Flexible ureteroscope sheath and assembly thereof

Abstract

The flexible ureteroscope sheath comprises a first tube body, and the first tube body is provided with a first inner cavity extending in the axial direction of the first tube body in a penetrating mode; the inner side face of the first pipe body is further provided with a first spiral groove spirally extending around the axis of the first pipe body. The flexible ureteroscope sheath can be directly shaped into a linear long strip along a zebra guide wire and placed in a target position in a ureter through a hard ureteroscope, then the flexible ureteroscope sheath is opened by inserting the supporting body into the first spiral groove, and an inner cavity of the first pipe body is used as an operation channel. According to the indwelling catheter mode, an inner core does not need to be used, the problems that the kidney is damaged by the inner core due to the fact that the indwelling catheter is too deep, the inner core penetrates through the ureter due to the fact that the advancing direction deviates from the ureter cavity and the like are solved, safety and reliability of the indwelling catheter process are improved, and harm to a patient is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a flexible ureteral access sheath and its components. Background Art

[0002] Urinary tract stones are a common disease, which can cause renal obstruction, hydronephrosis, infection and interstitial inflammation. In addition, due to the damaging effect of the cause of the stones themselves, the renal function of the patient will also be reduced. Flexible ureteroscopy is a common method for treating urinary tract stones at present, which has the advantages of minimally invasive, less pain, quick recovery, and the ability to directly observe and crush stones.

[0003] A general process of flexible ureteroscopy surgery includes: inserting a zebra guide wire with the aid of a semi-rigid ureteroscope, and then inserting a flexible ureteral access sheath into the ureter under the guidance of the zebra guide wire to establish an operation channel; then inserting a flexible ureteroscope through the flexible ureteral access sheath; subsequently, operations such as endoscopy and lithotripsy can be performed. Among them, the insertion of the flexible ureteral access sheath is a major difficulty.

[0004] The existing flexible ureteral access sheath generally includes an outer sheath 10 as shown in Figure 1 and an inner core 20 as shown in Figure 2 . The outer sheath 10 has a hollow lumen, and the distal end of the inner core 20 is formed with a conical head end 21, which is made of a rigid material. When in use, the inner core 20 is partially inserted into the lumen of the outer sheath 10, and the head end 21 at the distal end of the inner core 20 extends out from the distal end of the outer sheath 10. Then, the operator inserts the outer sheath 10 and the inner core 20 into the ureter together under the guidance of a flexible guide wire, and then pulls out the inner core 20, using the lumen of the outer sheath 10 as the operation channel. During the insertion process of the flexible ureteral access sheath, the operator cannot directly observe the situation inside the ureter and can only operate outside the body based on experience and feel, which is likely to cause many problems, such as inserting the tube too deep, resulting in the head end 21 of the inner core 20 damaging the kidney; the advancing direction deviating from the ureteral lumen, resulting in the inner core 20 penetrating the ureter, etc. Summary of the Invention

[0005] The purpose of the present invention is to provide a flexible ureteral access sheath and its components, aiming to enable the flexible ureteral access sheath to be inserted in a softer and thinner manner and improve the safety of catheter insertion.

[0006] To achieve the above purpose, the present invention provides a flexible ureteral access sheath, including a flexible first tube body, the first tube body having a first inner cavity extending axially therethrough, and a first helical groove spirally extending around its own axis being provided on the inner side surface of the first tube body, the first helical groove extending to the proximal end face of the first tube body.

[0007] Optionally, the cross-section of the first helical groove is arc-shaped.

[0008] Optionally, the flexible ureteroscope sheath further includes a flexible second tube body having a second inner cavity extending axially therethrough; the second tube body is disposed in the first inner cavity of the first tube body and connected to the inner side surface of the first tube body.

[0009] Optionally, a second helical groove extending helically around its own axis is provided on the outer side surface of the second tube body, and the second helical groove extends to the proximal end face of the second tube body; the notch of the second helical groove coincides with the notch of the first helical groove and combines to form a helical chamber surrounding the axis of the second tube body.

[0010] Optionally, the cross-section of the helical chamber is any one of a circle, a triangle, and a quadrilateral.

[0011] Optionally, the first helical groove further extends to the distal end face of the first tube body, and the second helical groove further extends to the distal end face of the second tube body.

[0012] Optionally, the first tube body and the second tube body are connected after being separately formed.

[0013] To achieve the above object, the present invention further provides a flexible ureteroscope sheath assembly, including a support body and the aforementioned flexible ureteroscope sheath, and the support body is used to partially penetrate into the first helical groove.

[0014] Optionally, the support body is a guide wire.

[0015] Optionally, the support body is a three-dimensional helical spring structure.

[0016] Compared with the prior art, the flexible ureteroscope sheath and its assembly of the present invention have the following advantages:

[0017] The aforementioned flexible ureteroscope sheath includes a first tube body having a first inner cavity extending axially therethrough; a first helical groove extending helically around its own axis is further provided on the inner side surface of the first tube body, and the first helical groove penetrates through the proximal end face of the first tube body; such a flexible ureteroscope sheath can be directly shaped into a linear strip along a zebra guide wire and inserted into the target position in the ureter through a rigid ureteroscope, and then the flexible ureteroscope sheath is expanded by inserting a support body into the first helical groove, so as to use the inner cavity of the first tube body as an operation channel. This catheterization method can ignore the physiological stenosis of the ureter and does not require the use of an inner core, so problems such as damage to the kidney caused by the inner core due to too deep catheterization and penetration of the ureter by the inner core due to deviation of the advancing direction from the ureter cavity will not occur, improving the safety and reliability of the catheterization process and reducing the harm to the patient. Description of the Drawings

[0018] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation to the present invention. Among them:

[0019] Figure 1 is a schematic structural view of an outer sheath of a flexible ureteroscope sheath in the prior art;

[0020] Figure 2 is a schematic structural view of an inner core of a flexible ureteroscope sheath in the prior art;

[0021] Figure 3 Schematic structural view of the flexible ureteroscope sheath provided by the present invention according to the first embodiment;

[0022] Figure 4 is a sectional view of the flexible ureteroscope sheath provided by the present invention according to the first embodiment;

[0023] Figure 5 Schematic structural view of the flexible ureteroscope sheath provided by the present invention according to the second embodiment;

[0024] Figure 6 is a partial sectional view of the second tube body of the flexible ureteroscope sheath provided by the second embodiment of the present invention.

[0025] [Explanation of reference numerals is as follows]:

[0026] 110 - first tube body, 111 - first inner cavity, 112 - first helical groove, 120 - second tube body, 121 - second inner cavity, 122 - second helical groove;

[0027] 10 - outer sheath, 20 - inner core, 21 - head end. Detailed implementation manners

[0028] The following illustrates the implementation manners of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation manners. Various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the diagrams provided in this embodiment only illustrate the basic concept of the present invention schematically. Therefore, only the components related to the present invention are shown in the diagrams, rather than being drawn according to the number, shape, and size of the components during actual implementation. The type, quantity, and ratio of each component during actual implementation can be arbitrarily changed, and the component layout type may also be more complex.

[0029] In addition, each of the embodiments described below has one or more technical features. However, this does not mean that the inventor must implement all the technical features in any one embodiment simultaneously, or can only separately implement some or all of the technical features in different embodiments. In other words, on the premise that implementation is possible, those skilled in the art can, according to the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all of the technical features in any one embodiment, or selectively implement a combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility during the implementation of the present invention.

[0030] As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural form "plural" includes more than two referents, unless the context clearly indicates otherwise. As used in this specification, the term "or" is generally used in the sense of including "and / or", unless the context clearly indicates otherwise, and the terms "mounted", "connected" and "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and can be the communication inside two elements or the interaction relationship between two elements. The relational terms such as "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor indicate or imply relative importance or implicitly specify the quantity of the indicated technical features. It should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be construed as a limitation on the present invention. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0031] The terms "proximal end" and "distal end" are used to describe the relative positions and relative orientations of the various elements and components of a medical device. Although non-limiting, the "proximal end" is usually the end of the medical device that is closer to the operator during normal use, and the "distal end" is the end that first enters the patient's body.

[0032] The object of the present invention is to provide a flexible ureteroscope sheath, aiming to adjust the structure of the flexible ureteroscope sheath so that it does not need to use a core with a rigid head end during the insertion process, and can be inserted in a softer and thinner form, so that the physiological stenosis of the ureter does not need to be considered, and the problem of the core damaging the kidney or ureter will not occur.

[0033] To make the object, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise scales, only for conveniently and clearly assisting in explaining the object of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0034] Figure 3 The structural schematic diagram of the flexible ureteroscope sheath provided by the first embodiment of the present invention is shown, Figure 4 is Figure 3 The partial cross-sectional view of the shown flexible ureteroscope sheath. Please refer to Figure 3 and Figure 4 , the flexible ureteroscope sheath includes a flexible first tube body 110, and the first tube body 110 has a first inner cavity 111 extending axially therethrough. Thus, the cavity wall of the first inner cavity 111 constitutes the inner side surface of the first tube body 110. A first spiral groove 112 extending helically around its own axis is formed on the inner side surface of the first tube body 110., the first spiral groove 112 extends to the proximal end face of the first tube body 110. The first spiral groove 112 is used as the accommodation space of a support body (not shown in the figure) during the entire flexible ureteroscope operation. It should be understood that the first spiral groove 112 is arranged within the entire axial length range of the first tube body 110.

[0035] Since the first tube body 110 is of a flexible structure, it can be shaped into a linear strip and the first inner cavity 111 can be collapsed and blocked. Therefore, the flexible ureteroscope sheath can be inserted into the target position in the ureter in the following way: first, shape the first tube body 110 into a linear strip along the zebra guide wire, and then insert it into the target position through a semi-rigid endoscope. After that, stabilize the first tube body 110, and then, introduce the support body into the accommodation space (i.e., the first spiral groove 112) to expand the first tube body 110 so that the first inner cavity 111 is opened. After that, the first inner cavity 111 of the first tube body 110 can be used as an operation channel to perform operations such as endoscopy and lithotripsy. In other words, the flexible ureteroscope sheath provided by this embodiment can be inserted into the ureter alone with a smaller outer diameter without being paired with a core with a rigid head end. On the one hand, it does not need to consider the problem of the physiological stenosis of the ureter, and on the other hand, it also avoids the problem of kidney damage caused by too deep catheter insertion or ureter damage caused by the advancing direction deviating from the axis of the lumen.

[0036] In this embodiment, the cross-sectional shape of the first helical groove 112 may be arc-shaped, or any other suitable shape, such as V-shaped, U-shaped, etc. Moreover, the first helical groove 112 preferably extends to the distal end face of the first tube body 110.

[0037] In this embodiment, the first helical groove 112 can be formed in any suitable manner. For example, when preparing the body of the first tube body 110 by injection molding, the first helical groove 112 is formed synchronously. This has the advantages of simple molding method, convenient operation, and no increase in production cost.

[0038] Figure 5 The structural schematic diagram of the flexible ureteroscope sheath provided by the second embodiment of the present invention is shown. The second embodiment is a further improvement made on the basis of the first embodiment. Please refer to Figure 5 , the flexible ureteroscope sheath further includes a flexible second tube body 120. The second tube body 120 is disposed in the first inner cavity 111 of the first tube body 110, and the outer side surface of the second tube body 120 is connected to the inner side surface of the first tube body 110. The second tube body 120 has a second inner cavity 121 extending axially therethrough.

[0039] Both the second tube bodies 120 are of flexible structures. Therefore, the flexible ureteroscope sheath can still be shaped into a linear strip so that the second inner cavity 121 of the second tube body 120 collapses and closes. Thus, the process of inserting the flexible ureteroscope sheath provided in this embodiment into the ureter is the same as that of the first embodiment. That is, the flexible ureteroscope sheath provided in this embodiment can be implanted into the ureter with a smaller diameter and does not need to be used with a core having a rigid head end. On the one hand, it does not need to consider the problem of physiological stenosis of the ureter. On the other hand, it also avoids the problems of damaging the kidney by the core due to excessive insertion depth of the catheter or damaging the ureter by the core due to the advancing direction deviating from the axis of the lumen. It can be understood that after the flexible ureteroscope sheath is inserted into the body and supported by the support body, the second inner cavity 121 of the second tube body 120 is opened and used as an operation channel to perform operations such as endoscopy and lithotripsy.

[0040] The second tube body 120 is equivalent to a lining layer. Compared with the first embodiment, the flexible ureteroscope sheath of this embodiment has a complete and smooth inner peripheral surface. The first helical groove 112 and the support body are both isolated from the operation channel, and there will be no problem of the flexible ureteroscope rubbing against the edge of the first helical groove 112 or the support body, and it can also reduce the resistance during the insertion process of the flexible ureteroscope.

[0041] Among them, the first tube body 110 and the second tube body 120 can be separately formed first and then assembled together. This can simplify the production process, reduce the processing difficulty, and cut down the production cost. The first tube body 110 and the second tube body 120 can be connected by bonding, welding or any other suitable means.

[0042] Optionally, a second helical groove 122 spirally extending around its own axis is further formed on the outer side surface of the second tube body 120, and the second helical groove 122 penetrates through the proximal end face of the second tube body 120. When assembling the first tube body 110 and the second tube body 120, the notch of the second helical groove 122 coincides with the notch of the first helical groove 112. Thus, the second helical groove 122 and the first helical groove 112 jointly form a helical chamber spirally extending around the axis of the second tube body 120. It can be understood that in the case where the first helical groove 112 extends to the distal end face of the first tube body 110, the second helical groove 122 correspondingly extends to the distal end face of the second tube body 120.

[0043] In this embodiment, there is no particular limitation on the forming method of the second helical groove 122, and it can be formed at one time when the second tube body 120 is injection-molded. Also, in this embodiment, there is no particular limitation on the shape of the cross-section of the helical chamber, and it can be circular, triangular, quadrilateral or any other suitable shape.

[0044] It should be noted that the "softness" mentioned herein is relative to hardness, with a smaller hardness and being easy to bend and deform. In the embodiments of the present invention, both the first tube body 110 and the second tube body 120 are made of soft polymer materials. Optional polymer materials include but are not limited to at least one of thermoplastic polyurethane elastomer rubber (TPU) and polytetrafluoroethylene (TPFE).

[0045] Furthermore, the embodiments of the present invention further provide a flexible ureteroscope sheath assembly, including a support body and the flexible ureteroscope sheath provided in the first embodiment or the second embodiment. The support body is used to partially penetrate into the accommodation space, that is, when the flexible ureteroscope sheath is the flexible ureteroscope sheath provided in the first embodiment, the support body partially penetrates into the first helical groove; when the flexible ureteroscope sheath is the flexible ureteroscope sheath provided in the second embodiment, the support body partially penetrates into the first helical groove and the second helical groove.

[0046] Optionally, the support body is a guide wire. When the guide wire partially penetrates into the accommodation space, the part of the guide wire penetrating into the accommodation space forms a three-dimensional spiral structure.

[0047] Alternatively, the support is a three-dimensional helical spring structure. During use, the three-dimensional helical spring structure is straightened, and then one end of the support is advanced along the accommodation space and finally restored to a three-dimensional helical structure.

[0048] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention is also intended to include these modifications and variations.

Claims

1. A flexible ureteroscope sheath, characterized in that, it includes a flexible first tube body, the first tube body has a first inner cavity extending axially therethrough, a first helical groove extending helically around its own axis is formed on the inner side surface of the first tube body, and the first helical groove extends to the proximal end face of the first tube body.

2. The flexible ureteroscope sheath according to claim 1, characterized in that, the cross-section of the first helical groove is arc-shaped.

3. The flexible ureteroscope sheath according to claim 1, characterized in that, the flexible ureteroscope sheath further includes a flexible second tube body, the second tube body has a second inner cavity extending axially therethrough; the second tube body is arranged in the first inner cavity of the first tube body and is connected to the inner side surface of the first tube body.

4. The flexible ureteroscope sheath according to claim 3, characterized in that, a second helical groove extending helically around its own axis is provided on the outer side surface of the second tube body, and the second helical groove extends to the proximal end face of the second tube body; the notch of the second helical groove coincides with the notch of the first helical groove and combines to form a helical chamber surrounding the axis of the second tube body.

5. The flexible ureteroscope sheath according to claim 4, characterized in that, the cross-section of the helical chamber is any one of circular, triangular, and quadrilateral.

6. The flexible ureteroscope sheath according to claim 4, characterized in that, the first helical groove further extends to the distal end face of the first tube body, and the second helical groove further extends to the distal end face of the second tube body.

7. The flexible ureteroscope sheath according to claim 4, characterized in that, the first tube body and the second tube body are connected after being separately formed.

8. A flexible ureteroscope sheath assembly, characterized in that, it includes a support body and the flexible ureteroscope sheath according to any one of claims 1-7, and the support body is used to be partially inserted into the first helical groove.

9. The flexible ureteroscope sheath assembly according to claim 8, characterized in that, the support body is a guide wire.

10. The flexible ureteroscope sheath assembly according to claim 8, characterized in that, the support body is a three-dimensional helical spring structure.

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