A left atrial appendage occluder robotic implantation control component and robot

Abstract

This application discloses a robotic implantation control component and robot for a left atrial appendage occluder, comprising: a sheath (2) having a sheath tip bending control guidewire (9) inside, having a first end and a second end opposite to each other, the first end being connected to a sheath handle (4), having a sheath lumen (21) for carrying a pigtail catheter (17) or an occlusion umbrella delivery rod (23); the sheath handle (4) having a control handle lumen (11), the sheath handle (4) having a handle channel for carrying the pigtail catheter (17) or the occlusion umbrella delivery rod (23), and the sheath handle (4) also having a flushing side tube (5), the flushing side tube (5) being connected to the handle channel. This application embodiment overcomes the defects of radiation exposure throughout the entire operation process by fully realizing remote control operation, and cooperates with the surgical robot to complete the entire left atrial appendage angiography, sheath placement, occluder delivery, positioning and release, and immediate occlusion effect evaluation.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a robotic implantation control component and robot for a left atrial appendage occluder. Background Technology

[0002] Left atrial appendage occluder implantation is currently one of the important treatment methods to prevent left atrial appendage thrombosis and detachment, which can lead to ischemic stroke. The main disease inducing left atrial appendage thrombosis is various types of atrial fibrillation. Currently, there are several types of left atrial appendage occluders routinely used in clinical practice, but their basic implantation method is minimally invasive interventional surgery.

[0003] The implantable devices for left atrial appendage occlusion mainly include: occlusion umbrella, guide wire, delivery and release rod, delivery sheath / dilatation tube, pigtail catheter, and release handle.

[0004] The main steps of left atrial appendage occluder implantation include: 1. Atrial septal puncture to establish access to the left atrium. 2. Replacement of the dedicated delivery sheath. 3. Guiding the tip of the delivery sheath into the appropriate location in the left atrial appendage using a pigtail catheter. 4. Selective left atrial appendage angiography and measurement of occluder parameters. 5. Insertion of the folded occluder umbrella through the sheath to the tip of the sheath. 6. Retraction of the sheath to release the occluder umbrella. 7. Left atrial appendage ostium angiography to confirm ideal occluder umbrella positioning. 8. External traction of the occluder umbrella to confirm anchoring stability. 9. Left atrial appendage angiography to assess occlusion effectiveness. 10. Unloading of the occluder umbrella.

[0005] The above procedure has the following drawbacks: 1. Continuous radiation exposure. Due to the long fluoroscopy time and numerous radiographs during the procedure, the radiation damage to the surgical personnel is significant. 2. Continuous holding and fine-tuning. During the delivery, positioning, and release of the occluder, the surgeon must continuously hold and dynamically fine-tune the sheath, resulting in high operational intensity. 3. Selectivity of the atrial septal puncture point. Because the tip of the sheath lacks active bending capability, the location of the atrial septal puncture point is crucial when using the pigtail catheter to locate the left atrial appendage opening and guide the tip of the sheath into the left atrial appendage. Summary of the Invention

[0006] This application provides a left atrial appendage occluder robotic implantation control component and robot. By fully realizing remote control operation, it overcomes the defects of radiation exposure throughout the operation process. It works in conjunction with the surgical robot to complete the entire left atrial appendage angiography, sheath placement, occluder delivery, positioning and release, and immediate occlusion effect evaluation.

[0007] This application provides a robotic implantation control component for a left atrial appendage occluder, comprising:

[0008] Sheath 2, which is provided with a sheath tip bending control guidewire (9) having a first end and a second end opposite to each other. The first end is connected to the sheath handle 4, and the second end is used to reach the target position based on the guidance of the sheath tip bending control guidewire 9. It has a sheath lumen 21 for carrying the pigtail catheter 17 or the occlusion umbrella delivery rod 23.

[0009] The sheath handle 4 has a control handle cavity 11, in which a control guide wire rotation shaft attachment point 10, a control guide wire sliding fixing point 12, and a control guide wire folding sliding fixing point 13 are provided for connecting the sheath head bending control guide wire 9. The sheath handle 4 has a handle channel for the pigtail catheter 17 or the occlusion umbrella delivery rod 23 to travel, and also has a third end and a fourth end. The third end is provided with a sheath head bending control wheel 3, which is operated to bend the sheath 2. The fourth end is provided with a sealing membrane 14 at the inlet of the handle channel. The sheath handle 4 is also provided with a flushing side tube 5, which is connected to the handle channel.

[0010] Optionally, the pigtail catheter 17 has a curved structure at one end, which can be inserted through the handle channel and exit from the second end of the sheath 2, and a pigtail catheter adapter 18 is provided on the other end of the pigtail catheter 17.

[0011] Optionally, the pig tail catheter 17 has a catheter channel for connection to the injection head 20 of an auto-injector.

[0012] Optionally, one end of the sealing umbrella conveyor rod 23 can be inserted through the handle channel, and the sealing umbrella conveyor rod 23 is used to connect the sealing umbrella;

[0013] The occlusion umbrella includes: a left atrial leaflet 25, a right atrial leaflet 26, and a central shaft 27. Both the left atrial leaflet 25 and the right atrial leaflet 26 can be accommodated in the inner lumen 21 of the sheath.

[0014] One end of the central shaft 27 of the occlusion umbrella passes through the right atrial leaflet 26 of the occlusion umbrella and is connected to the left atrial leaflet 25 of the occlusion umbrella. The other end has an occlusion umbrella tail connector 28, which is connected to the occlusion umbrella delivery rod 23.

[0015] Optionally, the other end of the sealing umbrella conveyor rod 23 is also provided with a conveyor rod adapter 24.

[0016] Optionally, the sheath 2 is further provided with a control wire travel microtube 30, and the control guide wire 9 at the head end of the sheath travels within the control wire travel microtube 30.

[0017] Optionally, an expansion tube 7 may also be included;

[0018] The expansion tube includes an opposing expansion tube head end 6 and an expansion tube tail end 8, and the expansion tube 7 is used to connect to the second end of the sheath tube 2.

[0019] This application also proposes a physiological robot, including the aforementioned left atrial appendage occluder robot implantation control component.

[0020] This application embodiment overcomes the defects of radiation exposure throughout the entire operation by fully realizing remote control operation, and cooperates with the surgical robot to complete the entire left atrial appendage angiography, sheath placement, occluder delivery, positioning and release, and immediate occlusion effect evaluation.

[0021] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this application more obvious and understandable, specific embodiments of this application are given below. Attached Figure Description

[0022] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0023] Figure 1 A schematic diagram of the basic structure of the left atrial appendage occluder robot implantation control component according to an embodiment of this application;

[0024] Figure 2 A partial schematic diagram of the control handle of the left atrial appendage occluder robot implantation control component according to an embodiment of this application;

[0025] Figure 3 This is a schematic diagram of the structure of the left atrial appendage occluder robot after implantation of the control component and loading of the pigtail catheter, according to an embodiment of this application.

[0026] Figure 4 This is a schematic diagram of the structure of the left atrial appendage occluder robot after the control component is implanted and the occlusion umbrella is loaded, according to an embodiment of this application. Detailed Implementation

[0027] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0028] This application provides a robotic implantation control component for a left atrial appendage occluder, such as... Figure 1 , Figure 2 , Figure 3 As shown, it includes:

[0029] The sheath 2 contains a sheath tip bending control guidewire 9, which has a first end and a second end. The first end is connected to the sheath handle 4, and the second end is used to reach the target position based on the guidance of the sheath tip bending control guidewire 9. The sheath has an inner lumen 21 for accommodating the pigtail catheter 17 or the occlusion umbrella delivery rod 23. In this example, the sheath 2 also has an X-ray marker 1 at the sheath tip.

[0030] The sheath handle 4 has a control handle cavity 11, within which are provided a control guidewire rotation shaft attachment point 10, a control guidewire sliding fixation point 12, and a control guidewire folding sliding fixation point 13 for connecting the sheath tip bending control guidewire 9. The sheath handle 4 has a handle channel for the passage of the pigtail catheter 17 or the occlusion umbrella delivery rod 23, and also has opposing third and fourth ends. The third end is provided with a sheath tip bending control wheel 3, which is operated to bend the sheath 2. A sealing membrane 14 is provided at the inlet of the handle channel at the fourth end. The sheath handle 4 also has a flushing side tube 5, which communicates with the handle channel. The control handle cavity 11 also contains a control handle rotation shaft 15 and a control handle rotation shaft head 16. The flushing side tube 5 is used to connect to the contrast agent delivery tube 19, which is then connected to the auto-injector head 20.

[0031] This application embodiment overcomes the defects of radiation exposure throughout the entire operation by fully realizing remote control operation, and cooperates with the surgical robot to complete the entire left atrial appendage angiography, sheath placement, occluder delivery, positioning and release, and immediate occlusion effect evaluation.

[0032] In some embodiments, the pigtail catheter 17 has a curved structure at one end, which can be inserted through the handle channel and exit through the second end of the sheath 2, and a pigtail catheter adapter 18 is provided on the other end of the pigtail catheter 17.

[0033] In some embodiments, the pig tail catheter 17 has a catheter channel for connection to the auto-injector head 20.

[0034] In some embodiments, one end of the sealing umbrella delivery rod 23 may be inserted through the handle channel, and the sealing umbrella delivery rod 23 is used to connect the sealing umbrella.

[0035] The occlusion umbrella includes: a left atrial leaflet 25, a right atrial leaflet 26, and a central shaft 27. Both the left atrial leaflet 25 and the right atrial leaflet 26 can be accommodated in the inner lumen 21 of the sheath.

[0036] One end of the central shaft 27 of the occlusion umbrella passes through the right atrial leaflet 26 of the occlusion umbrella and is connected to the left atrial leaflet 25 of the occlusion umbrella. The other end has an occlusion umbrella tail connector 28, which is connected to the occlusion umbrella delivery rod 23.

[0037] In some embodiments, the other end of the sealing umbrella delivery rod 23 is also provided with a delivery rod adapter 24.

[0038] In some embodiments, the sheath 2 further includes a control wire traveling microtube 30, and the bent control guide wire 9 at the head end of the sheath travels within the control wire traveling microtube 30. For example... Figure 4 As shown, a distal attachment point 29 for the sheath control wire is provided near the second end of the sheath tube 2, and one end of the microtube 30 for the control wire is located at the distal attachment point 29 for the sheath control wire.

[0039] In some embodiments, an expansion tube 7 is also included, which includes an opposing expansion tube head end 6 and an expansion tube tail end 8, and the expansion tube 7 is used to connect to the second end of the sheath tube 2.

[0040] This application also proposes a physiological robot, including the aforementioned left atrial appendage occluder robot implantation control component.

[0041] This application also proposes a use case for a robotic implantation control component for a left atrial appendage occluder, including the following steps:

[0042] 1. Guided by the left atrial appendage occlusion guide wire, insert the left atrial appendage occlusion device delivery sheath, remove the guide wire, and fully vent the air.

[0043] 2. Insert a pigtail catheter through the sheath, and after fully venting the air, fill the sheath lumen with heparinized saline.

[0044] 3. Install control adapters at the ends of the sheath and pigtail catheter, and use the adapters to load the sheath and pigtail catheter into the surgical robot control cabin and lock them in place.

[0045] 4. Connect the sheath side tube to the auto-injector connector, fully vent the air, and connect it to the contrast agent injection chamber. Set the following injection parameters: injection pressure, injection speed, and injection dose.

[0046] 5. The surgical team retreated to the control room and continued to perform subsequent procedures via the control panel.

[0047] 6. With the aid of remote fluoroscopy, the surgeon uses a handle or knob to adjust the curvature and direction of the sheath tip so that the sheath tip points towards the opening of the left atrial appendage.

[0048] 7. With the aid of remote fluoroscopy, the surgeon operates the handle or knob to adjust the advance pigtail catheter so that its tip enters the left atrial appendage.

[0049] 8. Under fluoroscopic guidance, fix the pigtail catheter and advance the sheath so that the tip of the sheath enters the middle of the left atrial appendage.

[0050] 9. With the patient in a right anterior oblique position of 30 degrees and a right foot position of 20 degrees, 10 ml of contrast agent was injected through the sheath to complete the left atrial appendage angiography. Before the angiography, a 10 mm radiopaque reference disc was placed in the field of view.

[0051] 10. Fix the left atrial appendage angiography image during maximum diastole and measure the left atrial appendage occlusion parameters: opening diameter and maximum depth diameter. Select an occluder model with a diameter greater than 4-8 mm.

[0052] 11. The surgeon and assistant re-enter the catheterization lab, unload the sheath and pigtail catheter, and withdraw the pigtail catheter.

[0053] 12. Load the plugger at the tail end of the sheath and advance the conveyor rod to the length mark. At this time, the head of the plugger is 5-8mm away from the head of the sheath.

[0054] 13. Reload the sheath and delivery rod into the operating cabin of the surgical robot, and the surgeon and assistant return to the control room.

[0055] 14. Under the guidance of remote fluoroscopy, the surgeon completes the positioning of the occluder by operating the handle or knob: simultaneously move the sheath and delivery rod, and advance the tip of the sheath to the predetermined release point of the left atrial appendage occluder.

[0056] 15. Secure the sheath and advance the occluder until its tip markings completely overlap with the sheath markings.

[0057] 16. After confirming the correct position of the sheath head under continuous fluoroscopy, fix the delivery rod, slowly retract the sheath, and observe the occluder head gradually opening.

[0058] 17. Continue retracting the sheath until the occluder is fully released.

[0059] 18. Activate the autoinjector and perform left atrial appendage angiography through the sheath to assess the immediate occlusion effect.

[0060] 19. If necessary, the occlusion effect should be confirmed by transthoracic ultrasound, esophageal ultrasound or endocavitary ultrasound.

[0061] 20. After confirming that the sealing effect is qualified, conduct the anchoring pull test of the plug: under continuous fluoroscopy, advance and retract the conveyor rod in small amplitudes. Observe that the tail of the plug moves slightly with the conveyor rod, but the overall position and attitude of the plug does not change, confirming that the anchoring of the plug is reliable.

[0062] 21. Release the occluder: Under continuous fluoroscopy, fix the sheath and rotate the delivery rod counterclockwise until its tip is completely separated from the occluder.

[0063] 22. Adjust the curvature of the sheath tip so that it points towards the opening of the left atrial appendage.

[0064] 23. Inject contrast agent again through the sheath and perform cine photography to reconfirm the immediate occlusion effect.

[0065] 24. Simultaneously withdraw the sheath and delivery rod until their tips are withdrawn into the right atrium.

[0066] 25. The surgeon returns to the catheterization lab, unloads the sheath and delivery rod, and the procedure is complete.

[0067] The proposed solution overcomes the drawbacks of radiation exposure throughout the entire operation by enabling fully remote control. This solution utilizes a surgical robot to complete the entire left atrial appendage angiography, sheath placement, occluder delivery, positioning and release, and immediate occlusion effect assessment. Therefore, the surgeon and their assistant do not need to stand beside the operating table, effectively avoiding radiation damage caused by fluoroscopy and angiography.

[0068] This application utilizes a surgical robot to hold and fine-tune the sheath, eliminating the need for continuous holding and dynamic fine-tuning by the surgeon during the delivery, positioning, and release of the occluder, significantly reducing the surgeon's workload. Furthermore, by actively bending the sheath tip, this application facilitates the use of a pigtail catheter to locate the left atrial appendage opening and guide the sheath tip into the left atrial appendage, overcoming the selectivity of the atrial septal puncture site during sheath placement.

[0069] This application, by adding an automatic injector, eliminates the need for surgical assistants to stand beside the operating table to inject contrast agents, significantly reducing radiation damage.

[0070] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0071] The sequence numbers of the embodiments in this application are for descriptive purposes only and do not represent the superiority or inferiority of the embodiments.

[0072] Through the above description of the embodiments, those skilled in the art can clearly understand that the methods of the above embodiments can be implemented by means of software plus necessary general-purpose hardware platforms. Of course, they can also be implemented by hardware, but in many cases the former is a better implementation method. Based on this understanding, the technical solution of this application, in essence, or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product is stored in a storage medium (such as ROM / RAM, magnetic disk, optical disk), and includes several instructions to cause a terminal (which may be a mobile phone, computer, server, or network device, etc.) to execute the methods described in the various embodiments of this application.

[0073] The embodiments of this application have been described above with reference to the accompanying drawings. However, this application is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of this application without departing from the spirit and scope of the claims. All of these forms are within the protection scope of this application.

Claims

1. A left atrial appendage occluder robot implantation manipulation assembly, characterized in that, It comprises: a sheath (2) provided with a sheath tip bending control guide wire (9) inside, having opposite first and second ends, the first end being connected to a sheath handle (4), the second end being used to reach a target position based on the guidance of the sheath tip bending control guide wire (9), having a sheath lumen (21) for walking a pigtail catheter (17) or an occlusion umbrella delivery rod (23), the pigtail catheter (17) having a curved structure at one end, which can pass from the handle channel and out from the second end of the sheath (2), the pigtail catheter (17) having a catheter channel for connecting with an automatic syringe injection head (20); the sheath handle (4) having a control handle lumen (11) provided with a control guide wire rotating shaft attachment point (10), a control guide wire sliding fixed point (12), and a control guide wire return sliding fixed point (13) inside, for connecting the sheath tip bending control guide wire (9), the sheath handle (4) having a handle channel for walking the pigtail catheter (17) or the occlusion umbrella delivery rod (23), and having opposite third and fourth ends, the third end being provided with a sheath tip bending control rotating wheel (3), the sheath tip bending control rotating wheel (3) being operated to achieve bending of the sheath (2), the handle channel entrance position of the fourth end being provided with a sealing film (14), the sheath handle (4) being further provided with a flushing side tube (5) communicating with the handle channel; the occlusion umbrella delivery rod (23) having one end passing from the handle channel, the occlusion umbrella delivery rod (23) being used to connect an occlusion umbrella; the occlusion umbrella comprising an occlusion umbrella left atrial umbrella leaf (25), an occlusion umbrella right atrial umbrella leaf (26), and an occlusion umbrella central shaft (27), the occlusion umbrella left atrial umbrella leaf (25) and the occlusion umbrella right atrial umbrella leaf (26) being accommodated in the sheath lumen (21); the occlusion umbrella central shaft (27) having one end passing through the occlusion umbrella right atrial umbrella leaf (26) and being connected to the occlusion umbrella left atrial umbrella leaf (25), and having an occlusion umbrella tail joint (28) at the other end, for connecting with the occlusion umbrella delivery rod (23) through the occlusion umbrella tail joint (28).

2. The left atrial appendage occluder robotic implant manipulation assembly of claim 1, wherein, the other end of the pigtail catheter (17) being provided with a pigtail catheter adapter (18).

3. The left atrial appendage occluder robotic implant manipulation assembly of claim 1, wherein, the other end of the occlusion umbrella delivery rod (23) being further provided with a delivery rod adapter (24).

4. The LAA occluder robot implant handling assembly of claim 1, wherein, the sheath (2) being further provided with a control steel wire walking micro tube (30) inside, the sheath tip bending control guide wire (9) walking in the control steel wire walking micro tube (30).

5. The LAA occluder robot implantation manipulation assembly of claim 1, wherein, further comprising a dilating tube (7); the dilating tube (7) comprising opposite dilating tube heads (6) and dilating tube tails (8), the dilating tube (7) being used to connect with the second end of the sheath (2).

6. A physiological robot, characterized by It comprises a left atrial appendage occluder robot implantation control assembly as claimed in any one of claims 1-5. It comprises a left atrial appendage occluder robot implantation control assembly as claimed in any one of claims 1-5.

Images