Sheath

Abstract

The utility model provides a sheath which comprises a slender sheath tube, a sheath base and a resistance detection piece, and the sheath tube defines a channel from the near end to the far end. The sheath base is suitable for being held by a user for use, and the sheath base is arranged at the near end of the sheath tube; the resistance detection piece is arranged on the outer wall of the sheath tube and used for detecting the resistance of the sheath tube entering the cavity.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the field of medical apparatus and instruments, and particularly relates to a sheath with resistance measuring function. BACKGROUND

[0002] In the operation of medical apparatus and instruments, especially when pushing a sheath tube through a narrow or curved cavity, the resistance inside the cavity is one of the key factors affecting the success of the operation. In current technology, the judgment of resistance mainly depends on the experience and hand feeling of doctors, and lacks accurate detection means. This method may lead to excessive pushing force in some complex situations (such as narrow cavity, large curvature or tissue adhesion), thereby damaging the cavity, and even causing serious complications such as bleeding or perforation. In addition, during the process of the sheath tube entering the cavity, the resistance is not constant, but changes constantly with the state of the cavity (such as the degree of expansion or the reaction of the tissue around the cavity) in the pushing process, which further increases the difficulty of the operation. In order to improve the success rate of sheathing and reduce the risk of operation, it is urgent to develop a technology that can detect the pushing resistance in real time and adjust the pushing strategy in time according to the resistance change. The existing sheathing method generally lacks accurate monitoring of resistance, which makes it difficult to judge when to adjust the pushing force or replace the instrument size during the pushing process, increasing the uncontrollability of the operation and the risk of damage to the cavity. Therefore, accurate resistance detection technology is crucial to ensure smooth and safe sheathing operation. SUMMARY

[0003] The utility model provides a kind of sheath, which comprises:

[0004] An elongated sheath tube defining a channel extending from a proximal end towards a distal end;

[0005] A sheath base adapted for being held by a user, the sheath base being disposed at the proximal end of the sheath tube;

[0006] A resistance detecting member disposed on the outer wall of the sheath tube for detecting the resistance of the sheath tube entering the cavity.

[0007] In some embodiments, the proximal end of the resistance detecting member is provided with a resistance wire bundle adapted to be connected with an external device.

[0008] In some embodiments, the sheath tube defines a pressure measuring channel extending from the proximal end towards the distal end, the distal end of the pressure measuring channel forms at least one pressure measuring port for sensing the pressure inside the cavity, and a pressure detecting member is disposed on the pressure measuring channel or any path connected therewith.

[0009] In some embodiments, the pressure sensor is disposed at the distal end of the pressure measuring channel.

[0010] In some embodiments, the sheath seat is provided with a pressure measuring interface in communication with the pressure measuring channel, and the pressure measuring interface is adapted to be connected with the pressure detecting member.

[0011] In some embodiments, the resistance detecting member comprises a pressure sensor.

[0012] The utility model discloses a resistance detecting member is arranged on the outer wall of the sheath tube, and is connected with external equipment through the resistance wire harness, can real -time detection sheath pipe when entering the resistance change of cavity way. This design effectively improves the sensitivity and accuracy of detection, can real -time feedback cavity way's state to operator, reduces the risk of blind operation, avoids the cavity way damage that can be caused due to the resistance is too big. BRIEF DESCRIPTION OF DRAWINGS

[0013] Fig. 1 The utility model provides the structure schematic diagram of sheathing system;

[0014] Fig. 2 The utility model provides the structure schematic diagram of sheath;

[0015] Fig. 3 The utility model provides the structure cross section drawing of sheath. DETAILED DESCRIPTION

[0016] The utility model or the technical scheme of utility model is further specifically explained below by specific embodiment, and the description of the drawings;

[0017] In the description of the utility model, it is understood that the orientation or position relation of the terms "front", "back", "upper", "lower" and the like is based on the orientation or position relation shown in the drawings, and is only for the convenience of describing the utility model and simplifying the description, and does not indicate or imply that the device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore can not be understood as a limitation on the utility model. In the present application, the proximal end should be interpreted as the part close to the operator (doctor), and the distal end should be understood as the part away from the doctor.

[0018] In the description of the utility model, it should be explained that, unless otherwise specified and limited, the terms "mounting", "connection" should be understood broadly, for example, can be mechanical connection or electrical connection, can be the communication inside two elements, can be directly connected, also can be indirectly connected through intermediate medium, for the ordinary skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0019] Please refer to Figs. 1-3The utility model provides a kind of sheathing system convenient to push, the sheathing system includes sheath and perfusion suction system, the perfusion suction system includes perfusion device, suction device and controller, the sheath includes sheath seat 2, sheath tube 1, perfusion connector 21, suction connector 22 and resistance detection piece 6, the sheath seat 2 is arranged in sheath tube 1 proximal end, the sheath seat 2 has perfusion connector 21 and suction connector 22, the suction connector 22 is suitable for being connected with suction device, the perfusion connector 21 is suitable for being connected with perfusion device, the perfusion device is by perfusion connector 21 and perfusion liquid to body cavity, the suction device is by suction connector 22 and draws out cavity waste liquid and calculus outside body, sheath tube 1 defines passage 110 to be passed through by external instrument, for example, urological mirror 3, the sheath tube 1 is suitable for entering human cavity way.The resistance detection piece 6 is arranged on sheath for detecting the movement resistance of sheath tube entering human cavity way and feedback resistance value.Specifically, resistance detection piece 6 is installed on sheath tube 1, for monitoring the contact force between sheath tube 1 and cavity wall in pushing process, the detection of resistance can be realized by multiple ways, such as using strain gauge, pressure sensor or micro force sensor, to perceive the external resistance change in the moving process of pushing sheath tube into cavity, can real-time feedback the state of cavity to operator, reduces the risk of blind operation, avoids the cavity damage possibly caused by excessive resistance.If resistance is too large, doctor can replace small size sheath or dilate cavity by perfusion liquid in cavity to facilitate smooth sheathing, if the above method is still difficult to perform, then it needs to consider that there is cavity blockage, and it is not suitable to continue to force sheathing.

[0020] In some embodiments of the utility model, the sheathing system further includes pressure detection piece 5, which is used to detect the pressure in the human cavity, and the pressure detection piece 5 can be arranged on the endoscope or the sheath to detect the pressure in the human cavity in real time; the perfusion device is connected with the perfusion connector 21 to send the perfusion liquid into the human cavity through the channel of the sheath tube 1; the controller is communicatively connected with the pressure detection piece, the resistance detection piece, and the perfusion device. Further, the sheath tube 1 defines a pressure measurement channel 111 extending from the proximal end to the distal end, the distal end of the pressure measurement channel 111 forms at least one pressure measurement port for sensing the pressure in the cavity, and the pressure detection piece is arranged on the pressure measurement channel or any path connected thereto. For example, the pressure sensor is arranged at the distal end of the pressure measurement channel. The sheath seat is provided with a pressure measurement interface 112 connected with the pressure measurement channel, and the pressure measurement interface is suitable for being connected with the pressure detection piece 5.

[0021] In an embodiment of the utility model, the perfusion device includes liquid inlet pipe 10, liquid storage bag 11 and perfusion pump, the perfusion pump is connected with liquid storage bag 11 through liquid inlet pipe 10, the perfusion pump is connected with the perfusion connector 21 on the sheath seat through liquid outlet pipe 12 and communicates, the suction device is connected with sheath tube 1, the suction device includes diaphragm pump, first negative pressure suction pipe 91, suction container 93 and second negative pressure suction pipe 92, one end of first negative pressure suction pipe 91 is connected with diaphragm pump, and the other end is connected with suction container 93, one end of second negative pressure suction 92 is connected with suction container 93, and the other end is connected with the suction connector 22 of sheath, so, when long time laser operation, the operation time is long, then the liquid that perfusion device fills in the body reduces the temperature in the cavity, however, too much cavity liquid can cause the excessive pressure in the cavity, and the doctor can suck the liquid in the cavity out of the body to reduce the pressure in the cavity through the suction device, in the embodiment, the perfusion pump, the diaphragm pump and the controller are integrated on the same host computer 100, and pressure detection element 5 and resistance detection element 6 are connected with host computer 100 through cavity pressure wire harness 51 and resistance wire harness 61 respectively, so, the structure of the whole perfusion suction system is greatly simplified, and perfusion, suction, pressure and resistance detection and control can be realized through a host computer, and the doctor can realize the flow size of perfusion and suction through the host computer, in some preferred embodiments, the flow range of perfusion and suction can be controlled in real time through the cavity pressure fed back by pressure detection element, for example, when the perfusion pressure detected by pressure detection element is too large, then the suction pressure is increased to reduce the pressure in the cavity.

[0022] Resistance detection element 6 facilitates the doctor to understand the pushing resistance of sheath tube during the process of pushing the sheath tube into the cavity.

[0023] Step 1): preset the highest warning resistance value, the lowest warning resistance value, the highest warning pressure value, the resistance detection element is used for detecting the resistance of sheath into the cavity, and the pressure detection element is used for detecting the pressure in the cavity in real time;

[0024] Step 2): during the process of pushing the sheath tube into the human cavity, when the resistance detection element detects that the pushing resistance reaches the highest warning resistance value, the perfusion device starts the perfusion mode to send the perfusion liquid into the cavity to expand the cavity, there are two situations here, the first situation: if the sheath resistance is reduced after expanding the cavity, then the sheath tube is continuously pushed, and the situation indicates that the large sheath resistance here is caused by the narrow cavity. The second situation, if the cavity pressure reaches the highest warning pressure value after expanding the cavity by the perfusion liquid, and the sheath resistance still exceeds the highest warning resistance value, then it proves that the volume of the perfusion expanded cavity is limited, and the sheath tube is still difficult to move, at this time, the small specification sheath is considered to be replaced;

[0025] Step 3) push the small size sheath into the cavity, repeat the sheath pushing method of step 2), if the sheath pushing resistance of the small size sheath still exceeds the maximum warning resistance value, it is proved that the sheath pushing resistance of the small size sheath is also too large, at this time, it is considered that there is a cavity blockage, and the sheath cannot be forced to push, and can be verified by a visible device such as an endoscope. In this way, the resistance detection piece is arranged on the sheath tube, when the resistance detection piece on the sheath tube detects that the resistance of the sheath tube moving into the cavity exceeds the maximum warning resistance value, the perfusion device is automatically started, the perfusion liquid is injected into the cavity to expand the cavity, and then the pushing resistance of the sheath tube is reduced, this method effectively avoids the cavity damage caused by too large resistance during sheath insertion, and improves the safety of operation. It is worth noting that when the method of expanding the cavity by the perfusion device cannot effectively reduce the resistance, or when the cavity pressure reaches the maximum warning value due to too much perfusion liquid, the sheath insertion system will prompt to replace the small size sheath for further operation, and the flexible multi-size sheath switching mechanism helps to continue the operation under complex cavity conditions, and avoids the interruption of operation caused by too large resistance. Further, after replacing the small size sheath, if the resistance still exceeds the warning value, the system can automatically determine that the cavity is blocked, avoid further damage caused by continuing operation under the blocked condition, provide an effective judgment basis for the doctor, and improve the accuracy of diagnosis.

[0026] In some preferred embodiments of the utility model, the controller is in communication connection with the pressure detection piece, the resistance detection piece, the perfusion device and the suction device, the perfusion device and the suction device cooperate to keep the cavity at a suitable pressure, and the main control machine is configured to execute a sheath insertion method, the sheath insertion method comprising the following steps:

[0027] Step 1): preset the maximum warning resistance value, the maximum warning pressure value, the minimum warning pressure value, the pressure control value and the perfusion flow rate, the controller controls the perfusion device to send the perfusion liquid into the body cavity, and can control the suction device to suck the liquid in the body cavity out of the body: the "pressure control value" here refers to the ideal pressure value or pressure interval in the cavity, and the "warning pressure value" here refers to the state that the pressure difference between the cavity and the pressure control value exceeds the value;

[0028] Step 2): during the sheath insertion process, when the resistance detection piece detects that the resistance reaches the maximum warning resistance value, the perfusion device opens the perfusion mode to expand the cavity, when the pressure in the cavity reaches the maximum warning pressure value, the perfusion device stops perfusion, continues to push the sheath, if the sheath insertion resistance decreases, continue to insert the sheath, when the sheath reaches the target position, the suction device opens the suction mode to reduce the pressure in the cavity;

[0029] If the sheath insertion resistance does not decrease after the perfusion device perfuses the liquid, the pressure in the cavity is regulated to the pressure control value by the cooperation of the perfusion device and the suction device, at this time, the sheath cannot continue to be inserted, and the small size sheath needs to be replaced;

[0030] Step 3) After replacing the small size sheath, re-sheathing, if the sheathing is smooth, it is considered to be a local stenosis of the cavity; after replacing the small size sheath, re-sheathing, when the resistance detection piece detects that the resistance reaches the highest warning resistance value, the sheath pushing method of step 2) is repeated, specifically, the perfusion device opens the perfusion mode to expand the cavity, when the pressure in the cavity reaches the highest warning pressure value, the perfusion device stops perfusion, and continues to push the sheath tube, if the sheathing resistance decreases, continue to sheath, when the sheath tube reaches the target position, the suction device opens the suction mode to reduce the pressure in the cavity; if the sheathing resistance does not decrease after the perfusion device perfuses the liquid, it still exceeds the highest warning resistance value, the pressure in the cavity is controlled at the pressure control value through the cooperation of the perfusion device and the suction device, at this time the system determines that the cavity is blocked.

[0031] The present embodiment can adjust the pressure in the cavity in real time during the sheathing process through the cooperation of the suction device and the perfusion device, and ensure that the cavity is in a suitable pressure range. The controller can automatically start or stop suction and perfusion according to the pressure value in the cavity fed back by the pressure detection piece, achieve a balanced state of perfusion and suction, effectively avoid overexpansion or collapse of the cavity, and thus maintain the stability of the cavity and ensure smooth operation. When replacing the small size sheath, if the sheathing resistance still exceeds the warning value, the system can automatically determine that the cavity is blocked, avoiding the doctor continuing to push and causing damage to the cavity. Through this intelligent judgment, the system provides a clear decision basis for the operation, avoiding complications caused by blind operation.

[0032] In the present embodiment, the sheathing resistance is reduced by perfusion expansion of the sheathing cavity, however, perfusion will change the pressure, based on this, the sheathing method provided by the present embodiment further includes a pressure control method in the cavity, which comprises: adjusting the perfusion and suction parameters according to the real-time monitored pressure value and the data change trend of the pressure value, so that the current cavity pressure is balanced at the pressure control value, and a balanced state of perfusion and suction is achieved, the perfusion parameter includes the perfusion flow rate, and the suction parameter includes the opening of the pressure relief valve and the suction pressure threshold value, the suction pressure threshold value is the suction pressure threshold value of the suction container preset by the controller, and the start and stop of the suction pump is controlled by setting the suction pressure threshold value. The pressure control method can select the pressure control method disclosed in CN116983498B. Through the optimization control of the pressure, the expansion of the cavity is ensured without causing damage to the cavity.

[0033] In one embodiment of the utility model, the sheathing system is configured with multiple sheathing modes, different sheathing modes have different maximum warning resistance values, the sheathing modes at least include high resistance sheathing mode and low resistance sheathing mode, the maximum warning resistance value of high resistance sheathing mode is greater than the maximum warning resistance value of low resistance sheathing mode. Doctors select appropriate sheathing modes according to the diameters, curvatures and elastic tenacities of sheathing paths, thus, the system can accurately control the pushing force of the sheath, ensure the implementation of appropriate pushing force range (such as 0.5-5N) under different cavity conditions, avoid the use of excessive pushing force to cause ureter injury, tear or perforation, and accurately control the adjustment of force, which greatly reduces the operation risk, and is particularly suitable for the thin cavity structure of ureter which is easy to be damaged. Multiple sheathing modes can be selected, such as high resistance sheathing mode, medium resistance sheathing mode and low resistance sheathing mode, different sheathing modes correspond to different maximum warning resistance values, namely different pushing forces.

[0034] The relationship between the pushing force and the sheathing cavity is explained in detail below.

[0035] If the sheathing cavity is a ureter with good elasticity and strong toughness, a high-resistance sheathing mode is selected; if the sheathing cavity is a ureter with poor elasticity, a low-resistance sheathing mode is selected. If there is a large bend in the sheathing cavity, a low-resistance sheathing mode is selected; if the sheathing cavity has a small bend, a high-resistance sheathing mode is selected. If the sheathing cavity is large in diameter, a high-resistance sheathing mode is selected, and if the sheathing cavity is narrow, a low-resistance sheathing mode is selected. In some examples, the sheathing cavity is a ureter, and the sheathing system has preset high-resistance and low-resistance sheathing modes according to the diameter, curvature, and elasticity of the ureter, to ensure that the pushing force meets the needs of different cavity conditions. For example, a large-diameter or straight ureter can use a high-resistance sheathing mode, while a small-diameter or highly curved ureter can use a low-resistance sheathing mode. The doctor can flexibly select the appropriate sheathing mode according to the individual anatomical structure, i.e., select the appropriate pushing force, to reduce the risk of cavity damage and ensure the safety of the operation. Specifically, the ureter anatomical structure shows that the ureter diameter is about 3-4 mm in a normal adult, but there are individual differences. If the ureter is thin, a smaller pushing force is needed when pushing the ureteroscope to prevent ureteral injury, and the pushing force is controlled in the range of 0.5-2 N; if the ureter is relatively thick, it can withstand a slightly larger pushing force, but generally not more than 5 N. The ureter curvature: the normal ureter has physiological curvature, such as at the sacroiliac joint and across the iliac blood vessels. If the curvature angle is large, a smaller and more gentle pushing force is needed when pushing the sheath tube to avoid damage, and the pushing force is controlled in the range of 0.5-1.5 N; while the relatively straight part of the ureter can appropriately increase the pushing force, and the pushing force is controlled to be not more than 3 N. The elasticity and toughness of the ureter: the elasticity and toughness of the ureter vary from individual to individual. The ureter with good elasticity and strong toughness can withstand a relatively large pushing force, and the pushing force is controlled in the range of 2-5 N; while for the ureter with poor elasticity, the pushing force is controlled in the range of 1-3 N, and too large a pushing force can easily cause the ureter to tear or perforate.

[0036] Exemplarily, the utility model provides a kind of method of pushing sheath into urinary tract, in the process of pushing sheath into urinary tract, the resistance that sheath is pushed will change along with the size of urinary tract, narrow, urinary tract extrusion pressure sensor on sheath in pushing process, the data of pressure sensor will be fed back to pressure monitoring instrument, the resistance of pushing sheath is judged by analyzing pressure size, when pushing resistance is too large, system will issue instruction, perfusion device starts to fill and fill urinary tract, urinary tract reaches certain pressure, and occluded urinary tract is expanded, then perfusion suction system continues to perfuse while, doctor pushes sheath into expanded urinary tract, when the pressure in urinary tract is too large, suction device starts to suck liquid in urinary tract out of body, system circulates according to the pressure detection value of perfusion suction system to control the pressure of urinary tract in pressure control value range, to sheath smoothly reaches urinary tract target position.The system working mode can reduce the damage to urinary tract of patient in the process of sending sheath.

[0037] The various embodiments of the utility model improve the safety, flexibility and accuracy of the sheathing operation by intelligent control system, real-time monitoring, automatic feedback regulation and other technologies, and ensure the protection of the cavity and the success rate of the operation.

[0038] In the description of the present specification, the description of the terms "one embodiment", "some embodiments", "specific example" or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the utility model. In the present specification, the illustrative description of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0039] Although the embodiments of the utility model have been shown and described, those skilled in the art can understand that various changes, modifications, replacements and variations can be made to these embodiments without departing from the principles and purposes of the utility model, and the scope of the utility model is defined by the claims and their equivalents.

Claims

1. A sheath characterized by, The application relates to a sheath for inserting into a cavity, comprising: an elongated sheath tube defining a channel extending from a proximal end to a distal end; a sheath holder adapted to be held by a user, the sheath holder being arranged at the proximal end of the sheath tube; a resistance detecting member arranged on the outer wall of the sheath tube for detecting the resistance of the sheath tube when inserted into the cavity.

2. The sheath of claim 1, wherein, The proximal end of the resistance detecting member is provided with a resistance wire bundle adapted to be connected to an external device.

3. The sheath of claim 1, wherein, The sheath tube defines a pressure measuring channel extending from the proximal end to the distal end, the distal end of the pressure measuring channel forms at least one pressure measuring port for sensing the pressure in the cavity, and a pressure detecting member is arranged on the pressure measuring channel or any path connected thereto.

4. The sheath of claim 3, wherein, The pressure detecting member is arranged at the distal end of the pressure measuring channel.

5. The sheath of claim 1, wherein, The sheath holder is provided with a pressure measuring interface connected to the pressure measuring channel, and the pressure measuring interface is adapted to be connected to the pressure detecting member.

6. The sheath of claim 1, wherein, The resistance detecting member comprises a pressure sensor.

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