Special delivery system for physiological cardiac pacing by probe method

Abstract

The invention relates to the technical field of medical equipment, and discloses a delivery system special for physiological cardiac pacing with a probe method, which comprises a delivery probe, the outer layer of the delivery probe is made of a polytetrafluoroethylene composite insulating material, the inner layer of the delivery probe is made of a titanium alloy or stainless steel alloy conductive material, two ends of the probe are exposed, one end of the probe enters cardiac muscle, and the other end of the probe is connected with an in-vitro tester; cardiac muscle stimulation and local cardiac muscle threshold value, sensing, impedance and QRS wave group width testing can be rapidly and simply carried out; the physiological pace-making electrode is composed of an internal hollow wire and an external silica gel insulating layer. The bendable delivery sheath is subjected to double-bend 3D pre-plasticity, one bend points to the ventricular septum, and the other bend can be adjusted in size through a rear handle; and the real-time image navigation system adopts X-ray images, provides real-time cardiac anatomical images and is used for guiding accurate implantation of the probe and the electrode. Through a delivery probe, an adjustable bending delivery sheath and a real-time image navigation technology, high-precision implantation of a physiological pacing electrode wire is realized, and the problem of inaccurate positioning in a traditional system is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a dedicated delivery system for probe-based cardiac physiological pacing. Background Art

[0002] With the increasing incidence of heart diseases, cardiac pacemakers have become a common treatment means for treating heart diseases, especially abnormalities of the cardiac conduction system. Existing cardiac pacing systems include an implantable cardiac pacemaker and a lead. The lead is inserted into the heart through a vein or surgery to connect the electrode to the heart tissue to achieve the pacing function. Existing pacemaker delivery systems mainly use rigid or semi-rigid catheters for electrode implantation. These delivery systems rely on an external controller for path guidance, and the electrode is fixedly implanted into the target area through the catheter.

[0003] However, existing cardiac pacemaker delivery systems have significant problems in terms of precise positioning and safety. Especially in complex cardiac anatomical structures, the rigidity of the catheter and the clumsiness of the operation limit the delivery accuracy. Traditional delivery catheters generally do not have the ability to flexibly adjust the path. This results in the situation that in some cases, the electrode cannot be accurately implanted into the target area of the heart, which may cause poor electrode contact or ineffective current transmission. In addition, due to the difficulty of traditional delivery systems in adapting to individual differences and complex anatomies, the risk of damage to blood vessels or heart tissues during the operation is relatively high. These problems often increase the postoperative complications and recovery time of patients. Summary of the Invention

[0004] In view of the deficiencies of the prior art, the present invention provides a dedicated delivery system for probe-based cardiac physiological pacing, which solves the problems of difficult precise positioning, insufficient flexibility during the delivery process, and poor long-term stability of the electrode in the existing delivery system.

[0005] To achieve the above objectives, the present invention is realized through the following technical solutions: A dedicated delivery system for probe-based cardiac physiological pacing, comprising:

[0006] A delivery probe, the outer layer of which is composed of a polytetrafluoroethylene composite insulating material, and the inner layer is made of a titanium alloy or stainless steel alloy conductive material. Both ends of the probe are exposed. One end enters the myocardium, and the other end is connected to an external tester, which can quickly and simply perform myocardial stimulation and test local myocardial thresholds, sensing, impedance, and QRS complex width;

[0007] A physiological pacing electrode, which consists of a hollow internal wire and an external silicone insulating layer. The wire reaches the surface of the ventricular septum along the sheath tube, and the body of the wire is rotated to slowly screw the helical structure at the head of the wire into the ventricular muscular septum;

[0008] Adjustable Curvature Delivery Sheath, double-curved 3D pre-shaped, one curve pointing to the interventricular septum, the other curve can be adjusted in size through the rear handle, with a hydrophilic coating on the inner surface, allowing free passage of electrode leads, having good support, and maintaining its stable shape even during long surgeries. High anti-kinking property and direct torque enable stable lead delivery. The sheath is marked with highly radiopaque polymer X-ray markers, having excellent visibility, which helps to ensure efficient operation. Using a probe allows for more control and high stability in the distal region;

[0009] Real-time Imaging Navigation System, using X-ray imaging technology, provides real-time three-dimensional cardiac anatomical images for guiding the precise implantation of probes and electrodes;

[0010] Biocompatibility Optimization Design, including all components in contact with the human body are made of biocompatible materials, and have antibacterial coating and automatic cleaning function.

[0011] Preferably, the structure of the delivery probe adopts a multi-segment adjustable design and is adjusted through a handle. Each segment has a length of 5 - 10 mm and can adjust the bending angle according to real-time feedback.

[0012] Preferably, the physiological pacing electrode is a multi-channel stimulating electrode, which can automatically adjust the current output mode according to the physiological characteristics of the heart to ensure the best pacing effect.

[0013] Preferably, the adjustable curvature delivery sheath, double-curved 3D pre-shaped, one curve pointing to the interventricular septum, the other curve can be adjusted in size through the rear handle, with a hydrophilic coating on the inner surface, allowing free passage of electrode leads, having good support, and maintaining its stable shape even during long surgeries. High anti-kinking property and direct torque enable stable lead delivery. The sheath is marked with highly radiopaque polymer X-ray markers, having excellent visibility, which helps to ensure efficient operation. Using a probe allows for more control and high stability in the distal region.

[0014] Preferably, the Real-time Imaging Navigation System uses X-ray imaging technology to ensure real-time monitoring during delivery and accurately guide the movement trajectories of probes and electrodes.

[0015] Preferably, the Biocompatibility Optimization Design uses medical-grade polytetrafluoroethylene, medical-grade silicone and nitinol materials to ensure the biocompatibility of the system after long-term implantation and has antibacterial protection function.

[0016] The usage method of the dedicated delivery system for probe-based cardiac physiological pacing includes the following steps:

[0017] Under the guidance of the imaging navigation system, insert the delivery probe into the patient's body through a minimally invasive incision and accurately reach the target position;

[0018] The advancement and path adjustment of the delivery probe are controlled through a handle to ensure stable contact between the probe and the cardiac tissue;

[0019] A real-time imaging navigation system is used to monitor the electrode implantation process to ensure its accuracy and stability;

[0020] After the operation is completed, the functions of the electrode and the pacing system are monitored to ensure long-term physiological adaptability and stability.

[0021] Preferably, the real-time imaging navigation system provides a three-dimensional anatomical map of the heart and combines computer vision algorithms to achieve precise electrode positioning and path planning.

[0022] The present invention provides a dedicated delivery system for probe-based cardiac physiological pacing. It has the following beneficial effects:

[0023] 1. By adopting the technology of combining a delivery probe with a real-time imaging navigation system, before the lead is implanted, the probe is used to find the optimal physiological pacing position in advance. This not only takes into account the cardiac anatomical relationship but also compares the probe position, enabling the lead to be implanted purposefully and precisely. It ensures that the pacing electrode is accurately implanted into the target area. Compared with traditional pacemaker delivery systems, this system can greatly improve the accuracy of electrode implantation, reduce errors, and avoid pacing failure or complications caused by inaccurate electrode positions.

[0024] 2. The present invention avoids the implantation method of repeatedly screwing the lead into the myocardium, reduces the damage to the myocardium caused by the helical structure of the lead, and at the same time avoids changes in the helical structure at the tip of the lead, thus effectively avoiding damage to the heart and blood vessels. This technology greatly improves the safety of the operation and avoids complications such as excessive blood vessel puncture and tissue damage caused by traditional delivery systems. In addition, the flexible design and automatic adjustment function of the system make the delivery process more flexible, adapt to the anatomical structures of different individuals, and reduce the surgical difficulty.

[0025] 3. The micro physiological electrode designed in the present invention has an adaptive elastic expansion mechanism, which can be stably fixed at the cardiac target position to avoid electrode displacement or loosening problems. The electrode surface is made of a highly conductive material and is treated with a platinum coating to ensure good contact with the cardiac tissue and improve the signal transmission efficiency. This design not only ensures the stability of the electrode after long-term implantation but also can simulate physiological pacing signals, improve the physiological adaptability of the heart, and reduce the physiological rejection reaction caused by traditional pacemakers. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a schematic structural diagram of the adjustable bending and tearable sheath tube of the present invention;

[0027] Figure 2 It is a schematic structural diagram of the lead of the present invention;

[0028] Figure 3 Schematic diagram of the probe structure of the present invention;

[0029] Figure 4 Structural diagram when the probe electrode of the present invention is integrated. Specific embodiments

[0030] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the specification of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts shall fall within the protection scope of the present invention.

[0031] Embodiment:

[0032] Please refer to the attached Figure 1 - attached Figure 4 , the embodiment of the present invention provides a dedicated delivery system for probe-based cardiac physiological pacing, and its design purpose is to solve the problems of accuracy, flexibility, safety and complex operation existing in traditional cardiac pacing systems. This system combines a delivery probe, a highly efficient physiological pacing electrode, an adjustable-bend delivery sheath, and real-time imaging navigation technology, and can accurately implant the pacing electrode into the target position in complex cardiac anatomical structures, ensuring the transmission effect of cardiac pacing signals, and thus providing a safer and more efficient treatment plan.

[0033] 1. Overall principle of the system

[0034] The core idea of this system is that the accurate positioning, testing and implantation of the physiological pacing electrode can be completed in one step. Through the probe-based delivery technology, the physiological pacing electrode is accurately implanted into the target part of the heart by using the delivery probe, and the high precision, high safety and physiological adaptability during the delivery process are ensured through the real-time imaging navigation system and the optimized design of biocompatibility.

[0035] Main principle:

[0036] Delivery probe: The probe is inserted into the patient's body through a minimally invasive incision and can be flexibly bent and adjusted in path with the help of a handle drive. A sensor is installed at the front end of the probe to monitor the contact force with the tissue in real time, ensuring that excessive pressure is not exerted on the heart tissue during the delivery process.

[0037] Physiological pacing electrode: The electrode is made of a highly conductive material (such as gold alloy or carbon nanotube) and is fixed in the target area through an adaptive expansion mechanism to ensure the accurate transmission of pacing signals. The surface of the electrode is treated with a platinum coating, which has extremely high conductivity and biocompatibility and can work stably for a long time.

[0038] Real-time Imaging Navigation System: This system uses X-ray imaging technology to provide anatomical images of the heart, assist in positioning the delivery path, and ensure accurate implantation of the electrode at the target location in the heart through real-time feedback.

[0039] Biocompatible Design: All components in contact with the human body (including the probe, control system, and electrode) are made of medical-grade biocompatible materials to ensure that there will be no rejection reaction or other complications to the patient after long-term implantation.

[0040] The dedicated delivery system for "probe method" cardiac physiological pacing searches for the optimal physiological pacing position by pre-implanting the probe before implanting the lead. This can ensure the precise implantation of the lead and complete the implantation process of physiological pacing in one go. Compared with the traditional method, the probe method has many unique advantages, which are specifically manifested in the following aspects:

[0041] Precisely Lock the Optimal Pacing Position

[0042] Before implanting the lead, the probe pre-locates the optimal pacing position. Combining the anatomical relationship with the probe position, it can achieve targeted and precise implantation, thereby reducing errors and avoiding unnecessary repeated adjustments.

[0043] Reduce Myocardial Injury

[0044] The traditional method of repeatedly screwing the lead into the myocardium is avoided by the probe method, significantly reducing the damage to the myocardium caused by the helical structure of the lead. In addition, this method can avoid changes in the helical structure at the tip of the lead and effectively protect the myocardium.

[0045] Real-time Monitoring to Ensure Safety

[0046] Use X-rays to compare the probe position to ensure that the helical part of the lead does not exceed the distal end of the probe. By real-time monitoring the lead impedance, a double insurance is added to avoid perforation or lead penetration through the ventricular septum.

[0047] Simplify the Operation Process

[0048] The probe method is particularly friendly to new operators, and the operation process does not rely on experience. The probe has an appropriate length, and the tail end has a scale display, which is convenient for measuring the specific length of the probe extending from the tip of the lead, further improving the surgical safety, simplifying the surgical steps, and saving surgical time.

[0049] 2. System Structure and Functional Modules

[0050] This system consists of the following main modules: delivery probe module, physiological pacing electrode module, adjustable bending delivery sheath module, real-time imaging navigation module, and biocompatible module. Each module works closely together to jointly achieve precise, efficient, and safe delivery of the cardiac pacing electrode.

[0051] 2.1 Delivery Probe Module

[0052] Function and Principle:

[0053] The delivery probe is one of the key components of this system. The wire used in the probe method is not fixed. It can be the wire developed by ourselves or the wire of existing mature technologies. Its main function is to guide the electrode from the incision to the target position in the heart.

[0054] Material and Structure: The outer layer of the probe is made of polytetrafluoroethylene (PTFE) composite material, which has good flexibility and low friction; the inner layer is made of titanium alloy or stainless steel alloy, which has sufficient rigidity to support the movement of the probe inside the blood vessel and the heart. The outer surface is treated with an antibacterial coating to ensure safety during the delivery process.

[0055] Intelligent Sensing System: The probe is equipped with a sensor array inside, including a pressure sensor, a temperature sensor and an acceleration sensor, which can real-time feedback the contact force between the probe and the tissue, temperature changes and position data. The information of these sensors will be transmitted to the control system for real-time adjustment of the path and propulsion pressure.

[0056] Power System: The probe is precisely controlled through the handle. The handle is used to adjust the bending degree and propulsion speed of the probe to ensure the stability of the path during the delivery process.

[0057] 2.2 Physiological Pacing Electrode Module

[0058] Function and Principle:

[0059] The physiological pacing electrode is responsible for transmitting the electrical signal of the heart to the control system and accurately transmitting the pacing signal to the target area. The design of the electrode aims to maximize the electrical contact with the heart tissue to ensure the efficient conduction of the pacing signal.

[0060] Electrode Material: The electrode is made of gold alloy or carbon nanotube material. These materials have extremely high electrical conductivity and corrosion resistance, and can maintain stable electrical conduction performance under high load and long-term use conditions.

[0061] Surface Treatment: The surface of the electrode is treated with a platinum coating, which has a higher charge density and electrical conductivity, enabling it to efficiently conduct the current signal to the heart tissue while reducing the friction when contacting the heart tissue.

[0062] 2.3 Adjustable Bending Delivery Sheath Module

[0063] Function and Principle:

[0064] Control System Design: This system adopts double-bend 3D pre-plasticity. One bend points to the interventricular septum, and the other bend can be adjusted in size through the rear handle. The inner surface is coated with a hydrophilic coating, which can freely pass the electrode wire, has good support, and can maintain its stable shape even during long operations. High anti-kinking property and direct torque enable stable lead delivery. The sheath tube is marked with a highly radiopaque polymer X-ray, with excellent visibility, which helps to ensure efficient operation. Using a probe can provide more control and high stability in the distal area.

[0065] 2.4 Real-time Imaging Navigation Module

[0066] Function and Principle:

[0067] The real-time imaging navigation system provides real-time cardiac anatomical images through X-ray imaging technology to ensure the precise positioning of the delivery probe and electrode.

[0068] Imaging System Integration: Through the use of X-ray imaging, this system provides more precise penetration ability and effectively monitors the position and status of the probe during delivery.

[0069] 2.5 Biocompatibility Module

[0070] Function and Principle:

[0071] All device components (probes, electrodes, sensors, etc.) that come into contact with the patient's body must have high biocompatibility to ensure that no rejection reaction or infection is caused during long-term implantation.

[0072] Biocompatible Materials: All materials in contact with tissues are made of highly biocompatible materials such as medical-grade polytetrafluoroethylene (PTFE), biodegradable polymers, polyurethane, and nitinol alloy to ensure that no adverse reactions occur after long-term implantation.

[0073] Antibacterial Coating: The outer surface of the delivery probe is coated with an antibacterial coating, which can effectively prevent the occurrence of bacterial infection during the operation.

[0074] 3. Implementation Methods and Steps

[0075] 3.1 Preoperative Preparation

[0076] Patient Evaluation and Image Acquisition: Before the operation, first obtain the patient's cardiac anatomical structure information through CT, MRI, or ultrasound imaging technology, and formulate a personalized treatment plan according to the patient's specific situation.

[0077] Surgical Equipment Preparation: Ensure that all equipment and materials meet the surgical requirements, and check the functions of the probe, physiological pacing electrode, and adjustable-bend delivery sheath.

[0078] 3.2 Delivery Process

[0079] Delivery probe insertion: Under the guidance of X-ray imaging navigation, the delivery probe is inserted into the patient's body through a minimally invasive incision, and the probe accurately reaches the target area of the heart through the control system.

[0080] Pacing test: After the probe implantation is completed, a pacing signal test is performed to ensure the best physiological pacing position can be found.

[0081] Electrode implantation: According to the real-time image feedback, the control system adjusts the activation parameters of the electrode, and through an automatic adjustment mechanism, ensures the stable contact between the electrode and the target area of the heart.

[0082] Pacing test: After the electrode implantation is completed, a pacing signal test is performed to ensure the electrode works properly and transmits an effective pacing signal.

[0083] 3.3 Postoperative monitoring

[0084] Postoperative evaluation: Continuously monitor the patient's cardiac pacing through a remote monitoring system to ensure the stability of the electrode and the pacing effect.

[0085] Regular examination: Regular cardiac imaging examinations are performed after the operation to ensure the stable operation of the electrode in the heart and avoid displacement or damage.

[0086] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A dedicated delivery system for cardiac physiological pacing by the probe method, characterized in that, Comprising: A delivery probe, which includes an outer layer made of a polytetrafluoroethylene composite insulating material and an inner layer made of a titanium alloy or stainless steel alloy conductive material. Both ends of the probe are exposed. One end enters the myocardium and the other end is connected to an external tester, enabling rapid and simple myocardial stimulation and testing of local myocardial thresholds, perception, impedance, and QRS complex width; A physiological pacing electrode, which consists of an internal hollow wire and an external silicone insulating layer. The wire reaches the surface of the ventricular septum along the sheath tube, and by rotating the body of the wire, the helical structure at the head of the wire is slowly screwed into the ventricular myocardial septum; An adjustable-bend delivery sheath, with a double-bend 3D pre-formed shape. One bend points to the ventricular septum and the other bend can be adjusted in size through a rear handle. The inner surface is coated with a hydrophilic coating, allowing the electrode wire to pass through freely, having good support, and maintaining its stable shape even during a long operation; High anti-kinking property and direct torque enable stable lead delivery. The sheath tube is marked with a highly radiopaque polymer X-ray marker, having excellent visibility, which helps to ensure efficient operation, and more control and high stability can be achieved for the distal region using the probe; A real-time imaging navigation system, which uses X-ray imaging to provide real-time cardiac anatomical images for guiding the precise implantation of the probe and the electrode; Biocompatibility optimization design, including that all components in contact with the human body are made of biocompatible materials, and having an antibacterial coating and an automatic cleaning function; 2. The dedicated delivery system for probe method cardiac physiological pacing according to claim 1, wherein Both ends of the delivery probe are exposed. One end enters the myocardium and the other end is connected to an external tester, enabling rapid and simple myocardial stimulation and testing of local myocardial thresholds, perception, impedance, and QRS complex width; 3. The dedicated delivery system for probe-based cardiac physiological pacing according to claim 1, characterized in that, The physiological pacing electrode consists of an internal hollow wire and an external silicone insulating layer. The wire reaches the surface of the ventricular septum along the sheath tube, and by rotating the body of the wire, the helical structure at the head of the wire is slowly screwed into the ventricular myocardial septum; 4. The dedicated delivery system for probe method cardiac physiological pacing according to claim 1, characterized in that, The adjustable-bend delivery sheath has a double-bend 3D pre-formed shape. One bend points to the ventricular septum and the other bend can be adjusted in size through a rear handle. The inner surface is coated with a hydrophilic coating, allowing the electrode wire to pass through freely, having good support, and maintaining its stable shape even during a long operation; High anti-kinking property and direct torque enable stable lead delivery. The sheath tube is marked with a highly radiopaque polymer X-ray marker, having excellent visibility, which helps to ensure efficient operation, and more control and high stability can be achieved for the distal region using the probe; 5. The dedicated delivery system for probe-based cardiac physiological pacing according to claim 1, characterized in that, The real-time imaging navigation system uses X-ray imaging to ensure real-time monitoring during delivery and accurately guide the movement trajectories of the probe and the electrode; 6. The dedicated delivery system for probe-based cardiac physiological pacing according to claim 1, characterized in that, The biocompatibility optimization design uses medical-grade polytetrafluoroethylene, medical-grade silicone, and nitinol materials to ensure the biocompatibility of the system after long-term implantation and has an antibacterial protection function; 7. Method of using a dedicated delivery system for probe-based cardiac physiological pacing. For the dedicated delivery system for probe-based cardiac physiological pacing according to any one of claims 1-7, it is characterized in that Including the following steps: Under the guidance of the imaging navigation system, control the advancement and path adjustment of the delivery probe through the handle to ensure stable contact between the electrode and the cardiac tissue; Control the advancement and path adjustment of the delivery probe through a precision control system to ensure stable contact between the probe and the cardiac tissue; After the probe reaches the target position, the pacing probe is activated in unipolar mode, and the morphology of the paced surface electrocardiogram is observed. If the surface 12-lead electrocardiogram during pacing does not meet the criteria for physiological cardiac pacing due to the position or depth of the probe, the probe can be withdrawn, the sheath angle can be adjusted, and the probe can be reinserted to repeat the above operations. After meeting the requirements for physiological cardiac pacing, the septal sheath and the probe within the sheath are fixed externally, and the position of the distal end of the probe is compared, and the spiral bare wire is screwed into the designated depth. The probe and the septal sheath are withdrawn, and the parameters of the electrode wire are tested again. The real-time imaging navigation system is used to monitor the electrode implantation process to ensure its accuracy and stability; After the operation, the functions of the electrode and the pacing system are monitored to ensure long-term physiological adaptability and stability.

8. The dedicated delivery system for probe-based cardiac physiological pacing according to claim 7, characterized in that, The real-time imaging navigation system provides anatomical images of the heart and combines computer vision algorithms to achieve precise electrode positioning and path planning.

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