Thrombus aspiration plugging sheath system based on special-shaped cavity

Abstract

The utility model discloses a thrombus aspiration plugging sheath system based on a special-shaped cavity, which comprises a vacuum device, an aspiration plugging sheath, an aspiration plugging sheath and an aspiration plugging sheath, and is characterized in that the vacuum device comprises a negative pressure needle cylinder and a piston buckle arranged on the side wall of the negative pressure needle cylinder; the balloon sheath tube comprises a tube body, a balloon used for blocking is arranged at the far end of the tube body, a connector connected with the vacuum device is arranged on the side of the near end of the tube body in a supporting mode, and a plurality of special-shaped cavities are formed in the tube body; the thrombus dragging instrument is used for blocking blood flow to reduce blood loss during thrombus suction and intercepting the thrombus to prevent the thrombus from escaping when the thrombus is dragged; the vacuum device is arranged on the side branch of the near end of the balloon sheath tube, and the thrombus dragging instrument is arranged in the balloon sheath tube. According to the embodiment of the utility model, the balloon filling opening and the thrombus suction opening are formed in the catheter body, a multi-cavity structure is adopted, the balloon sheathing canal blocks blood flow, and the thrombus dragging instrument is matched with a vacuum device to suck, drag and take out thrombus.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a thrombus aspiration and occlusion sheath system based on an irregularly shaped cavity. Background Technology

[0002] Balloon sheaths are primarily used for the efficient removal of thrombi in arteries or veins. While various methods exist for removing thrombi in blood vessels, they all have significant drawbacks. For example, traditional open-cut thrombectomy is too invasive. Aspiration using large-lumen catheters results in excessive blood loss. Using baskets or balloons for thrombectomy allows the thrombus to escape, or even be flushed away by the blood, causing potentially fatal ectopic vascular embolism. While complex electric or pneumatic instruments improve efficiency, they also result in substantial blood loss and are expensive and complex to operate, hindering widespread adoption. Therefore, currently, there is no thrombectomy device that is inexpensive, highly efficient, minimizes blood loss, is easy to operate, and can be widely used in clinical practice. Utility Model Content

[0003] To overcome the shortcomings of the prior art, this invention provides a thrombus aspiration and occlusion sheath system with an irregular cavity. The advantages of this invention compared to the prior art are: after entering the thrombus area, the device can inflate a balloon to block blood flow and reduce blood loss; while the basket or thrombectomy balloon pulls the thrombus into the sheath, it intercepts the thrombus to prevent escape; simultaneously, negative pressure aspiration and dragging are performed, thereby efficiently removing the thrombus.

[0004] A thrombus aspiration and occlusion sheath system with an irregular cavity includes:

[0005] A vacuum device, comprising a large-nipple negative pressure syringe and a piston buckle disposed on the side wall of the negative pressure syringe; a balloon sheath, comprising a tube body, the distal end of the tube body being provided with a balloon for occlusion, the proximal end of the tube body being provided with a base for connecting instruments, the proximal end of the tube body being provided with an interface for connecting the vacuum device, and the tube body being provided with multiple irregularly shaped cavities;

[0006] A thrombus dragging device is used to block blood flow to reduce blood loss during thrombus aspiration and to intercept thrombus during thrombus pulling to prevent thrombus escape; the vacuum device is located in the proximal side branch of the balloon sheath, and the balloon catheter is located inside the balloon sheath.

[0007] In some embodiments, the balloon body is an compliant balloon.

[0008] In some embodiments, the tube body includes a balloon cavity and a working cavity, the balloon cavity being connected to the balloon, and the working cavity being connected to the distal suction port of the balloon sheath.

[0009] In some embodiments, the diameter of the working cavity is larger than the diameter of the balloon cavity.

[0010] In some embodiments, the cross-section of the working cavity is configured to be irregular.

[0011] In some embodiments, the base adopts one or more combinations of a detachable hemostatic valve structure, a Y-shaped connector structure, a hemostatic valve structure, and a Luer connector structure.

[0012] In some embodiments, the sheath tip is provided with an X-ray imaging ring.

[0013] In some embodiments, the thrombus dragging device is one or more combinations of balloon catheters, baskets, and stents.

[0014] In some embodiments, the outer diameter of the balloon sheath is 4-16F.

[0015] In some embodiments, the length of the balloon sheath ranges from 60 to 125 cm. Attached Figure Description

[0016] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings.

[0017] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with or without letter suffixes may indicate different instances of similar parts. The drawings generally illustrate various embodiments by way of example rather than limitation and are used, together with the description and claims, to illustrate the disclosed embodiments. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method. The accompanying drawings, which are provided to further understand the present invention and form part of this application, illustrate embodiments of the present invention and, together with their description, serve to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0018] Figure 1 This is a schematic diagram of the procedure involving balloon catheter thrombectomy;

[0019] Figure 2 This is a schematic diagram of the balloon sheath system according to an embodiment of the present invention;

[0020] Figure 3 This is a cross-sectional schematic diagram of the tube body of the balloon sheath according to an embodiment of the present invention;

[0021] Figure 4This is a cross-sectional schematic diagram of the tube body of the balloon sheath according to an embodiment of the present invention;

[0022] Figure 5 This is a schematic diagram of the irregular cross-section of the balloon sheath in an embodiment of this utility model;

[0023] The above figures include the following reference numerals:

[0024] 10-Vacuum device; 101-Negative pressure syringe; 102-Piston buckle; 20-Balloon sheath; 201-Tube body; 202-Balloon; 203-Base; 204-Aspiration port; 205-Balloon cavity; 206-Working chamber; 207-Balloon inflation port; 208-Aspiration port; 209-Polymer outer layer; 210-Metal reinforcing layer; 211-Polymer inner layer; 212-Contrast ring; 30-Thrombus dragging device; 40-

[0025] Sheath balloon syringe; 50-thrombectomy balloon syringe. Detailed Implementation

[0026] The specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings, but these are not intended to limit the scope of the present invention.

[0027] It should be understood that various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be considered as limiting, but merely as an example of embodiments. Other modifications within the scope and spirit of this invention will be apparent to those skilled in the art.

[0028] The accompanying drawings, which are included in and form part of this specification, illustrate embodiments of the present invention and, together with the general description of the present invention given above and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

[0029] These and other features of the present invention will become apparent from the following description of preferred forms of embodiments given as non-limiting examples, with reference to the accompanying drawings.

[0030] It should also be understood that although the present invention has been described with reference to some specific examples, those skilled in the art can certainly implement many other equivalent forms of the present invention, which have the features described in the claims and are therefore all within the scope of protection defined herein.

[0031] The above and other aspects, features and advantages of the present invention will become more apparent when taken in conjunction with the accompanying drawings and in view of the following detailed description.

[0032] Specific embodiments of the present invention will now be described with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely examples of the present invention, which may be implemented in various ways. Well-known and / or repeated functions and structures are not described in detail to avoid unnecessary or redundant details that could obscure the present invention. Therefore, the specific structural and functional details disclosed herein are not intended to be limiting, but merely to serve as the basis and representative basis for the claims to teach those skilled in the art to use the present invention in a variety of substantially any suitable detailed structures.

[0033] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this utility model are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the utility model described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0034] This specification may use the phrases “in one embodiment,” “in another embodiment,” “in yet another embodiment,” or “in other embodiments,” all of which may refer to one or more of the same or different embodiments according to the present invention.

[0035] like Figure 1 The embodiment of this utility model provides a suction-blocking sheath system with an irregular cavity. The balloon sheath 20 is brought close to the thrombus. The balloon inflator 40 inflates the balloon 202 through the balloon inflation port 207 to block blood flow. The thrombus dragging device 30 passes through the thrombus, and the balloon 202 on the balloon sheath 20 is inflated using the thrombectomy balloon syringe 50, confining the thrombus between the balloon 202 and the thrombus dragging device 30. The vacuum device 10 applies negative pressure and pulls the thrombus dragging device 30 outward. Under the dragging, squeezing, and negative pressure suction, the thrombus enters the sheath and is sucked out. This achieves complete removal of the thrombus. Figure 2-4 As shown, the suction and sealing sheath system involved in this embodiment includes a vacuum device 10, which includes a negative pressure syringe 101 and a piston buckle 102 disposed on the side wall of the negative pressure syringe 101.

[0036] The balloon sheath 20 includes a tube body 201, a balloon 202 for occlusion at the distal end of the tube body 201, a base 203 for connecting instruments at the proximal end of the tube body 201, and a suction port 208 for connecting the vacuum device 10 at the proximal side of the tube body 201. The tube body 201 contains multiple cavities. A thrombus dragging device 30 is used to occlude blood flow and pull thrombi.

[0037] The vacuum device 10 is located on the proximal side branch of the balloon sheath 20, and the thrombus dragging device 30 is located inside the balloon sheath 20 to perform its function.

[0038] Furthermore, a suction port 204 is provided at the distal end of the tube body 201. The suction port 204 is used for thrombus aspiration to achieve the function of thrombus removal. The balloon 202 is located on one side of the suction port 204. That is, the position of the suction port 204 is closer to the head end of the tube body 201 than the position of the balloon 202. This makes it easier to prevent blood from being aspirated by the suction port after the blood vessel is blocked by the balloon 202, and to aspirate and pull out the thrombus through the suction port 204.

[0039] Furthermore, the tube body 201 has a multi-cavity structure. For example, the tube body 201 is configured as a dual-cavity structure. Specifically, a balloon cavity 205 and a working cavity 206 are provided within the tube body 201. The balloon cavity 205 is used to provide liquid or gas for inflating the balloon 202 and is connected to the balloon 202. The working cavity 206 is used for aspirating thrombi and their thrombectomy basket or thrombectomy balloon working channel. It is connected to the thrombectomy port 204, where the thrombus is aspirated through the thrombectomy port 204 and discharged through the working cavity 206. The working cavity 206 can also be used to deliver guidewires for guiding the tube body 201 and deliver related instruments. The balloon cavity 205 and the working cavity 206 are integrated within the tube body 201. To ensure the strength of each cavity, a high-temperature resistant polymer material can be applied to the inner wall of each cavity in the balloon cavity 205 and the working cavity 206 to ensure that each cavity does not deform.

[0040] Furthermore, in order to achieve the corresponding functions, the balloon cavity 205 extends from the base 203 of the tube 201 to the balloon 202.

[0041] In a specific implementation, the balloon sheath in this embodiment has an outer diameter of 4-16F and an effective length of 60-125cm. The balloon sheath is typically used with a compliant balloon catheter of 3-8F size. The working lumen should be as large as possible to ensure the aspiration of large thrombi. The working lumen 206 is used to deliver the thrombectomy balloon catheter, and the commonly used thrombectomy balloon catheter has an outer diameter of 3-8F.

[0042] In addition, an X-ray imaging ring is provided on the tip of the balloon sheath 20, which is used to display the position of the tip of the tube 201 and the balloon 202.

[0043] In addition, the thrombus dragging device 30 is a combination of one or more of the following: balloon catheter, basket, and stent.

[0044] In addition, the balloon body 202 is a compliant balloon made of rubber. After being filled with fluid, it has a specified maximum expansion volume. Under internal pressure of a certain intensity or above, it conforms to the shape and size of the target blood vessel lumen. The balloon has good wall adhesion and is soft and does not damage the blood vessel.

[0045] In addition, the outer tube is made of polymer materials, which have various hardness levels. Commonly used polymer materials are Pebax series from Arkema, and the middle layer is made of braided mesh, thiourea tube, and various combinations thereof.

[0046] Furthermore, the inner tube is made of PTFE material. The inner tube serves as a channel for thrombus aspiration and instrument delivery. The use of PTFE material can reduce the friction coefficient of the inner wall of the sheath and increase the smoothness of the inner lumen during sheath use.

[0047] Furthermore, the vacuum device 10 can also be a vacuum pump.

[0048] Furthermore, the cross-sections of the balloon cavity 205 and the working cavity 206 are configured as irregular shapes.

[0049] In other embodiments, the vacuum device push rod can be connected to a cylinder, an electric vacuum pump, etc., to increase its suction force and negative pressure accuracy.

[0050] like Figure 5 As shown, in other embodiments, the cross-sections of the working cavity 206 and the balloon cavity 205 can also be configured as other irregular shapes.

[0051] The above embodiments are only for illustrating the technical concept and features of this utility model. Their purpose is to enable those skilled in the art to understand the content of this utility model and implement it. They should not be used to limit the protection scope of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be covered within the protection scope of this utility model.

Claims

1. A thrombus aspiration and occlusion sheath system based on an irregularly shaped cavity, characterized in that... Includes: a vacuum device, the vacuum device comprising a negative pressure syringe and a piston buckle disposed on the side wall of the negative pressure syringe; A balloon sheath, comprising a tube body, a balloon for occlusion at the distal end of the tube body, a base for connecting devices at the proximal end of the tube body, and a suction port for connecting to the vacuum device at the proximal end of the tube body, and multiple cavities within the tube body; a thrombus dragging device, used to occlude blood flow and pull thrombi. The vacuum device is located in the proximal side branch of the balloon sheath, and the thrombus drag The pulling device is installed inside the balloon sheath to operate; A suction port is provided at the distal end of the tube body. The suction port is used for thrombus aspiration to achieve the function of thrombus removal. The balloon is located on one side of the suction port. The position of the suction port is closer to the head end of the tube body than the position of the balloon. This makes it easier to prevent blood from being drawn out by the suction port after the blood vessel is blocked by the balloon. The thrombus is then aspirated and pulled out through the suction port. The tubing has a dual-lumen structure, comprising a balloon cavity and a working cavity. The balloon cavity, connected to the balloon, provides liquid or gas for inflation. The working cavity, connected to the balloon, is used for aspirating thrombi and their thrombectomy basket or working channel of the thrombectomy balloon. The thrombus is aspirated through the aspiration port and discharged through the working cavity. The working cavity can also be used to deliver guidewires for guiding the tubing and related instruments. The balloon cavity and the working cavity are integrated within the tubing to ensure the strength of each cavity. A high-temperature resistant polymer material is applied to the inner wall of each cavity to prevent deformation. The balloon cavity extends from the base of the tube to the location of the balloon; The outer diameter of the balloon sheath is 4-16F, and the effective length is 60-125cm. The balloon sheath is used with a compliant balloon catheter of 3-8F to ensure the aspiration of large thrombi. The working chamber is used to deliver the thrombectomy balloon catheter. The outer diameter of the commonly used thrombectomy balloon catheter is 3-8F. An X-ray imaging ring is provided on the tip of the balloon sheath, which is used to display the position of the tip of the sheath and the balloon. The thrombus dragging device is one or more combined structures of balloon catheter, basket and stent; The balloon body is a compliant balloon made of rubber, which has a good wall-fitting shape and is soft and does not damage blood vessels; The outer tube is made of polymer material. The inner tube is made of PTFE material and serves as the delivery channel for thrombus aspiration and instruments. The use of PTFE material can reduce the friction coefficient of the inner wall of the sheath and increase the smoothness of the inner lumen during sheath use. The cross-sections of the balloon cavity and the working cavity are set to irregular shapes; The vacuum device push rod can be connected to a cylinder or an electric vacuum pump to increase its suction force and negative pressure accuracy.

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