Balloon puncture device sheath with gas resistance reduction system and puncture device

Abstract

The balloon puncture device sheath with the gas resistance reduction system contains a shell, a sealing system, a sleeve, a gas resistance reduction system, a positioning mechanism and a working channel. The sleeve contains a connecting end, a pipe body, a balloon, a balloon inflation valve and an air passage. The gas resistance reduction system is connected with the balloon and the balloon inflation valve through the air passage, so that the balloon can be connected with the outside. When the balloon puncture device sheath with the gas resistance reduction system passes through the abdominal wall, the abdominal wall extrudes the balloon, the gas in the balloon is discharged, and the balloon is folded into a conical structure. The puncture device contains the balloon puncture device sheath with the gas resistance reduction system and a puncture rod. The conical structure formed after the balloon is folded is a one-way rotating body without special-shaped convex platform or edge structure, so that the cross section of the sleeve gradually increases when passing through the abdominal wall, the movement process is smoother, the movement resistance is effectively reduced, and the clinical use is more convenient and safe.

Description

Technical Field

[0001] This utility model relates to a laparoscopic surgical instrument, and more particularly to a trocar used in laparoscopic surgery. Background Technology

[0002] Laparoscopic surgery is becoming increasingly widespread, and to avoid iatrogenic infections, the use of disposable trocars in laparoscopic surgery is also increasing. Effective fixation of the trocar cannula has always been a concern in the use of existing trocars. Poor fixation of the trocar can lead to displacement during surgery, which in severe cases can result in its removal, interruption of the procedure, or excessive insertion into the body, causing accidental injury to organs or tissues.

[0003] To solve the problem of fixing the trocar, there are several solutions. Currently, the most ideal fixation method is a balloon trocar, which uses a balloon that is inflated after entering the body and an external positioning device to stably fix the trocar to the abdominal wall.

[0004] The current standard clinical procedure is as follows: First, with the balloon deflated and the balloon in its collapsed state, the trocar is inserted into the abdominal wall. After entering the abdominal wall, the trocar is removed. Then, the balloon is inflated through the inflation valve, and the positioning device is adjusted to fix the sheath to the abdominal wall. After the surgery, the air in the balloon is emptied using the deflation device, and then the sheath is removed.

[0005] However, when the balloon is emptied of gas using a deflation device, if the balloon's contraction direction is not directionally controlled, the balloon contracts randomly in all directions simultaneously. Therefore, the external shape of the balloon after gas expulsion is also random, with varying sharp edges and angles. Because the internal pressure of the balloon is lower than the external pressure, these sharp edges and angles possess a certain strength, resulting in significant resistance when the balloon enters and exits the abdominal wall. Especially when the balloon is deflated inside the body, the inability to directionally control the contraction process using hands or external tools leads to considerable resistance when the balloon is withdrawn from the abdominal wall, easily causing accidental tissue damage.

[0006] Therefore, the balloon closure process of current balloon puncture devices needs further improvement to better meet clinical needs. Summary of the Invention

[0007] The purpose of this invention is to solve the problem of high resistance to the movement of the sheath through the abdominal wall caused by the free shape of the balloon with sharp edges and acute angles during the free contraction of the balloon in existing balloon trocars. By using a gas drag reduction system, the balloon is directionally controlled during the gas expulsion process, allowing it to conform to the outer wall of the sheath and slowly and smoothly contract in the opposite direction of movement, forming a cone-like structure. This reverse cone-shaped structure is a unidirectional increase in the direction of movement, without any irregular protruding platforms or sharp edges. This allows the cross-section of the sheath to gradually increase as it passes through the abdominal wall, making the movement smoother, effectively reducing resistance, and making it more convenient and safer for clinical use.

[0008] The balloon puncture device sheath with a gas drag reduction system of this utility model is characterized in that: the balloon puncture device sheath 100 with a gas drag reduction system includes a shell 1, a sealing system 2, a sleeve 3, a gas drag reduction system 4, a positioning mechanism 5, and a working channel 6.

[0009] A. The sealing system 2 includes an end sealing mechanism 21 and a one-way sealing valve 22. The sealing system 2 performs dynamic sealing when the surgical instrument is inserted and static sealing when the surgical instrument is removed. The sealing system 2 is located at the proximal end 11 of the housing 1.

[0010] B. The sleeve 3 includes a connecting end 31, a tube body 32, a balloon 33, a balloon inflation valve 34, and an air passage 35; the connecting end 31 is located at the proximal end of the sleeve 3 and is connected to the sealing system 2 and the housing 1; the balloon 33 is located at the distal end of the tube body 32, and the balloon inflation valve 34 is located at the proximal end of the tube body 32 and / or on the connecting end 31; the air passage 35 is connected to the balloon inflation valve 34 and the balloon 33.

[0011] C. The gas drag reduction system 4 is connected to the balloon 33 and the balloon inflation valve 34 through the airway 35; when the gas drag reduction system 4 is closed, the balloon (33) can be inflated through the balloon inflation valve 34, or the balloon 33 can be kept in an inflated state; when the gas drag reduction system 4 is open, the internal space of the balloon (33) is connected to the outside through the airway 35 and the gas drag reduction system 4, and the balloon puncture sheath 10 with the gas drag reduction system... When the balloon 33 enters or is withdrawn from the body cavity, as the balloon 33 enters the abdominal wall, the abdominal wall compresses the balloon 33. The gas in the balloon 33 is slowly discharged from the exhaust section 41 constructed by the gas drag reduction system 4 as the abdominal wall compresses it. As the gas is discharged, the balloon 33 adheres to the outer wall of the sleeve 3 and slowly and smoothly retracts in the opposite direction of the movement direction of the sleeve 3, thereby effectively reducing the resistance of the balloon puncture sheath 100 with the gas drag reduction system when passing through the abdominal wall.

[0012] D. The positioning mechanism 5 is provided on the sleeve 3, and the positioning mechanism 5 adjusts and locks the distance between itself and the balloon 33;

[0013] E. The working channel 6 is located inside the sleeve 3 and the housing 1, and the sealing system 2 seals the working channel 6.

[0014] The gas drag reduction system 4 is connected to the balloon 33 and the balloon inflation valve 34 through the airway 35, and can directionally control the deflation and retraction process of the balloon 33. Therefore, when the gas drag reduction system 4 is turned on, the balloon 33 can communicate with the outside. When the balloon puncture sheath 100 with the gas drag reduction system passes through the abdominal wall, the abdominal wall and the balloon 33 form a surface contact, which uniformly compresses the balloon 33. As the gas in the balloon 33 is slowly expelled, the balloon 33 begins to slowly retract from the part that contacts the abdominal wall and adheres to the tube body 32. As the balloon 33 is gradually pulled into the abdominal wall, the balloon 33 adheres to the tube body 32 and gradually retracts, forming a cone-shaped structure. This conical structure is a unidirectional rotating body in the direction of movement, with a gradually increasing cross-section. It does not have irregular protruding platforms or sharp edges, which allows the sleeve 3 to gradually increase in cross-section as it passes through the abdominal wall, making the movement smoother, effectively reducing movement resistance, and making it more convenient and safer for clinical use.

[0015] To confirm the clinical efficacy of the above-mentioned technical solution, the applicant conducted a simulated puncture experiment on artificial skin. A balloon puncture device with a working diameter of 5 mm was used as the experimental verification target. The puncture and withdrawal processes of the balloon 33 under two states—free emptying and slow air release through the gas drag reduction system 4—were compared. The specific experimental data are shown in Table 1.

[0016] Table 1. Results of motion resistance tests under different conditions

[0017]

[0018] As can be seen from the data in Table 1, when the balloon is freely emptied through the venting device, the average values ​​of its puncture force and pull-out force reach 46.46N and 47.44N, respectively. When the gas drag reduction system 4 is activated, after the balloon 33 is squeezed by the abdominal wall and oriented to conform to the tube 32 into a conical structure, the average values ​​of its puncture force and pull-out force drop to 25.82N and 26.28N, respectively, which are reduced by 44.43% and 44.61%, respectively, and have a significant effect on reducing movement resistance.

[0019] The gas drag reduction system 4 is a dynamic exhaust mechanism 42; the dynamic exhaust mechanism 42 includes an exhaust port 42-1 and a safety cap 42-2; the safety cap 42-2 is detachably installed on the exhaust port 42-1, and the removal force of the safety cap 42-2 is less than the destructive pressure of the balloon 33. When the pressure exceeds the removal force of the safety cap 42-2, the safety cap 42-2 automatically falls off the exhaust port 42-1, the gas drag reduction system 4 is activated, the balloon 33 is connected to the outside, and during movement, the abdominal wall squeezes the balloon 33, and the gas in the balloon 33 is slowly discharged from the body through the exhaust port 42-1. The exhaust port 42-1 constitutes the exhaust part 41, and the balloon 33 slowly and smoothly retracts in the opposite direction of movement against the outer wall of the sleeve 3, thereby effectively reducing the movement resistance of the balloon puncture sheath 100 with the gas drag reduction system when passing through the abdominal wall. The dynamic venting mechanism 42 can automatically detach under certain pressure. Therefore, when the sleeve 3 is punctured or removed, the pressure inside the balloon 33 increases under the compression of the abdominal wall. When the removal force of the safety cap 42-2 is reached, the safety cap 42-2 automatically detaches, and the gas drag reduction system 4 automatically opens, making it very convenient to use. Moreover, since the safety cap 42-2 is designed with an automatic detachment function, it can also serve as a safety protection measure, effectively preventing the balloon 33 from accidentally bursting due to excessive pressure inside the body.

[0020] The removal force of the safety cap 42-2 is adjustable. This adjustment accommodates the safety pressure of balloons 33 of different sizes and strengths, ensuring the balloons 33 remain inflated under working pressure while allowing for easy removal when needed, thus guaranteeing the activation of the gas drag reduction system 4. The removal force can be adjusted by varying the contact area between the cap 42-2 and the exhaust port 42-1, or by adding locking devices with different locking forces, among other methods. These methods are not detailed here, but they all fall within the scope of this application.

[0021] The gas drag reduction system 4 is an airway communication mechanism 43. The airway communication mechanism 43 can be an exhaust switch or other component installed on the sleeve 3 and communicating with the airway 35, or it can be a separate component that can open the balloon inflation valve 34.

[0022] The airway communication mechanism 43 includes an exhaust channel 43-1, an inflation valve opening mechanism 43-2, and a connecting and fixing mechanism 43-3. The inflation valve opening mechanism 43-2 can open the balloon inflation valve 34, connecting the exhaust channel 43-1 with the airway 35. The connecting and fixing mechanism 43-3 connects and fixes the airway communication mechanism 43 to the balloon puncture sheath 100 with a gas drag reduction system. During movement, the abdominal wall compresses the balloon 33, and the gas in the balloon 33 is slowly discharged from the body through the exhaust channel 43-1. The exhaust channel 43-1 constitutes the exhaust part 41. The balloon 33 fits against the outer wall of the sleeve 3 and slowly and smoothly retracts in the opposite direction of movement, thereby effectively reducing the movement resistance of the balloon puncture sheath 100 with a gas drag reduction system when passing through the abdominal wall. When the airway communication mechanism 43 is an independent component, it connects the internal space of the balloon 33 to the outside through the exhaust channel 43. The inflation valve opening mechanism 43-2 keeps the balloon inflation valve 34 continuously open, maintaining the connection between the exhaust channel 43-1 and the airway 35. For ease of clinical operation, the airway communication mechanism 43 typically includes a connecting and fixing mechanism 43-3, allowing the other communication mechanisms 43 to be fixed to the sleeve 3 without specific control. The connecting and fixing mechanism 43-3 can connect and fix the airway communication mechanism 43 to the sleeve 3 in various ways, such as interference fit or snap-fit. The applicant will not provide specific examples here, but all of these methods are within the scope of protection of this application.

[0023] The gas drag reduction system 4 is located on the proximal end of the connection end 31 and / or the tube body 32. This allows medical staff to easily observe the status of the gas drag reduction system 4 during surgery, and it is also very convenient to activate the gas drag reduction system 4.

[0024] The gas drag reduction system 4 is also equipped with a warning device 44 to display and / or warn about the internal pressure of the balloon 33. The warning device 44 can alert the operator to the internal pressure status of the balloon 33, such as whether it is inflated or nearing its safety limit, thus minimizing the risk of surgical interruption due to pressure relief caused by the gas drag reduction system 4. If the internal pressure of the balloon 33 is insufficient, the operator can also be alerted to prevent weakening or loss of the balloon's internal fixation function, making clinical use safer and more convenient.

[0025] The warning device 44 displays and / or warns of the pressure within the balloon 33 through sound, and / or shape, and / or light, and / or color codes, and / or numerical values. The warning device 44 can display or alert to the pressure within the balloon 33 through one or more of the above methods. The applicant has only listed a few of these alerting methods here; those skilled in the art can choose other alerting methods as needed. The applicant will not provide examples of each, but none of these methods depart from the scope of protection of this application.

[0026] The warning device 44 is equipped with a working pressure indicator 44-1. When the balloon 33 reaches the working pressure, the working pressure indicator 44-1 displays the working pressure status of the balloon 33. The pressure indicator 44-1 can indicate different states of the internal pressure of the balloon 33, such as low pressure, normal working pressure, or over-safe pressure. The pressure indicator 44-1 can be displayed in different forms or combinations, such as color codes, pressure levels, and numerical values.

[0027] The balloon 33 is connected to the balloon 33 and the balloon inflation valve 34 via a first airway 35-1. The gas drag reduction system 4 is installed on the first airway 35-1 or connected to the balloon inflation valve 34 via a second airway 35-2. The gas drag reduction system 4, the balloon 33, and the balloon inflation valve 34 are connected through the airway 35, forming a closed gas structure. This closed gas structure ensures that the pressure inside the balloon 33 and the pressure of the gas drag reduction system 4 remain consistent. Under normal operating conditions, the internal pressure of the balloon 33 is constant. When the gas drag reduction system 4 is released, the balloon 33 can slowly deflate under the pressure of the abdominal wall. The balloon 33 gradually closes up against the tube 32 and passes smoothly through the abdominal wall.

[0028] The balloon inflation valve 34 is a one-way valve 34-1. The one-way valve 34-1 typically has a spring-type structure, including a return spring 34-11, a valve body 34-12, and a sealing ring 34-13. When pressure is applied by an external air source such as a syringe, the valve body 34-12 moves backward, the return spring 34-11 retracts, and the air inlet channel opens, allowing inflation into the air passage 35. After inflation is complete, removing the external air source, the return spring 34-11 returns to its original position, pushing the valve body 34-12 to press against the sealing ring 34-13, forming a seal. This one-way air inlet design eliminates the need for additional closure of the balloon inflation valve 34 after inflation, making it more convenient to use.

[0029] The balloon puncture device sheath 100 also includes a gas interface 7, which can be connected to a carbon dioxide pneumoperitoneum machine to inject carbon dioxide gas into the working channel 6.

[0030] The puncture device of this utility model includes a balloon puncture device sheath 100 with a gas drag reduction system and a puncture rod 200. The puncture rod 200 can be installed on the balloon puncture device sheath 100 with the gas drag reduction system, and the puncture rod 200 is inserted into the sleeve 3. The working part 200-1 of the puncture rod 200 usually has a size that matches the working channel 6. After being inserted into the sleeve 3, it can be used to puncture the abdominal wall.

[0031] In clinical use, after inserting the puncture rod 200 into the sleeve 3, the proximal end of the balloon puncture device sheath 100 with the gas drag reduction system is held, and the abdominal wall is punctured. After reaching a suitable position in the abdominal cavity, the end of the syringe or other instruments is pushed into the one-way valve 34-1. The one-way valve 34-1 opens, and gas is injected into the balloon 33 through the airway 35. The inflation status can be observed through the gas drag reduction system 4. When the pressure reaches the normal working pressure range, the syringe or other inflation instruments are removed, and the one-way valve 34-1 closes. The positioning mechanism 5 is adjusted to a suitable position, and the balloon puncture device with the gas drag reduction system of this utility model is fixed at the surgical site. The puncture rod 200 is removed, and the surgical instruments can then be inserted into the body cavity through the working channel 6 for surgical operation. When the instruments are in the working channel, the end sealing mechanism 21 performs dynamic sealing. When the surgical instruments are pulled out, the one-way sealing valve 22 performs static sealing. After the surgery, the gas drag reduction system 4 is activated, allowing the internal space of the balloon 33 to communicate with the outside. When the balloon trocar sheath 100 with the gas drag reduction system passes through the abdominal wall, a surface contact is formed between the abdominal wall and the balloon 33, uniformly compressing the balloon 33. As the gas inside the balloon 33 is slowly expelled, the balloon 33 begins to slowly close from the point of contact with the abdominal wall, adhering to the tube body 32. As the balloon 33 is gradually pulled into the abdominal wall, it gradually closes to the tube body 32, forming a cone-like structure. This cone-shaped structure is a unidirectional rotating body in the direction of movement, with a gradually increasing cross-section without any irregular protruding platforms or sharp edges. This allows the sheath 3 to gradually increase in cross-section as it passes through the abdominal wall, making the movement smoother, effectively reducing resistance, and making it more convenient and safer for clinical use.

[0032] The balloon puncture device sheath of this utility model with a gas drag reduction system includes a shell 1, a sealing system 2, a sleeve 3, a gas drag reduction system 4, a positioning mechanism 5, and a working channel 6. The sleeve 3 includes a connecting end 31, a tube body 32, a balloon 33, a balloon inflation valve 34, and an airway 35; the connecting end 31 is located at the proximal end of the sleeve 3 and is connected to the sealing system 2 and the shell 1; the balloon 33 is located at the distal end of the tube body 32, and the balloon inflation valve 34 is located at the proximal end of the tube body 32 and / or on the connecting end 31; the airway 35 is connected to the balloon inflation valve 34 and the balloon 33. The gas drag reduction system 4 is connected to the balloon 33 and the balloon inflation valve 34 via the airway 35. When the gas drag reduction system 4 is activated, the balloon 33 can communicate with the outside. When the balloon trocar sheath 100 with the gas drag reduction system passes through the abdominal wall, a surface contact is formed between the abdominal wall and the balloon 33, uniformly compressing the balloon 33. As the gas inside the balloon 33 is slowly expelled, the balloon 33 begins to slowly close from the point of contact with the abdominal wall, adhering to the tube body 32. As the balloon 33 is gradually pulled into the abdominal wall, it gradually closes to the tube body 32, forming a cone-like structure. This cone-shaped structure is a unidirectional rotating body in the direction of movement, with a gradually increasing cross-section without any irregular protruding platforms or sharp edges. This allows the sheath 3 to gradually increase in cross-section as it passes through the abdominal wall, making the movement smoother, effectively reducing resistance, and making it more convenient and safer for clinical use. Attached Figure Description

[0033] Figure 1 This is a schematic diagram of the balloon when it is freely emptied.

[0034] Figure 2 This is a schematic diagram of the structure of the balloon puncture device sheath with a gas drag reduction system of this utility model, which includes a dynamic exhaust mechanism.

[0035] Figure 2-1 yes Figure 2 The main view.

[0036] Figure 2-2 yes Figure 2-1 AA sectional view.

[0037] Figure 2-3 yes Figure 2-1 The right view.

[0038] Figure 2-4 yes Figure 2-3 BB cross-sectional view.

[0039] Figure 3 yes Figure 2 A schematic diagram of the structure when the safety cap detaches.

[0040] Figure 3-1 yes Figure 3 The main view.

[0041] Figure 3-2 yes Figure 3-1 CC section view.

[0042] Figure 3-3 yes Figure 3-1 The right view.

[0043] Figure 3-4 yes Figure 3-3 DD sectional view.

[0044] Figure 3-5 It is a safety cap with adjustable pressure.

[0045] Figure 4 This is a schematic diagram of the balloon of the present invention, which includes a single-hole warning device and a gas drag reduction system, when the internal pressure of the balloon is lower than the normal operating pressure.

[0046] Figure 4-1 yes Figure 4 The main view.

[0047] Figure 4-2 yes Figure 4-1 EE sectional view.

[0048] Figure 5 This is a schematic diagram of the structure of a 4-balloon balloon under normal operating pressure.

[0049] Figure 5-1 yes Figure 5 The main view.

[0050] Figure 5-2 yes Figure 5-1 FF sectional view.

[0051] Figure 6 This is a schematic diagram of the structure when the internal pressure of the 4-balloon balloon is higher than the normal operating pressure.

[0052] Figure 6-1 yes Figure 6 The main view.

[0053] Figure 6-2 yes Figure 6-1 GG cross-sectional view.

[0054] Figure 7 This is a schematic diagram of the balloon of the balloon puncture device sheath with gas drag reduction system of this utility model, which includes a multi-channel warning device, when the balloon is under normal working pressure.

[0055] Figure 7-1 yes Figure 7 The main view.

[0056] Figure 7-2 yes Figure 7-1 HH cross-sectional view.

[0057] Figure 8 This is a schematic diagram of the structure when the internal pressure of the 7-balloon is higher than the normal operating pressure.

[0058] Figure 8-1 yes Figure 8 The main view.

[0059] Figure 8-2 yes Figure 8-1 Section II.

[0060] Figure 9 This is a schematic diagram of the structure of the balloon puncture device sheath with a gas drag reduction system of this utility model, which includes an airway connection mechanism.

[0061] Figure 9-1 yes Figure 9 A sectional view.

[0062] Figure 10 This is a schematic diagram of the puncture device of this utility model.

[0063] Figure 11 This is a schematic diagram illustrating the working principle of the balloon puncture device sheath with gas drag reduction system of this utility model when it is pulled out of the body cavity.

[0064] In the above figure:

[0065] 100 is the sheath of the balloon puncture device with a gas drag reduction system of this utility model, 200 is the puncture rod, 200-1 is the working part, and 900 is the puncture device.

[0066] 1 is the housing, 2 is the sealing system, 3 is the sleeve, 4 is the gas drag reduction system, 5 is the positioning mechanism, 6 is the working channel, and 7 is the gas interface.

[0067] 21 is the end sealing mechanism, 22 is the one-way sealing valve; 31 is the connecting end, 32 is the tube body, 33 is the balloon, 34 is the balloon inflation valve, 35 is the airway; 41 is the exhaust section, 42 is the dynamic exhaust mechanism, 43 is the airway connection mechanism, and 44 is the warning device.

[0068] 34-1 is a one-way air valve, 35-1 is the first air passage, 35-2 is the second air passage; 42-1 is the exhaust port, 42-2 is the safety cover, 43-1 is the exhaust channel, 43-2 is the inflation valve opening mechanism, 43-3 is the connection and fixing mechanism, and 44-1 is the working pressure indicator.

[0069] 34-11 is the return spring, 34-12 is the valve body, 34-13 is the sealing ring, 34-14 is the air inlet valve housing, 42-21 is the plug, 42-22 is the connecting strip, and 44-11 is the indicator valve diaphragm. Detailed Implementation

[0070] Example 1: Balloon puncture sheath with gas drag reduction system of this utility model, including dynamic exhaust mechanism.

[0071] refer to Figures 1 to 1 -6 and Figures 2 to 2-3 The balloon puncture sheath with gas drag reduction system in this embodiment includes a shell 1, a sealing system 2, a sleeve 3, a gas drag reduction system 4, a positioning mechanism 5, and a working channel 6.

[0072] The sealing system 2 includes an end sealing mechanism 21 and a one-way sealing valve 22. The sealing system 2 performs dynamic sealing when the surgical instrument is inserted and static sealing when the surgical instrument is removed. The sealing system 2 is located at the proximal end 11 of the housing 1.

[0073] The sleeve 3 includes a connecting end 31, a tube body 32, a balloon 33, a balloon inflation valve 34, and an air passage 35; the connecting end 31 is located at the proximal end of the sleeve 3 and is connected to the sealing system 2 and the housing 1; the balloon 33 is located at the distal end of the tube body 32, and the balloon inflation valve 34 is located at the proximal end of the tube body 32 and / or on the connecting end 31; the air passage 35 is connected to the balloon inflation valve 34 and the balloon 33.

[0074] The gas drag reduction system 4 is connected to the balloon 33 and the balloon inflation valve 34 through the air passage 35, enabling directional control of the balloon 33's deflation and retraction processes. When the gas drag reduction system 4 is closed, the balloon (33) can be inflated or kept inflated through the balloon inflation valve 34. When the gas drag reduction system 4 is open, the internal space of the balloon (33) is connected to the outside through the air passage 35 and the gas drag reduction system 4. When the balloon puncture sheath 100 of the system enters or is withdrawn from the body cavity, as the balloon 33 enters the abdominal wall, the abdominal wall compresses the balloon 33. The gas in the balloon 33 is slowly discharged from the exhaust section 41 constructed by the gas drag reduction system 4 as the abdominal wall compresses it. As the gas is discharged, the balloon 33 adheres to the outer wall of the sleeve 3 and slowly and smoothly retracts in the opposite direction of the movement direction of the sleeve 3, thereby effectively reducing the resistance of the balloon puncture sheath 100 with the gas drag reduction system when passing through the abdominal wall.

[0075] The positioning mechanism 5 is provided on the sleeve 3, and the positioning mechanism 5 adjusts and locks the distance between itself and the balloon 33.

[0076] The working channel 6 is located inside the sleeve 3 and the housing 1, and the sealing system 2 seals the working channel 6.

[0077] refer to Figure 1 The balloon 33 is prone to forming a free shape with sharp edges or acute angles during the free contraction process, resulting in high resistance to movement when the sleeve 3 passes through the abdominal wall.

[0078] In this embodiment, the gas drag reduction system 4 is connected to the balloon 33 and the balloon inflation valve 34 through the airway 35. Therefore, when the gas drag reduction system 4 is activated, the balloon 33 can communicate with the outside. When the balloon puncture sheath 100 with the gas drag reduction system passes through the abdominal wall, a surface contact is formed between the abdominal wall and the balloon 33, uniformly compressing the balloon 33. As the gas inside the balloon 33 is slowly expelled, the balloon 33 begins to slowly contract from the point of contact with the abdominal wall, adhering to the tube body 32. As the balloon 33 is gradually pulled into the abdominal wall, it gradually contracts, adhering to the tube body 32, forming a cone-shaped structure. (Refer to...) Figure 11 This conical structure is a unidirectional rotating body in the direction of movement, with a gradually increasing cross-section. It does not have irregularly shaped protruding platforms or sharp edges, which allows the sleeve 3 to gradually increase in cross-section as it passes through the abdominal wall, making the movement smoother, effectively reducing movement resistance, and making it more convenient and safer for clinical use.

[0079] refer to Figures 2 to 3-4 In this embodiment, the gas drag reduction system 4 is a dynamic exhaust mechanism 42; the dynamic exhaust mechanism 42 includes an exhaust port 42-1 and a safety cap 42-2. The safety cap 42-2 is detachably mounted on the exhaust port 42-1. The removal force of the safety cap 42-2 is less than the breaking pressure of the balloon 33. When the pressure exceeds the removal force of the safety cap 42-2, the safety cap 42-2 automatically detaches from the exhaust port 42-1, the gas drag reduction system 4 is activated, and the balloon 33 communicates with the outside. During movement, the abdominal wall compresses the balloon 33, and the gas in the balloon 33 is slowly discharged from the body through the exhaust port 42-1. The exhaust port 42-1 constitutes the exhaust section 41. (See reference...) Figure 3-4 The balloon 33, adhering to the outer wall of the sleeve 3, slowly and smoothly retracts in the opposite direction of movement, thereby effectively reducing the resistance of the balloon trocar sheath 100 with the gas drag reduction system as it passes through the abdominal wall. (Refer to...) Figure 11The dynamic venting mechanism 42 can automatically detach under certain pressure. Therefore, when the sleeve 3 is punctured or removed, the pressure inside the balloon 33 increases under the compression of the abdominal wall. When the removal force of the safety cap 42-2 is reached, the safety cap 42-2 automatically detaches, and the gas drag reduction system 4 automatically opens, making it very convenient to use. Moreover, since the safety cap 42-2 is designed with an automatic detachment function, it can also serve as a safety protection measure, effectively preventing the balloon 33 from accidentally bursting due to excessive pressure inside the body.

[0080] refer to Figure 3-5 The removal force of the safety cap 42-2 is adjustable. This adjustable force accommodates the safety pressure of balloons 33 of different sizes and strengths, ensuring the balloons 33 remain inflated under normal operating pressure while allowing for easy removal when needed to ensure the operation of the gas drag reduction system 4. In this embodiment, the removal force is adjusted by varying the contact area between the plug 42-21 of the cap 42-2 and the exhaust port 42-1. In practical applications, those skilled in the art can also adjust the force by adding locking devices with different locking forces, etc. These methods are not described in detail here, but they all fall within the scope of this application. Furthermore, the safety cap 42-2 is also equipped with a connecting strap 42-22, which connects the safety cap 42-2 to the exhaust port 42-1, preventing the safety cap 42-2 from scattering freely and interfering with surgical procedures when it automatically detaches.

[0081] To verify the clinical efficacy of the above-mentioned technical solution, the applicant conducted a simulated puncture experiment on artificial skin. A balloon puncture device with a working diameter of 5 mm was used as the experimental target. The puncture and withdrawal processes of the balloon 33 under two conditions were compared: free emptying and slow air release through the gas drag reduction system 4. The specific experimental data are shown in Table 1.

[0082] Table 1. Results of motion resistance tests under different conditions

[0083]

[0084] As can be seen from the data in Table 1, when the balloon is freely emptied through the venting device, the average values ​​of its puncture force and pull-out force reach 46.46N and 47.44N, respectively. When the gas drag reduction system 4 is activated, after the balloon 33 is squeezed by the abdominal wall and oriented to conform to the tube 32 into a conical structure, the average values ​​of its puncture force and pull-out force drop to 25.82N and 26.28N, respectively, which are reduced by 44.43% and 44.61%, respectively, and have a significant effect on reducing movement resistance.

[0085] In this embodiment, the balloon inflation valve 34 is a one-way valve 34-1. The one-way valve 34-1 has a spring-type structure, including a return spring 34-11, a valve body 34-12, and a sealing ring 34-13. When pressure is applied by an external air source such as a syringe, the valve body 34-12 moves backward, the return spring 34-11 retracts, and the air inlet channel opens, allowing inflation into the air passage 35. After inflation is complete, the external air source such as the syringe is removed, the return spring 34-11 returns to its original position, pushing the valve body 34-12 to move and compress the sealing ring 34-13, forming a seal. (See reference...) Figure 2-4 and Figure 3-4 This one-way air intake design eliminates the need to seal the balloon inflation valve 34 after inflation is complete, making it more convenient to use.

[0086] The positioning mechanism 5 is made of elastic medical material and can move up and down along the outside of the sleeve 3 to adjust the distance between it and the balloon 33, so as to adapt to the abdominal wall thickness of different patients and achieve effective fixation of the balloon puncture sheath with gas drag reduction system of this utility model.

[0087] refer to Figure 1 and Figure 2 In this embodiment, the balloon puncture device sheath 100 also includes a gas interface 7, which can be connected to a carbon dioxide pneumoperitoneum machine to inject carbon dioxide gas into the working channel 6.

[0088] When the balloon 33 is inflated, the external inflation mechanism presses the one-way valve 34-1, the return spring 34-11 retracts, the first air passage 35-1 opens, and gas enters the air passage 35 through the one-way valve 34-1 to inflate the balloon 33. When the safety cap 42-2 disengages, the second air passage 35-2 opens, the gas drag reduction system 4 activates, and under external pressure, the gas inside the balloon 33 is discharged from the exhaust port 42-1 through the second air passage 35-2, and the balloon 33 closes to the tube body 32.

[0089] In this embodiment, due to the gas drag reduction system 4, when the gas drag reduction system 4 is activated, under the compression of the abdominal wall, the gas inside the balloon 33 is discharged from the exhaust port 42-1 through the airway 35. The balloon 33 then conforms to the tube 32 and contracts, forming a cone-like structure. This cone-shaped structure is a unidirectional rotating body in the direction of movement, with a gradually increasing cross-section without any irregular protruding platforms or sharp edges. This allows the sleeve 3 to gradually increase in cross-section as it passes through the abdominal wall, making the movement smoother and effectively reducing resistance, making it more convenient and safer for clinical use.

[0090] Example 2: Balloon puncture sheath with gas drag reduction system of this utility model, including a warning mechanism

[0091] refer to Figure 1-7 and Figure 1-8 The difference between this embodiment and embodiment 1 is that in this embodiment, the gas drag reduction system 4 is further provided with a warning device 44 to display and / or warn about the internal pressure of the balloon 33.

[0092] In this embodiment, the warning device 44 can alert the operator to the internal pressure status of the balloon 33, such as whether it is inflated or close to the safety limit, so as to avoid interruption of the operation due to the gas drag reduction system 4 protecting and depressurizing during the operation. If the internal pressure of the balloon 33 is insufficient, the operator can also be alerted to prevent the internal fixation of the balloon 33 from weakening or being lost, making the clinical use safer and more convenient.

[0093] The warning device 44 displays and / or warns of the pressure inside the balloon 33 through sound, and / or shape, and / or light, and / or color code, and / or numerical value.

[0094] In this embodiment, the warning device 44 is provided with a working pressure indicator 44-1. When the balloon 33 reaches the working pressure, the working pressure indicator 44-1 displays the working pressure status of the balloon 33. The working pressure indicator 44-1 is an indicator diaphragm 44-11, and the shape of the indicator diaphragm 44-11 displays and warns of the pressure inside the balloon 33.

[0095] refer to Figures 4 to 6-2 The working pressure indicator 44-1 is a single-channel indicator diaphragm 44-11 disposed on the safety cover 42-2, and is controlled by the indicator diaphragm 44-11. (Reference) Figures 4 to 4-2 When the internal pressure of the balloon 33 is insufficient, the indicator valve diaphragm 44-11 is in a collapsed state. (Reference) Figures 5 to 5-2When the balloon 33 is under normal operating pressure, the indicator valve diaphragm 44-11 is in a normal horizontal position. (Reference) Figures 6 to 6-2 When the internal pressure of the balloon 33 is too high, the indicator valve diaphragm 44-11 is in an expanded and bulging state.

[0096] For a single-channel design, since the safety cover 42-2 is a hollow cover structure, the connection between it and the exhaust port 42-1 is a simple cover connection, so the connection force will be relatively weak and accidental detachment may occur.

[0097] To prevent the aforementioned accidental occurrence, the working pressure indicator 44-1 can also be a multi-channel indicator diaphragm 44-11 disposed on the safety cover 42-2. (See reference) Figures 7 to 8-2 The safety cover 42-2 is provided with three indicator valve diaphragms 44-11. This indicator structure can both realize the pressure indication and warning function of the indicator valve diaphragms 44-11, and maintain the blockage between the plug 42-21 of the safety cover 42-2 and the exhaust port 42-1, thereby strengthening the connection between the safety cover 42-2 and the exhaust port 42-1.

[0098] The applicant has only provided specific examples illustrating the structure for pressure indication and warning using shape. In practical applications, those skilled in the art can also display or indicate the pressure within the balloon 33 using one or more of the above methods in combination. The applicant has only listed the above-mentioned indication methods; those skilled in the art can choose other indication methods as needed. The applicant will not provide examples of each method here, but none of them depart from the scope of protection of this application.

[0099] In this embodiment, since the safety cap 42-2 is also provided with the pressure indicator 44-1, the pressure status inside the balloon 33 can be indicated in real time during clinical use. When the pressure is insufficient, gas can be added at any time, and when the pressure is too high, the pressure can be released to keep the internal pressure of the balloon at the normal working pressure state for a long time, so as to better ensure the smooth progress of the clinical process and ensure clinical safety.

[0100] Example 3: Balloon puncture sheath with gas drag reduction system of this utility model, including airway connection structure.

[0101] refer to Figures 3 to 3 -7. The difference between this embodiment and embodiment 1 is that in this embodiment, the gas drag reduction system 4 is a gas passage connection mechanism 43.

[0102] The airway communication mechanism 43 can be an exhaust switch or other component disposed on the sleeve 3 and communicating with the airway 35, or it can be a separate component that can open the balloon inflation valve 34. In this embodiment, the airway communication mechanism 43 is a separate component that can open the balloon inflation valve 34.

[0103] The airway communication mechanism 43 includes an exhaust channel 43-1, an inflation valve opening mechanism 43-2, and a connecting and fixing mechanism 43-3. The inflation valve opening mechanism 43-2 can open the balloon inflation valve 34 to connect the exhaust channel 43-1 with the airway 35, and the connecting and fixing mechanism 43-3 connects and fixes the airway communication mechanism 43 to the balloon puncture sheath 100 with the gas drag reduction system.

[0104] refer to Figure 9 and Figure 9-1 In this embodiment, the inflation valve opening mechanism 43-2 includes a hollow conical structure, the hollow channel forms the exhaust channel 43-1, the end of which abuts against the valve body 34-12. When the return spring 34-11 is compressed, the first air passage 35-1 opens. The outer wall of the inflation valve opening mechanism 43-2 is connected to the inner wall of the inflation valve housing 34-14 of the balloon inflation valve 34 through an interference fit, forming the connection and fixing mechanism 43-3.

[0105] In this embodiment, the exhaust channel 43-1 is directly connected to the first air passage 35-1 and is located at the air inlet end of the first air passage 35-1.

[0106] In this embodiment, the independently configured airway connection mechanism 43 can directly open the balloon inflation valve 34 when needed, and can be stored separately when not needed, without affecting the operation of the surgical procedure. It is very flexible in use.

[0107] Example 4: The puncture device of this utility model with a gas drag reduction system

[0108] refer to Figure 10 In this embodiment, the puncture device 900 includes the balloon puncture device sheath 100 with gas drag reduction system and the puncture rod 200 described in the previous embodiment.

[0109] refer to Figure 10 The puncture rod 200 can be mounted on the balloon puncture sheath 100 with a gas drag reduction system, and the puncture rod 200 is inserted into the sleeve 3. The working part 200-1 of the puncture rod 200 typically has a size that matches the working channel 6. After being inserted into the sleeve 3, it can be used to puncture the abdominal wall. (Refer to...) Figure 5-1 .

[0110] In clinical use, after inserting the puncture rod 200 into the sleeve 3, the proximal end of the balloon puncture device sheath 100 with the gas drag reduction system is held, and the abdominal wall is punctured. Once a suitable position in the abdominal cavity is reached, the end of the syringe or other instrument is pushed into the one-way valve 34-1. The one-way valve 34-1 opens, and gas is injected inward. The balloon 33 is inflated through the airway 35, and the pressure of the gas drag reduction system 4 increases accordingly. When the pressure reaches the normal operating pressure range, the syringe or other inflating instrument is removed, and the one-way valve 34-1 closes. The positioning mechanism 5 is adjusted to a suitable position, and the balloon puncture device with the gas drag reduction system of this invention is fixed at the surgical site. The puncture rod 200 is removed, and the surgical instrument can then be inserted into the body cavity through the working channel 6 for surgical operation. When the instrument is in the working channel, the end sealing mechanism 21 provides a dynamic seal; when the surgical instrument is removed, the one-way sealing valve 22 provides a static seal. (Reference) Figure 11 When the surgery is completed or when it is necessary to remove the sleeve 3 from the body, the gas drag reduction system 4 is activated, allowing the internal space of the balloon 33 to communicate with the outside. When the balloon trocar sheath 100 with the gas drag reduction system passes through the abdominal wall, a surface contact is formed between the abdominal wall and the balloon 33, uniformly compressing the balloon 33. As the gas inside the balloon 33 is slowly expelled, the balloon 33 begins to slowly close from the point of contact with the abdominal wall, adhering to the tube body 32. As the balloon 33 is gradually pulled into the abdominal wall, it gradually closes to the tube body 32, forming a cone-like structure. This cone-shaped structure is a unidirectional rotating body in the direction of movement, with a gradually increasing cross-section without any irregular protruding platforms or sharp edges. This allows the sleeve 3 to gradually increase in cross-section as it passes through the abdominal wall, making the movement smoother, effectively reducing resistance, and making it more convenient and safer for clinical use.

[0111] When the dynamic exhaust mechanism 42 is used, the safety cover 42-2 is designed to automatically detach, so the safety cover 42-2 can also play a safety protection role, which can effectively avoid the safety risk of the balloon 33 bursting unexpectedly due to excessive pressure inside the body.

[0112] It should be noted that the structures disclosed and described herein can be replaced by other structures with the same effect, and the embodiments described herein are not the only structures for implementing this utility model. Although preferred embodiments of this utility model have been described and illustrated herein, those skilled in the art will understand that these embodiments are merely illustrative, and those skilled in the art can make numerous variations, improvements, and substitutions without departing from this utility model. Therefore, the scope of protection of this utility model should be defined in accordance with the spirit and scope of the appended claims.

Claims

1. A balloon puncture device sheath with a gas drag reduction system, characterized in that: The balloon puncture sheath (100) with gas drag reduction system includes a shell (1), a sealing system (2), a sleeve (3), a gas drag reduction system (4), a positioning mechanism (5), and a working channel (6); A. The sealing system (2) includes an end sealing mechanism (21) and a one-way sealing valve (22). The sealing system (2) performs dynamic sealing when the surgical instrument is inserted and static sealing when the surgical instrument is removed. The sealing system (2) is located at the proximal end (11) of the housing (1). B. The sleeve (3) includes a connecting end (31), a tube (32), a balloon (33), a balloon inflation valve (34), and an airway (35); the connecting end (31) is located at the proximal end of the sleeve (3) and is connected to the sealing system (2) and the housing (1); the balloon (33) is located at the distal end of the tube (32), the balloon inflation valve (34) is located at the proximal end of the tube (32), and / or on the connecting end (31); the airway (35) is connected to the balloon inflation valve (34) and the balloon (33); C. The gas drag reduction system (4) is connected to the balloon (33) and the balloon inflation valve (34) through the airway (35); when the gas drag reduction system (4) is closed, the balloon (33) can be inflated through the balloon inflation valve (34), or the balloon (33) can be kept in an inflated state; when the gas drag reduction system (4) is open, the internal space of the balloon (33) is connected to the outside through the airway (35) and the gas drag reduction system (4), and the balloon puncture sheath (1) with the gas drag reduction system is connected to the outside. 00) When the balloon (33) enters or is pulled out of the body cavity, as the balloon (33) enters the abdominal wall, the abdominal wall squeezes the balloon (33), and the gas in the balloon (33) is slowly discharged from the exhaust section (41) constructed by the gas drag reduction system (4) as the abdominal wall is squeezed. As the gas is discharged, the balloon (33) adheres to the outer wall of the sleeve (3) and slowly and smoothly closes in the opposite direction of the movement direction of the sleeve (3), thereby effectively reducing the resistance of the balloon puncture sheath (100) with the gas drag reduction system when passing through the abdominal wall; D. The positioning mechanism (5) is provided on the sleeve (3), and the positioning mechanism (5) adjusts and locks the distance between itself and the balloon (33); E. The working channel (6) is located inside the sleeve (3) and the housing (1), and the sealing system (2) seals the working channel (6).

2. The balloon puncture device sheath with gas drag reduction system according to claim 1, characterized in that: The gas drag reduction system (4) is a dynamic exhaust mechanism (42); the dynamic exhaust mechanism (42) includes an exhaust port (42-1) and a safety cap (42-2); the safety cap (42-2) is detachably installed on the exhaust port (42-1), and the removal force of the safety cap (42-2) is less than the destructive pressure of the balloon (33). When the pressure exceeds the removal force of the safety cap (42-2), the safety cap (42-2) automatically detaches from the exhaust port (42-1), and the gas drag reduction system (4) is restored. When opened, the balloon (33) is connected to the outside. During movement, the abdominal wall squeezes the balloon (33), and the gas in the balloon (33) is slowly discharged from the body through the exhaust port (42-1). The exhaust port (42-1) constitutes the exhaust part (41). The balloon (33) adheres to the outer wall of the sleeve (3) and slowly and smoothly closes in the opposite direction of movement, forming a cone-shaped structure facing the direction of movement. This can effectively reduce the movement resistance of the balloon puncture sheath (100) with gas drag reduction system when passing through the abdominal wall.

3. The balloon puncture device sheath with gas drag reduction system according to claim 2, characterized in that: The removal force of the safety cap (42-2) can be adjusted.

4. The balloon puncture device sheath with gas drag reduction system according to claim 1, characterized in that: The gas drag reduction system (4) is a gas passage connection mechanism (43).

5. The balloon puncture device sheath with gas drag reduction system according to claim 4, characterized in that: The airway communication mechanism (43) includes an exhaust channel (43-1), an inflation valve opening mechanism (43-2), and a connection and fixing mechanism (43-3). The inflation valve opening mechanism (43-2) can open the balloon inflation valve (34) to connect the exhaust channel (43-1) with the airway (35). The connection and fixing mechanism (43-3) connects and fixes the airway communication mechanism (43) to the balloon puncture sheath (100) with the gas drag reduction system. During the movement, the abdominal wall squeezes the balloon (33), and the gas in the balloon (33) is slowly discharged from the body through the exhaust channel (43-1). The exhaust channel (43-1) constitutes the exhaust part (41). The balloon (33) fits against the outer wall of the sleeve (3) and slowly and smoothly closes in the opposite direction of movement, thereby effectively reducing the movement resistance of the balloon puncture sheath (100) with the gas drag reduction system when passing through the abdominal wall.

6. The balloon puncture device sheath with gas drag reduction system according to claim 1, characterized in that: The gas drag reduction system (4) is located on the proximal end of the connection end (31) and / or the tube body (32).

7. The balloon puncture device sheath with gas drag reduction system according to claim 1, characterized in that: The gas drag reduction system (4) is also equipped with a warning device (44) to display and / or warn about the internal pressure of the balloon (33).

8. The balloon puncture device sheath with gas drag reduction system according to claim 7, characterized in that: The warning device (44) displays and / or warns of the pressure inside the balloon (33) by means of sound, and / or shape, and / or light, and / or color code, and / or numerical value.

9. The balloon puncture device sheath with gas drag reduction system according to claim 8, characterized in that: The warning device (44) is provided with a working pressure indicator (44-1). When the balloon (33) reaches the working pressure, the working pressure indicator (44-1) displays the working pressure status of the balloon (33).

10. The balloon puncture device sheath with gas drag reduction system according to claim 1, characterized in that: The balloon (33) is connected to the balloon (33) and the balloon inflation valve (34) through the first airway (35-1); the gas drag reduction system (4) is set on the first airway (35-1) or connected to the balloon inflation valve (34) through the second airway (35-2). The gas drag reduction system (4), the balloon (33), and the balloon inflation valve (34) are connected through the airway (35) to form a closed gas structure.

11. The balloon puncture device sheath with gas drag reduction system according to claim 1, characterized in that: The balloon inflation valve (34) is a one-way valve (34-1).

12. The balloon puncture device sheath with gas drag reduction system according to claim 1, characterized in that: The balloon puncture sheath (100) also contains a gas interface (7), which can be connected to a carbon dioxide pneumoperitoneum machine to inject carbon dioxide gas into the working channel (6).

13. A puncture device, characterized in that: The puncture device (900) includes the balloon puncture device sheath (100) with gas drag reduction system as described in claim 1 and the puncture rod (200); the puncture rod (200) can be installed on the balloon puncture device sheath (100) with gas drag reduction system, and the puncture rod (200) is inserted into the sleeve (3).

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