Anchoring device and interventional circulatory assist system

Abstract

The application provides an anchoring device and an interventional circulatory assistance system. The anchoring device comprises a support part and an anchoring part. The support part is annular. The anchoring part has at least two elastic arms. One end of the elastic arm is connected with the support part. The other end of the elastic arm is a free end. The anchoring device can be placed into a blood vessel with the interventional circulatory assistance system. The anchoring device has an anchoring form and a transmission form. In the anchoring form, the free end of the elastic arm abuts against the blood vessel wall under the action of self elasticity. In the transmission form, each elastic arm is inwardly folded under the action of external force. The anchoring device is switched between the anchoring form and the transmission form through stress deformation of the elastic arms of the anchoring part. The anchoring device is fixed in the blood vessel, and the positioning problem of the interventional circulatory assistance system in the blood vessel is solved.

Description

Technical Field

[0001] This application relates to the field of cardiac device technology, and more particularly to an anchoring device and interventional circulatory support. Background Technology

[0002] For high-risk, complex coronary artery disease patients, myocardial ischemia caused by transient blood flow blockage during percutaneous coronary intervention or increased cardiac load due to contrast agent injection can lead to circulatory collapse or even sudden death.

[0003] In related technologies, blood supply is achieved in the body through two mechanical devices: mechanical pumps and valves. These mechanical devices will shake during operation and need to be clamped by the aortic valve. Summary of the Invention

[0004] In view of this, embodiments of this application aim to provide an anchoring device and an interventional circulatory support system to solve the problem of positioning in blood vessels.

[0005] To achieve the above objectives, the technical solution of this application embodiment is implemented as follows:

[0006] A first aspect of this application provides an anchoring device, comprising:

[0007] The support portion is ring-shaped;

[0008] An anchoring part has at least two elastic arms, one end of which is connected to the support part, and the other end of which is a free end;

[0009] The anchoring device can be inserted into a blood vessel along with the interventional circulatory support system. The anchoring device has an anchoring mode and a delivery mode. In the anchoring mode, the free end of the elastic arm abuts against the blood vessel wall under its own elastic force. In the delivery mode, each of the elastic arms retracts inward under the action of external force.

[0010] In some implementations, the anchoring part and the support part are integrally formed, each of the elastic arms is connected to one end of the axial direction of the support part, and the annular area within the support part serves as the suction port of the interventional circulation auxiliary system.

[0011] In some embodiments, the anchoring part is sleeved on the support part, the support part having a receiving cavity for blood transfer, and the elastic arm can retract into the receiving cavity of the support part in the transfer mode.

[0012] In some implementations, the support includes a cylinder and a plurality of spring pieces disposed within the cylinder. The side wall of the cylinder is provided with a plurality of first openings. The spring arm is disposed outside the first opening, and the spring piece is disposed inside the first opening. In the conveying mode, the spring arm presses the spring piece inward through the first opening under the action of external force. In the anchoring mode, the spring piece closes the first opening from the inside.

[0013] In some implementations, a through hole is formed at one end of the spring near the root of the spring arm for the blood to drain out during the anchoring configuration.

[0014] In some embodiments, the support includes a collar, which is sleeved on the axial first end of the cylinder and the two are fixedly connected, and one end of the elastic arm is connected to the collar.

[0015] In some implementations, the support includes a rigid frame, and the cylinder is fitted over the rigid frame.

[0016] In some embodiments, the rigid frame includes an axially extending bracket and a first sleeve connected to one end of the bracket. The support portion includes a collar, which is sleeved on the axial first end of the cylinder and the two are fixedly connected. One end of the elastic arm is connected to the collar. The collar, the cylinder, and the first sleeve are nested and fixedly connected in a radially inward direction.

[0017] In some embodiments, the collar, the cylinder and the first sleeve are respectively formed with mounting holes, the mounting holes extending radially through the collar, the cylinder and the first sleeve, and the end of the spring piece near the first sleeve is formed with a stepped portion, the stepped portion passing through and fixed in the mounting hole.

[0018] In some embodiments, the sidewall of the rigid frame is formed with a plurality of second openings extending along the bracket, wherein the second openings are disposed between two adjacent brackets; in the conveying mode, the spring arm presses the spring piece inward through the first opening and the second opening under the action of external force; in the anchoring mode, the spring piece closes the first opening from the inside of the first opening through the second opening.

[0019] In some embodiments, a contact pad is formed at the end of the spring arm away from the support portion, and the contact pad protrudes from the spring arm toward the side closer to the blood vessel wall and / or toward the side away from the blood vessel wall.

[0020] In some embodiments, the spring arm includes an axially connected section and an inclined section connected to each other, the axially connected section extending axially along the support portion, a first end of the axially connected section being connected to the support portion, and the inclined section extending obliquely outward from a second end of the axially connected section.

[0021] In some embodiments, a portion of the inclined segment is bent in its width direction to form a bend.

[0022] In some implementations, the width of the bent portion is smaller than the width of the non-bent portion of the inclined segment.

[0023] In some embodiments, the inclined segment includes a first straight segment and a second straight segment, the first straight segment being connected to the axial connecting segment, the bending portion connecting the first straight segment and the second straight segment, and the first straight segment and the second straight segment extending along the same straight line.

[0024] In some embodiments, the bending portion includes a first bending segment, a second bending segment, and a third bending segment. The first bending segment connects to the first straight segment and extends obliquely to a first side in the width direction of the first straight segment. The second bending segment extends obliquely from the end of the first bending segment to a second side in the width direction. The third bending segment extends obliquely from the end of the second bending segment to the first side in the width direction and connects to the second straight segment.

[0025] In some implementations, the first and third bend segments are arranged symmetrically about the center of the second bend segment.

[0026] A second aspect of this application provides an interventional circulatory support system, comprising:

[0027] Any of the above anchoring devices;

[0028] A blood transport conduit has an inlet and an outlet, and the anchoring device is connected to the blood transport conduit;

[0029] A power unit, connected to the transmission pipe, is used to drive the flow of blood within the transmission pipe.

[0030] In some embodiments, the anchoring device is provided at the inlet of the transmission pipe, and the inner region of the support forms the inlet of the transmission pipe; and / or, the anchoring device is provided at the portion of the transmission pipe located between the inlet and the outlet.

[0031] In some embodiments, the power unit includes an external suction pump and a pump tube, the pump tube connecting the transmission pipe and the outlet of the external suction pump. The external suction pump has a blood storage chamber. The external suction pump is used to periodically generate negative and positive pressure. When negative pressure is generated, blood flows through the transmission pipe and the pump tube to the blood storage chamber. When positive pressure is generated, blood in the blood storage chamber flows through the pump tube to the transmission pipe and flows out from the outlet.

[0032] In some implementations, the power unit includes a motor, an impeller, and a flexible drive shaft. The impeller is disposed inside the transmission pipe, and the flexible drive shaft connects the impeller and the motor shaft of the motor. Driven by the flexible drive shaft, the impeller drives the blood to flow unidirectionally from the inlet to the outlet.

[0033] The anchoring device provided in this application embodiment has a ring-shaped support portion and at least two elastic arms. One end of each elastic arm is connected to the support portion, and the other end is a free end. The anchoring device can be inserted into a blood vessel along with an interventional circulatory support system. The anchoring device has an anchoring mode and a delivery mode. In the anchoring mode, the free end of the elastic arm abuts against the blood vessel wall under its own elastic force. In the delivery mode, each elastic arm retracts inward under external force. This application achieves the switching between the anchoring mode and the delivery mode of the anchoring device through the force deformation of the elastic arms of the anchoring portion, so that the anchoring device itself is fixed in the blood vessel without the need for valves to complete the fixation of the interventional circulatory support system, thus solving the problem of blood draw and transfusion for patients with valvular disease. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of the structure of the first type of anchoring device provided in the embodiments of this application;

[0035] Figure 2 This is a schematic diagram of the structure of the second type of anchoring device provided in the embodiments of this application;

[0036] Figure 3 for Figure 1 Schematic diagram of the middle anchorage and collar;

[0037] Figure 4 for Figure 1 Schematic diagram of the middle cylinder;

[0038] Figure 5 for Figure 1 Schematic diagram of the rigid frame structure;

[0039] Figure 6 for Figure 1 A schematic diagram of the structure of a shrapnel.

[0040] Figure 7 A schematic diagram of the structural parameters of a spring arm provided in an embodiment of this application;

[0041] Figure 8 This is a schematic diagram of the structure of the first type of contact pad provided in the embodiments of this application;

[0042] Figure 9 This is a schematic diagram of the structure of the second type of contact pad provided in the embodiments of this application;

[0043] Figure 10 This is a schematic diagram of the structure of the third type of contact pad provided in the embodiments of this application;

[0044] Figure 11 This is a schematic diagram of the structure of a spring arm provided in an embodiment of this application;

[0045] Figure 12 This is a schematic diagram of the structure of the first interventional assisted circulation system provided in the embodiments of this application;

[0046] Figure 13 for Figure 12 A schematic diagram of the structure in the transmission mode;

[0047] Figure 14 for Figure 12 A schematic diagram of the structure in the anchoring configuration;

[0048] Figure 15 This is a schematic diagram of the structure of a second type of interventional assisted circulation system provided in an embodiment of this application.

[0049] Explanation of reference numerals in the attached figures

[0050] Anchoring device 1; Support part 11; Receiving cavity 11a; Mounting hole 11b; Cylinder 111; First opening 111a; Spring piece 112; Through hole 112a; Stepped part 112b; Collar 113; Rigid frame 114; Second opening 114a; Bracket 1141; First sleeve 1142; Second sleeve 1143; Third sleeve 115; Anchoring part 12; Spring arm 12a; Contact pad 12a1; First transition section 12a11; First contact section 12a12; First thickened section 12a13; First extension section 12a14; First corner 12a1a; Second transition section 12a11'; Second contact section 12a12'; Second thickened section 12a13'; Second extension section 12a14'; Second corner 12a1 a'; Third transition section 12a11”; Third contact section 12a12”; Third thickened section 12a13”; Third extension section 12a14”; Third corner 12a1a”; Axial connection section 12a2; Inclined section 12a3; Bending section 12a31; First bending section 12a311; Second bending section 12a312; Third bending section 12a313; First straight section 12a32; Second straight section 12a33; Transmission pipe 2; Inlet 2a; Outlet 2b; Power unit 3; External suction pump 31; Outer shell 311; Blood storage chamber 311a; Air chamber 311b; Air inlet / outlet 311b1; Elastic membrane 312; Pump pipe 32; Motor 31'; Impeller 32'; Flexible transmission shaft 33'; Blood vessel a; Transfer pipe b. Detailed Implementation

[0051] It should be noted that, unless otherwise specified, the embodiments and technical features in the embodiments of this application can be combined with each other, and the detailed descriptions in the specific implementation should be understood as explanations of the purpose of this application and should not be regarded as undue limitations on this application.

[0052] The present application will now be described in further detail with reference to the accompanying drawings and specific embodiments. The terms "first," "second," etc., used in the embodiments of this application are for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly including at least one feature. In the description of the embodiments of this application, "multiple" means at least two, that is, including two or more, such as two or three, unless otherwise explicitly specified.

[0053] During percutaneous coronary intervention (PCI), the prophylactic implantation of a percutaneous mechanical circulatory support (PMCS) is used to partially improve cardiac function, increase myocardial blood supply, and enhance tolerance to myocardial ischemia. This ensures effective circulation is maintained even in the event of circulatory collapse, promoting postoperative recovery. Related techniques include interventional pumps or left ventricular assist devices (LVADs), which achieve their blood supply function through mechanical pumps and valves, respectively. Due to fluid impact on the device or asymmetrical device assembly, the mechanical device may experience swaying during operation, requiring clamping with the aortic valve. Therefore, these two types of devices are not suitable for patients with aortic valve disease.

[0054] In view of this, please refer to Figure 1 In a first aspect of the present application, an anchoring device 1 is provided for an interventional auxiliary circulation system. The anchoring device 1 includes a support portion 11 and an anchoring portion 12.

[0055] The support part 11 is tubular, and the anchoring part 12 has at least two elastic arms 12a. One end of the elastic arm 12a is connected to the support part 11, and the other end of the elastic arm 12a is a free end.

[0056] For example, the connection between the spring arm and the support 11 can be a detachable connection or an integral molding.

[0057] The anchoring device 1 can be inserted into blood vessel a along with the interventional circulatory support system. The anchoring device 1 has an anchoring mode and a delivery mode. In the anchoring mode, the free end of the elastic arm 12a abuts against the wall of blood vessel a. Under its own elastic force, it provides radial support for fixing the interventional circulatory support system in blood vessel a. When the interventional circulatory support system shakes under the impact of blood, it will cause the elastic arm 12a to deform. Since the elastic arm 12a has the tendency to return to its original shape, the elastic arm 12a generates radial support force to counteract the shaking, thereby achieving the effect of stabilizing the interventional circulatory support system and ensuring the safety and effectiveness of the system. In the delivery mode, each elastic arm 12a retracts inward under the action of external force, and is then inserted into or removed from blood vessel a along with the interventional circulatory support system. That is to say, the radial dimension of the anchoring device 1 is reduced in the delivery mode, which facilitates the insertion or removal of the anchoring device 1 from blood vessel a. Understandably, before the surgery, the anchoring device 1 retracts the elastic arm 12a through a transfer mode and then inserts it into the blood vessel a. During the surgery, the anchoring device 1 fixes the system in the blood vessel a through an anchoring mode. After the surgery, the blood vessel a is removed through a transfer mode. This process can be performed through interventional methods, which reduces the surgical risk.

[0058] The anchoring device 1 provided in this embodiment switches between anchoring and delivery modes by deforming the elastic arm 12a of the anchoring part 12 under stress. In the anchoring mode, the anchoring device 1 is fixed in the blood vessel a by its own elastic arm 12a, eliminating the need for fixation of the interventional circulatory support system by means of valves or other tissues within the blood vessel a, thus alleviating the blood supply problem for patients with valve disease. At the same time, the anchoring device 1 contracts in the delivery mode to reduce its radial size, facilitating the insertion or removal of the anchoring device 1 in the blood vessel a via interventional means before or after surgery, thereby reducing the surgical risk for the patient.

[0059] Understandably, the interventional circulatory system with anchoring device 1 can be used to assist in blood supply to patients with aortic valve disease. Exemplarily, the interventional circulatory system with anchoring device 1 is used in percutaneous coronary intervention for patients with aortic valve disease, placed within the descending aorta, and secured to the vessel wall a by the elastic arm 12a.

[0060] In one embodiment, please refer to Figure 2 The anchoring part 12 and the support part 11 are integrally formed. Each elastic arm 12a is connected to one end of the axial direction of the support part 11. The annular area inside the support part 11 serves as the suction port of the interventional circulatory support system. That is to say, the elastic arm 12a and the support part 11 are not detachably connected. The anchoring device 1 is set as the suction port of the interventional circulatory support system. When the interventional circulatory support system performs blood suction, the swaying caused by the blood impact will cause the elastic arm 12a to deform. Since the elastic arm 12a has the tendency to return to its original shape, the elastic arm 12a generates radial support force to counteract the swaying, thereby achieving the effect of stabilizing the interventional circulatory support system and ensuring the safety and effectiveness of the system.

[0061] The number of spring arms 12a is unlimited; there can be two, three, or more.

[0062] For example, the anchoring part 12 has four elastic arms 12a, which are arranged around the support part 11 at equal intervals to improve the stability of the interventional circulation auxiliary system.

[0063] In other embodiments, please refer to Figure 1 and Figures 3 to 6 The anchoring part 12 is sleeved on the supporting part 11, and the supporting part 11 forms a receiving cavity 11a for blood transfer. The elastic arm 12a can retract into the receiving cavity 11a in the transfer mode. That is to say, the supporting part 11, as part of the interventional circulatory support system, is used for blood transfer. The elastic arm 12a retracts into the receiving cavity 11a in the transfer mode. In this way, the anchoring device 1 has a compact structure, and the receiving cavity 11a simultaneously realizes the functions of the elastic arm 12a retracting to receive and transfer blood.

[0064] For example, the manufacturing method of the spring arm 12a involves first cutting a semi-finished product from a straight tube using wire cutting or laser cutting technology, and then shaping the semi-finished product using heat setting technology. Taking two spring arms 12a arranged at relative intervals on the support portion 11 as an example, the geometric characteristic parameters after shaping are as follows: Figure 7 As shown, the opening diameter of the two elastic arms 12a in their natural state is D1. Based on the actual diameter of the descending aorta a in the patient, a suitable opening diameter is selected to provide sufficient radial force. The height of the two elastic arms 12a after opening is H1. It can be understood that different opening diameters D1 correspond to different heights H1. The angle between the line connecting the end of the elastic arm 12a near the support 11 and the free end of the elastic arm and the axis of the anchoring device 1 is C1. When adjusting the height H1 according to D1, preferably, C1 is between 30° and 60°. When the elastic arm 12a extends from the side near the support 11 to the side away from the support, there are multiple bends, such as... Figure 7 As shown, the angle between the spring arm 12a and the axial direction of the anchoring device 1 changes four times, from A1 to A4. The magnitude of each change is called the transition angle, i.e., the transition angle is from B1 to B3. The transition angle divides the spring arm 12a into several combined arms, so A1 to A4 can also refer to each combined arm with a different orientation. The first and last angles of the spring arm 12a have a significant impact on the spring arm 12a, corresponding to... Figure 7 In the diagram, A1 and A4 are considered. The larger A1 is, the more difficult it is for the elastic arm 12a to retract in the transmission mode; the smaller A4 is, the larger the contact area between the elastic arm 12a and the blood vessel a. When designing the shape of the elastic arm 12a, given that D1 and H1 are already determined, the angles of A1 and A4 are determined first. Several directional changes can be designed in the middle for transition. For example, the number of transition angles is no more than 4.

[0065] In one embodiment, please refer to Figure 1 The support part 11 includes a cylindrical body 111 and a plurality of spring pieces 112 disposed inside the cylindrical body 111. The side wall of the cylindrical body 111 is provided with a plurality of first openings 111a. A spring arm 12a is provided on the outer side of the first opening 111a, and a spring piece 112 is provided on the inner side of the first opening 111a. In the conveying mode, the spring arm 12a is pressed inward through the first opening 111a by an external force. In the anchoring mode, the spring piece 112 closes the first opening 111a from the inside. That is to say, the spring piece 112 is disposed in the inner side of the first opening 111a in an openable and closable manner. In the conveying mode, it can cooperate with the spring arm 12a to retract into the receiving cavity 11a to insert or remove the anchoring device 1. In the anchoring mode, it closes the receiving cavity 11a to transfer blood.

[0066] Understandably, the materials of the spring arm 12a and the spring piece 112 of the anchoring part 12 need to be able to recover their original shape after the transfer mode changes to the anchoring mode. The material stiffness should be moderate, providing sufficient radial force to stabilize the position of the interventional cyclic auxiliary system, without increasing the difficulty of deformation due to excessive stiffness. Therefore, the spring arm 12a and the spring piece 112 can be shape memory alloys, such as nickel-titanium alloys.

[0067] In one embodiment, please refer to Figure 1 and Figure 6 A through hole 112a is formed at one end of the spring piece 112 near the root of the spring arm 12a for blood to flow out in the anchored state. In this way, by draining some of the blood transported in the receiving cavity 11a to the outside of the receiving cavity 11a, the gap between the spring arm 12a and the spring piece 112 can be flushed, reducing the risk of thrombosis and improving the safety of the device.

[0068] In one embodiment, please refer to Figure 1 The support part 11 includes a collar 113, which is sleeved on the first axial end of the cylinder 111 and the two are fixedly connected. One end of the elastic arm 12a is connected to the collar 113. The connection method between the collar 113 and the cylinder 111 is not limited, and can be welding or bonding, etc.

[0069] In one embodiment, please refer to Figure 5 The support portion 11 includes a rigid frame 114, and the cylinder 111 is fitted over the rigid frame 114. This increases the structural strength and rigidity of the cylinder 111. For example, the cylinder 111 can be made of a flexible material, such as an e-PTFE film, thereby reducing the overall thickness during transport, while the rigid frame 114 provides support for the cylinder 111.

[0070] In some embodiments, the rigid frame 114 includes an axially extending bracket 1141 and a first sleeve 1142 connected to one end of the bracket 1141. The support portion 11 includes a collar 113, which is sleeved on the axial first end of the cylinder 111 and the two are fixedly connected. One end of the elastic arm 12a is connected to the collar 113. The collar 113, the cylinder 111, and the first sleeve 1142 are nested and fixedly connected in a radially inward direction.

[0071] In one embodiment, the collar 113, the cylinder 111, and the first sleeve 1142 are respectively provided with mounting holes 11b. The mounting holes 11b penetrate the collar 113, the cylinder 111, and the first sleeve 1142 radially. A stepped portion 112b is formed at one end of the spring piece 112 near the first sleeve 1142, and the stepped portion 112b passes through and is fixed in the mounting hole 11b. It is understood that the thickness of the stepped portion 112b is equal to or close to the sum of the thicknesses of the mounting holes 11b of the collar 113, the cylinder 111, and the first sleeve 1142. This results in a compact structure and a secure fixation.

[0072] In one embodiment, the sidewall of the rigid frame 114 has multiple second openings 114a extending along the support 1141 to the first sleeve 1142, wherein the second openings 114a are located between two adjacent supports 1141. In the conveying mode, the spring arm 12a, under the action of external force, presses the spring piece 112 inward through the first opening 111a and the second opening 114a. In the anchoring mode, the spring piece 112 closes the first opening 111a from the inside through the second opening 114a. That is, the rigid frame 114 has a large-area hollow structure, and the hollow area is larger than the hollow area of ​​the cylinder 111, so that the spring arm 12a presses the spring piece 112 inward through the first opening 111a and the second opening 114a into the receiving cavity 11a. The circumferential arrangement of the supports 1141 is staggered from the first opening 111a to ensure that the spring arm 12a can enter the interior of the receiving cavity 11a when it is retracted inward. In this way, by setting an opening, the collar 113, the cylinder 111 and the first sleeve 1142 are fixed, and the spring arm 12a and the spring piece 112 can enter the receiving cavity 11a, saving the material of the rigid frame 114.

[0073] In other embodiments, the rigid frame 114 of the cylinder 111 includes a first sleeve 1142 and a second sleeve 1143, and the support part 11 includes a collar 113 and a third sleeve 115. The collar 113 is sleeved on the first axial end of the cylinder 111 and the two are fixedly connected. One end of the elastic arm 12a is connected to the collar 113. The third sleeve 115 is sleeved on the second axial end of the cylinder 111 and the two are fixedly connected. The second sleeve 1143 is sleeved on the second axial end of the cylinder 111 and the two are fixedly connected. The collar 113, the cylinder 111 and the first sleeve 1142 are nested and fixedly connected in a radially inward direction. The third sleeve 115, the cylinder 111 and the second sleeve 1143 are nested and fixedly connected in a radially inward direction.

[0074] The method of fixing the third sleeve 115 to the cylinder 111 and the second sleeve 1143 is not limited. For example, the third sleeve 115 has a first step and a second step formed by the thickness decreasing from the second axial end to the first axial end of the cylinder 111. The third sleeve 115 is fixedly connected to the cylinder 111 and the second sleeve 1143 through the second step. Specifically, the support part 11 also includes a pin. The third sleeve 115 has a pin hole formed on the side wall of the second step, and the cylinder 111 and the second sleeve 1143 have corresponding pin holes. Fixing is achieved through an interference fit between the pin hole and the pin. The interference fit means that the pin is inserted into the pin hole and presses against the wall surface of the pin hole. It is understood that the difference in thickness between the second step and the first step is equal to or close to the thickness of the cylinder 111 and the second sleeve 1143.

[0075] In one embodiment, a contact pad 12a1 is formed at the end of the elastic arm 12a away from the support portion 11. The contact pad 12a1 protrudes from the elastic arm 12a toward the side closer to the wall of the blood vessel a and / or toward the side away from the wall of the blood vessel a. It is understood that the elastic arm 12a has a small thickness and width, which may result in insufficient radial force; the contact area between the elastic arm 12a and the blood vessel a is small, which may cause damage to the blood vessel a. This embodiment improves the radial force and increases the contact area with the blood vessel a by providing the contact pad 12a1, thereby reducing the surgical risk for the patient.

[0076] For example, please refer to Figure 8 The contact pad 12a1 protrudes from the elastic arm 12a towards the side closer to the vessel wall a. The cross-sectional shape of the contact pad 12a1 can be defined by four line segments: the first transition segment 12a11, the first contact segment 12a12, the first thickened segment 12a13, and the first extension segment 12a14. The following describes the state of each segment under the anchoring configuration. The first extension segment 12a14 extends a distance along the end of the elastic arm 12a away from the support portion 11, and then extends towards the side closer to the vessel wall a to form the first thickened segment 12a13. The first thickened segment 12a13 extends axially towards the support portion 11 to form the first contact segment 12a12. The direction of the first contact segment 12a12 is not necessarily consistent with the axial direction of the support portion 11. Specifically, the first contact segment 12a12 can be inclined at 0 to 20° towards the side away from the vessel wall a. The first contact segment 12a12 extends towards the side away from the vessel wall a and connects with the elastic arm 12a to form the first transition segment 12a11. For example, the line segments are transitioned by rounded corners.

[0077] Understandably, the thickness of each section varies depending on the location of the anchoring device 1 on the interventional circulation auxiliary system. Specifically, to achieve the purpose of thickening, when the anchoring device 1 is located at the suction port of the interventional circulation auxiliary system, the length of the first thickened section 12a13 is equal to 2 to 4 times the thickness of the spring arm 12a, and the length of the first contact section 12a12 is 0.5 to 2 times the length of the first thickened section 12a13; when the anchoring device 1 is not located at the suction port of the interventional circulation auxiliary system, the length of the first thickened section 12a13 is equal to 2 to 8 times the thickness of the spring arm 12a, and the length of the first contact section 12a12 is 1 to 2 times the length of the first thickened section 12a13. The angle of the first bend 12a1a formed by the first thickened section 12a13 and the first contact section 12a12 is 90° to 135°; the first transition section 12a11 and the elastic arm 12a form a cone shape, preferably the angle between the first transition section 12a11 and the elastic arm 12a is not greater than 30 degrees.

[0078] Understandably, the part of the elastic arm 12a that contacts the blood vessel a is mainly the first contact segment 12a12 of the contact pad 12a1. The first contact segment 12a12 increases the contact area between the elastic arm 12a and the blood vessel a, reducing the pressure in the contact area and thus reducing damage to the blood vessel a; the first thickened segment 12a13 increases the thickness of the end of the elastic arm 12a away from the support part 11, increasing the radial force of the anchoring structure. At the same time, during the operation, the tissue of the blood vessel a around the contact pad 12a1 may proliferate, causing the contact pad 12a1 to be wrapped by the proliferating tissue. Due to the presence of the first thickened segment 12a13, the time required for the proliferating tissue to completely wrap the contact pad 12a1 is increased, thus increasing the time the device can be placed in the human body, reducing the difficulty of retrieving the device, and reducing surgical risks.

[0079] Furthermore, finite element analysis was performed on the spring arm 12a of this embodiment and the spring arm 12a without the contact pad 12a1 to analyze the force state of the two types of spring arms 12a under a 21mm blood vessel a. The calculation results show that the radial force of the spring arm 12a with the contact pad 12a1 is 1.17N, while the radial force of the branch without the contact pad 12a1 is 0.48N, approximately doubling the radial force. Simultaneously, with the contact pad 12a1 present, the pressure on the wall of blood vessel a is 3.3MPa; while without the contact pad 12a1, the pressure on blood vessel a is 7.15MPa. In other words, adding the contact pad 12a1 increases the radial force, further ensuring the stability of the equipment operation. While increasing the radial force, it also reduces the pressure on the wall of blood vessel a, thereby reducing damage to blood vessel a.

[0080] For example, please refer to Figure 9The contact pad 12a1 protrudes from the elastic arm 12a toward the side opposite to the wall of the blood vessel a. The cross-sectional shape of the contact pad 12a1 can be defined by four line segments: the second transition segment 12a11', the second contact segment 12a12', the second thickened segment 12a13', and the second extension segment 12a14'. The following describes the state of each segment in the anchoring configuration. The second extension segment 12a14' extends a distance along the end of the elastic arm 12a away from the support portion 11; the second extension segment 12a14' extends axially away from the support portion 11 to form the second contact segment 12a12'; the second contact segment 12a12' extends toward the side closer to the wall of the blood vessel a to form the second thickened segment 12a13'; the second thickened segment 12a13' extends axially toward the support portion 11 and connects with the elastic arm 12a to form the second transition segment 12a11'. Referring to the description of the contact pad 12a1 in the above embodiments, the definition or function of the second contact segment 12a12', the second thickened segment 12a13', and the second corner 12a1a' are the same as those of the first contact segment 12a12, the first thickened segment 12a13, and the first corner 12a1a.

[0081] For example, please refer to Figure 10 The contact pad 12a1 protrudes from the elastic arm 12a towards the side closer to the wall of the blood vessel a and towards the side away from the wall of the blood vessel a. The cross-sectional shape of the contact pad 12a1 can be defined by four line segments: the third transition segment 12a11”, the third contact segment 12a12”, the third thickened segment 12a13”, and the third extended segment 12a14”. It is understood that the contact pad 12a1 is a combination of the two embodiments described above, and the third corner 12a1a” and the first corner 12a1a have the same definition or function.

[0082] In one embodiment, please refer to Figure 3 The spring arm 12a includes an axial connecting section 12a2 and an inclined section 12a3 connected to each other. The axial connecting section 12a2 extends axially along the support portion 11, and the first end of the axial connecting section 12a2 is connected to the support portion 11. The inclined section 12a3 extends inclinedly outward from the second end of the axial connecting section 12a2. That is, the axial connecting section 12a2 facilitates the inclined section 12a3 to begin tilting at a suitable position.

[0083] In one embodiment, please refer to Figure 11The inclined segment 12a3 is partially bent in the width direction to form a bend 12a31. It is understood that the bend 12a31 reduces the stiffness of the spring arm 12a, thereby reducing the radial force of the spring arm 12a. Therefore, the bend is only localized in the inclined segment 12a3 to maintain sufficient radial force to achieve the anchoring function in the anchoring configuration. In other words, for the anchoring device 1 not located at the aspiration port of the interventional circulatory support system, the thickness is lower, and localized bending may lead to insufficient radial force; therefore, the bend 12a31 is not provided. It is understood that for the anchoring device 1 located at the aspiration port of the interventional circulatory support system, the thickness is higher, and therefore its stiffness is also higher. Excessive stiffness may affect the device's passage through the curved blood vessel a, increasing the difficulty of the surgery. Therefore, the bend 12a31 is formed by locally bending the inclined segment 12a3 in the width direction to reduce stiffness and decrease the difficulty of the surgery.

[0084] Specifically, please refer to Figure 7 The bend 12a31 is formed at the transition angle B1. In the delivery state, the interventional assisted circulation system is inserted into blood vessel a through the transport tube b. When the transport tube b bends inside blood vessel a, the anchoring device 1 deforms at the transition angle B1 and the area on both sides. Thus, the bend 12a31 is formed to reduce the stiffness near the transition angle B1, making the anchoring device 1 easier to bend and easier to pass through blood vessel a.

[0085] In one embodiment, the shape of the bent portion 12a31 can also be processed by laser cutting; the width of the bent portion 12a31 is smaller than the width of the non-bent portion of the inclined segment 12a3; if both regions use the same width... Figure 11 The curved shape increases the overall length of the spring arm, leading to increased costs and a further decrease in radial support force.

[0086] In one embodiment, the inclined segment 12a3 includes a first straight segment 12a32 and a second straight segment 12a33. The first straight segment 12a32 is connected to the axial connecting segment 12a2, and the bent portion 12a31 connects the first straight segment 12a32 and the second straight segment 12a33. The first straight segment 12a32 and the second straight segment 12a33 extend along the same straight line. In this way, by placing the bent portion 12a31 between the first straight segment 12a32 and the second straight segment 12a33, the inclined segment 12a3 of the elastic arm 12a, while forming the bent portion 12a31 to reduce stiffness, will not significantly affect the angle at which the elastic arm 12a a abuts against the wall of the blood vessel a in the anchored state, thereby reducing damage to the blood vessel a.

[0087] In one embodiment, the bending portion 12a31 includes a first bending segment 12a311, a second bending segment 12a312, and a third bending segment 12a313. The first bending segment 12a311 is connected to the first straight segment 12a32 and extends obliquely to a first side in the width direction of the first straight segment 12a32. The second bending segment 12a312 extends obliquely from the end of the first bending segment 12a311 to a second side in the width direction. The third bending segment 12a313 extends obliquely from the end of the second bending segment 12a312 to the first side in the width direction and is connected to the second straight segment 12a33. Understandably, during the stress process, areas of local geometric discontinuity are often stress concentration points and are prone to damage. Therefore, when connecting the first bending segment 12a311, the second bending segment 12a312, and the third bending segment 12a313, it is necessary to ensure that the curved surface formed at the connection between the first bending segment 12a311 and the second bending segment 12a312, and between the second bending segment 12a312 and the third bending segment 12a313, is tangent to the second bending segment 12a312. This improves the continuity and smoothness of the overall curve, thereby reducing the occurrence of excessive stress that could affect the service life of the spring arm 12a.

[0088] In one embodiment, the first bending segment 12a311 and the third bending segment 12a313 are symmetrically distributed about the center of the second bending segment 12a312. During the manufacturing of the spring arm 12a, only the connection relationship between the first bending segment 12a311 and the second bending segment 12a312 needs to be designed. Then, rotating the side of the first bending segment 12a311 and the second bending segment 12a312 closest to the first bending segment 12a311 about the center of the second bending segment 12a312 by 180 degrees yields the complete drawing of the bending portion 12a31, thus improving design efficiency.

[0089] Furthermore, finite element simulations were performed on the elastic arm 12a with and without the bend 12a31. The same load was applied to both types of elastic arms 12a to deform them, and the deformation amplitude of the two types of elastic arms 12a was obtained using the finite element analysis method. Under the same load, the deformation amplitude of the elastic arm 12a with the bend 12a31 was significantly increased, proving that the stiffness of the elastic arm 12a with the bend 12a31 was reduced, thus making it easier to transport within the blood vessel a.

[0090] The second aspect of the embodiments of this application is referred to. Figures 12 to 15 An interventional circulation auxiliary system is provided, including any of the above-mentioned anchoring devices 1, transmission pipes 2 and power devices 3.

[0091] The transmission conduit 2, used for transporting blood, has an inlet 2a and an outlet 2b, and an anchoring device 1 is connected to the transmission conduit 2. A power unit 3 is connected to the transmission conduit 2 and is used to drive the blood flow within the transmission conduit 2. That is, under the action of the power unit 3, blood flows from the inlet 2a to the outlet 2b through the interventional circulatory support system. It is understood that the power unit 3 can be located inside the body or partially outside the body. The driving method of the power unit 3 is not limited; exemplaryly, it can be electrically driven or mechanically driven.

[0092] For example, the interventional circulatory support system is used for percutaneous coronary intervention. Driven by the power unit 3, blood is drawn in from the inlet 2a and discharged from the outlet 2b, which is equivalent to transporting blood from the side closer to the heart to the distance, maintaining effective blood circulation for the patient.

[0093] In one embodiment, please refer to Figure 14 The interventional circulatory support system inserts or removes blood vessel a via a transport tube b. In delivery mode, insertion or removal is performed by placing the transport tube b over the interventional circulatory support system, making the operation simple and convenient.

[0094] The anchoring device 1 can be installed at multiple locations on the transmission pipe 2. In one embodiment, the anchoring device 1 is installed at the inlet 2a of the transmission pipe 2, and the internal area of ​​the support portion 11 forms the inlet 2a of the transmission pipe 2. In another embodiment, the anchoring device 1 is installed at the location between the inlet 2a and the outlet 2b of the transmission pipe 2. In yet another embodiment, the anchoring device 1 is installed at both the inlet 2a and the location between the inlet 2a and the outlet 2b of the transmission pipe 2, wherein the internal area of ​​the support portion 11 of the anchoring device 1 at the inlet 2a of the transmission pipe 2 forms the inlet 2a of the transmission pipe 2. It is understood that when the distance between the inlet 2a and the outlet 2b is relatively large, in order to ensure that the inlet 2a and the outlet 2b do not sway during operation, it is necessary to install anchoring devices 1 at both the inlet 2a and the location between the inlet 2a and the outlet 2b of the transmission pipe 2, so as to provide support for both the inlet 2a and the outlet 2b; when the distance between the inlet 2a and the outlet 2b is relatively small, the anchoring device 1 can be installed at only one location. This improves the stability of the interventional circulatory support system and reduces surgical risks.

[0095] In one embodiment, please refer to Figures 12 to 14The power unit 3 includes an external suction pump 31 and a pump tube 32. The pump tube 32 connects the transmission pipe 2 and the outlet 2b of the external suction pump 31. The external suction pump 31 has a blood storage chamber 311a. The external suction pump 31 is used to periodically generate negative and positive pressure. When negative pressure is generated, blood flows through the transmission pipe 2 and the pump tube 32 to the blood storage chamber 311a. When positive pressure is generated, the blood in the blood storage chamber 311a flows through the pump tube 32 to the transmission pipe 2 and flows out from the outlet 2b. In other words, the mechanical energy is converted into the kinetic energy of the blood by the suction pump, storing blood under negative pressure and supplying blood under positive pressure, thus completing the patient's blood circulation. Specifically, the outlet 2b of the transmission pipe 2 is a three-way valve with a valve. The external suction pump 31 includes a housing 311 and an elastic diaphragm 312. The elastic diaphragm 312 divides the space inside the housing 311 into two non-communicating blood storage chambers 311a and air chambers 311b. The blood storage chamber 311a is used to store blood, and the air chamber 311b has an inlet / outlet port 311b1. When the power unit 3 is working, it draws in and draws out air through the inlet / outlet port 311b1, driving the elastic diaphragm 312 to move, thereby discharging blood from the blood storage chamber 311a or drawing blood to store in the blood storage chamber 311a. When blood is discharged from the blood storage chamber 311a, it flows through the pump tube 32 to the three-way tube. The valve in the three-way tube prevents the blood from flowing to the inlet 2a, allowing the blood to enter the aorta from the outlet 2b. When blood is drawn from the body and stored in the blood storage chamber 311a, it enters from the inlet 2a and passes through the transmission pipe 2 into the blood storage chamber 311a. At this time, the valve prevents the blood from flowing to the outlet 2b.

[0096] For example, the insertion and removal process of the interventional circulatory support system can be as follows: First, the power unit 3 is removed, and the interventional circulatory support system is disassembled into two parts. These parts are placed in saline solution, and the saline solution is used to fill the internal cavity to prevent air from entering the body. The portion containing the anchoring device 1, the transfer conduit 2, and the pump tube 32 is compressed into the transport tube b in the saline solution. The transport tube b, along with the internal devices, is then delivered into the blood vessel a. The position is confirmed to be appropriate under contrast imaging or ultrasound imaging. After confirming the appropriate position, the transport tube b is withdrawn and the internal devices are released. The elastic arm 12a of the anchoring device 1 opens under its own elastic force, fixing the device to the blood vessel a. Once the transfer conduit 2 is completely withdrawn from the transport tube b, the external aspiration pump 31 is connected, and the interventional circulatory support system begins operation. Based on the patient's electrocardiogram data, the internal air pressure of the air chamber 311b is adjusted to achieve blood draw and transfusion via the three-way valve. After the interventional circulatory support system finishes working, first remove the external suction pump 31, then insert the pump tube 32 into the transfer tube b; the transfer tube b is sent into the body along the pump tube 32, and when it reaches the anchoring device 1, the spring arm 12a is deformed by pushing the transfer tube b forward and finally the system except for the external suction pump 31 is housed in the transfer tube b, as shown in the figure; finally, the transfer tube b together with the interventional circulatory support system is removed from the body.

[0097] In one embodiment, please refer to Figure 15 The power unit 3 includes a motor 31', an impeller 32', and a flexible drive shaft 33'. The impeller 32' is located inside the transmission pipe 2. The flexible drive shaft 33' connects the impeller 32' and the motor 31' shaft of the motor 31'. Driven by the flexible drive shaft 33', the impeller 32' drives the blood to flow unidirectionally from the inlet 2a to the outlet 2b. That is, blood exchange only occurs at the inlet 2a and outlet 2b of the transmission pipe 2, and the blood does not flow into the body through the power unit 3. One end of the motor 31' is connected to an external power source to obtain electrical energy, which is then converted into the kinetic energy of the blood. Specifically, when the motor 31' is working, it drives the impeller 32' to rotate, drawing blood in from the inlet 2a and discharging it from the outlet 2b. The power source is located outside the body, and electrical energy is transmitted from the power source to the motor 31' inside the body via wires. This embodiment also shows the case where only one anchoring device 1 is used. No anchoring device 1 is provided at the inlet 2a; the stability of the entire device is maintained only by the anchoring device 1 located between the inlet 2a and the outlet 2b. To improve the support effect of the anchoring device 1, the anchoring device 1 includes four spring arms 12a.

[0098] For example, the insertion and removal process of the interventional circulatory support system can be as follows: First, remove the power unit 3, disassemble the interventional circulatory support system into two parts, place them in physiological saline and fill the internal cavity with physiological saline to prevent air from entering the body; compress the interventional circulatory support system into the transport tube b in physiological saline; send the transport tube b along with the internal device into the blood vessel a, and confirm the position is appropriate under angiography or ultrasound images; after confirming the position is appropriate, remove the transport tube b and release the interventional circulatory support system, and the elastic arm 12a of the anchoring device 1 opens under its own elastic force, fixing the interventional circulatory support system to the blood vessel a. When the transport tube 2 is completely withdrawn from the transport tube b, connect the power supply, and the interventional circulatory support system begins to work. Driven by the impeller 32', blood is drawn in from the inlet 2a and discharged from the outlet 2b. After the interventional circulatory support system finishes working, the power supply is first disconnected, and then the wire at one end of the motor 31' is inserted into the transfer tube b. The transfer tube b is sent into the body along the wire. When it reaches the anchoring device 1, the spring arm 12a is deformed by pushing the transfer tube b forward, and finally the system except the external suction pump 31 is taken into the transfer tube b. Finally, the transfer tube b and the interventional circulatory support system are removed from the body.

[0099] The various embodiments / implementations provided in this application can be combined with each other without creating contradictions.

[0100] The above description is merely a preferred embodiment of this application and is not intended to limit the application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

Claims

1. An anchoring device for an interventional circulation auxiliary system, characterized in that, include: Support section; An anchoring part has at least two elastic arms, one end of which is connected to the support part, and the other end of which is a free end; The anchoring device can be inserted into the blood vessel along with the interventional circulatory support system. The anchoring device has an anchoring mode and a delivery mode. In the anchoring mode, the free end of the elastic arm abuts against the blood vessel wall under its own elastic force. In the delivery mode, each of the elastic arms retracts inward under the action of external force. The support includes a cylinder and a plurality of spring pieces disposed inside the cylinder. The side wall of the cylinder is provided with a plurality of first openings. The spring arm is disposed outside the first opening and the spring piece is disposed inside the first opening. In the conveying mode, the spring arm squeezes the spring piece inward through the first opening under the action of external force. In the anchoring mode, the spring piece closes the first opening from the inside.

2. The anchoring device according to claim 1, characterized in that, The anchoring part is sleeved on the supporting part, and the supporting part forms a receiving cavity for blood transmission. The elastic arm can retract into the receiving cavity of the supporting part in the transmission mode.

3. The anchoring device according to claim 2, characterized in that, The end of the spring near the root of the spring arm has a through hole for the blood to flow out during the anchoring state.

4. The anchoring device according to claim 2, characterized in that, The support includes a collar, which is sleeved on the first axial end of the cylinder and the two are fixedly connected. One end of the elastic arm is connected to the collar.

5. The anchoring device according to claim 2, characterized in that, The support includes a rigid frame, and the cylindrical body is sleeved outside the rigid frame.

6. The anchoring device according to claim 5, characterized in that, The rigid frame includes an axially extending bracket and a first sleeve connected to one end of the bracket. The support part includes a collar, which is sleeved on the first axial end of the cylinder and the two are fixedly connected. One end of the elastic arm is connected to the collar. The collar, the cylinder and the first sleeve are nested and fixedly connected in a radially inward direction.

7. The anchoring device according to claim 6, characterized in that, The collar, the cylinder, and the first sleeve are respectively formed with mounting holes. The mounting holes penetrate the collar, the cylinder, and the first sleeve radially. The end of the spring piece near the first sleeve is formed with a stepped portion, which is inserted into and fixed in the mounting hole.

8. The anchoring device according to claim 6, characterized in that, The rigid frame has a plurality of second openings extending along the brackets on its sidewalls, wherein the second openings are located between two adjacent brackets; in the conveying mode, the spring arm presses the spring piece inward through the first opening and the second opening under the action of external force; in the anchoring mode, the spring piece closes the first opening from the inside through the second opening.

9. The anchoring device according to claim 1, characterized in that, A contact pad is formed at the end of the elastic arm away from the support portion, and the contact pad protrudes from the elastic arm toward the side closer to the blood vessel wall and / or toward the side away from the blood vessel wall.

10. The anchoring device according to claim 1, characterized in that, The spring arm includes an axial connecting section and an inclined section that are connected to each other. The axial connecting section extends along the axial direction of the support portion. The first end of the axial connecting section is connected to the support portion. The inclined section extends obliquely outward from the second end of the axial connecting section.

11. The anchoring device according to claim 10, characterized in that, A portion of the inclined segment is bent in its width direction to form a bent portion, the width of which is smaller than the width of the non-bent portion of the inclined segment.

12. The anchoring device according to claim 11, characterized in that, The inclined segment includes a first straight segment and a second straight segment. The first straight segment is connected to the axial connecting segment. The bent portion connects the first straight segment and the second straight segment. The first straight segment and the second straight segment extend along the same straight line.

13. The anchoring device according to claim 12, characterized in that, The bending portion includes a first bending segment, a second bending segment, and a third bending segment. The first bending segment connects to the first straight segment and extends obliquely to a first side in the width direction of the first straight segment. The second bending segment extends obliquely from the end of the first bending segment to a second side in the width direction. The third bending segment extends obliquely from the end of the second bending segment to the first side in the width direction and connects to the second straight segment. The first bending segment and the third bending segment are arranged symmetrically about the center of the second bending segment.

14. An interventional circulatory support system, characterized in that, include: The anchoring device according to any one of claims 1 to 13; A blood transport conduit having an inlet and an outlet, wherein the anchoring device is connected to the blood transport conduit; A power unit, connected to the transmission pipe, is used to drive the flow of blood within the transmission pipe.

15. The system according to claim 14, characterized in that, The anchoring device is provided at the inlet of the transmission pipe, and the inner area of ​​the support forms the inlet of the transmission pipe; and / or, the anchoring device is provided at the part of the transmission pipe located between the inlet and the outlet.

16. The system according to claim 14, characterized in that, The power unit includes an external suction pump and a pump tube. The pump tube connects the transmission pipe and the outlet of the external suction pump. The external suction pump has a blood storage chamber. The external suction pump is used to periodically generate negative pressure and positive pressure. When negative pressure is generated, blood flows through the transmission pipe and the pump tube to the blood storage chamber. When positive pressure is generated, the blood in the blood storage chamber flows through the pump tube to the transmission pipe and flows out from the outlet.

17. The system according to claim 14, characterized in that, The power unit includes a motor, an impeller, and a flexible drive shaft. The impeller is disposed inside the transmission pipe, and the flexible drive shaft connects the impeller and the motor shaft of the motor. Driven by the flexible drive shaft, the impeller drives the blood to flow unidirectionally from the inlet to the outlet.

Images