Method for accurately matching valves in heart valve interventional operation

Abstract

The invention discloses a method for accurately matching a valve in a heart valve interventional operation. The method comprises the following steps: firstly, pre-expanding a pressure sensing balloon under specified pressure in vitro; the surface pressure of the pressure sensing balloon in the pre-expanding state is corrected to zero; then, the pressure same as the specified pressure is adopted at the target position to enable the pressure sensing balloon to expand again, and real-time pressure distribution data and morphological change of the pressure sensing balloon in the re-expansion state at the target position are obtained; therefore, the valve model and the valve release strategy in the interventional operation are accurately matched according to the real-time pressure distribution data and the morphological change. The dynamic pressure distribution and morphological change of the valve anchoring area are monitored in real time through the pressure sensing balloon, the valve model and the release strategy are accurately matched, the risks of perivalvular leakage, displacement, secondary intervention and the like are effectively reduced, the valve adaptability and the operation safety of a patient with complex lesions are remarkably improved, and the method is suitable for various intervention scenes such as TAVR and TMVR.

Description

Technical Field

[0001] This invention relates to the field of medical technology, specifically to a method for precisely matching valves during cardiac valve intervention surgery. Background Technology

[0002] Interventional cardiac valve surgery is an innovative treatment that repairs or replaces diseased heart valves using minimally invasive catheter techniques. It can be performed without open-chest surgery, making it particularly suitable for elderly, high-risk, or patients who cannot tolerate traditional surgery. Selecting a matching valve size is one of the most crucial steps in interventional cardiac valve surgery. However, current techniques rely heavily on experience for valve selection. In current cardiac valve surgery, surgeons predict balloon size using CT images and then select the valve size based on the balloon's post-expansion morphology (such as the "waist sign" and regurgitation), leading to subjective errors. Furthermore, the assessment of anchoring force is inaccurate: calcified lesions cause uneven distribution of valve anchoring force, and traditional methods cannot quantify stress data in different areas, easily resulting in inappropriate valve size selection. Improperly sized artificial valve implantation will affect treatment outcomes. For example, selecting a valve that is too small can lead to paravalvular leakage; while selecting a valve that is too large may cause incomplete valve deployment, displacement, or postoperative regurgitation, affecting the patient's long-term prognosis. Summary of the Invention

[0003] The purpose of this invention is to provide a method for precise valve matching in cardiac valve intervention surgery that achieves accurate positioning, good wall adhesion, and good results.

[0004] This invention provides a method for precisely matching valves during cardiac valve interventional surgery, specifically including the following steps: 1) Pre-inflate the pressure-sensing balloon in vitro at a specified pressure; and correct the surface pressure of the pre-inflated pressure-sensing balloon to zero; 2) At the target location, apply the same pressure as the specified pressure to re-inflate the pressure-sensing balloon described in step 1), and acquire real-time pressure distribution data and morphological changes of the re-inflated pressure-sensing balloon at the target location; furthermore, the re-inflated pressure-sensing balloon simulates the state of a valve in the body. 3) Based on real-time pressure distribution data, morphological changes, and the simulated valve condition of the pressure-sensing balloon in the body, a three-dimensional model of the target location is established, and the valve type and valve release strategy in the interventional surgery are accurately matched.

[0005] The pressure-sensing balloon in its re-inflated state can simulate the state of the valve in the body, quantifying the lumbar compression depth and the size of the unblocked area after the pressure-sensing balloon re-inflates.

[0006] Furthermore, the method of the present invention also includes inserting a catheter into the precisely matched valve in step 3) to the target position and deploying the valve according to the valve release strategy.

[0007] Furthermore, the method of the present invention also includes a pre-selection process for the pressure-sensing balloon in step 1); The pre-selection process includes selecting a pressure-sensing balloon of appropriate size through preoperative assessment; The pre-expansion process includes setting a specified pressure through preoperative assessment.

[0008] Furthermore, the preoperative assessment process in the method of the present invention includes acquiring cardiac CT angiography images and / or ultrasound of the patient to assess the valve annulus diameter and calcification.

[0009] Furthermore, the method of the present invention also includes optimizing valve size selection and release strategy through artificial intelligence; The artificial intelligence optimization process specifically includes: Database construction: Integrate historical surgical data, including pressure distribution of pressure-sensing balloons, morphological changes of pressure-sensing balloons after re-inflation, corresponding valve models and valve release strategies, and postoperative monitoring. Deep learning model: Input pressure distribution, morphological changes, and valve material; Output recommended valve model, valve release location, and valve release strategy. Real-time feedback and alarm: The system dynamically displays real-time pressure distribution data and morphological changes of the pressure-sensing balloon during the procedure, and triggers an alarm when the local pressure exceeds the support force of the stent.

[0010] Furthermore, the pressure-sensing balloon in the method of the present invention is a balloon with a flexible electronic pressure-sensitive sensor array integrated on its surface and made of a non-compliant material. The pressure-sensing balloon can detect and provide feedback on the pressure distribution on the surface of the balloon in real time.

[0011] Furthermore, the pressure-sensing balloon in the method of the present invention is a blood perfusion type pressure-sensing balloon.

[0012] Furthermore, the valve release strategy in the method of the present invention includes the anchoring zone location, instrument characteristics, and intraoperative dynamic adjustment; the instrument characteristics include the selection of self-expanding or ball-expanding type and the selection of stent model.

[0013] Furthermore, in the method described in this invention, after the catheter is inserted into the precisely matched valve to the target position, the precisely matched artificial valve is deployed by balloon dilation or a self-expanding stent.

[0014] Furthermore, the method described in this invention is applicable to transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR).

[0015] The method for precisely matching valves during cardiac valve interventional surgery described in this invention has the following advantages: The method for precise valve matching in cardiac valve interventional surgery described in this invention utilizes a pressure-sensing balloon integrating a flexible electronic pressure-sensitive sensor array. Combined with real-time intraoperative pressure distribution and morphological change data, the balloon, in its re-inflated state, simulates the valve's condition within the body, achieving precise quantitative matching of valve size selection and deployment strategies. Compared to traditional experience-dependent methods, this method dynamically captures the anchoring force distribution characteristics of calcified lesions and quantitatively assesses the stress-bearing capacity of each region of the valve annulus, thus avoiding subjective errors. Through preoperative pre-inflation calibration and real-time intraoperative data feedback, "high-risk anchoring areas" (such as uneven calcification or weak areas) can be accurately identified, guiding the selection of anatomically appropriate valve size and support parameters, effectively avoiding problems such as paravalvular leakage, displacement, or incomplete deployment. Simultaneously, combined with a perfusion-type balloon design, partial blood flow can be maintained during assessment, reducing the risk of tissue ischemia and significantly improving surgical safety and long-term valve stability.

[0016] This invention further introduces an artificial intelligence optimization system, which integrates historical surgical data with real-time pressure-morphological characteristics through a deep learning model to dynamically recommend the optimal valve model and release strategy (such as self-expansion depth and bulb dilation pressure). Intraoperative real-time monitoring and alarm mechanisms (such as local pressure over-limit warnings) assist surgeons in quickly adjusting their procedures, avoiding anchoring failure due to insufficient stent support. This method overcomes the limitations of traditional single-image assessment, achieving end-to-end optimization of "anatomical adaptation - mechanical response - postoperative prognosis," significantly reducing the rate of secondary intervention and complications. Furthermore, its applicability is broad, extending to various interventional scenarios such as TAVR and TMVR, and is particularly suitable for high-risk cases such as complex calcified lesions or bicuspid valves, providing a standardized and intelligent technical platform for personalized valve treatment. Detailed Implementation

[0019] A method for precisely matching valves during interventional heart valve surgery includes the following steps: 1) Pre-inflate the pressure-sensing balloon in vitro at a specified pressure; and correct the surface pressure of the pre-inflated pressure-sensing balloon to zero; 2) At the target location, apply the same pressure as the specified pressure to re-inflate the pressure-sensing balloon described in step 1), and acquire real-time pressure distribution data and morphological changes of the re-inflated pressure-sensing balloon at the target location; furthermore, the re-inflated pressure-sensing balloon simulates the state of a valve in the body. 3) Based on real-time pressure distribution data, morphological changes, and the simulated valve condition of the pressure-sensing balloon in the body, a three-dimensional model of the target location is established, and the valve type and valve release strategy in the interventional surgery are accurately matched.

[0020] In other embodiments, the method further includes inserting a catheter into the precisely matched valve in step 3) to the target location and deploying the valve according to a valve release strategy.

[0021] In other embodiments, the method further includes a pre-selection process for the pressure-sensing balloon described in step 1); The pre-selection process includes selecting a pressure-sensing balloon of appropriate size through preoperative assessment; The pre-expansion process includes setting a specified pressure through preoperative assessment.

[0022] In other embodiments, the preoperative assessment process includes acquiring cardiac CT angiography images and / or ultrasound of the patient to assess the annular diameter and calcification.

[0023] In other embodiments, the method further includes optimizing valve size selection and release strategies using artificial intelligence; The artificial intelligence optimization process specifically includes: Database construction: Integrate historical surgical data, including pressure distribution of pressure-sensing balloons, morphological changes of pressure-sensing balloons after re-inflation, corresponding valve models and valve release strategies, and postoperative monitoring. Deep learning model: Input pressure distribution, morphological changes, and valve material; Output recommended valve model, valve release location, and valve release strategy. Real-time feedback and alarm: The system dynamically displays real-time pressure distribution data and morphological changes of the pressure-sensing balloon during the procedure, and triggers an alarm when the local pressure exceeds the support force of the stent.

[0024] In other embodiments, the pressure-sensing balloon is a balloon with a flexible electronic pressure-sensitive sensor array integrated on its surface and made of a non-compliant material, which can detect and provide feedback on the pressure distribution on the balloon surface in real time.

[0025] In other embodiments, the pressure-sensing balloon is a blood perfusion pressure-sensing balloon.

[0026] In other embodiments, the valve release strategy includes anchoring zone location, device characteristics, and intraoperative dynamic adjustment; the device characteristics include selection of self-expanding or ball-expanding type and stent model selection.

[0027] In other embodiments, after the catheter is inserted to the target location with a precisely matched valve, the precisely matched artificial valve is deployed by balloon dilation or a self-expanding stent.

[0028] In other embodiments, the method is applicable to TAVR or TMVR.

[0029] Example 1: A method for precisely matching valves during interventional heart valve surgery includes the following steps: 1) Pre-inflate the pressure-sensing balloon in vitro at a specified pressure; and correct the surface pressure of the pre-inflated pressure-sensing balloon to zero; Specifically, a pressure-sensing balloon of appropriate size is selected and a specified pressure is set through preoperative assessment. The preoperative assessment process includes acquiring cardiac CT angiography images and / or ultrasound of the patient to assess the valve annulus diameter and calcification.

[0030] In this embodiment 1, the pressure-sensing balloon is a balloon with a flexible electronic pressure-sensitive sensor array integrated on its surface and made of a non-compliant material. The pressure-sensing balloon can detect and provide feedback on the pressure distribution on the surface of the balloon in real time.

[0031] 2) At the target location, apply the same pressure as the specified pressure to re-inflate the pressure-sensing balloon described in step 1), and acquire real-time pressure distribution data and morphological changes of the re-inflated pressure-sensing balloon at the target location; furthermore, the re-inflated pressure-sensing balloon simulates the state of a valve in the body. 3) A three-dimensional model of the target location is established based on real-time pressure distribution data, morphological changes, and the simulated valve condition of the pressure-sensing balloon in vivo, and precisely matched with the valve type and valve release strategy in the interventional surgery. The valve release strategy includes the anchoring zone location, instrument characteristics, and intraoperative dynamic adjustments; the instrument characteristics include the selection of self-expanding or balloon-expanding type and the selection of stent type.

[0032] Finally, the precisely matched valve from step 3) is inserted through a catheter to the target location, and the valve is deployed according to the valve deployment strategy. After the precisely matched valve is inserted through the catheter to the target location, the precisely matched artificial valve is deployed by balloon dilation or a self-expanding stent.

[0033] In this embodiment 1, the method further includes optimizing valve size selection and release strategy through artificial intelligence; The artificial intelligence optimization process specifically includes: Database construction: Integrate historical surgical data, including pressure distribution of pressure-sensing balloons, morphological changes of pressure-sensing balloons after re-inflation, corresponding valve models and valve release strategies, and postoperative monitoring. Deep learning model: Input pressure distribution, morphological changes, and valve material; Output recommended valve model, valve release location, and valve release strategy. Real-time feedback and alarm: The system dynamically displays real-time pressure distribution data and morphological changes of the pressure-sensing balloon during the procedure, and triggers an alarm when the local pressure exceeds the support force of the stent.

[0034] In the precise matching process of step 3) of this embodiment, the real-time pressure distribution data, morphological changes, lumbar compression depth after the pressure-sensing balloon is re-inflated, and the size of the unblocked area are used as reference criteria.

Claims

1. A method for precisely matching valves during cardiac valve interventional surgery, characterized in that, Specifically, the steps include the following: 1) Pre-inflate the pressure-sensing balloon in vitro at a specified pressure; and correct the surface pressure of the pre-inflated pressure-sensing balloon to zero; 2) Apply the same pressure as the specified pressure at the target location to re-inflate the pressure-sensing balloon described in step 1), and obtain real-time pressure distribution data and morphological changes of the re-inflated pressure-sensing balloon at the target location; and simulate the state of the valve in the body through the re-inflated pressure-sensing balloon. 3) Based on real-time pressure distribution data, morphological changes, and the simulated valve condition of the pressure-sensing balloon in the body, a three-dimensional model of the target location is established, and the valve type and valve release strategy in the interventional surgery are accurately matched.

2. The method for precisely matching valves in cardiac valve interventional surgery according to claim 1, characterized in that: The method further includes inserting a catheter into the precisely matched valve in step 3) to the target location and deploying the valve according to the valve release strategy.

3. The method for precisely matching valves in cardiac valve interventional surgery according to claim 1, characterized in that: The method also includes the pre-selection process of the pressure-sensing balloon in step 1); The pre-selection process includes selecting a pressure-sensing balloon of appropriate size through preoperative assessment; The pre-expansion process includes setting a specified pressure through preoperative assessment.

4. The method for precisely matching valves in cardiac valve interventional surgery according to claim 3, characterized in that: The preoperative assessment process includes acquiring cardiac CT angiography images and / or ultrasound of the patient to assess the valve annulus diameter and calcification.

5. The method for precisely matching valves in cardiac valve interventional surgery according to claim 1, characterized in that: The method also includes optimizing valve size selection and release strategies using artificial intelligence; The artificial intelligence optimization process specifically includes: Database construction: Integrate historical surgical data, including pressure distribution of pressure-sensing balloons, morphological changes of pressure-sensing balloons after re-inflation, corresponding valve models and valve release strategies, and postoperative monitoring. Deep learning model: Input pressure distribution, morphological changes, and valve material; Output recommended valve model, valve release location, and valve release strategy. Real-time feedback and alarm: The system dynamically displays real-time pressure distribution data and morphological changes of the pressure-sensing balloon during the procedure, and triggers an alarm when the local pressure exceeds the support force of the stent.

6. The method for precisely matching valves in cardiac valve interventional surgery according to claim 1, characterized in that: The pressure-sensing balloon is a balloon with a flexible electronic pressure-sensitive sensor array integrated on its surface and made of a non-compliant material. The pressure-sensing balloon can detect and provide feedback on the pressure distribution on the surface of the balloon in real time.

7. The method for precisely matching valves in cardiac valve interventional surgery according to claim 6, characterized in that: The pressure-sensing balloon is a blood flow perfusion type pressure-sensing balloon.

8. The method for precisely matching valves in cardiac valve interventional surgery according to claim 1, characterized in that: The valve release strategy includes anchoring zone location, instrument characteristics, and intraoperative dynamic adjustment; the instrument characteristics include the selection of self-expanding or ball-expanding type and stent model selection.

9. The method for precisely matching valves in cardiac valve interventional surgery according to claim 2, characterized in that: After the catheter is inserted to the target position with a precisely matched valve, the precisely matched artificial valve is deployed by balloon dilation or a self-expanding stent.

10. The method for precisely matching valves in cardiac valve interventional surgery according to claim 1, characterized in that: The method is applicable to transcatheter aortic valve replacement or transcatheter mitral valve replacement.