel 12, and a pressure measuring port 142 is provided between the first tip balloon 31 and the occlusion component 20. When the occlusion component is depressurized, the sidewall of the first tip balloon 31 can form an annular contact area with the inner wall of the blood vessel. By providing a second filling cavity within the catheter body 10 that communicates with the interior of the first tip balloon 31, and by forming a second filling port 121 at the proximal end of the catheter body 10, the occlusion device provided in this embodiment can fill the first tip balloon 31 with an expansion medium through the second filling port 121, thereby expanding the first tip balloon 31. This allows the first tip balloon 31 to temporarily occlude the blood vessel after expansion. By placing the pressure measuring port 142 between the first tip balloon 31 and the occlusion component 20, the pressure at the pressure measuring port 142 can be rapidly reduced if the occlusion device provided in this application enters a branch blood vessel or a vascular dissection, thereby alerting the operator that the occlusion device has entered a branch blood vessel or a vascular dissection.

[0052] In a preferred embodiment, the maximum diameter of the first proximal balloon 31 provided in this embodiment is less than or equal to the diameter of the aorta.

[0053] In a preferred embodiment, the minimum diameter of the first proximal balloon 31 provided in this embodiment is greater than or equal to the diameter of the renal artery.

[0054] In a preferred embodiment, the maximum diameter of the first head balloon 31 provided in this embodiment is less than or equal to 8 mm.

[0055] In a preferred embodiment, the maximum diameter of the first head balloon 31 provided in this embodiment is less than or equal to 10 mm.

[0056] In a preferred embodiment, the maximum diameter of the first head balloon 31 provided in this embodiment is less than or equal to 15 mm.

[0057] In a preferred embodiment, the maximum diameter of the first head balloon 31 provided in this embodiment is less than or equal to 18 mm.

[0058] In one specific embodiment, the surface of the first head balloon 31 provided in this embodiment is coated with a lubricating layer.

[0059] In one specific embodiment, a radiopaque ring is provided on the first head balloon 31 provided in this embodiment, and the radiopaque ring can be radiopaque under X-ray irradiation.

[0060] In a preferred embodiment, the first head balloon 31 provided in this embodiment contracts in its natural state and expands after being inflated.

[0061] In a preferred embodiment, a one-way valve is provided on the second filling port 121 provided in this embodiment.

[0062] In a preferred embodiment, the first pressure-releasing channel 11 and the second pressure-releasing channel 12 provided in this embodiment are coaxially arranged. Of course, in other embodiments, the first pressure-releasing channel 11 and the second pressure-releasing channel 12 provided in this embodiment may also be non-coaxially arranged.

[0063] In one specific embodiment, when performing resuscitation aortic balloon occlusion on a patient using the occlusion device provided in this embodiment, the length of the occlusion device required to achieve the target location vascular occlusion is first measured outside the patient using the occlusion device. Then, this location is marked using the adjustable locking buckle 40. Next, a puncture is performed on the patient's femoral artery. After the puncture is completed, the occlusion device provided in this embodiment can be inserted into the patient's blood vessel through the interventional sheath. When the first tip balloon 31 exits from the distal end of the interventional sheath, the first tip balloon 31 can be inflated through the second filling port 121. After the first tip balloon 31 is inflated, the temporary occlusion effect of the first tip elastic balloon and the blood pressure monitoring results from the distal pressure measuring port 142 of the occlusion device can be used to prevent the operator from pushing the catheter into a branch vessel or vascular dissection. After the occlusion device is pushed to the target occlusion position by the guidance of the first tip balloon 31, an expansion medium can be injected into the occlusion component 20 through the first inflation port 111 to expand the occlusion component 20 and monitor blood pressure changes. When the blood pressure reaches the target range, the target blood vessel is occluded, and blood pressure can continue to be monitored through the pressure measuring port 142. After the blood vessel at the target position is occluded, the occlusion device is fixed to the human body or other object by the adjustable locking buckle 40 on the occlusion device to prevent the position of the occlusion device from moving during the process. When it is necessary to depressurize the occlusion component 20, the first tip balloon 31 must first be inflated to avoid damage to the blood vessel caused by the elastic deformation of the catheter. After the occlusion component 20 is depressurized, the first tip balloon 31 can be depressurized, the fixed adjustable locking buckle 40 can be released, the occlusion device can be removed, and the operation is completed.

[0064] See Figure 2As shown, in the second embodiment of this application, a third inflation / deflation channel 13 is provided inside the catheter body 10. The third inflation / deflation channel 13 forms a third filling port 131 at the proximal end of the catheter body 10. The multidimensional contact guide part 30 includes: a second tip balloon 32. The interior of the second tip balloon 32 is connected to the third inflation / deflation channel 13, and a pressure measuring port 142 is provided on the distal end of the second tip balloon 32. The pressure measuring cavity 14 penetrates the second tip balloon 32. When the occlusion component is depressurized, the sidewall of the second tip balloon 32 can form an annular contact area with the inner wall of the blood vessel. By providing a third filling cavity within the catheter body 10 that communicates with the interior of the second tip balloon 32, and by forming a third filling port 131 at the proximal end of the catheter body 10, the occlusion device provided in this embodiment can fill the second tip balloon 32 with an expansion medium through the third filling port 131, thereby expanding the second tip balloon 32. This allows the second tip balloon 32 to temporarily occlude the blood vessel after expansion. By placing the pressure measuring port 142 on the distal end of the second tip balloon 32, the pressure at the pressure measuring port 142 can rapidly increase when the occlusion device provided in this application enters a branch vessel or vascular dissection, thereby alerting the operator that the occlusion device has entered a branch vessel or vascular dissection.

[0065] In a preferred embodiment, the maximum diameter of the first tip balloon 32 provided in this embodiment is less than or equal to the diameter of the aorta.

[0066] In a preferred embodiment, the minimum diameter of the first proximal balloon 32 provided in this embodiment is greater than or equal to the diameter of the renal artery.

[0067] In a preferred embodiment, the maximum diameter of the first head balloon 32 provided in this embodiment is less than or equal to 8 mm.

[0068] In a preferred embodiment, the maximum diameter of the first head balloon 32 provided in this embodiment is less than or equal to 10 mm.

[0069] In a preferred embodiment, the maximum diameter of the first head balloon 32 provided in this embodiment is less than or equal to 15 mm.

[0070] In a preferred embodiment, the maximum diameter of the first head balloon 32 provided in this embodiment is less than or equal to 18 mm.

[0071] In one specific embodiment, the surface of the second head balloon 32 provided in this embodiment is coated with a lubricating layer.

[0072] In one specific embodiment, the second head balloon 32 provided in this embodiment is provided with a radiopaque ring, which can be radiopaque under X-ray irradiation.

[0073] In a preferred embodiment, the second head balloon 32 provided in this embodiment contracts naturally and expands after being inflated.

[0074] In a preferred embodiment, a one-way valve is provided on the third filling port 131 provided in this embodiment.

[0075] In a preferred embodiment, the first pressure-relieving channel 11 and the third pressure-relieving channel 13 provided in this embodiment are coaxially arranged. Of course, in other embodiments, the first pressure-relieving channel 11 and the third pressure-relieving channel 13 provided in this embodiment may also be non-coaxially arranged.

[0076] In one specific embodiment, when performing resuscitation aortic balloon occlusion on a patient using the occlusion device provided in this embodiment, the length of the occlusion device required to achieve the target location vascular occlusion is first measured outside the patient using the occlusion device. Then, this location is marked using the adjustable locking buckle 40. Next, a puncture is performed on the patient's femoral artery. After the puncture is completed, the occlusion device provided in this embodiment can be inserted into the patient's blood vessel through the interventional sheath. When the second tip balloon 32 exits from the distal end of the interventional sheath, the second tip balloon 32 can be inflated through the third filling port 131. After the second tip balloon 32 is inflated, the temporary occlusion effect of the second tip elastic balloon and the blood pressure monitoring results from the distal pressure measuring port 142 of the occlusion device can be used to prevent the operator from pushing the catheter into a branch vessel or vascular dissection. After the occlusion device is pushed to the target occlusion position by the guidance of the second-end balloon 32, an expansion medium can be injected into the occlusion component 20 through the first inflation port 111 to expand the occlusion component 20 and monitor blood pressure changes. When the blood pressure reaches the target range, the target blood vessel is occluded, and blood pressure can continue to be monitored through the pressure measuring port 142. After the blood vessel at the target position is occluded, the occlusion device is fixed to the human body or an object therein using the adjustable locking buckle 40 to prevent the occlusion device from moving during the process. When it is necessary to depressurize the occlusion component 20, the second-end balloon 32 must first be inflated to avoid damage to the blood vessel caused by the elastic deformation of the catheter. After the occlusion component 20 is depressurized, the second-end balloon 32 can be depressurized, the fixed adjustable locking buckle 40 can be released, the occlusion device can be removed, and the operation is completed.

[0077] See Figures 3 to 5As shown, the multidimensional contact guide 30 in this embodiment includes a main body 33 and an elastic guide structure 34 connected to the main body 33. The first end of the main body 33 is connected to the distal end of the catheter body 10. The pressure measuring channel 14 passes through the main body 33 and forms a pressure measuring port 142 at the second end of the main body 33. When the occlusion component is depressurized, the sidewall of the elastic guide structure 34 can form at least two sub-contact areas with the inner wall of the blood vessel. By configuring the multidimensional contact guide 30 provided in this embodiment as a main body 33 and an elastic guide structure 34 connected to the main body 33, the occlusion device provided in this embodiment can guide the catheter body 10 through the elastic guide structure 34 and buffer the elastic deformation force at the distal end of the catheter body 10 when the occlusion component 20 is depressurized. At the same time, by passing through the pressure measuring channel 14 through the main body 33 and forming a pressure measuring port 142 at the second end of the main body 33, the pressure at the pressure measuring port 142 can rapidly increase when it enters a non-target branch blood vessel or vascular dissection. This allows the operator to judge whether the occlusion device has entered a non-target branch blood vessel or vascular dissection based on the pressure change at the pressure measuring port 142, and to promptly withdraw the occlusion device and adjust its position when it enters a non-target branch blood vessel or vascular dissection.

[0078] See Figure 3As shown, in the third embodiment of this application, the elastic guiding structure 34 in this embodiment is composed of at least two arc-shaped bodies, the first end of each arc-shaped body is connected to the second end of the main body 33, and the second ends of each arc-shaped body are spliced ​​together. When performing resuscitation balloon occlusion on a patient using the occlusion device provided in this embodiment, the length of the occlusion device required to achieve the target vascular occlusion is first measured outside the patient's body. Then, this position is marked using the adjustable locking buckle 40. Next, a puncture is performed on the patient's femoral artery. After the puncture is completed, the occlusion device provided in this embodiment can be inserted into the patient's blood vessel through an interventional sheath. During the insertion of the occlusion device into the interventional sheath, the elastic guide structure 34 needs to be compressed first. Then, the compressed elastic guide structure 34 is inserted into the interventional sheath. After the compressed elastic guide structure 34 exits from the distal end of the interventional sheath, it will automatically unfold and abut against the inner wall of the blood vessel. After the occlusion device enters the patient's blood vessel, the blood pressure monitoring results from the unfolded elastic guide structure 34 and the distal pressure measuring port 142 of the occlusion device can be used to prevent the operator from pushing the catheter into a branch vessel or vascular dissection. After the occlusion device is pushed to the target occlusion position by the guidance of the elastic guide structure 34, an expansion medium can be injected into the occlusion component 20 through the first filling port 111 to expand the occlusion component 20 and monitor blood pressure changes. When the blood pressure reaches the target range, the target blood vessel is occluded, and blood pressure can continue to be monitored through the pressure measuring port 142. After the blood vessel at the target position is occluded, the occlusion device is fixed to the human body or objects thereon using the adjustable locking buckle 40 to prevent the occlusion device from moving during the process. When the pressure of the occlusion component 20 is released, the unfolded elastic guide structure 34 can fully abut against the blood vessel wall, which can evenly distribute the force of the elastic deformation of the catheter onto the blood vessel wall, thereby effectively reducing damage to the blood vessel. After the pressure of the occlusion component 20 is released, the fixed adjustable locking buckle 40 can be released, the occlusion device can be removed, and the operation is completed.

[0079] In a preferred embodiment, the maximum radial diameter of the elastic guide structure 34 provided in this embodiment is less than or equal to the artery diameter.

[0080] In a preferred embodiment, the minimum radial diameter of the elastic guiding structure 34 provided in this embodiment is greater than or equal to the diameter of the renal artery.

[0081] In a preferred embodiment, the maximum radial diameter of the elastic guide structure 34 provided in this embodiment is less than or equal to 8 mm.

[0082] In one specific embodiment, the surface of the arc-shaped body provided in this embodiment is coated with a lubricating layer.

[0083] In one specific embodiment, the arc-shaped body provided in this embodiment is equipped with a developing mark ring, which can be developed under X-ray irradiation.

[0084] In a preferred embodiment, the arc-shaped body provided in this embodiment is made of an elastic polymer, which is naturally arc-shaped and can be compressed into a straight line.

[0085] See Figure 4 As shown, in the fourth embodiment of this application, the elastic guiding structure 34 provided in this embodiment consists of at least two arc-shaped bodies, the first end of each arc-shaped body being hinged to the second end of the main body 33; or, the elastic guiding structure 34 consists of at least two straight bodies, the first end of each straight body being hinged to the second end of the main body 33. The working process of performing resuscitation aortic balloon occlusion on a patient using the occlusion device provided in this embodiment is basically the same as the working process of performing resuscitation aortic balloon occlusion on a patient using the occlusion device in the third specific embodiment described above, and will not be described in detail here.

[0086] In one specific embodiment, the arc-shaped body or straight body provided in this embodiment has a fully unfolded unfolded state and a closed state with side-by-side arrangement.

[0087] In a preferred embodiment, when the arc-shaped body or straight body provided in this embodiment is in an unfolded state, the arc-shaped body or straight body provided in this embodiment forms a preset angle with the main body, and the second end of the arc-shaped body or straight body extends in a direction close to the first end of the main body.

[0088] In a preferred embodiment, the unfolding diameter of the elastic guiding structure 34 provided in this embodiment is less than or equal to the artery diameter.

[0089] In a preferred embodiment, the unfolded diameter of the elastic guiding structure 34 provided in this embodiment is greater than or equal to the diameter of the renal artery.

[0090] In a preferred embodiment, the unfolding diameter of the elastic guide structure 34 provided in this embodiment is less than or equal to 8 mm.

[0091] In one specific embodiment, the surface of the arc-shaped or straight body provided in this embodiment is coated with a lubricating layer.

[0092] In one specific embodiment, the arc-shaped or straight body provided in this embodiment is equipped with a developing mark ring, which can be developed under X-ray irradiation.

[0093] In a preferred embodiment, the arc-shaped body provided in this embodiment is made of an elastic polymer, which is naturally arc-shaped and can be compressed into a straight line.

[0094] See Figure 5 As shown in the fifth embodiment of this application, the elastic guiding structure 34 in this embodiment consists of at least two rings, one end of each ring is connected to the second end of the main body 33, and the other ends of each ring are connected to each other. The working process of performing resuscitation aortic balloon occlusion on a patient using the occlusion device provided in this embodiment is basically the same as the working process of performing resuscitation aortic balloon occlusion on a patient using the occlusion device in the third specific embodiment described above, and will not be described in detail here.

[0095] In a preferred embodiment, the maximum radial diameter of the elastic guide structure 34 provided in this embodiment is less than or equal to the artery diameter.

[0096] In a preferred embodiment, the minimum radial diameter of the elastic guiding structure 34 provided in this embodiment is greater than or equal to the diameter of the renal artery.

[0097] In a preferred embodiment, the maximum radial diameter of the elastic guide structure 34 provided in this embodiment is less than or equal to 8 mm.

[0098] In one specific embodiment, the surface of the ring provided in this embodiment is coated with a lubricating layer.

[0099] In one specific embodiment, the ring provided in this embodiment is equipped with a developing mark ring, which can be developed under X-ray irradiation.

[0100] In a preferred embodiment, the ring provided in this embodiment is made of an elastic polymer, which is naturally arc-shaped and can be compressed into a straight line.

[0101] The aforementioned lubricating layer can be a compliant hydrophilic coating; including a smooth topcoat or a combination of a smooth topcoat and a basecoat. The smooth topcoat can include a biocompatible hydrophilic polymer, such as sodium hyaluronate and at least one polymer of aziridine, polyvinylpyrrolidone, polyethylene oxide, polypropylene oxide, polyacrylamide, a soft polyurethane with a hardness less than 80A, methylcellulose, polyacrylic acid, and polyvinyl alcohol. In some examples, the topcoat can include at least one of polyvinyl methyl ether, maleic anhydride, low-hardness polyether block amides, or a 2:1 copolymer thereof or a copolymer solvent system co-dissolved in suitable other proportions, such as acetone / tetrahydrofuran (THF) or dimethylacetamide (DMA), used alone or mixed with ketones or aromatic solvents. The smooth topcoat can include a composition formed by drying and / or curing a composition comprising sodium hyaluronate, aziridine, and a surfactant. The base coating comprises one or more ethyl acrylates, PEO, N-vinylpyrrolidone, hydroxyethyl methacrylate, hexamethylene diisocyanate, hydrophilic polyether aliphatic polyurethanes, which are dried, cured, or crosslinked; the base coating also comprises at least one of polyethylene oxide (PEO) or N-vinylpyrrolidone.

[0102] In the above embodiments, the occlusion component can be a balloon or a covered capsule. The shape can be spherical, ellipsoidal, conical, cylindrical, teardrop-shaped, gourd-shaped, or any other shape that can occlude blood vessels; the shape is not unique.

[0103] See Figure 6 and Figure 7 As shown, in the embodiment of the covered capsule 50, the catheter body 10 is provided with a covered capsule indwelling cavity 15: before being pushed out, the covered capsule 50 is in a contracted state in the covered capsule indwelling cavity 15. After being pushed out from the covered capsule indwelling cavity 15 by the push tube 51 (rod), it will expand into a capsule.

[0104] In summary, the occlusion device provided in this embodiment has at least the following beneficial technical effects: The occlusion device provided in this application provides a multi-dimensional contact guide at the distal end of the catheter body. When the occlusion device is inserted into a blood vessel, the multi-dimensional contact guide can always move along the extension direction of the blood vessel, thereby allowing the catheter body provided in this application to move to the designated position of the blood vessel under the guidance of the multi-dimensional contact guide and block the blood vessel through the occlusion component. At the same time, when the occlusion component is depressurized, the sidewall of the multi-dimensional contact guide can form an annular contact area or at least two sub-contact areas with the inner wall of the blood vessel. The multi-dimensional contact guide provided in this application increases the dimension of the contact area, which can buffer the elastic deformation force of the distal end of the catheter body when the occlusion component is depressurized, and avoid the distal end of the occlusion device from puncturing the blood vessel.

[0105] The above are merely preferred embodiments of this application and are not intended to limit this application. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An occlusion device, comprising: The occlusion device comprises: a catheter body (10) provided with a first pressure filling and releasing channel (11) in the catheter body (10), the first pressure filling and releasing channel (11) forming a first filling port (111) at the proximal end of the catheter body (10); an occlusion component (20) provided in the middle of the catheter body (10) and in communication with the first pressure filling and releasing channel (11); a multi-dimensional contact guide (30) provided at the distal end of the catheter body (10), the side wall of the multi-dimensional contact guide (30) being capable of forming an annular contact area or at least two sub-contact areas with the inner wall of the blood vessel dissection or the non-target blood vessel, the multi-dimensional contact guide (30) being used to guide the movement of the catheter body (10) and buffer the elastic deformation force at the distal end of the catheter body (10) when the occlusion component (20) releases pressure; the occlusion device further comprises a pressure measuring cavity (14) provided in the catheter body (10) and forming a pressure measuring device connecting port (141) at the proximal end of the catheter body (10), the distal end of the pressure measuring cavity (14) forming a pressure measuring port (142) at the distal end of the catheter body (10); the catheter body (10) is provided with a second pressure filling and releasing channel (12), the second pressure filling and releasing channel (12) forming a second filling port (121) at the proximal end of the catheter body (10), and the multi-dimensional contact guide (30) comprises: a first head-end balloon (31) in communication with the second pressure filling and releasing channel (12) inside, and the pressure measuring port (142) is provided between the first head-end balloon (31) and the occlusion component (20), and the side wall of the first head-end balloon (31) is capable of forming the annular contact area with the inner wall of the blood vessel when the occlusion component releases pressure.

2. An occlusion device, comprising: The occlusion device comprises a catheter body (10), a first pressure filling and releasing channel (11) is arranged in the catheter body (10), the first pressure filling and releasing channel (11) forms a first filling port (111) at the proximal end of the catheter body (10); an occlusion component (20) is arranged in the middle of the catheter body (10) and communicates with the first pressure filling and releasing channel (11); a multi-dimensional contact guide (30) is arranged at the distal end of the catheter body (10), the side wall of the multi-dimensional contact guide (30) can form an annular contact area or at least two sub-contact areas with the inner wall of the blood vessel dissection or the non-target blood vessel, the multi-dimensional contact guide (30) is used for guiding the movement of the catheter body (10) and buffering the elastic deformation force at the distal end of the catheter body (10) when the occlusion component (20) releases pressure; the occlusion device further comprises a pressure measuring cavity (14), the pressure measuring cavity (14) is arranged in the catheter body (10) and forms a pressure measuring device connecting port (141) at the proximal end of the catheter body (10), the distal end of the pressure measuring cavity (14) forms a pressure measuring port (142) at the distal end of the catheter body (10); a third pressure filling and releasing channel (13) is arranged in the catheter body (10), the third pressure filling and releasing channel (13) forms a third filling port (131) at the proximal end of the catheter body (10), the multi-dimensional contact guide (30) comprises: A second head-end balloon (32), the inside of the second head-end balloon (32) communicates with the third pressure filling and releasing channel (13), and the distal end of the second head-end balloon (32) is provided with the pressure measuring port (142), the pressure measuring cavity (14) penetrates through the second head-end balloon (32), and the side wall of the second head-end balloon (32) can form the annular contact area with the inner wall of the blood vessel when the occlusion component releases pressure.

3. An occlusion device, comprising: The occlusion device comprises a catheter body (10), a first pressure charging and discharging channel (11) arranged in the catheter body (10), a first charging port (111) formed at a proximal end of the catheter body (10), an occlusion component (20) arranged in a middle part of the catheter body (10) and communicated with the first pressure charging and discharging channel (11), a multi-dimensional contact guide (30) arranged at a distal end of the catheter body (10), a side wall of the multi-dimensional contact guide (30) capable of forming an annular contact area or at least two sub-contact areas with an inner wall of a blood vessel dissection or a non-target blood vessel, the multi-dimensional contact guide (30) used for guiding movement of the catheter body (10) and buffering an elastic deformation force at the distal end of the catheter body (10) when the occlusion component (20) discharges pressure, the occlusion device further comprises a pressure measuring cavity (14) arranged in the catheter body (10) and forming a pressure measuring device connecting port (141) at the proximal end of the catheter body (10), a distal end of the pressure measuring cavity (14) forming a pressure measuring port (142) at the distal end of the catheter body (10), the multi-dimensional contact guide (30) comprising a main body (33) and an elastic guide structure (34) connected with the main body (33), a first end of the main body (33) connected with the distal end of the catheter body (10), the pressure measuring cavity (14) penetrating through the main body (33) and forming the pressure measuring port (142) at a second end of the main body (33), a side wall of the elastic guide structure (34) capable of forming at least two sub-contact areas with the inner wall of the blood vessel when the occlusion component discharges pressure.

4. The occlusion device of claim 3, wherein, The elastic guide structure (34) is composed of at least two arc-shaped bodies, a first end of each of the arc-shaped bodies is connected with the second end of the main body (33), and second ends of the arc-shaped bodies are spliced together.

5. The occlusive device of claim 3, wherein, The elastic guide structure (34) is composed of at least two arc-shaped bodies, a first end of each of the arc-shaped bodies is connected with the second end of the main body (33), and second ends of the arc-shaped bodies are spliced together. The elastic guide structure (34) is composed of at least two straight bodies, a first end of each of the straight bodies is connected with the second end of the main body (33).

6. The occlusive device of claim 3, wherein, The elastic guide structure (34) is composed of at least two circular rings, one end of each of the circular rings is connected with the second end of the main body (33), and the other end of each of the circular rings is connected with each other.

7. The occlusion device of any of claims 1-6, wherein, The occlusion device further comprises an adjustable lock buckle (40) sleeved on an outer part of the catheter body (10).

8. The occlusion device of any of claims 1-6, wherein, The multi-dimensional contact guide (30) is provided with a developing mark ring, a surface of the multi-dimensional contact guide (30) is coated with a lubricating layer, and the catheter body (10) is provided with a scale.

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