CN216570341U - Double-layer biliary tract stent - Google Patents
Double-layer biliary tract stent Download PDFInfo
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- CN216570341U CN216570341U CN202121778779.1U CN202121778779U CN216570341U CN 216570341 U CN216570341 U CN 216570341U CN 202121778779 U CN202121778779 U CN 202121778779U CN 216570341 U CN216570341 U CN 216570341U
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Abstract
The utility model discloses a double-layer biliary tract stent. The support mainly includes: the first layer of bracket is of a hollow tubular structure, and the side wall of the first layer of bracket is provided with at least one through hole; the second layer support is positioned in the first layer support and is of a hollow tubular structure, at least one positioning sheath is arranged on the side wall of the second layer support, and the positioning sheath can be switched between a state of protruding from the through hole and a state of retreating to the inside of the first layer support through the relative rotation of the second layer support and the first layer support. When the biliary tract stent is moved out, the positioning sheath can enter the outer-layer stent, biliary tract tissues are not scratched due to protrusion, and discomfort or inflammation and infection risks of patients are avoided.
Description
Technical Field
The utility model relates to the technical field of medical materials, in particular to a double-layer biliary tract stent.
Background
A biliary stent is generally a stent installed between the papilla of the duodenum and the deep biliary tract. Biliary stricture and obstruction may be caused by gallstone, cancer of bile duct and abnormal proliferation of tissue, if obstruction of biliary tract may cause symptoms of yellow gall, inflammation of liver and even cirrhosis, etc., and biliary tract stent may be used for treating biliary stricture.
The front and back of the bracket are communicated, so that bile can be smoothly discharged when the bracket is arranged in a biliary tract, most common biliary tract brackets on the market at present have a structure with an opened positioning sheath on one side, and the biliary tract is easily scratched and bleeds when a doctor installs or takes the biliary tract.
SUMMERY OF THE UTILITY MODEL
In view of the above, an object of the present invention is to provide a double-layered biliary stent that can reliably discharge bile and can avoid damage to the biliary tract.
In order to achieve the above object, the present invention provides a double-layered biliary stent. This double-deck biliary tract support includes:
the first layer of bracket is of a hollow tubular structure, and the side wall of the first layer of bracket is provided with at least one through hole;
the second layer support is positioned in the first layer support and is of a hollow tubular structure, at least one positioning sheath is arranged on the side wall of the second layer support, and the positioning sheath can be switched between a state of protruding from the through hole and a state of retreating to the inside of the first layer support through the relative rotation of the second layer support and the first layer support.
Optionally, the positioning sheath is formed by tilting a part of a sidewall of the second layer support relative to the rest of the sidewall of the second layer support.
Optionally, a first through hole is formed in a side wall of the first layer of bracket at the first end, a second through hole is formed in a side wall of the first layer of bracket at the second end, and the first through hole and the second through hole are arranged at the same side position relative to the axis of the first layer of bracket;
a first positioning sheath is arranged on the side wall of the first end side of the second-layer bracket, a second positioning sheath is arranged on the side wall of the second end side of the second-layer bracket, and the first positioning sheath and the second positioning sheath are arranged at the same side position relative to the axis of the second-layer bracket;
in the use state of the double-layered biliary stent, the second positioning sheath is switchable between a state of protruding from the second through-hole and a state of retracting into the first-layer stent by relative rotation between the second-layer stent and the first-layer stent, and the first positioning sheath is locked to the first-layer stent when the second positioning sheath is in the state of protruding from the second through-hole.
Optionally, the first positioning sheath and the second positioning sheath are tilted in a manner opposite to each other along the direction in which the second layer of stent extends.
Optionally, a third through hole facing opposite to the second through hole is provided on a side wall of the second end side of the first layer bracket, and the third through hole and the second through hole do not overlap in the extending direction of the first layer bracket;
and a fourth through hole opposite to the second positioning sheath in direction is arranged on the side wall of the second layer bracket at the second end side, and the fourth through hole is communicated with the third through hole under the state that the second positioning sheath protrudes from the second through hole.
Optionally, the length of the first layer of scaffold is less than the length of the second layer of scaffold.
Optionally, the first end side is an operation end side, the second end side is a distal end side away from the operation end side,
the inner diameter of the end portion on the second end side of the first-layer stent is smaller than the outer diameter of the end portion on the second end side of the second-layer stent.
Optionally, the positioning sheath has a curved outer edge.
Optionally, the first layer of scaffold and the second layer of scaffold are at least one material selected from polycarbonate, thermoplastic polyurethane elastomer, polyurethane, polyethylene, nylon, polyether-polyamide block copolymer, and polyvinylidene fluoride.
Optionally, the first layer of bracket and the second layer of bracket are in any one of a circular arc shape, a dog-ear shape and a double-ring shape.
The utility model has the advantages of
In the double-layer biliary tract stent provided by the embodiment of the utility model, the side wall of the first layer stent is provided with at least one through hole, the side wall of the second layer stent is provided with at least one positioning sheath, and the positioning sheath can be switched between a state of protruding from the through hole and a state of retreating into the first layer stent through the relative rotation of the second layer stent and the first layer stent, namely when the stent is taken out from a patient, the positioning sheath can be retreated into the first layer stent through the through hole through the relative rotation of the second layer stent and the first layer stent, so that biliary tract tissues are not scratched due to the protrusion of the positioning sheath, and the risk of discomfort or inflammation infection of the patient is avoided.
Drawings
Fig. 1 is a schematic structural diagram of a double-layered biliary stent according to an embodiment of the present invention.
Fig. 2 is a schematic structural diagram of a first layer of a scaffold according to an embodiment of the present invention.
Fig. 3 is a schematic structural diagram of a second layer of a bracket according to an embodiment of the present invention.
Fig. 4 is a schematic structural diagram of a positioning sheath according to an embodiment of the present invention.
Fig. 5 is a schematic cross-sectional view of a second end side (distal end side) of a double-layer biliary tract stent provided in an embodiment of the present invention.
Fig. 6 is a schematic cross-sectional view of a first end side (proximal end side) of a double-layered biliary stent provided in an embodiment of the present invention.
Description of the reference numerals
1-a first layer of scaffold; 11-a first via; 12-a second via; 13-a third via;
2-a second layer of scaffold; 21-a second localization sheath; 22-a second localization sheath; 23-fourth via.
Detailed Description
Reference will now be made in detail to the exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, like numbers in different drawings represent the same or similar elements unless otherwise indicated. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of systems and methods consistent with certain aspects of the utility model, as detailed in the appended claims.
Fig. 1 is a schematic structural diagram illustrating a double-layered biliary stent according to an exemplary embodiment. Referring to fig. 1, the double-layered biliary stent includes: a first layer of scaffolds 1 and a second layer of scaffolds 2.
The embodiment improves the traditional biliary tract stent, and improves the original single-layer biliary tract stent into a double-layer biliary tract stent, so that the injury to the bile duct caused by the doctor in the process of disassembling or replacing the biliary tract stent can be reduced.
Specifically, the first layer bracket 1 is an outer layer bracket and adopts a hollow tubular structure, and the side wall of the first layer bracket 1 is provided with at least one through hole; the second layer support 2 is an inner layer support, is positioned in the first layer support 1 and is of a hollow tubular structure, at least one positioning sheath is arranged on the side wall of the second layer support 2, and the positioning sheath can be switched between a state of protruding from the through hole and a state of retreating to the inside of the first layer support through the relative rotation of the second layer support 2 and the first layer support 1.
In the double-layer biliary tract stent, under the drainage state, the positioning sheath on the side wall of the second layer stent 2 protrudes through the through hole of the first layer stent 1, so that the inner cavity of the second layer stent 2 is communicated with the biliary tract; when the stent is taken out from a patient, the positioning sheath can be retracted into the first-layer stent 1 from a state of protruding through the through hole by relative rotation of the second-layer stent 2 and the first-layer stent 1, so that when a doctor removes the stent, the positioning sheath of the inner-layer stent contracts into the outer-layer stent, biliary tract tissues cannot be scratched due to protruding, and discomfort or inflammation and infection risks of the patient are avoided.
In one embodiment, as shown in fig. 2, a first through hole 11 is provided on a side wall of a first end side (proximal side) of the first layer stent 1, and a second through hole 12 is provided on a side wall of a second end side (distal side) of the first layer stent 1. As shown in fig. 2, the first through hole 11 and the second through hole 12 are provided at the same side position with respect to the axis of the first-layer stent 1, and thus the orientation of the second through hole 12 and the positioning sheath extending from the second through hole 12 can be determined by observing the orientation of the first through hole 11. Of course, the first through hole 11 and the second through hole 12 may be disposed on opposite sides with respect to the axis of the bracket, respectively, or disposed in other relative positional relationships.
A third through hole 13 facing opposite to the second through hole 12 may be provided on a side wall of the second end side (distal end side) of the first layer stent 1, and the third through hole 13 and the second through hole 12 do not overlap in the extending direction of the first layer stent 1. Because the far end side of the first layer bracket 1 is provided with two through holes communicated with the biliary tract cavity, the first layer bracket is beneficial to the rapid discharge of bile. Moreover, even if one of the two through holes is blocked by gallstones or other tissues, the other through hole can still ensure the communication with the bile duct cavity. The third through hole 13 and the second through hole 12 are opposite in direction, so that the situation that the two through holes are blocked can be avoided as much as possible.
The overall shape of the first-layer stent 1 is not particularly limited as long as it is a tube shape suitable for insertion into a lumen such as a biliary tract. The overall arc shape is schematically shown in fig. 2, but is not limited thereto, and the overall shape may be appropriately changed depending on the application site.
In one embodiment, as shown in fig. 3, a first positioning sheath 21 is provided on a side wall of a first end side (proximal side) of the second-layer stent 2 (inner-layer stent), and a second positioning sheath 22 is provided on a side wall of a second end side (distal side) of the second-layer stent 2, as shown in fig. 3, the first positioning sheath 21 and the second positioning sheath 22 are provided at the same side position with respect to the axis of the second-layer stent 2, whereby the position of the distal-side positioning sheath located in the body can be known by observing the position of the proximal-side positioning sheath 31. Of course, the two positioning sheaths can be arranged on opposite sides of the axis of the second layer stent or in other positional relationships.
As shown in fig. 3 and 4, the positioning sheath is formed by tilting a part of the sidewall of the second-layer holder 2 with respect to the remaining part of the sidewall of the second-layer holder 2. Thus, the positioning sheath can be integrally formed on the second layer stent 2, which not only saves the cost of the stent, but also helps to smoothly switch the positioning sheath between a state of protruding from the through hole and a state of retreating into the first layer stent.
In one embodiment, the positioning sheath has a curved outer edge. Through the outer fringe shape of arc line type, not only can reduce the injury that the location sheath caused to the disease when being fixed in the biliary tract, can rotate more smoothly when receiving with first layer support 1 cooperation moreover.
For example, in a state where the first-layer stent 1 and the second-layer stent 2 are assembled together (for example, in a state where a double-layer biliary stent is used), as shown in fig. 1, 4, 5, and 6, the second positioning sheath 22 protrudes through the second through hole 12, and the first positioning sheath 21 may protrude through the first through hole 11 like the second positioning sheath, or may be locked to an edge in the vicinity of the first through hole 11 without protruding into the through hole, for example, an end edge of the first-layer stent 1, a recess provided in the end edge, or the like. By relatively rotating the second layer holder 2 and the first layer holder 1, the second positioning sheath 22 can be switched between a state of protruding from the second through hole 12 and a state of retreating into the first layer holder 1. In the retracted state, the second positioning sheath 22 is retracted inside the first-layer stent 1.
Alternatively, the first positioning sheath 21 and the second positioning sheath 22 of the present embodiment may be turned up in such a manner as to oppose each other in the direction in which the second-layer stent 2 extends, as shown in fig. 3, and this structure may allow easy and stable relative positioning between the second-layer stent 2 and the first-layer stent 1, and more stable positioning in the bile duct in a simple manner.
In addition, because the positioning sheath on the first end side and the positioning sheath on the second end side are arranged in the same direction (for example, at a position corresponding to the extending direction of the stent), a doctor can check whether the positioning sheath on the first end side is retracted, and can judge whether the positioning sheath on the second end side is retracted, for example, when the first positioning sheath 21 on the first end side (the end closer to the biliary tract inlet) is staggered 180 degrees with the first through hole 11, the second positioning sheath 22 on the second end side (the end farther from the biliary tract inlet) can be represented to be retracted, so that the doctor can check and operate conveniently, and the operation is convenient.
In the above embodiment, since the outer stent has the corresponding opening at the protruding position of the positioning sheath, the remote opening (the second through hole 12) can make the first positioning sheath 21 protrude from the outer stent, and make bile flow out from the second through hole 12, so as to prevent bile from accumulating in the biliary tract to cause biliary tract pathological changes or inflammation, and the proximal opening (the first through hole 11) can allow a physician to determine whether the remote positioning sheath is in an open state during a clinical operation, and at the same time, the hole can also be used as a bile flow channel.
In addition, a fourth through hole 23 facing the second positioning sheath 22 may be provided in a side wall on the second end side (distal end side) of the second layer holder 2, and the fourth through hole 23 may communicate with the third through hole 13 in a state where the second positioning sheath 22 protrudes from the second through hole 12. The support is communicated front and back, so that the support can discharge bile smoothly when inside the biliary tract, and the hole structures (the third through hole 13 of the first layer of support 1 and the fourth through hole 23 of the second layer of support 2) are arranged on the side wall of the biliary tract support, so that bile can be discharged smoothly when gallstones block a certain through hole on the far end side.
It should be understood that the structure and number of the positioning sheaths are not limited in this embodiment, the positioning sheaths may be a single-piece, double-piece, or four-piece or more than four-piece structure, and the number may be determined according to the operation requirement, so that the biliary tract stent is more stably positioned in the bile duct. The positioning sheath of the inner layer bracket of the embodiment corresponds to the through holes of the outer layer bracket one by one.
Optionally, the length of the first layer stent 1 of the embodiment is smaller than the length of the second layer stent 2.
The length of the first-layer stent 1 is smaller than that of the second-layer stent 2, so that the first positioning sheath 21 of the inner-layer biliary stent can be easily locked to the first-layer stent 1 as shown in fig. 6, and the outer-layer biliary stent can be prevented from sliding toward the duodenal end or deep into the tissue. The length of the first-layer stent 1 is smaller than that of the second-layer stent 2, so that the biliary stent can be conveniently positioned by a doctor, and the doctor can also be helped to judge the position relationship between the first-layer stent 1 and the second-layer stent 2, for example, when the first positioning sheath 21 is dislocated from the first through hole 11 by 180 degrees, the second positioning sheath 22 can be withdrawn, or the first positioning sheath 21 is contracted into the first-layer stent 1 and the second positioning sheath 22 can be withdrawn, or the first positioning sheath 21 protrudes through the first through hole 11 of the first-layer stent 1 and the second positioning sheath 22 can be protruded, so that the doctor can conveniently view and operate the biliary stent, and the operation is convenient.
Optionally, the first end side of the present embodiment is an operation end side, and the second end side is a distal end side far away from the operation end side; and the inner diameter of the end part of the second end side of the first layer of bracket is smaller than the outer diameter of the end part of the second end side of the second layer of bracket, namely, the inner diameter of the opening at the farthest position of the outer layer biliary tract bracket is slightly smaller than the outer diameter of the inner layer biliary tract bracket. This can more reliably prevent the second layer stent (inner layer stent) 2 from coming off the distal end side of the first layer stent (outer layer stent) 1.
The length and the outer diameter of the double-layer biliary tract stent of the embodiment can be determined or used according to the condition of different patients. The internal diameter of the most remote opening of the outer biliary tract stent is slightly smaller than the external diameter of the inner biliary tract stent, so that the outer biliary tract stent is fixed in the first positioning sheath 21 by the first positioning sheath 21 of the inner biliary tract stent, as shown in fig. 6, the outer biliary tract stent can be prevented from sliding towards the duodenum end or the tissue deep position.
Regarding the material of the double-layered biliary stent, in one embodiment, the first-layer stent 1 and the second-layer stent 2 may be at least one material selected from polycarbonate, thermoplastic polyurethane elastomer, polyurethane, polyethylene, nylon, polyether-polyamide block copolymer, and polyvinylidene fluoride.
The inner stent and the outer stent of this embodiment are made of the same material, and the biliary stent is generally made of a material having a certain elasticity and rigidity, such as one or more of polycarbonate, thermoplastic polyurethane elastomer, polyurethane, polyethylene, nylon, polyether-polyamide block copolymer, and polyvinylidene fluoride, so as to prevent the stent from damaging the biliary tract.
In one embodiment, the cross-sectional shapes of the first-layer bracket 1 and the second-layer bracket 2 can be arc-shaped, horn-shaped, double-ring-shaped and the like, so that the applicability is strong, and the device can be suitable for various symptoms or physical states. The biliary tract stent is not limited to one double-layer stent at a time in use, and can be arranged on a single affected part in a single operation by using a plurality of stents, and the number of the stents is judged according to the actual clinical evaluation of doctors. It should be understood that the present invention has various designs on the outer diameter and length dimensions of the biliary stent, which can be selected by the physician after the evaluation of the physical condition and signs of the patient.
The method for producing the double-layered biliary stent may be injection molding, machine molding, extrusion coating molding, cast molding, or the like. The method of manufacturing the double-layered biliary stent according to the embodiment of the present invention is not particularly limited as long as the double-layered biliary stent can be manufactured.
Next, the use of the double-layered biliary stent of the present embodiment in a practical procedure will be described.
The physician first evaluates the condition of the patient preoperatively and then determines the appropriate surgical approach to use the double-layered biliary stent of the present embodiment for biliary endoscopy drainage. For example, in the operation, a physician may first insert a biliary endoscope through the oral cavity, the esophagus, the stomach, and into the opening of the duodenal papilla, i.e., the bile duct outlet, introduce a radiopaque guide wire into the biliary tract, and then push the double-layered biliary tract stent of the present embodiment into the biliary tract along the guide wire, where the distal positioning sheath (the second positioning sheath 22) may be completely protruded from the outer biliary tract stent or contracted within the outer biliary tract stent; then the saccule conduit is inserted into the inner layer biliary tract stent, after the saccule is expanded, the saccule conduit is rotated and drives the inner layer biliary tract stent due to the friction force between the saccule and the inner wall of the stent, so that the positioning sheath at the far end side of the inner layer biliary tract stent can be popped out from the gap (the second through hole 12) of the outer layer biliary tract stent. The proximal positioning sheath (first positioning sheath 21) is not inserted into the biliary tract, but is locked to the proximal end edge of the first-layer stent 1 (outer-layer stent) as a means for stopping the mastoid. In the above steps, the physician can observe and ensure whether the double-layer biliary tract stent smoothly reaches the affected part under the assistance of the X-ray, and the time for placing the stent in the patient is generally about 1 to 3 months after being placed in the patient according to the assessment of the physician.
When the patient needs to remove the stent or replace the stent, the doctor can rotate the inner-layer biliary stent to enable the positioning sheath of the inner-layer biliary stent to be contracted into the outer-layer biliary stent, and the inner-layer biliary stent and the outer-layer biliary stent are taken out. Specifically, in the dismantlement in-process, the doctor can be earlier with biliary tract endoscope through the oral cavity in the art, the esophagus, the stomach, go deep to the opening part of duodenum mastoid, find the position of installing the biliary tract support, switch on the guide wire into novel double-deck biliary tract support, let in the double-deck biliary tract support with sacculus pipe via the guide wire again, and expand the sacculus in order to withstand the inner wall of inner support, carry out anticlockwise or clockwise rotation, inner biliary tract support begins to rotate along with the sacculus pipe direction because of frictional force this moment, the location sheath of distal end side is because of the structural design of corresponding hole scarf, can be driven the location sheath and return to in hole (second through hole 12), finally be fixed in outer support pipe wall, then pull out outside the biliary tract in the lump with sacculus pipe. And after the inner biliary tract stent is removed, taking out the outer biliary tract stent in the same way.
When the double-layer biliary tract stent is taken out from a patient, the second-layer stent 2 can be rotated to enable the through holes of the first-layer stent 1 to place the positioning sheaths inside the first-layer stent 1, so that biliary tract tissues are not scratched due to protrusion, the risk of discomfort or inflammation and infection of the patient is avoided, and the first-layer stent 1 is provided with the corresponding through holes at the protrusion position of the positioning sheaths, so that the positioning sheaths protrude out of the first-layer stent 1, bile can flow out through the through holes, and biliary tract lesion or inflammation caused by accumulation of bile in the biliary tract is prevented; meanwhile, the positioning sheath is designed to be an arc curve, so that the injury to a patient when the positioning sheath is fixed on a biliary tract can be reduced, and the positioning sheath can be better rotated and folded when being matched with the first-layer bracket 1; moreover, the inner diameter of the farthest opening (the second through hole 12) of the outer biliary tract stent is slightly smaller than the outer diameter of the inner biliary tract stent, and the length of the outer biliary tract stent is slightly shorter than that of the inner biliary tract stent, so that the outer biliary tract stent can be fixed in the first positioning sheath 21 by the first positioning sheath 21, and the outer biliary tract stent is prevented from sliding towards the duodenal end or deep tissue.
Other embodiments of the utility model will be apparent to those skilled in the art from consideration of the specification and practice of the utility model disclosed herein. This application is intended to cover any variations, uses, or adaptations of the utility model following, in general, the principles of the utility model and including such departures from the present disclosure as come within known or customary practice within the art to which the utility model pertains. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the utility model being indicated by the following claims.
For example, the stent of the present invention is not limited in its application to the biliary tract, but may be applied to other lumens in the body where drainage is desired.
It will be understood that the utility model is not limited to the precise arrangements described above and shown in the drawings and that various modifications and changes may be made without departing from the scope thereof. The scope of the utility model is limited only by the appended claims.
Claims (9)
1. A double-layered biliary stent, comprising:
the first layer of bracket is of a hollow tubular structure, and the side wall of the first layer of bracket is provided with at least one through hole;
the second layer support is positioned in the first layer support and is of a hollow tubular structure, at least one positioning sheath is arranged on the side wall of the second layer support, and the positioning sheath can be switched between a state of protruding from the through hole and a state of retreating to the inside of the first layer support through the relative rotation of the second layer support and the first layer support.
2. The double-layered biliary stent of claim 1, wherein the positioning sheath is formed by tilting a portion of a sidewall of the second-layer stent relative to a remaining portion of the sidewall of the second-layer stent.
3. The double-layered biliary stent according to claim 1 or 2, wherein a first through hole is provided in a side wall of the first layer stent on the first end side, a second through hole is provided in a side wall of the first layer stent on the second end side, and the first through hole and the second through hole are provided in the same side position with respect to an axis of the first layer stent;
a first positioning sheath is arranged on the side wall of the first end side of the second layer of bracket, a second positioning sheath is arranged on the side wall of the second end side of the second layer of bracket, and the first positioning sheath and the second positioning sheath are arranged at the same side position relative to the axis of the second layer of bracket;
in the use state of the double-layered biliary stent, the second positioning sheath is switchable between a state of protruding from the second through-hole and a state of retracting into the first-layer stent by relative rotation between the second-layer stent and the first-layer stent, and the first positioning sheath is locked to the first-layer stent when the second positioning sheath is in the state of protruding from the second through-hole.
4. The double-layered biliary stent of claim 3, wherein the first positioning sheath and the second positioning sheath are tilted in a manner opposite to each other along a direction in which the second-layered stent extends.
5. The double-layered biliary stent according to claim 3, wherein a third through hole facing opposite to the second through hole is provided in a side wall of the first-layer stent on the second end side, and the third through hole and the second through hole do not overlap in an extending direction of the first-layer stent;
and a fourth through hole opposite to the second positioning sheath in direction is arranged on the side wall of the second end side of the second layer bracket, and the fourth through hole is communicated with the third through hole under the condition that the second positioning sheath protrudes from the second through hole.
6. The double-layered biliary stent of claim 1, wherein the first-layer stent has a length that is less than a length of the second-layer stent.
7. The double-layered biliary stent of claim 3, wherein the first end side is an operation end side, the second end side is a distal end side away from the operation end side,
the inner diameter of the end portion on the second end side of the first-layer stent is smaller than the outer diameter of the end portion on the second end side of the second-layer stent.
8. The double-layered biliary stent of claim 2, wherein the positioning sheath has an arcuate outer edge.
9. The double-layered biliary stent according to claim 1, wherein the first-layer stent and the second-layer stent have any one of a circular arc shape, a dog-ear shape, and a double loop shape.
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