Sheath tube device
By designing sheathing device in the blood pumping device, including sheathing tube, perfusion tube, drain tube and support unit, the problem of insufficient discharge and temperature detection of infusion waste liquid is solved, the safety and service life are improved, and the sheathing tube is ensured is ensured. Restore straightness after bending, and monitor the temperature and position in real time to protect the fiber optic unit.
Patent Information
- Application Number
- CN202310761331.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-06-27
- Publication Date
- 2024-12-27
AI Technical Summary
The existing blood pumping device lacks a drainage pipeline, which causes the infusion of waste liquid to enter the human body directly, and lacks a temperature detection solution, resulting in poor safety, insufficient anti-bending and torsional properties of the sheath tube, which is easy to twist during implantation or intervention. Deformation or discounting affects the infusion of the infusion solution and the transmission of optical fiber signal.
A sheath device is designed, including a sheath tube, a perfusion tube and a support unit, with a drain tube and a temperature measuring unit, and the support unit is located outside or inside the perfusion tube and a discharge tube to provide mechanical strength and flexibility. Avoid excessive bending and torsion, fiber optic units and temperature measuring units extend within the sheath to ensure real-time monitoring and positioning.
Effectively avoid damage to the human body by infusing waste liquid, improve the safety and service life of the device, ensure that the sheath is restored to straightness after bent, enhance the bending resistance, monitor the temperature and position in real time, and protect the optical fiber unit from being affected. Overbending damage.
Smart Images

Figure CN119185760A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to a sheath device. Background Art
[0002] In the related art, some blood pumping devices have no drainage pipeline, which causes glucose and other perfusion waste liquids to directly enter the human body, causing physical discomfort to the patient. Such products also lack corresponding temperature detection solutions, and cannot monitor in real time the abnormal temperature rise caused by friction of components such as bearings in the body, resulting in poor safety. In addition, the sheath of related products has poor anti-bending and / or anti-torsion performance. When the sheath passes through the bend of the aorta or the vein through the right heart, it often causes excessive twisting, or it is easy to twist or bend during the process of pushing the intervention from the wound, which in turn affects the infusion of the perfusion fluid, increases the operating load of the pump, and greatly reduces the service life of the matching perfusion pump; it even affects the signal transmission of the optical fiber. Summary of the invention
[0003] In order to overcome at least one of the problems in the related art, a first aspect of the present invention provides a sheath device.
[0004] Wherein, the sheath device comprises a sheath, an irrigation tube and a support unit; The sheath tube comprises a first hollow portion extending along the axial direction of the sheath tube; The perfusion tube and the support unit are both disposed in the first hollow portion and extend along the axial direction of the sheath tube respectively; The sheath comprises an inner layer, a braided layer and an outer layer, wherein the inner layer, the braided layer and the outer layer are sequentially sleeved; the braided layer is made of metal wire, and / or the inner layer and the outer layer are made of polymer material.
[0005] In an optional embodiment, the sheath device further includes a drainage tube; The support unit is located outside the perfusion tube and the drainage tube; or, the support unit is a plurality of groups, and is located inside the perfusion tube and the drainage tube respectively; or, the support unit is a plurality of groups, and part of it is located inside the perfusion tube and the drainage tube, and the rest is located outside the perfusion tube and the drainage tube; or, the support unit is a plurality of groups, and part of it is located inside one of the perfusion tube and the drainage tube, and the rest is located outside the perfusion tube and the drainage tube.
[0006] In an optional embodiment, the sheath tube further includes at least one of a temperature measuring unit, an optical fiber unit or a cable unit, wherein the temperature measuring unit, the optical fiber unit or the cable unit is disposed in the first hollow portion and extends along the axial direction respectively.
[0007] In an optional embodiment, the side wall of the distal end of the sheath tube is provided with a through hole, the extension direction of the through hole is perpendicular to the axis of the sheath tube, and the distal end of the optical fiber unit passes through the through hole and then adheres to the outer wall of the sheath tube and extends along the axial direction; and / or, the cable unit includes a cable, a shielding layer sleeved on the outside of the cable, and a cable protective layer sleeved outside the shielding layer.
[0008] In an optional embodiment, at least one of the irrigation tube, the drainage tube, the support unit, the temperature measurement unit, the optical fiber unit and the cable unit extends freely in the first hollow portion of the sheath tube.
[0009] In an optional embodiment, the support unit is a metal wire.
[0010] In an optional embodiment, the sheath tube further comprises a middle layer, wherein the inner layer, the braided layer, the middle layer and the outer layer are sequentially sleeved; The inner layer, the middle layer and the outer layer are made of polymer materials, and the hardness of the outer layer is lower than that of the inner layer and the middle layer.
[0011] In an optional embodiment, the sheath device further includes an optical fiber unit; The sheath tube is provided with a second hollow portion extending along the axial direction of the sheath tube; The optical fiber unit is arranged in the second hollow portion and extends along the axial direction of the sheath tube.
[0012] In an optional embodiment, the side wall of the distal end of the sheath tube is provided with a through hole, the extension direction of the through hole is perpendicular to the axis of the sheath tube, the through hole is connected to the second hollow portion, and the distal end of the optical fiber unit passes through the through hole and adheres to the outer wall of the sheath tube and extends along the axial direction.
[0013] A second aspect provides a fluid pumping device, which is used in conjunction with any sheath device described in the first aspect.
[0014] The technical solution of the present invention has the following advantages or beneficial effects: (1) The sheath device disclosed in the present invention integrates an infusion tube and a drainage tube; the distal end of the drainage tube is connected to the waste liquid discharge channel in the fluid pumping device, and a portion of the infusion liquid entering the fluid pumping device through the infusion tube is diverted to the waste liquid discharge channel of the fluid pumping device, and is used to flush the friction pairs such as bearings, thereby discharging particles generated by wear and heat generated by friction from the fluid pumping device, and after entering the drainage tube, it is discharged from the proximal end of the sheath device. This avoids damage to the human body caused by abnormally high temperature and wear particles, and improves the safety of the fluid pumping device. The sheath device is also provided with a support unit, the mechanical strength of the support unit ensures that the sheath can be restored to a straight state after the bending deformation force is removed, and the flexibility ensures that the sheath device can adapt to the curved path of the implantation or intervention process and deform, and smoothly reach the target position. That is, the support unit effectively improves the bending resistance of the sheath device, avoiding the problem that the various components in the sheath cannot work due to excessive bending. It is more advantageous to arrange the support unit in the inner cavity of the perfusion tube and the drainage tube respectively, so as to effectively support the perfusion tube and the drainage tube respectively, and prevent the perfusion tube and the drainage tube from being folded when the sheath tube is bent and deformed, thereby blocking the flow of liquid and causing the product to fail. The support unit of this arrangement directly acts on the perfusion tube and the drainage tube, and its supporting function is more direct, which can effectively play the supporting role of the support unit on the perfusion tube and the drainage tube.
[0015] (2) The sheath device is also integrated with an optical fiber measurement unit and a temperature measurement unit, thereby realizing real-time monitoring of the position of the fluid pumping device and monitoring of abnormally high temperatures inside the sheath device or the fluid pumping device.
[0016] (3) At least one of the irrigation tube, drainage tube, support unit, temperature measurement unit, optical fiber unit and cable unit extends unconstrained in the first hollow portion of the sheath tube, ensuring that at least one of the above elements has sufficient freedom in the sheath tube. When the irrigation tube or drainage tube jumps or moves, the above unconstrained element in the sheath tube can move with the collision of the irrigation tube or drainage tube, thereby avoiding damage to the fixed end due to alternating loads when both ends of the above elements are fixed in the sheath tube.
[0017] (4) The sheath includes an inner layer, a braided layer and an outer layer, wherein the inner layer, the braided layer and the outer layer are sequentially arranged; the braided layer is made of metal wire, and / or the inner layer and the outer layer are made of polymer materials; thereby effectively improving the mechanical strength of the sheath device. Compared with a single-layer sheath structure, a multi-layer sheath containing a braided layer improves the overall axial torsional force resistance of the sheath unit and avoids excessive kinking of the sheath. When an outer layer with low hardness is further provided, the outer layer of the sheath can provide resilience, making it easier for the sheath to return to its original state after bending, thereby further improving the overall bending resistance and radial support force of the sheath device.
[0018] (5) A second hollow portion extending along the axial direction of the sheath is provided in the sheath; the optical fiber unit is provided in the second hollow portion; this arrangement not only enables the optical fiber unit to have an independent assembly space, but also provides sufficient support for the optical fiber and limits the displacement of the optical fiber unit. The wall surface of the second hollow portion can block the load applied to the optical fiber unit when components such as the perfusion tube or the drainage tube are vibrating, thereby preventing the optical fiber unit from bending, deforming, or even breaking, and effectively ensuring the safety of the optical fiber unit. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation of the present invention. Figure 1 is a cross-sectional schematic diagram of a sheath device according to a first embodiment of the present invention; Figure 2 is a schematic diagram of an assembled state of a sheath tube device according to an embodiment of the present invention; Figure 3 is a schematic cross-sectional view of a sheath device according to a second embodiment of the present invention; Figure 4 is a cross-sectional schematic diagram of a sheath device according to a third embodiment of the present invention; Figure 5 is a cross-sectional schematic diagram of a sheath device according to a fourth embodiment of the present invention; Figure 6 FIG. 5 is a schematic cross-sectional view of a sheath device according to a fifth embodiment of the present invention. DETAILED DESCRIPTION
[0020] The following is a description of exemplary embodiments of the present invention in conjunction with the accompanying drawings, including various details of the embodiments of the present invention to facilitate understanding, which should be considered as merely exemplary. Therefore, it should be recognized by those of ordinary skill in the art that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present invention. Similarly, for clarity and conciseness, the description of well-known functions and structures is omitted in the following description.
[0021] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The singular forms of "a", "said" and "the" used in this application and the appended claims are also intended to include plural forms unless the context clearly indicates other meanings. It should also be understood that the term "and / or" used herein refers to and includes any or all possible combinations of one or more associated listed items.
[0022] It should be understood that although the terms first, second, third, etc. may be used in the present application to describe various information, these information should not be limited to these terms. These terms are only used to distinguish the same type of information from each other. For example, without departing from the scope of the present application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Depending on the context, the word "if" as used herein may be interpreted as "at the time of" or "when" or "in response to determining".
[0023] In the prior art, a blood pumping device is a commonly used medical device that works in the patient's body to assist the blood flow of the corresponding organs. For some blood pumping devices, when it pumps blood from the distal end to the proximal end, the blood will enter the blood pumping device from the distal end to the proximal end accordingly. Therefore, the blood pumping device needs to be injected with perfusion fluid from the proximal end and the distal end, and at least part of the perfusion fluid is discharged into the blood. However, for some blood pumping devices, the perfusion waste such as glucose injected into the blood pumping device is all discharged into the human body after passing through the components in the blood pumping device, causing physical discomfort to the patient. In particular, the perfusion waste containing wear particles entering the human body will cause serious risks such as thrombosis. In addition, during the operation of the blood pumping device, when the rotating shaft rotates at a high speed, the friction pairs of the bearings and the like will generate a lot of heat, and local high temperature phenomena will occur. In practice, such products lack corresponding temperature detection solutions, and cannot monitor the abnormal temperature rise caused by friction of components such as bearings in the body in real time, and there is a problem of poor safety. More importantly, the sheath of the relevant products has poor anti-bending and / or anti-torsion performance. When the sheath passes through the aorta bend or the vein passes through the right heart, it often twists excessively, or is easily twisted or folded during the insertion process from the wound. The excessively bent or folded perfusion pipeline affects the infusion of the perfusion fluid, increases the operating load of the pump, and greatly reduces the service life of the matching perfusion pump. In particular, when the sheath is bent, in severe cases, it will block the flow of perfusion fluid and the signal transmission of the optical fiber, and even cause the problem of optical fiber breaking, making it impossible for the operator to understand the specific location of the blood pumping device in the human body in real time.
[0024] In order to solve at least one of the above problems, the first aspect of the present invention provides a sheath device, wherein the sheath device comprises a sheath, an irrigation tube, a drainage tube and a support unit; the sheath comprises a first hollow portion extending along the axial direction of the sheath; the irrigation tube, the drainage tube and the support unit are all arranged in the first hollow portion and extend along the axial direction of the sheath, respectively.
[0025] The sheath device provided in one embodiment of the present disclosure is used in connection with a fluid pumping device, which at least solves the problem that the waste perfusion liquid cannot be discharged and the perfusion pipeline cannot normally transport the perfusion liquid due to excessive bending of the sheath. Figure 1 and 2As shown, the distal end of the sheath device of the present disclosure is provided with a fluid pumping device, and the fluid pumping device works in the target environment and is used to transport the fluid in the target environment from the distal end to the proximal end. For example, taking the human body as the target environment, the fluid pumping device pumps blood from the distal end to the proximal end. Exemplarily, the fluid pumping device includes a transmission bearing 101 and a transmission shaft 102, and an impeller unit (not shown in the figure) is provided at the distal end of the transmission shaft. The transmission bearing is used to support the transmission shaft, and drives the impeller unit to rotate at high speed along with the transmission shaft under the drive of the driving load. As shown in FIG. Figure 2 As shown, a rotation drive module 107 is provided at the proximal end of the sheath device, and the rotation drive module transmits the driving load to the fluid pumping device through a wire to drive the impeller unit to rotate. In practice, friction pairs such as transmission bearings will produce wear particles during high-speed rotation. If the particles are directly discharged into the human body, medical risks such as thrombosis will occur. Furthermore, a large amount of heat will be generated when the friction pair rotates at high speed, which will cause local high temperature in the fluid pumping device and solute precipitation problems in the perfusion fluid, such as precipitation of glucose or sodium chloride. In addition, local high temperature will also affect the properties of the fluid in the target environment and even affect the normal operation of the fluid in the target environment.
[0026] In order to solve the above problems, Figure 1 and 2 In the illustrated embodiment, an irrigation tube 105 and a drainage tube 108 are integrated inside the sheath device. Preferably, the inner diameter of the irrigation tube is larger than the inner diameter of the drainage tube. It is understandable that only a portion of the irrigation liquid is discharged as waste liquid, so its discharged flow rate is significantly smaller than the flow rate in the irrigation tube. Therefore, in order to reduce the overall radial dimension of the sheath unit, the diameters of the irrigation tube and the drainage tube can be differentiated so that the inner diameter of the drainage tube is smaller than the inner diameter of the irrigation tube. This distinction in inner diameter is also beneficial to the operator, allowing them to simply distinguish the two pipelines by observing the diameters, eliminating the problem of incorrectly connecting the two pipelines. The distal end of the drainage tube is connected to the waste liquid discharge channel in the fluid pumping device, and the distal end of the perfusion tube is connected to the perfusion channel of the fluid pumping device. The perfusion liquid entering the fluid pumping device through the perfusion tube will be split, one part will be discharged into the target environment through the perfusion channel of the fluid pumping device, and the other part will enter the waste liquid discharge channel, enter and be used to flush the friction pairs such as bearings, and then discharge the particles generated by wear and the heat generated by friction from the fluid pumping device, and enter the drainage tube 108, and then be discharged from the proximal end of the sheath device. Figure 1 As shown in the cross-sectional view in FIG. 1 , the sheath tube 104 is provided with a first hollow portion (i.e. Figure 1The hollow portion inside the sheath tube); the perfusion tube 105 and the drainage tube 108 are both arranged in the first hollow portion, and extend along the axial direction of the sheath tube respectively. In a preferred embodiment, a support unit 206 is also provided in the sheath tube device, and the support unit is also in the first hollow portion and extends along the axial direction. Exemplarily, the support unit can be a skeleton lining wire. The axial length of the support unit is the same as the axial length of the sheath tube, and it has sufficient mechanical strength and flexibility. The mechanical strength ensures that the sheath tube can return to a straight state after the bending deformation force is removed, and the flexibility ensures that the sheath tube device can adapt to the curved path of the implantation process and deform, and smoothly reach the target position.
[0027] In an optional embodiment, the support unit is a metal wire. In order to enable the support unit to take into account both mechanical strength and flexibility, a metal wire is selected as the support unit in an embodiment of the present disclosure. Exemplarily, the support unit may be a metal wire made of stainless steel or nickel-titanium alloy. Preferably, a memory alloy is selected. More preferably, a nickel-titanium alloy is selected, which is easy to rebound to the initial state when the sheath is bent, and has excellent mechanical properties to avoid excessive bending of the sheath.
[0028] In an optional embodiment, the support unit is located outside the perfusion tube and the drainage tube; or, the support unit is a plurality of groups, and they are located inside the perfusion tube and the drainage tube respectively; or, the support unit is a plurality of groups, and some of them are located inside the perfusion tube and the drainage tube, and the rest are located outside the perfusion tube and the drainage tube; or, the support unit is a plurality of groups, and some of them are located inside one of the perfusion tube and the drainage tube, and the rest are located outside the perfusion tube and the drainage tube. In the present disclosure, the main purpose of providing the support unit 206 is to prevent the sheath from excessively bending and affecting the flow performance of the perfusion tube and the drainage tube. To this end, the support unit can be provided outside the perfusion tube and the drainage tube, and of course, it can also be provided outside the perfusion tube and the drainage tube; even multiple groups of support units can be provided according to the needs of use to obtain the required mechanical strength and flexibility, etc. Figure 1 In the example shown, when the usage scenario does not require high bending of the perfusion tube and the drainage tube, a support unit can be provided inside the sheath tube and outside the drainage tube and the perfusion tube. Figure 3 In the embodiment shown, the support unit is arranged in the inner cavity of the irrigation tube and the drainage tube respectively. The purpose of this arrangement is to effectively support the irrigation tube and the drainage tube respectively, and to prevent the irrigation tube and the drainage tube from being folded when the sheath tube is bent and deformed, thereby blocking the flow of liquid and causing product failure. Figure 1 The embodiment shown, Figure 3The supporting unit in the UPS directly acts on the perfusion tube and the drainage tube, and its supporting function is more direct, which can effectively play the supporting role of the supporting unit on the perfusion tube and the drainage tube. Figure 1 , Figure 3 The diameter of each support unit in can be set to be less than Figure 1 The single support unit shown. Specifically, Figure 3 The diameter of the support unit can be 0.3mm-0.5mm, and Figure 1 The diameter of the support unit in the embodiment can be 0.5mm-0.8mm. Figure 3 The diameter of the support unit is small, so without changing the inner diameter of the perfusion tube and the drainage tube, the perfusion tube and the drainage tube can still maintain good flowability to meet the perfusion and drainage requirements during use. Figure 1 and Figure 2 In addition to the embodiment shown, the user can also set the support unit only in one of the infusion tube or the drainage tube. It is understandable that the diameter of the support unit in this arrangement is relatively large. Figure 1 The result is that the support effect of the support unit will be weaker than Figure 1 In some other embodiments, it is also possible to Figure 1 On the basis of the above, a supporting unit is further provided in one of the irrigation tube or the drainage tube, thereby improving the supporting effect of the sheath device as a whole.
[0029] In an optional embodiment, the sheath tube further includes at least one of a temperature measuring unit 201, an optical fiber unit 202 or a cable unit, wherein the temperature measuring unit, the optical fiber unit or the cable unit is arranged in the first hollow part and extends along the axis direction respectively. In practice, how to monitor the position of the fluid pumping device in the implantation or intervention process in real time, and how to monitor the temperature change at the fluid pumping device in real time, are very important to the user. To this end, the present disclosure adopts a temperature measuring unit and an optical fiber unit to solve the above problems. Exemplarily, the temperature measuring unit can be a thermocouple, and the optical fiber unit is composed of an optical fiber sensor 109 and an optical fiber. The thermocouple and the optical fiber are both arranged in the first hollow part of the sheath tube and extend to the distal end of the sheath tube along the axis of the sheath tube. Among them, the thermocouple can be buried in the shell of the fluid pumping device or attached to the surface of the shell after extending from the distal end of the sheath tube. Since the shell of the fluid pumping device has good thermal conductivity, when the thermocouple is buried or attached to the surface of the shell, the local high temperature caused by the friction pair such as the bearing can be monitored. Correspondingly, the proximal end of the sheath is also provided with a receiving module connected to the thermocouple to collect the measurement data of the thermocouple. Exemplarily, the distal end of the thermocouple is provided with a sensor, which is installed inside or on the surface of the shell to measure the temperature, monitor the temperature change, and prevent the temperature from being too high and affecting human health. Figure 1 and 2 In the illustrated embodiment, the sheath is provided with a through hole 103 at the distal end adjacent to the fluid pumping device, the through hole penetrates the side wall of the sheath, and the extension direction is perpendicular to the axis of the sheath. The optical fiber sensor can pass through the through hole 103 after passing through the sheath, so as to monitor the signal of the external environment. Since the through hole 103 is arranged adjacent to the fluid pumping device, the change of the measurement signal of the optical fiber sensor passing through the through hole 103 can reflect the position of the fluid pumping device. Exemplarily, the optical fiber sensor measures the pressure of the target environment, and judges whether the position is correct or whether the target position is reached according to the pressure size or the pressure difference. In addition, in order to facilitate the user to observe the position of the fluid pumping device, the proximal end of the sheath is also provided with an optical fiber transmission module 106, the optical fiber transmission module is connected to the optical fiber sensor to receive and process the signal transmitted by it in real time, and the user can confirm whether the fluid pumping device has reached the target position through the processed signal. In other embodiments, a motor unit is provided inside the fluid pumping device, and correspondingly, a cable unit is integrated in the sheath unit, and the cable unit is connected to the wiring terminal of the motor to provide driving power for it.
[0030] In an optional embodiment, the distal end of the sheath is provided with a through hole 103, and the distal end of the optical fiber unit passes through the through hole and sticks to the outer wall of the sheath and extends along the axial direction; and / or, the cable unit includes a cable 205, a shielding layer 204 sleeved on the outside of the cable, and a cable protective layer 203 sleeved outside the shielding layer. Figure 2 In the embodiment shown, in order to further improve the measurement accuracy of the position of the fluid pumping device, in this embodiment, the optical fiber unit is arranged along the outer surface of the sheath tube after passing through the through hole 103, and extends along the axial direction of the sheath tube to be close to the fluid pumping device, so as to reflect the position of the fluid pumping device as intuitively as possible. The cable is a three-core cable, which is used to power the motor of the fluid pumping device, and the shielding layer can prevent electromagnetic waves or magnetic fields from interfering with the human body.
[0031] Exemplarily, in some embodiments described in the present disclosure, the size of each component of the sheath device is also an important design factor to be considered. The present disclosure obtains the preferred size of each component of the sheath device through experiments, for example, the outer diameter of the sheath is between 9Fr-12Fr, and the wall thickness of the sheath is between 0.3mm-0.7mm. The outer diameter of the perfusion tube is between 0.9mm-1.3mm, and the inner diameter is between 0.6-1.0mm; the outer diameter of the drainage tube is between 0.6mm-0.9mm, and the inner diameter is between 0.5-0.8mm; the outer diameter of the cable protective layer is between 0.8-1.2mm; the specification of the three-core cable is between 28-34AWG. The thermocouple is arranged with positive and negative poles, with an outer diameter of 0.15mm-0.3mm; the diameter of the optical fiber sensor is between 0.15-0.4mm. The diameter of the support unit is between 0.5mm-0.8mm, preferably 0.021inch. The sheath tube can be made of pebax, PA, PP, PCTG; the perfusion tube and drainage tube can be made of pebax, PA, PVC, PI, PTFE, FEP, PCTG, TPU, etc. The through hole 103 can be circular or waist-shaped, etc. The maximum diameter of the through hole is between 0.3mm and 0.6mm, and is larger than the maximum cross-sectional area of the optical fiber sensor.
[0032] In an optional embodiment, at least one of the perfusion tube, drainage tube, support unit, temperature measurement unit, optical fiber unit and cable unit extends unconstrained in the first hollow part of the sheath tube. In use, the two ends of the three-core cable in the cable unit need to be electrically connected to the target connection points on the motor, so it can be understood that the two ends of the cable unit are in a constrained state. In actual use, due to the fluctuation of the pressure inside the perfusion tube or drainage tube, the fluctuating pressure will cause the perfusion tube and / or drainage tube to jump or move, and then collide with the device in the sheath tube and affect the position of the device in the sheath tube. To this end, in one embodiment of the present disclosure, at least one of the perfusion tube, drainage tube, support unit, temperature measurement unit, optical fiber unit and cable unit is arranged in the sheath tube without constraint, that is, at least one of the above elements has sufficient freedom in the sheath tube. When the perfusion tube or drainage tube jumps or moves, the above elements in the sheath tube can move with the collision of the perfusion tube or drainage tube, so as to avoid the fixed end being damaged by the alternating load when the two ends of the above elements are fixed. In a preferred embodiment, the elements in the sheath are all disposed in the first hollow portion without restraint.
[0033] In an optional embodiment, the sheath tube includes an inner layer, a braided layer and an outer layer, wherein the inner layer, the braided layer and the outer layer are sequentially arranged; the braided layer is made of metal wire, and / or the inner layer and the outer layer are made of polymer materials. For a structure using an ordinary single-layer sheath tube, its strength to withstand torsional force is still insufficient. For this reason, in an embodiment of the present disclosure, a braided tube processing technology is used to manufacture a multi-layer sheath tube to improve the torsional resistance of the sheath tube device. Figure 4 In the illustrated embodiment, the sheath is composed of an inner layer 401, a braided layer 403 and an outer layer 402. The braided layer is arranged between the inner layer and the outer layer. During manufacture, the braided layer can be wrapped around the surface of the inner layer, and then the outer layer can be sleeved on the braided layer. Preferably, the inner layer of the sheath is made of a polymer material, including but not limited to pebax, PTFE, PA or FEP, etc., with a wall thickness between 0.05mm-0.2mm. The braided layer can be formed by multiple groups of single wires that are not connected to each other, or it can be in the form of a braided mesh, or adopt a spiral shape similar to a spring, etc. It should be noted that the above is only an example and does not constitute a limitation on the scope of protection. The user can flexibly adjust the form of the braided layer according to the required strength. The wire diameter of the braided layer can be between 0.1mm-0.2mm, and the PPI is between 30-120, preferably 40-60, (where PPI refers to the number of spindles per inch, that is, how many intersections there are per inch). Exemplarily, when a mesh-shaped braided layer is used, the braided mesh shape can adopt an 8*8 or 4*4 composite structure. Preferably, the braided layer is made of metal material to obtain sufficient mechanical strength, and the exemplary material may be stainless steel or nickel-titanium alloy. Finally, the outer layer of the sheath may be made of polymer material, such as pebax, PTFE, PA or FEP. Compared with the single-layer sheath structure, the multi-layer sheath containing the braided layer in this embodiment improves the overall anti-axial torsion performance of the sheath unit and avoids excessive kinking of the sheath.
[0034] In an optional embodiment, Figure 5 As shown, the sheath includes an inner layer 401, a braided layer 403, a middle layer 402 and an outer layer 501, wherein the inner layer, the braided layer, the middle layer and the outer layer are sequentially arranged; the braided layer is made of metal wire, and / or the inner layer, the middle layer and the outer layer are made of polymer materials, and the hardness of the outer layer is lower than that of the inner layer and the middle layer. Figure 5 In the embodiment shown, the inner layer of the sheath tube, the braided layer and Figure 4 In keeping with the embodiment shown, the middle layer of the sheath is Figure 4 The outer layer of the sheath tube shown in the figure is consistent. In this embodiment, the outer layer of the sheath tube is also made of polymer material, such as TPU and PU. However, its hardness is lower than that of the middle layer and the inner layer of the sheath tube. Preferably, the hardness of the outer layer 501 is between 85A-55D, and the wall thickness of the outer layer is between 0.05-0.2mm. Compared with Figure 4 The embodiment shown, Figure 5 In the embodiment shown, the outer layer can provide resilience, making it easier for the sheath to return to its original state after being bent, thereby further improving the overall anti-bending ability and radial supporting force of the sheath device.
[0035] In an optional embodiment, the sheath device also includes an optical fiber unit; the sheath includes a second hollow portion extending along the axial direction of the sheath; the optical fiber unit is disposed in the second hollow portion and extends along the axial direction of the sheath. In practice, the optical fiber unit includes an optical fiber sensor and an optical fiber, and the optical fiber is used to transmit the measurement signal of the optical fiber sensor. Excessive bending of the optical fiber will affect signal transmission and may even cause the optical fiber to break. Therefore, how to protect the optical fiber unit from excessive bending is an issue that needs to be addressed. To this end, Figure 6 In the embodiment shown, a second hollow portion extending along the axis of the sheath is provided in the sheath, and a wall 601 is provided between the second hollow portion and the first hollow portion so that the two hollow portions cannot communicate with each other. The optical fiber unit is provided in the second hollow portion, and other components are provided in the first hollow portion. The cross-section of the second hollow portion may be olive-shaped, elliptical, crescent-shaped or circular, and the wall thickness of the wall 601 is between 0.1 mm and 0.25 mm. This arrangement not only enables the optical fiber unit to have an independent assembly space, but also provides sufficient support for the optical fiber and limits the displacement of the optical fiber unit. Moreover, the wall of the second hollow portion can block the load applied to the optical fiber unit when components such as the perfusion tube or the drainage tube are jumping, thereby preventing the optical fiber unit from bending, deforming or even breaking, and effectively ensuring the safety of the optical fiber unit.
[0036] In an optional embodiment, the distal end of the sheath is provided with a through hole 103 penetrating the second hollow portion, and the distal end of the optical fiber unit passes through the through hole and extends along the axis direction along the outer wall of the sheath. Similar to the embodiment described above, in order to measure environmental signals, the optical fiber unit needs to extend the optical fiber sensor out of the sheath and close to the fluid pumping device. Figure 6 In the embodiment shown, a through hole 103 is provided, which penetrates the side wall of the sheath tube and extends in a direction perpendicular to the axis of the sheath tube. In addition, the through hole penetrates the wall of the sheath tube to connect the second hollow part with the environment outside the sheath tube. The optical fiber sensor can extend out of the sheath tube through the through hole and approach the fluid pumping device to monitor the position of the fluid pumping device. Figure 6In the illustrated embodiment, the sheath is further provided with a temperature measuring unit 201 or a cable unit and other elements, wherein the temperature measuring unit or the cable unit is arranged in the first hollow portion and extends respectively along the axial direction. In this embodiment, the elements integrated inside the sheath are the same or similar to the scheme described above, and the details can be found in the above text, which will not be repeated here. It should be noted that the number of the above-mentioned hollow portions is not limited to 2, and the user can set a plurality of them as needed to respectively install the elements to be protected.
[0037] A second aspect of the present disclosure provides a fluid pumping device, which is used in conjunction with any sheath device described in the first aspect.
[0038] The above specific implementation methods do not constitute a limitation on the scope of protection of the present invention. After considering the specification and practicing the technical solutions disclosed in this application, those skilled in the art will easily think of other implementation methods of the present disclosure. This application is intended to cover any modification, use or adaptive changes of the present disclosure, which follow the general principles of the present disclosure and include common knowledge or customary technical means in the technical field that are not disclosed in the present disclosure. The description and examples are regarded as exemplary only, and the true scope and spirit of the present disclosure are indicated by the following claims.
[0039] It should be understood that the present disclosure is not limited to the exact structures that have been described above and shown in the drawings, and that various modifications and changes may be made without departing from the scope thereof. The scope of the present disclosure is limited only by the appended claims.
Claims
1. A sheath device, Features: It includes a sheath tube, an irrigation tube, and a support unit; The sheath tube comprises a first hollow portion extending along the axial direction of the sheath tube; The perfusion tube and the support unit are both disposed in the first hollow portion and extend along the axial direction of the sheath tube respectively; The sheath comprises an inner layer, a braided layer and an outer layer, wherein the inner layer, the braided layer and the outer layer are sequentially sleeved; the braided layer is made of metal wire, and / or the inner layer and the outer layer are made of polymer material.
2. The sheath device according to claim 1, characterized in that: The sheath device also includes a drainage tube; The support unit is located outside the perfusion tube and the drainage tube; or, the support unit is a plurality of groups, and is located inside the perfusion tube and the drainage tube respectively; or, the support unit is a plurality of groups, and part of it is located inside the perfusion tube and the drainage tube, and the rest is located outside the perfusion tube and the drainage tube; or, the support unit is a plurality of groups, and part of it is located inside one of the perfusion tube and the drainage tube, and the rest is located outside the perfusion tube and the drainage tube.
3. The sheath device according to claim 2, characterized in that: The sheath tube further includes at least one of a temperature measuring unit, an optical fiber unit or a cable unit, wherein the temperature measuring unit, the optical fiber unit or the cable unit is disposed in the first hollow portion and extends along the axial direction respectively.
4. The sheath device according to claim 3, characterized in that: The side wall of the distal end of the sheath tube is provided with a through hole, the extension direction of the through hole is perpendicular to the axis of the sheath tube, and the distal end of the optical fiber unit passes through the through hole and adheres to the outer wall of the sheath tube and extends along the axial direction; and / or, the cable unit includes a cable, a shielding layer sleeved on the outside of the cable, and a cable protective layer sleeved outside the shielding layer.
5. The sheath device according to claim 4, characterized in that: At least one of the irrigation tube, the drainage tube, the support unit, the temperature measurement unit, the optical fiber unit and the cable unit extends freely in the first hollow portion of the sheath tube.
6. The sheath device according to any one of claims 1 to 5, characterized in that: The supporting unit is a metal wire.
7. The sheath device according to any one of claims 1 to 5, characterized in that: The sheath tube also includes a middle layer, wherein the inner layer, the braided layer, the middle layer and the outer layer are sequentially sleeved; The inner layer, the middle layer and the outer layer are made of polymer materials, and the hardness of the outer layer is lower than that of the inner layer and the middle layer.
8. The sheath device according to claim 1, characterized in that: The sheath device also includes an optical fiber unit; The sheath tube is provided with a second hollow portion extending along the axial direction of the sheath tube; The optical fiber unit is arranged in the second hollow portion and extends along the axial direction of the sheath tube.
9. The sheath device according to claim 8, characterized in that: The side wall of the distal end of the sheath tube is provided with a through hole, the extension direction of the through hole is perpendicular to the axis of the sheath tube, the through hole is connected to the second hollow part, and the distal end of the optical fiber unit passes through the through hole and extends along the axial direction against the outer wall of the sheath tube.
10. A fluid pumping device, used in conjunction with the sheath device according to any one of claims 1 to 9.
Citation Information
Patent Citations
Reinforced compound sheathing canal, preparation method and application thereof
CN105105894A
Perfusion liquid conveying device and control method thereof
CN112891732A
Multi-layer braided sheath tube
CN113332562A
Blood circulation assistance system
CN116036463A
Percutaneous left heart drainage tube
CN211132392U
