Balloon puncture outfit with pressure indicating device and pressure control method

Abstract

The invention discloses a balloon puncture outfit with a pressure indicating device and a pressure control method, and relates to the technical field of medical instruments. The puncture outfit comprises a puncture outfit body and a pressure indicating device, the puncture outfit body comprises a sleeve, a limiting balloon, an indicating balloon and the like, and the sleeve and the indicating balloon are synchronously inflated and deflated through an air bag air guide channel; the pressure indicating device is composed of a fixed transparent tube, a movable transparent tube and the like, a tube body is provided with an underpressure area, a normal area and an overpressure area, and an indicating rod axially moves along with pressure to feed back the state. The control method comprises the steps of puncture preparation, tissue puncture and the like, a pressure interval corresponding value can be adjusted by rotating the movable transparent tube, and normal pressure is continuously monitored and maintained in an operation. The device does not need external equipment, pressure visual judgment is achieved, the surgical risk is reduced, components are made of disposable sterile materials, cross infection is avoided, and the minimally invasive surgery requirement is met.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a puncture device system for minimally invasive surgeries such as laparoscopy. BACKGROUND

[0002] In the field of minimally invasive surgeries such as laparoscopy, puncture devices are the core medical devices for establishing surgical working channels, and their performance directly affects the safety, accuracy and postoperative recovery of patients. Currently, the puncture device fixation methods commonly used in clinical practice mainly include threaded fixation and balloon fixation. Among them, the threaded fixation method achieves fixation through the mechanical engagement of the threaded structure on the outer wall of the sleeve with the human tissue, but has defects such as large influence of tissue texture on fixation stability, easy mechanical damage to surrounding tissues, and large adjustment difficulty, which limits its application in complex body position surgeries.

[0003] Balloon fixation technology has gradually become the mainstream fixation solution for minimally invasive surgery puncture devices due to its advantages such as uniform stress during fixation, less damage to tissues, and adaptation to various surgical body positions.

[0004] The balloon fixation puncture technology in the prior art, as shown in Fig. 1-2 The positioning balloon 300 arranged outside the sleeve 100 enters the abdominal cavity 200 of the human body along with the sleeve 100 in the un-inflated state, and then adheres to the inner wall of the abdominal cavity 200 after inflation to form a support, thereby establishing a stable surgical working channel.

[0005] When the positioning balloon is under pressure, the fixation force is insufficient, and the sleeve is prone to displacement and shaking during the surgery, which may cause deviation in the operation of surgical instruments, and even damage the internal organs of the abdominal cavity; when the balloon is over-pressurized, especially when the puncture device is at a special angle (such as Fig. 3 The balloon pressure cannot be released, continuously pressing the tissues in the abdominal cavity, leading to local blood circulation disorder, causing tissue edema, ischemic injury, and postoperative complications such as abdominal pain and abdominal distension, prolonging the recovery period of the patient.

[0006] Therefore, the skilled in the art is committed to developing a balloon puncture device with a pressure indicating device. SUMMARY

[0007] To achieve the above objectives, the present invention first provides a balloon puncture device with a pressure indicator, comprising a puncture device body and a pressure indicator device. The puncture device body includes a cannula, a limiting balloon, an indicating balloon, an air delivery channel for the balloon, a one-way valve, an outer cover, a piston rod, a retaining ring, a stopcock body, and a stopcock valve. The cannula is provided with an air inlet branch, a through hole, an indicating balloon groove, a tracheal groove, a limiting balloon groove, and a pressure indicator device mounting hole. The air inlet branch is connected to the pressure indicator device mounting hole via an air passage. The air delivery channel for the balloon is disposed within the tracheal groove, with one end connected to the air inlet branch through the through hole, and the other end... The device connects the indicator balloon and the limiting balloon respectively, with a one-way valve installed at the inlet port. The indicator balloon and the limiting balloon are flexible, sealed balloons, each embedded in its corresponding slot in the sleeve, and they are synchronously inflated and deflated via an air duct. The outer cover is detachably connected to the sleeve, and a stopcock and a stopcock valve are fitted to its surface. The piston rod is a rigid rod-shaped structure that can be inserted into the sleeve. A retaining ring is fitted onto the sleeve and located between the indicator balloon and the limiting balloon. The pressure indicating device includes an inner fixed transparent tube and an outer movable transparent tube. The butt joint at the front end of the tube is fixed to the mounting hole of the pressure indicator device on the sleeve, so that the pressure indicator device is connected to the gas path of the gas inlet branch pipe; the tail end of the fixed transparent tube is provided with an outwardly extending internally threaded tube section; the tail end of the movable transparent tube is provided with an inwardly extending externally threaded tube section; the externally threaded tube section of the movable transparent tube is threaded into the internally threaded tube section of the fixed transparent tube, and its end extends into the tube of the fixed transparent tube; and the end of the externally threaded tube section of the movable transparent tube is a pressure plate; the rod head of the indicator rod is installed in the fixed transparent tube, and its body passes through the externally threaded tube section of the movable transparent tube. Extending beyond the fixed and movable transparent tubes; a spring is positioned between the rod head and the pressure plate; the movable transparent tube is divided into three regions by scale lines: an under-pressure zone at the front, a normal zone in the middle, and an over-pressure zone at the rear; the indicator rod can move axially with changes in balloon system pressure, providing feedback on the pressure status through the region where the indicator rod head is located; rotating the movable transparent tube simultaneously adjusts the position of the scale lines and the distance between the pressure plate and the indicator rod head, thereby changing the spring force and adjusting the pressure value corresponding to each pressure zone.

[0008] Furthermore, the outer cover is detachably connected to the sleeve via threads.

[0009] Furthermore, all parts that come into contact with the human body are made of disposable sterile materials.

[0010] The present invention also provides another balloon puncture device with a pressure indicator, comprising a puncture device body and a pressure indicator device. The puncture device body includes a cannula, a limiting balloon, an indicating balloon, an air delivery channel for the balloon, a one-way valve, an outer cover, a piston rod, a fixing ring, a stopcock body, and a stopcock valve. The cannula is provided with an air inlet tube, a through hole, an indicating balloon groove, a tracheal groove, and a limiting balloon groove. The air delivery channel for the balloon is disposed in the tracheal groove, one end of which is connected to the air inlet tube through the through hole, and the other end is connected to the indicating balloon and the limiting balloon respectively. The one-way valve is installed at the port of the air inlet tube. The indicating balloon and the limiting balloon are flexible, sealed balloons, respectively embedded in corresponding slots in the sleeve, and both are synchronously inflated and deflated through the balloon air channel; the outer cover is detachably connected to the sleeve, and a stopcock and a stopcock valve are fitted onto its surface; the piston rod is a rigid rod-shaped structure that can be inserted into the sleeve; the fixing ring is fitted onto the sleeve and located between the indicating balloon and the limiting balloon; the pressure indicating device is connected to the indicating balloon through a flexible air hose, and the pressure indicating device includes an inner fixed transparent tube and an outer movable transparent tube; the front end of the fixed transparent tube has a... The pressure indicator is fixed to the mounting hole of the connector and sleeve, allowing the pressure indicator to connect to the gas path of the gas inlet branch pipe; the fixed transparent tube has an outwardly extending internally threaded section at its tail end; the movable transparent tube has an inwardly extending externally threaded section at its tail end; the externally threaded section of the movable transparent tube is threaded into the internally threaded section of the fixed transparent tube, and its end extends into the tube of the fixed transparent tube; the end of the externally threaded section of the movable transparent tube is a pressure plate; the head of the indicator rod is installed inside the fixed transparent tube, and its body extends through the externally threaded section of the movable transparent tube to... In addition to the fixed and movable transparent tubes, a spring is positioned between the rod head and the pressure plate. The movable transparent tube is divided into three pressure zones by scale lines: an under-pressure zone at the front, a normal zone in the middle, and an over-pressure zone at the rear. The indicator rod can move axially with changes in the balloon system pressure, and the pressure status is fed back through the area where the indicator rod head is located. Rotating the movable transparent tube can simultaneously adjust the position of the scale lines and the distance between the pressure plate and the indicator rod head, thereby changing the spring force and adjusting the pressure value corresponding to each pressure zone.

[0011] Furthermore, the outer cover is detachably connected to the sleeve via threads.

[0012] Furthermore, all parts that come into contact with the human body are made of disposable sterile materials.

[0013] The following will further explain the concept, specific structure, and technical effects of the present invention in conjunction with the accompanying drawings, so as to fully understand the purpose, features, and effects of the present invention.

[0014] This invention integrates the pressure indicator device with the trocar body through a unified design, enabling visual judgment of pressure status without relying on complex external monitoring equipment. The combination of a three-level pressure indication mechanism and a manual pressure relief function effectively solves the problems of ambiguous pressure judgment and lack of early warning in traditional trocars, reducing surgical risks. Each component has a simple structure and is easy to assemble. All parts that come into contact with the human body are made of disposable sterile materials to avoid cross-infection, while controlling manufacturing costs, meeting the economic and practical requirements of clinical application. Attached Figure Description

[0015] Fig. 1 This is a diagram showing the state of the limiting balloon before it inflates after the puncture device has penetrated human tissue, according to the prior art of this invention. Fig. 2 yes Fig. 1 Diagram showing the trocar at its normal angle after the mid-limit balloon has inflated; Fig. 3 yes Fig. 2 Diagram showing the balloon under overpressure when the puncture device is at a special angle. Fig. 4 This is a perspective view of the puncture device body according to a specific embodiment of the present invention; Fig. 5 yes Fig. 4 Exploded view of the components of the central puncture device; Fig. 6 This is a cross-sectional view of a pressure indicating device according to a specific embodiment of the present invention; Fig. 7 This is a schematic diagram of the installation of a pressure indicating device according to an alternative embodiment of the present invention. Detailed Implementation

[0016] The following description, with reference to the accompanying drawings, illustrates several preferred embodiments of the present invention to make its technical content clearer and easier to understand. The present invention can be embodied in many different forms, and the scope of protection of the present invention is not limited to the embodiments mentioned herein.

[0017] In the accompanying drawings, components with the same structure are indicated by the same numerical designation, and components with similar structures or functions are indicated by similar numerical designations. The dimensions and thicknesses of each component shown in the drawings are arbitrary, and the present invention does not limit the dimensions and thicknesses of each component. To make the illustrations clearer, the thickness of some components has been appropriately exaggerated in the drawings.

[0018] like Fig. 4-5As shown, the balloon puncture device with pressure indicator of the present invention includes a piston rod 1, an outer cover 2, an indicator balloon 3, a cannula 4, a limiting balloon 5, a fixing ring 6, an air duct channel 7, a stopcock body 8, a stopcock valve 9, a pressure indicator device 10, and a one-way valve 11.

[0019] The sleeve 4 serves as the core support component of the device, and is provided with an air inlet branch pipe 41, a through hole 42, an indicator balloon groove 43, an air tube groove 44, a limiting balloon groove 45, and a pressure indicator device mounting hole 46 that is connected to the air inlet branch pipe 41.

[0020] The outer cover 2 is detachably connected to the cannula 4 via threads. Its surface is fitted with a stopcock body 8 and a stopcock valve 9, forming the on / off control mechanism for the surgical working channel. The piston rod 1 is a rigid rod-shaped structure that is inserted into the cannula 4 during puncture, serving to guide the puncture direction and protect the inner wall of the cannula and the tissue.

[0021] The indicator balloon 3 and the limiting balloon 5 are flexible sealing balloons, respectively embedded in corresponding slots of the sleeve 4, and are connected by an air passage 7 located in the airway slot 44. The upper tube head 71 of the air passage 7 is connected to the air inlet branch pipe 41 of the sleeve 4 through a through hole 42; the indicator balloon air hole 73 of the air passage 7 is connected to the indicator balloon 3; and the lower tube head 74 of the air passage 7 is connected to the limiting balloon 5. A one-way valve 11 is installed at the port of the air inlet branch pipe 41 to realize one-way gas injection and retention control.

[0022] The fixation ring 6 is fitted onto the cannula 4 and positioned between the indicating balloon 3 and the limiting balloon 5. During the procedure, its position is adjusted to compress the human tissue between the fixation ring 6 and the limiting balloon 5, thereby enhancing the stability of the trocar fixation.

[0023] like Fig. 6As shown, the pressure indicating device 10 includes an inner fixed transparent tube 106 and an outer movable transparent tube 109. The connector 101 at the front end of the fixed transparent tube 106 is fixed to the pressure indicating device mounting hole 46 of the sleeve 4, allowing the pressure indicating device 10 to communicate with the air supply branch pipe 41. The tail end of the fixed transparent tube 106 is provided with an outwardly extending internally threaded tube section 1061. The tail end of the movable transparent tube 109 is provided with an inwardly extending externally threaded tube section 1091. The externally threaded tube section 1091 of the movable transparent tube 109 is threadedly fitted into the internally threaded tube section 1061 of the fixed transparent tube 106, and its end extends into the tube of the fixed transparent tube 106. The end of the externally threaded tube section 1091 of the movable transparent tube 109 is a pressure plate 1092. The indicator rod 105 has its head 1051 installed inside the fixed transparent tube 106, and its body extends through the externally threaded section 1091 of the movable transparent tube 109 to the outside of both the fixed and movable transparent tubes 106 and 109. A spring 108 is positioned between the head 1051 and the pressure plate 1092. The movable transparent tube 109 is divided into three pressure zones by graduations: a front underpressure zone 102, a middle normal pressure zone 103, and a rear overpressure zone 104. The indicator rod 105 can move axially back and forth as the balloon system pressure changes. When the balloon pressure and spring force are balanced, the pressure status can be visually fed back through the area where the indicator rod head 1051 is located.

[0024] During the surgical procedure, medical staff hold the outer cover 2 and align the tip of the cannula 4, equipped with the piston rod 1, with the pre-set puncture site. Axial pressure is slowly applied to complete the tissue puncture. At this time, both the indicator balloon 3 and the limiting balloon 5 are in a naturally contracted state to avoid creating additional resistance to the puncture path. After the puncture is completed, the cannula 4 is fixed and the piston rod 1 is slowly withdrawn, so that the cannula 4 and the outer cover 2 together form a stable surgical working channel. Then, the external inflation device is connected to the input end of the one-way valve 11, and sterile gas is slowly injected. The gas is diverted through the gas inlet tube 41 to the balloon delivery channel 7 and the balloon system, pushing the indicator balloon 3 and the limiting balloon 5 to expand synchronously. During inflation, medical staff observe the position of the indicator rod 105 on the pressure indicator device 10 to determine the pressure status: In the initial inflation stage, the indicator rod 1051 remains in the under-pressure zone 102, indicating insufficient balloon pressure and the need for continued inflation; when the pressure reaches the clinically preset normal range, the indicator rod 1051 moves to the normal zone 103. At this time, both balloons have fully expanded and adhere to the surrounding tissue. Medical staff can fine-tune the position of the fixing ring 6 to compress the tissue between the fixing ring 6 and the limiting balloon 5, using the elastic tension of the tissue to firmly fix the cannula 4 and prevent displacement during surgery. If over-inflation causes excessive pressure, the indicator rod 105 will enter the over-pressure zone 104, forming a clear visual warning. Medical staff can manually depressurize to release some gas until the indicator rod 105 returns to the normal zone 103, effectively avoiding the risk of tissue compression damage.

[0025] During the procedure, medical staff can manually adjust the pressure in the three pressure zones—underpressure zone 102, normal zone 103, and overpressure zone 104—by rotating the movable transparent tube 109, based on the specific circumstances and the actual state of the indicator balloon 3. For example, rotating the movable transparent tube 109 clockwise moves it relative to the fixed transparent tube 106, causing the pressure plate 1092 to move forward as well. This shortens the distance between the rod head 1051 and the pressure plate 1092, further compressing the spring 108 and increasing its elasticity. Simultaneously, the scale on the movable transparent tube 109 moves forward, increasing the pressure within the normal pressure range. Conversely, if the movable transparent tube 109 is rotated counterclockwise, the pressure plate 1092 moves backward, increasing the distance between the rod head 1051 and the pressure plate 1092. The spring 108 extends further, reducing the spring force. At the same time, the scale on the movable transparent tube 109 also moves backward, and the corresponding pressure within the normal pressure scale range also decreases.

[0026] In another alternative embodiment, the pressure indicator as described above is connected to the indicator airbag 3 via a flexible air hose 30. In this embodiment, the pressure indicator can indicate the pressure of the limiting balloon 5 by means of the pressure of the indicator airbag 3, and the connection via the flexible air hose 30 makes it easier for the operator to operate the pressure indicator for observation and calibration procedures.

[0027] This embodiment integrates the pressure indicator device with the trocar body through an integrated design, enabling visual judgment of pressure status without relying on complex external monitoring equipment. The combination of the three-level pressure indication mechanism and manual pressure relief function effectively solves the problems of ambiguous pressure judgment and lack of early warning in traditional trocars, reducing surgical risks. Each component has a simple structure and is easy to assemble. All parts that come into contact with the human body are made of disposable sterile materials to avoid cross-infection, while controlling manufacturing costs, meeting the economic and practical requirements of clinical application.

[0028] The preferred embodiments of the present invention have been described in detail above. It should be understood that those skilled in the art can make numerous modifications and variations based on the concept of the present invention without creative effort. Therefore, all technical solutions that can be obtained by those skilled in the art based on the concept of the present invention through logical analysis, reasoning, or limited experimentation on the basis of existing technology should be within the scope of protection defined by the claims.

Claims

1. A balloon puncture device with a pressure indicator, characterized in that, The device includes a trocar body and a pressure indicator. The trocar body comprises a cannula, a limiting balloon, an indicating balloon, an air delivery channel for the balloon, a one-way valve, an outer cover, a piston rod, a retaining ring, a stopcock body, and a stopcock valve. The cannula has an air inlet branch, a through hole, an indicating balloon groove, a tracheal groove, a limiting balloon groove, and a pressure indicator mounting hole. The air inlet branch is connected to the pressure indicator mounting hole via an air path. The air delivery channel for the balloon is located within the tracheal groove, with one end connected to the air inlet branch through the through hole, and the other end connected to both the indicating balloon and the limiting balloon. The one-way valve is installed... It is installed at the inlet port of the air inlet tube; the indicating balloon and the limiting balloon are flexible sealing balloons, respectively embedded in the corresponding slots of the sleeve, and the two are synchronously inflated and deflated through the air inlet channel; the outer cover and the sleeve are detachably connected, and a stopcock and a stopcock valve are fitted on its surface; the piston rod is a rigid rod structure that can be inserted into the sleeve; the fixing ring is fitted on the sleeve and located between the indicating balloon and the limiting balloon; the pressure indicating device includes an inner fixed transparent tube and an outer movable transparent tube; the connector at the front end of the fixed transparent tube is connected to the sleeve pressure... The pressure indicator is fixed in place by a mounting hole, allowing it to connect to the gas supply line of the gas inlet branch pipe. The fixed transparent tube has an outwardly extending internally threaded section at its tail end; the movable transparent tube has an inwardly extending externally threaded section at its tail end; the externally threaded section of the movable transparent tube is threaded into the internally threaded section of the fixed transparent tube, and its end extends into the fixed transparent tube; the end of the externally threaded section of the movable transparent tube is a pressure plate; the head of the indicator rod is installed inside the fixed transparent tube, and its body extends through the externally threaded section of the movable transparent tube into the fixed transparent tube. In addition to the visible tube and the movable transparent tube, a spring is positioned between the rod head and the pressure plate. The movable transparent tube is divided into three regions by scale lines: the under-pressure zone at the front, the normal zone in the middle, and the over-pressure zone at the rear. The indicator rod can move axially with the pressure changes of the balloon system, and the pressure status is fed back through the region where the indicator rod head is located. Rotating the movable transparent tube can simultaneously adjust the position of the scale lines and the distance between the pressure plate and the indicator rod head, thereby changing the spring force and adjusting the pressure value corresponding to each pressure zone.

2. The balloon puncture device with pressure indicator according to claim 1, characterized in that, The outer cover is detachably connected to the sleeve via threads.

3. The balloon puncture device with pressure indicator according to claim 1, characterized in that, All parts that come into contact with the human body are made of disposable sterile materials.

4. A balloon puncture device with a pressure indicator, characterized in that, The device includes a trocar body and a pressure indicating device. The trocar body comprises a cannula, a limiting balloon, an indicating balloon, an air delivery channel for the balloon, a one-way valve, an outer cover, a stopcock rod, a retaining ring, a stopcock body, and a stopcock valve. The cannula has an air inlet tube, a through hole, an indicating balloon groove, a tracheal groove, and a limiting balloon groove. The air delivery channel for the balloon is located in the tracheal groove, with one end connected to the air inlet tube through the through hole, and the other end connected to both the indicating balloon and the limiting balloon. A one-way valve is installed at the port of the air inlet tube. The indicating balloon and the limiting balloon are flexible sealing balloons. The outer cover is fitted into the corresponding slot in the sleeve, and both are synchronously inflated and deflated through the air bladder's air channel. The outer cover and sleeve are detachably connected, and a stopcock and stopcock valve are fitted to its surface. The piston rod is a rigid rod-shaped structure that can be inserted into the sleeve. The retaining ring is fitted onto the sleeve and is located between the indicating balloon and the limiting balloon. The pressure indicating device is connected to the indicating air bladder through an air duct. The pressure indicating device includes an inner fixed transparent tube and an outer movable transparent tube. The connector at the front end of the fixed transparent tube is connected to the pressure indicating device of the sleeve. The mounting hole is fixed, allowing the pressure indicator to connect to the air supply line of the gas inlet pipe; the fixed transparent tube has an outwardly extending internally threaded section at its tail end; the movable transparent tube has an inwardly extending externally threaded section at its tail end; the externally threaded section of the movable transparent tube is threaded into the internally threaded section of the fixed transparent tube, and its end extends into the tube of the fixed transparent tube; the end of the externally threaded section of the movable transparent tube is a pressure plate; the rod head is installed inside the fixed transparent tube, and its body extends through the externally threaded section of the movable transparent tube to the outside of both the fixed and movable transparent tubes; a spring is located between the rod head and the pressure plate; the movable transparent tube is divided into three areas by scale lines: the underpressure area at the front, the normal area in the middle, and the overpressure area at the rear; the indicator rod can move axially with the pressure changes of the balloon system, and the pressure status is fed back through the area where the rod head is located; rotating the movable transparent tube can simultaneously adjust the position of the scale lines and the distance between the pressure plate and the rod head of the indicator rod, thereby changing the spring force and adjusting the pressure value corresponding to each pressure area.

5. The balloon puncture device with pressure indicator according to claim 4, characterized in that, The outer cover is detachably connected to the sleeve via threads.

6. The balloon puncture device with pressure indicator according to claim 4, characterized in that, All parts that come into contact with the human body are made of disposable sterile materials.

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