Tearable sheath capable of measuring pressure

Abstract

The utility model provides a tearable sheath with a pressure measurable function and a negative pressure suction system, the tearable sheath comprises a tearable sheath tube and a handle, the tearable sheath tube longitudinally extends from the near end to the far end, a main channel and a pressure measuring channel which longitudinally extend from the near side to the far side are defined in the tearable sheath tube, and the pressure measuring channel is used for measuring the pressure of the tearable sheath tube. The far end of the pressure measuring channel is provided with a pressure measuring port for sensing the pressure of the cavity, and the pressure measuring channel or any path communicated with the pressure measuring channel is provided with a pressure detection device for detecting the pressure in the cavity; the handle comprises a sheath base arranged at the near end of the tearable sheath tube and a first tearing piece and a second tearing piece which are connected to the sheath base, the sheath base is provided with a tearable crack capable of being torn off in the axial direction, the near end of the sheath base is provided with a connecting part, the connecting part comprises a channel penetrating through the connecting part, the channel is communicated with the main channel, and the tearable crack is communicated with the main channel. The connecting part is suitable for being in sealing connection with the dilator in a detachable mode.

Description

Technical Field

[0001] This utility model relates to a medical device, specifically a pressure-measuring tearable sheath, suitable for guiding instruments and real-time monitoring of intracavitary pressure during medical surgery. Background Technology

[0002] Tearable sheaths are a common catheter-assist device in the medical device field, typically used to guide other medical devices into specific locations within a patient's body. In certain interventional procedures, such as cardiac electrophysiology, vascular intervention, and urological surgeries, catheter positioning and stability are crucial for surgical success. Traditional catheter sheaths are mostly non-tearable, requiring removal of the catheter and sheath together after surgery, which may cause additional damage to patient tissues. Furthermore, traditional catheter sheaths often lack real-time pressure monitoring, making it difficult for medical personnel to understand pressure changes within the cavity in a timely and accurate manner during certain procedures, thus increasing surgical risks. With the advancement of medical technology, higher demands are placed on catheter sheaths. For example, in urological surgeries, operations on the urethra and kidneys require high precision and safety. Traditional catheter sheaths struggle to effectively prevent sudden pressure changes within the cavity, leading to problems such as fluid reflux and tissue damage. Moreover, due to the complexity of the surgical environment, catheter sheaths may require frequent adjustments and repositioning during operation; traditional catheter sheaths, due to their non-tearable structure, are often difficult to maneuver flexibly in complex surgical environments. Against this backdrop, tearable sheaths have emerged. The tearable sheath design allows for easy tearing and removal after catheter insertion via a tear seam on the handle, preventing any interference with the catheter or other inserts. This design not only reduces the complexity of procedures during surgery but also minimizes potential harm to the patient. The tearable sheath design also improves the safety and efficiency of catheter guidance, especially in surgeries requiring precise positioning. However, existing tearable sheaths still have some technical shortcomings. First, they typically lack real-time pressure monitoring, making it difficult to obtain information on pressure changes within the cavity during surgery, increasing the risk of complications such as fluid reflux and organ damage. Second, existing tearable sheath designs may not tear smoothly enough, resulting in incomplete tearing or fragmentation after tearing. This not only increases the difficulty of the procedure but may also leave foreign bodies in the patient's body, further increasing surgical risks. Summary of the Invention

[0003] In response to the aforementioned technical problems, this utility model provides a tearable sheath with pressure measurement function, which aims to provide a tearable sheath that can monitor pressure changes in the cavity in real time, and has good operability and safety during tearing operations, thereby meeting the needs of modern surgery for higher safety, operability and precision of catheter sheaths.

[0004] The tearable sheath provided by this utility model includes:

[0005] A tearable sheath extends longitudinally from a proximal end to a distal end. The tearable sheath defines a main channel and a pressure measuring channel extending longitudinally from the proximal side to the distal side. The distal end of the pressure measuring channel has a pressure measuring port for sensing the pressure of the cavity. A pressure detection device is provided on the pressure measuring channel or any path connected to it to detect the pressure inside the cavity.

[0006] The handle includes a sheath seat located at the proximal end of the tearable sheath and a first tearing element and a second tearing element connected to the sheath seat. The sheath seat has a tearable slit that can be torn axially. The proximal end of the sheath seat has a connecting portion, which includes a passage passing through it and communicating with the main channel. The connecting portion is adapted to be detachably and sealingly connected to the expander.

[0007] In some embodiments, the tearable sheath includes a negative pressure connector, the negative pressure connector including a main pipe and at least one connector disposed on the main pipe, the main pipe being adapted to be detachably and sealingly connected to the connector, and the proximal end of the main pipe being provided with a sealing cap.

[0008] In some embodiments, the tearable sheath includes a pressure sensor comprising a pressure-sensitive element and a signal line. The pressure-sensitive element is located at the distal end of a pressure-measuring channel to detect pressure within the cavity. The signal line passes through the pressure-measuring channel. The handle is provided with a data cable connector for connecting to the signal line, and the data cable connector is adapted to connect to an external device.

[0009] In some embodiments, the handle has a pressure measuring cavity communicating with a pressure measuring channel, and a pressure sensor is provided inside the pressure measuring cavity.

[0010] In some embodiments, one of the first tear member and the second tear member is provided with a data cable connector, which is connected to a signal line.

[0011] In some embodiments, one of the first tear member and the second tear member has a pressure measuring cavity communicating with the pressure measuring channel, and the pressure measuring cavity is provided with a pressure-sensitive element.

[0012] In some embodiments, one of the first tear member and the second tear member has a pressure measuring cavity communicating with the pressure measuring channel, and the proximal end of the pressure measuring cavity is provided with a pressure measuring connector, which is adapted to be connected to a pressure detection device.

[0013] In some embodiments, the pressure measuring channel has an outer wall facing the outside and an inner wall facing the main channel on its distal side, and the distal outer wall of the pressure measuring channel is open to form a pressure measuring port communicating with the outside; or, the distal inner wall of the pressure measuring channel is open to form a pressure measuring port communicating with the main channel; or, both the distal outer wall and the distal inner wall of the pressure measuring channel are open to form pressure measuring ports communicating with the outside and the main channel; preferably, the openings of the inner wall and the outer wall of the pressure measuring channel are radially offset.

[0014] In some embodiments, the connecting portion includes a circumferentially extending circumferential outer wall that can be inserted into the proximal end of the expander or a negative pressure connector, and the circumferential outer wall is provided with a limiting portion that engages with the expander.

[0015] The tearable sheath provided by this invention can monitor pressure changes in the cavity in real time. Medical personnel can obtain pressure data in the cavity in real time during the operation, thereby effectively preventing complications such as fluid reflux and tissue damage caused by excessively high or low pressure, and improving the safety and success rate of the operation.

[0016] Another objective of this invention is to provide a negative pressure suction system, which includes a suction device and the aforementioned tearable sheath. The tearable sheath is detachably connected to a negative pressure connector, which includes a main pipe and at least one connector disposed on the main pipe. The main pipe is adapted to be detachably and sealed in communication with the connector. A sealing cap is provided at the proximal end of the main pipe, and the connector is adapted to be sealed in connection with the suction device. Attached Figure Description

[0017] Figures 1-4 This is a schematic diagram of the structure of a tearable sheath provided in one embodiment of the present invention;

[0018] Figure 5 This is a schematic diagram of the negative pressure suction system provided by this utility model;

[0019] Figures 6-8 A schematic diagram of the structure of a tearable sheath provided in another embodiment of this utility model;

[0020] Figures 9-11 A schematic diagram of the tearable sheath provided for another embodiment of the present invention;

[0021] Figures 12-14 A schematic diagram of the expansion component provided by this utility model. Detailed Implementation

[0022] The present invention or its technical solution will be further described in detail below through specific embodiments and in conjunction with the accompanying drawings.

[0023] In the description of this utility model, it should be understood that the terms "front," "rear," "upper," "lower," etc., indicating the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this utility model 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, and therefore should not be construed as a limitation of this utility model. In this application, the proximal end should be interpreted as the part closer to the operator (doctor), and the distal end should be understood as the part farther away from the doctor.

[0024] In the description of this utility model, it should be noted that, unless otherwise specified and limited, the terms "installation" and "connection" should be interpreted broadly. For example, they can refer to mechanical or electrical connections, or internal connections between two components. They can be direct connections or indirect connections through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0025] Example 1: Pressure-measuring tearable sheath: This utility model provides a tearable sheath with pressure-measuring function, which aims to provide a tearable sheath that can monitor pressure changes in the cavity in real time, and has good operability and safety in tearing operation, thereby meeting the needs of modern surgery for higher safety, operability and accuracy of catheter sheaths.

[0026] Please see Figure 1 This utility model provides a tearable sheath capable of measuring pressure, comprising a tearable sheath tube 11 and a handle 12. The handle 12 is provided with a handle tear slit that can be torn axially. The tearable sheath tube 11 extends longitudinally from a proximal end to a distal end. The interior of the tearable sheath tube 11 defines a main channel 111 extending longitudinally from the proximal end to the distal end and a pressure measuring channel 112. The distal end of the pressure measuring channel has a pressure measuring port 113 for sensing cavity pressure. A pressure detection device is provided on the pressure measuring channel 112 or any path connected to it to detect the pressure within the cavity. The handle 12 includes a sheath seat 121 located at the proximal end of the tearable sheath tube and a first tearing element 122 and a second tearing element 123 connected to the sheath seat. The sheath seat 121 is provided with a tearable slit that can be torn axially. Please refer to [link to relevant documentation]. Figures 2-4The sheath seat 121 has a connecting portion 125 at its proximal end. The connecting portion 125 includes a passage 126 passing through it, which communicates with the main channel 111. The connecting portion 125 is adapted to be detachably and sealingly connected to the dilator 2. The handle and sheath can be easily torn open by the cooperation of the first tear piece 122 and the second tear piece 123 on the handle to expose or remove the guiding device. The tearable sheath provided by this invention can monitor pressure changes within the cavity in real time. Medical personnel can obtain pressure data within the cavity in real time during surgery, thereby effectively preventing complications such as fluid reflux and tissue damage caused by excessively high or low pressure, and improving the safety and success rate of the surgery.

[0027] Please refer to some embodiments of this utility model. Figure 1 and Figure 2 The tearable sheath includes a negative pressure connector 3, which comprises a main pipe 31 and at least one connector 32 communicating with the main pipe 31. The main pipe 31 is adapted to be detachably and sealed to the connecting part 125, and a sealing cap 33 is provided at the proximal end of the main pipe 31. In this embodiment, the negative pressure connector 3 is provided with a pressure relief sliding cover 321; the tearable sheath can be connected to a negative pressure suction device through the negative pressure connector 3 to extract waste liquid, stones, etc.

[0028] As mentioned earlier, to achieve the pressure measurement function of the tearable sheath, a pressure measurement channel is opened on the sheath tube, and a pressure measurement port is used to sense pressure. A pressure sensor can be placed in the pressure measurement channel or any path connected to it to detect the pressure within the pressure measurement channel connected to the pressure measurement port. For some embodiments of this utility model, please refer to... Figure 2One of the first tear element 122 and the second tear element 123 has a pressure measuring cavity 127 communicating with the pressure measuring channel. A pressure measuring connector 128 is provided at the proximal end of the pressure measuring cavity 127, which is adapted to connect to the pressure detection device 7. In actual use, the pressure detection device 7 receives pressure signals from the pressure measuring cavity 127 through the pressure measuring connector 128. These signals are pressure data detected within the cavity by the pressure measuring cavity. Because the pressure measuring cavity is directly connected to the pressure measuring channel, accurate pressure data can be transmitted to external detection devices, thereby achieving real-time monitoring of the pressure within the cavity during surgery or medical procedures. First, the connection between the pressure measuring cavity and the pressure measuring channel allows the pressure signal to be transmitted to external devices without interference, ensuring measurement accuracy. Second, the pressure measuring connector makes the installation and use of the device more convenient; users can quickly and reliably connect or disconnect the pressure detection device to meet the needs of different clinical scenarios. Furthermore, this design allows the device to adapt to various specifications of pressure detection equipment, improving system compatibility. The pressure detection device used in this embodiment can be a pressure detection device provided by existing technology, such as the pressure detection device disclosed in CN116649945A. The pressure detection device provided in this embodiment includes a housing, an aerogel insulator, and a pressure detection component. The housing has a pressure measuring chamber and a mounting chamber. The pressure measuring chamber has an air inlet for communicating with the pressure measuring interface of the sheath and a vent for communicating with the outside. A switch is provided at the vent. The pressure detection component is disposed in the mounting chamber. The pressure measuring chamber is aligned with the pressure detection component to form an outlet. The outlet is sealed by the aerogel insulator. The aerogel insulator is used to transmit the pressure of the pressure measuring chamber to the pressure detection component.

[0029] Further, please refer to Figure 5 This embodiment provides a negative pressure suction system, including a suction device 9 and a tearable sheath. The tearable sheath is detachably connected to a negative pressure connector 3. The negative pressure connector 3 includes a main pipe 31 and at least one connector 32 connected to the main pipe. The main pipe 31 is adapted to be detachably and sealed in communication with a connecting part 125. A sealing cap 33 is provided at the proximal end of the main pipe 31. The connector 32 is adapted to be sealed in connection with the suction device 9. An endoscope 10 passes through the main pipe 31 and enters the tearable sheath 11. A pressure sensor for measuring intracavitary pressure transmits a pressure signal value to the negative pressure device. The negative pressure device adjusts the negative pressure suction pressure according to the magnitude of the pressure signal value.

[0030] The pressure measuring channel has an outer wall facing outwards and an inner wall facing the main channel of the tearable sheath. In some embodiments, the outer wall of the pressure measuring channel is open to form a pressure measuring port communicating with the outside. This externally-facing pressure measuring channel port communicates with the high-pressure area inside the cavity, resulting in high measurement accuracy and accurate feedback of the cavity pressure. However, foreign objects can easily enter the pressure measuring cavity through the outer pressure measuring port, leading to a decrease in measurement accuracy after the pressure measuring channel is blocked. In other embodiments, the inner wall of the pressure measuring channel is open to form a pressure measuring port communicating with the main channel. This pressure measuring port communicates with the low-pressure area inside the cavity, resulting in a lower measured value relative to the overall cavity pressure, but eliminating the risk of foreign objects blocking the pressure measuring channel. For some embodiments of this utility model, please refer to... Figure 4 The pressure measuring channel has openings on both its outer and inner walls to form a pressure measuring port communicating with the outside world and the main channel. In this embodiment, the openings on the inner and outer walls are radially aligned, and the fully-through pressure measuring port communicates with both the high-pressure and low-pressure areas within the cavity, resulting in high measurement accuracy and accurate feedback of the cavity pressure. However, this design also carries the risk of pipe blockage. Alternatively, the openings on the inner and outer walls can be staggered, for example, in a Z-shape. The Z-shaped pressure measuring port communicates with both the high-pressure and low-pressure areas within the cavity, providing high measurement accuracy, accurate feedback of the cavity pressure, and eliminating the risk of pipe blockage. Preferably, the openings on the inner and outer walls of the pressure measuring channel are staggered.

[0031] In other embodiments of this utility model, please refer to Figures 6-8 The pressure sensor includes a pressure-sensitive element 51 and a signal line 52. The pressure-sensitive element 51 is located at the distal end of the pressure measuring channel 112 to detect the pressure within the cavity. The signal line 52 passes through the pressure measuring channel. The handle is provided with a data cable connector 6 connected to the signal line 52. The data cable connector 6 is suitable for connection to external devices. A control button 60 is provided on the data line of the data cable connector 6 to control the pressure of negative pressure suction, etc. In this embodiment, one of the first tear piece 122 and the second tear piece 123 is provided with a data cable connector 6, which is connected to the signal line 52. Specifically, one of the first tear piece 122 and the second tear piece 123 is provided with a data cable connector, such as a TYP-C connector, which is connected to the signal line. The TYP-C connector is suitable for connection to external pressure monitoring equipment, such as a negative pressure suction system. The pressure signal is transmitted to the external pressure monitoring equipment through the TYP-C connector. The use of the TYP-C connector has several advantages, including fast transmission speed, stable interface, and convenient connection.

[0032] In other embodiments of this utility model, please refer to Figures 9-11The handle 12 has a pressure measuring cavity 127 communicating with the pressure measuring channel, and a pressure-sensitive element 51 is provided inside the pressure measuring cavity 127. For example, one of the first tear piece and the second tear piece has a pressure measuring cavity communicating with the pressure measuring channel, and a pressure-sensitive element 51 is provided inside the pressure measuring cavity. The pressure-sensitive element 51 outputs a pressure value through a data cable connector 6. It can be understood that the pressure measuring cavity 127 is a sealed cavity, and for calibration purposes, the sealed cavity is equipped with a calibration valve 8.

[0033] Example 2 Expansion Component: Please refer to Figure 12-13 This embodiment provides an expansion assembly, which includes a tearable sheath and an expander. The tearable sheath includes a tearable sheath tube 11 and a handle 12. The handle 12 is provided with a handle tear slit 121 that can be torn axially. The handle 12 includes a sheath seat 121 located at the proximal end of the tearable sheath tube and a first tearing element 122 and a second tearing element 123 connected to the sheath seat. The sheath seat 121 is provided with a tearable slit that can be torn axially. The proximal end of the sheath seat has a connecting portion 125. The connecting portion 125 includes a passage 126 passing through it, which communicates with a main channel 111. The connecting portion 125 includes a circumferentially extending circumferential outer wall. The circumferential outer wall can be inserted and engaged with the proximal end of the expander or a negative pressure connector. Further, the circumferential outer wall is provided with at least one limiting buckle, thereby achieving a limiting engagement between the tearable sheath and the expander or negative pressure connector through the limiting buckle. Exemplarily, the circumferential outer wall is provided with limiting buckles 1251 and 1252.

[0034] The expander 2 provided in this embodiment includes an elongated tube 21 and an operating end 22 located near the proximal end of the tube. The elongated tube 21 is adapted to penetrate a tearable sheath 11. The operating end 22 defines a connecting channel that communicates with the elongated tube. The operating end 22 has a circumferentially extending inner wall 220. Specifically, the inner wall 220 is inserted into and rotatably engaged with the outer wall of the connecting portion. The inner wall 220 is provided with at least one limiting groove 221, 222. The inner wall 220 is rotatably engaged with the outer wall, and the limiting buckles 1251, 1252 are limited in place by the limiting grooves 221, 222. Thus, when the connecting portion is inserted into the inner wall of the operating end, rotation causes the limiting buckles to engage with the limiting grooves to maintain their relative fixation. To ensure a tight seal, a sealing ring 23 is provided between the inner wall 220 and the outer wall.

[0035] In some embodiments of this invention, the dilator has a tapered tip 212 with barbs 213 to enhance tissue penetration. Exemplarily, the proximal body of the elongated tube 21 is made of stainless steel, while its distal end 215 is made of a transparent polymer material, allowing an endoscope to be placed within the internal channel for observation of the insertion.

[0036] Please refer to some embodiments of this utility model. Figure 14 When the tearable sheath enters the body cavity, negative pressure aspiration and irrigation have not yet begun. At this time, the dilator is inserted into the tearable sheath to ensure that the tearable sheath can smoothly enter the body cavity. Because the dilator occupies the tearable sheath, foreign objects can easily enter the pressure measuring channel, causing blockage and a sharp drop in pressure measuring accuracy. Based on this, the distal outer and inner walls of the pressure measuring channel are both open to form a pressure measuring port communicating with the outside and the main channel. A cavity 210 is formed inside the dilator, and the side wall of the cavity has a side hole 211 communicating with the pressure measuring port 113. Foreign objects can enter through the side hole 211 of the dilator and be discharged from its cavity. Specifically, the diameter of the side hole is not smaller than the diameter of the pressure measuring port. The diameter of the side hole of the dilator is not smaller than the diameter of the pressure measuring port, ensuring that foreign objects can smoothly pass through the side hole and be discharged from the cavity, preventing blockage of the pressure measuring channel, and improving the safety and convenience of the surgical operation.

[0037] Please see Figures 12-13 The first tear handle 122 and the second tear handle 123 are provided with friction protrusions 120 to enhance friction and prevent the sheath from slipping.

[0038] In the description of this specification, references to terms such as "one embodiment," "some embodiments," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0039] Although embodiments of the present invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the present invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A pressure-measuring tearable sheath, characterized in that, The tearable sheath includes: A tearable sheath extends longitudinally from a proximal end to a distal end. The tearable sheath defines a main channel and a pressure measuring channel extending longitudinally from the proximal side to the distal side. The distal end of the pressure measuring channel has a pressure measuring port for sensing the pressure of the cavity. A pressure detection device is provided on the pressure measuring channel or any path connected to it to detect the pressure inside the cavity. The handle includes a sheath seat located at the proximal end of the tearable sheath and a first tearing element and a second tearing element connected to the sheath seat. The sheath seat has a tearable slit that can be torn axially. The proximal end of the sheath seat has a connecting portion, which includes a passage passing through it and communicating with the main channel. The connecting portion is adapted to be detachably and sealingly connected to the expander.

2. The tearable sheath according to claim 1, characterized in that, The tearable sheath includes a negative pressure connector, which includes a main pipe and at least one connector disposed on the main pipe. The main pipe is adapted to be detachably and sealed to the connector. A sealing cap is provided at the proximal end of the main pipe.

3. The tearable sheath according to claim 1, characterized in that, The tearable sheath includes a pressure sensor, which includes a pressure-sensitive element and a signal line. The pressure-sensitive element is located at the far end of the pressure measuring channel to detect the pressure inside the cavity. The signal line passes through the pressure measuring channel. The handle is provided with a data cable connector that connects to the signal line. The data cable connector is suitable for connecting to external devices.

4. The tearable sheath according to claim 1, characterized in that, The handle has a pressure measuring cavity that communicates with the pressure measuring channel, and a pressure sensor is installed inside the pressure measuring cavity.

5. The tearable sheath according to claim 3, characterized in that, One of the first tear piece and the second tear piece is provided with a data cable connector, which is connected to a signal line.

6. The tearable sheath according to claim 4, characterized in that, One of the first tear piece and the second tear piece has a pressure measuring cavity communicating with the pressure measuring channel, and the pressure measuring cavity is provided with a pressure sensitive element.

7. The tearable sheath according to claim 1, characterized in that, One of the first tear piece and the second tear piece has a pressure measuring cavity communicating with the pressure measuring channel. The proximal end of the pressure measuring cavity is provided with a pressure measuring connector, which is adapted to be connected to a pressure detection device.

8. The tearable sheath according to claim 1, characterized in that, The pressure measuring channel has an outer wall facing the outside and an inner wall facing the main channel on its distal side. The distal outer wall of the pressure measuring channel is open to form a pressure measuring port communicating with the outside; or, the distal inner wall of the pressure measuring channel is open to form a pressure measuring port communicating with the main channel; or, both the distal outer wall and the inner wall of the pressure measuring channel are open to form a pressure measuring port communicating with the outside and the main channel.

9. The tearable sheath according to claim 8, characterized in that, The openings on the inner wall of the pressure measuring channel are radially offset from the openings on the outer wall.

10. The tearable sheath according to claim 1, characterized in that, The connecting part includes a circumferentially extending circumferential outer wall, which can be inserted and mated with the proximal end of the expander or the negative pressure connector, and the circumferential outer wall is provided with a limiting part that fits into the limiting part of the expander.

11. A negative pressure suction system, characterized in that, The negative pressure suction system includes a suction device and a tearable sheath as described in any one of claims 1 to 10. The tearable sheath is detachably connected to a negative pressure connector, which includes a main pipe and at least one connector disposed on the main pipe. The main pipe is adapted to be detachably and sealed in communication with the connector. A sealing cap is provided at the proximal end of the main pipe, and the connector is adapted to be sealed in connection with the suction device.

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