Conveying devices and conveying systems
By designing the distance relationship between the push rod of the conveying device and the anchor (L1≥L2), the problem of difficulty in retrieving the existing conveying device in the blood vessels at the bifurcation is solved, and smooth recovery and reduced blood vessel damage is achieved.
Patent Information
- Application Number
- CN202111349241.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-11-15
- Publication Date
- 2025-09-02
- Estimated Expiration
- 2041-11-15
AI Technical Summary
The problem of difficulty in retraction in the blood vessels at the bifurcation is mainly due to the presence of anchors that cause vascular folds to accumulate and hook.
A conveying device is designed, including a sheath core, a seeker, an anchor, a push rod and a sheath tube. By defining the distance relationship between the push rod handle and the sheath tube handle (L1≥L2), the push rod is pushed to abut with the anchor before retracing, blocking the anchor to solve the retracement difficulty.
It realizes that the delivery device avoids hooking and scratching with the blood vessels during the retraction process, ensuring smooth recovery and reducing damage to the blood vessels.
Smart Images

Figure CN116115400B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a delivery device and a delivery system. Background Art
[0002] Due to various diseases or injuries, the human aorta is prone to damage to the aortic endothelium or vascular wall, forming an aneurysm disease. Once the aneurysm ruptures, blood gushes out of the blood vessels, causing insufficient blood supply to the human body, leading to shock or death. For aneurysm disease, the treatment of aneurysms in different locations varies. The most common treatments are surgical treatment, aneurysm embolization, and endovascular repair of aneurysms. Surgical treatment mainly involves aneurysm resection and arterial reconstruction; for some visceral aneurysms, coil embolization can be used to form a thrombus in the aneurysm to prevent further expansion, rupture, and bleeding; endovascular repair uses a covered artificial vascular stent for endovascular repair of the aneurysm, which is less invasive and has significant efficacy.
[0003] Endovascular repair has become the mainstream method for treating cardiovascular diseases in recent years due to its advantages of less trauma and obvious efficacy. With the continuous improvement of interventional technology, the advantages of endovascular repair are becoming increasingly prominent. The use of covered stents requires the use of a delivery device to deliver them to the lesion site for treatment. The covered stent must first be compressed into the sheath of the delivery device. Generally, the femoral artery or iliac artery is selected for puncture. A guidewire is used to establish a track. The delivery device is passed through the iliac artery-abdominal aorta-thoracic aorta-aortic arch-ascending aorta to establish a delivery path. After being delivered to the designated location of the lesion, the covered stent is released, the stent is deployed and adheres to the aneurysm wall. The membrane covering the stent can isolate the blood flow from the lesion site, eliminating the impact of blood flow on the aneurysm wall at the lesion site and re-establishing a normal blood circulation channel. After the stent is released, the guidewire and delivery device are withdrawn, thereby achieving interventional treatment of aneurysms and arterial dissections.
[0004] In existing delivery device designs, the inner sheath core of the delivery device is equipped with an anchor at the front end to significantly enhance the stability of stent release. This allows for better stent release to the desired location, resulting in more stable stent deployment and no stent ejection. However, because the delivery devices required for iliac artery bifurcation stents are primarily used in vessels at the iliac bifurcation, which have smaller diameters, the process of advancing the stent to the desired location can easily cause or exacerbate vascular wrinkling and accumulation. After stent deployment, the sheath is detached from the front guide. Due to the wrinkling and accumulation caused by the delivery device during delivery, the sheath is not guided by the guide and adheres to the vessel, making it difficult to advance the sheath and retract the sheath core. Furthermore, due to the presence of the proximal anchor, the sheath core can easily scrape against the vessel during withdrawal, or become caught in the vessel due to severe wrinkling and accumulation. This can further complicate withdrawal and necessitate further endovascular retraction to facilitate successful delivery. Summary of the Invention
[0005] The technical problem to be solved by the present invention is to provide a delivery device and a delivery system to address the problem in the prior art that the delivery device is difficult to withdraw in the blood vessel at the bifurcation due to the presence of the anchor.
[0006] The technical solution adopted by the present invention to solve its technical problem is:
[0007] One embodiment of the present invention provides a delivery device for delivering an implant, comprising a sheath core, a guide head and an anchor, wherein the guide head is located at the distal end of the sheath core, and the anchor is located on the sheath core and close to the proximal end of the guide head. The delivery device also includes a push rod which is sleeved on the sheath core and can move axially relative to the sheath core, a push rod handle provided at the proximal end of the push rod, a sheath tube which is coaxially sleeved on the push rod and can move axially relative to the push rod, and a sheath tube handle provided at the proximal end of the sheath tube, the push rod handle is coaxially sleeved on the sheath core, the proximal end of the sheath core is exposed from the proximal end of the push rod handle, the sheath tube handle is coaxially sleeved on the push rod, and the push rod includes a hollow cylinder. The outer diameter of the hollow cylinder is greater than or equal to the maximum radial width of the anchor; when the delivery device completes the release of the implant and is ready to withdraw, the distance between the distal end of the push rod handle and the proximal end of the sheath handle is defined as L1, and the distance between the distal end of the push rod and the proximal end of the anchor is defined as L2, then L1 and L2 satisfy: L1≥L2; when the implant is fully released, the distance that the sheath handle drives the sheath to withdraw is defined as S1, then, when the implant is loaded, the distance L0 reserved between the push rod handle and the sheath handle is greater than the sum of S1 and L2, so that when the delivery device is withdrawn, the push rod can be pushed forward to abut against the anchor.
[0008] In one embodiment, the anchoring member includes an anchoring bottom and an anchoring portion extending distally from the anchoring bottom, and the proximal end surface of the anchoring bottom includes a plane perpendicular to the axial direction and has an arc transition with the anchoring portion.
[0009] In one embodiment, the anchoring member further includes a welding portion located on the proximal side of the anchoring bottom and welding the anchoring member to the sheath core, and the inner diameter of the push rod is greater than the maximum radial width of the welding portion.
[0010] In one embodiment, a stop mark is provided at the proximal end of the sheath core.
[0011] In one embodiment, the distal end surface of the push rod includes a plane perpendicular to the axis and an arc transition surface circumferentially arranged around the plane.
[0012] In one embodiment, the distal end surface of the push rod is coated with a hydrophilic coating.
[0013] In one embodiment, the push rod handle includes a first shell, a push rod handle end cover and a fastener. The first shell is fixedly connected to the proximal end of the push rod. The push rod handle end cover is located at the proximal end opening of the first shell. The fastener is controlled by the push rod handle end cover to fix the push rod relative to the sheath core.
[0014] The present invention further provides a delivery system, comprising the delivery device as described above, wherein the delivery system further comprises an implant, and the implant is hooked on the anchor.
[0015] When the above-mentioned delivery device completes the complete release of the implant, the distance between the distal end of the push rod handle and the proximal end of the sheath handle is defined as L1, and the distance between the distal end of the push rod and the proximal end of the anchor is defined as L2. By limiting L1 and L2 to satisfy: L1 ≥ L2, when the delivery device is retracted, the push rod can be pushed forward to abut against the anchor, so that the anchor bottom that is easy to scratch or hook with the blood vessel is blocked by the push rod and then retracted into the sheath together, so as to solve the problem of difficulty in retracting the delivery device caused by the anchor being easy to scratch or hook with the blood vessel wall. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The present invention will be further described below with reference to the accompanying drawings and embodiments, in which:
[0017] Figure 1 This is a schematic structural diagram of a delivery device according to an embodiment of the present invention after completing the release of a stent graft;
[0018] Figure 2 yes Figure 1 A schematic structural diagram of the distal end portion of the delivery device shown;
[0019] Figure 3 yes Figure 1 a cross-sectional view of the distal portion of the delivery device;
[0020] Figure 4 This is a schematic diagram of the partial structure of a delivery device before releasing the stent graft according to an embodiment of the present invention;
[0021] Figure 5 yes Figure 4 sectional view of
[0022] Figure 6 This is a structural diagram of a push rod of a conveying device according to an embodiment of the present invention completing shielding of an anchor member;
[0023] Figure 7 yes Figure 6 A schematic structural diagram of the distal end portion of the delivery device shown;
[0024] Figure 8 yes Figure 7 a cross-sectional view of the distal portion of the delivery device;
[0025] Figure 9 is a cross-sectional view of a push rod handle (sheath core not shown) of a delivery device according to one embodiment of the present invention;
[0026] Figure 10 This is a schematic structural diagram of the inner shaft of a conveying device according to one embodiment of the present invention;
[0027] Figure 11 yes Figure 6 Enlarged view of point A in the middle;
[0028] Figure 12 is a partial cross-sectional view of a push rod handle of a conveying device according to one embodiment of the present invention;
[0029] Figure 13 yes Figure 12 Enlarged view of point B in the middle;
[0030] Figure 14 A schematic structural diagram of a delivery device according to an embodiment of the present invention, in which the push rod and the sheath core are retracted together into the sheath tube;
[0031] Figure 15 is a schematic structural diagram of an anchor member of a delivery device according to another embodiment of the present invention;
[0032] Figure 16 is a partial structural schematic diagram of a conveying device according to another embodiment of the present invention;
[0033] Figure 17 is a partial cross-sectional view of a schematic structural diagram of a delivery device according to another embodiment of the present invention when a push rod has completed shielding the anchor member;
[0034] Figure 18 yes Figure 17 sectional view. DETAILED DESCRIPTION
[0035] To make the above-mentioned objects, features, and advantages of the present invention more readily apparent, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following description sets forth numerous specific details to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.
[0036] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods.
[0037] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used in this specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.
[0038] In this application, "proximal" refers to the end closest to the operator, "proximal side" refers to the side closest to the operator, "distal" refers to the end farther from the operator, and "distal side" refers to the side farther from the operator. "Axial" refers to the direction parallel to the line connecting the distal and proximal centers of the medical device, and "radial" refers to the direction perpendicular to the axial direction.
[0039] In this application, "covered stent" refers to a structure in which the surface of a bare stent is covered with a thin film, and a bare stent refers to a structure comprising a plurality of wavy rings without a thin film between the wavy rings.
[0040] Example 1
[0041] like Figure 1As shown, the delivery device 10 includes a guide head 11, an anchor 12, a sheath core 13, a push rod 14, a push rod handle 15, a sheath tube 16 and a sheath tube handle 17. The guide head 11 is located at the distal end of the sheath core 13, and the anchor 12 is located on the sheath core 13 and close to the proximal end of the guide head 11. The push rod 14 is coaxially sleeved on the sheath core 13 and can move axially relative to the sheath core 13. The proximal end of the push rod 14 is fixed with a push rod handle 15, and the push rod handle 15 is coaxially sleeved on the sheath core 13, and the proximal end of the sheath core 13 is exposed from the proximal end of the push rod handle 15. The sheath tube 16 is coaxially sleeved on the push rod 14 and can move axially relative to the push rod 14. The proximal end of the sheath tube 16 is fixed with a sheath tube handle 17, and the sheath tube handle 17 is coaxially sleeved on the push rod 14, as shown in FIG. Figure 1 As shown, in this embodiment, the sheath handle 17 is located at the distal end of the push rod handle 15. When the delivery device completes the release of the implant (the implant in this embodiment is a coated stent) and is ready to be withdrawn (i.e., after the coated stent is completely released), the push rod 14 can be pushed to move distally along the sheath core 13 until the distal end face of the push rod 14 abuts the proximal end face of the anchor 12, and then the push rod handle end cover 154 is used to fix the push rod handle 15 and the sheath core 13 so that the push rod 14 and the sheath core 13 are relatively stationary. Then, the push rod handle 15 is pushed proximally and the sheath core 13 is withdrawn together into the sheath tube 16 until the proximal end of the guide head 11 enters the sheath tube 16 (the state before the implant is released, as shown in FIG. Figure 4 As shown), the rear end cover of the sheath handle 17 is locked, and finally the sheath 16, the push rod 14 and the sheath core 13 are withdrawn from the human body together.
[0042] like Figure 1-5 As shown, a certain distance is reserved between the distal end of the push rod 14 and the anchor 12, so that the stent graft 40 can be loaded into the reserved position between the anchor 12 and the push rod 14 and the distal end of the stent graft 40 is hooked on the anchor 12, as shown in FIG. Figure 4-5 In the state before the stent graft is released, the distal end of the sheath 16 surrounds the stent graft 40 and is sleeved on a portion of the guide head 11. After loading, the stent graft 40 is delivered to the lesion site using the delivery device 10, and the push rod 14 and the sheath core 13 are kept relatively locked. At the same time, the push rod handle 15 is fixed. The relative movement between the sheath 16 and the push rod 14 can be achieved by operating the sheath handle 17. The sheath 16 is withdrawn axially in the proximal direction until the push rod is exposed and the lug of the implant is detached from the anchoring portion 122, thereby achieving the complete release of the stent graft 40 (the distance the sheath handle drives the sheath to withdraw when the implant is completely released is defined as S1, reference Figure 1 shown), i.e. from Figure 4-5 The status shown changes to Figure 1-3 The status shown.
[0043] Specifically, if Figure 1-3As shown, the proximal end of the guide head 11 is fixed to the distal end of the sheath core 13, and the anchor 12 is fixed to the outer wall of the sheath core 13 and close to the proximal end of the guide head 11. The sheath core 13 and the guide head 11 are connected to each other as a hollow structure and form a guide wire hole 50 to facilitate the delivery device 10 to deliver the coated stent 40 along the guide wire.
[0044] In this embodiment, the anchor 12 is a U-shaped structure, which has a simple structure, good fixing effect and low cost. Figure 1-3 As shown, the anchor 12 includes an anchoring base 121, an anchoring portion 122, and a welding portion 123. The anchoring base 121 is welded to the outer wall of the sheath core 13 near the guide head 11 via the welding portion 123. The anchoring portion 122 is formed as two claws extending distally from the anchoring base 121. The two claws are integrally formed with the anchoring base 121 to form a U-shaped structure. The claws and the anchoring base 121 form two corners at both ends of the anchoring base 121. In conventional delivery devices, the reserved distance between the first handle and the second handle is generally only sufficient for the second handle to drive the sheath tube backward to release the implant. If the sheath core 13 is directly withdrawn, the exposed corners or the welding portion between the anchoring base 121 and the sheath core 13 are likely to get caught on or scratch the blood vessels at the bifurcation.
[0045] like Figure 1 Combine Figure 9 As shown, the push rod 14 includes a rigid section 141 connected to the distal end of the push rod handle 15 and a flexible section 142 passing through the sheath tube 16. In one embodiment, the distal end face of the flexible section 142 includes a plane perpendicular to the axial direction and a circular arc transition surface circumferentially arranged around the plane. Driven by the push rod handle 15, the push rod 14 can move axially relative to the sheath core 13. The push rod 14 includes a hollow cylinder, the outer diameter of the hollow cylinder is greater than or equal to the maximum radial width of the anchor 12, and the inner diameter of the push rod 14 is greater than the maximum radial width of the weld 123 between the anchor and the push rod, so that when the push rod 14 is pushed axially to the distal end, the distal end face of the push rod 14 can abut against the proximal end face of the anchor 12, as shown in FIG. Figure 7-8 The sheath tube 16 can move axially relative to the push rod 14 under the drive of the sheath tube handle 17, as shown in FIG. Figure 1 Combine Figure 9 As shown, the sheath handle 17 is sleeved on the rigid section 141, which facilitates the sliding of the sheath handle 17 on the push rod 14. The flexible section 142 is used to fill the cavity formed between the sheath 16 and the sheath core 13, which can increase the anti-bending performance of the sheath 16. Figure 1In the state shown, the delivery device 10 needs to be withdrawn from the human body. When the delivery device 10 is ready to be withdrawn, the sheath handle 17 and the sheath core 13 are first fixed so that the sheath 16 and the sheath core 13 remain stationary relative to the human body, and then the push rod handle 15 is controlled to move the push rod 14 axially to the proximal side of the anchor 12 so that the distal end surface of the push rod 14 abuts against the proximal end surface of the anchor 12, as shown in FIG. Figure 7-8 As shown, the push rod handle end cover 154 is then tightened to fix the push rod 14 and the sheath core 13 relative to each other and then withdrawn together into the sheath tube 16, so that the push rod 14 covers the U-shaped anchor. Finally, the sheath tube handle 17 is locked, so that the push rod 14, the sheath core 13 and the sheath tube 16 are withdrawn from the human body together.
[0046] In this embodiment, if Figure 1-3 As shown, the anchor 12 is a U-shaped structure with the opening of the anchor facing the distal end of the delivery device. Among them, the push rod 14 is a hollow cylindrical long rod, and the outer diameter of the push rod 14 is the same as or slightly larger than the maximum radial dimension of the U-shaped structure. In this embodiment, the outer diameter of the push rod 14 is equal to the maximum width of the U-shaped anchor 12. When the distal end face of the push rod 14 is pushed to abut the proximal end face of the anchor 12, the anchor 12 of the U-shaped structure and the push rod 14 can be regarded as a whole, so that the push rod 14 can shield and protect the anchor 12, and ensure that when the sheath core 13 and the push rod 14 are withdrawn into the sheath tube 16 together, the anchor 12 is not exposed to the push rod 14 in the radial direction when viewed from the proximal end, and the anchor 12 and the push rod 14 are tightly connected at this time. After tightening the push rod handle end cover 154, the anchor 12 is not flexible relative to the push rod 14 and the sheath core 13 and the push rod 14 are fixed by the push rod handle 15, so that the anchor 12 is shielded and fixed to the distal end of the push rod.
[0047] The distal end face of the push rod 14 is a plane perpendicular to the L axis and the periphery has a smooth arc transition, which can reduce the scraping between the push rod 14 and the inner wall of the blood vessel when the push rod 14 is pushed forward to block the anchor 12, thereby avoiding unnecessary damage to the blood vessel. In other embodiments, a hydrophilic coating can also be applied on the smooth arc surface to make the advancement of the push rod 14 more lubricated and smooth.
[0048] like Figure 1 、 Figure 9 Combine Figure 14 As shown, the push rod handle 15 is coaxially sleeved on the sheath core 13, and its distal end is fixedly connected to the proximal end of the rigid section 141. The push rod handle 15 includes a first shell 151, a central axis 152 for fixing the push rod 14, a fastener 153, and a push rod handle end cover 154 for controlling the fastener 153 to be fixed or separated from the sheath core 13. The first shell 151 is surrounded by a receiving cavity 1511 with openings at both ends. The first shell 151 has multiple symmetrical clip plates 1512 extending into the receiving cavity 1511. The push rod handle end cover 154 is located at the proximal opening of the first shell 151.
[0049] Further, if Figure 9-10 As shown, fixing grooves 1521 are set at corresponding positions of the central axis 152 and the clamping plates 1512. One end of each clamping plate 1512 is fixed to the inner wall of the first shell 151, and the other end is fixed to the central axis 152 or in the fixing groove 1521, thereby fixing the central axis 152 in the receiving cavity 1511 formed by the first shell 151.
[0050] The clamping plate 1512 can be fixed to the inner wall of the first shell 151 by gluing, welding or mechanical structural connection, or, in other embodiments, the clamping plate 1512 and the first shell 151 are integrally formed by injection molding.
[0051] like Figure 6-10 Combine Figure 12-13 As shown, the distal end of the central axis 152 is fixed to the proximal end of the rigid section 141, the proximal end of the central axis 152 extends from the proximal end of the first shell 151 and is provided with an external thread, the push rod handle end cover 154 is provided with an internal thread so that the central axis 152 and the push rod handle end cover 154 are connected by threads, and the push rod handle end cover 154 is provided with a connecting portion 1541 connected to the proximal end of the fastener 153. The fastener 153 is sleeved on the sheath core 13 ( Figure 9 and Figure 12 The sheath core is not shown) and is located between the push rod handle end cover 154 and the proximal end of the central axis 152. The proximal end of the fastener 153 is an elastic portion 1531 that can be tightened under pressure. The push rod handle end cover 154 and the fastener 153 are slidably connected around the elastic portion 1531 through the connecting portion 1541, and the connecting surfaces of the two are inclined relative to the axial direction, so that when the push rod handle end cover 154 is screwed in (tightened) axially toward the distal end relative to the central axis 152 through the thread, a radial extrusion force is generated on the elastic portion 1531, so that the fastener 153 clamps the sheath core 13 ( Figure 9 and 12 The sheath core is not shown in the figure) so as to achieve relative fixation of the sheath core 13 and the push rod 14. By rotating the push rod handle end cover 154 in the reverse direction, the fixed relationship between the sheath core 13 and the push rod 14 is released, so that the push rod 14 can move axially relative to the sheath core 13.
[0052] In this embodiment, if Figure 13 As shown, the push rod handle end cap 154 is connected to the proximal end of the central shaft 152 via a two-stage buckle and threaded connection. After the threads are completely loosened, the buckle 155a of the push rod handle end cap 154 contacts the buckle 155b on the central shaft 152. At this time, the buckle connection prevents the push rod handle end cap 154 from falling off. The end cap of the sheath handle is installed at the rear end of the sheath handle in the same manner as the push rod handle end cap 154, and a rubber plug is placed between the central shaft and the push rod to prevent blood leakage.
[0053] The sheath core 13 is also provided with a stop mark, which can be specifically set as a stop line 132 around the circumference of the sheath core 13, such as Figure 11 As shown, when the push rod 14 is pushed forward so that the distal end surface of the push rod 14 abuts against the proximal end surface of the anchor 12, the stop line 132 leaks out from the proximal end of the push rod handle 15, as shown in FIG. Figure 6-8 Combine Figure 11 As shown, it shows that the push rod 12 has covered the part of the sheath core between the anchor 12 and the push rod 14. When the stop mark is leaked, the push rod 14 is stopped. At this time, the structural state of the guide head 11 side of the conveying device 10 is as follows Figure 7-8 shown.
[0054] like Figure 1-6 As shown, the delivery device 10 further includes a sheath 16 and a sheath handle 17. The sheath 16 and the sheath handle 17 are coaxially sleeved on the push rod 14 and can move axially relative to the push rod 14. The distal end of the sheath handle 17 is fixed to the proximal end of the sheath 16. When the delivery device 10 completes the release of the coated stent 40 and is ready to be withdrawn, the distance between the distal end of the push rod handle 15 and the proximal end of the second handle is defined as L1, and the distance between the distal end of the push rod 14 and the proximal end of the anchor is defined as L2. Figure 1 As shown, L1 and L2 satisfy: L1 ≥ L2, so that after the coated stent 40 is released, the distance reserved between the push rod handle 15 and the sheath handle 17 can satisfy the push rod handle 15 to push the push rod 14 toward the distal end until the distal end face of the push rod 14 abuts the proximal end face of the anchor 12, so that the push rod 14 can shield and protect the anchor 12 during the process of withdrawing the push rod 14 and the anchor 12 together into the sheath. This allows the delivery device 10 to avoid, during the retraction process, the problem of difficulty in pushing forward and covering the anchoring member due to the adhesion of the sheath 16 to the blood vessel and the lack of the guide head 11 to guide the transition, which in turn prevents the delivery device from being directly retracted. Alternatively, it can avoid the problem of the anchoring member 12 being easily hooked or scraped against the blood vessel by the direct retraction of the sheath core 13 due to the presence of the anchoring member 12. This allows the sheath core 13 to be safely recovered into the sheath 16 under the protection of the anchoring member when the push rod is pushed forward, thereby solving the problem of difficulty in retracting the delivery device 10 due to the anchoring member 12.
[0055] Furthermore, when the implant is loaded, the distance L0 (e.g. Figure 14 The relative distance L0 between the middle push rod handle 15 and the sheath handle 17 (which can be equivalent to the relative state of the two handles after the implant is loaded but before release) must be greater than the sum of the distance S1, the sheath handle moves backward to release the implant, and the aforementioned L2. The distance S1 is primarily determined by the sum of the axial lengths of the anchor and the implant; L2 is the minimum reserved value for L1.
[0056] The delivery device 10 is loaded with the stent graft 40 at the reserved position between the anchor 12 and the push rod 14. The distal end structure of the delivery device 10 after loading is as follows: Figure 4-5 As shown. The stent graft 40 is delivered to the lesion site by the delivery device 10, and the sheath 16 is driven to withdraw axially toward the proximal end by the sheath handle 17 (at this time, the sheath core 13 and the push rod 14 are fixed and stationary relative to the human body). After the stent graft 40 is released at the lesion site, the delivery device 10 needs to be withdrawn from the human body. After the stent graft 40 is released, the distal end structure of the delivery device 10 is as shown. Figure 1-3 shown.
[0057] After the delivery device 10 releases the stent graft 40, Figure 1-3 As shown, at this time, the delivery device 10 has completed the release of the stent graft and is ready to withdraw. The specific process of shielding the anchor 12 by the push rod 14 is as follows:
[0058] (1) Loosen the push rod handle end cap 154 to allow the push rod 14 and the sheath core 13 to move relative to each other, keep the sheath handle and the sheath core 13 stationary relative to the human body, and first push the push rod handle 15 axially toward the distal end until the stop line 132 on the sheath core 13 leaks out from the proximal end of the push rod handle 15. Figure 11 Combine Figure 6-8 As shown, stop pushing the push rod handle 15. At this time, the distal end surface of the push rod 14 abuts against the proximal end surface of the anchor 12, so that the push rod blocks the anchor 12. Figure 6-8 During this process, the position of the distal end of the push rod handle 15 and the push rod 14 of the delivery device 10 relative to the sheath handle 17 changes as follows: Figure 1 The state moves to Figure 6 status.
[0059] (2) Tighten the push rod handle end cap 154 using the threaded structure to fix the push rod 14 and the sheath core 13 relatively, keep the sheath handle 17 stationary relative to the human body, and pull the push rod handle 15 toward the proximal end until the proximal side of the guide head 11 is accommodated in the sheath 16, as shown in FIG. Figure 14 During this process, the position of the push rod handle 15, push rod 14, and guide head 11 of the delivery device 10 relative to the sheath handle 17 changes as follows: Figure 6 The state moves to Figure 14 status.
[0060] (3) Finally, the entire delivery device 10 is slowly withdrawn from the body.
[0061] Example 2
[0062] like Figure 15-18 As shown, the delivery device of this embodiment is different from the first embodiment in that the anchoring member 22 is a three-dimensional multi-claw type. Figure 15 As shown, the anchor 22 includes an anchor bottom 221 , an anchor portion 222 and a welding portion 223 for welding the anchor 22 to the sheath core. The anchor portion 222 extends distally from the anchor bottom 221 and is a plurality of claws uniformly distributed circumferentially around the sheath core 23 .
[0063] like Figure 16-18 As shown, the outer diameter of the push rod 24 is equal to the outer diameter of the anchor 22, so that when the distal end surface of the push rod 14 abuts the proximal end surface of the anchor 12, as shown in FIG. Figure 17-18 As shown, the push rod 14 shields the anchor 12, and when the anchor 22 and the push rod 24 are withdrawn into the sheath, the corners or welds will not scrape or hook against the inner wall of the blood vessel. The distal end face of the push rod 24 abuts the proximal end face of the anchor 22. At this time, the anchor 22 and the push rod 24 can be regarded as the same cylinder without transition, as shown in FIG. Figure 17-18 As shown, the peripheral side of the end surface of the distal end of the push rod 24 is a transitional smooth arc surface.
[0064] The present invention also provides a delivery system, comprising the delivery device as described above, and further comprising an implant that is detachably hooked on the anchor. In this embodiment, the implant is a coated stent.
[0065] The present invention provides a delivery device. For the delivery device that completes the release of the implant, the distance between the distal end of the push rod handle and the proximal end of the sheath handle is defined as L1, and the distance between the distal end of the push rod and the proximal end of the anchor is defined as L2. By limiting L1 and L2 to satisfy: L1≥L2, when the delivery device is retracted, the push rod can be pushed forward to abut against the anchor, so that the anchor bottom that is easy to scratch or hook with the blood vessel is blocked by the push rod and then retracted into the sheath together, so as to solve the problem of difficulty in retracting the delivery device caused by the anchor being easy to scratch or hook with the blood vessel wall.
[0066] It is understandable that the delivery device claimed for protection in this application can also be used to deliver other medical devices such as left atrial appendage occluders, atrial septal defect occluders, filters, etc. according to actual needs, and is not limited to the coated stent in this application.
[0067] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0068] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.
Claims
1. A delivery device for delivering an implant, comprising a sheath core, a guide head and an anchor, wherein the guide head is located at the distal end of the sheath core, the anchor is located on the sheath core and close to the proximal end of the guide head, the delivery device further comprising a push rod sleeved on the sheath core and movable axially relative to the sheath core, a push rod handle disposed at the proximal end of the push rod, a sheath tube coaxially sleeved on the push rod and movable axially relative to the push rod, and a sheath tube handle disposed at the proximal end of the sheath tube, characterized in that: The push rod handle is coaxially sleeved on the sheath core, and the proximal end of the sheath core is exposed from the proximal end of the push rod handle. The sheath handle is coaxially sleeved on the push rod, and the push rod includes a hollow cylinder, and the outer diameter of the hollow cylinder is greater than or equal to the maximum radial width of the anchor; when the delivery device completes the release of the implant and is ready to withdraw, the distance between the distal end of the push rod handle and the proximal end of the sheath handle is defined as L1, and the distance between the distal end of the push rod and the proximal end of the anchor is defined as L2, then L1 and L2 satisfy: L1≥L2; when the implant is fully released, the distance that the sheath handle drives the sheath to withdraw is defined as S1, then, when the implant is loaded, the reserved distance L0 between the push rod handle and the sheath handle is greater than the sum of S1 and L2, so that when the delivery device is withdrawn, the push rod can be pushed forward to abut against the anchor.
2. The conveying device according to claim 1, characterized in that The anchoring member includes an anchoring bottom and an anchoring portion extending distally from the anchoring bottom. The proximal end surface of the anchoring bottom includes a plane perpendicular to the axial direction and forms an arc transition with the anchoring portion.
3. The conveying device according to claim 2, characterized in that The anchoring member further includes a welding portion located at a proximal end side of the anchoring bottom and welding the anchoring member to the sheath core. The inner diameter of the push rod is greater than the maximum radial width of the welding portion.
4. The conveying device according to claim 1, characterized in that The proximal end of the sheath core is provided with a stop mark.
5. The conveying device according to claim 1, characterized in that The distal end surface of the push rod includes a plane perpendicular to the axial direction and an arc transition surface circumferentially arranged around the plane.
6. The conveying device according to claim 1, characterized in that The distal end surface of the push rod is coated with a hydrophilic coating.
7. The conveying device according to claim 1, characterized in that The push rod handle includes a first shell, a push rod handle end cover and a fastener. The first shell is fixedly connected to the proximal end of the push rod. The push rod handle end cover is located at the proximal end opening of the first shell. The fastener is controlled by the push rod handle end cover to fix the push rod relative to the sheath core.
8. A conveying system, characterized in that: The delivery device comprises the delivery device according to any one of claims 1 to 7, wherein the delivery system further comprises an implant, and the implant is hooked on the anchor.
Citation Information
Patent Citations
Delivery system
CN108245290A
Conveying device
CN110870811A