An atrial septal shunt system

Abstract

This application relates to an atrial septal shunt stoma system, belonging to the field of medical device technology. The atrial septal shunt stoma system includes a sheath, a cutter, and a catcher. The catcher includes a push rod, a fixation base, and a catcher claw. The push rod is movably inserted through the sheath and the cutter, with its proximal end located outside the sheath. The fixation base is located at the distal end of the push rod, and the proximal end of the catcher claw is connected to the fixation base. This application, by placing a cutter at the distal end of the sheath and a catcher, with the push rod of the catcher movably inserted through the sheath, and an ablation electrode on the outer wall of the catcher claw, facilitates both the grasping and cutting of atrial septal tissue and its ablation. This enables the shunt stoma of the atrial septum, reduces the regenerative capacity of the atrial septal tissue at the stoma site, and improves the stability of the stoma size, thus preventing the stoma size from shrinking rapidly after surgery.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an atrial septal shunt stoma system. Background Technology

[0002] Atrial septal ostomy is an interventional procedure that improves hemodynamics by creating an artificial gap in the atrial septum of the heart. It is mainly used to promote the mixing of blood between the left and right atria, improve systemic oxygen supply, and relieve hypertension.

[0003] Traditional atrial septal puncture is performed by balloon dilation after percutaneous atrial septal puncture to create an atrial septal septum; however, the myocardial tissue at the septum site tends to rebound, and the septum may shrink or even close completely after a period of time.

[0004] In view of the above, this application is hereby submitted. Summary of the Invention

[0005] The purpose of this application is to overcome the shortcomings of the prior art and provide an atrial septal shunt stoma system.

[0006] To achieve the above objectives, the technical solution adopted in this application is as follows: A septal shunt system includes a sheath, a cutter, and a catcher. The sheath has an axially connected chamber connecting its distal and proximal ends. The cutter has an axially connected chamber connecting its distal and proximal ends and is located at the distal end of the sheath. The catcher includes a push rod, a fixing seat, and a catcher claw. The push rod movably passes through the sheath and the cutter, with its proximal end located outside the sheath. The fixing seat is located at the distal end of the push rod. The proximal end of the catcher claw is connected to the fixing seat. An ablation electrode is disposed on the outer wall of the catcher claw. The catcher claw can switch between an extended and retracted state under external force.

[0007] Compared with the prior art, the beneficial effects of this application are as follows: This application provides a cutter at the distal end of the sheath and a grabber with its push rod movably inserted through the sheath. The grabber claw of the grabber is equipped with an ablation electrode, which facilitates both grabbing and cutting of the atrial septum tissue and ablation of the atrial septum tissue. This enables the shunting of the atrial septum, reduces the regenerative capacity of the atrial septum tissue at the stoma site, and improves the stability of the stoma size, thereby preventing the stoma size from shrinking in a short period of time after surgery. Attached Figure Description

[0008] The embodiments described in this application are not limited to the figures described below, which are only some of the embodiments described in this application. Those skilled in the art can obtain figures of other embodiments based on the content of this application.

[0009] Figure 1 A partial perspective view of a room-separating ostomy system provided in one embodiment of this application; Figure 2 A partial cross-sectional view of a room-separating ostomy system provided in one embodiment of this application; Figure 3 A schematic diagram showing the disassembled room-separating ostomy system provided in one embodiment of this application; Figures 4A to 4E Flowchart of the procedure for creating a septal shunt stoma.

[0010] In the figure, 1-sheath, 2-cutter, 21-connector, 22-blade, 3-catcher, 31-push rod, 32-fixed base, 33-catch claw, 4-ablation electrode, 5-collection tube, 6-collector, 61-collection part, 62-connecting rod part, 7-development ring. Detailed Implementation

[0011] To make the objectives, advantages, and features of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, used only to facilitate and clearly illustrate the purpose of the embodiments of this application. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and sometimes use different scales.

[0012] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application.

[0013] It is understood that spatial relation terms such as "below," "under," "below," "below," "above," "over," etc., can be used here to describe the relationship between one element or feature shown in the figure and other elements or features. It should be understood that, in addition to the orientation shown in the figure, spatial relation terms also include different orientations of the device in use and operation. For example, if the device in the figure is flipped, the element or feature described as "below" or "under" or "below" of the other element or feature will be oriented "over" the other element or feature. Therefore, the exemplary terms "below" and "under" can include both upper and lower orientations. Furthermore, the device may also include other orientations (e.g., rotated 90° or other orientations), and the spatial descriptive terms used herein will be interpreted accordingly.

[0014] It should be noted that when one element is considered to be "connected" to another element, it can be directly connected to the other element or connected to the other element through an intermediary element. In the following embodiments, "connection" should be understood as "electrical connection," "communication connection," etc., if the connected circuits, modules, units, etc., have the transmission of electrical signals or data between them.

[0015] It should be noted that the singular forms of “a,” “one,” and “the” can also include the plural forms, unless the context clearly indicates otherwise.

[0016] It should also be understood that the terms “comprising / including” or “having” specify the presence of the stated features, wholes, steps, operations, devices, parts or combinations thereof, but do not preclude the possibility of the presence or addition of one or more other features, wholes, steps, operations, devices, parts or combinations thereof.

[0017] It should also be understood that, unless otherwise specified or indicated, the terms “first,” “second,” “third,” etc., in the specification are used only to distinguish the various devices, elements, and steps in the specification, and not to indicate the logical or sequential relationships between the various devices, elements, and steps.

[0018] In the description of this application, it should be noted that the term "distal" usually refers to the end of the medical device that first enters the patient's body during normal operation, while "proximal" usually refers to the end of the medical device that is closer to the operator during normal operation.

[0019] Please see Figures 1-3 This application provides an atrial septal shunt system, which includes a sheath 1, a cutter 2, and a catcher 3. The sheath 1 has a chamber that connects its distal and proximal ends along its axial direction. The cutter 2 has a chamber that connects its distal and proximal ends along its axial direction and is located at the distal end of the sheath 1. The catcher 3 includes a push rod 31, a fixing seat 32, and a catcher 33. The push rod 31 is movably inserted through the sheath 1 and the cutter 2, and the proximal end of the push rod 31 is located outside the sheath 1. The fixing seat 32 is located at the distal end of the push rod 31. The proximal end of the catcher 33 is connected to the fixing seat 32. An ablation electrode 4 is provided on the outer wall of the catcher 33. The catcher 33 can switch between an extended state and a contracted state under the action of external force.

[0020] This application provides a cutter 2 at the distal end of the sheath 1, and a push rod of the grabber 3 is movably inserted through the sheath 1. An ablation electrode 4 is provided on the outer wall of the grabber claw 33 of the grabber 3. This facilitates the grabbing and cutting of the atrial septum tissue, as well as the ablation of the atrial septum tissue. It can achieve a shunt stoma of the atrial septum, reduce the regenerative capacity of the atrial septum tissue at the stoma site, and improve the stability of the stoma size, so as to avoid the stoma size from shrinking in a short period of time after surgery.

[0021] In some embodiments, the grasping claw 33 includes a plurality of grasping arms 331, the inner wall of the grasping arms 331 is provided with barbs 332, and the ablation electrode 4 is disposed on the outer wall of the grasping arms 331.

[0022] In some embodiments, the barbs 332 are angled away from the distal end of the capture arm 331.

[0023] In some embodiments, a plurality of capture arms 331 are distributed at equal intervals along the circumference of the mounting base 32.

[0024] In some embodiments, when the gripper 33 is in the extended state, the size of the gripper 33 is larger than the outer diameter of the sheath 1 in the radial direction.

[0025] When the grabbing claw 33 is in the extended state, the grabbing arm 331 can be an arc-shaped structure, a straight structure, or a bent structure composed of multiple arc-shaped parts and multiple straight parts spaced apart.

[0026] In some implementations, the gripper claw 33 is made of shape memory alloy.

[0027] In some embodiments, the outer surface of the gripper 33 is provided with an insulating coating.

[0028] In some embodiments, the push rod 31 can be made of metal or polymer; the fixing base 32 can be made of metal or polymer.

[0029] In some embodiments, the atrial septal shunt system further includes a receiving tube 5, the interior of which forms a chamber that connects its distal and proximal ends along its axial direction. The receiving tube 5 is movably inserted through the sheath 1 and the cutter 2, with the proximal end of the receiving tube 5 located outside the sheath 1. A push rod 31 is movably inserted through the receiving tube 5, with the proximal end of the push rod 31 located outside the receiving tube 5.

[0030] When the grasping claw 33 is in the extended state, the grasping claw 33 extends out of the storage tube 5 to grasp the interatrial septum tissue; when the grasping claw 33 is in the retracted state, the grasping claw 33 retracts into the storage tube 5.

[0031] The grabbing claw 33 can be partially or completely retracted into the storage tube 5 under the drive of the storage tube 5 or the push rod 31.

[0032] In use, the fixing base 32 and the grasping claw 33 are pushed from the proximal end to the distal end by the push rod 31, which can extend part or all of the grasping claw 33 out of the receiving tube 5. The part of the grasping claw 33 protruding from the receiving tube 5 opens up and can be used to grasp atrial septal tissue. The larger the dimension of the part of the grasping claw 33 protruding from the receiving tube 5 in the axial direction of the push rod 31, and the larger the dimension of the part of the grasping claw 33 protruding from the receiving tube 5 in the radial direction of the push rod 31, the more atrial septal tissue can be grasped.

[0033] In some embodiments, the atrial septal diversion ostomy system further includes a receiver 6, which includes a receiver 61 and a connecting rod 62 connected in sequence. The connecting rod 62 is movably inserted through the catcher 3, with the proximal end of the connecting rod 62 located outside the catcher 3. The proximal end of the receiver 61 is connected to the distal end of the connecting rod 62. The proximal end of the receiver 61 is provided with a receiver cavity 63, which is arranged around the connecting rod 62 and is adapted to the cutter 2.

[0034] In this application, the connecting rod 62 is movably inserted into the capture device 3, and a storage cavity 63 adapted to the cutter 2 is provided at the proximal end of the storage part 61. This facilitates the cutting of the atrial septum tissue through the cooperation of the storage device 6 and the cutter 2, and also allows the cut atrial septum tissue to be wrapped in the receiving space formed by the combination of the storage device 6 and the cutter 2. During the system retraction process, the cut tissue will not easily fall off, thus avoiding the removal of the cut tissue from the atrium.

[0035] In some embodiments, the interior of the receiver 6 is formed with a chamber communicating with its distal and proximal ends along its axial direction for accommodating guidewires and / or puncture needles.

[0036] In some embodiments, the storage container 6 is made of metal or polymer.

[0037] In some embodiments, the cutter 2 includes a connecting portion 21 and a blade portion 22 connected in sequence, wherein the proximal end of the connecting portion 21 is connected to the distal end of the sheath 1.

[0038] The material of cutter 2 can be metal.

[0039] This application does not impose any particular restrictions on the number and shape of the cutting edge 22. For example, the number of cutting edge 22 may be no less than two, and they may be serrated; or the cutting edge 22 may be a ring structure.

[0040] In some embodiments, the blade portion 22 is electrically connected to a power source, so that the blade portion 22 can serve as an ablation electrode. After or during cutting, the blade portion 22 is energized to ablate the adjacent interatrial septum tissue.

[0041] In some embodiments, the ablation electrode 4 may include at least one of a radiofrequency ablation electrode, a pulsed ablation electrode, an ultrasonic ablation electrode, a microwave ablation electrode, and a cryoablation electrode.

[0042] In some embodiments, the atrial septal shunt system further includes a radiopaque ring 7, which is sleeved on the sheath 1.

[0043] In some embodiments, the sheath 1 includes a first tube segment and a second tube segment connected sequentially from its distal end to its proximal end, wherein the hardness of the first tube segment is less than that of the second tube segment. The atrial septal shunt system further includes a pull cord, a pull cord channel, and a bending ring. The bending ring is disposed in the first tube segment. The distal end of the pull cord is connected to the bending ring. The pull cord channel extends axially along the sheath tube 1. The pull cord is movably inserted through the pull cord channel. Specifically, the proximal end of the pull cord passes through the pull cord channel and extends to the outside of the pull cord channel.

[0044] In use, by pulling the proximal end of the pull line, the first section of the sheath tube 1 can be bent.

[0045] In some embodiments, the sheath 1 is a hollow, multi-layered tube structure, the pull wire channel is disposed in the inner wall of the sheath 1, and the bending ring is disposed in the inner wall of the first tube segment.

[0046] In some embodiments, the draw cable channel is a hollow tubular structure.

[0047] In some embodiments, the pull wire channel is disposed on the outer wall of the sheath 1, and the bending ring is sleeved on the outer wall of the first pipe section.

[0048] In this application, the sheath tube 1, the connecting part 21 of the cutter 2, the push rod 31, the fixing seat 32, the storage tube 5, and the connecting rod part 62 are arranged coaxially.

[0049] In this application, the polymer material may be at least one selected from acrylonitrile-butadiene-styrene copolymer (ABS), polyethylene (PE), polypropylene (PP), polyether block amide (PEBAX), polycarbonate (PC), polyurethane (PU), polyamide fiber (Nylon), polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), and polybutene (PB). The metallic material may be a single metal or an alloy, and the alloy may be stainless steel, nickel-titanium based shape memory alloy, nickel-iron based shape memory alloy, or copper-based shape memory alloy.

[0050] To enable those skilled in the art to better understand the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0051] Example 1 Please see Figures 1-3 This embodiment provides an atrial septal shunt system, which includes a sheath 1, a cutter 2, a catcher 3, an ablation electrode 4, a receiving tube 5, a receiving device 6, and a radiopaque ring 7.

[0052] The sheath 1 has a chamber forming inside, connecting its distal and proximal ends along its axial direction. The sheath 1 includes a first tube segment and a second tube segment connected sequentially from its distal to its proximal end. The hardness of the first tube segment is less than that of the second tube segment. The system also includes a pull wire, a pull wire channel, and a bending ring. The sheath 1 is a hollow, multi-layered tube structure. The pull wire channel is disposed in the inner wall of the sheath 1 and is a hollow tubular structure. The pull wire channel extends along the axial direction of the sheath 1. The bending ring is disposed in the inner wall of the first tube segment. The pull wire is movably inserted through the pull wire channel. Specifically, the proximal end of the pull wire passes through the pull wire channel and extends to the outside of the pull wire channel. The pull wire channel is a hollow tubular structure.

[0053] The cutter 2 has a cavity formed inside that connects its distal and proximal ends along its axial direction. The cutter 2 includes an integrally formed connecting part 21 and a blade part 22. The distal end of the sheath 1 is sleeved on the proximal end of the connecting part 21. The distal end of the sheath 1 and the proximal end of the connecting part 21 are connected by threads. The connecting part 21 has a ring structure. The material of the cutter 2 can be a metal material (such as stainless steel). There are four blade parts 22, which are evenly distributed on the distal end face of the connecting part 21.

[0054] The catcher 3 includes a push rod 31, a fixed base 32, and a catching claw 33. The fixed base 32 and the catching claw 33 are integrally formed and connected. Both the fixed base 32 and the catching claw 33 are made of shape memory alloy material (such as nickel-titanium alloy). The fixed base 32 is sleeved on the distal end of the push rod 31, and the fixed base 32 and the push rod 31 are connected by threads. The catching claw 33 can switch between an extended state and a retracted state under the action of external force. The catching claw 33 includes several catching arms 331. The inner wall of the catching arms 331 is provided with barbs 332. The several catching arms 331 are evenly distributed along the circumference of the fixed base 32. When the catching claw 33 is in the extended state, the size of the catching claw 33 is larger than the outer diameter of the sheath 1 in the radial direction. The catching arms 331 are composed of three straight parts and two arc-shaped parts. The straight parts and arc-shaped parts are arranged alternately, and the straight parts connect to adjacent arc-shaped parts. The bending directions of the two arc-shaped parts are opposite.

[0055] The ablation electrode 4 is a radio frequency ablation electrode. The ablation electrode 4 is electrically connected to the radio frequency power supply and is located on the outer wall of the capture arm 331.

[0056] The receiving tube 5 has a chamber forming axially connecting its distal and proximal ends. The receiving tube 5 is movably inserted through the sheath 1 and the cutter 2. The distal end of the receiving tube 5 can move along the chambers of the sheath 1 and the cutter 2 and extend out of the sheath 1, while the proximal end of the receiving tube 5 is located outside the sheath 1. A push rod 31 is movably inserted through the receiving tube 5. The distal end of the push rod 31 can move along the chambers of the receiving tube 5 and extend out of the receiving tube 5, while the proximal end of the push rod 31 is located outside the receiving tube 5. The push rod 31 is used to move the grasping claw 33. When the grasping claw 33 is in the extended state, it extends out of the receiving tube 5 to grasp the interatrial septum tissue; when the grasping claw 33 is in the retracted state, it retracts into the receiving tube 5.

[0057] The receiver 6 includes a receiving portion 61 and a connecting rod portion 62 connected in sequence. The connecting rod portion 62 is movably inserted through the catcher 3. The distal end of the connecting rod portion 62 can move along the chamber of the catcher 3 and extend out of the catcher 3, while the proximal end of the connecting rod portion 62 is located outside the catcher 3. The receiver 6 is made of a polymer material. The proximal end of the receiving portion 61 and the distal end of the connecting rod portion 62 are integrally formed and connected. The proximal end of the receiving portion 61 is provided with a receiving cavity 63, which is arranged around the connecting rod portion 62 and is adapted to the cutter 2. The receiver 6 has a chamber formed inside that connects its distal and proximal ends along its axial direction to accommodate guide wires and / or puncture needles.

[0058] The developing ring 7 is fitted onto the sheath tube 1. The sheath tube 1, the connecting part 21 of the cutter 2, the push rod 31, the fixing seat 32, the storage tube 5, and the connecting rod part 62 are coaxially arranged.

[0059] In the actual surgical procedure, the atrial septum is punctured beforehand to create a puncture site. A guidewire is then passed through the puncture site and inserted into the left atrium to establish a device intervention channel. The system provided in this embodiment is used to perform atrial septal shunt. The operation steps are as follows: (1) Advance the atrial septal shunt system provided in this embodiment along the guidewire until the receiving part 61 passes through the puncture site on the atrial septum and reaches the left atrium, as shown. Figure 4A As shown, the atrial septum tissue at the puncture site naturally rebounds and contracts to wrap around the connecting rod portion 62; (2) Retract the sheath 1 and the receiving tube 5 to release the catcher 3 from the receiving tube 5, and the catcher claw 33 of the catcher 3 is in an extended state; retract the connecting rod 62 to bring the receiving part 61 into contact with the atrial septum tissue. At this time, the state of the atrial septum shunt stoma system is as follows: Figure 4B As shown; (3) Advance the push rod 31 to move the capture device 3 until the capture arm 311 pierces the atrial septum tissue, the ablation electrode 4 contacts the atrial septum tissue, and the barbs 332 pass through the atrial septum tissue to fix the atrial septum tissue during subsequent ablation operations. At this time, the state of the atrial septum shunt system is as follows: Figure 4C As shown; (4) Turn on the radiofrequency power supply to energize the ablation electrode 4 to ablate the atrial septum tissue at the puncture site, thereby reducing the regenerative capacity of the atrial septum tissue around the puncture site and preventing the stoma size from shrinking in a short period after the stoma is completed; advance the receiving tube 5 to bind the capture device 3 and part of the ablated atrial septum tissue tightly in the receiving tube 5. At this time, the state of the atrial septum shunt stoma system is as follows: Figure 4D As shown; (5) Advance the sheath 1 to allow the cutter 3 to cut the interatrial septum tissue, and insert the cutter 3 into the receiving cavity 63 of the receiving part 61. The cut interatrial septum tissue is encased in the instrument, such as... Figure 4E As shown; the blade part 22 can be electrically connected to a power source, so that the blade part 22 can be used as an ablation electrode. After cutting or during cutting, the blade part 22 can be energized to ablate the nearby interatrial septum tissue. (6) Withdraw the entire system along the guidewire to complete the atrial septal shunt procedure.

[0060] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application and are not intended to limit the scope of protection of this application. Although this application has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of this application without departing from the substance and scope of the technical solutions of this application.

Claims

1. A septal shunt stoma system, characterized in that, The device includes a sheath, a cutter, and a catcher. The sheath has an internal chamber that connects its distal and proximal ends along its axial direction. The cutter has an internal chamber that connects its distal and proximal ends along its axial direction and is located at the distal end of the sheath. The catcher includes a push rod, a fixing seat, and a catching claw. The push rod movably passes through the sheath and the cutter, with its proximal end located outside the sheath. The fixing seat is located at the distal end of the push rod. The proximal end of the catching claw is connected to the fixing seat. An ablation electrode is provided on the outer wall of the catching claw. The catching claw can switch between an extended and retracted state under external force.

2. The atrial septal shunt stoma system as described in claim 1, characterized in that, The catching claw includes several catching arms, the inner wall of which is provided with barbs, and the ablation electrode is disposed on the outer wall of the catching arm.

3. The atrial septal shunt stoma system as described in claim 2, characterized in that, Several capture arms are evenly spaced along the circumference of the fixed base.

4. The atrial septal shunt stoma system as described in claim 2, characterized in that, When the grasping claw is in the extended state, the size of the grasping claw is larger than the outer diameter of the sheath in the radial direction of the sheath.

5. The atrial septal shunt stoma system as described in claim 1, characterized in that, The grabbing claw is made of shape memory alloy.

6. The atrial septal shunt stoma system as described in claim 1, characterized in that, It also includes a receiving tube, the interior of which forms a chamber that connects its distal and proximal ends along its axial direction. The receiving tube is movably inserted through the sheath and the cutter, with the proximal end of the receiving tube located outside the sheath. The push rod is movably inserted through the receiving tube, with the proximal end of the push rod located outside the receiving tube. When the grasping claw is in the extended state, the grasping claw extends out of the receiving tube to grasp the interatrial septum tissue; When the grabbing claw is in the retracted state, the grabbing claw retracts into the storage tube.

7. The atrial septal shunt stoma system as described in claim 6, characterized in that, The grabbing claw can retract partially or completely into the storage tube under the drive of the storage tube or the push rod.

8. The atrial septal shunt stoma system as described in claim 1, characterized in that, It also includes a receiver, which includes a receiver and a connecting rod connected in sequence. The connecting rod is movably inserted through the catcher. The proximal and distal ends of the connecting rod are located outside the catcher. The proximal end of the receiver is connected to the distal end of the connecting rod. The proximal end of the receiver is provided with a receiver cavity, which is arranged around the connecting rod and is adapted to the cutter.

9. The atrial septal shunt stoma system as described in claim 8, characterized in that, The receiver has a chamber formed inside it that connects its distal and proximal ends along its axial direction to accommodate a guidewire and / or a puncture needle.

10. The atrial septal shunt stoma system as described in claim 1, characterized in that, The cutter includes a connecting part and a blade part connected in sequence, with the proximal end of the connecting part connected to the distal end of the sheath.

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