CN116784954A - Flexible guide sheath, guide device for removing kidney stones and nephroscope - Google Patents

Abstract

The utility model discloses a flexible guiding sheath, a guiding sheath tube, a flexible part and a rigid part, wherein the flexible guiding sheath tube is provided with a tubular structure; under the working state, the guiding sheath tube and the cooperative device penetrating through the guiding sheath tube cooperatively move, and the flexible part of the guiding sheath tube performs bending movement under the cooperative action to reach the preset bending amplitude; the bending amplitude of the guiding sheath tube is controlled by the bending amplitude of the cooperative device, and when the cooperative device moves, the guiding sheath tube moves along with the bending of the cooperative device to drive the guiding sheath tube to adjust the movement direction or the bending of the cooperative device so as to control the guiding sheath tube to move to any target sheath implantation area. The rigidity and the elasticity of the guide sheath are ensured, the guide sheath is not flattened by external force, the guide sheath is ensured to smoothly enter the organ cavity, the requirement of bending and extrusion is met, and the flexible sheath tube can be matched with the cooperative device for movement, so that the expected effect is achieved. Is suitable for percutaneous nephrolithotripsy and stone extraction operation, and can be widely applied to ureteroscope operation and other operations requiring perfusion.

Description

Flexible guide sheath, guide device for removing kidney stones and nephroscope

Technical Field

The utility model relates to the field of medical equipment, in particular to a flexible guide sheath, a guide device for removing kidney stones and a nephroscope.

Background

The disposable ureteral introducer sheath is used for urological surgery, and an upright operation channel is not created, so that an endoscope and other instruments can be assisted to enter the urological cavity channel, and a continuous operation channel is provided for the endoscope and other instruments. Can protect ureter when the instrument exchanges repeatedly, reduce the trauma to it, protect accurate instrument and soft mirror simultaneously from damaging. The ureteral guiding sheath consists of a guiding sheath and a dilator. Wherein the guiding sheath consists of a guiding sheath tube and a guiding sheath joint, and the dilator consists of a dilator catheter, a dilator joint and a dilator push handle.

The utility model patent with publication number CN217548109U provides an introducer sheath comprising: an introducer sheath, an introducer sheath connector, an expander catheter and a hand button; wherein, the expander catheter is arranged in the guiding sheath tube in a penetrating way, and the front end of the expander catheter extends out from the front end of the guiding sheath tube; the rear end of the guiding sheath tube is connected with the hand buckle through the guiding sheath joint; the rear end of the dilator catheter passes through the inner cavity of the guide sheath joint to be connected with the hand buckle; the guiding sheath tube is provided with a fold structure within a preset distance from the front end, and the fold structure is configured to be capable of being bent and extended forwards in a controlled manner. Although the bending direction of the guiding sheath tube can be changed by the fold structure at the front end of the guiding sheath tube, the range of turning of the fold structure can be limited by a preset distance section, and meanwhile, the characteristics of hardness, flexibility and the like of the guiding sheath tube are not considered. At present, if a guiding sheath with a bending function pursues flexibility to avoid damaging mucous membranes or tissues of a cavity of a patient when the guiding sheath is inserted into the cavity, the guiding sheath is softer and softer, and lacks support and operability, meanwhile, when the guiding sheath turns, the guiding sheath tube is bent or excessively bent to easily cause the flattening of the guiding sheath tube by external force, and the requirement of bending and extrusion cannot be met, so that the guiding sheath tube cannot smoothly enter the cavity of the patient, is not beneficial to accurately entering the part required by an operation, and cannot achieve an ideal use effect.

Disclosure of Invention

The utility model aims to provide a flexible guide sheath, a guide device for removing kidney stones and a nephroscope, which solve the defect that the flexible guide sheath cannot meet the requirement of bending extrusion when in use, ensure the rigidity and elasticity of the guide sheath, and protect the flexible guide sheath from being flattened by external force, thereby ensuring that the guide sheath smoothly enters an organ cavity to meet the requirement of bending extrusion, and the flexible sheath tube can move in cooperation with an endoscope cooperative device to achieve the expected effect. Is suitable for percutaneous nephrolithotripsy and stone extraction operation, and can be widely applied to ureteroscope operation and other operations requiring perfusion.

The utility model provides a flexible guide sheath, which comprises a guide sheath tube and a flexible guide sheath tube, wherein the guide sheath tube is provided with a tubular structure with a flexible part and a rigid part;

under the working state, the guiding sheath tube and the cooperative device penetrating through the guiding sheath tube move cooperatively, and the flexible part of the guiding sheath tube bends under the cooperative action to reach the preset bending amplitude;

the bending amplitude of the guiding sheath tube is controlled by the bending amplitude of the cooperative device, and when the cooperative device moves, the guiding sheath tube moves along with the bending of the cooperative device to drive the guiding sheath tube to adjust the movement direction or the bending of the cooperative device so as to control the guiding sheath tube to move to any target sheath implantation area.

Preferably, the guiding sheath tube is provided with a composite tube structure, the composite tube structure is sequentially provided with a first layer structure, a second layer structure and a third layer structure with a central channel from inside to outside, and the first layer structure and the third layer structure wrap the second layer structure, so that the strength and the flexibility of the composite tube structure are ensured.

Preferably, the flexible portion and the rigid portion are connected through a transition portion, and the flexible portion, the transition portion and the rigid portion are divided according to the length direction of the outer surface of the guiding sheath tube to form a flexible section, a transition section and a rigid section, so that the distal end of the guiding sheath tube is soft and the proximal end of the guiding sheath tube is stiff.

Preferably, the third layer structure is configured as an elastic material having a hardness of less than 30 °.

Preferably, the second layer structure is a support structure formed by spiral braiding of guide wires, and the support structure is spirally distributed along the outer surface of the first layer structure.

Preferably, the first layer structure is made of an ultra-thin material to reduce the wall thickness of the guiding sheath.

Preferably, the flexible segment has a hardness less than the hardness of the transition segment and the transition segment has a hardness less than the hardness of the rigid segment.

Preferably, the pitches of the second layer structures respectively corresponding to the flexible section, the transition section and the rigid section are the same; and/or the number of the groups of groups,

the pitch of the second layer structure in the flexible section is greater than the pitch of the second layer structure in the transition section, and the pitch of the second layer structure in the transition section is greater than the pitch of the second layer structure in the rigid section.

Preferably, the guide wire section includes any one of a regular pattern and an irregular pattern.

Preferably, if the pitches of the second layer structures are the same, the pitch winding densities of the second layer structures corresponding to the flexible section, the transition section and the rigid section are all set between 0.3 and 2 mm; and/or the number of the groups of groups,

if the pitches of the second layer structures are different, the pitch winding density of the second layer structures corresponding to the flexible sections is set to be 0.3-0.8 mm, the pitch winding density of the second layer structures corresponding to the transition sections is set to be 0.8-1.2 mm, and the pitch winding density of the second layer structures corresponding to the rigid sections is set to be 1.2-2 mm.

Preferably, the cooperative apparatus includes:

an endoscope body including at least a plurality of interconnected joint tube sections;

and the traction mechanism is respectively connected with the connecting pipe sections and is used for traction of bending motion of the endoscope main body and driving the flexible part of the flexible guide sheath to bend, and the cooperation device is controlled to drive the flexible guide sheath to move in the up-down direction and the left-right direction.

The utility model also provides a guiding device for removing kidney stones, which comprises the flexible guiding sheath, wherein the flexible guiding sheath is detachably connected with the dilator.

The utility model also provides a nephroscope for percutaneous nephroscope operation, which comprises the flexible guide sheath.

Compared with the prior art, the utility model has the following advantages:

firstly, the flexible guide sheath provided by the utility model ensures the rigidity and elasticity of the guide sheath tube through the setting of the hardness of the material, and protects the flexible guide sheath from being flattened by external force, thereby ensuring that the guide sheath smoothly enters into an organ cavity, meeting the requirement of bending extrusion, and ensuring that the flexible sheath tube can move cooperatively with an endoscope coordination device to achieve the expected effect.

Under the working state, the guiding sheath tube and a cooperative device sleeved in the guiding sheath tube move cooperatively, and under the cooperative action, the flexible part of the guiding sheath tube bends to reach the preset turning amplitude, so that the guiding sheath tube is controlled to enter an organ cavity to any target sheath implantation area;

the distal end part is arranged as a flexible part, and the proximal end part is arranged as a first rigid section, and the connection of the two ensures that the damage to organs caused by the guide sheath in the implantation process is reduced to the greatest extent.

Secondly, the utility model adopts a three-layer composite tube, namely an innermost ultra-thin PTFE tube, a stainless steel wire-wound spring and an outer Pebax tube; the second rigid section, the transition section and the second flexible section are arranged in a segmented mode according to the length direction, and the effect that the front end of the flexible sheath is soft and the rear end of the flexible sheath is stiff is achieved by using Pebax pipes with different hardness.

The spiral braided structure or the snake bone structure adopted by the utility model ensures that the sheath tube is stressed in 360 degrees along the whole circumference, and can meet the requirement of bending extrusion.

The flexible part adopted by the utility model is generally made of materials within Shore A30, and the flexible guide sheath can be matched with an endoscope cooperative device through repeated animal experiments and simulation verification, so as to achieve the expected effect.

Finally, the device is suitable for percutaneous nephrolithotripsy and stone extraction operations, can be widely applied to ureteroscope operations and other operations requiring perfusion, and has extremely wide application range.

Drawings

FIG. 1 is a schematic cross-sectional illustration of a flexible introducer sheath according to an embodiment of the utility model;

FIG. 2 is a diagram showing an example of a three-stage arrangement of a flexible introducer sheath in accordance with an embodiment of the present utility model;

FIG. 3 is a diagram showing an example of three layers of the flexible guide sheath according to an embodiment of the present utility model;

FIG. 4 is an exemplary view of a flexible introducer sheath with different pitch settings in accordance with an embodiment of the utility model;

FIGS. 4A and 4B are partially enlarged views of different pitches between the second rigid section, the transition section and the second flexible section of the flexible guide sheath, respectively, in accordance with an embodiment of the present utility model;

FIG. 5 is an enlarged partial illustration of the differential stiffness setting between the second rigid section, transition section and second flexible section of the flexible guide sheath, respectively, in accordance with an embodiment of the present utility model;

FIG. 6 is a view showing an example of the structure of an endoscope in the embodiment of the present utility model;

FIGS. 7-9 are illustrations of a configuration of a flexible guide sheath mated with an endoscope in accordance with an embodiment of the present utility model;

fig. 10 is a diagram showing an example of a guide device for removing kidney stones according to the embodiment of the utility model.

Detailed Description

Other advantages and effects of the present utility model will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present utility model with reference to specific examples. The utility model may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present utility model. It is to be understood that the terms "center," "longitudinal," "transverse," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are directional or positional relationships as indicated based on the drawings, merely to facilitate describing the utility model and simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus are not to be construed as limiting the utility model. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", etc. may explicitly or implicitly include one or more such feature. In the description of the present utility model, unless otherwise indicated, the meaning of "a plurality" is two or more.

It should be noted that, unless explicitly stated or limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art in a specific case.

In addition, in the description of the present utility model, "proximal" and "proximal" of "proximal" are terms commonly used in the medical arts. Specifically, the "proximal end" is an end close to the operator, the "proximal end" is an end face close to the operator, the "distal end" is an end far away from the operator, and the "distal end face" is an end face far away from the operator.

Example 1

Referring to fig. 1, the present utility model provides a flexible introducer sheath comprising:

an introducer sheath 1 having a tubular structure of a flexible portion 11 and a rigid portion 12, a distal end portion of the introducer sheath 1 being provided as the flexible portion 11 and a proximal end portion of the introducer sheath 1 being provided as the rigid portion 12;

under the working state, the guiding sheath tube 1 and a cooperative device penetrating through the guiding sheath tube 1 cooperatively move, and the flexible part 11 of the guiding sheath tube 1 performs bending movement under the cooperative action to reach a preset bending amplitude, so that the guiding sheath tube 1 is controlled to enter an organ cavity to any target sheath implantation area; the preset bending amplitude is controlled by the hardness range of the flexible sheath and the bending radius that can be reached by the following endoscope 2. The preset bending amplitude in this embodiment is the preset bending amplitude that can be achieved by the cooperation device with the flexible guiding sheath, and the bending amplitude can be 10mm to 15mm, so that the preset bending amplitude is enough to achieve any target sheath implantation area.

The bending amplitude of the guiding sheath tube 1 is controlled by the bending amplitude of the cooperative device, and when the cooperative device moves, the guiding sheath tube 1 moves along with the bending of the cooperative device to drive the guiding sheath tube 1 to adjust the movement direction or the bending of the cooperative device so as to control the guiding sheath tube 1 to move to any target sheath implantation area.

The flexible guiding sheath provided in this embodiment is a structural arrangement of a disposable flexible guiding sheath, and can be understood as being divided into two components, the head end of the guiding sheath tube 1 is about 10cm and is a flexible part 11, the material hardness is soft, the material hardness of the rear end of the guiding sheath tube 1 is greatly increased, and the elasticity is very strong. At the same time, the length of the head end of the guiding sheath tube 1 is about 10cm and is a flexible part 11, the maximum bending angle exceeds 270 degrees, and the limit turning radius is smaller than 1cm.

In various embodiments of the utility model, the cooperating means is an endoscope 2 endoscope or other urolithiasis surgical kit. When the cooperative device is an endoscope 2, the endoscope 2 is arranged in the guiding sheath tube 1 in a penetrating way, the guiding sheath tube 1 moves under the cooperative cooperation of the endoscope 2, and the bending amplitude of the guiding sheath tube 1 is controlled by the bending amplitude of the endoscope 2; when the endoscope 2 moves, the guiding sheath tube 1 moves along with the bending of the endoscope 2, so that the guiding sheath tube 1 is driven to adjust the movement direction or the bending of the endoscope 2, and the guiding sheath tube 1 is controlled to reach a target sheath implantation area. If the diameter of the endoscope 2 adopted in the embodiment is 10mm, the bending angle can reach plus or minus 275 degrees, the minimum bending angle of the endoscope 2 reaches the bending radius of about 10mm, the hardness of the flexible guide sheath is 25 degrees or other ranges lower than 30 degrees, the bending range of the endoscope 2 with the flexible guide sheath can reach at least 270 degrees, and the bending angle range of the bending radius is 10mm to 15mm, so that the flexible guide sheath can be ensured to easily enter the cavity of a patient, namely, any position required by the operation is favorable for smooth operation, and the purpose of implanting the sheath is achieved.

The working principle is as follows: the curvature of the flexible guide sheath employed in this embodiment cooperates with the curvature of the endoscope 2 in the renal calyx to reach the target sheath implantation area, such as near the lithotripsy. Under the working condition, the flexibility of the flexible guide sheath can reach the lower cup position under the coordination of the endoscope 2, and the bending radius which can be reached by the coordination of the flexible guide sheath and the endoscope 2 is 10mm-15mm, so that the flexible guide sheath can be suitable for the corresponding calculi operation. The endoscope 2 in the present embodiment can be generally moved into the upper cup and the middle cup, and when the endoscope 2 is moved into the lower cup, the flexible guide sheath passes through the endoscope 2 to reach the stone position of the lower cup, which can be understood that the flexible guide sheath can also reach the stone position of the lower cup, so as to complete the stone breaking task and the stone cleaning task.

The core of the utility model is that the guiding sheath tube 1 is in an open state when being stressed, the softer is more easily flattened, the central channel of the guiding sheath tube 1 is narrowed, the endoscope 2 is difficult to enter, the hardness of the guiding sheath tube 1 in the prior art is more than 30 ℃, the supporting property is better, and the tube body is difficult to be flattened; however, the hardness of the guiding sheath tube 1 needs to reach below 30 degrees, and the central channel of the tube body is easy to compress, so that the hardness of the guiding sheath tube 1 provided by the embodiment needs to reach below 30 degrees, the originality of the guiding sheath tube 1 is maintained, and the bending amplitude of the guiding sheath tube is ensured. In the embodiment, three sections of pipe sections are adopted for setting, and the effect of the object is verified through the endoscope 2 and animal experiments in a soft and hard matching mode.

In one embodiment, the guiding sheath 1 is provided as a composite tube structure, the composite tube structure is sequentially provided with a first layer structure 16, a second layer structure 17 and a third layer structure 18 with central channels from inside to outside, and the first layer structure 16 and the third layer structure 18 wrap the second layer structure 17, so that the strength and flexibility of the composite tube structure are ensured. In this embodiment, as shown in fig. 3, the flexible guiding sheath 1 is a composite tube of three-layer structure.

In one embodiment, referring to fig. 2, the flexible portion and the rigid portion are connected by a transition portion, and the flexible portion, the transition portion and the rigid portion are divided according to the length direction of the outer surface of the guiding sheath 1 to form a flexible section 13, a transition section 15 and a rigid section 14, so that the distal end of the guiding sheath 1 is soft and the proximal end is stiff. It can be understood that the three sections are divided into the outermost layer structure of the guiding sheath tube 1, and the outer layer structure realizes the effect that the front end of the flexible sheath tube 1 is soft and the rear end is stiff by using Pebax tubes with different hardness in a segmented manner.

First layer structure second layer structure third layer structure the first layer structure 16 is arranged to be made of ultra-thin material to reduce the wall thickness of the guiding sheath 1, such as PTFE tube;

the second layer structure 17 is a supporting structure formed by spiral braiding of guide wires, and the supporting structure is spirally distributed along the outer surface of the first layer structure, namely a spiral braiding structure formed by spiral braiding of guide wires and covering the first layer structure 16; the guide wire used in this embodiment may be a steel wire, a spring wire, or other braided wire. The guide wire plays a supporting role, and is used for providing support for bending and preventing bending. In various embodiments of the utility model, the guidewire cross-section includes any of a regular pattern or an irregular pattern, such as a circle, rectangle, square, oval, profile, etc.

The third layer 18 is configured as an elastomeric material having a hardness of less than 30 °, such as Pebax tubes. The three layers are bonded together, the first layer 16 is the innermost ultra-thin PTFE tube, the second layer 17 is the stainless steel wound spring wire, the third layer 18 is the outer Pebax tube, the guide wire is wrapped between the PTFE tube and the Pebax tube,

in one embodiment, the second layer of structure 17 adopts stainless steel coiled spring wires, and the stainless steel coiled spring wires can strengthen the structural strength of the tube body, but simultaneously the inner layer and the outer layer are required to wrap the stainless steel coiled spring wires, so that the friction between the inner surface and the outer surface of the sheath tube is reduced. The outer surface of the outer Pebax tube, which is the third layer 18, is provided with a hydrophilic coating which is sufficiently activated with physiological saline before use to provide a very low coefficient of friction to the outer surface of the sheath for easy passage through the ureter. In addition, the guiding sheath tube 1 needs to stay in the urinary tract for a period of time in operation, and the hydrophilic coating can prevent the guiding sheath tube 1 from being adhered to the ureter, so that the guiding sheath tube 1 is easy to withdraw from the ureter, and the ureter is prevented from being damaged. And the thickness of the first layer structure 16, namely the outer layer Pebax tube is moderate, so that the strength of the tube body can be supplemented, and the flexibility requirement of the guiding sheath tube 1 can be met by adjusting the hardness of the Pebax tube. In the embodiment of the utility model, the guide wire spiral winding structure comprises: in a first embodiment, as shown in fig. 4, the pitches of the coiled wires are different, and the third layer 18, i.e., the outer layer, has different Pebax hardness. In a second embodiment, as shown in fig. 5, the same pitch of the coiled wire is generally within 0.5-2 mm, and the third layer 18, i.e., the outer layer, has different Pebax hardness and is disposed within 30 degrees of Shore a.

In one embodiment, the hardness of the flexible section is smaller than that of the transition section, and the hardness of the transition section is smaller than that of the rigid section, so that the effect that the front end of the flexible sheath tube 1 is soft and the rear end is stiff is achieved by using Pebax pipes with different hardness in a segmented mode.

Referring to fig. 4a-4b, which are enlarged partial views, in order to ensure that the intermediate layer provides support for the bending of the flexible guide sheath, and also prevents the bending function, the density is set as follows: in one embodiment, the pitches of the corresponding second layer structures 17 in the flexible section 13, the transition section 15 and the rigid section 14 are all the same;

in another embodiment, the pitch of the second layer 17 in the flexible section 13 is greater than the pitch of the second layer 17 in the transition section 15, and the pitch of the second layer 17 in the transition section 15 is greater than the pitch of the second layer 17 in the rigid section 14.

In various embodiments of the utility model, the guide wire spiral wind density ranges are set as follows: in a first aspect, if the thread pitches of the braided structure around the guide wire of the guiding sheath 1 are the same as those of the second layer structure 17, the thread pitch winding density of the second layer structure 17 corresponding to each of the flexible section 13, the transition section 15 and the rigid section 14 is set between 0.3 mm and 2 mm; in a second aspect, if the thread pitches of the braided structure around the guide wire of the guiding sheath 1, that is, the thread pitches of the second layer structure 17 are different, the thread pitch winding density of the second layer structure 17 corresponding to the flexible section 13 is set to 0.3-0.8 mm, the thread pitch winding density of the second layer structure 17 corresponding to the transition section 15 is set to 0.8-1.2 mm, and the thread pitch winding density of the second layer structure 17 corresponding to the rigid section 14 is set to 1.2-2 mm.

The core point of the embodiment of the utility model is a spiral weaving structure, and the reason why the spiral weaving structure is not flattened is as follows: because the flexible guiding sheath tube 1 is internally provided with the braiding structure formed by the spiral steel wires, the flexible guiding sheath tube can be well protected from being flattened by external force. The hardness of the rear end part is greatly improved compared with that of the head end part, the rigidity and the elasticity of the flexible guide sheath are ensured, and the flexible guide sheath can be ensured to smoothly enter the organ cavity. The braiding mode is a spiral structure, so that the flexible guiding sheath tube 1 is stressed in 360 degrees along the whole circumference, and the requirement of bending extrusion can be met; the flexible part is generally within Shore A30, and the flexible guiding sheath tube 1 can be matched with the endoscope 2 to achieve the expected effect through repeated animal experiments and simulation verification.

In various embodiments of the present utility model, as shown in fig. 6, the cooperating means comprise an endoscope 2, i.e. comprise:

an endoscope body including at least a plurality of interconnected joint tube sections; the connecting tube sections can be snake bone hinged or other braiding structures;

and the traction mechanism (not shown in the figure) is respectively connected with the connecting pipe sections and is used for traction of bending motion of the endoscope main body to drive the flexible part of the flexible guide sheath to bend and control the cooperative device to drive the flexible guide sheath to move in the up-down direction and the left-right direction.

In this embodiment, the endoscope body is formed by connecting a plurality of connecting tube sections to form a flexible tube body with a bendable section 19, the flexible tube body comprises at least one working channel running working mode, and the bendable section 19 of the flexible tube body is connected with a traction mechanism and used for controlling the tensioning or loosening of the flexible tube body so as to control the bending direction of the endoscope body or the advancing movement direction caused by bending; it will be understood that the endoscope 2 main body includes a lens portion 22 and a scope portion 21, the scope portion 21 being a portion formed by connecting a plurality of connecting tube sections, the lens portion 22 being provided at a distal end face of the flexible tube body; the flexible tubing in this embodiment may be a snake bone structure or other braided structure. The working modes in this embodiment include a stone crushing mode, a stone cleaning mode, and the like, and the working channels include a laser channel, an imaging channel, a suction channel, a perfusion channel, and the like. An endoscope.

The flexible portion 11, i.e. the flexible section 13, of the flexible guide sheath may bend as the endoscope 2 is bent, or depending on the direction in which the endoscope 2 is bent, the flexible section 19 of the endoscope 2 may be formed as shown in fig. 7, pushing the flexible guide sheath forward.

Referring to fig. 7-9, the endoscope 2 works in conjunction with a flexible guide sheath in the renal pelvis as follows: the flexible guide sheath can control the guide sheath tube 1 to bend according to the use requirement, and can directly bend into a position required by the operation under the visual guidance of the endoscope 2. The endoscope 2 is used for observing specific operation conditions in the cavity, and the flexible guide sheath can convey the endoscope 2 and the guide sheath tube 1 to a place where operation is needed, so that the endoscope 2 and the guide sheath tube are combined into a whole. The flexible guide sheath is not in the most needed position for operation, thereby achieving the effect of operation. In this embodiment, the flexible guide sheath is placed in advance into the mouth of the renal calyx 3, and reaches the front end of the flexible guide sheath to slightly expose along with the extension of the endoscope 2 into the guide sheath tube 1, the flexible guide sheath enters the renal pelvis along with the extension of the endoscope 2, and searches for stones in the renal pelvis along with the bending of the endoscope 2, and after searching for the stones, the relative position of the flexible guide sheath and the endoscope 2 is properly adjusted, and the distance between the suction sheath mouth of the flexible guide sheath and the broken small stones is generally less than 2mm and not more than 5mm, so that the stone breaking process can be started.

In particular, after entering the renal pelvis, it is necessary to be able to advance in the direction of the endoscope 2. After the endoscope 2 cannot extend out of the flexible guide sheath for a certain distance, the flexible guide sheath is pushed under the obvious bending state of the electronic mirror, and the flexible guide sheath is possibly pushed too much to cause the soft-mirror snake bone to be disjointed or damaged. When in use, the endoscope 2 is preferably firstly withdrawn to the opening of the guide sheath tube 1 of the flexible guide sheath, and the flexible guide sheath is simultaneously pushed along with the forward pushing of the endoscope 2.

The head end portion of the flexible guide sheath flexible portion 11 may be bent along with the bending of the endoscope 2, or may be pushed forward according to the direction in which the endoscope 2 is bent. Because the second layer 17, i.e. the inner part, is provided with spiral wires, it is well protected from being flattened by external forces. Compared with the head end of the flexible part 11, the rigidity of the rigid section 12 is greatly improved, the rigidity and the elasticity of the flexible guide sheath are ensured, and the flexible guide sheath can be ensured to smoothly enter the organ cavity. The technical difficulties are mainly that the materials of the flexible part 11 and the rigid section 12 are seamlessly connected, and the inner and outer surfaces are smooth, and the connection place is not visible in a normal state. Therefore, the damage to organs in the implantation process of the flexible guide sheath can be reduced to the greatest extent. The flexible guide sheath is used with the endoscope 2, and particularly after entering the renal pelvis, the flexible portion 11 at the front end and the rigid section 12 at the rear end can be advanced along with the direction of the endoscope 2, so that the strength of the flexible portion and the rigid section 12 at the rear end are required to be matched with the endoscope 2 to adjust the corresponding material hardness design, and more verification is required. The most suitable material hardness data is then found, from which the corresponding flexible guide sheath is manufactured.

The flexible guide sheath is very widely applicable.

Example two

Referring to fig. 10, the present utility model provides a guide device for removing kidney stones, comprising:

a dilator and a flexible guiding sheath according to a first embodiment of the present utility model, the dilator 4 is connected to the guiding sheath tube interface 5 through the flexible guiding sheath. I.e. the flexible introducer sheath comprises:

an introducer sheath 1 having a tubular structure of a flexible portion 11 and a rigid portion 12, a distal end portion of the introducer sheath 1 being provided as the flexible portion 11 and a proximal end portion of the introducer sheath 1 being provided as the rigid portion 12;

under the working state, the guiding sheath tube 1 and a cooperative device penetrating through the guiding sheath tube 1 cooperatively move, and the flexible part 11 of the guiding sheath tube 1 performs bending movement under the cooperative action to reach a preset bending amplitude, so that the guiding sheath tube 1 is controlled to enter an organ cavity to any target sheath implantation area; the preset bending amplitude is controlled by the hardness range of the flexible sheath and the bending radius that can be reached by the following endoscope 2. The preset bending amplitude which can be achieved by the cooperative device with the flexible guiding sheath is 10mm to 15mm.

The bending amplitude of the guiding sheath tube 1 is controlled by the bending amplitude of the cooperative device, and when the cooperative device moves, the guiding sheath tube 1 moves along with the bending of the cooperative device to drive the guiding sheath tube 1 to adjust the movement direction or the bending of the cooperative device so as to control the guiding sheath tube 1 to move to any target sheath implantation area. The cooperating device used in this embodiment may be an endoscope 2, and the flexible guiding sheath cooperates with the endoscope 2 by a working method: the use of a dilator helps facilitate insertion of the introducer sheath, making the transition from the dilator to the sheath as atraumatic as possible. The flexible guiding sheath enters the renal pelvis along with the bending of the endoscope 2 and is directly close to the calculus, the technical point is the matching degree of the flexible sheath and the bending of the endoscope 2, and the obtained data is verified through repeated debugging in the embodiment, so that the effect is optimal. The embodiment requires a small bending radius of the flexible guide sheath, cannot be flattened by the cavity, reduces the channel space and is debugged. The function near the stone is that stone is cleared more easily in the stone breaking process, dust after stone breaking can not be turned in the operation space under the condition of negative pressure suction, the definition of operation visual field is affected, and in the stone cleaning process, the stone can be generally located between lateral wall renal papillae of the renal cup 3 due to the structure of the renal cup 3 in the endoscope 2 cleaning process, the water flow at the front end of the endoscope 2 can impact the periphery of the stone and the lateral wall of the renal cup 3, and continuously perfuses with large water flow in the same direction, the stone can be driven to rotationally float, the large water flow in a certain direction can be formed, meanwhile, the stone is completely involved in the large water flow along with the effect of large suction flow, at the moment, the endoscope is slowly retracted, the endoscope 2 is pushed and pulled back in the guide sheath tube 1 along with the back and forth, the stone can enter the inside of the flexible guide sheath tube 1 due to the large perfusion and the large suction continuous effect, and the stone can flow out along with the large suction flow effect of the endoscope at the moment. The same phenomenon also exists in the lithotripsy process, when the endoscope brings the flexible guide sheath to approach the stones crushed by the laser, such as less than 3mm, the stones can easily enter into the large water flow, and the stones can be easily brought out of the body by the large water flow in a way that the endoscope 2 withdraws from the guide sheath, thereby completing the purpose of stone cleaning.

Application example 1

The utility model also provides a nephroscope for percutaneous nephroscope operation, which comprises the flexible guide sheath according to the first embodiment of the utility model, namely, the flexible guide sheath comprises: the guiding sheath tube 1 is provided with a guiding tube,

an introducer sheath 1 having a tubular structure of a flexible portion 11 and a rigid portion 12, a distal end portion of the introducer sheath 1 being provided as the flexible portion 11 and a proximal end portion of the introducer sheath 1 being provided as the rigid portion 12;

under the working state, the guiding sheath tube 1 and a cooperative device penetrating through the guiding sheath tube 1 cooperatively move, and the flexible part 11 of the guiding sheath tube 1 performs bending movement under the cooperative action to reach a preset bending amplitude, so that the guiding sheath tube 1 is controlled to enter an organ cavity to any target sheath implantation area; the preset bending amplitude is controlled by the hardness range of the flexible sheath and the bending radius that can be reached by the following endoscope 2. The preset bending amplitude which can be achieved by the cooperative device with the flexible guiding sheath is 10mm to 15mm.

The bending amplitude of the guiding sheath tube 1 is controlled by the bending amplitude of the cooperative device, and when the cooperative device moves, the guiding sheath tube 1 moves along with the bending of the cooperative device to drive the guiding sheath tube 1 to adjust the movement direction or the bending of the cooperative device so as to control the guiding sheath tube 1 to move to any target sheath implantation area. The cooperating means employed in the present embodiment may be an endoscope 2.

Conventional percutaneous nephrolithotripsy and lithotomy are minimally invasive operations for treating kidney and ureteral upper segment stones. Is suitable for kidney and ureter upper segment calculus and kidney cast calculus with diameter larger than 2 cm. Mainly aims at the operation of large calculus and complex calculus. Percutaneous puncture of renal calyx 3 then establishes an operating channel with a diameter of approximately 0.5-1 cm, and through puncture guidance, expands the channel, and puts the channel into an endoscope under direct vision, and uses air pressure trajectory or laser to crush and take out stones, or performs operations such as expanding and cutting a narrow boundary of a renal pelvis and a ureter. The conventional percutaneous nephrolithotomy uses a stone-taking basket to grasp stone fragments to the outside of the body through a hard lens channel, wherein the stone-taking basket is divided into a basket for finding the stone fragments, and the stone fragments are grasped by the basket and are withdrawn to the outside of the body together with the hard lens. This process is repeated.

The nephroscope for percutaneous nephroscope provided by the utility model is suitable for operation of all stones, enters the renal calyx through the dilator tube and the flexible guide sheath, and the flexible guide sheath is propped against stones, so that the stone breaking efficiency is greatly improved. The original stone crushing time is reduced by more than half, the stone crushing task and the stone cleaning task can be rapidly completed, when large water flow and large suction occur, the endoscope or other hard lenses bring the flexible guide sheath to be close to stones crushed by laser, for example, the stones are easy to be taken out of the body by water flow in a mode that the endoscope 2 is retracted in the flexible guide sheath when the stones are smaller than 3mm, and therefore the purpose of reducing the operation time is achieved.

The embodiments of the present utility model have been described in detail with reference to the drawings, but the present utility model is not limited to the above embodiments. Even if various changes are made to the present utility model, it is within the scope of the appended claims and their equivalents to fall within the scope of the utility model.

Claims (13)

1. A flexible introducer sheath, comprising:

an introducer sheath having a tubular structure with a flexible portion and a rigid portion;

under the working state, the guiding sheath tube and the cooperative device penetrating through the guiding sheath tube move cooperatively, and the flexible part of the guiding sheath tube bends under the cooperative action to reach the preset bending amplitude;

the bending amplitude of the guiding sheath tube is controlled by the bending amplitude of the cooperative device, and when the cooperative device moves, the guiding sheath tube moves along with the bending of the cooperative device to drive the guiding sheath tube to adjust the movement direction or the bending of the cooperative device so as to control the guiding sheath tube to move to any target sheath implantation area.

2. The flexible introducer sheath of claim 1,

the guiding sheath tube is arranged into a composite tube structure, the composite tube structure is sequentially provided with a first layer structure, a second layer structure and a third layer structure, wherein the first layer structure, the second layer structure and the third layer structure are provided with a central channel, and the second layer structure is wrapped by the first layer structure and the third layer structure, so that the strength and the flexibility of the composite tube structure are ensured.

3. The flexible introducer sheath of claim 2, wherein the flexible portion is connected to the rigid portion by a transition portion, and wherein the flexible portion, the transition portion, and the rigid portion are divided in a length direction of the outer surface of the introducer sheath to form a flexible segment, a transition segment, and a rigid segment, thereby providing a flexible distal end of the introducer sheath and a stiff proximal end.

4. The flexible guide sheath of claim 3, wherein the third layer structure is configured as an elastic material having a hardness of less than 30 °.

5. A flexible guide sheath according to claim 3, wherein the second layer is provided as a support structure of helically woven guide wires and the support structure is helically arranged along the outer surface of the first layer.

6. A flexible introducer sheath as recited in claim 3, wherein the first layer structure is provided as an ultra-thin material to reduce the introducer sheath wall thickness.

7. The flexible guide sheath of claim 3, wherein the flexible segment has a hardness less than a hardness of the transition segment and the transition segment has a hardness less than a hardness of the rigid segment.

8. The flexible guide sheath of claim 5, wherein the pitches of the respective second layer structures in the flexible segment, the transition segment, and the rigid segment are all the same; and/or the number of the groups of groups,

the pitch of the second layer structure in the flexible section is greater than the pitch of the second layer structure in the transition section, and the pitch of the second layer structure in the transition section is greater than the pitch of the second layer structure in the rigid section.

9. The flexible guide sheath of claim 5, wherein the guidewire cross-section comprises any one of a regular pattern or an irregular pattern.

10. The flexible introducer sheath of claim 5,

if the pitches of the second layer structures are the same, the pitch winding densities of the second layer structures corresponding to the flexible section, the transition section and the rigid section are all set between 0.3 and 2 mm; and/or the number of the groups of groups,

if the pitches of the second layer structures are different, the pitch winding density of the second layer structures corresponding to the flexible sections is set to be 0.3-0.8 mm, the pitch winding density of the second layer structures corresponding to the transition sections is set to be 0.8-1.2 mm, and the pitch winding density of the second layer structures corresponding to the rigid sections is set to be 1.2-2 mm.

11. The flexible introducer sheath of claim 1, wherein the cooperating means comprises:

an endoscope body including at least a plurality of interconnected joint tube sections;

and the traction mechanism is respectively connected with the connecting pipe sections and is used for traction of bending motion of the endoscope main body and driving the flexible part of the flexible guide sheath to bend, and the cooperation device is controlled to drive the flexible guide sheath to move in the up-down direction and the left-right direction.

12. A guide device for removing kidney stones, comprising a flexible guide sheath according to any of claims 1 to 11, which is detachably connected to a dilator.

13. A nephroscope for percutaneous nephroscope surgery, comprising a flexible introducer sheath according to any one of claims 1 to 11.