Interventional device and percutaneous heart pump system
By using a flexible sheath over the guidewire and a detachable interventional device, the problems of cumbersome guidewire pushing and high material consumption are solved, achieving efficient and low-cost interventional procedures.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-03-20
- Publication Date
- 2026-04-03
AI Technical Summary
In existing technologies, pushing the interventional guidewire into the human body is a cumbersome operation that requires a lot of materials and is difficult to efficiently pass through the heart valve.
An interventional device is used, including an interventional guidewire and a flexible sheath. The flexible sheath is placed on the outside of the interventional guidewire, and a detachable connection is achieved using connectors. After the flexible sheath is in the target position, it separates from the interventional guidewire, leaving only the guidewire in the body.
It simplifies the guidewire insertion process, reduces consumable usage, improves operational efficiency and safety, and lowers costs.
Smart Images
Figure CN224070965U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to interventional devices and percutaneous heart pump systems. Background Technology
[0002] In the medical field, interventional medical devices, such as blood pumps, are frequently used to treat patients. Taking a blood pump as an example, during intervention, a guidewire is typically inserted into the body first, and then the blood pump is threaded onto the guidewire, allowing it to be pushed along the guidewire into the body. However, current techniques often require multiple auxiliary tools to complete the insertion of the guidewire, resulting in a cumbersome, inefficient, and resource-intensive process. Utility Model Content
[0003] Therefore, it is necessary to provide an interventional device and a percutaneous heart pump system to address the aforementioned technical problems.
[0004] This application provides an interventional device for percutaneous insertion into a blood vessel. The interventional device includes an interventional guidewire and a flexible sheath. The interventional guidewire has a first end and a second end, the first end being the distal end of the interventional guidewire and the second end being the proximal end of the interventional guidewire. The flexible sheath is sleeved on the outside of the interventional guidewire, and the distal end of the flexible sheath is detachably connected to the first end of the interventional guidewire, so that after the interventional device is pushed to the target location in the body, the flexible sheath can be detached from the interventional guidewire to withdraw the flexible sheath.
[0005] In one embodiment, the interventional device further includes a connector fixed to a first end of the interventional guidewire, and the distal end of the flexible sheath is detachably connected to the connector.
[0006] In one embodiment, the interventional device further includes at least one of the following features:
[0007] The connector is made of metal.
[0008] The connector is bonded to the distal end of the flexible sheath with water-soluble adhesive.
[0009] The connector is looped around the outer circumferential surface of the interventional guidewire;
[0010] The hardness of the distal end of the connector is greater than the hardness of the proximal end of the connector.
[0011] The connector has an annular slot at its proximal end, and the flexible sheath is fitted into the annular slot at its distal end.
[0012] In one embodiment, the connector includes a proximal segment and a distal segment located distal to the proximal segment, the distal end of the flexible sheath being looped around the outer peripheral surface of the proximal segment; wherein the distal segment has a first outer diameter in the radial direction of the interventional guidewire, the first outer diameter gradually decreasing in the direction from the second end to the first end; and / or, the proximal segment has a second outer diameter in the radial direction of the interventional guidewire, the second outer diameter gradually decreasing in the direction from the first end to the second end.
[0013] In one embodiment, the connector further includes an intermediate section connecting the proximal segment and the distal segment; the intermediate section is cylindrical; the intermediate section has a third outer diameter equal to the maximum outer diameter of the distal segment or the proximal segment.
[0014] In one embodiment, the connector also has one of the following features:
[0015] A first rounded edge is provided at the connection between the proximal segment and the intermediate segment;
[0016] A second rounding is provided at the connection between the distal segment and the middle segment;
[0017] The distal end face of the distal segment is configured as an arc-shaped surface;
[0018] The outer diameter of the flexible sheath is the same as the third outer diameter of the intermediate section, so that the outer peripheral surface of the flexible sheath and the outer peripheral surface of the intermediate section are smoothly connected.
[0019] In one embodiment, the connector is configured as any one of a spindle shape, an ellipse shape, or a cylinder shape; and / or, the connector has a maximum outer diameter in the radial direction of the interventional guidewire and an axial length extending in the axial direction of the interventional guidewire, the axial length being greater than the maximum outer diameter.
[0020] In one embodiment, the interventional device further has at least one of the following features:
[0021] The flexible sheath includes PI material;
[0022] The outer diameter of the flexible sheath is 0.03mm~0.04mm;
[0023] The diameter of the interventional guidewire is 0.015mm~0.02mm;
[0024] The ratio of the diameter of the interventional guidewire to the outer diameter of the flexible sheath is 0.3 to 0.5.
[0025] In one embodiment, the first end of the interventional guidewire includes a connected mounting portion and a positioning portion, the mounting portion being connectable to the flexible sheath; the positioning portion is located distal to the mounting portion and has a J-shape or pigtail shape.
[0026] This application also provides a transcutaneous cardiac pump system, the transcutaneous cardiac pump system comprising:
[0027] Blood pump, the blood pump having a distal opening and a proximal opening; and
[0028] As described in any of the above interventional devices, after the interventional guidewire of the interventional device is separated from the flexible sheath, the blood pump can be inserted onto the interventional guidewire.
[0029] In the aforementioned interventional device and percutaneous cardiac pump system, the interventional device can use a smaller diameter guidewire as its core. By nesting a flexible sheath around the guidewire, the overall rigidity of the interventional device can be increased to a certain extent, allowing the device to carry the guidewire into the body and cross cardiac valves (such as the aortic, tricuspid, or pulmonary valves). Furthermore, the flexible sheath is detachably connected to the guidewire, so that after the interventional device reaches the target location within the body, the flexible sheath can be detached from the guidewire, allowing it to be withdrawn independently while the guidewire remains inside to supply the blood pump. Therefore, the interventional device of this application can directly push the guidewire to the target location within the body without the need for a pre-insertion of a larger guidewire, thus reducing not only the number of steps involved in inserting the guidewire but also the amount of consumables used. Attached Figure Description
[0030] Figure 1 This is a schematic diagram of the existing procedure for pushing an interventional guidewire into the human body.
[0031] Figure 2 This is a schematic diagram of the intervention device according to an embodiment of this application.
[0032] Figure 3 for Figure 2 A partial enlarged view of part A of the interventional device.
[0033] Figure 4 This is a schematic diagram illustrating the usage process of the intervention device according to an embodiment of this application.
[0034] Figure 5 for Figure 2 A schematic diagram of the middle connector.
[0035] Figure 6 This is a schematic diagram of the structure of a connector according to another embodiment of this application.
[0036] Figure 7 This is a schematic diagram of the structure of a connector according to another embodiment of this application.
[0037] Figure 8 This is a schematic diagram of the structure of a connector according to another embodiment of this application.
[0038] Figure 9 This is a schematic diagram of the structure of a connector according to another embodiment of this application.
[0039] Icon labels:
[0040] 101. Thick guidewire; 102. Hollow tube; 103. Thin guidewire; 10. Interventional device; 100. Interventional guidewire; 110. First end; 111. Installation part; 112. Positioning part; 120. Second end; 200. Connector; 210. Proximal segment; 220. Distal segment; 221. Arc-shaped surface; 230. Intermediate segment; 201. Annular groove; 300. Flexible sheath; 310. Distal end; 311. Connecting surface; 320. Proximal end; 20. Heart; 21. Aortic valve; 22. Aorta. Detailed Implementation
[0041] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.
[0042] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and 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, and therefore should not be construed as a limitation of this application.
[0043] Furthermore, where the terms "first" and "second" appear, these terms are 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 with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.
[0044] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.
[0045] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.
[0046] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.
[0047] In the medical field, interventional medical devices, such as blood pumps, are frequently used for treatment. Before inserting the blood pump, an interventional guidewire needs to be advanced to the target location within the body. The blood pump is then threaded onto the guidewire, allowing it to be pushed along the guidewire to the target location. Therefore, because the blood pump must be threaded onto the guidewire (i.e., the guidewire must pass through the inside of the blood pump), the guidewire is typically a small-diameter, thin wire. However, this small-diameter guidewire is very soft and easily obstructed by internal tissues after insertion, making it difficult for the guidewire to cross heart valves, such as the aortic, tricuspid, or pulmonary valves.
[0048] See Figure 1 In some existing technologies, multiple auxiliary tools are needed to push such an interventional guidewire (i.e., a thin guidewire) into the human body. For example... Figure 1 As shown in (a) to (e), taking the advancement of the interventional guidewire through the aorta to the left ventricle as an example, the specific operational steps required to advance such an interventional guidewire into the human body using current technology are as follows:
[0049] First step, see Figure 1 In (a), a large-diameter guidewire 101 is pushed into the left ventricle via the aorta 22; because the diameter of the guidewire 101 is large, the guidewire 101 can cross the aortic valve 21.
[0050] Step 2, see Figure 1 In (b), the hollow tube 102 is inserted onto the thick guide wire 101, so that the hollow tube 102 can be pushed along the thick guide wire 101 and cross the aortic valve 21 to enter the left ventricle.
[0051] Step 3, see Figure 1 In step (c), the thick guide wire 101 is pulled out of the hollow tube 102 and out of the body so that the hollow tube 102 remains inside the body.
[0052] Step 4, see Figure 1 In step (d), a small-diameter guidewire 103 (i.e., interventional guidewire) is inserted into the hollow tube 102 and pushed into the ventricle along the inner lumen of the hollow tube 102;
[0053] Step 5, see Figure 1 In step (e), the hollow tube 102 is withdrawn outside the body, leaving the guidewire 103 inside the body, thereby enabling the guidewire 103 to be delivered into the body. The guidewire 103 can be used for the insertion of interventional medical devices such as blood pumps.
[0054] In other words, current technology requires at least the above five steps to push a small-diameter interventional guidewire into the human body. The procedure is cumbersome and inefficient. Furthermore, a thicker guidewire must be inserted into the body beforehand, and then a thinner guidewire is replaced by a hollow tube. This thicker guidewire is typically around 0.035mm in diameter, requiring significantly more consumables than the thinner guidewire, resulting in a large consumption of materials for this method.
[0055] See Figure 2 In view of the above, this application proposes an interventional device 10, which can be used to assist in the insertion of a blood pump into the human body. The blood pump can be a left ventricular interventional pump or a right ventricular interventional pump. In other embodiments, the interventional device 10 can also be used in interventional medical devices in the cardiovascular field, such as assisted interventional catheters and interventional balloons. The interventional device 10 can directly push a smaller diameter interventional guidewire 100 to the target location in the body without the need to pre-insert a larger guidewire, thereby reducing not only the number of steps required to insert the interventional guidewire 100 into the body but also the amount of consumables used.
[0056] See Figure 2 In some embodiments, the interventional device 10 includes an interventional guidewire 100 and a flexible sheath 300. The interventional guidewire 100 has a first end 110 and a second end 120; the first end 110 is the distal end of the interventional guidewire 100; the second end 120 is the proximal end of the interventional guidewire 100. The flexible sheath 300 is sleeved on the outside of the interventional guidewire 100, and the flexible sheath 300 has a distal end 310 and a proximal end 320. The distal end 310 of the flexible sheath 300 is detachably connected to the first end 110, allowing the flexible sheath 300 to be detached from the interventional guidewire 100 and withdrawn after the interventional device 10 is pushed to the target location within the body.
[0057] See Figure 2 and Figure 4 Taking the interventional device 10 being pushed into the left ventricle via the aorta as an example, the steps for pushing the interventional guidewire 100 into the left ventricle are as follows:
[0058] First step, such as Figure 4 As shown in (a), the entire interventional device 10 is pushed into the body through the incision and passes through the aorta 22, across the aortic valve 21, and into the left ventricle. In this step, the flexible sheath 300, which is placed over the interventional guidewire 100, can increase the overall rigidity of the interventional device 10 to a certain extent, compared to the single interventional guidewire 100, so that the interventional device 10 can cross the aortic valve 21.
[0059] The second step, as Figure 4As shown in (b), the flexible sheath 300 of the interventional device 10 is detached from the interventional guidewire 100 to remove the flexible sheath 300 separately from the body, thereby leaving the interventional guidewire 100 of the interventional device 10 inside the body.
[0060] Therefore, the interventional device 10 of this application can directly push the smaller diameter interventional guidewire 100 to the target position in the body through the above two steps, without the need to push the thicker guidewire into the body in advance. This not only reduces the number of operation steps for pushing the interventional guidewire 100 into the body and the time spent pushing the interventional guidewire 100, but also reduces the amount of consumables used, which is beneficial to saving costs.
[0061] It should be noted that in this article, "proximal" refers to the end closer to the surgeon and farther from the patient's body, while "distal" refers to the end farther from the surgeon and closer to the patient's body. For example... Figure 2 The top end of the intervention device 10 is the proximal end, and the bottom end is the distal end.
[0062] In this application, the interventional guidewire 100 is used to guide interventional medical devices such as blood pumps into the human body. The length of the interventional guidewire 100 can be selected to be different lengths according to actual needs. For example, the interventional guidewire 100 can be a thin guidewire with a small diameter, and the cross-section of the interventional guidewire 100 is approximately circular.
[0063] The first end 110 of the interventional guidewire 100 may include a connected mounting portion 111 and a positioning portion 112. The mounting portion 111 may be connected to a flexible sheath 300. The positioning portion 112 is located distal to the mounting portion 111 and is used to abut against cardiac tissue (such as the left ventricular wall) to support and position the interventional guidewire 100. Optionally, the positioning portion 112 may be J-shaped or pigtail-shaped. It should be noted that the axial direction of the interventional guidewire 100 described herein refers to its length direction; the radial direction of the interventional guidewire 100 refers to its diameter direction.
[0064] The flexible sheath 300 can be detachably connected directly to the first end 110 of the interventional guidewire 100. Considering that the diameter of the interventional guidewire 100 is generally small, to reduce the difficulty of connecting the flexible sheath 300 and the small-diameter interventional guidewire 100, the interventional device 10 may optionally include a connector 200. The connector 200 is fixed to the first end 110 of the interventional guidewire 100 and is configured to connect the interventional guidewire 100 and the flexible sheath 300. On the one hand, the flexible sheath 300 can provide support for the interventional guidewire 100 through the connector 200, which is beneficial for the flexible sheath 300 to support the interventional guidewire 100 across the heart valve. On the other hand, since the interventional guidewire 100 has a small diameter, the indirect connection between the interventional guidewire 100 and the flexible sheath 300 through the connector 200 is easier and facilitates operation.
[0065] See Figure 2 and Figure 3 For connector 200, connector 200 can be connected to the outer surface of the first end 110 of interventional guidewire 100. Connector 200 is looped around the outer peripheral surface of the first end 110. The diameter of connector 200 is larger than the diameter of interventional guidewire 100, so that the outer peripheral surface of connector 200 has a larger area for connection of flexible sheath 300, thereby reducing the difficulty of connecting flexible sheath 300 and interventional guidewire 100.
[0066] The connection method between the connector 200 and the interventional guidewire 100 is preferably a fixed connection method that is not easily detached. For example, the connector 200 and the interventional guidewire 100 can be connected by welding.
[0067] See Figure 2 and Figure 3 The flexible sheath 300 is a hollow cylindrical tube. The inner diameter of the flexible sheath 300 is slightly larger than the outer diameter of the interventional guidewire 100, allowing the flexible sheath 300 to be fitted over the interventional guidewire 100. The flexible sheath 300 is flexible, enabling both the flexible sheath 300 and the interventional guidewire 100 to adapt to the shape of the blood vessel and undergo bending and deformation.
[0068] The flexible sheath 300 can be made of PI material (i.e., polyimide). The PI material provides the flexible sheath 300 with a certain degree of rigidity, enabling it to support the interventional guidewire 100 and work together with it to be pushed into the body and reach the target location. Furthermore, compared to metal materials, the PI material has a certain degree of flexibility, making it less likely to damage internal tissues during insertion.
[0069] Of course, the flexible sheath 300 can also be made of other materials to change its rigidity, thereby meeting different support requirements.
[0070] See Figure 2 and Figure 3 The distal end 310 of the flexible sheath 300 is detachably connected to the connector 200. When the flexible sheath 300 is connected to the interventional guidewire 100 via the connector 200, the flexible sheath 300 can provide support for pushing the interventional guidewire 100 into the human body. After the flexible sheath 300 and the interventional guidewire 100 reach the target position in the body, the flexible sheath 300 can be separated from the connector 200 to disconnect the connection between the flexible sheath 300 and the interventional guidewire 100, allowing the flexible sheath 300 to be withdrawn from the body independently, while the interventional guidewire 100 remains in the body.
[0071] See Figure 2 and Figure 3 Regarding the detachable connection between the distal end 310 of the flexible sheath 300 and the connector 200, in some embodiments, the distal end 310 of the flexible sheath 300 and the connector 200 are bonded together with a water-soluble adhesive. When the interventional device 10 enters the body, the water-soluble adhesive at the bonding site between the flexible sheath 300 and the connector 200 gradually dissolves upon contact with blood. Once the interventional device 10 reaches the target location, the water-soluble adhesive at the bonding site is completely dissolved. At this point, the flexible sheath 300 can detach from the connector 200, allowing the flexible sheath 300 to be withdrawn independently from the body, leaving the interventional guidewire 100 inside. It is understood that the water-soluble adhesive should be food-grade or a harmless adhesive material.
[0072] Of course, in other embodiments, the proximal end 320 of the flexible sheath 300 is looped around the connector 200, and the distal end 310 of the flexible sheath 300 is interference-fitted with the connector 200. The interference fit between the flexible sheath 300 and the connector 200 binds them together. When the interventional device 10 is pushed, the thrust applied to the flexible sheath 300 can be transmitted to the interventional guidewire 100 via the connector 200. Subsequently, after the interventional device 10 reaches the target position within the body, an external force is used to pull the flexible sheath 300, causing it to overcome the interference fit between the distal end 310 and the outer surface of the connector 200, forcing the flexible sheath 300 to detach from the connector 200, thus allowing the flexible sheath 300 to be extracted separately from the body.
[0073] See Figure 2 and Figure 3 Optionally, the distal end 310 of the flexible sheath 300 is also provided with a connecting surface 311. The shape of the connecting surface 311 can be set to fit and nest with the shape of the proximal end of the connector 200 so that the connecting surface 311 of the distal end 310 of the flexible sheath 300 and the connector 200 can be bonded together with water-soluble adhesive.
[0074] Based on the above structural design, the usage process of the intervention device 10 in this application embodiment is as follows: (Refer to...) Figure 4 As shown in section (a), taking the application to the left ventricle of heart 20 as an example: the interventional device 10 is first pushed into heart 20 as a whole, so that when the distal end of the interventional device 10 passes through aortic valve 21 to reach the target position, the water-soluble adhesive of the flexible sheath 300 and connector 200 gradually dissolves and loosens. (See also...) Figure 4 As shown in section (b), once the water-soluble adhesive between the flexible sheath 300 and the connector 200 is completely dissolved, the flexible sheath 300 can detach from the connector 200. This allows the proximal end 320 of the flexible sheath 300 to be pulled out of the body, while the interventional guidewire 100 remains inside the body. Finally, a blood pump is inserted onto the interventional guidewire 100 and pushed along it into the heart 20, completing the interventional procedure.
[0075] Therefore, the interventional device 10 of this application embodiment can use a smaller diameter interventional guidewire 100 as the inner core, with a flexible sheath 300 nested outside the interventional guidewire 100. The combination of the interventional guidewire 100 and the flexible sheath 300 increases the rigidity of the individual thin guidewire, facilitating its insertion into the body without the need to pre-insert a thick guidewire and then replace it with a thinner one. Furthermore, the distal end 310 of the flexible sheath 300 is detachably connected to the connector 200 fixed to the first end 110 using water-soluble adhesive. This allows the water-soluble adhesive to dissolve when the flexible sheath 300 and the interventional guidewire 100 reach the target position within the body, making it easy to separate the flexible sheath 300 from the connector 200 and the interventional guidewire 100. The flexible sheath 300 can then be withdrawn separately from the body, while the interventional guidewire 100 remains inside, thus completing the insertion of the interventional guidewire 100. Therefore, the procedure for inserting the interventional guidewire 100 into the human body is simple and efficient. Moreover, compared to the existing technology which requires pre-inserting a thick guidewire and then replacing it with a thin guidewire, the embodiments of this application do not require the use of a thick guidewire, thereby reducing the amount of consumables used.
[0076] Understandably, by properly configuring the composition ratio or amount of the water-soluble adhesive used to bond the flexible sheath 300 and the connector 200, the water-soluble adhesive at the bonding point between the flexible sheath 300 and the connector 200 will completely dissolve when the interventional device 10 reaches the target location within the body at the expected time. In other words, if the interventional device 10 does not reach the target location within the body before the expected time, the water-soluble adhesive between the flexible sheath 300 and the connector 200 will not dissolve or will only partially dissolve, allowing the flexible sheath 300 to maintain its connection with the interventional guidewire 100 and to support the interventional guidewire 100 to assist in its advancement.
[0077] In certain unforeseen circumstances, such as inexperienced physicians manipulating the interventional device 10 or significant resistance along the insertion path within the patient's body, these factors may prolong the insertion time of the interventional device 10. Before the interventional guidewire 100 reaches its target location within the body, the water-soluble adhesive on the flexible sheath 300 and the connector 200 may dissolve prematurely. Therefore, alternatively, the proximal end 320 of the flexible sheath 300 may be looped around the connector 200, with the inner surface of the distal end 310 and the outer surface of the connector 200 providing an interference fit. This enhances the stability of the connection between the flexible sheath 300 and the connector 200.
[0078] Because the inner surface of the distal end 310 and the outer surface of the connector 200 are interference-fitted, there is a certain constraint between them. Therefore, even if the water-soluble adhesive of the flexible sheath 300 and the connector 200 dissolves prematurely, the flexible sheath 300 will not completely detach from the connector 200. The flexible sheath 300 can also maintain its connection with the interventional guidewire 100, supporting the interventional guidewire 100 to assist in its advancement. After the interventional device 10 is advanced to the target position within the body, external force is used to pull the flexible sheath 300, causing it to overcome the constraint of the interference fit between the outer surfaces of the distal end 310 and the connector 200, forcing the flexible sheath 300 to separate from the connector 200, allowing it to be extracted separately from the body.
[0079] Of course, the distal end 310 of the flexible sheath 300 and the connector 200 can also be detachably connected in other ways. For example, in Figure 9 In the illustrated embodiment, the proximal end of the connector 200 is provided with an annular groove 201; the distal end 310 of the flexible sheath 300 is embedded in the annular groove 201. The annular groove 201 has a certain depth, and the distal end 310 and the inner wall of the annular groove 201 are interference-fitted, so that the distal end 310 can be stably embedded in the annular groove 201. Without being subjected to strong external force, the distal end 310 is not easily dislodged from the annular groove 201. When the interventional device 10 is pushed from the outside to the inside (i.e., along the Y-direction) towards the target position within the body, the distal end 310 is tightly pressed against the annular groove 201, and the distal end 310 of the flexible sheath 300 is not easily dislodged from the annular groove 201. Once the intervention device 10 reaches the target position, the flexible sheath 300 is pulled out forcefully, causing the distal end 310 of the flexible sheath 300 to be pulled out from the annular groove 201 of the connector 200. This allows the flexible sheath 300 to be separated from the intervention guidewire 100, and the flexible sheath 300 can then be pulled out of the body separately.
[0080] Furthermore, the distal end 310 of the flexible sheath 300 can also be bonded and fixed in the annular groove 201 using water-soluble adhesive to enhance the stability of the connection between the two. Thus, even if the water-soluble adhesive between the flexible sheath 300 and the connector 200 dissolves prematurely, because the distal end 310 of the flexible sheath 300 is still inserted in the annular groove 201, when the interventional device 10 is pushed from the outside in (i.e., along the Y-direction) towards the target position within the body, the distal end 310 is tightly pressed against the annular groove 201, and the distal end 310 of the flexible sheath 300 is not easily dislodged from the annular groove 201, thereby ensuring that the interventional device 10 can continue to be pushed towards the target position as a whole.
[0081] It is worth mentioning that the application scenarios of the interventional device 10 in this application embodiment are not limited to blood pumps. For example, the interventional device 10 can also be applied to other interventional medical devices, such as interventional balloons, interventional catheters, etc.
[0082] See Figure 3 In some embodiments, the diameter D1 of the interventional guidewire 100 can be selected from 0.015mm to 0.02mm, for example, the diameter D1 of the interventional guidewire 100 can be selected from 0.015mm, 0.016mm, 0.017mm, 0.018mm, 0.019mm, 0.02mm or any value between 0.015mm and 0.02mm; the outer diameter D2 of the flexible sheath 300 can be selected from 0.03mm to 0.04mm, for example, the outer diameter D2 of the flexible sheath 300 can be selected from 0.03mm, 0.032mm, 0.034mm, 0.036mm, 0.038mm, 0.04mm or any value between 0.03mm and 0.04mm.
[0083] The ratio D1 / D2 of the diameter D1 of the interventional guidewire 100 to the outer diameter D2 of the flexible sheath 300 is 0.3 to 0.5. For example, the ratio D1 / D2 can be selected as 0.3, 0.32, 0.34, 0.36, 0.38, 0.4, 0.42, 0.44, 0.46, 0.48, 0.5, or any value between 0.3 and 0.5. This ensures that the diameter D1 of the interventional guidewire 100, the outer diameter D2 of the flexible sheath 300, and their ratio D1 / D2 are within the aforementioned suitable range. This helps to balance the rigidity and flexibility of the connection between the interventional guidewire 100 and the flexible sheath 300, ensuring that the flexible sheath 300 can provide sufficient support while maintaining the small diameter of the interventional guidewire 100, facilitating the subsequent insertion of the blood pump onto the interventional guidewire 100.
[0084] In some embodiments, the connector 200 has a ring-shaped structure. The connector 200 is looped around the outer peripheral surface of the interventional guidewire 100. The connector 200 is welded to the outer peripheral surface of the interventional guidewire 100. The proximal end of the connector 200 is bonded to the distal end 310 of the flexible sheath 300 with water-soluble adhesive. Because the connector 200 is configured as a ring-shaped structure adapted to the flexible sheath 300, the flexible sheath 300 can be bonded to the connector 200 at all points in the circumferential direction of the interventional guidewire 100, which can improve the bonding strength and prevent the flexible sheath 300 from falling off when pushed into the human body with the interventional guidewire 100. Furthermore, in different application scenarios, connectors 200 of different diameters can be selected to assemble the interventional device 10 to adapt to different passage requirements.
[0085] See Figure 2 and Figure 3 In some embodiments, the distal end of connector 200 is more rigid than the proximal end, resulting in higher rigidity at the distal end of connector 200, which facilitates penetration of tissues with greater resistance, such as heart valves. This allows the interventional guidewire 100 to more easily cross the aortic valve 21 under the guidance of connector 200, thereby reaching the target location within the heart 20.
[0086] In some embodiments, the connector 200 is made of a metallic material, such as stainless steel. The metallic material provides sufficient rigidity while maintaining a degree of flexibility to facilitate the insertion of the interventional guidewire 100 into the human body. Furthermore, the metallic material has poor X-ray transmission properties, thus it can serve as an ultrasound positioning marker, allowing for ultrasound localization of the first end 110 of the interventional guidewire 100. Therefore, the interventional device 10 can simultaneously utilize the imaging characteristics of both DSA (digital subtraction angiography) guidance and ultrasound guidance, enabling interventional procedures to be performed in more scenarios and expanding the application range of the interventional device 10.
[0087] To improve the passability and safety of the connector 200 when it is inserted into the human body along with the interventional guide wire 100, the structural design of the connector 200 can be optimized.
[0088] See Figure 2 and Figure 5 In some embodiments, the connector 200 includes a proximal segment 210 and a distal segment 220 located distal to the proximal segment 210. In this embodiment, the distal segment 220 and the proximal segment 210 are sequentially arranged along the axial direction of the interventional guidewire 100, and the proximal end of the distal segment 220 is connected to the distal end of the proximal segment 210. The distal end 310 of the flexible sheath 300 (see...) Figure 2 The inner circumferential surface of the proximal segment 210 is wrapped around the outer circumferential surface of the proximal segment 210. The proximal segment 210 is detachably connected to the distal end of the flexible sheath 300.
[0089] See Figure 2 and Figure 5 Optionally, the distal segment 220 has a first outer diameter D3 in the radial direction of the interventional guidewire 100, which gradually decreases in size from the second end 120 to the first end 110 of the interventional guidewire 100. For example, the shape of the distal segment 220 can be configured as a cone, pyramid, or spherical shape with gradually decreasing size. Thus, the connector 200 is divided into a proximal segment 210 and a distal segment 220, with the distal segment 220 gradually decreasing in size towards the first end 110, so that the distal end of the connector 200 forms a tapered tip, which facilitates passage through narrow areas, reduces resistance during push, improves the ability of the interventional guidewire 100 to pass through complex anatomical structures, and is beneficial for passing through heart valves.
[0090] See Figure 2 and Figure 5 In some other embodiments, the second outer diameter D4 of the proximal segment 210 gradually decreases along the direction from the first end 110 to the second end 120. The shape of the proximal segment 210 can be configured as a cone, pyramid, spherical, or other structures with gradually decreasing dimensions. This reduces the resistance of the flexible sheath 300 fitting onto the proximal segment 210 along the direction from the second end 120 to the first end 110, facilitating assembly. Furthermore, during insertion into the body, the thrust applied to the flexible sheath 300 is along the direction from the second end 120 to the first end 110. Under this thrust, the distal end 310 of the flexible sheath 300 is pressed against the outer circumferential surface of the proximal segment 210, resulting in a tighter connection. The thrust can be transmitted from the flexible sheath 300 through the proximal segment 210 to the interventional guidewire 100. Thus, even if the water-soluble adhesive on the flexible sheath 300 and the connector 200 dissolves prematurely, the flexible sheath 300 will not completely detach from the connector 200, and the flexible sheath 300 can remain connected to the interventional guidewire 100. When the flexible sheath 300 is subsequently withdrawn, the proximal segment 210 provides less resistance during withdrawal, making it easier to separate the flexible sheath 300 from the proximal segment 210 for individual withdrawal.
[0091] See Figure 3 and Figure 5In some embodiments, the connector 200 may further include an intermediate section 230 connecting the proximal segment 210 and the distal segment 220. The proximal segment 210, intermediate section 230, and distal segment 220 are arranged sequentially along the axial direction of the interventional guidewire 100. The proximal segment 210 is connected to the distal end 310 of the flexible sheath 300. The intermediate section 230 is cylindrical. The intermediate section 230 has a third outer diameter D5 in the radial direction of the interventional guidewire 100, the third outer diameter D5 being greater than or equal to the first outer diameter D3 of the distal segment 220; the outer diameter D2 of the flexible sheath 300 is equal to the third outer diameter D5 of the intermediate section 230. Even if the water-soluble adhesive of the flexible sheath 300 and the connector 200 dissolves in advance, the distal end 310 of the flexible sheath 300 is not likely to cross the middle section 230. Thus, the thrust applied to the flexible sheath 300 can be transmitted to the interventional guidewire 100 through the proximal section 210, enabling the flexible sheath 300 to support the interventional guidewire 100 and assist in pushing the interventional guidewire 100.
[0092] In addition, the outer peripheral surface of the distal end 310 of the flexible sheath 300 is smoothly connected to the outer peripheral surface of the middle section 230, reducing the friction when the interventional device 10 is pushed into the human body and avoiding getting stuck in blood vessels or tissues.
[0093] Optionally, a first rounded edge is provided at the junction of the proximal segment 210 and the intermediate segment 230. A second rounded edge is provided at the junction of the distal segment 220 and the intermediate segment 230. This makes the overall outer surface of the connector 200 smoother without sharp edges or corners, thus avoiding damage to human tissue.
[0094] See Figure 6 In some embodiments, the distal end face of the distal segment 220 is configured as an arcuate surface 221. Optionally, the arcuate surface 221 is specifically a circular arc surface. This avoids the distal end of the connector 200 forming a sharp corner, thereby preventing the distal segment 220 from damaging human tissue, such as a heart valve, and improving safety.
[0095] See Figures 5 to 7 Regarding the overall appearance of the connector 200, the connector 200 may optionally be configured as any one of the following shapes: spindle-shaped, elliptical, or cylindrical.
[0096] See Figure 7 The connector 200 has a maximum outer diameter L2 in the radial direction along the interventional guidewire 100. This maximum outer diameter setting of the connector 200 allows passage through the narrowest point of the internal delivery path. It is understood that the narrowest point of the internal delivery path varies among different patients, such as the elderly and children, obese patients, or thin patients. Therefore, the maximum outer diameter of the connector 200 in its expanded form should be rationally designed according to the narrowest point of the internal delivery path for the actual patient in the application, which will not be detailed here.
[0097] See Figure 7 The connector 200 also has an axial length L1 extending along the axis of the interventional guidewire 100. The axial length L1 is greater than the maximum outer diameter L2 of the connector 200. This not only increases the area of the outer periphery of the connector 200 by increasing its axial length, thus improving the stability of the flexible sheath 300 connection, but also ensures that the outer diameter of the connector 200 is not excessively large, facilitating passage through narrow areas of the push path.
[0098] See Figure 7 For example, the connector 200 is spindle-shaped with an elliptical longitudinal section. Thus, when the connector 200 is inserted into the human body along with the interventional guidewire 100, the connector 200 can adapt to the curved path within the body.
[0099] See Figure 8 In other embodiments, the connector 200 may have only a proximal segment 210 and a distal segment 220. Furthermore, the proximal segment 210 may be cylindrical, while the distal segment 220 may be conical. The proximal segment 210 has a second outer diameter D4 in the radial direction of the interventional guidewire 100, the second outer diameter D4 being greater than or equal to the maximum value of the first outer diameter D3, resulting in a larger area on the outer peripheral surface of the proximal segment 210 for connection to the distal end 310 of the flexible sheath 300, thereby improving the stability of the connection between the proximal segment 210 and the flexible sheath 300.
[0100] Another embodiment of this application provides a percutaneous cardiac pump system, which includes a blood pump and an interventional device 10. The blood pump has a distal opening and a proximal opening; the interventional device 10 is the same as described in any of the above embodiments. After the interventional guidewire 100 of the interventional device 10 is separated from the flexible sheath 300, the blood pump can be inserted onto the interventional guidewire 100.
[0101] Based on the structural design of the interventional device 10, the percutaneous cardiac pump system can use a small-diameter interventional guidewire 100 as the inner core, with a flexible sheath 300 nested outside the interventional guidewire 100. The combination of the interventional guidewire 100 and the flexible sheath 300 can improve the strength of a single thin guidewire, making it easier to insert the interventional guidewire 100 into the body, and thus making it easier to insert the blood pump along the interventional guidewire 100 into the body. This makes the interventional operation simple and efficient, and can also reduce the amount of consumables used.
[0102] Specifically, the blood pump can be a left-sided ventricular interventional pump or a right-sided ventricular interventional pump. See also... Figure 4As shown, when the blood pump is used as a left ventricular interventional pump, the proximal opening is the blood outlet, and the distal opening is the blood inlet. The blood pump is pushed into the left ventricle via the aorta 22 through the interventional guidewire 100, such that the distal opening of the blood pump is located within the left ventricle, while the proximal opening is located within the aorta 22. Blood from the left ventricle flows into the blood flow channel within the blood pump from the distal opening and flows out into the aorta 22 from the proximal opening, thus assisting the left ventricle in pumping blood.
[0103] When the blood pump is used as a right ventricular interventional pump, the proximal opening is the blood inlet, and the distal opening is the blood outlet. The blood pump is advanced through the right ventricle to the pulmonary artery via an interventional guidewire 100, with the proximal opening of the blood pump located within the right ventricle and the distal opening within the pulmonary artery. Blood from the right ventricle flows into the blood flow channel within the blood pump from the proximal opening and exits into the pulmonary artery from the distal opening, thus assisting the right ventricle in pumping blood.
[0104] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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.
[0105] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.
Claims
1. An interventional device for percutaneous insertion into a blood vessel, characterized in that, The interventional device includes: An interventional guidewire, the interventional guidewire having a first end and a second end, the first end being the distal end of the interventional guidewire, and the second end being the proximal end of the interventional guidewire; and A flexible sheath is fitted over the outside of the interventional guidewire. The distal end of the flexible sheath is detachably connected to the first end of the interventional guidewire, so that after the interventional device is pushed to the target position in the body, the flexible sheath can be detached from the interventional guidewire to be withdrawn.
2. The interventional device according to claim 1, characterized in that, The interventional device also includes a connector, which is fixed to the first end of the interventional guidewire, and the distal end of the flexible sheath is detachably connected to the connector.
3. The interventional device according to claim 2, characterized in that, The interventional device also includes at least one of the following features: The connector is made of metal. The connector is bonded to the distal end of the flexible sheath with water-soluble adhesive. The connector is looped around the outer circumferential surface of the interventional guidewire; The hardness of the distal end of the connector is greater than the hardness of the proximal end of the connector. The connector has an annular slot at its proximal end, and the flexible sheath is fitted into the annular slot at its distal end.
4. The interventional device according to claim 2, characterized in that, The connector includes a proximal segment and a distal segment located distal to the proximal segment, the distal end of the flexible sheath being looped around the outer peripheral surface of the proximal segment; wherein the distal segment has a first outer diameter in the radial direction of the interventional guidewire, the first outer diameter gradually decreasing in the direction from the second end to the first end; and / or, The proximal segment has a second outer diameter in the radial direction of the interventional guidewire, the second outer diameter gradually decreasing in the direction from the first end to the second end.
5. The interventional device according to claim 4, characterized in that, The connector further includes an intermediate section connecting the proximal segment and the distal segment; the intermediate section is cylindrical; the intermediate section has a third outer diameter, which is equal to the maximum outer diameter of the distal segment or the proximal segment.
6. The interventional device according to claim 5, characterized in that, The connector also has one of the following features: A first rounded edge is provided at the connection between the proximal segment and the intermediate segment; A second rounding is provided at the connection between the distal segment and the middle segment; The distal end face of the distal segment is configured as an arc-shaped surface; The outer diameter of the flexible sheath is the same as the third outer diameter of the intermediate section, so that the outer peripheral surface of the flexible sheath and the outer peripheral surface of the intermediate section are smoothly connected.
7. The interventional device according to any one of claims 4 to 6, characterized in that, The connector is configured in any one of the following shapes: spindle-shaped, elliptical, or cylindrical; and / or, The connector has a maximum outer diameter in the radial direction of the interventional guidewire and an axial length extending in the axial direction of the interventional guidewire, the axial length being greater than the maximum outer diameter.
8. The interventional device according to any one of claims 1 to 6, characterized in that, The interventional device also has at least one of the following features: The flexible sheath includes PI material; The outer diameter of the flexible sheath is 0.03mm~0.04mm; The diameter of the interventional guidewire is 0.015mm~0.02mm; The ratio of the diameter of the interventional guidewire to the outer diameter of the flexible sheath is 0.3 to 0.
5.
9. The interventional device according to any one of claims 1 to 6, characterized in that, The first end of the interventional guidewire includes a connected mounting portion and a positioning portion, the mounting portion being able to be connected to the flexible sheath; the positioning portion is located distal to the mounting portion, and the positioning portion has a J-shape or pigtail shape.
10. A transcutaneous cardiac pump system, characterized in that, The transcutaneous cardiac pump system includes: Blood pump, the blood pump having a distal opening and a proximal opening; and In any one of the interventional devices as described in claims 1 to 9, after the interventional guidewire of the interventional device is separated from the flexible sheath, the blood pump can be inserted onto the interventional guidewire.