Carotid stent delivery system

Abstract

The utility model discloses a carotid artery stent delivery system, the delivery system includes handle component, delivery system pipe body, conical head, the conical head is fixed in the farthest end of delivery system pipe body, and carotid artery stent sets up in the delivery system pipe body, the delivery system pipe body is through handle component, the delivery system pipe body includes inner tube and outer tube, the inner tube sets up in the outer tube, the inner tube is through outer tube, and one end extends the proximal end of outer tube, the outer tube farthest end wall has the tubular space for placing carotid artery stent, the conical head is fixed in the farthest end of delivery system pipe body, and the relative movement of outer tube is controlled through handle component, thereby releases the support. The utility model discloses a carotid artery stent delivery system, can slowly release support, improves release accuracy.

Description

Technical Field

[0001] This utility model relates to the field of carotid artery stent delivery technology, and in particular to a carotid artery stent delivery system. Background Technology

[0002] Cerebrovascular diseases are a major threat to human health today, ranking as the third leading cause of death after cardiovascular diseases and cancer. Stroke is the most common major chronic disease, and it is divided into ischemic stroke and hemorrhagic stroke. More than 80% of strokes are ischemic strokes, and about 20-30% of ischemic strokes are caused by carotid artery stenosis.

[0003] Carotid artery stenosis is a hemodynamic disorder of the neck vessels caused by factors such as atherosclerosis, aortitis, and fibromuscular dysplasia. Carotid artery stenosis has become a leading cause of ischemic stroke and a significant cause of disability and death. Current clinical treatments for carotid artery stenosis mainly include carotid endarterectomy (CEA) and carotid artery stenting (CAS). CAS, with its safety, effectiveness, minimally invasive nature, and significant therapeutic effects, has become the primary treatment for carotid artery stenosis. Existing carotid stents are mainly self-expanding. During stent placement, a delivery device delivers an external catheter and an internal stent to the lesion site. Then, by manipulating the relative movement of different components on the delivery system, the stent is advanced out of the catheter, causing it to self-expand and support the lesion.

[0004] Patent CN105193532A discloses a carotid artery stent system, a type of arterial interventional medical device. It includes a carotid artery stent and a delivery device. The carotid artery stent is inserted into the diseased blood vessel via the delivery device. The carotid artery stent is pre-compressed and inserted into the outer sheath of the delivery device. The stent is released to the diseased area by retracting the delivery device.

[0005] Patent CN105050549A discloses a support delivery system and related methods. The handle assembly of the tubular housing support delivery system includes a second lead screw with a first lead thread having a first pitch and a first helical orientation, a second lead screw with a second lead thread having a second pitch and a second helical orientation different from the first helical orientation, and a housing defining threads with first and second pitches. The first lead screw is mechanically connected to the tubular housing, and the second lead screw is mechanically connected to the support. When a portion of the housing rotates, the housing threads engage the lead screws, thereby inducing the lead screws to move in the opposite direction, thus causing the tubular housing to unfold the support.

[0006] Patent CN116269965A discloses a stent delivery system, which includes a handle portion and a conduit portion for carrying and releasing the stent. The handle portion includes: a handle housing in which the conduit portion is inserted; a finger wheel rotatably disposed within the handle housing and partially exposed outside; a transmission mechanism connected to the finger wheel and the conduit portion; and a ratchet mechanism disposed within the handle housing and configured to prevent the finger wheel from rotating in the opposite direction, ensuring that the finger wheel can only rotate in the selected direction and, through the transmission mechanism, operate the conduit portion to release the stent. This stent delivery system reduces the operator's operational requirements. Even if the finger wheel is operated in the opposite direction, it effectively prevents the finger wheel from reversing and damaging the internal structure of the handle portion, especially the transmission mechanism, thereby ensuring the normal use of the stent delivery system and not increasing the risk of stent misplacement.

[0007] In existing product technologies, most carotid artery stent delivery systems use a needle-push method. Although it has good delivery capability, it is not easy to control the speed during clinical use. When releasing the stent, it may not be accurately released to the target position, resulting in the inability to completely cover the lesion site. Utility Model Content

[0008] To address the aforementioned technical problems, this invention provides a carotid artery stent delivery system that can slowly release the stent, improving release accuracy.

[0009] To solve the above-mentioned technical problems, the technical solution proposed by this utility model is as follows:

[0010] A carotid artery stent delivery system includes a handle assembly, a delivery system body, and a conical tip. The conical tip is fixed to the distal end of the delivery system body. A carotid artery stent is disposed within the delivery system body. The delivery system body extends through the handle assembly. The delivery system body includes an inner tube and an outer tube. The inner tube is disposed within the outer tube and extends through the outer tube, with one end extending proximally to the outer tube. The distal wall of the outer tube has a cylindrical space for placing the carotid artery stent. The tip is fixed to the distal end of the delivery system body. The outer tube is moved relative to the stent by controlling the handle assembly, thereby releasing the stent.

[0011] A further improvement to the above technical solution is as follows:

[0012] Preferably, the conveying system tube body further includes a Luer connector, a stainless steel retaining ring, a strain relief sleeve, and a platinum-iridium ring. The proximal end of the inner tube is connected to the Luer connector. The strain relief sleeve is fixed to the distal end of the handle assembly, locking the handle assembly between the Luer connector and the strain relief sleeve. The stainless steel retaining ring is fixed to the proximal end of the outer tube and is connected to the handle assembly to control the movement of the outer tube. The Luer connector is fixed to the proximal end of the inner tube and is connected to the handle assembly.

[0013] Preferably, platinum-iridium rings are provided at both ends of the carotid artery stent.

[0014] Preferably, the outer tube consists of a distal tube body, a mid-section tube body, and a proximal tube body. The mid-section tube body is located between the distal tube body and the proximal tube body. The inner diameter of the distal tube body is greater than the inner diameter of the proximal tube body, which is greater than the inner diameter of the mid-section tube body. The distal end of the inner tube body is located inside the mid-section tube body, and the carotid artery stent is disposed inside the distal tube body.

[0015] Preferably, the conveying system pipe body is further provided with a stainless steel pipe sleeve, which is fitted inside the inner pipe and located between the Luer joint and the stainless steel fixing ring. The stainless steel pipe sleeve is set in the inner cavity of the near end of the pipe body as a reinforcing pipe structure. The stainless steel pipe sleeve is first fixed to the inner pipe and then set in the near end of the pipe body.

[0016] Preferably, the handle assembly includes a housing, a traction cable, a turntable, and a pulley. The housing is divided into two parts and has an inner cavity. The turntable and pulley are respectively located at the far end and near end of the housing. The turntable and pulley are rotatably mounted on the housing. A portion of the turntable is located outside the housing for manual operation. One end of the traction cable is connected to an outer tube, and the other end of the traction cable is fixed to the turntable after wrapping around the pulley. The pulley, turntable, and traction cable constitute a sliding device.

[0017] Preferably, the handle assembly further includes a safety lock, and the outer circumference of the turntable is provided with multiple slots. The safety lock is installed in the housing and can lock or remove the slots of the turntable.

[0018] Preferably, the outer circumference of the turntable is provided with multiple rubber sleeves, and a groove is formed between adjacent rubber sleeves. The rubber sleeves are provided with multiple protrusions.

[0019] Preferably, the handle assembly further includes a paddle, the inner ring of the outer circumference of the turntable is provided with serrations, the serrations of the inner ring of the turntable engage with the paddle, and the paddle is fixed on the housing.

[0020] The carotid artery stent delivery system provided by this utility model has the following advantages compared with the prior art:

[0021] (1) The carotid artery stent delivery system of this utility model has a reinforcing tube at the proximal end of the outer tube to improve the proximal support and pushability, and a softer material with a lower coefficient of friction at the distal end to improve the distal flexibility and bending ability. The inner diameter of the middle section of the tube is reduced to fit the outer diameter of the inner tube to the maximum extent. The gap between the inner and outer tubes is reduced to avoid bending of the inner tube during delivery and improve the accuracy of release.

[0022] (2) The carotid artery stent delivery system of this utility model has a turntable and a pulley system consisting of two fixed pulley groups. The pulleys can change the direction of force by rotating counterclockwise. The central axis of the turntable acts as a take-up reel to pull the delivery catheter back, achieving a large-range delivery with a short handle. The horizontal spacing between the two fixed pulley groups allows the release stroke to be completely contained within the handle, while the handle length is not too long. The diameter ratio of the turntable and the pulley is set to reduce the force exerted by the operator during use. The operator can slowly rotate the turntable to pull the traction line back, thereby achieving the purpose of slowly releasing the stent. The delivery catheter moves smoothly axially in the handle without bending, which facilitates the transmission of release force. The safety lock prevents the stent from being released prematurely, causing product failure.

[0023] (3) In clinical use, the carotid artery stent delivery system of this utility model achieves slow release and precise positioning by controlling the turntable. At the same time, after the stent is fully released, the turntable can be rotated in the opposite direction to retract the outer tube of the distal stent loading part. This helps to prevent the conical head from hanging the stent upside down during the delivery system retrieval process. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the carotid artery stent delivery system of this utility model.

[0025] Figure 2 This is a schematic diagram of the structure of the conveying system pipe of this utility model.

[0026] Figure 3 This is a schematic diagram of the structure of the outer tube of this utility model.

[0027] Figure 4 This is a schematic diagram of the structure of Embodiment 1 of this utility model.

[0028] Figure 5 This is a schematic diagram of the right shell in Embodiment 1 of this utility model.

[0029] Figure 6 This is a schematic diagram of the turntable in Embodiment 1 of this utility model.

[0030] Figure 7 This is a structural schematic diagram of Embodiment 2 of the present invention.

[0031] Explanation of the labels in the diagram:

[0032] 1. Carotid artery stent; 2. Handle assembly; 21. Left shell; 22. Right shell; 23. Traction wire; 24. Safety lock; 241. Switch; 242. Snap-fit; 25. Turntable; 251. Slot; 252. Rubber sleeve; 26. Paddle; 27. Stainless steel rod; 28. Pulley; 29. ​​Gear; 3. Delivery system tube body; 31. Luer connector; 32. Inner tube; 33. Stainless steel tube sleeve; 34. Stainless steel retaining ring; 35. Strain release sleeve; 36. Outer tube; 361. Distal tube body; 362. Mid-section tube body; 363. Proximal tube body; 37. Quick exchange port; 38. First platinum-iridium ring; 39. Second platinum-iridium ring; 4. Conical head; 5. Extension tube; 6. Sliding tube. Detailed Implementation

[0033] The specific embodiments of this utility model are described in detail below. It should be understood that the specific embodiments described herein are for illustration and explanation only and are not intended to limit the scope of this utility model.

[0034] In this application, for ease of description, the terms "distal end" and "proximal end" are introduced from the operator's perspective, where "distal end" refers to the end furthest from the operator when using the support delivery system, and "proximal end" refers to the end closest to the operator when using the support delivery system. "Distal end" and "proximal end" are defined merely for ease of description and are not restrictive.

[0035] Example 1

[0036] Figure 1 This illustration shows one embodiment of the carotid artery stent delivery system of the present invention. The delivery system includes a handle assembly 2, a delivery system tube 3, and a conical head 4. The conical head 4 is fixed to the distal end of the delivery system tube 3. The carotid artery stent 1 is disposed inside the delivery system tube 3. The delivery system tube 3 passes through the handle assembly 2 and is fixed at its tail end. The relative movement of the delivery system tube 3 is controlled by the handle assembly 2, thereby releasing the stent.

[0037] In this embodiment, as Figure 2As shown, the delivery system tube body 3 includes a Luer connector 31, an inner tube 32, a stainless steel sleeve 33, a stainless steel retaining ring 34, a strain release sleeve 35, an outer tube 36, a first platinum-iridium ring 38, and a second platinum-iridium ring 39. The inner tube 32 is disposed inside the outer tube 36, penetrates the outer tube 36, and extends from the proximal end of the outer tube 36. The proximal end of the inner tube 32 is connected to the Luer connector 31, and the distal end is located at the quick exchange port 37. The distal end of the outer tube 36 forms the quick exchange port 37. The distal wall of the outer tube 36 has a cylindrical space for placing the carotid artery stent 1. The tip 4 is fixed to the distal end of the delivery system tube body 3. The first platinum-iridium ring 38 and the second platinum-iridium ring 39 are respectively disposed at both ends of the carotid artery stent 1, providing precise positioning functionality. The strain relief sleeve 35 is fixed to the distal end of the handle assembly 2, locking the handle assembly 2 between the Luer connector 31 and the strain relief sleeve 35, preventing the handle assembly 2 from moving relative to the outer tube 36, and also providing anti-bending function. A stainless steel retaining ring 34 is fixed to the proximal end of the outer tube 36, connected to the handle assembly 2, controlling the retraction of the outer tube 36, thereby releasing the support. A stainless steel sleeve 33 is fitted onto a section of the proximal end of the inner tube 32, located between the Luer connector 31 and the stainless steel retaining ring 34. The Luer connector 31 is fixed to the proximal end of the inner tube 32, and one section of the Luer connector 31 is connected to the handle assembly 2.

[0038] In this embodiment, as Figure 3As shown, the outer tube 36 consists of a distal tube body 361, a middle tube body 362, and a proximal tube body 363. The proximal tube body 363 is preferably made of wire mesh and polyamide material and has an inner cavity. A stainless steel sleeve 33 is installed within the inner cavity of the proximal tube body 363 as a reinforcing tube structure. The stainless steel sleeve 33 has an inner diameter of 0.82±0.02mm, an outer diameter of 1.20±0.01mm, and a length of 160±5mm. The proximal tube body 363 has an inner diameter of 1.27±0.02mm, and the inner tube 32 has an outer diameter of 0.062±0.02mm. The stainless steel sleeve 33 is first fixed to the inner tube 32 by welding or adhesive and then installed within the proximal tube body 363 to form a tight fit. During the initial release of the support, a large initial kinetic energy is generated, and the response is first felt at the proximal end of the conveying system tube body. This design significantly improves the support and pushing performance at the proximal end of the conveying system and prevents the tube body from bending during use. The middle section tube 362 has an outer diameter of 0.93±0.01mm and an inner diameter of 0.73±0.01mm. The inner diameter order is: distal tube 361 > proximal tube 363 > middle tube 362. The length of the middle section tube 362 is 1000mm≤L≤1200mm. During stent release, the interaction force between the outer and inner tubes minimizes the gap between them, preventing excessive bending of the inner tube within the outer tube. This ensures uniform and effective transmission of the release force, avoiding the problem of the stent instantly protruding from the catheter and improving the accuracy of stent release. The inner layer of the distal tube 361 is made of PTFE material with a low coefficient of friction, reducing stent loading and minimizing friction with the inner tube during release. The outer layer is made of Pebax material with high flexibility, improving the flexibility and bending resistance of the distal end of the delivery system.

[0039] In this embodiment, a quick exchange port 37 is formed at the connection between the distal tube body 361 and the mid-section tube body 362, the distal end of the inner tube 32 is located inside the mid-section tube body 362, and the carotid artery stent 1 is disposed inside the distal tube body 361.

[0040] like Figures 4 to 6As shown, in this embodiment, the handle assembly 2 consists of a housing, a traction cable 23, a safety lock 24, a turntable 25, a paddle 26, a stainless steel rod 27, and a pulley 28. The housing includes a left shell 21 and a right shell 22. The turntable 25 and the pulley 28 are respectively located at the far end and near end of the housing, and are spaced apart. The stainless steel rod 27 is fixed in the opening groove of the housing, and the pulley 28 is fixed on the stainless steel rod 27, changing the direction of movement of the traction cable 23. The turntable 25 is rotatably mounted on the housing via a central shaft. The outer circumference of the turntable 25 is provided with multiple rubber sleeves 252, and a groove 251 is formed between adjacent rubber sleeves 252. The rubber sleeves are provided with multiple protrusions to increase friction and facilitate operation. Part of the turntable 25 is located outside the housing for manual operation. One end of the traction cable 23 is connected to a stainless steel fixing ring 34, and the other end of the traction cable 23 is fixed to the turntable 25 near the central shaft after wrapping around the pulley 28. The inner ring of the outer circumference of the turntable 25 is serrated, and the serrations of the inner ring of the turntable 25 engage with the lever 26. The lever 26 is fixed to the housing, and one or two levers can be provided. The pulley 28, the turntable 25 and the traction line 23 constitute a sliding device.

[0041] In this embodiment, the safety lock 24 is engaged within the slot 251 of the turntable 25. The safety lock 24 is I-shaped, comprising a switch part 241 and a locking part 242. The switch part 241 is located outside the housing and has a raised structure to increase friction, with a non-smooth surface. One end of the locking part 242 is tapered, used to engage with the slot 251 of the turntable 25. A limiting groove is fixedly provided on the right housing 22, and the locking part 242 slides within the limiting groove. A spring is provided between the housing and the safety lock 24 to reset the safety lock 24.

[0042] In this embodiment, as Figure 4As shown, the turntable 25 and pulley 28 form a two-fixed-pulley mechanism. Pulley 28 is designed to rotate counter-clockwise to change the direction of force. The central axis of the turntable 25 acts as a take-up reel, collecting the traction cable during the backward pulling of the delivery catheter, enabling long-range delivery with a short handle. The two fixed pulleys are horizontally spaced 80-150mm apart, ensuring the release stroke is fully contained within the handle while preventing excessive handle length. The turntable is located at the top of the handle and rotates clockwise, facilitating true one-handed release. During the release of the stent, the traction cable 23 ensures unidirectional delivery of the catheter, preventing rebound and avoiding clinical accidents. The diameter ratio of the turntable 25 to the pulley 28 is 3:1 to 2:1, which minimizes the force exerted on the turntable 25 by the operator during use. Simultaneously, the operator can slowly rotate the turntable 25 to retract the traction wire fixed to the outer tube, thereby achieving slow stent release and improving release accuracy. The straight groove guide rail 6 has an OD of 2.0-2.5mm and a delivery system outer diameter of 1.98-2.03mm, ensuring smooth axial movement of the delivery system within the handle without bending, facilitating the transmission of release force. A safety lock 24 is installed on the handle. Before use, the safety lock is in the locked position, preventing axial movement of the outer tube (i.e., preventing forward or backward movement). This avoids premature stent release due to movement of the outer tube during transport, surgical preparation, or when the stent delivery system reaches the target blood vessel, thus preventing product failure.

[0043] Example 2

[0044] like Figure 7 As shown, the difference between this embodiment and Embodiment 1 lies in the different handle assembly structure. In this embodiment, the handle assembly uses a gear and rack structure to drive the outer tube to move.

[0045] In this embodiment, the handle assembly 2 includes a gear 29, and also includes an extension tube 5 and a sliding tube 6. One end of the extension tube 5 is fixed to the handle assembly 2, and a strain relief sleeve 35 is arranged in the proximal cavity of the extension tube 5 to prevent the conveying system from bending. The distal end of the sliding tube 6 is fixed to the outer tube 36 and is slidably disposed inside the extension tube 5. The sliding tube 6 can move axially along the sliding groove provided in the housing. In this embodiment, the turntable 25 does not have an inner ring serration. The turntable 25 is provided with a coaxial disk, and the outer ring of the coaxial disk has teeth that mesh with the gear 29. The gear 29 is fixed in the housing and can rotate relative to the housing. One side of the sliding tube 6 has a rack that meshes with the gear 29, and the top of the gear 29 meshes with the coaxial disk of the turntable 25 to form a sliding control assembly. A paddle is disposed on one side of the gear 29, and a safety lock 24 is locked in the slot of the turntable 25 to ensure that the outer tube 36 will not move when not in operation. By opening the safety lock 24 and slowly turning the turntable 25, the gear 29 and sliding tube 6 are driven to retract, thereby achieving the purpose of slowly releasing the bracket and accurately positioning it; at the same time, after the bracket is fully released, the turntable 25 can be rotated in the opposite direction to retract the far end of the outer tube that holds the bracket, preventing the conical head from hanging the bracket upside down during the recovery process of the conveying system.

[0046] The above embodiments are merely preferred embodiments of this utility model and are not intended to limit the utility model in any way. Although this utility model has been disclosed above with reference to preferred embodiments, it is not intended to limit the utility model. Therefore, any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of this utility model without departing from the scope of the utility model's technical solution should fall within the protection scope of this utility model's technical solution.

Claims

1. A carotid artery stent delivery system, characterized in that, The delivery system includes a handle assembly, a delivery system tube, and a conical head. The conical head is fixed to the distal end of the delivery system tube. A carotid artery stent is disposed within the delivery system tube. The delivery system tube extends through the handle assembly. The delivery system tube includes an inner tube and an outer tube. The inner tube is disposed within the outer tube and extends through the outer tube, with one end extending beyond the proximal end of the outer tube. The distal wall of the outer tube has a cylindrical space for placing the carotid artery stent. The conical head is fixed to the distal end of the delivery system tube. The outer tube is moved relative to the conical head by the handle assembly to release the stent.

2. The carotid artery stent delivery system according to claim 1, characterized in that, The conveying system tube body also includes a Luer connector, a stainless steel retaining ring, a strain relief sleeve, and a platinum-iridium ring. The proximal end of the inner tube is connected to the Luer connector. The strain relief sleeve is fixed to the distal end of the handle assembly, locking the handle assembly between the Luer connector and the strain relief sleeve. The stainless steel retaining ring is fixed to the proximal end of the outer tube and is connected to the handle assembly to control the movement of the outer tube. The Luer connector is fixed to the proximal end of the inner tube and is connected to the handle assembly.

3. The carotid artery stent delivery system according to claim 2, characterized in that, Platinum-iridium rings are respectively installed at both ends of the carotid artery stent.

4. The carotid artery stent delivery system according to claim 2, characterized in that, The outer tube consists of a distal tube body, a mid-section tube body, and a proximal tube body. The mid-section tube body is located between the distal and proximal tube bodies. The inner diameter of the distal tube body is greater than the inner diameter of the proximal tube body, which is greater than the inner diameter of the mid-section tube body. The distal end of the inner tube body is located inside the mid-section tube body. The carotid artery stent is placed inside the distal tube body.

5. The carotid artery stent delivery system according to claim 4, characterized in that, The conveying system pipe body is also provided with a stainless steel pipe sleeve, which is fitted inside the inner pipe and located between the Luer joint and the stainless steel fixing ring. The stainless steel pipe sleeve is set in the inner cavity of the near end of the pipe body as a reinforcing pipe structure. The stainless steel pipe sleeve is first fixed to the inner pipe and then set in the near end of the pipe body.

6. The carotid artery stent delivery system according to claim 2, characterized in that, The handle assembly includes a housing, a traction cable, a turntable, and a pulley. The housing is divided into two parts and has an inner cavity. The turntable and pulley are respectively located at the far end and near end of the housing. The turntable and pulley are rotatably mounted on the housing. A portion of the turntable is located outside the housing for manual operation. One end of the traction cable is connected to an outer tube, and the other end of the traction cable is fixed to the turntable after wrapping around the pulley. The pulley, turntable, and traction cable constitute a sliding device.

7. The carotid artery stent delivery system according to claim 6, characterized in that, The handle assembly also includes a safety lock. The outer circumference of the turntable is provided with multiple slots. The safety lock is installed in the housing and can lock or remove the slots of the turntable.

8. The carotid artery stent delivery system according to claim 7, characterized in that, The turntable has multiple rubber sleeves on its outer circumference, with grooves formed between adjacent rubber sleeves, and multiple protrusions on the rubber sleeves.

9. The carotid artery stent delivery system according to claim 6, characterized in that, The handle assembly also includes a paddle, and the inner ring of the outer circumference of the turntable is provided with serrations. The serrations of the inner ring of the turntable engage with the paddle, and the paddle is fixed to the housing.

Images