Conveying system
By using a segmented sheath core design and employing loading and pushing sections with different material combinations, the problems of high sheath core cost and long resolution time were solved, resulting in cost reduction and improved production efficiency.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- LIFETECH SCI (SHENZHEN) CO LTD
- Filing Date
- 2024-12-31
- Publication Date
- 2026-05-26
AI Technical Summary
The sheath cores of existing stent products are mainly composed of PI braided mesh tubes, which results in high costs and long desorption time after sterilization, affecting production efficiency.
The sheath core adopts a segmented design, including a loading section and a pushing section. By using different material combinations, the pushing section has high strength and fast resolution, while the loading section has good flexibility. The overall strength and flexibility are balanced through thermal fusion connection.
It reduced production costs, shortened the post-sterilization analysis time, and improved production efficiency and the stability of the delivery process.
Smart Images
Figure CN224269529U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of interventional medical device technology, and in particular to a delivery system. Background Technology
[0002] Currently, most stent delivery systems consist of a sheath, a sheath core assembly, and a handle. The sheath core assembly comprises a tip and a sheath core. The sheath core is typically made of high-strength, flexurally resistant PI (polyimide) braided mesh tubing. PI (polyimide) braided mesh tubing is a composite material primarily formed from PI (polyimide), generally composed of a PI (polyimide) tube, a stainless steel braided mesh tubing, and a PTFE (polytetrafluoroethylene) inner lining, resulting in high material and production costs. Since all interventional medical devices require sterilization, often using ethylene oxide, which is a toxic carcinogen, post-sterilization desorption is necessary to reduce residual ethylene oxide levels. Insufficient desorption can lead to excessive ethylene oxide residue, harming patients. Because PI materials have a strong adsorption capacity for ethylene oxide, products containing PI often have long desorption times after sterilization, significantly reducing production efficiency.
[0003] To address this issue, while maintaining high strength and flexural resistance, modifying the sheath core structure to optimize the proportion of PI braided mesh can significantly reduce product costs and bring greater economic benefits. Utility Model Content
[0004] Therefore, it is necessary to provide an improved delivery system to address the problems of high cost and long resolution time caused by the existing sheath cores mostly being composed of PI (polyimide) braided mesh tubes, as follows:
[0005] A delivery system is provided, comprising an outer conduit and an inner sheath. The sheath includes a loading section and a pushing section connected sequentially from distal to proximal. The loading section further includes an anchoring area and a first connecting area connected sequentially from distal to proximal. The pushing section includes a second connecting area and a pushing area connected sequentially from distal to proximal. The first connecting area and the second connecting area have equal outer diameters and continuous outer surfaces after docking. The anchoring area includes at least one anchoring element, which forms close contact with the loaded support after being pressed against it.
[0006] In one embodiment, the strength of the push segment is greater than the strength of the load segment, and the parsing rate of the push segment is greater than the parsing rate of the load segment.
[0007] In one embodiment, a portion of the first connecting region and the anchoring region adjacent to each other serves as a transition region. Within the transition region, the inner layer of the first connecting region is a polyimide braided mesh extending from the anchoring region, and the outer layer is any one of polyethylene, polyamide, and polyether block polyamide.
[0008] In one embodiment, the anchoring area includes a plurality of anchors distributed along the axial direction.
[0009] In one embodiment, the inner layers of the first connection region and the second connection region are relatively independent, and the inner layers of the first connection region and the second connection region have the same diameter but different materials.
[0010] In one embodiment, the first connection region includes a connection layer extending between the inner and outer layers of the second connection region, the connection layer being heat-shrinkable to tightly connect the first connection region and the second connection region.
[0011] In one embodiment, a reinforcing layer is provided on the outer side of the first connection area and the second connection area, the reinforcing layer extending across the connection layer at both ends in the axial direction.
[0012] In one embodiment, the inner layer of the second connection region is a polyetheretherketone material.
[0013] In one embodiment, the inner layer of the second connection region is any one of polyethylene, polyamide, or polyether block polyamide.
[0014] In one embodiment, the outer layer of the second connection region is any one of polyethylene, polyamide, and polyether block polyamide.
[0015] Compared with existing technologies, this invention provides a delivery system comprising an outer catheter and an inner sheath. The sheath includes a loading section and a pushing section connected sequentially from distal to proximal. The loading section further includes an anchoring area and a first connecting area connected sequentially from distal to proximal. The pushing section includes a second connecting area and a pushing area connected sequentially from distal to proximal. The first and second connecting areas are connected by heat fusion. Compared with traditional sheaths composed of pure PI (polyimide) braided mesh, the delivery system provided by this invention divides the sheath into a loading section and a pushing section connected sequentially. After docking, the outer diameters are equal, the outer surfaces are continuous, and a complete sheath is formed. Objectively, this design can meet the requirements of loading the adjacent loading section with a certain strength and flexibility, while the pushing section has higher strength. Therefore, the segmented sheath core can be optimized to meet more different needs, such as further improving the strength of the pushing segment, making the pushing process more stable and reliable. Similarly, due to the segmented design, the proportion of PI (polyimide) braided mesh tube in the overall structure is greatly reduced, which reduces costs while improving the overall resolution speed. Attached Figure Description
[0016] Figure 1 This is a schematic diagram of the conveying system in Embodiment 1 of this utility model;
[0017] Figure 2 This is a schematic diagram of the sheath core of the conveying system in Embodiment 1 of this utility model;
[0018] Figure 3 This is a cross-sectional schematic diagram of the sheath core of the conveying system in Embodiment 1 of this utility model;
[0019] Figure 4 yes Figure 3 Enlarged view of region A in the middle;
[0020] Figure 5 This is a partial cross-sectional schematic diagram of the sheath core of the conveying system in another embodiment of Embodiment 1 of this utility model;
[0021] Figure 6 This is a cross-sectional schematic diagram of the sheath core of the conveying system in Embodiment 2 of this utility model;
[0022] Figure 7 This is a partial cross-sectional schematic diagram of the sheath core of the conveying system in another embodiment of Embodiment 2 of this utility model. Detailed Implementation
[0023] To make the objectives, technical solutions, and advantages of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present utility model and are not intended to limit the present utility model.
[0024] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined. The "connection" mentioned in the embodiments includes both direct connection between two components and indirect connection via other components.
[0025] The technical solution of this utility model will be further described in detail below with reference to specific embodiments.
[0026] Example 1
[0027] Reference Figure 1-4 , Figure 1 This is a schematic diagram of the conveying system 100 in Embodiment 1 of this utility model. Figure 2 This is a schematic diagram of the sheath core 120 of the conveying system 100 in Embodiment 1 of this utility model. Figure 3 This is a cross-sectional schematic diagram of the sheath core 120 of the conveying system 100 in Embodiment 1 of this utility model. Figure 4 yes Figure 3 An enlarged schematic diagram of region A in the middle. Embodiment 1 provides a delivery system 100, which includes a catheter 110 located on the outer side and a sheath core 120 located on the inner side. During operation, the sheath core 120 and the catheter 110 move relative to each other along the axial direction, thereby driving the implant to the predetermined implantation position, release, or secondary retrieval.
[0028] When the implant is a stent or a similar compressible implant, the stent is usually compressed and loaded between the catheter 110 and the sheath 120. After the implant is transported to the predetermined position along with the catheter 110 and the sheath 120, the sheath 120 is pushed out or the catheter 110 is withdrawn to expose the implant. Then, by utilizing the natural expansion property of the implant, the implant expands and presses against and anchors itself in the predetermined position, thereby achieving implantation.
[0029] Therefore, most of the time, the implant is affected by the catheter 110 and the sheath core 120. Therefore, Embodiment 1 optimizes the sheath core 120. When the stent-type implant is in operation, it is installed on the distal side of the sheath core 120. Thus, the sheath core 120 includes a TIP head 121, a loading section 122 and a pushing section 123 arranged sequentially from the distal end to the proximal end. The loading section 122 is mainly used to accommodate the implant. When the implant is loaded into the delivery system, the implant is compressed to the position of the loading section 122. The inner side of the implant is the sheath core 120 and the outer side is the catheter 110.
[0030] In this embodiment, the loading section 122 needs to maintain a certain strength while also taking into account a certain degree of flexibility. Therefore, the loading section 122 can mainly use PI (polyimide) braided mesh tube, or PA (polyamide fiber) braided mesh tube, Pebax (polyether block polyamide) braided mesh tube, etc. To ensure the reliability of the conveying, the strength of the pushing section 123 can be set to be greater than that of the loading section 122, thereby improving the overall strength of the sheath core 120. Therefore, in this embodiment, the pushing section 123 can mainly use Peek (polyether ether ketone) material, which can ensure high strength and is also easier to decompose than the loading section 122. The pushing section 122 can also use HDPE (high-density polyethylene) material, so that the decomposition rate of the pushing section 122 is greater than that of the loading section 122.
[0031] It should be noted that since implantable medical devices need to enter the human body, sterilization is required. Common sterilization methods generally use ethylene oxide. However, ethylene oxide itself is a toxic and carcinogenic substance. Therefore, after sterilization, it needs to be desorbed under specific conditions to reduce the residual amount of ethylene oxide. If the desorption is insufficient, the residual amount of ethylene oxide will exceed the standard, which will harm the patient's body. Furthermore, because PI (polyimide) materials have a strong adsorption capacity for ethylene oxide, products containing PI often have a long desorption time after sterilization, which greatly reduces the production efficiency. Therefore, by using different materials and a segmented design for the loading section 122 and the pushing section 123, the requirements for flexibility and strength mentioned above can be met, while also reducing the desorption time, thereby improving production efficiency. Thus, the core point of this utility model is that the pushing section 123 and the loading section 122 are at least partially discontinuously connected, or more specifically, for the pushing section 123, the layer that connects to the PI layer of the loading section 122 is not made of PI material.
[0032] As for the loading section 122, the loading section 122 further includes an anchoring area 1221 and a first connecting area 1222 connected sequentially from the distal side to the proximal side. The anchoring area 1221 includes at least one anchoring element 1220. Taking the stent as an implant, the anchoring element 1220 forms a tight contact with the stent after it is attached to the stent. The friction between the two is relatively large, so that the contact position between the stent and the anchoring element 1220 is relatively fixed.
[0033] In another embodiment, the anchoring area 1221 includes a plurality of anchoring elements 1220 along the axial direction. Under the action of the plurality of anchoring elements 1220, multiple positions of the bracket contact the anchoring elements 1220 along the axial direction to achieve fixation, thereby making it difficult for the bracket itself to undergo relative displacement at multiple positions along the axial direction, thus playing a role in preventing the bracket from shortening.
[0034] Anchoring area 1221 is the area in loading section 122 that mainly contacts the support. As for the first connecting area 1222, the first connecting area 1222 receives anchoring area 1221 at the far end and is connected to pushing section 123 at the near end.
[0035] For the push segment 123, the push segment 123 includes a second connecting region 1232 and a push region 1231 connected sequentially from the distal side to the proximal side. The push region 1231 extends along the conduit 110 to the outside of the body, while the second connecting region 1232 is used to connect with the first connecting region 1222 to achieve the connection between the loading segment 122 and the push segment 123. In this embodiment, the inner layer 1234 of the push region 1231 is a Peek (polyether ether ketone) material tube, and the outer layer 1235 is a PE (polyethylene) material tube. Alternatively, the outer layer can also be made of PA (polyamide) or Pebax (polyether block polyamide).
[0036] Since the first connection area 1222 and the second connection area 1232 are interconnected, the first connection area 1222 and the second connection area 1232 also include a connection layer 124. The connection layer 124 spans the first connection area 1222 and the second connection area 1232. The connection layer 124 is made of thin-walled PET heat shrink tubing (or PTFE heat shrink tubing). The first connection area 1222 and the second connection area 1232 are tightly connected by heat shrinking. In other embodiments, glue dispensing, bonding or other methods can also be used for fixing, but in this embodiment, heat fusion is preferred.
[0037] Since the first connecting region 1222 receives the anchoring region 1221, a portion adjacent to the first connecting region 1222 and the anchoring region 1221 serves as a transition region 1223. Within the transition region 1223, the inner layer 1224 of the first connecting region 1222 is a PI braided mesh extending from the anchoring region 1221, and the outer layer 1225 is a PE (polyethylene) material pipe. The outer layer 1225 can also be made of PA (polyamide) or Pebax (polyether block polyamide) material. At the proximal end of the transition region 1223, i.e., the first connecting region... On the proximal side of region 1222, the first connecting region 1222 also includes a connecting layer 124 located between the inner layer 1224 and the outer layer 1225, which is the PET layer mentioned above; similarly, the inner layer 1234 of the second connecting region 1232 is a tube made of Peek (polyether ether ketone) material, and the outer layer 1235 is a tube made of PE (polyethylene) material. At the same time, the outer layer 1235 can also be made of PA (polyamide) or Pebax (polyether block polyamide) material. The second connecting region 1232 also includes a connecting layer 124 located between the inner layer and the outer layer.
[0038] In this embodiment, the entire sheath core 120 is sequentially distributed from the distal end to the proximal end as a TIP head 121, an anchoring area 1221, a first connecting area 1222, a second connecting area 1232, and a pushing area 1231. In this embodiment, each region of the sheath core 120 has the following properties:
[0039] The inner layers of the first connecting region 1222 and the second connecting region 1232 are relatively independent, with the same diameter but different materials. The outer layers of the first connecting region 1222 and the second connecting region 1232 are continuous, with the same diameter and the same material.
[0040] The connecting layer 124 of the first connecting region 1222 and the second connecting region 1232 is continuous, and the material and diameter are the same;
[0041] The diameter of the anchoring area 1221 is the same as the diameter of the inner layer of the first connecting area 1222, and the materials of the anchoring area 1221 and the inner layer of the first connecting area 1222 are the same.
[0042] In this embodiment, the outer layers of the first connection region 1222 and the second connection region 1232 are continuous, while the inner layers are relatively independent, meaning that the two are made of different materials.
[0043] In another embodiment, reference Figure 5 , Figure 5This is a partial cross-sectional schematic diagram of the sheath core of the conveying system in another embodiment of the present utility model. In order to make the connection between the loading section 122 and the pushing section 123 tighter, an additional reinforcing layer 125 is provided on the outside of the first connecting area 1222 and the second connecting area 1232. The reinforcing layer 125 spans the connecting layer 124 at both ends in the axial direction. In this embodiment, the reinforcing layer 125 is made of FEP heat shrink tubing. Through the further heat shrink reinforcement on the outside of the FEP heat shrink tubing, a better connection is achieved.
[0044] Example 2
[0045] This embodiment is an improvement on embodiment 1, with the main difference being in the design of the push segment. In this embodiment, refer to... Figure 6 , Figure 6 This is a cross-sectional schematic diagram of the sheath core of the conveying system in Embodiment 2 of this utility model. The pushing section 223 in this embodiment includes only one layer, that is, the inner and outer layers in the previous embodiment are made of the same material, preferably PE (polyethylene) material, but PA (polyamide) or Pebax (polyether block polyamide) material can also be used. Thus, the pushing section 223 can be directly heat-fused and fixed with the loading section 222, thereby further reducing the overall resolution time.
[0046] In another embodiment, reference Figure 7 , Figure 7 This is a partial cross-sectional schematic diagram of the sheath core of the conveying system in another embodiment of Embodiment 2 of this utility model. In order to make the connection between the loading section 222 and the pushing section 223 tighter, an additional reinforcing layer 225 is provided on the outside of the first connecting area 2222 and the second connecting area 2232. The projection of the reinforcing layer 225 on the axis covers the proximal end of the first connecting area 2222 and the distal end of the second connecting area 2232. In this embodiment, the reinforcing layer 225 is made of FEP heat shrink tubing. Through the further heat shrink reinforcement on the outside of the FEP heat shrink tubing, better connection is achieved.
[0047] It should be noted that the technical features of the above embodiments can be combined arbitrarily and can also be applied simultaneously to various left atrial appendage occluders and left atrial appendage occluders with similar structures. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described; however, as long as the combination of these technical features is not contradictory, it should be considered within the scope of this specification.
[0048] It should also be noted that the above embodiments do not exclude the technical solution of adding anchor spikes. In order to meet specific situations, the above embodiments can be equipped with anchor spikes as needed.
[0049] The embodiments described above are merely illustrative of several implementations of this utility model, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the utility model patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this utility model, and these all fall within the protection scope of this utility model. Therefore, the protection scope of this utility model patent should be determined by the appended claims.
Claims
1. A conveying system, characterized in that, The delivery system includes an outer conduit and an inner sheath. The sheath includes a loading section and a pushing section connected sequentially from the distal end to the proximal end. The loading section includes an anchoring area and a first connecting area connected sequentially from the distal end to the proximal end. The pushing section includes a second connecting area and a pushing area connected sequentially from the distal end to the proximal end. The first connecting area and the second connecting area have the same outer diameter and continuous outer surface after docking. The anchoring area includes at least one anchoring element, which forms a tight contact with the loaded support after being pressed against it.
2. The conveying system according to claim 1, characterized in that, The strength of the push segment is greater than the strength of the load segment, and the parsing rate of the push segment is greater than the parsing rate of the load segment.
3. The conveying system according to claim 1, characterized in that, A portion of the first connecting area and the anchoring area adjacent to each other serves as a transition area. Within the transition area, the inner layer of the first connecting area is a polyimide braided mesh extending from the anchoring area, and the outer layer of the first connecting area is any one of polyethylene, polyamide, and polyether block polyamide.
4. The conveying system according to claim 1, characterized in that, The anchoring zone includes multiple anchoring elements distributed along the axial direction.
5. The conveying system according to claim 3, characterized in that, The inner layers of the first connection area and the second connection area are relatively independent. The inner layers of the first connection area and the second connection area have the same diameter but different materials.
6. The conveying system according to claim 3, characterized in that, The first connection area includes a connection layer that extends between the inner and outer layers of the second connection area. The connection layer is heat-shrinkable to tightly connect the first connection area and the second connection area.
7. The conveying system according to claim 6, characterized in that, A reinforcing layer is provided on the outer side of the first connection area and the second connection area, and the reinforcing layer extends across the connection layer at both ends in the axial direction.
8. The conveying system according to claim 3, characterized in that, The inner layer of the second connection region is made of polyetheretherketone material.
9. The conveying system according to claim 4, characterized in that, The inner layer of the second connecting region is any one of polyethylene, polyamide, or polyether block polyamide.
10. The conveying system according to claim 4, characterized in that, The outer layer of the second connecting region is any one of polyethylene, polyamide, or polyether block polyamide.