Intraoperative leadless pacemaker sheath head pressure measurement device

Abstract

A kind of in- situ pressure measuring device of leadless cardiac pacemaker sheath head, including leadless cardiac pacemaker sheath and pressure measuring module.Leadless pacemaker sheath includes cylindrical head, and the head includes end face, outer side and inner side;Pressure measuring module includes pressure monitoring sensing unit, signal processing transmission unit, power supply unit and flexible encapsulation layer, flexible encapsulation layer is wrapped pressure monitoring sensing unit, signal processing transmission unit and power supply unit, and pressure measuring module is fixed to head;Pressure monitoring sensing unit is located at end face and is conformed to end face;Signal processing transmission unit and power supply unit are located at outer side and are conformed to outer side.Pressure monitoring sensing unit is configured to monitor the pressure signal of end face, signal processing transmission unit is configured to process pressure signal and is transmitted to outside by wireless mode.This application can monitor in real time and wirelessly transmit the change data of head pressure of leadless pacemaker sheath during operation.

Description

Technical Field

[0001] This invention relates to the field of leadless pacemaker delivery systems, and more specifically to an intraoperative pressure measurement device for the tip of a leadless pacemaker sheath. Background Technology

[0002] Leadless pacemakers integrate all components of a pacemaker system into a miniaturized device, eliminating the need for pacing leads and allowing direct implantation into the heart chambers to provide pacing therapy. Compared to traditional transvenous pacemakers with pacing leads, leadless pacemakers offer significant advantages such as smaller size, simpler implantation, no need for a chest pocket, reduced risk of infection, fewer complications, and improved patient comfort.

[0003] The most commonly used leadless pacemakers in clinical practice currently employ a "claw-like" fixation design. To ensure stable implantation at the target location, a "swan neck" technique has been developed. Specifically, the operator inserts the delivery sheath along with the leadless pacemaker into the interventricular septum myocardium. Under right anterior oblique fluoroscopy, the sheath shape is adjusted so that the delivery system bends into a swan neck shape at the end of the device cannula, and contrast agent is injected. Using this method, it is empirically believed that a stable leadless pacemaker against the interventricular septum myocardium ensures proper fixation during release, thereby achieving ideal pacing electrical parameters and reducing the risk of dislocation during and after the procedure.

[0004] However, this "swan neck" method is ultimately an empirical approach, lacking crucial data support and carrying certain surgical risks. Due to differences in operator experience and feel, it's difficult to precisely control the pressure and degree of bending at the sheath tip. If too little force is applied, or if there are variations in the patient's cardiac anatomy, even if a "swan neck" is formed, insufficient pressure at the tip may result in poor fixation of the leadless pacemaker. Conversely, if too much force is applied, or if the patient has individual differences such as a thin interventricular septum myocardium, there are reports that this can cause the sheath to perforate the interventricular septum myocardium, leading to serious surgical complications and even endangering life. Therefore, there is an urgent need to improve this leadless pacemaker delivery system to ensure surgical safety as much as possible while maintaining effective sheath contact with the target implantation site in the interventricular septum, avoiding excessive pressure that could cause damage or even perforation of the interventricular septum myocardium. Summary of the Invention

[0005] The purpose of this invention is to provide a pressure measurement device for the tip of a leadless pacemaker sheath during surgery. This device is directly lined within the tip of the leadless pacemaker delivery sheath and can monitor and wirelessly transmit pressure change data at the tip of the leadless pacemaker sheath in real time.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] A pressure measuring device for the tip of a leadless pacemaker sheath during surgery, the device comprising a leadless pacemaker sheath and a pressure measuring module, the leadless pacemaker sheath comprising a cylindrical tip, the tip comprising an end face, an outer surface and an inner surface;

[0008] The pressure measurement module includes a pressure monitoring and sensing unit, a signal processing and transmission unit, a power supply unit, and a flexible encapsulation layer. The pressure monitoring and sensing unit is electrically connected to the signal processing and transmission unit, and the signal processing and transmission unit is electrically connected to the power supply unit. The flexible encapsulation layer encapsulates the pressure monitoring and sensing unit, the signal processing and transmission unit, and the power supply unit, and fixes the pressure measurement module to the head end.

[0009] The pressure monitoring and sensing unit is located on the end face and conforms to the end face; the signal processing and transmission unit and the power supply unit are located on the outer side and conform to the outer side.

[0010] The pressure monitoring sensing unit is configured to monitor the pressure signal of the end face, and the signal processing and transmission unit is configured to process the pressure signal and transmit it to the outside world wirelessly.

[0011] Preferably, the pressure monitoring sensing unit includes a first electrode layer, a piezoelectric material layer, and a second electrode layer along its thickness direction.

[0012] Preferably, the piezoelectric material layer comprises a flexible piezoelectric polymer material or an inorganic piezoelectric material.

[0013] Preferably, the flexible piezoelectric polymer material includes polyvinylidene fluoride, polyvinylidene fluoride-trifluoroethylene copolymer, or polylactic acid;

[0014] The inorganic piezoelectric material includes lithium niobate or lead zirconate titanate;

[0015] The materials of the first electrode layer and the second electrode layer include one or more combinations of gold, silver, copper, aluminum, iron, carbon nanotubes, graphene, and carbon black.

[0016] Preferably, the first electrode layer and the second electrode layer are formed on the piezoelectric material layer by magnetron sputtering.

[0017] Preferably, the pressure monitoring sensing unit has a thickness of 0.1 mm to 1 mm and a width of 1 mm to 2 mm; and / or,

[0018] The inner diameter of the head end is 7mm and the outer diameter is 8mm.

[0019] Preferably, the flexible encapsulation layer is adhered to the end face, outer side, and inner side of the head end by bio-hydrogel; and the length and thickness of the flexible encapsulation layer adhered to the inner side are 1 mm.

[0020] Preferably, the signal processing and transmission unit includes a signal amplification circuit, a filtering circuit, an analog-to-digital conversion circuit, and a Bluetooth circuit.

[0021] Preferably, the device further includes a data receiving and display terminal, which is configured to wirelessly receive the pressure signal and convert the pressure value into data for display.

[0022] Preferably, the data receiving and display terminal is further configured as follows:

[0023] The pressure value is compared with the first pre-input value and the second pre-input value.

[0024] When the pressure value is less than the first pre-input value, a prompt will be displayed saying "The head end is not properly attached and the sheath needs to be adjusted appropriately";

[0025] When the pressure value is greater than the first pre-input value and less than the second pre-input value, a prompt "Head end fits well, pacemaker can be released" is displayed;

[0026] When the pressure value is greater than the second pre-input value, a prompt will be displayed saying "The head end is too tight and the sheath needs to be pulled back appropriately".

[0027] The advantages of this invention are:

[0028] This invention provides a pressure measurement device for the tip of a leadless pacemaker sheath during surgery. The device is directly lined within the tip of the leadless pacemaker delivery sheath and can monitor and wirelessly transmit pressure change data at the tip of the sheath in real time. This is used to quantitatively assess the adhesion of the sheath tip before device release during surgery, thereby improving surgical safety and release effectiveness, and also reducing X-ray exposure time. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the main structure of a pressure measuring device at the tip of an intraoperative leadless pacemaker sheath in an embodiment of the present invention;

[0030] Figure 2 This is a cross-sectional structural schematic diagram of a pressure measuring device at the tip of an intraoperative leadless pacemaker sheath in an embodiment of the present invention;

[0031] Figure 3 This is a cross-sectional structural diagram of a pressure monitoring sensing unit according to an embodiment of the present invention;

[0032] Figure 4This is a side view of a pressure measurement device at the tip of an intraoperative leadless pacemaker sheath, according to an embodiment of the present invention.

[0033] Figure 5 This is a schematic diagram of the flat structure of a pressure measurement module in an embodiment of the present invention. Detailed Implementation

[0034] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments.

[0035] See appendix Figure 1 , Figure 1 This is the main structure of a pressure measurement device for the tip of a leadless pacemaker sheath during surgery. In this embodiment, the device includes a leadless pacemaker sheath 1, a pressure measurement module 2, and a data receiving and display terminal 3.

[0036] See appendix Figures 2 to 5 The leadless pacemaker sheath 1 includes a cylindrical tip, which includes an end face 11, an outer surface 12, and an inner surface 13. The leadless pacemaker sheath 1 is prior art and will not be described further here. This embodiment is for delivering the sheath to Medtronic's Micra-TPS leadless pacemaker 4.

[0037] The pressure measurement module 2 includes a pressure monitoring and sensing unit 21, a signal processing and transmission unit 22, a power supply unit 23, and a flexible encapsulation layer 24. The pressure monitoring and sensing unit 21 is electrically connected to the signal processing and transmission unit 22, and the signal processing and transmission unit 22 is electrically connected to the power supply unit 23. The flexible encapsulation layer 24 encapsulates the pressure monitoring and sensing unit 21, the signal processing and transmission unit 22, and the power supply unit 23, and fixes the pressure measurement module to the head end.

[0038] Among them, the pressure monitoring sensing unit 21 is located on the end face 11 and conforms to the end face 11; the signal processing and transmission unit 22 and the power supply unit 23 are located on the outer side 12 and conform to the outer side 12.

[0039] The pressure monitoring sensing unit 21 is configured to monitor the pressure signal of the end face 11, and the signal processing and transmission unit 22 is configured to process the pressure signal and transmit it to the outside via wireless means. The data receiving and display terminal 3 is configured to wirelessly receive the pressure signal and convert the pressure value into data for display.

[0040] Specifically, the shape of the pressure monitoring sensor unit 21 matches the end face 11 of the head end. That is, the pressure monitoring sensor unit 21 is a ring-shaped structure. When the leadless pacemaker sheath 1 enters the blood vessel and reaches the target position, the pressure generated by its contact with the interventricular septum causes the pressure monitoring sensor unit 21 to generate an electrical signal. The intensity of the electrical signal is proportional to the pressure of the head end of the leadless pacemaker sheath 1 against the septum, thus obtaining the pressure signal at the head end. The pressure monitoring sensor unit 21 is located on the end face 11, which allows it to directly reflect the contact pressure without affecting the release of the leadless pacemaker 4.

[0041] The signal processing and transmission unit 22 is shaped to match the outer surface 12 of the head end. The signal processing and transmission unit 22 and the power supply unit 23 are located on the outer surface 12. The power supply unit 23 provides power to the signal processing and transmission unit 22; it can be a separate unit or integrated into the signal processing and transmission unit 22. The power supply unit 23 can be a miniature lithium battery. It should be noted that the leadless pacemaker sheath 1 is a disposable product and will not be reused. The pressure monitoring sensor unit 21 is attached to the leadless pacemaker sheath 1 and is used only during surgery. Its energy consumption is very low, so a miniature lithium battery can fully support its energy requirements.

[0042] The signal processing and transmission unit 22 includes a signal amplification circuit, a filtering circuit, an analog-to-digital conversion circuit, and a Bluetooth circuit. The pressure signal from the pressure monitoring and sensing unit 21 is amplified and filtered. After analog-to-digital conversion, the data is wirelessly transmitted to an external receiving device via a low-power Bluetooth circuit. The data receiving and display terminal 3 receives data from the signal processing and transmission unit via Bluetooth, analyzes and displays the received data using customized software, and presents the specific numerical values ​​of pressure changes at the sheath tip in real time for the operator to refer to and adjust the sheath's fit.

[0043] The pressure monitoring sensing unit 21 includes a first electrode layer 211, a piezoelectric material layer 212, and a second electrode layer 213 along its thickness direction. This thickness direction is consistent with the length direction of the leadless pacemaker sheath 1. The piezoelectric material layer 212 generates an electrical signal when it deforms. The intensity of the electrical signal is proportional to the deformation, and the deformation is proportional to the pressure. Therefore, the pressure change at the tip of the leadless pacemaker sheath 1 can be measured by measuring the changes in the electrical signals of the first electrode layer 211 and the second electrode layer 213.

[0044] The piezoelectric material layer 212 may include a flexible piezoelectric polymer material or an inorganic piezoelectric material. Flexible piezoelectric polymer materials include polyvinylidene fluoride (PVDF), polyvinylidene fluoride-trifluoroethylene copolymer (P(VDF-TrFE)), or polylactic acid (PLA). Inorganic piezoelectric materials include lithium niobate (LiNbO3), lead zirconate titanate (PZT), or zinc oxide (ZnO). To obtain higher sensitivity and biocompatibility, PVDF or P(VDF-TrFE), which has good flexibility and biocompatibility, is preferred as the piezoelectric material layer 212. The materials of the first electrode layer 211 and the second electrode layer 213 include one or more combinations of gold, silver, copper, aluminum, iron, carbon nanotubes, graphene, and carbon black. The first electrode layer 211 and the second electrode layer 213 are formed on the piezoelectric material layer 212 using magnetron sputtering technology. The pressure monitoring sensing unit 21 has a thickness of 0.1 mm to 1 mm, preferably 0.5 mm, and a width of 1 mm to 2 mm, preferably 1 mm; the inner diameter of the tip of the leadless pacemaker sheath 1 is 7 mm and the outer diameter is 8 mm.

[0045] The flexible encapsulation layer 24 is attached to the end face 11, outer side 12, and inner side 13 of the head end using bio-hydrogel. The flexible encapsulation layer 24 fixes each component of the pressure measurement module 2 in its corresponding position. Since the pressure monitoring and sensing unit 21 is fixed to the end face 11, to better encapsulate and fix the pressure monitoring and sensing unit 21, the flexible encapsulation layer 24 extends from the outer side 12 to the end face 11, and then from the end face 11 to the inner side 13. In this embodiment, the length and thickness of the flexible encapsulation layer 24 attached to the inner side 13 are 1 mm. The material of the flexible encapsulation layer 24 can be a biocompatible and blood-compatible insulating material, such as polylactic acid, polyvinyl alcohol, polytetrafluoroethylene, rubber, etc., or it can be some composite materials. It should be noted that the flexible encapsulation layer 24 extends to the inner side 13, which is very thin. Although the claw of the leadless pacemaker 4 will come into contact with it, the claw of the leadless pacemaker 4 is made of flexible memory metal and is very thin. Firstly, the claw of the leadless pacemaker 4 will not scratch the pressure monitoring sensing unit 21, and secondly, the pressure monitoring sensing unit 21 will not affect the release effect of the leadless pacemaker 4.

[0046] Furthermore, the data receiving and display terminal 3 is further configured as follows:

[0047] The pressure value is compared with the first pre-input value and the second pre-input value.

[0048] When the pressure value is less than the first pre-input value, a prompt will be displayed saying "The head end is not properly attached and the sheath needs to be adjusted appropriately";

[0049] When the pressure value is greater than the first pre-input value but less than the second pre-input value, a message will be displayed saying "The head is in good contact with the device and the pacemaker can be released".

[0050] When the pressure value exceeds the second pre-input value, a prompt will be displayed saying "The head end is too tight and the sheath needs to be pulled back appropriately".

[0051] The data receiving and display terminal displays the pressure value at the tip of the leadless pacemaker sheath in real time, along with corresponding prompts, which helps the surgeon determine the contact status of the leadless pacemaker, ensuring surgical safety and the release effect of the leadless pacemaker.

[0052] The above description describes the preferred embodiments of the present invention and the technical principles applied thereto. For those skilled in the art, any obvious changes such as equivalent transformations or simple substitutions based on the technical solutions of the present invention, without departing from the spirit and scope of the present invention, shall fall within the protection scope of the present invention.

Claims

1. A pressure measuring device for the tip of a leadless pacemaker sheath during surgery, the device comprising a leadless pacemaker sheath and a pressure measuring module, the leadless pacemaker sheath comprising a cylindrical tip, the tip comprising an end face, an outer surface, and an inner surface; characterized in that, The pressure measurement module includes a pressure monitoring and sensing unit, a signal processing and transmission unit, a power supply unit, and a flexible encapsulation layer. The pressure monitoring and sensing unit is electrically connected to the signal processing and transmission unit, and the signal processing and transmission unit is electrically connected to the power supply unit. The flexible encapsulation layer encapsulates the pressure monitoring and sensing unit, the signal processing and transmission unit, and the power supply unit, and fixes the pressure measurement module to the head end. The pressure monitoring and sensing unit is located on the end face and conforms to the end face; the signal processing and transmission unit and the power supply unit are located on the outer side and conform to the outer side. The pressure monitoring sensing unit is configured to monitor the pressure signal of the end face, and the signal processing and transmission unit is configured to process the pressure signal and transmit it to the outside world wirelessly.

2. The intraoperative leadless pacemaker sheath pressure measuring device as described in claim 1, characterized in that, The pressure monitoring sensing unit includes a first electrode layer, a piezoelectric material layer, and a second electrode layer along its thickness direction.

3. The intraoperative leadless pacemaker sheath pressure measuring device as described in claim 2, characterized in that, The piezoelectric material layer includes flexible piezoelectric polymer materials or inorganic piezoelectric materials.

4. The intraoperative leadless pacemaker sheath pressure measuring device as described in claim 3, characterized in that, The flexible piezoelectric polymer material includes polyvinylidene fluoride, polyvinylidene fluoride-trifluoroethylene copolymer, or polylactic acid. The inorganic piezoelectric material includes lithium niobate or lead zirconate titanate; The materials of the first electrode layer and the second electrode layer include one or more combinations of gold, silver, copper, aluminum, iron, carbon nanotubes, graphene, and carbon black.

5. The intraoperative leadless pacemaker sheath pressure measuring device as described in claim 4, characterized in that, The first electrode layer and the second electrode layer are formed on the piezoelectric material layer by magnetron sputtering technology.

6. The intraoperative leadless pacemaker sheath pressure measuring device as described in claim 2, characterized in that, The pressure monitoring sensing unit has a thickness of 0.1 mm to 1 mm and a width of 1 mm to 2 mm; and / or, The inner diameter of the head end is 7mm and the outer diameter is 8mm.

7. The intraoperative leadless pacemaker sheath pressure measuring device as described in claim 6, characterized in that, The flexible encapsulation layer is attached to the end face, outer side, and inner side of the head end by bio-hydrogel; and the length and thickness of the flexible encapsulation layer attached to the inner side is 1 mm.

8. The intraoperative leadless pacemaker sheath pressure measuring device as described in claim 1, characterized in that, The signal processing and transmission unit includes a signal amplification circuit, a filtering circuit, an analog-to-digital conversion circuit, and a Bluetooth circuit.

9. The intraoperative leadless pacemaker sheath pressure measuring device as described in claim 1, characterized in that, The device also includes a data receiving and display terminal, which is configured to wirelessly receive the pressure signal and convert the pressure value into data for display.

10. The intraoperative leadless pacemaker sheath pressure measuring device as described in claim 9, characterized in that, The data receiving and display terminal is further configured as follows: The pressure value is compared with the first pre-input value and the second pre-input value. When the pressure value is less than the first pre-input value, a prompt will be displayed saying "Poor head contact, sheath needs to be adjusted appropriately"; When the pressure value is greater than the first pre-input value and less than the second pre-input value, a message "Head tip fits well, pacemaker can be released" is displayed. When the pressure value is greater than the second pre-input value, a prompt will be displayed saying "The head end is too tight and the sheath needs to be pulled back appropriately".

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