Near-end release self-expansion type peripheral vascular stent conveying system and using method

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a near-end release self-expansion type peripheral vascular stent conveying system and a using method.The conveying system comprises a conveying sleeve, the front end of the conveying sleeve is connected with a stent release protective sleeve to form a return sleeve section, and a stent is installed at the front end of a recovery sleeve and fixed in the return sleeve section through the protective sleeve; the outer sheath cannula is positioned on the outer side of the recovery cannula; the method comprises the steps that after the lesion position is preliminarily determined, the lesion position is fed into a conveying sleeve, a recycling sleeve and an outer sheath sleeve along a guide wire; a contrast agent is injected, the lesion position is determined again, and the near end of the stent completely covers the near end of the lesion; and the conveying sleeve is withdrawn, the protective sleeve is withdrawn into the recycling sleeve, and the stent is gradually expanded until the whole stent is completely expanded. The release direction of the stent is changed, the stent is released from the proximal end, a contrast agent is injected through the sheath radiography connecting tube to confirm the lesion position, the stent is adjusted to the proper position and then completely released, and it is ensured that the stent fully covers the lesion section and does not exceed the opening too much.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a proximal release self-expanding peripheral vascular stent delivery system and a use method thereof. Background Art

[0002] Currently, the self-expanding peripheral vascular stents used in clinical practice all start to release from the distal end, such as Figure 6 As shown, the sheath is withdrawn to release the stent starting from the distal end ("proximal" refers to the end close to the heart in the direction of blood flow, and "distal" refers to the end away from the heart in the direction of blood flow). Especially for some lesions involving the opening of blood vessels, releasing from the distal end often leads to inaccurate positioning of the proximal lesion, including insufficient coverage of the lesion segment, or exceeding the lesion too long, thereby affecting the success rate and treatment effect of the operation; and it is often necessary to use a long sheath to inject contrast agent when releasing the stent to determine the location of the lesion during the operation.

[0003] In order to improve the positioning accuracy of the stent, balloon-expandable stents are also used clinically. However, the problem with balloon-expandable stents is that they cannot be repositioned after balloon expansion. In addition, due to the material and manufacturing process of the stent, the radial strength of the balloon-expandable stent is higher, and the vascular compliance is worse than that of the self-expanding stent.

[0004] At present, there are also some stent post-release delivery systems and methods to improve the accuracy of stent positioning. The covered stents using the post-release system are currently used in the aortic system, such as COOK's Zenith TX. Post-release is to open the proximal bare stent anchoring area after the covered stent body is released, so the stent can be adjusted to the ideal position and then anchored to achieve more accurate release. However, the diameter of the peripheral vascular stent is thinner than the aorta, so the post-release delivery system and method with a complex design is not easy to implement on the peripheral vascular stent delivery system with a thinner diameter. Therefore, in the release of peripheral vascular stents, a release system and release method with a simpler design that can adjust the proximal position of the stent is needed. Summary of the invention

[0005] In view of the shortcomings of the prior art, the present invention provides a proximal-release self-expanding peripheral vascular stent delivery system and a method of use, which can change the release direction of the stent, start the release from the proximal end, inject contrast agent through the outer sheath angiography connecting tube to confirm the lesion location, adjust the stent to a suitable position and then release it completely to ensure that the stent fully covers the lesion segment.

[0006] The specific technical solutions adopted are as follows:

[0007] A proximal release self-expanding peripheral vascular stent delivery system, comprising a delivery sleeve, a stent release protection sleeve, a recovery sleeve, an outer sheath sleeve, an outer sheath angiography connecting tube, a stent and a guide wire;

[0008] The inner diameter of the delivery sleeve is adapted to the diameter of the guide wire, and can be pushed to the lesion location along the guide wire;

[0009] The front end of the delivery sleeve is connected to a stent release protection sleeve, the first end of the stent release protection sleeve is integrally arranged with the front end of the delivery sleeve, the second end of the stent release protection sleeve is turned over and sleeved back on the delivery sleeve to form a sleeve section, the stent is fixed in the sleeve section by the stent release protection sleeve, and is in a compressed state, and can be released and opened as the stent release protection sleeve is withdrawn;

[0010] The recovery sleeve gap is set between the delivery sleeve and the outer sheath sleeve, and the stent is pre-installed at the front end of the recovery sleeve, so that the stent is placed as a whole between the stent release protection sleeve and the recovery sleeve when it is not released;

[0011] The outer sheath sleeve is located outside the recovery sleeve, and the outer sheath sleeve can move relative to the recovery sleeve; the front end of the outer sheath sleeve is spaced from the rear end of the return sleeve section of the stent release protection sleeve;

[0012] The outer sheath contrast agent connecting tube is arranged at the rear end of the outer sheath sleeve and is used for pushing contrast agent.

[0013] Furthermore, the stent release protection sleeve is made of flexible material.

[0014] Furthermore, the stent release protection sleeve is made of polyethylene material or polyurethane material.

[0015] Furthermore, the stent is a self-expanding peripheral vascular stent.

[0016] Furthermore, the bracket has different specifications and models.

[0017] A method for using a proximal release self-expanding peripheral vascular stent delivery system comprises the following steps:

[0018] Step 1: After the lesion location is initially determined, the guide wire passes through the peripheral vascular lesion segment, and then is sent along the guide wire into the delivery cannula, the recovery cannula, and the outer sheath cannula to reach the lesion location;

[0019] Step 2: Inject contrast agent into the peripheral blood vessels through the tube interface of the outer sheath angiography connecting tube to determine the lesion position again so that the proximal end of the stent completely covers the proximal end of the lesion; withdraw the delivery sheath under fluoroscopy to link the stent and release the protective sheath, and adjust the position of the stent after the proximal end of the stent is partially opened so that the proximal end of the stent is located at the proximal end of the lesion;

[0020] Step 3: withdraw the delivery sheath, release the stent protection sheath into the recovery sheath, gradually withdraw from the stent, and gradually open and release the stent from the proximal end until the entire stent is fully expanded.

[0021] The beneficial effects of the present invention are:

[0022] The present invention can be applied to the interventional treatment of peripheral arterial disease, and the proximal release of the self-expanding stent of the peripheral blood vessel is realized by a more convenient design, so as to improve the accuracy of the proximal positioning of the blood vessel. It is particularly suitable for lesions involving the opening of the blood vessel, such as the renal artery, the superior mesenteric artery, the bifurcation of the superficial femoral artery and the deep femoral artery, the opening of the iliac artery on the opposite side of the puncture route, etc. (due to the influence of factors such as hemodynamics, the incidence of stenosis and occlusion at the opening of the blood vessel is high, and such patients have a large group in clinical treatment). Insufficient coverage of the proximal end of the stent is likely to lead to treatment failure or the need to supplement additional stents; excessive coverage beyond the proximal end is likely to affect the aorta or other adjacent blood vessels, affecting the hemodynamics and long-term effects. The present invention changes the release direction of the stent, starts to release from the proximal end, and after the proximal end of the stent is partially opened, the contrast agent is pushed through the outer sheath angiography connecting tube to confirm the position of the lesion, and the stent is adjusted to a suitable position before being fully released, which can ensure that the stent can fully cover the lesion segment without exceeding the opening too much. Reduce the unsuccessful operation or increased complications caused by inaccurate stent release positioning. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic structural diagram of the stent compression state of the proximal release self-expanding peripheral vascular stent delivery system of the present invention;

[0024] Figure 2 It is a structural schematic diagram of the stent release process of the proximal release self-expanding peripheral vascular stent delivery system of the present invention;

[0025] Figure 3 It is a schematic structural diagram of the proximal release self-expanding peripheral vascular stent delivery system of the present invention when the stent is fully released;

[0026] Figure 4 This is an enlarged schematic diagram of the local structure of the present invention. Figure 1 ;

[0027] Figure 5 This is an enlarged schematic diagram of the local structure of the present invention. Figure 2 ;

[0028] Figure 6 It is a schematic diagram of the structure of an existing self-expanding peripheral artery stent delivery and release system;

[0029] Among them, 1. delivery sleeve; 2. recovery sleeve; 3. stent release protection sleeve; 4. outer sheath sleeve; 5. outer sheath angiography connecting tube; 6. stent; 7. guide wire. DETAILED DESCRIPTION

[0030] In order to better explain the present invention and facilitate understanding, the technical solutions and effects of the present invention are described in detail below through specific implementation modes in conjunction with the accompanying drawings.

[0031] In the description of the present invention, it is necessary to understand that the proximal end refers to the end close to the heart according to the direction of blood flow, and the distal end refers to the end away from the heart according to the direction of blood flow; the axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the device or component, and the radial direction refers to the direction perpendicular to the axial direction; the inside and the outside are positions defined by the distance relative to the center of the device or component, wherein the inside is the position close to the center of the device or component, and the outside is the position away from the center of the device or component. The description of the above-mentioned directional words is only for the convenience of describing the embodiments of the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the embodiments of the present invention.

[0032] like Figure 1-5 As shown, this embodiment provides a proximal release self-expanding peripheral vascular stent delivery system, including a delivery sleeve 1, a stent release protection sleeve 3, a recovery sleeve 2, an outer sheath sleeve 4, an outer sheath angiography connecting tube 5 and a stent 6;

[0033] The delivery sleeve 1 is pushed to the lesion position along the guide wire 7, and the inner diameter of the delivery sleeve 1 is adapted to the diameter of the guide wire 7 (the commonly used diameter of the guide wire 7 is 0.035 inches, 0.018 inches); the front end of the delivery sleeve 1 is connected with a stent release protection sleeve 3, the first end of the stent release protection sleeve 3 is integrally arranged with the front end of the delivery sleeve 1, and the second end of the stent release protection sleeve 3 is turned over and retracted on the delivery sleeve 1 to form a retracting section, and the stent 6 is fixed in the retracting section by the stent release protection sleeve 3, and is in a compressed state, and can be released and opened as the stent release protection sleeve 3 is withdrawn; the stent release protection sleeve 3 can be made of a flexible material with elasticity and tensile strength, such as polyethylene material, polyurethane material, which can wrap the stent 6 to make it in a compressed state, and can smoothly pass through the narrow or occluded lesion section in the blood vessel. The outer sheath sleeve 4 is located outside the recovery sleeve 2, and the outer sheath sleeve 4 can move relative to the recovery sleeve 2; the front end of the outer sheath sleeve 4 is spaced from the rear end of the retracting section of the stent release protection sleeve 3. An outer sheath angiography connecting tube 5 is provided at the tail end of the outer sheath sleeve 4, so that contrast agent can be injected through the outer sheath angiography connecting tube 5 before releasing the stent 6, so as to display the lesion position in real time and better guide the positioning accuracy; the recovery sleeve 2 is gapped between the delivery sleeve 1 and the outer sheath sleeve 4, the recovery sleeve 2 is coaxially designed with the delivery sleeve 1, and the stent 6 is pre-installed at the front end of the recovery sleeve 2, so that the stent 6 is placed as a whole between the stent release protection sleeve 3 and the recovery sleeve 2 when it is not released; when releasing the stent, the recovery sleeve 2 is fixed, and the delivery sleeve 1 is withdrawn, so that the stent release protection sleeve 3 connected to the delivery sleeve 1 can be gradually withdrawn into the recovery sleeve 2 along the end of the recovery sleeve 2.

[0034] The length and diameter of the stent 6 can have different specifications and models (currently the commonly used diameter for peripheral blood vessels is 4mm-14mm, and the length is 20mm-200mm); before the stent release protection sleeve 3 is released, the stent 6 is synchronously transported with the movement of the delivery sleeve 1 and the recovery sleeve 2.

[0035] In the present invention, the stent 6 adopts a self-expanding peripheral vascular stent. When the stent 6 arrives at the diseased section along with the delivery sheath 1, the recovery sheath 2 is fixed, and the delivery sheath 1 is withdrawn, so that the stent release protection sheath 3 can be against the recovery sheath 2, thereby gradually detaching from the stent 6 and withdrawing into the recovery sheath 2. The stent 6 is gradually opened and released starting from the proximal end until the entire stent 6 is fully opened.

[0036] Method of using the above stent delivery system:

[0037] Step 1: DSA (subtraction angiography) angiography is used to preliminarily determine the location of the lesion. After the guide wire 7 passes through the peripheral vascular lesion segment, the guide wire 7 is sent into the delivery sleeve 1, the recovery sleeve 2 and the outer sheath sleeve 4 to reach the lesion location;

[0038] Step 2: Inject contrast agent into the peripheral blood vessels through the tube interface of the outer sheath angiography connecting tube 5, and the contrast agent flows out from the distal end after passing through the inner cavity of the outer sheath sleeve 4, so as to determine the lesion position again, so that the proximal end of the stent 6 completely covers the proximal end of the lesion; under DSA fluoroscopy, withdraw the delivery sleeve 1 and the stent release protection sleeve 3, and adjust the position of the stent 6 after the proximal end of the stent 6 is partially opened, so that the proximal end of the stent 6 is located at the proximal end position of the lesion predetermined by the operator;

[0039] Step 3: After adjusting the position under fluoroscopy, withdraw the delivery sheath 1, and the stent release protection sheath 3 enters the recovery sheath 2, thereby gradually withdrawing from the stent 6. The stent 6 is gradually opened and released from the proximal end until the entire stent 6 is fully expanded. After that, the delivery sheath 1, the stent release protection sheath 3, the recovery sheath 2 and the outer sheath sheath 4 are completely withdrawn from the body.

[0040] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A proximal release self-expanding peripheral vascular stent delivery system, characterized in that: It includes a delivery sleeve, a stent release protection sleeve, a recovery sleeve, an outer sheath sleeve, an outer sheath angiography connecting tube, and a stent; The inner diameter of the delivery sleeve is adapted to the diameter of the guide wire, and can be pushed to the lesion location along the guide wire; The front end of the delivery sleeve is connected to a stent release protection sleeve, the first end of the stent release protection sleeve is integrally arranged with the front end of the delivery sleeve, the second end of the stent release protection sleeve is turned over and sleeved back on the delivery sleeve to form a sleeve section, the stent is fixed in the sleeve section by the stent release protection sleeve, and is in a compressed state, and can be released and opened as the stent release protection sleeve is withdrawn; The recovery sleeve gap is set between the delivery sleeve and the outer sheath sleeve, and the stent is pre-installed at the front end of the recovery sleeve, so that the stent is placed as a whole between the stent release protection sleeve and the recovery sleeve when it is not released; The outer sheath sleeve is located outside the recovery sleeve, and the outer sheath sleeve can move relative to the recovery sleeve; the front end of the outer sheath sleeve is spaced from the rear end of the return sleeve section of the stent release protection sleeve; The outer sheath contrast agent connecting tube is arranged at the rear end of the outer sheath sleeve and is used for pushing contrast agent.

2. A proximal release self-expanding peripheral vascular stent delivery system according to claim 1, characterized in that: The support release protection sleeve is made of flexible material.

3. A proximal release self-expanding peripheral vascular stent delivery system according to claim 2, characterized in that: The stent release protection sleeve is made of polyethylene material or polyurethane material.

4. A proximal release self-expanding peripheral vascular stent delivery system according to claim 1, characterized in that: The stent is a self-expanding peripheral vascular stent.

5. The proximal release self-expanding peripheral vascular stent delivery system according to claim 1, characterized in that: The bracket has different specifications and models.

6. A method for using a proximal release self-expanding peripheral vascular stent delivery system according to any of the above claims, characterized in that: The following steps are involved: Step 1: After the lesion location is initially determined, the guide wire passes through the peripheral vascular lesion segment, and then is sent along the guide wire into the delivery cannula, the recovery cannula, and the outer sheath cannula to reach the lesion location; Step 2: Inject contrast agent into the peripheral blood vessels through the tube interface of the outer sheath angiography connecting tube to determine the lesion position again so that the proximal end of the stent completely covers the proximal end of the lesion; withdraw the delivery sheath under fluoroscopy to link the stent and release the protective sheath, and adjust the position of the stent after the proximal end of the stent is partially opened so that the proximal end of the stent is located at the proximal end of the lesion; Step 3: withdraw the delivery sheath, release the stent protection sheath into the recovery sheath, gradually withdraw from the stent, and gradually open and release the stent from the proximal end until the entire stent is fully expanded.

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