Intracardiac balloon pacing implant kit

Abstract

This invention discloses an intraperitoneal balloon-assisted pacing implant kit, comprising: a guiding component, a dilation catheter component, and an inflation / deflation component. The guiding component includes a first guidewire, a portion of which is located inside the pericardial cavity of the target heart. The dilation catheter component includes a main tube and a balloon. The main tube has parallel guiding and air intake channels. The first guidewire is slidably connected within the guiding channels, guiding the main tube into the body. The balloon is positioned on the main tube and connected to the air intake channel. The main tube has a groove along its axial direction. Guided by the first guidewire, the balloon is embedded in the pericardial cavity of the target heart. Air is introduced through the air intake channel, causing the balloon to extend along the groove and surround the outside of the ventricle. The inflation / deflation component is connected to the balloon. With the support of ECG gating technology, the balloon expands during cardiac systole and contracts during diastole within the pericardial cavity, thereby compressing the left and right ventricles during cardiac systole.

Description

Technical Field

[0001] This invention relates to the field of cardiopulmonary resuscitation equipment, specifically to an intracardiac balloon-assisted pacing implant kit. Background Technology

[0002] Chest compressions in cardiopulmonary resuscitation (CPR) are a fundamental and crucial first aid technique, widely and systematically applied in both out-of-hospital and in-hospital emergency care. The effectiveness of manual chest compressions depends on the rescuer's endurance and skill. Manual compressions during CPR can only provide about 30% of normal cardiac output. Manual CPR is also limited by the extended manual stop time, and its quality is particularly poor when performed during patient transport.

[0003] Based on this, in order to reduce the resistance encountered during external chest compressions and the dependence on the endurance and skills of personnel, a technique of surgically opening the chest cavity and directly contacting the heart for intrathoracic cardiac compression has emerged. Due to the high difficulty and risk of the surgery and the poor prognosis, this technique has been almost eliminated in clinical practice except for its use in open-chest surgery. Therefore, some devices and techniques have emerged that use minimally invasive puncture techniques to insert balloon catheters into the chest cavity to perform compressions inside and outside the chest.

[0004] While the aforementioned devices do not require open-chest surgery, the complex anatomy of the heart and thoracic cavity, with its numerous organs and membranes, and intricate surrounding blood vessels, makes it difficult, despite the theoretical feasibility of implanting a balloon within the thoracic cavity and using it to compress the heart during inflation. Anatomical analysis reveals that stable and effective balloon implantation is practically impossible, rendering balloons and similar structures unsuitable for extracardiac placement within the thoracic cavity. Specifically, the complexity of the intrathoracic organs and blood vessels makes stable implantation and fixation challenging, potentially impacting the timing of emergency treatment. Furthermore, the balloon can affect blood vessels surrounding the heart, compressing not only the heart but also vital vessels such as aorta, coronary arteries, or other major blood vessels, thus impairing normal cardiac function. Therefore, there is a need for an implantable cardiac assist device that is more suitable for the heart's anatomy, allowing for direct chest compressions without open-chest surgery. Summary of the Invention

[0005] The purpose of this invention is to overcome the problems in the prior art and provide an intracardiac balloon-assisted pacing implant kit suitable for cardiac anatomy.

[0006] This invention provides an intraperitoneal balloon-assisted pacing implant kit, comprising: a guiding component, a dilation catheter component, and an inflation / deflation component. The guiding component includes a first guidewire, a portion of which is located inside the pericardial cavity of the target heart. The dilation catheter component includes a main tube and a balloon. The main tube has parallel guiding and air intake channels. The first guidewire is slidably connected within the guiding channels, guiding the main tube into the body. The balloon is positioned on the main tube and connected to the air intake channel. The main tube has a groove along its axial direction. Guided by the first guidewire, the balloon is embedded in the pericardial cavity of the target heart. Air is introduced through the air intake channel, causing the balloon to extend along the groove and surround the ventricle. The inflation / deflation component is connected to the balloon, allowing the balloon to expand / contract within the pericardial cavity, thereby compressing the ventricle.

[0007] Optionally, the guiding assembly also includes a first catheter, the end of the first catheter facing the human body entering the pericardial cavity, a first guidewire placed inside the first catheter, the first catheter guiding the portion of the first guidewire facing the human body into the pericardial cavity, when part of the first guidewire enters the pericardial cavity, the first catheter withdraws out of the human body to disengage the first guidewire from the first catheter, the first guidewire is made of shape memory alloy, and the portion of the first guidewire extending out of the first catheter deforms and bends to encircle the outer side of the visceral pericardium in the pericardial cavity.

[0008] Optionally, the deformed portion of the first guidewire encircles the visceral pericardium at the interventricular groove.

[0009] Optionally, the main tube includes an indwelling section, which is placed inside the pericardial cavity. The indwelling section also has a receiving cavity, which is located between the air intake channel and the guiding channel. The receiving cavity and the guiding channel are connected. An air bag is located in the receiving cavity. A groove is opened on the lower side wall of the indwelling section along the length of the indwelling section, and the groove connects the guiding channel to the outside.

[0010] Optionally, the airbag includes an inner membrane layer and an outer membrane layer. The outer membrane layer is made of non-elastic PC material, and the inner membrane layer is made of latex. When the air pressure inside the airbag increases, the inner membrane layer extends.

[0011] Optionally, the inflation / deflation assembly includes an inflation component, a deflation component, a processing element, and a detection component. The inflation component and the deflation component are respectively connected to the end of the air intake channel away from the human body. The detection component is signal-connected to the processing element, and the processing element is signal-connected to the inflation component and the deflation component. The detection component is used to detect the electrocardiogram (ECG) signal of the target heart. The processing element sends an inflation signal to the inflation component or a deflation signal to the deflation component according to the different ECG signals.

[0012] Optionally, the electrocardiogram (ECG) signals include QRS wave ECG signals and T wave ECG signals. When the processing element receives a QRS wave ECG signal, it sends an inflation signal to the inflation device; when the processing element receives a T wave ECG signal, it sends a deflation signal to the deflation device.

[0013] Furthermore, the guiding assembly also includes: a puncture guidewire, the end of which faces the human body and is inserted into the pericardial cavity via puncture; a first catheter is slidably connected to the outside of the puncture guidewire; the puncture guidewire is used to guide the end of the first catheter facing the human body into the pericardial cavity; when the end of the first catheter enters the pericardial cavity, the puncture guidewire can slide out from the end of the first catheter away from the human body; when the puncture guidewire slides out of the first catheter, the first guidewire slides into the first catheter from the end of the first catheter away from the human body.

[0014] Optionally, the first catheter is a deep vein catheter.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: In use, using existing puncture techniques, one end of the first guidewire is inserted into the pericardial cavity, so that part of the first guidewire is located within the pericardial cavity. Then, an expansion catheter assembly is introduced from the distal end of the first guidewire, allowing the first guidewire to pass through the guide channel in the main tube, thereby guiding the main tube towards the body and allowing part of the main tube facing the body to enter the pericardial cavity. The balloon also enters the pericardial cavity along with the main tube. Subsequently, by inflating the air inlet channel, the balloon extends out of the slot. With the support of ECG gating technology, the balloon expands during cardiac systole and contracts during diastole within the pericardial cavity, thereby compressing the left and right ventricles during cardiac systole. This achieves an artificial assisted heartbeat that is more suitable for the cardiac anatomy, increasing ventricular pumping function. The balloon is inflated by the inflation / deflation assembly, thus allowing the balloon to expand within the pericardial cavity. Intracardiac expansion, due to the anatomical structure of the pericardial cavity, causes the balloon to extend downwards within the limited pericardial cavity after opening, tending to envelop the left and right ventricles. This makes the balloon's position more stable and produces a more effective hemodynamic effect, achieving a cardiac compression effect more suited to the heart's anatomy. The balloon compresses the heart (compresses the ventricles) within the pericardial cavity, increasing the force and amplitude of ventricular contraction. After inflation, the air in the balloon is then suctioned out by the inflation / deflation assembly, allowing the ventricles to fully relax, thus forming a cycle of assisted compression. Depending on the situation, medical personnel can use various methods and appropriate criteria to determine the timing and duration of inflation / deflation. During the above process, a guide assembly is used to insert part of the dilation catheter assembly into the pericardial cavity, allowing the balloon to perform cardiac compression / assisted compression within the pericardial cavity. Attached Figure Description

[0016] Figure 1 A cross-sectional view of the intracardiac balloon-assisted pacing implant kit provided in an embodiment of the present invention in a non-compression state;

[0017] Figure 2 A cross-sectional view of the intracardiac balloon-assisted pacing implant kit provided in an embodiment of the present invention in the compression state;

[0018] Figure 3 This is a side view of a portion of the pericardial insufflation-assisted pacing implant kit provided in an embodiment of the present invention during use.

[0019] Figure 4 A cross-sectional view of the intracardiac balloon pacing implant kit provided in an embodiment of the present invention during cardiac compression;

[0020] Figure 5 This is a detailed structural cross-sectional view of the intracardiac balloon-assisted pacing implant kit provided in an embodiment of the present invention.

[0021] Explanation of reference numerals in the attached figures:

[0022] 1. Guiding assembly; 11. First guidewire; 12. First catheter; 2. Dilation catheter assembly; 21. Main body; 211. Guiding channel; 212. Air inlet channel; 213. Receiving cavity; 214. Groove; 22. Airbag. Detailed Implementation

[0023] The following detailed description of a specific embodiment of the present invention is provided in conjunction with the accompanying drawings. However, it should be understood that the scope of protection of the present invention is not limited to the specific embodiment.

[0024] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the technical solution of this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0025] The present invention will be described below through several specific embodiments. To keep the following description of the embodiments clear and concise, detailed descriptions of known functions and components may be omitted. When any component of an embodiment of the present invention appears in more than one drawing, the component may be represented by the same reference numerals in each drawing.

[0026] refer to Figure 1 , Figure 2 , Figure 3 and Figure 4 , Figure 1 This is a cross-sectional view of the intracardiac balloon-assisted pacing implantation kit provided in an embodiment of the present invention in a non-compression state. Figure 2 This is a cross-sectional view of the intracardiac balloon-assisted pacing implant kit provided in an embodiment of the present invention during compression. Figure 3This is a side view of a portion of the pericardial balloon-assisted pacing implant kit provided in an embodiment of the present invention during use. Figure 4 This is a cross-sectional view of the intracardiac balloon pumping kit provided in an embodiment of the present invention during chest compressions, as shown below. Figure 1 , Figure 2 , Figure 3 and Figure 4 As shown, this embodiment of the invention provides an intrapericardial balloon-assisted implantation kit, including: a guiding component 1, a dilation catheter assembly 2, and an inflation / deflation assembly. The guiding component 1 includes a first guidewire 11, a portion of which is located within the pericardial cavity of the target heart. The dilation catheter assembly 2 includes a main tube 21 and a balloon 22. The main tube 21 has parallel guiding channels 211 and air inlet channels 212. The first guidewire 11 is slidably connected within the guiding channel 211. 11 guides the main body 21 to move into the human body. The airbag 22 is located on the main body 21 and is connected to the air intake channel 212. The main body 21 has a groove 214 along its axial direction. Under the guidance of the first guide wire 11, the airbag 22 is embedded in the pericardial cavity of the target heart. Air is introduced through the air intake channel 212 so that the airbag 22 extends out along the groove 214 and surrounds the outside of the heart. The inflation and deflation assembly is connected to the airbag 22 so that the airbag 22 expands / contracts in the pericardial cavity to compress the ventricle.

[0027] Specifically, refer to Figures 1 to 3In use, using existing puncture techniques, one end of the first guidewire 11 is inserted into the pericardial cavity, so that part of the first guidewire 11 is located within the pericardial cavity. Then, the dilation catheter assembly 2 is introduced from the distal end of the first guidewire 11, allowing the first guidewire 11 to pass through the guide channel 211 in the main tube 21, thereby guiding the main tube 21 inwards, so that part of the main tube 21 facing the body enters the pericardial cavity. The balloon 22 also enters the pericardial cavity along with the main tube 21. At this time, the balloon 22 is still folded within the slot 214 of the main tube and has not yet unfolded. Subsequently, by inflating the air inlet channel 211, the balloon 22 extends out of the slot 214. Inflation of the balloon 22 is then performed through the inflation / deflation assembly, causing the balloon 22 to expand and inflate within the pericardial cavity. Due to the anatomical structure of the pericardial cavity, after the balloon 22 opens, it will... The balloon 22 extends downwards within the pericardial cavity and tends to envelop the left and right ventricles, thus making the position of the balloon more stable and producing a more effective hemodynamic effect. This achieves a cardiac compression effect that is more suitable for the cardiac anatomy. The balloon 22 compresses the heart (compresses the ventricles) within the pericardial cavity, producing a certain increase in ventricular contraction force and amplitude. After inflation, the air in the balloon 22 is then suctioned out by the inflation / deflation assembly, allowing the ventricles to fully relax, thus forming a cycle of assisted compression. Depending on the situation, medical personnel can use various methods and appropriate criteria to determine the timing and duration of inflation / deflation. During the above process, a portion of the dilation catheter assembly is inserted into the pericardial cavity using the guiding assembly, allowing the balloon to perform cardiac compression / assisted compression within the pericardial cavity.

[0028] In the above process, the guide component 1 is used to insert part of the dilation catheter component 2 into the pericardial cavity, so that the balloon 22 performs compression resuscitation / pulsation on the heart in the pericardial cavity. Due to the anatomical structure of the pericardial cavity, after the balloon 22 is opened, it will extend downward within the limited pericardial cavity and tend to wrap around the left and right ventricles, thereby making the position of the balloon 22 more stable and producing a more effective hemodynamic effect, achieving a heart compression effect that is more suitable for the heart's anatomy.

[0029] refer to Figure 5 The guiding component 1 also includes a first catheter 12, the end of the first catheter 12 facing the human body entering the pericardial cavity, a first guidewire 11 placed inside the first catheter 12, the first catheter 12 guiding the part of the first guidewire 11 facing the human body into the pericardial cavity, when part of the first guidewire 11 enters the pericardial cavity, the first catheter 12 withdraws out of the human body so that the first guidewire 11 is detached from the first catheter 12, the first guidewire 11 is made of shape memory alloy, the first guidewire 11 has a deformation tendency when heated, the part of the first guidewire 11 extending out of the first catheter 12 deforms and bends so as to surround the outer side of the visceral pericardium in the pericardial cavity, the balloon 22 expands after inflation and surrounds the outer side of the visceral pericardium, and the balloon 22 covers the outer side of the ventricle when it expands.

[0030] In use, the first catheter 12 is first inserted into the pericardial cavity. Then, the first guidewire 11 is advanced into the pericardial cavity along the interior of the first catheter 12. The tip of the first guidewire 11 should avoid contact with the myocardium to prevent arrhythmias. The free coiling state of the first guidewire 11 within the pericardial cavity can be observed under fluoroscopy. The first catheter 12 is then withdrawn, leaving the first guidewire 11 as a guide. Sufficient length (usually ≥20cm) should be retained at the distal end of the first guidewire 11 to ensure stability during subsequent procedures. After disinfection of the surgical area, the dilation catheter assembly 2 is introduced from the distal end of the first guidewire 11. The dilation guidewire... The main tube 21 of the tube assembly 2 is provided with a guide channel 211. It is necessary to ensure that the first guide wire 11 passes through without any kinks. When pushing, a rotating forward method is used to reduce tissue resistance, so that the first guide wire 11 passes into the guide channel 211 in the main tube 21, thereby guiding the main tube 21 into the human body. This allows part of the main tube 21 facing the human body to enter the pericardial cavity. Under fluoroscopic monitoring, the main tube 21 is pushed along the guide wire to the target position in the pericardial cavity. When pushing, attention should be paid to the tension of the first guide wire 11 to avoid penetrating the visceral layer of the pericardium. The balloon 22 also enters the pericardial cavity along with the main tube 21.

[0031] The atrioventricular groove (AV groove) is a ring-shaped depression on the surface of the heart that separates the ventricles. It contains important coronary vessels (such as the right coronary artery and the coronary sinus). The visceral pericardium is closely attached to the myocardium at this location, forming a natural guidewire anchoring area. Therefore, the deformed portion of the first guidewire 11 encircles the visceral pericardium at the AV groove, thereby guiding the dilation catheter assembly 2 to encircle the visceral pericardium at the AV groove.

[0032] Optionally, the main tube 21 includes an indwelling section, which is placed inside the pericardial cavity. The indwelling section also has a receiving cavity 213, which is located between the air intake channel 212 and the guiding channel 211. The receiving cavity 213 and the guiding channel 211 are connected. The airbag 22 is located in the receiving cavity 213. A groove 214 is opened on the lower side wall of the indwelling section along the length of the indwelling section. The groove 214 connects the guiding channel 211 to the outside.

[0033] The indwelling segment naturally wraps around the outside of the heart as the head of the first guidewire 11 bends. After the indwelling segment reaches the pericardial cavity, air is blown out through the air inlet channel 212 to expel the airbag 22 in the receiving cavity 213. Part of the airbag 22 extends out from the slot 214. As the inflation and deflation assembly inflates, the airbag 22 expands and then abuts against the outer wall of the heart.

[0034] Optionally, the airbag 22 includes an inner membrane layer and an outer membrane layer. The outer membrane layer is made of non-elastic PC material, and the inner membrane layer is made of latex. When the air pressure inside the airbag 22 increases, the inner membrane layer extends. The main purpose of the inner membrane layer contacting the ventricle is that when the airbag 22 is inflated, the pressure is squeezed inward, while the outer wall of the airbag cannot extend, which can more effectively generate pressure on the outer wall of the heart and increase the pumping effect of the heart.

[0035] Optionally, the inflation / deflation assembly includes an inflation component, a deflation component, a processing element, and a detection element. The inflation component and the deflation component are respectively connected to the end of the air inlet channel 212 away from the human body. The detection element is signal-connected to the processing element, and the processing element is signal-connected to the inflation component and the deflation component. The detection element is used to detect the electrocardiogram (ECG) signal of the target heart. The processing element sends an inflation signal to the inflation component or a deflation signal to the deflation component according to the different ECG signals. The inflation component can use a miniature air pump (piezoelectric / centrifugal), a high-precision flow valve, and a pressure buffer tank. The flow rate range is 0-500 mL / s (adjustable), and the maximum output pressure is 300 mmHg (safety threshold can be set). It can use a Venturi effect acceleration module to complete emergency inflation within 50ms. It has a built-in HEPA filter to ensure the sterility of medical gas. The deflation component may include a vacuum generator (vortex type), a pressure relief solenoid valve, and a gas recovery bag. It uses active negative pressure suction (-50 to -100 mmHg) and an adaptive pressure relief algorithm to prevent excessive negative pressure in the pericardial cavity.

[0036] Optionally, the electrocardiogram (ECG) signals include QRS wave ECG signals and T wave ECG signals. When the processing element receives a QRS wave ECG signal, it sends an inflation signal to the inflation device; when the processing element receives a T wave ECG signal, it sends a deflation signal to the deflation device.

[0037] Furthermore, the guiding component 1 also includes: a puncture guidewire, the end of the puncture guidewire facing the human body being inserted into the pericardial cavity via puncture, and a first catheter 12 being slidably connected to the outside of the puncture guidewire. The puncture guidewire is used to guide the end of the first catheter 12 facing the human body into the pericardial cavity. When the end of the first catheter 12 enters the pericardial cavity, the puncture guidewire can slide out from the end of the first catheter 12 away from the human body. When the puncture guidewire slides out of the first catheter 12, the first guidewire 11 slides into the first catheter 12 from the end of the first catheter 12 away from the human body.

[0038] Optionally, a J-shaped guide wire can be used as the puncture guide wire, and the first catheter 12 is a deep vein catheter.

[0039] An implementation method is provided, including:

[0040] S1, perform pericardiocentesis, inserting the end of the guidewire facing the body into the pericardial cavity;

[0041] S2, the end of the first catheter 12 facing the human body is fitted onto the end of the puncture guidewire away from the human body. Under the guidance of the puncture guidewire, the end of the first catheter 12 facing the human body is inserted into the pericardial cavity, and then the puncture guidewire is slid out from the end of the first catheter 12 away from the human body.

[0042] S3, slide the first guidewire 11 from the end of the first catheter 12 away from the human body into the first catheter 12, and insert the first guidewire 11 into the pericardial cavity. At the same time, manipulate the tail of the first guidewire 11 to rotate it clockwise and further insert it, so that the first guidewire 11 slides along the right apex of the heart surface toward the atrioventricular groove, and finally approaches the atrioventricular groove. Then, withdraw the first catheter 12 along the first guidewire 11 from the human body.

[0043] S4, after the first guidewire 11 is disengaged from the first catheter 12, the balloon dilation catheter is slidably connected to the outside of the first guidewire 11. Under the guidance of the first guidewire 11, the balloon dilation catheter enters the pericardial cavity and encircles the heart.

[0044] S5 uses a detection element to detect the electrocardiogram of the target heart. When a QRS wave indicating the start of the heart's systolic phase is detected, the processing element sends an inflation signal to the inflation element. When a T wave indicating the start of the heart's diastolic phase is detected, the processing element sends a deflation signal to the inflation element, thereby more effectively performing intracardiac pacing and increasing cardiac output.

[0045] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A pericardial intracavitary balloon-assisted pacing implant kit, characterized in that, include: The assembly includes a guiding component (1), an expansion conduit assembly (2), and an inflation / deflation assembly, wherein... The guiding assembly (1) includes a first guidewire (11), a portion of which is located inside the pericardial cavity of the target heart; The dilation catheter assembly (2) includes a main tube (21) and an air bag (22). The main tube (21) has a guide channel (211) and an air inlet channel (212) that are parallel to each other. The first guide wire (11) is slidably connected in the guide channel (211) and guides the main tube (21) to move into the human body. The air bag (22) is disposed on the main tube (21) and is connected to the air inlet channel (212). The main tube (21) has a groove (214) along its axial direction. Under the guidance of the first guide wire (11), the air bag (22) is embedded in the pericardial cavity of the target heart. Air is introduced through the air inlet channel (212) so that the air bag (22) extends out along the groove (214) and surrounds the outside of the heart. The inflation and deflation assembly is connected to the air bag (22) so that the air bag (22) expands / contracts in the pericardial cavity to compress the ventricle.

2. The intracardiac balloon-assisted pacing implant kit as described in claim 1, characterized in that, The guiding component (1) further includes a first catheter (12), the end of the first catheter (12) facing the human body enters the pericardial cavity, the first guidewire (11) is placed inside the first catheter (12), the first catheter (12) guides the part of the first guidewire (11) facing the human body into the pericardial cavity, when part of the first guidewire (11) enters the pericardial cavity, the first catheter (12) withdraws out of the human body so that the first guidewire (11) is detached from the first catheter (12), the first guidewire (11) is made of shape memory alloy, and the part of the first guidewire (11) extending out of the first catheter (12) deforms and bends so as to surround the outer side of the visceral pericardium in the pericardial cavity.

3. The intracardiac balloon-assisted pacing implant kit as described in claim 2, characterized in that, The deformed portion of the first guidewire (11) surrounds the outer pericardial visceral layer at the interventricular groove.

4. The intracardiac balloon-assisted pacing implant kit as described in claim 3, characterized in that, The main tube (21) includes an indwelling section, which is placed inside the pericardial cavity. The indwelling section also has a receiving cavity (213), which is located between the air intake channel (212) and the guide channel (211). The receiving cavity (213) and the guide channel (211) are connected. The airbag (22) is located in the receiving cavity (213). The groove (214) is opened on the lower side wall of the indwelling section along the length of the indwelling section. The groove (214) connects the guide channel (211) to the outside.

5. The intracardiac balloon-assisted pacing implant kit as described in claim 1, characterized in that, The airbag (22) includes an inner membrane layer and an outer membrane layer. The outer membrane layer is made of non-elastic PC material, and the inner membrane layer is made of latex. When the air pressure inside the airbag (22) increases, the inner membrane layer extends.

6. The intracardiac balloon-assisted pacing implant kit as described in claim 1, characterized in that, The inflation / deflation assembly includes an inflation component, a deflation component, a processing element, and a detection component. The inflation component and the deflation component are respectively connected to the end of the air intake channel (212) away from the human body. The detection component is signal-connected to the processing element. The processing element is signal-connected to the inflation component and the deflation component. The detection component is used to detect the electrocardiogram signal of the target heart. The processing element sends an inflation signal to the inflation component or a deflation signal to the deflation component according to the different electrocardiogram signals.

7. The intracardiac balloon-assisted pacing implant kit as described in claim 6, characterized in that, The electrocardiogram (ECG) signals include QRS wave ECG signals and T wave ECG signals. When the processing element receives a QRS wave ECG signal, it sends an inflation signal to the inflation component; when the processing element receives a T wave ECG signal, it sends a deflation signal to the deflation component.

8. The intracardiac balloon-assisted pacing implant kit as described in claim 1, characterized in that, The guiding component (1) further includes: a puncture guidewire, the end of which faces the human body and enters the pericardial cavity via puncture, and a first catheter (12) which is slidably connected to the outside of the puncture guidewire. The puncture guidewire is used to guide the end of the first catheter (12) facing the human body into the pericardial cavity. When the end of the first catheter (12) enters the pericardial cavity, the puncture guidewire can slide out from the end of the first catheter (12) away from the human body. When the puncture guidewire slides out of the first catheter (12), the first guidewire (11) slides into the first catheter (12) from the end of the first catheter (12) away from the human body.

9. The intracardiac balloon-assisted pacing implant kit as described in claim 2, characterized in that, The first catheter (12) is a deep vein catheter.

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