Component for loading self-expanding stent, assembly comprising component and self-expanding stent loading system
By designing components of the taper change zone in the catheter loading system, the problem of over-pushing of the sheath in the catheter loading system is solved, and a more stable loading process and better stent release effect is achieved.
Patent Information
- Application Number
- CN202420840240.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-22
- Publication Date
- 2025-03-14
- Estimated Expiration
- 2034-04-22
AI Technical Summary
When the existing catheter loading system loads the self-expanding bracket from the guide sheath into the catheter, it is easy to cause the sheath to be over-pushed into the conical wall, causing excessive compression of the distal end of the bracket to affect the release effect and radial support force.
A member for loading a self-expanding stent is designed, including a sheath insertion channel and a catheter insertion channel in the tube body, and a taper change zone is provided between the channels. By providing a position signal through the taper variation from the small taper region to the large taper region, the operator can stop the sheath push and avoid excessive compression.
It effectively avoids excessive push of the sheath into the conical wall, reduces excessive compression of the distal end of the stent, and improves the stability of the loading system and the release effect of the stent.
Smart Images
Figure CN222604758U_ABST
Abstract
Description
Technical Field
[0001] The present invention belongs to the field of vascular access, and in particular relates to a component for loading a self-expanding stent, a component containing the component, and a self-expanding stent loading system. Background Art
[0002] Catheters are commonly used intravascular devices in the medical field. They are usually inserted into the femoral artery, radial artery, carotid artery or jugular vein of the patient and pass through the patient's blood vessels to reach the heart, brain or other target anatomical structures. During use, the catheter needs to pass through curved blood vessels to reach the anatomical location, and needs to have good pressure resistance, strong twist control, pushability, strong bending resistance and timely response.
[0003] Medical catheters usually include a tube body, a tapered buffer tube and a connecting component, wherein the tube body is connected to the inside of the tapered portion of the connecting component, and the tapered buffer tube is sleeved at the proximal end of the tube body and the outside of the tapered portion of the connecting component. The tapered buffer tube helps to prevent bending at the connection between the tube body and the connecting component during use of the catheter. The tube body and the connecting component are fixed together by gluing. The tapered buffer tube is fixed to the connecting component by interference fit or bonding.
[0004] The stent is located in the guide sheath before delivery. The operator needs to guide the stent out of the guide sheath and load it into the catheter at the same time. The connecting component can assist in completing the stent loading process. In order to smoothly load the stent from the guide sheath into the catheter, the connecting component is usually set to a tapered wall with a gradually decreasing inner diameter. When the guide sheath is gradually pushed toward the distal end, the tip of the sheath is easily pushed onto the tapered wall and squeezed. This process often causes excessive squeezing and deformation of the distal end of the stent, affecting the release effect and radial support force of the stent.
[0005] The art needs to develop a component for loading a self-expanding stent, an assembly including the component, and a self-expanding stent loading system, which can provide position prompts to the operator to avoid pushing the sheath too far into the tapered wall, causing excessive squeezing of the distal end of the stent inside the sheath. Summary of the invention
[0006] In view of the shortcomings of the prior art, one of the purposes of the present application is to provide a component for loading a self-expanding stent, the component comprising a tubular body, the interior of the tubular body having a tubular channel along the axial direction, the tubular channel being divided into different regions including a sheath insertion channel at the proximal end and a catheter insertion channel at the distal end;
[0007] A tapered change zone is arranged at the distal end of the sheath insertion channel, and the tapered change zone includes a small tapered zone and a large tapered zone from near to far, and the proximal end of the large tapered zone is connected to the distal end of the small tapered zone.
[0008] After the sheath is inserted into the sheath insertion channel, it passes through the small tapered area and then enters the large tapered area. Due to the large tapered area, there is obvious resistance to the advancement of the distal end of the sheath, which can be sensed by the operator, thereby reminding the operator of the position. At this time, the sheath can stop pushing and instead push the loaded self-expanding stent so that it is pushed into the catheter placed in the catheter insertion channel.
[0009] During the pushing process of the sheath, the taper change zone provides the operator with a position signal through the taper change. After sensing the signal, the operator stops pushing the sheath to avoid pushing the sheath too far into the conical wall and causing excessive squeezing of the distal end of the stent inside it.
[0010] Preferably, the intersection of the small taper area and the large taper area is defined as a taper change point; the fully collapsed outer diameter of the self-expanding stent to be loaded is OD1, and the outer diameter of the sheath tube loaded with the self-expanding stent to be loaded is QD1;
[0011] Preferably, the diameter of the tapered change point is ≤ the outer diameter QD1 of the sheath tube containing the self-expanding stent to be loaded;
[0012] Preferably, the distal diameter of the large tapered region is ≥ the fully collapsed outer diameter OD1 of the self-expanding stent to be loaded.
[0013] The diameter of the tapered change point ≤ the outer diameter QD1 of the sheath tube loaded with the self-expanding stent can better fix the sheath tube in the tubular channel, facilitate operation, and make it easier to sense that the sheath tube has reached the tapered change point.
[0014] The distal diameter of the large tapered area is ≥ the fully collapsed outer diameter OD1 of the self-expanding stent to be loaded, so as to ensure that the self-expanding stent to be loaded still has compression space during the pushing process to prevent damage caused by excessive compression.
[0015] Preferably, the taper of the large taper area is greater than the taper of the small taper area by more than 10% (e.g., 20%, 50%, 70%, 100%, 220%, 250%, 280%, 350%, 400%, 450%, 500%, 600%, 700%, 800%, etc.). A taper change of more than 10% makes the position signal of the taper change point easier to perceive.
[0016] Preferably, the taper of the small taper area is 20-160° (e.g., 25°, 35°, 60°, 70°, 90°, 120°, 150°, 155°, etc.). The taper of 20-160° in the small taper area allows the sheath to be better confined in the sheath insertion area to avoid uncontrollable shaking.
[0017] Preferably, the proximal diameter of the small taper area is larger than the outer diameter QD1 of the sheath tube loaded with the self-expanding stent; the diameter of the taper change point is 0.9 to 1 times, preferably 0.9 to 0.95 times, of the outer diameter QD1 of the sheath tube loaded with the self-expanding stent. The setting makes the position information of the taper change easier to perceive.
[0018] Preferably, the diameter of the catheter insertion channel minus 2 times the wall thickness of the catheter to be inserted is 0 to 0.1% larger than the distal diameter of the large tapered area. Preferably, the diameter of the catheter insertion channel minus 2 times the wall thickness of the catheter to be inserted is the same as the distal diameter of the large tapered area.
[0019] Preferably, the sheath insertion channel and the catheter insertion channel of the tubular channel are coaxial.
[0020] The second object of the present application is to provide an assembly for loading a self-expanding stent, comprising the component for loading a self-expanding stent as described in the first object, and a buffer tube sleeved on the outside of the distal end of the component.
[0021] The third object of the present application is to provide a system for loading a self-expanding stent, comprising: a catheter and a component for loading a self-expanding stent as described in the second object, the catheter being placed in a catheter insertion channel, and the buffer tube being sleeved on the outside of the connection between the catheter and the loading component.
[0022] Compared with the prior art, this application has the following beneficial effects:
[0023] The component for loading the self-expanding stent provided in the present application has a tapered change zone. During the sheath pushing process, when passing through the tapered change zone, the operator can sense the position information of the distal end of the sheath through the change from a small taper to a large taper, so as to give a signal to stop the sheath pushing and start the stent pushing, thereby avoiding the situation in the prior art where the sheath is pushed too far into the tapered wall and causes excessive squeezing of the distal end of the stent when the sheath is pushed in a tapered wall with a gradually decreasing inner diameter. BRIEF DESCRIPTION OF THE DRAWINGS
[0024] Figure 1 The component for loading the self-expanding stent provided in Example 1;
[0025] Figure 2 This is a schematic diagram of the structure of the assembly for loading the self-expanding stent described in Example 2. DETAILED DESCRIPTION
[0026] The technical solution of the present application is further explained below in conjunction with the specific implementation methods. However, it should be noted that the specific implementation methods are only a specific implementation and explanation of the essence of the technical solution of the present application, and should not be understood as a limitation on the protection scope of the present application.
[0027] The present application is further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the related application, rather than to limit the application. It is also necessary to explain that, for ease of description, only the parts related to the related application are shown in the accompanying drawings.
[0028] In the description of this application, it should be understood that the terms "distal end" and "proximal end" should be understood as viewed from the direction of the surgical operator, the "distal end" is the end away from the surgical operator, and the "proximal end" is the end close to the surgical operator. The term "axial" should be understood as the direction of stent pushing, the length direction of the guide wire or the length direction of the stent, and the "radial" should be understood as the perpendicular direction of the "axial".
[0029] In the description of the present application, it should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other.
[0030] like Figure 1 ( Figure 1 As shown in the structural schematic diagram of a component for loading a self-expanding stent provided in Example 1, Example 1 provides a component for loading a self-expanding stent, including a tubular body 100, wherein the tubular body 100 has a tubular channel 200 in the axial direction, and the tubular channel 200 is divided into different regions including a sheath insertion channel 210 at the proximal end and a catheter insertion channel 220 at the distal end;
[0031] A taper change zone is set at the distal end of the sheath insertion channel 210, and the taper change zone includes a small taper zone 211 and a large taper zone 212 from near to far, and the proximal end of the large taper zone 212 is connected to the distal end of the small taper zone 211, and the intersection of the small taper zone 211 and the large taper zone 212 is defined as a taper change point 213.
[0032] The fully collapsed outer diameter of the self-expanding stent 300 to be loaded is OD1, and the outer diameter of the sheath 400 loaded with the self-expanding stent to be loaded is QD1; the diameter of the taper change point 213 is ≤ the outer diameter QD1 of the sheath 400 loaded with the self-expanding stent 300 to be loaded; the distal end diameter of the large taper area 212 is ≥ the fully collapsed outer diameter OD1 of the self-expanding stent 300 to be loaded. The diameter of the tapered change point 213 is the distal inner diameter of the small tapered area 211, which is less than or equal to (preferably less than) the outer diameter QD1 of the sheath 400, so that when the sheath 400 is pushed to this position, a large resistance change occurs, that is, the resistance suddenly increases, which is easy for the operator to sense and obtain a sense prompt that the sheath has reached the position. At this time, the pushing of the sheath 400 can be stopped, and the self-expanding stent 300 is pushed alone. The self-expanding stent 300 is pushed out from the inside of the sheath 400, moves along the large tapered area 212, and enters the inner cavity of the catheter 500 in the catheter insertion channel 220. After the self-expanding stent 300 completely enters the catheter 500, the loading of the self-expanding stent 300 is completed.
[0033] The taper of the small taper area is 30°, and the taper of the large taper area is 100% greater than that of the small taper area.
[0034] In other embodiments, the taper of the large taper area can be any taper that is greater than the taper of the small taper area by more than 10%. The taper of the small taper area is any taper between 20° and 160°.
[0035] In a preferred embodiment, the proximal diameter of the small tapered area 211 is larger than the outer diameter QD1 of the sheath tube 400 loaded with the self-expanding stent 300 to be loaded; the diameter of the tapered change point 213 is 0.9 to 1 times (e.g., 0.91 times, 0.93 times, 0.96 times, 0.98 times, etc.) the outer diameter QD1 of the sheath tube 400 loaded with the self-expanding stent 300 to be loaded. The diameter of the tapered change point 213 is slightly smaller than the outer diameter of the sheath tube 400 to better stabilize the sheath tube, improve loading stability and stent shape retention.
[0036] In a preferred specific embodiment, the diameter of the catheter insertion channel 220 minus 2 times the wall thickness of the catheter 500 to be inserted is 0 to 0.1% (for example, 0.01%, 0.03%, 0.05%, 0.07%, 0.09%, etc.) larger than the distal diameter of the large tapered area 212. Preferably, the diameter of the catheter insertion channel 220 minus 2 times the wall thickness of the catheter 500 to be inserted is the same as the distal diameter of the large tapered area 212.
[0037] The sheath insertion channel 210 and the catheter insertion channel 220 of the tubular channel 200 are coaxial.
[0038] like Figure 2 ( Figure 2As shown in the structural schematic diagram of the component for loading the self-expanding stent described in Example 2, a component for loading the self-expanding stent includes the component for loading the self-expanding stent described in Example 1, and a buffer tube 700 sleeved on the outside of the tube body 100 of the component for loading the self-expanding stent. Figure 2 Also shown is a catheter 500 inserted into the distal end (catheter insertion channel 220) of the component tubular channel 200 for loading the self-expanding stent, and a sheath 400 inserted into the proximal end (sheath insertion channel 210) of the component tubular channel 200 for loading the self-expanding stent, wherein the sheath 400 is filled with a stent 300 to be loaded, and the proximal end of the stent 300 to be loaded is connected to a push guide wire 600. The buffer tube 700 is sleeved on the outside of the connection between the catheter 500 and the tube body 100 of the loading component.
[0039] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present application.
Claims
1. A component for loading a self-expanding stent, characterized in that: The component comprises a tubular body, wherein the tubular body has a tubular passage in the axial direction, and the tubular passage is divided into different regions including a sheath insertion passage at the proximal end and a catheter insertion passage at the distal end; A tapered change zone is arranged at the distal end of the sheath insertion channel, and the tapered change zone includes a small tapered zone and a large tapered zone from near to far, and the proximal end of the large tapered zone is connected to the distal end of the small tapered zone.
2. The component according to claim 1, characterized in that The intersection of the small taper area and the large taper area is defined as a taper change point; the fully collapsed outer diameter of the self-expanding stent to be loaded is OD1, and the outer diameter of the sheath tube loaded with the self-expanding stent to be loaded is QD1; The diameter of the tapered change point is ≤ the outer diameter QD1 of the sheath tube containing the self-expanding stent to be loaded; The distal end diameter of the large tapered region is ≥ the fully collapsed outer diameter OD1 of the self-expanding stent to be loaded.
3. The component according to claim 1, characterized in that The taper of the large taper area is greater than that of the small taper area by more than 10%.
4. The component according to claim 1, characterized in that The taper of the small taper area is 20-160°.
5. The component according to claim 2, characterized in that The proximal diameter of the small taper zone is larger than the outer diameter QD1 of the sheath tube loaded with the self-expanding stent; the diameter of the taper change point is 0.9 to 1 times the outer diameter QD1 of the sheath tube loaded with the self-expanding stent.
6. The component according to claim 1, characterized in that The diameter of the catheter insertion channel minus twice the wall thickness of the catheter to be inserted is 0-0.1% larger than the distal end diameter of the large taper area.
7. The component according to claim 1, characterized in that The diameter of the catheter insertion channel minus 2 times the wall thickness of the catheter to be inserted is the same as the distal end diameter of the large tapered area.
8. The component according to any one of claims 1 to 7, characterized in that: The sheath insertion channel and the catheter insertion channel of the tubular channel are coaxial.
9. An assembly for loading a self-expanding stent, characterized in that: The assembly comprises a component for loading a self-expanding stent according to any one of claims 1 to 8, and a buffer tube sleeved on the outside of the distal end of the component.
10. A self-expanding stent loading system, characterized in that: The system for loading a self-expanding stent comprises: a catheter and the assembly for loading a self-expanding stent as claimed in claim 9, wherein the catheter is placed in a catheter insertion channel, and the buffer tube is sleeved outside the connection between the catheter and the assembly for loading a self-expanding stent.