Protection device
By designing a flexible and deformable delivery catheter and guidewire system, combined with a protective umbrella controlled by wire pulling, the problem of protective umbrella release deviation was solved, enabling smooth release of the protective umbrella and interception of plaque emboli, thus improving the safety and efficiency of the surgery.
Patent Information
- Application Number
- CN202422700983.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-06
- Publication Date
- 2025-11-11
- Estimated Expiration
- 2034-11-06
AI Technical Summary
In existing technologies, the protective umbrella is difficult to release smoothly from the distal end of the delivery catheter and is prone to deviation, affecting the progress of the surgery.
A protective device including a delivery catheter, a guidewire, a protective umbrella, and a pull wire was designed. The distal end of the catheter is elastically deformable, the protective umbrella can move and unfold on the guidewire, and its release and retrieval are controlled by the pull wire. The protective umbrella is provided with filter holes for intercepting plaque emboli.
It enables the smooth release and retrieval of the protective umbrella, preventing its movement during surgery, effectively intercepting plaque emboli, and reducing the risk of postoperative complications.
Smart Images

Figure CN223529593U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical devices, and more specifically, to a protective device. Background Technology
[0002] Carotid artery stenosis (CAS) is a partial or complete blockage of the carotid artery caused by atherosclerosis, thrombosis, or trauma. It commonly occurs at the bifurcation of the common carotid artery and the origin of the internal carotid artery. The internal carotid artery is one of the main blood vessels supplying the brain. Once stenosis of the internal carotid artery leads to acute occlusion, the patient may experience severe cerebral ischemia and stroke symptoms, or even death.
[0003] Carotid artery stenting is one of the main treatments for carotid artery stenosis. The procedure typically involves puncturing the femoral artery, guiding a guidewire to the diseased vessel, and deploying a protective umbrella. This umbrella, positioned at the front of the diseased vessel, prevents thrombi from entering the brain. A balloon dilator is then used to dilate the stenotic segment. Once dilated, a stent is placed along the guidewire, and finally, the protective umbrella is retrieved, completing the procedure. However, current techniques often struggle to successfully deploy the protective umbrella from the distal end of the delivery catheter, and it is prone to displacement after deployment, thus affecting the progress of the procedure. Utility Model Content
[0004] To overcome the problems of difficulty in releasing the protective umbrella in existing technologies, and the tendency for the protective umbrella to deviate after release.
[0005] This utility model provides a protective device, which includes:
[0006] The delivery conduit has a through main cavity in the middle, and the distal end of the delivery conduit can be elastically deformed to change the inner diameter.
[0007] A guide wire is inserted into the main cavity, and a take-up frame is fixed to the outer periphery of the middle part of the guide wire. The take-up frame has a take-up hole.
[0008] The protective umbrella is elastically deformable to change its outer contour. The protective umbrella has a number of filter holes evenly spaced on it, and the middle part of the protective umbrella also has a guide hole that fits and is sleeved on the guide wire.
[0009] The wire is drawn, with its distal end fixedly connected to the proximal end of the protective umbrella. The wire passes through the take-up hole, and its proximal end extends out of the proximal end of the main cavity.
[0010] Preferably, a slider sleeved outside the guide wire is fixed to the middle of a surface of the protective umbrella facing the distal end of the guide wire; when the protective umbrella moves to the outside of the main cavity and unfolds, the protective umbrella is an arc-shaped structure protruding towards the distal end of the guide wire.
[0011] Preferably, when the protective umbrella moves outside the main cavity and unfolds, the aperture of the filter holes on the protective umbrella gradually increases from the middle of the protective umbrella to the edge of the protective umbrella, and the projected area of each filter hole on the plane where the cross-section of the delivery conduit is located is the same.
[0012] Preferably, the protective umbrella comprises:
[0013] The skeleton is a ring-shaped skeleton that can be elastically deformed;
[0014] An elastic membrane is fixed to the skeleton at its outer edge. The elastic membrane has a plurality of filter holes evenly spaced on it. The guide hole is also provided in the middle of the elastic membrane. The slider is also fixed in the middle of a surface of the elastic membrane facing the distal end of the guide wire.
[0015] When the protective umbrella moves outside the main cavity and unfolds, the elastic membrane is an arc-shaped structure protruding toward the distal end of the guide wire, and the distal end of the wire is fixedly connected to the skeleton.
[0016] Preferably, the guidewire comprises, from its distal end to its proximal end, the following components:
[0017] First equal-diameter section;
[0018] The second variable diameter section has an outer diameter that gradually increases in the direction from the distal end of the guidewire to the proximal end of the guidewire. A limiting block is also fixed on the outer periphery of the second variable diameter section, and the limiting block is located near the distal end of the guidewire.
[0019] The third equal diameter section, the take-up frame is fixed to the outer periphery of the third equal diameter section;
[0020] The protective umbrella is disposed on the outer periphery of the second diameter-changing section.
[0021] Preferably, the delivery conduit is a dual-lumen delivery conduit, and the delivery conduit also has a side lumen. The inner diameter of the side lumen is smaller than the inner diameter of the main lumen. The side lumen and the main lumen extend in the same direction and are arranged side by side with intervals.
[0022] Preferably, the delivery conduit comprises:
[0023] Smooth lining;
[0024] The reinforcing layer is an arc-shaped sheet structure. The central angle corresponding to the cross-section of the reinforcing layer is 240° to 300°. The reinforcing layer is sleeved on one side of the outer surface of the smooth inner lining, and the reinforcing layer is disposed near the far end of the smooth inner lining.
[0025] The outer layer is a tubular structure disposed outside the smooth inner liner and the reinforcing layer. The outer layer includes a first segment, a second segment, and a third segment connected sequentially from the proximal end to the distal end. The hardness of the first segment, the second segment, and the third segment gradually decreases. The third segment includes a covering layer and an elastic layer disposed opposite to each other. The covering layer is disposed on the outer surface of the reinforcing layer. The central angle corresponding to the cross-section of the elastic layer is 60° to 120°. The elastic layer is disposed corresponding to the notch of the reinforcing layer.
[0026] Preferably, a marking ring is also provided at the distal end of the smooth inner liner.
[0027] Beneficial effects:
[0028] The beneficial effects of adopting the technical solution of this utility model are as follows:
[0029] (1) A main cavity is opened in the middle of the delivery conduit. The guide wire passes through the main cavity. A take-up frame is fixed on the outer periphery of the middle of the guide wire. A take-up hole is opened on the take-up frame. A guide hole is opened in the middle of the protective umbrella to fit and be sleeved on the guide wire. The distal end of the pull wire and the proximal end of the protective umbrella are fixedly connected. The pull wire passes through the take-up hole. The proximal end of the pull wire extends to the proximal end of the main cavity. The protective umbrella can be moved on the guide wire by pulling the wire. Pushing the pull wire moves the protective umbrella toward the distal end of the guide wire. Pulling the pull wire moves the protective umbrella toward the proximal end of the guide wire.
[0030] (2) The distal end of the delivery catheter can be elastically deformed to change its inner diameter. In the initial state without external force, the inner diameter of the entire delivery catheter remains consistent. When the delivery catheter is delivered to the narrow area of the internal carotid artery, the distal end of the delivery catheter is subjected to the pressure of the blood vessel and is squeezed and folded, which makes the inner and outer diameters of the distal end of the delivery catheter smaller at the same time, which is conducive to the insertion of the delivery catheter. When it is necessary to release or retrieve the protective umbrella, the distal end of the delivery catheter is subjected to the pressure of the protective umbrella and is stretched open, making the inner and outer diameters of the distal end of the delivery catheter larger than the initial state, which is conducive to the smooth release and retrieval of the protective umbrella.
[0031] (3) The protective umbrella can be elastically deformed to change its outer contour. When the protective umbrella is retracted into the delivery catheter and squeezed, it can shrink and fold inward. When the protective umbrella is released outside the delivery catheter and is not squeezed by external force, it can be unfolded. Therefore, the protective umbrella can be moved on the guidewire and released outside the delivery catheter or retracted into the delivery catheter by pulling the wire. After the protective umbrella is released to the distal end of the delivery catheter and reaches the distal end of the narrow area of the internal carotid artery, it can be unfolded and locked at the blood vessel to avoid the protective umbrella moving during the operation.
[0032] (4) The protective umbrella has several filter holes that are evenly spaced apart, which are used to allow blood to pass through and to intercept plaque emboli.
[0033] When this invention is applied to a surgical scenario, firstly, medical personnel insert the protective device into the patient's internal carotid artery. This involves inserting the distal end of the delivery catheter and the distal end of the guidewire together into the internal carotid artery and reaching the distal end of the stenotic area. Before releasing the protective umbrella, it is positioned within the main lumen and close to its distal end. By pulling the guidewire, the protective umbrella moves towards the distal end of the guidewire. After the protective umbrella is released beyond the distal end of the delivery catheter and reaches the distal end of the stenotic area of the internal carotid artery, it can unfold and lock into place at the blood vessel, preventing movement during the procedure. Then, after a stent is installed in the stenotic area of the internal carotid artery, plaque emboli may dislodge during stent release. The protective umbrella's filter holes allow blood to pass through and intercept the plaque emboli, preventing postoperative complications. After the stent is installed, pulling the guidewire retracts the protective umbrella, carrying the plaque emboli, back into the delivery catheter. Finally, the entire protective device is removed, completing the procedure. Attached Figure Description
[0034] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained from these drawings without creative effort.
[0035] Figure 1 This is a schematic diagram of the structure of a protective device according to this utility model;
[0036] Figure 2 This is a utility model Figure 1 Enlarged view of a portion of the image;
[0037] Figure 3 This is a schematic diagram of the elastic membrane structure in this utility model;
[0038] Figure 4 This is a schematic diagram of the guide wire structure in this utility model;
[0039] Figure 5 This is a schematic diagram of the structure of the smooth inner liner, reinforcing layer and marking ring in this utility model;
[0040] Figure 6 This is a schematic diagram of the delivery conduit in this utility model;
[0041] Figure 7 This is a cross-sectional view of the delivery conduit in this utility model;
[0042] In the picture:
[0043] 1-Delivery conduit, 101-Main lumen, 102-Side lumen, 2-Smooth inner liner, 3-Reinforcing layer, 4-Outer layer, 401-First section, 402-Second section, 403-Third section, 403a-Covering layer, 403b-Elastic layer, 5-Marking ring, 6-Guide wire, 6a-First equal diameter section, 6b-Second variable diameter section, 6c-Third equal diameter section, 601-Limiting block, 602-Take-up frame, 603-Take-up hole, 7-Skeleton, 8-Elastic membrane, 801-Filter hole, 802-Guide hole, 803-Slider, 9-Wire drawing. Detailed Implementation
[0044] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this utility model, not all of them. Therefore, the following detailed description of the embodiments of this utility model provided in the accompanying drawings is not intended to limit the scope of the claimed utility model, but merely to represent selected embodiments of this utility model. All other embodiments obtained by those skilled in the art based on the embodiments of this utility model without inventive effort are within the scope of protection of this utility model.
[0045] It should be noted that in interventional medicine, the end of the instrument closer to the operator is usually called the proximal end, and the end farther away from the operator is called the distal end. Specifically, the distal end refers to the end of the instrument that can be freely inserted into the animal or human body. The proximal end refers to the end operated by the user or machine, or the end used to connect to other devices.
[0046] Please refer to Figures 1 to 7This embodiment provides a protective device, which includes a delivery conduit 1, a guide wire 6, a protective umbrella, and a pull wire 9. A main cavity 101 is formed in the middle of the delivery conduit 1. The guide wire 6 passes through the main cavity 101. A take-up frame 602 is fixed to the outer periphery of the middle of the guide wire 6. A take-up hole 603 is formed on the take-up frame 602. A guide hole 802 is formed in the middle of the protective umbrella and fits around the guide wire 6. The distal end of the pull wire 9 is fixedly connected to the proximal end of the protective umbrella. The pull wire 9 passes through the take-up hole, and the proximal end of the pull wire 9 extends beyond the proximal end of the main cavity 101. The protective umbrella can be moved on the guide wire 6 by pulling the pull wire 9. Pushing the pull wire 9 moves the protective umbrella toward the distal end of the guide wire 6, and pulling the pull wire 9 moves the protective umbrella toward the proximal end of the guide wire 6. The distal end of catheter 1 is elastically deformable to change its inner diameter. In the initial state without external force, the inner diameter of the entire delivery catheter 1 remains consistent. When the delivery catheter 1 is delivered to the narrow area of the internal carotid artery, the distal end of the delivery catheter 1 is subjected to vascular pressure, causing it to be compressed and folded. This reduces both the inner and outer diameters of the distal end of the delivery catheter 1, facilitating insertion. When the protective umbrella needs to be released or retrieved, the distal end of the delivery catheter 1 is subjected to pressure from the protective umbrella, causing it to expand and increase its inner and outer diameters to be larger than the initial state, facilitating smooth release and retrieval. The protective umbrella is elastically deformable to change its outer contour. When the protective umbrella is retracted into the delivery catheter 1 and compressed, it can... The protective umbrella, which retracts and folds internally, can unfold when released from the delivery catheter 1 without being squeezed by external force. Therefore, it can be moved on the guidewire 6 and released outside the delivery catheter 1 or retrieved back into the delivery catheter 1 via the pull wire 9. After the protective umbrella is released to the distal end of the delivery catheter 1 and reaches the distal end of the stenotic area of the internal carotid artery, it can unfold and lock into place at the blood vessel, preventing movement of the protective umbrella during surgery. The protective umbrella has several evenly spaced filter holes 801 for allowing blood to pass through and intercepting plaque emboli. When applying this invention to an actual surgical scenario, medical personnel first insert the protective device into the patient's internal carotid artery, that is, the distal end of the delivery catheter 1 and the distal end of the guidewire 6 are inserted together into the internal carotid artery and reach the distal end of the stenotic area, releasing... Before the protective umbrella, it is positioned within the main lumen 101 and near its distal end. The protective umbrella is pushed by the pull wire 9, causing it to move towards the distal end of the guide wire 6. After the protective umbrella is released to the distal end of the delivery catheter 1 and reaches the distal end of the narrowing of the internal carotid artery, it can be unfolded and locked at the blood vessel to prevent the protective umbrella from moving during the operation. Then, after the stent is installed in the narrowing area of the internal carotid artery, since plaque emboli may dislodge during the stent release process, the blood passes through the filter hole 801 of the protective umbrella and intercepts the plaque emboli to avoid postoperative sequelae. After the stent is installed, the protective umbrella, carrying the plaque emboli, is retrieved into the delivery catheter 1 by the pull wire 9. Finally, the protective device is completely removed, and the operation is completed.
[0047] In a preferred embodiment, a slider 803 is fixed to the middle of a surface of the protective umbrella facing the distal end of the guide wire 6, which is sleeved on the guide wire 6. The slider 803 is set corresponding to the guide hole 802, which is conducive to the smooth movement of the protective umbrella on the guide wire 6 under the action of the pushing or pulling force of the wire 9. When the protective umbrella moves to the outside of the main cavity 101 and unfolds, the protective umbrella has an arc-shaped structure protruding towards the distal end of the guide wire 6, which is conducive to the protective umbrella intercepting plaque emboli. When the protective umbrella is retrieved, the plaque emboli are wrapped inside the protective umbrella and retrieved together.
[0048] In a preferred embodiment, when the protective umbrella moves outside the main cavity 101 and unfolds, the diameter of the filter holes 801 on the protective umbrella gradually increases from the middle to the edge of the protective umbrella, and the projected area of each filter hole 801 on the plane of the cross-section of the delivery conduit 1 is the same, so that each filter hole 801 has the same interception effect on plaque emboli. The closer the filter hole 801 is to the skeleton 7, the better the blood permeability. In a preferred embodiment, the projected shape of the filter hole 801 is circular, which has a good blood permeability and makes the structure of the elastic membrane 8 more stable.
[0049] In a preferred embodiment, the protective umbrella includes a frame 7 and an elastic membrane 8. The frame 7 is an elastically deformable annular frame 7 made of elastic metal material. The elastic membrane 8 is a polymer membrane made of Pebax material or TPU material. The outer edge of the elastic membrane 8 is fixed to the frame 7. When the protective umbrella is inside the main lumen 101 of the delivery catheter 1, the frame 7 and the elastic membrane 8 are compressed and folded inward. When the protective umbrella is outside the delivery catheter 1, the frame 7 is not compressed by external force, the elastic membrane 8 unfolds, and the frame 7 is locked at the blood vessel. The elastic membrane 8 has a plurality of filter holes 801 evenly spaced. The middle part of the elastic membrane 8 also has a guide hole 802. A slider 803 is fixed in the middle of the surface of the elastic membrane 8 facing the distal end of the guidewire 6. When the protective umbrella moves to the outside of the main lumen 101 and unfolds, the elastic membrane 8 is an arc-shaped structure protruding towards the distal end of the guidewire 6. The distal end of the pull wire 9 is fixedly connected to the frame 7. The pull wire 9 pulls the frame 7 to drive the protective umbrella to move as a whole.
[0050] In a preferred embodiment, the guidewire 6 includes a first constant diameter section 6a, a second variable diameter section 6b, and a third constant diameter section 6c sequentially from its distal end to its proximal end; the outer diameter of the second variable diameter section 6b gradually increases in the direction from the distal end of the guidewire 6 to the proximal end of the guidewire 6, and a limiting block 601 is fixed on the outer periphery of the second variable diameter section 6b, the limiting block 601 being disposed near the distal end of the guidewire 6; a take-up bracket 602 is fixed on the outer periphery of the third constant diameter section 6c; wherein, a protective umbrella is disposed on the outer periphery of the second variable diameter section 6b, limiting the movement of the protective umbrella on the second variable diameter section 6b.
[0051] In a preferred embodiment, the delivery catheter 1 is a dual-lumen delivery catheter 1, and the delivery catheter 1 also has a side lumen 102. The inner diameter of the side lumen 102 is smaller than the inner diameter of the main lumen 101. The side lumen 102 and the main lumen 101 extend in the same direction and are arranged side by side with intervals. The side lumen 102 is used for rapid exchange of guidewire 6.
[0052] In a preferred embodiment, the delivery conduit 1 includes a smooth inner liner 2, a reinforcing layer 3, and an outer layer 4. The smooth inner liner 2 is a tubular structure with good lubricity, facilitating the release and retrieval of the protective umbrella. The reinforcing layer 3 is an arc-shaped sheet structure made of elastic metal material, with a central angle of 240° to 300° corresponding to the cross-section of the reinforcing layer 3. The reinforcing layer 3 is fitted onto one side of the outer surface of the smooth inner liner 2, and is positioned near the distal end of the smooth inner liner 2. The outer layer 4 is a tubular structure disposed outside the smooth inner liner 2 and the reinforcing layer 3. The outer layer 4 includes a first segment 401, a second segment 402, and a third segment 403 connected sequentially from the proximal end to the distal end. The hardness of the first segment 401, the second segment 402, and the third segment 403 gradually decreases. The outer layer is made of polymer material. The third segment 403 includes a covering layer 403a and an elastic layer 403b disposed opposite to each other. The covering layer 403a is disposed on the reinforcing layer. On the outer surface of layer 3, the central angle corresponding to the cross-section of the elastic layer 403b is 60° to 120°. The elastic layer 403b is set with a notch corresponding to the reinforcing layer 3, so as to have a certain support performance. At the same time, it allows the distal end of the delivery catheter 1 to be elastically deformable and its inner diameter to be variable. The distal end of the delivery catheter 1 can be elastically deformed to change its inner diameter. In the initial state without external force, the inner diameter of the entire delivery catheter 1 remains consistent. When the delivery catheter 1 is delivered to the narrow area of the internal carotid artery, the elastic layer 403b is subjected to the pressure of the blood vessel and is squeezed and folded, so that the inner and outer diameters of the distal end of the delivery catheter 1 become smaller at the same time, which is conducive to the insertion of the delivery catheter 1. When it is necessary to release or retrieve the protective umbrella, the elastic layer 403b is subjected to the pressure of the protective umbrella and is stretched open, so that the inner and outer diameters of the distal end of the delivery catheter 1 are larger than the initial state, which is conducive to the smooth release and retrieval of the protective umbrella.
[0053] In a preferred embodiment, a marking ring 5 is provided at the distal end of the smooth inner liner 2 to facilitate identification of the location of the distal end of the delivery conduit 1.
[0054] The above are merely preferred embodiments of this utility model and are not intended to limit the scope of this utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of this utility model should be included within the protection scope of this utility model.
Claims
1. A protective device, characterized in that, It includes: The delivery conduit has a through main cavity in the middle, and the distal end of the delivery conduit can be elastically deformed to change the inner diameter. A guide wire is inserted into the main cavity, and a take-up frame is fixed to the outer periphery of the middle part of the guide wire. The take-up frame has a take-up hole. The protective umbrella is elastically deformable to change its outer contour. The protective umbrella has a number of filter holes evenly spaced on it, and the middle part of the protective umbrella also has a guide hole that fits and is sleeved on the guide wire. The wire is drawn, with its distal end fixedly connected to the proximal end of the protective umbrella. The wire passes through the take-up hole, and its proximal end extends out of the proximal end of the main cavity.
2. The protection device as described in claim 1, characterized in that: A slider is fixed to the center of a surface of the protective umbrella facing the distal end of the guide wire, and the slider is configured to correspond to the guide hole; when the protective umbrella moves to the outside of the main cavity and unfolds, the protective umbrella is an arc-shaped structure protruding towards the distal end of the guide wire.
3. The protection device as described in claim 2, characterized in that: When the protective umbrella moves outside the main cavity and unfolds, the diameter of the filter holes on the protective umbrella gradually increases from the middle of the protective umbrella to the edge of the protective umbrella, and the projected area of each filter hole on the plane where the cross-section of the delivery conduit is located is the same.
4. The protection device as described in claim 3, characterized in that, The protective umbrella includes: The skeleton is a ring-shaped skeleton that can be elastically deformed; An elastic membrane is fixed to the skeleton at its outer edge. The elastic membrane has a plurality of filter holes evenly spaced on it. The guide hole is also provided in the middle of the elastic membrane. The slider is also fixed in the middle of a surface of the elastic membrane facing the distal end of the guide wire. When the protective umbrella moves outside the main cavity and unfolds, the elastic membrane is an arc-shaped structure protruding toward the distal end of the guide wire, and the distal end of the wire is fixedly connected to the skeleton.
5. The protection device as described in claim 1, characterized in that, The guidewire comprises, from its distal end to its proximal end, the following: First equal-diameter section; The second variable diameter section has an outer diameter that gradually increases in the direction from the distal end of the guidewire to the proximal end of the guidewire. A limiting block is also fixed on the outer periphery of the second variable diameter section, and the limiting block is located near the distal end of the guidewire. The third equal diameter section, the take-up frame is fixed to the outer periphery of the third equal diameter section; The protective umbrella is disposed on the outer periphery of the second diameter-changing section.
6. The protection device as described in claim 1, characterized in that: The delivery conduit is a dual-lumen delivery conduit, and the delivery conduit also has a side lumen. The inner diameter of the side lumen is smaller than the inner diameter of the main lumen. The side lumen and the main lumen extend in the same direction and are arranged side by side at intervals.
7. A protective device as described in claim 1, characterized in that, The delivery conduit includes: Smooth lining; The reinforcing layer is an arc-shaped sheet structure. The central angle corresponding to the cross-section of the reinforcing layer is 240° to 300°. The reinforcing layer is sleeved on one side of the outer surface of the smooth inner lining, and the reinforcing layer is disposed near the far end of the smooth inner lining. The outer layer is a tubular structure disposed outside the smooth inner liner and the reinforcing layer. The outer layer includes a first segment, a second segment, and a third segment connected sequentially from the proximal end to the distal end. The hardness of the first segment, the second segment, and the third segment gradually decreases. The third segment includes a covering layer and an elastic layer disposed opposite to each other. The covering layer is disposed on the outer surface of the reinforcing layer. The central angle corresponding to the cross-section of the elastic layer is 60° to 120°. The elastic layer is disposed corresponding to the notch of the reinforcing layer.
8. The protection device as described in claim 1, characterized in that: A marking ring is also provided at the distal end of the smooth inner liner.