Percutaneous ventricular reconstruction system

Abstract

Provided is a percutaneous ventricular reconstruction system, comprising: a first treatment device (10), comprising a balloon (5), and an emitting electrode (1) and a receiving electrode (2) arranged in the balloon (5); a second treatment device (20), comprising a supporting frame that can be folded or unfolded, the supporting frame being covered with a film, and the film carrying a strain detection unit (201); a conveying mechanism (30), configured for conveying the supporting frame; and a control host (40), configured for sending a stimulation signal to the ventricle by means of the emitting electrode (1) in response to strain data fed back by the strain detection unit (201), acquiring a detection signal by means of the receiving electrode (2) to determine the volume of the left ventricle, and further controlling the conveying mechanism (30) to convey the supporting frame to a desired position after the balloon (5) is inflated, the control host (40) comprising an adjustment unit (401) configured for adjusting the emitted energy of the emitting electrode (1). The percutaneous ventricular reconstruction system can quantitatively summarize the profiles of the stress and strain borne by the myocardium.

Description

Percutaneous ventricular reconstruction system Technical Field

[0001] The present application relates to the technical field of medical equipment, and in particular to a percutaneous ventricular reconstruction system. Background Art

[0002] Heart failure (HF) is a serious clinical syndrome caused by myocardial damage, which leads to changes in myocardial structure and function, ultimately resulting in impaired ventricular pumping and / or filling function. The number of HF patients worldwide has reached 22.5 million, with approximately 2 million new cases each year. It is estimated that in 2010, the direct and indirect costs of HF treatment in the United States reached $39.2 billion. The incidence of HF in China is approximately 0.9% of the total population, with over 11 million HF patients nationwide. HF is considered a "malignant tumor" among cardiovascular diseases, and existing treatments can only help patients prolong their lives, but cannot yet achieve a cure. Therefore, there is an urgent need to conduct in-depth research on the pathological mechanisms of HF and develop new treatments.

[0003] Studies have shown that coronary artery disease (CAD) has become the leading cause of heart failure in recent years, accounting for 56%-65% of all cases. CAD-induced heart failure (ischemic HF) is primarily due to post-MI myocardial remodeling and chronic myocardial blood supply insufficiency, leading to nutritional disorders and atrophy of myocardial tissue and fibrosis. Biomechanical factors play a crucial role in the development and progression of HF, but their impact on ischemic HF remains poorly understood. Therefore, it is necessary to clarify which biomechanical factors influence the development and progression of ischemic HF and, in turn, to elucidate the biomechanical mechanisms of ischemic HF.

[0004] Summary of the Invention

[0005] In order to solve at least one technical problem existing in the prior art, the present application provides a percutaneous ventricular reconstruction system that can quantitatively summarize the stress and strain patterns of the myocardium.

[0006] In order to achieve the above objectives, the technical solutions provided by this application are as follows:

[0007] A percutaneous ventricular reconstruction system, comprising:

[0008] The first treatment device includes: a balloon and a transmitting electrode and a receiving electrode therein;

[0009] A second treatment device includes: a support frame, the support frame being foldable or unfoldable, the support frame being covered with a membrane, and the membrane carrying a strain detection unit;

[0010] A conveying mechanism, used for conveying the support frame;

[0011] a control host electrically connected to the strain detection unit, the transmitting electrode, the receiving electrode, and the transmission mechanism, and configured to: in response to strain data fed back by the strain detection unit, send a stimulation signal to the ventricle via the transmitting electrode, acquire a detection signal via the receiving electrode to determine the volume of the left ventricle, and further control the transmission mechanism to transmit the stent to a desired position after the balloon is inflated;

[0012] The control host includes an adjusting unit for adjusting the emission energy of the transmitting electrode.

[0013] As a preferred embodiment, the system includes: a pressure pump, which is connected to the balloon, and is configured to receive a start signal from the control host to expand the balloon, wherein the start signal is generated based on the strain data.

[0014] As a preferred embodiment, the system includes: a pressure acquisition device for acquiring electrocardiogram signals or pressure data, the pressure acquisition device is connected to the control host, and the control host also determines whether an abnormality occurs based on the electrocardiogram signals and / or pressure data.

[0015] As a preferred embodiment, the desired position includes: a heart atrium position and a heart ventricle position.

[0016] As a preferred embodiment, the first treatment device includes: an inner tube having an axis, the balloon is sleeved on the outside of the inner tube and extends along the axis, and the transmitting electrode and the receiving electrode are arranged between the outer wall of the inner tube and the balloon.

[0017] As a preferred embodiment, the inner tube has a hollow structure, the hollow structure is connected to the pressure pump, and the inner tube is provided with a connecting hole connected to the balloon.

[0018] As a preferred embodiment, the control host has an input unit for inputting a transmission control signal to transmit energy corresponding to different transmitting electrodes.

[0019] As a preferred embodiment, the control host determines the filling volume of the balloon according to the left ventricular volume; and the start signal includes an identifier representing the pressurization time or pressurization volume.

[0020] As a preferred embodiment, a developing ring is provided at both ends of the emitting electrode and the receiving electrode for positioning and controlling the positions of the emitting electrode and the receiving electrode.

[0021] As a preferred embodiment, the system includes a guiding catheter, which is pre-placed into the ventricle via the radial artery, and the balloon is advanced into the ventricle along the guiding catheter. Beneficial effects:

[0022] The percutaneous ventricular reconstruction system provided in the embodiment of the present application is composed of a balloon catheter with electrodes, an implantable support frame, a mechanism for transmitting the support frame, and a control host. The control host changes the distribution of the electromagnetic field between the transmitting and receiving electrodes in a weak electric field by controlling the emission energy of the transmitting electrode to simulate the spatiotemporal dynamic characteristics of calcium signals and ROS signals of different myocardial cells, and reveal the mechanical and biological characteristics of cytoskeletal protein expression during the occurrence and development of ischemic heart failure. In addition, there is a membrane on the support frame, and a strain detection unit is carried on the membrane to calculate the stress and strain on the myocardium and the support frame by analyzing the stress distribution. After the balloon is expanded, it is used to assist in adjusting the position of the support frame in the ventricle, so that its positioning and fitting tension can be accurately controlled. The percutaneous ventricular reconstruction system provided in the embodiment of the present application can clarify which biomechanical factors affect the occurrence and development of ischemic heart failure, and then clarify the biomechanical mechanism of ischemic heart failure.

[0023] With reference to the following description and drawings, the specific embodiments of the present application are disclosed in detail, indicating the manner in which the principles of the present application can be adopted. It should be understood that the embodiments of the present application are not limited in scope.

[0024] Features described and / or illustrated with respect to one embodiment may be used in the same or similar manner in one or more other embodiments, combined with features in other embodiments, or substituted for features in other embodiments.

[0025] It should be emphasized that the term "include / comprising" when used herein refers to the presence of features, integers, steps or components, but does not exclude the presence or addition of one or more other features, integers, steps or components. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without expending creative labor.

[0027] FIG1 is a schematic diagram of a percutaneous ventricular reconstruction system provided in an embodiment of the present application;

[0028] FIG2 is a block diagram of the module structure of the percutaneous ventricular reconstruction system provided in an embodiment of the present application;

[0029] FIG3 is a schematic structural diagram of a first treatment device provided in an embodiment of the present application;

[0030] FIG4 is a schematic diagram showing the module structure of the control host provided in an embodiment of the present application.

[0031] Explanation of the accompanying drawings: 10. First treatment device; 1. Transmitting electrode; 2. Receiving electrode; 3. Development ring; 4. Inner tube; 5. Balloon; 20. Second treatment device; 201. Strain detection unit; 30. Transmission mechanism; 40. Control host; 50. Pressure pump; 60. Pressure acquisition device; 70. Guide catheter; 401. Adjustment unit; 402. Input unit; 403. Storage unit. DETAILED DESCRIPTION

[0032] The technical solution of the present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not used to limit the scope. After reading the present invention, modifications of various equivalent forms of the present invention by those skilled in the art all fall within the scope defined in this application.

[0033] It should be noted that when an element is referred to as being “disposed on” another element, it may be directly on the other element or there may be an intermediate element. When an element is referred to as being “connected to” another element, it may be directly connected to the other element or there may be an intermediate element at the same time.

[0034] The following describes and illustrates the percutaneous ventricular reconstruction system according to an embodiment of this specification, with reference to Figures 1 to 4 . It should be noted that, in the embodiments of the present invention, identical reference numerals denote identical components. For the sake of brevity, detailed descriptions of identical components will be omitted in different embodiments, and descriptions of identical components may be cross-referenced.

[0035] The present specification provides a percutaneous ventricular reconstruction system, as shown in Figures 1 to 4, the system includes: a first treatment device 10, including: a balloon 5, a transmitting electrode 1 and a receiving electrode 2; a second treatment device 20, including: a support frame, the support frame can be folded or unfolded, the support frame is covered with a membrane, and the membrane carries a strain detection unit 201; a transmission mechanism 30, used to transmit the support frame; a control host 40, electrically connected to the strain detection unit 201, the transmitting electrode 1, the receiving electrode 2 and the transmission mechanism 30, and configured to: respond to the strain data fed back by the strain detection unit 201, send a stimulation signal to the ventricle through the transmitting electrode 1, and obtain a detection signal through the receiving electrode 2 to determine the left ventricular volume, and further control the transmission mechanism 30 to transmit the support frame to the desired position after the balloon 5 is expanded; the control host 40 includes an adjustment unit 401 for adjusting the transmission energy of the transmitting electrode 1.

[0036] The percutaneous ventricular reconstruction system provided in the embodiment of the present application is composed of a balloon catheter with electrodes, an implantable support frame, a mechanism for transmitting the support frame, and a control host. The control host changes the distribution of the electromagnetic field between the transmitting and receiving electrodes in a weak electric field by controlling the emission energy of the transmitting electrode to simulate the spatiotemporal dynamic characteristics of calcium signals and ROS signals of different myocardial cells, and reveal the mechanical and biological characteristics of cytoskeletal protein expression during the occurrence and development of ischemic heart failure. In addition, there is a membrane on the support frame, and a strain detection unit is carried on the membrane to calculate the stress and strain on the myocardium and the support frame by analyzing the stress distribution. After the balloon is expanded, it is used to assist in adjusting the position of the support frame in the ventricle, so that its positioning and fitting tension can be accurately controlled. The percutaneous ventricular reconstruction system provided in the embodiment of the present application can clarify which biomechanical factors affect the occurrence and development of ischemic heart failure, and then clarify the biomechanical mechanism of ischemic heart failure.

[0037] In this specification, the system includes: a pressure pump 50, which is connected to the balloon 5, and the pressure pump 50 is configured to receive a start signal from the control host 40 to expand the balloon 5, and the start signal is generated based on the strain data.

[0038] The strain sensing unit 201 can be a strain gauge mounted on the membrane of the stent. When the strain data exceeds a preset value, it indicates excessive stress on the stent, necessitating adjustment of the stent position. Specifically, when the strain data exceeds the preset value, the control host 40 generates a start signal and transmits it to the pressure pump 50, thereby inflating the balloon 5 to ensure proper contact tension and sealing between the stent and the ventricular wall.

[0039] Furthermore, the left ventricular volume is determined by the stimulation signal emitted by the transmitting electrode 1 and the detection signal received by the receiving electrode 2, and the filling volume of the balloon 5 is determined based on the left ventricular volume. In this embodiment, the activation signal includes an identifier representing the pressurization time or pressurization amount, so that the balloon 5 can achieve a better support effect on the ventricle.

[0040] In this specification, the control host 40 has an input unit 402 for inputting a transmission control signal to transmit energy corresponding to different transmitting electrodes, thereby changing the distribution of the electromagnetic field between the transmitting and receiving electrodes to simulate the spatiotemporal dynamic characteristics of different myocardial cell calcium signals and ROS signals, and determine the stress conditions and blocking effects of the support frame under different biomechanical factors.

[0041] In an embodiment of the present invention, the control host 40 has a storage unit 403 for storing data fed back by the receiving electrode 2, the strain detection unit 201, the pressure acquisition device 60, etc., as well as judgment, simulation, and control data generated by the control host 40.

[0042] In this specification, the first treatment device 10 includes: an inner tube 4 having an axis, the balloon 5 is sleeved on the outside of the inner tube 4 and extends along the axis, the transmitting electrode 1 and the receiving electrode 2 are arranged on the outer wall of the inner tube 4 and located inside the balloon 5.

[0043] Furthermore, as shown in FIG3 , the inner tube 4 has a hollow structure, which is connected to the pressure pump 50. The inner tube 4 is provided with a connecting hole connected to the balloon 5. Thus, after starting the pressure pump 50, the balloon 5 can be expanded to assist in delivering the second treatment device 20, accurately controlling its positioning and fitting tension. A developing ring 3 is provided at both ends of the transmitting electrode 1 and the receiving electrode 2 for positioning and controlling the position of the transmitting electrode 1 and the receiving electrode 2. The developing ring 3 is visible under the irradiation of radiation, so that the transmitting electrode 1 and the receiving electrode 2 can still be observed after being implanted in the human body, making it convenient for the operator to accurately position and control the position of the transmitting electrode 1 and the receiving electrode 2.

[0044] In addition, in order to ensure that the balloon 5 is successfully implanted into the ventricle, the system further includes a guiding catheter 70 . The guiding catheter 70 is pre-entered into the ventricle via the radial artery, and the balloon 5 is advanced into the ventricle along the guiding catheter 70 .

[0045] In this specification, the system includes: a pressure acquisition device 60 for acquiring electrocardiogram signals or pressure data, the pressure acquisition device 60 is connected to the control host 40, and the control host 40 also determines whether an abnormality occurs based on the electrocardiogram signals and / or pressure data.

[0046] In this specification, the desired position includes: a heart atrium position and a heart ventricle position.

[0047] In this specification, the second treatment device 20 is specifically an implantable ventricular volume reduction device. For details, please refer to the patent document with publication number CN109009589A. The ventricular volume reduction device is equipped with a transmission mechanism 30. The transmission mechanism 30 drives the ventricular volume reduction device to deliver it to the desired position. This is prior art and will not be described in detail in this application.

[0048] It is known to those skilled in the art that various aspects of the present invention may be implemented as a system, method or computer program product. Therefore, various aspects of the present invention may be specifically implemented in the following forms, namely: a complete hardware implementation, a complete software implementation (including firmware, resident software, microcode, etc.), or an implementation combining hardware and software aspects, which may be collectively referred to herein as a "circuit", "module" or "system". In addition, in some embodiments, various aspects of the present invention may also be implemented in the form of a computer program product in one or more computer-readable media, which contains computer-readable program code. The implementation of the method and / or system of an embodiment of the present invention may involve performing or completing a selected task manually, automatically or in a combination thereof.

[0049] It should be understood that each block in the flowchart and / or block diagram, as well as combinations of blocks in the flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device, thereby producing a machine such that when these computer program instructions are executed by the processor of the computer or other programmable data processing device, a device is generated that implements the functions / actions specified in one or more blocks in the flowchart and / or block diagram.

[0050] These computer program instructions may also be stored in a computer-readable medium, which causes a computer, other programmable data processing apparatus, or other device to operate in a specific manner, so that the instructions stored in the computer-readable medium produce an article of manufacture that includes instructions for implementing the functions / actions specified in one or more blocks in the flowchart and / or block diagram.

[0051] Computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer, other programmable data processing apparatus or other apparatus to produce a computer-implemented process, such that the instructions executed on the computer, other programmable apparatus or other apparatus provide a process for implementing the functions / actions specified in the flowchart and / or block diagram blocks.

[0052] It should be understood that the above description is for illustration and not for limitation. Many embodiments and applications beyond the examples provided will be apparent to those skilled in the art upon reading the above description. For comprehensive purposes, all articles and references, including disclosures of patent applications and publications, are incorporated herein by reference.

Claims

1. A percutaneous ventricular reconstruction system, characterized in that: include: The first treatment device includes: a balloon and a transmitting electrode and a receiving electrode therein; A second treatment device includes: a support frame, the support frame being foldable or unfoldable, the support frame being covered with a membrane, and the membrane carrying a strain detection unit; A conveying mechanism, used for conveying the support frame; a control host electrically connected to the strain detection unit, the transmitting electrode, the receiving electrode, and the transmission mechanism, and configured to: in response to strain data fed back by the strain detection unit, send a stimulation signal to the ventricle via the transmitting electrode, acquire a detection signal via the receiving electrode to determine the volume of the left ventricle, and further control the transmission mechanism to transmit the stent to a desired position after the balloon is inflated; The control host includes an adjusting unit for adjusting the emission energy of the transmitting electrode.

2. The percutaneous ventricular reconstruction system according to claim 1, wherein: The system includes a pressure pump connected to the balloon, and configured to receive a start signal from the control host to expand the balloon, wherein the start signal is generated based on the strain data.

3. The percutaneous ventricular reconstruction system according to claim 1, wherein: The system includes: a pressure acquisition device for acquiring electrocardiogram signals or pressure data, wherein the pressure acquisition device is connected to the control host, and the control host further determines whether an abnormality occurs based on the electrocardiogram signals and / or pressure data.

4. The percutaneous ventricular reconstruction system according to claim 1, wherein: The desired positions include: a heart atrium position and a heart ventricle position.

5. The percutaneous ventricular reconstruction system according to claim 2, wherein: The first treatment device includes an inner tube having an axis, the balloon is sleeved on the outside of the inner tube and extends along the axis, and the transmitting electrode and the receiving electrode are arranged between the outer wall of the inner tube and the balloon.

6. The percutaneous ventricular reconstruction system according to claim 5, wherein: The inner tube has a hollow structure, the hollow structure is connected to the pressure pump, and a communication hole connected to the balloon is provided on the inner tube.

7. The percutaneous ventricular reconstruction system according to claim 1, wherein: The control host has an input unit for inputting a transmission control signal to transmit energy corresponding to different transmitting electrodes.

8. The percutaneous ventricular reconstruction system according to claim 1, wherein: The control host determines the filling volume of the balloon according to the left ventricular volume; the start signal includes an identifier representing the pressurization time or pressurization volume.

9. The percutaneous ventricular reconstruction system according to claim 5, wherein: A developing ring is provided at both ends of the emitting electrode and the receiving electrode for positioning and controlling the positions of the emitting electrode and the receiving electrode.

10. The percutaneous ventricular reconstruction system according to claim 1, wherein: The system includes a guiding catheter that is previously advanced into a ventricle via a radial artery, and the balloon is advanced into the ventricle along the guiding catheter.

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