CN109248012B

CN109248012B - Implant delivery system

Info

Publication number: CN109248012B
Application number: CN201710577386.6A
Authority: CN
Inventors: 王逸斐; 肖本好
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2017-07-14
Filing date: 2017-07-14
Publication date: 2020-12-25
Anticipated expiration: 2037-07-14
Also published as: CN109248012A; WO2019011274A1

Abstract

The invention discloses a conveying system of an implant, which comprises an inner sheath core pipe and an outer sheath pipe which is movably sleeved outside the inner sheath core pipe and is provided with a cavity; and at least one anchoring unit fixed on the outer surface of the inner sheath core tube, wherein the anchoring unit comprises a clamping piece sleeved on the outer surface of the inner sheath core tube and at least one anchoring piece connected with the clamping piece, the anchoring piece comprises a deformation part capable of bending relative to the inner sheath core tube and a locking part connected with the deformation part, and the deformation part and the locking part are matched with the clamping piece to form an anchoring piece when being accommodated in a cavity between the outer sheath tube and the inner sheath core tube. Thus, the implant does not shift from the inner sheath core tube during delivery of the implant. And in the releasing process, when the releasing position of the implant needs to be adjusted, the implant can be prevented from being released in advance.

Description

Implant delivery system

Technical Field

The present invention relates to implantable medical devices, and in particular to implant delivery systems.

Background

For diseases such as angiostenosis, aneurysm and vascular dissection, the luminal stent interventional operation has the advantages of small wound, quick recovery, less complications, good treatment effect and the like.

The metal framework structure of the self-expandable stent lumen stent is usually made of nickel-titanium alloy, and after a heat setting process, the lumen stent has the capability of recovering the shape of the lumen stent. The body of the delivery system of such stents typically comprises an outer sheath and an inner sheath-core tube pre-assembled within the outer sheath. The proximal end of the inner sheath core tube is thicker, the distal end is thinner, the lumen stent is accommodated in a cavity between the outer sheath tube and the distal end part of the inner sheath core tube, the distal end of the stent is tightly attached to the distal end face of the thicker part of the inner sheath core tube, and the inner sheath core tube is used for connecting a guide head (or called Tip head) and accommodating and passing through a guide wire. When the conveying system reaches a lesion part, the outer sheath tube is withdrawn towards the near end, so that the outer sheath tube and the lumen stent move relatively, the lumen stent is released from the outer sheath tube, and the lumen stent is unfolded and attached to the inner wall of the blood vessel by the aid of resilience of the lumen stent. The lumen stent and the sheath core tube in the conveying system are connected only through friction force, when the inner sheath core tube and the outer sheath tube are bent through the bending part of a human body blood vessel, the lumen stent is easy to shift, subsequent release can be influenced, and when the outer sheath tube is withdrawn, the stent can be easily shifted, so that the release position is not ideal, and the treatment effect is influenced.

The rigid bulge arranged on the inner sheath core tube penetrates through the hollow part of the lumen support, so that the lumen support can be limited to move relative to the inner sheath core tube in the cavity between the inner sheath core tube and the outer sheath tube. However, such a conveying system still has the following drawbacks: (1) in the conveying process of the lumen stent, when the outer sheath tube and the sheath-core tube jointly pass through the bending part of the lumen of a human body, the clearance between the sheath-core tube and the outer sheath tube is reduced on the side with smaller bending radius of the bent blood vessel; at the side with larger bending radius of the bent blood vessel, the clearance between the sheath core tube and the outer sheath tube is increased, at the moment, the distance between the rigid protrusion and the inner wall of the outer sheath tube is increased, the rigid protrusion is easy to separate from the lumen stent, and the lumen stent may be separated from the restriction of the protrusion, so that the position of the lumen stent in the outer sheath tube is deviated, and the subsequent release is influenced. (2) When the sheath core tube and the outer sheath tube reach the lesion site and the operator withdraws the outer sheath tube to release the lumen stent, the lumen stent may be completely released from the outer sheath tube quickly, and if the release position is not ideal, the release position cannot be adjusted. (3) When the luminal stent is partially released from the inside of the outer sheath, if the release position of the luminal stent is found to be not ideal, the distal end position of the outer sheath needs to be adjusted, and the luminal stent may be completely released from the inside of the outer sheath in advance during the adjustment process.

Disclosure of Invention

In view of the above, there is a need for an implant delivery system that reliably secures an implant to a sheath-core tube even in tortuous vessels. Avoiding the deviation between the implant and the inner sheath core tube. And the implant can be gradually released in the releasing process, so that the defect that the releasing position cannot be adjusted after the implant is suddenly released is avoided, and the implant is prevented from being completely released in advance in the process of adjusting the releasing position of the released implant.

The invention provides an implant delivery system, which comprises an inner sheath core tube and an outer sheath tube which is movably sleeved outside the inner sheath core tube and is provided with a cavity. The delivery system further includes at least one anchoring unit secured to an outer surface of the inner sheath core tube. The anchoring unit comprises a hoop member sleeved on the outer surface of the inner sheath core pipe and at least one anchoring member connected with the hoop member. The anchor member includes a deformable portion which is bendable with respect to the inner sheath core tube, and a locking portion which is connected to the deformable portion. The deformation part and the locking part are matched with the clamping piece to form an anchor when being accommodated in a cavity between the outer sheath tube and the inner sheath tube. Thus, when the anchor is received in the cavity between the outer sheath tube and the inner sheath tube, the anchor can hook the implant and limit relative movement between the implant and the inner sheath tube. When the outer sheath tube moves axially towards the proximal end relative to the inner sheath core tube, the anchoring element is released from the cavity between the outer sheath tube and the inner sheath core tube, the deformation part expands outwards along the radial direction of the inner sheath core tube, the implant is separated from the anchoring element, and then the implant is released from the outer sheath tube.

In one embodiment, when the deformation portion and the locking portion are subjected to the same external force, the amount of elastic deformation of the locking portion is smaller than that of the deformation portion.

In one embodiment, the elastic modulus of the material of which the locking portion is made is smaller than or equal to the elastic modulus of the material of which the deformation portion is made.

In one embodiment, the diameter of the locking portion is greater than or equal to the diameter of the deformation portion.

In one embodiment, the locking portion is a hollow tubular body or a spherical body sleeved on the distal end portion of the deformation portion.

In one embodiment, when the locking portion is accommodated in the outer sheath tube, a length of the locking portion in an axial direction of the inner sheath core tube is larger than a gap between the caulking piece and the outer sheath tube.

In one embodiment, the length of the locking portion is greater than 0.1mm and less than 15mm when the inner sheath core tube is received in the outer sheath tube.

In one embodiment, the anchor further comprises a securing portion connected between the gripping member and the deformation portion. In one embodiment, the anchoring unit comprises 1 to 12 anchors.

In one embodiment, the 1 to 12 anchors are disposed symmetrically or asymmetrically about the central axis of the inner sheath core tube.

In one embodiment, an outer surface of the grip member or an outer surface of the inner sheath tube is provided with a receiving space for receiving the locking portion and the deforming portion.

In one embodiment, at least one pair of guide holes are formed between any two end surfaces or outer walls of the hoop member, and the anchor member has a U-shaped structure formed by bifilar wires, and both ends of the U-shaped structure penetrate through the pair of guide holes respectively.

In one embodiment, the inner diameter of the inner sheath tube near the distal end is larger than the inner diameter of the inner sheath tube near the proximal end, and the tightening member of the anchoring unit is inserted between the distal tube of the inner sheath tube and the inner sheath core tube.

In one embodiment, when the locking portion is accommodated in the outer sheath tube, a length of the locking portion in an axial direction of the inner sheath core tube is larger than a gap between the inner sheath core tube and the outer sheath tube.

The invention provides a delivery system of an implant, which comprises an inner sheath core pipe and an outer sheath pipe which is movably sleeved outside the inner sheath core pipe and is provided with a cavity; the delivery system further comprises at least one anchoring unit fixed on the outer surface of the inner sheath core tube, the anchoring unit comprises at least one anchoring piece connected with the inner sheath core tube, the anchoring piece comprises a deformation part capable of being bent relative to the inner sheath core tube and a locking part connected with the deformation part, and the deformation part and the locking part are matched with the inner sheath core tube to form an anchoring piece when being accommodated in a cavity between the outer sheath tube and the inner sheath core tube.

In one embodiment, when the locking portion is accommodated in the outer sheath tube, a length of the locking portion in an axial direction of the inner sheath core tube is larger than a gap between the inner sheath core tube and the outer sheath tube. The delivery system of the invention has the advantages that the anchoring component arranged on the inner sheath core pipe instead of the rigid bulge is used for restraining the lumen stent, and the delivery system at least has the following advantages:

(1) when the tube body loaded with the implant is conveyed in a human body lumen, after the locking part of the anchoring part penetrates through the hollow-out part at the end part of the implant, the deformation part of the anchoring part is bent towards the inner sheath core tube and is restrained between the inner sheath core tube and the outer sheath tube, even if the anchoring part passes through a bent human body lumen part, the anchoring part cannot be separated from the implant, and the risk that the implant falls off from the rigid protrusion due to the fact that a gap is generated between the rigid protrusion and the inner wall of the outer sheath tube in the prior art is avoided.

(2) When the tube body loaded with the implant is conveyed to a curved human body blood vessel, the gap between the inner sheath core tube and the outer sheath tube is increased on the side with the larger bending radius of the curved blood vessel, and at the moment, if the whole tube body is squeezed by the inner wall of the curved blood vessel or the tube body is slightly bent due to pushing of an operator, the anchoring piece is subjected to external force, the deformation part is elastically deformed, and the locking part is driven to expand outwards along the radial direction of the inner sheath core tube. When the deformation part and the locking part are subjected to the same external force, the elastic deformation amount of the locking part is smaller than that of the deformation part. Therefore, when the tip end of the locking portion, which is less likely to be elastically deformed, contacts the inner wall of the outer sheath tube, the locking portion stops expanding outward and restricts the deforming portion from continuing to expand outward. At this time, the entire anchoring member reaches a stable state, and the stent is still fixed to the inner sheath core tube by the anchoring member. Therefore, the delivery system can effectively prevent the anchoring element from being separated from the lumen stent when the tube body passes through the bent blood vessel part.

(3) The implant can be gradually released within the length range of the locking part under the constraint of the sheath until all the anchoring elements are exposed, thereby avoiding the defect that the release position can not be adjusted after the implant is suddenly released.

(4) When the release position of the implant needs to be adjusted in the operation process, an operator can withdraw the tube body and adjust the position of the far end of the tube body, the implant is fixed on the inner sheath core tube in the adjustment process, and the implant and the outer sheath tube cannot move relatively, so that the implant is effectively prevented from being released from the outer sheath tube in advance.

(5) During the operation, when the implant is partially released, such as when the size of the implant is found to be not in accordance with the size of the diseased region, since the proximal portion of the implant is still fixed on the inner sheath core tube by the anchoring unit, the released implant can be retrieved into the cavity between the outer sheath tube and the inner sheath core tube by driving the outer sheath tube to move axially towards the distal end relative to the inner sheath core tube, and the tube body is withdrawn from the patient to replace the implant with a suitable size.

(6) When the locking part of the anchoring unit is released from the gap between the outer sheath tube and the inner sheath tube, the deformable part which is easy to deform is quickly driven to restore to the natural state, the implant is not connected with the inner sheath tube through the anchoring piece any more, and the implant can be quickly released from the outer sheath tube and expanded.

Drawings and description of the drawings

Fig. 1a to 1c are front views of a lumen stent delivery system provided in accordance with an embodiment, the delivery system including a handle, a tube body and an anchoring unit, the tube body including an outer sheath tube, an inner sheath core tube and an inner sheath tube, wherein fig. 1a is a schematic view of the anchoring unit, the inner sheath core tube and the inner sheath tube being accommodated in the outer sheath tube, fig. 1b is a schematic view of the anchoring unit, the inner sheath core tube and the inner sheath tube not being accommodated in the outer sheath tube, and fig. 1c is a partial enlarged view of a portion a in fig. 1 b;

fig. 2a and 2b are schematic structural views of the anchoring unit in fig. 1b, wherein the anchoring unit includes four anchoring elements and a tightening member, fig. 2a is a schematic view of the anchoring unit not being accommodated in the sheath tube, and fig. 2b is a schematic view of the anchoring unit being accommodated in the sheath tube;

fig. 3a and 3b are partial sectional views of the anchoring unit of fig. 1c, the tube body being in a section parallel to the axial direction of the tube body, wherein fig. 3a is a schematic view of the anchoring element being accommodated in the tube body with the deforming part and the locking part hooked on the lumen stent, and fig. 3b is a schematic view of the deforming part and the locking part being expanded outward in the radial direction of the inner sheath core tube;

FIG. 4a is a schematic structural view of another embodiment of an anchoring unit;

FIG. 4b is a schematic structural view of another embodiment of an anchoring unit;

FIG. 5 is a schematic structural view of another embodiment of a tube;

fig. 6a to 6d are schematic structural views of an anchoring unit in a delivery system according to a second embodiment, the anchoring unit includes a hoop member and an anchor member, wherein fig. 6a is a front view of the anchoring unit, fig. 6b is a front view of the hoop member, fig. 6c is a schematic view of a combination manner of the anchor member and the hoop member, and fig. 6d is a schematic view of the anchoring unit accommodated in an outer sheath tube;

FIG. 7 is a partial cross-sectional view of the anchoring unit of FIG. 6d when received in the sheath tube, the anchoring unit being taken in a cross-section parallel to the axial direction of the tube body; FIGS. 8a and 8b are schematic views showing the loading process of the luminal stent into the sheath of the second embodiment, wherein FIG. 8a is a schematic view showing the luminal stent connected to a part of the anchoring elements, and FIG. 8b is a schematic view showing the luminal stent connected to all of the anchoring elements and gradually accommodated in the sheath;

fig. 9a and 9b are schematic views of an anchoring unit in a delivery system according to a third embodiment, wherein fig. 9a is a front view of the anchoring unit; FIG. 9b is a front view of an intermediate product in the process of making the anchoring unit;

FIG. 10 is a cross-sectional view of the anchoring unit and the distal segment of the inner sheath in a cross-section parallel to the axial direction of the inner sheath in the delivery system according to the third embodiment;

FIG. 11 is a schematic view of the anchoring unit of FIG. 9a being embedded in the distal segment of the inner sheath;

fig. 12a and 12b are schematic views of an anchoring unit and a distal end section of an inner sheath tube having a receiving groove and a receiving hole in a delivery system according to a third embodiment, wherein fig. 12a is a schematic view showing a deformed portion and a locking portion not received in the receiving groove and the receiving hole, and fig. 12b is a schematic view showing a portion of the deformed portion and the locking portion received in the receiving groove and the receiving hole, respectively;

FIG. 13a is a schematic view of a third embodiment providing only one anchor;

FIGS. 13b and 13c are a front view of the anchoring unit provided in FIG. 13a after the deformation portion is completely deformed and a cross-sectional view of the distal end section of the inner sheath core tube in a cross-section parallel to the axial direction of the inner sheath core tube;

FIGS. 14a, 14b and 14c are schematic views of the anchoring unit and the distal section of the inner sheath core tube in the delivery system according to the fourth embodiment;

FIG. 14d is a cross-sectional view of the distal section of the inner sheath core tube in a cross-section parallel to the axial direction of the inner sheath core tube;

fig. 15 is a cross-sectional view of the anchoring unit and the distal end section of the inner sheath core tube of the delivery system according to the fifth embodiment, the cross-sectional view being taken in a section parallel to the axial direction of the inner sheath core tube.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. In the field of interventions, the end proximal to the operator is often referred to as the proximal end and the end distal to the operator as the distal end.

To more clearly describe the structure of the delivery system and the implant, the terms "proximal" and "distal" are defined herein as terms commonly used in the interventional medical field. Specifically, in the field of interventional medicine, "distal" refers to the end that is distal from the operator during a surgical procedure, and "proximal" refers to the end that is proximal to the operator during the surgical procedure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Example one

Referring to fig. 1a to 1c, a delivery system 100 for delivering an implant to a lesion in a body lumen is provided. The delivery system 100 includes a tube 10, an anchoring unit 20, and a handle 30. In this embodiment, the implant is a luminal stent 200.

The handle 30 includes a first housing 31 and a second housing 32 that are symmetrically disposed. The first housing 31 and the second housing 32 are axially movable relative to each other, and the first housing 31 is located closer to the distal end than the second housing 32.

The tube body 10 includes a hollow inner sheath tube 11 axially penetrating the handle 30, a hollow inner sheath core tube 13 penetrating the inner sheath tube 11 and having a distal end extending out of the inner sheath tube 11, an outer sheath tube 12 movably sleeved outside the inner sheath tube 11 and having a cavity with the inner sheath core tube 13, and a hollow Tip head 14 disposed at the distal end of the inner sheath core tube 13 and being opaque to X-rays. The compressed luminal stent 200 is loaded in the cavity between the distal end of the inner sheath core tube 13 and the distal end of the outer sheath tube 12 and is in frictional contact with the outer surface of the inner sheath core tube 13. The inner sheath 11 is connected to the first housing 31. The outer sheath 12 is connected to the second housing 32. Thus, the operator can drive the outer sheath 12 to move in the axial direction relative to the inner sheath tube 13 by the relative movement between the second housing 32 and the first housing 31 of the operating handle 30, withdraw the outer sheath tube 12 proximally, and finally release the lumen stent 200 from within the outer sheath tube 12. In other embodiments, the handle may have other configurations, for example, a slider may be disposed on the handle and vertically connected to the sheath 12, and the operator may drag the slider to drive the sheath 12 to move axially.

The inner sheath 11 axially penetrates the proximal end face and the distal end face of the handle 30. The inner sheath tube 11 is fixedly connected with an inner sheath core tube 13 positioned inside the inner sheath tube 11. The fixing means may be welding, bonding, sewing, heat fusing or screwing, etc. which are commonly used in the art and will not be described in detail here. In this embodiment, the inner sheath tube 11 is made of a polymer material having toughness. It is understood that in other embodiments, the inner sheath tube 11 may be made of a metal material. It is also understood that, in other embodiments, the inner sheath tube 11 may be a combination of a tube body made of a polymer material and a tube body made of a metal material. For example, the tube body part of the inner sheath tube 11 near the distal end is accommodated in the outer sheath tube 12 and made of a tough polymer material, so as to improve the passability of the inner sheath tube 11 in the curved human body lumen; the proximal end of the inner sheath 11 is formed of a metallic material inside the handle 30 to improve the support of the proximal end of the inner sheath 11.

The outer sheath tube 12 is sleeved outside the inner sheath tube 11 and the inner sheath core tube 13, and can move axially relative to the inner sheath tube 11 and the inner sheath core tube 13 under the driving of the handle 30. When the sheath tube 12 is driven to advance towards the far end, the lumen stent 200 can be accommodated in the sheath tube 12; release of the luminal stent 200 from within the outer sheath 12 can be achieved when the outer sheath 12 is driven proximally back. The sheath tube 12 is made of a polymer material or a metal material having toughness. It is understood that in other embodiments, a stiffer stiffening tube (not shown) may be provided around the proximal end of the outer sheath 12 or may be axially connected to the proximal end of the outer sheath 12. This can improve the passability of the sheath tube 12 through the handle 30.

The proximal tube body of the inner sheath core tube 13 is accommodated in the inner sheath tube 11. The tube body of the inner sheath core tube 13 housed in the inner sheath tube 11 is fixed to the inner sheath tube 11 by a common connection method in the art such as welding, bonding, sewing, heat fusion, or screwing, so as to improve the support of the inner sheath core tube 13. When the outer sheath tube 12 moves axially relative to the inner sheath tube 11 and the inner sheath core tube 13, friction occurs between the outer wall of the inner sheath tube 11 and the inner wall of the outer sheath tube 12, and the inner sheath core tube 13 and the inner sheath tube 11 fixed together are less likely to be displaced or bent relative to each other. The distal end of the inner sheath core tube 13 penetrates out of the distal end of the inner sheath tube 11, i.e. the tube body of the inner sheath core tube 13 near the distal end is not wrapped by the inner sheath tube 11. The compressed stent 200 is loaded in a cavity formed between a tube body of the inner sheath tube 13 not covered by the inner sheath tube 11 and the outer sheath tube 12. The distal end of the inner sheath core tube 13 is connected with a radiopaque hollow Tip 14, which can be injection molded or bonded. The inner cavity of the inner sheath core pipe 13 is communicated with the inner cavity of the Tip head 14. The inner sheath core tube 13 and the inner lumen of the Tip head 14 are used to receive and pass over a guide wire (not shown).

It will be appreciated that in other embodiments, the delivery device may not contain the inner sheath 11.

Referring also to fig. 2a, the anchoring unit 20 is disposed on the outer surface of the tube body of the inner sheath core tube 13 not covered by the inner sheath tube 11. The anchoring unit 20 includes a tension member 21 fitted around the outer surface of the inner sheath core tube 13 and at least one anchoring member 22 connected to the tension member 21. In this embodiment, the number of anchors 22 is four. The four anchors 22 are symmetrically disposed about the central axis of the inner sheath core tube 13. It will be appreciated that in other embodiments, the anchor members 22 may be disposed asymmetrically about the central axis of the inner sheath core tube 13.

Each anchor member 22 includes a deformation portion 221 connected to the hoop member 21 and bendable with respect to the hoop member 21, and a locking portion 222 connected to the deformation portion. Since the outer sheath tube 12 is axially movable relative to the inner sheath core tube 13, the deformed portion 221 and the locking portion 222 of the anchor member 22 are movably accommodated in a cavity formed between the outer sheath tube 12 and the inner sheath core tube 13 (as shown in fig. 2 b).

Referring to fig. 3a, when the anchoring member 22 is accommodated in the cavity formed between the outer sheath tube 12 and the inner sheath tube 13, the deformation portion 221 is bent toward the proximal end, and the deformation portion 221 and the locking portion 222 point toward the proximal end and cooperate with the inner sheath tube 13 to form an anchor. The plurality of anchors hook over the proximal hollows (i.e., the valley skeletons) of the lumen stent 200, securing the lumen stent 200 to the inner sheath/core tube 13.

Referring to fig. 3b, when the outer sheath tube 12 moves axially toward the proximal end with respect to the inner sheath core tube 13, the anchoring elements 22 are gradually released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13, and the deformation portions 221 and the locking portions 222 are expanded outward in the radial direction of the inner sheath core tube 13, return to the natural expanded state, and are separated from the lumen stent 200. The luminal stent 200, after being released from its fixation with the anchoring elements 22, is eventually released completely from the outer sheath 12 and deployed against the vessel wall.

The deformation portion 221 is made of a material having flexibility (for example, a polymer material such as polytetrafluoroethylene), a metal material having a certain hardness (for example, a metal material such as stainless steel, or a polymer material such as polyether block amide), or a material having elasticity (for example, an alloy material such as nickel-titanium alloy). Therefore, the deformation portion 221 may be deformed to some extent when an external force is applied.

The locking portion 222 is made of a material having a hardness greater than that of the deformable portion 221, so that the amount of deformation of the locking portion 222 is smaller than that of the deformable portion 221 when the deformable portion 221 and the locking portion 222 are subjected to the same external force. Such difference in the amount of deformation makes the locking portion 222 not deformed when the deformation portion 221 is deformed by an external force during the transportation of the lumen stent 200, and therefore, the locking portion 222 stops expanding outward in the radial direction of the inner sheath core tube 13 after contacting the inner wall of the outer sheath tube 12, and the connection between the anchoring element 22 and the lumen stent 200 can be continuously maintained, avoiding connection failure. In the present embodiment, the deformation portion 221 is made of a nickel-titanium alloy having a shape memory function. The lock 222 is made of stainless steel.

Referring again to fig. 3a, when the locking portion 222 is accommodated in the outer sheath tube 12, the length L1 of the locking portion 222 in the axial direction of the inner sheath core tube 13 is larger than the gap w between the inner sheath core tube 13 and the outer sheath tube 12. This is provided for the purpose of forming a skeleton in which the anchor is hooked on the lumen stent 200 in cooperation with the locking portion 222 and the inner sheath core tube 13 after the deformation portion 221 is bent. If disconnection between the luminal stent 200 and the anchoring element 22 is desired, the locking portions 222 need to be deployed outward to return to a natural state. However, the lock 222 needs a certain space to be expanded outward, which is at least equal to the length L1 of the lock 222, so that in the present invention, the length L1 of the lock 222 is set to be greater than the gap w between the inner sheath core tube 13 and the outer sheath tube 12, so that the lock 222 cannot be expanded outward when being accommodated in the outer sheath tube 13, thereby ensuring a more reliable connection between the anchor 22 and the lumen stent 200.

When the anchor member 22 is accommodated in the outer sheath tube 12, the length L1 of the locking portion 222 in the axial direction of the inner sheath core tube 13 is 5 mm. . When the tube 10 with the lumen stent 200 is placed at the lesion site, the deformed portion 221 and the locking portion 222 also need to be released from the cavity between the outer sheath tube 12 and the inner sheath tube 13 during the release of the lumen stent 200, so that the arrangement can prevent the vessel from being scratched after the locking portion 222 is released from the outer sheath tube 12. Furthermore, if the anchor unit 20 includes two or more anchoring elements 22, the length L1 of the locking portion 222 being less than one-half of the inner diameter of the vessel at the release position can also avoid interference between the anchoring elements 22, affecting separation of the anchoring elements 22 from the luminal stent 200.

It will be appreciated that in other embodiments, the length L1 of the locking portion 222 may be designed differently according to the inner diameter of the released blood vessel, and preferably, the length L1 of the locking portion 222 is greater than 0.1mm and less than 15mm, so as to ensure that the locking portion 222 is not easy to be accidentally removed due to uncontrollable deformation in the locked state, and avoid damage to the inner wall of the blood vessel when the locking portion 222 is too long and unlocked.

Preferably, the diameter of the locking portion 222 is greater than or equal to the diameter of the deformation portion 221. For example, the locking portion 222 and the deformation portion 221 may be a single wire with the same diameter, and the two may be connected together by laser welding, adhesion, or other means commonly used in the art, or may be an integral body, such as one or the same metal wire (not limited to), so that the locking portion 222 and the deformation portion 221 exhibit different mechanical properties through different heat treatment processes. The locking portion 222 may also be a tubular body or a spherical body sleeved on the distal end of the deformation portion 221, so as to further ensure that the amount of elastic deformation of the deformation portion 221 is greater than that of the locking portion 222 when the deformation portion 221 and the locking portion 222 are subjected to the same external force.

It will be appreciated that in other embodiments, each anchor unit may comprise only 1 anchor. It will also be appreciated that in other embodiments, each anchor unit may include a greater number of anchors to increase the secure reliability of the anchor unit connection to the luminal stent. However, to ensure that the diameter of the tube is such that it can pass smoothly through a curved body lumen, the number of anchors should be less than or equal to 12.

Referring to fig. 1c and fig. 2a again, the clamping member 21 is sleeved on the outer surface of the inner sheath core tube 13 and fixedly connected to the outer surface of the inner sheath core tube 13 by adhesion, interference fit, stitching, hot melting, or welding (e.g., laser spot welding). In this embodiment, the tension member 21 is fixed to the outer surface of the inner sheath core tube 13 by adhesion. The gripping member 21 is a sleeve having a wall thickness. The inside diameter of the tension member 21 is larger than or equal to the outside diameter of the inner sheath core tube 13. The outer diameter of the grip member 21 is smaller than the inner diameter of the outer sheath tube 12. The tightening member 21 may be made of a polymer material or a metal material.

It will be appreciated that in other embodiments, anchor member 22 may further include a securing portion 223 (shown in FIG. 4 a) connected between gripping member 21 and deformation portion 221. The pipe wall of the tightening member 21 has a through hole in the axial direction. The length of the clinch member 21 in the axial direction of the inner sheath core tube 13 is smaller than the length of the fixing portion 223 in the axial direction of the inner sheath core tube 13. Therefore, after the fixing portion 223 of the anchor 22 axially penetrates through the through hole 212, one end of the fixing portion 223 far away from the deformation portion 221 is formed into a sphere by laser spot welding, and the diameter of the sphere is larger than that of the through hole, so that the fixing portion 223 is prevented from falling off from the clamping member 21.

The fixing portion 223 and the deforming portion 221 may be made of the same material or different materials, so long as the deforming portion 221 is made of a material having elasticity, the purpose of detachable connection with the lumen stent 200 can be achieved. Preferably, in order to secure the connection reliability between the anchor member 22 and the tightening member 21, the fixing portion 223 should be made of a material having a certain hardness.

It will also be appreciated that in other embodiments, the fastener 21 may have other attachment means to the anchor member 22 at the anchor portion 223. For example, the pipe wall of the tightening member 21 has a blind hole in the axial direction. The length of the clinch member 21 in the axial direction of the inner sheath core tube 13 is longer than the length of the fixing portion 223 in the axial direction of the inner sheath core tube 13. Thus, the fixing portion 223 of the anchor 22 is inserted into the blind hole and fixed to the fastener 21 by heat fusion, welding, adhesion, screwing, or the like.

It will also be appreciated that in other embodiments, the tightening member 21 may be a thin-walled sheet in order to reduce the size of the anchoring unit 20. The fixing portion 223 of the anchoring member 22 is located on the inner wall of the fastening member 21 and fixed to the fastening member 21 by heat fusion, welding, adhesion, or screwing (as shown in fig. 4 b). That is, the fixing portion 223 is located between the band 21 and the outer surface of the inner sheath core tube 13. The relative movement between the fixing portion 223 and the outer surface of the inner sheath core tube 13 is restricted by the tightening member 21, thereby achieving the purpose of fixing the anchoring unit 20 to the inner sheath core tube 13.

It will also be appreciated that in other embodiments, the grip member 21 may also be a hollow sleeve made of a heat shrinkable material. The fixing portion 223 of the anchor member 22 is provided between the clinch member 21 and the outer surface of the inner sheath core tube 13. By heating the clinch member 21 to the heat shrinkage temperature of the heat shrinkable material, the clinch member 21 is heat-shrunk and tightly wraps the inner sheath core tube 13, thereby restricting the relative movement between the fixing portion 223 of the anchor member 22 and the outer surface of the inner sheath core tube 13.

It will be appreciated that in other embodiments, the body 10 may not include the inner sheath 11. Specifically, referring to fig. 5, the tube body 10 includes a hollow inner sheath core tube 13 axially penetrating through the handle 30 (see fig. 1a), an outer sheath tube 12 movably sleeved outside the inner sheath core tube 13, and a hollow Tip head 14 disposed at the distal end of the inner sheath core tube 13 and opaque to X-rays. The inner sheath core tube 13 includes a first tube 131 near the proximal end and a second tube 132 axially connected to the distal end of the first tube 131, and the diameter of the first tube 131 is larger than that of the second tube 132. Thus, the compressed luminal stent 200 can be housed in the cavity between the sheath 12 and the second tube 132 and in frictional contact with the second tube 132. The anchoring unit 20 is provided on the second tube 132 and is detachably connected to the luminal stent 200 (see fig. 1 b). It is understood that the first tube 131 and the second tube 132 may be made of different materials. For example, the first tube 131 is made of a flexible polymer material, and the second tube 132 is made of a metal material, so as to ensure the distal flexibility and the proximal support of the inner sheath core tube 13. It is also understood that in other embodiments, the first tube 131 and the second tube 132 can be made of the same material. For example, the first tube 131 and the second tube 132 are made of a flexible polymer material. It will also be appreciated that in other embodiments, the inner sheath core tube 13 may also include a third tube (not shown). The third tube can be sleeved on the proximal tube portion of the first tube 131. The third tube may also be axially connected to the proximal end of the first tube 131. The hardness of the third tube is higher than that of the first tube 131 to enhance the straightening and improve the proximal end support of the inner sheath core tube 13.

It is understood that in other embodiments, the delivery system 100 may further include a three-way valve and a hose fixedly mounted to the handle 30 for delivering irrigation fluid or contrast media. Thus, before the operation, the operator can introduce the flushing fluid through the three-way valve and the hose to flush the outside of the inner sheath or to discharge the air between the outer sheath and the inner sheath. The digital contrast can also be performed by injecting contrast agent through a three-way valve and a hose before or during the operation.

Before being implanted in a patient, the luminal stent 200 needs to be loaded into the tubular body 10 of the delivery system 100 and then delivered to the lesion in the patient by the delivery system 100. The loading process for the luminal stent 200 is as follows: the lumen stent 200 is placed on the outer surface of the inner sheath core tube 13, the deformation part 221 and the locking part 222 of the anchoring member 22 are made to penetrate through the hollow part (i.e., the framework at the valley part) of the proximal end of the lumen stent 200, then the locking part 222 is pressed towards the direction of the inner sheath core tube 13, at this time, the deformation part 221 is deformed and bent relative to the inner sheath core tube 13, so that the locking part 222, the deformation part 221 and the inner sheath core tube 13 are matched to form an anchoring member to hook the lumen stent 200, and the lumen stent 200 is fixed outside the inner sheath core tube 13. The outer sheath 12 is pushed distally and the anchor member 22 is compressed and received in the cavity between the outer sheath 12 and the inner sheath core 13. The outer sheath 12 is continuously pushed distally until the stent 200 is gradually compressed from the proximal end to the distal end and is accommodated in the cavity between the outer sheath 12 and the inner sheath core tube 13. After the loading is completed, the lumen stent 200 is fixed on the inner sheath core tube 13 by the anchoring unit 20, and the anchoring unit 20 restricts the relative movement between the lumen stent 200 and the inner sheath core tube 13.

It is understood that, during the loading of the lumen stent 200, after the lumen stent 200 is fixed to the outside of the inner sheath core tube 13, the position of the inner sheath tube 11 may be kept unchanged, and the inner sheath tube 11 is driven to move axially toward the proximal end with respect to the outer sheath tube 12, so as to receive the anchoring elements 22 and the lumen stent 200 into the cavity between the outer sheath tube 12 and the inner sheath core tube 13.

When the tubular body 10 loaded with the luminal stent 200 reaches the lesion site in preparation for releasing the luminal stent 200, the second housing 32 of the handle 30 is withdrawn proximally, driving the outer sheath 12 to move axially proximally relative to the inner sheath core 13. When the locking portion 222 is released from the cavity between the outer sheath tube 12 and the inner sheath tube 13, the deformation portion 221 can be restored to the natural expanded state, at which the anchoring elements 22 are automatically separated from the lumen stent 200, i.e., the lumen stent 200 is no longer connected to the inner sheath tube 13. As the outer sheath 12 continues to move axially proximally relative to the inner sheath core 13, the luminal stent 200 is released from the outer sheath 12 and expands and adheres to the vessel wall by virtue of its super-elasticity.

When the lumen stent 200 is not completely released and the released part of the lumen stent 200 is short, the whole tube body 10 can be directly retracted, the position of the distal end of the tube body 10 is adjusted, and the distal end of the tube body 10 is observed through the developing mark point on the lumen stent 200 under the assistance of the digital image until the distal end of the tube body 10 is adjusted to the more ideal release position. When the luminal stent 200 is partially released, if it is necessary to adjust the release position of the luminal stent 200, the withdrawal of the outer sheath 12 can be stopped and the entire tube body 10 can be pulled proximally. During pulling of the tube 10, the released portion of the lumen stent 200 may be subjected to a friction force from the inner wall of the blood vessel or other stent or implantable device engaged with the lumen stent 200, and such a friction force may cause the unreleased portion of the lumen stent 200 and the anchoring elements 22 to be subjected to a pulling force toward the distal end, causing the deformed portion 221 and the locking portions 222, which would otherwise be hooked on the lumen stent 200, to be also subjected to a pulling force toward the distal end and to have a tendency to expand outward in the radial direction of the inner sheath tube 13. However, since the inner wall of the outer sheath tube 12 suppresses this tendency, the deformation portion 221 can maintain the engagement with the locking portion 222 and the inner sheath core tube 13. Therefore, the lumen stent 200 is always fixed on the inner sheath core tube 13 by the anchoring unit 20, so that the relative movement between the outer sheath tube 12 and the lumen stent 200 is not caused when the operator withdraws the tube body 10, and the lumen stent 200 is prevented from being released in advance due to the relative movement between the outer sheath tube 12 and the lumen stent 200.

Therefore, the delivery system provided by the invention is particularly suitable for delivering the implant of which the release position needs to be adjusted in the release process so that the released implant is matched with other implants, such as placing a chimney stent or a top hat stent in the left subclavian artery for simultaneously opening the aortic arch stenosis and the left subclavian artery stenosis, or delivering a tracheal stent and an esophageal stent to realize the adjustment and recovery of the release position of the product.

When the lumen stent 200 is not completely released, the locking portions 222 and the deforming portions 221 are restricted by the inner wall of the outer sheath tube 12 from expanding outward, and the lumen stent 200 is still fixed on the inner sheath core tube 13 by the anchoring unit 20. At this time, if the type of the lumen stent 200 is found not to match the lesion site, and the lumen stent needs to be replaced, the outer sheath 12 may be driven to move axially distally relative to the inner sheath core 13, so that the released portion of the lumen stent 200 is compressed again and recovered into the cavity between the outer sheath 12 and the inner sheath core 13, and the tube 10 is withdrawn from the patient to replace the appropriate lumen stent.

The using process of the conveying system 100 provided by the embodiment comprises the following steps:

the first step is as follows: percutaneous puncture is carried out to put a guide wire to a lesion part;

the second step is that: conveying the tube body 10 pre-loaded with the tube cavity bracket 200 to a lesion part along a guide wire;

the third step: driving the outer sheath 12 proximally. Thereby, the outer sheath tube 12 moves axially relative to the inner sheath tube 13 and the lumen stent 200, and the lumen stent 200 is gradually released from the outer sheath tube 12. With the aid of medical images, whether the initial release position of the luminal stent 200 meets clinical requirements is evaluated through the visualized marking points on the luminal stent 200.

The fourth step: if the initial release position of the luminal stent 200 is desired, the outer sheath tube 12 may continue to be driven proximally axially relative to the inner sheath core tube 13 until the luminal stent 200 is fully released from within the outer sheath tube 12.

The fifth step: if the initial release position of the luminal stent 200 is not ideal, the withdrawal of the sheath 12 can be stopped, the entire body 10 can be withdrawn, and the position of the distal end of the body 10 can be adjusted. In the process of adjusting the position of the distal end of the tube 10, since the lumen stent 200 is fixed on the inner sheath core tube 13 by the anchoring unit 20, no relative movement occurs between the lumen stent 200 and the outer sheath tube 12, the inner sheath core tube 13, and the lumen stent 200 is effectively prevented from being released from the outer sheath tube 12 in advance.

And a sixth step: when the distal end of the body 10 is adjusted to the desired release position, the outer sheath 12 is again driven proximally axially relative to the inner sheath core 13. When the anchoring elements 22 are released from the cavity between the outer sheath tube 12 and the inner sheath tube 13, the deformed portions 221 and the locking portions 222 of the anchoring elements 22 are restored to the natural expanded state and are automatically separated from the anchored stent 200. At this time, the lumen stent 200 is not connected to the inner sheath tube 13 any more, and after the lumen stent 200 is released from the outer sheath tube 12 in its entirety, the lumen stent 200 is made to be naturally expanded and attached to the blood vessel wall of the lesion site due to its superelasticity.

The seventh step: the handle 30 is withdrawn, which causes the inner sheath core tube 13 to move proximally relative to the outer sheath tube 12. After the anchoring member 22 on the outer surface of the inner sheath core tube 13 is received in the outer sheath tube 12, the entire delivery system 100 is withdrawn, and the tube 10 is removed from the patient.

Compared with the prior art, the conveying system provided by the embodiment has at least the following beneficial effects:

(1) when the tube body loaded with the lumen stent is conveyed in a human body lumen, after the locking part of the anchoring part penetrates through the hollow-out part at the end part of the lumen stent, the deformation part of the anchoring part is bent towards the inner sheath core tube and is restrained between the inner sheath core tube and the outer sheath tube, even if the anchoring part passes through a bent human body lumen part, the anchoring part cannot be separated from the lumen stent, and the risk that the lumen stent falls off from the rigid protrusion due to the fact that a gap is generated between the rigid protrusion and the inner wall of the outer sheath tube in the prior art is avoided.

(2) When the tube body loaded with the lumen stent is conveyed to a curved human blood vessel, the gap between the inner sheath core tube and the outer sheath tube is increased on the side with the larger bending radius of the curved blood vessel, and at the moment, if the whole tube body is squeezed by the inner wall of the curved blood vessel or the tube body is bent due to pushing of an operator, the anchoring piece is subjected to external force, the deformation part can be elastically deformed, and the locking part is driven to be outwards expanded along the radial direction of the inner sheath core tube. When the tip end of the locking portion, which is less likely to be elastically deformed, contacts the inner wall of the outer sheath tube, the locking portion stops expanding outward and restricts the deforming portion from continuing to expand outward. At this time, the entire anchoring member reaches a stable state, and the stent is still fixed to the inner sheath core tube by the anchoring member. Therefore, the delivery system of the embodiment can effectively prevent the anchoring element from being separated from the lumen stent when the tube body passes through the bent blood vessel part.

(3) The lumen stent is fixed on the inner sheath core tube by the anchoring unit, and the lumen stent can be gradually released from the outer sheath tube, so that the defect that the release position cannot be adjusted after the lumen stent is suddenly released is avoided.

(4) When the release position of the lumen stent needs to be adjusted in the operation process, an operator can withdraw the tube body and adjust the position of the far end of the tube body, the lumen stent is fixed on the inner sheath core tube in the adjustment process, and the lumen stent and the outer sheath tube cannot move relatively, so that the lumen stent is effectively prevented from being released from the outer sheath tube in advance.

(5) During operation, when the lumen stent is partially released, if the size of the lumen stent is found not to be accordant with the size of a lesion part, because the part of the lumen stent close to the proximal end is still fixed on the inner sheath core tube through the anchoring unit, the released lumen stent can be recovered into a cavity between the outer sheath tube and the inner sheath core tube again by driving the outer sheath tube to move axially towards the distal end relative to the inner sheath core tube, and then the tube body is withdrawn out of the patient body, so that the lumen stent with proper size is replaced.

(6) When the anchoring piece of the anchoring unit is released from the gap between the outer sheath tube and the inner sheath tube, the deformation part drives the locking part to restore to the natural state, the lumen stent is not connected with the inner sheath tube through the anchoring piece any more, and the lumen stent can be quickly released from the outer sheath tube and expanded.

Example two

The structure of the lumen stent delivery system provided in this embodiment is substantially the same as the structure of the lumen stent delivery system 100 provided in the first embodiment. The difference is that in the present embodiment, the structure of the tightening member, the number and structure of the anchoring members are different from those of the first embodiment.

Specifically, referring to fig. 6a, in the present embodiment, the anchoring unit 40 includes a sleeve-shaped hoop 41 having a certain wall thickness, and at least one anchoring element 42 connected to the hoop 41.

Referring also to fig. 6b, the tightening member 41 has at least one pair of guide holes 411. The guide holes 411 include a first hole 411a formed in the distal end surface of the fastener member 41 and a second hole 411b formed in the outer wall of the fastener member 41, and the first hole 41a and the second hole 41b communicate with each other to form a pair of guide holes 411. In the present embodiment, the number of the anchors 42 is three. The number of the guide holes 411 is six pairs. It will be appreciated that in other embodiments, the guide hole 411 may be formed by at least one pair of guide holes communicating with each other between any two end surfaces or outer walls of the clamping member 41, such as but not limited to a first hole at the distal end surface and a second hole at the proximal end surface of the clamping member 41, or a first hole at the proximal end surface and a second hole at the outer wall of the clamping member 41.

Referring also to fig. 6c, each anchor 42 comprises a U-shaped structure of twin wires. Each U-shaped structure comprises two straight rods and an arc rod connected between the two straight rods. Both ends of each U-shaped structure penetrate through a pair of guide holes 411 of the tightening member 41, respectively. Therefore, the arc rod of the U-shaped structure is attached to the outer wall of the clamp 41 to serve as the fixing portion 423 of the anchor 42. Two straight rods of U-shaped configuration are passed out from the distal end face of the tightening member 41 through a pair of guide holes 411, respectively, as deformed portions 421 of the anchor member 42. The locking portion 422 of the anchor 42 is a hollow tubular body that fits over the distal ends of the two straight rods of the U-shaped structure and binds the two straight rods together. Thus, the locking portion 422 can restrict the U-shaped structure from falling off the tightening member 41. It is understood that in other embodiments, the locking part 422 may have other shapes such as a sphere, as long as the diameter of the locking part 422 is greater than or equal to the diameter of the deformation part 421, so that the amount of elastic deformation of the locking part 422 is less than that of the deformation part 421 when the deformation part 421 and the locking part 422 receive the same external force.

The U-shaped configuration of the anchor 42 is a bendable wire, column, strip, ribbon, or flap, etc. The U-shaped structure may be made of a material having flexibility (e.g., a polymer material). The U-shaped structure may also be made of a material having elasticity (e.g., an alloy material). In this embodiment, each U-shaped structure is woven from nickel-titanium wires.

It will be appreciated that in other embodiments, the anchor member may have other shapes such as an L-shape, an S-shape, or a V-shape, so long as the deformed portion of the anchor member can be bent and passed through the guide hole.

Referring to fig. 6d, when the locking part 422 and the deforming part 421 are accommodated in the cavity between the outer sheath tube and the inner sheath tube, the deforming part 421 is bent toward the inner sheath tube, and at this time, the deforming part 421, the locking part 422 and the inner sheath tube form an anchor. And the inner wall of the outer sheath tube restricts the deformation portion 421 and the locking portion 422 from expanding radially outward along the inner sheath core tube.

Referring to fig. 7 together, when the lock portion 422 is accommodated in the outer sheath tube, a length L2 of the lock portion 422 in the axial direction of the inner sheath core tube is larger than a gap w between the inner sheath core tube and the outer sheath tube. Thus, even when the locking portion 422 is only partially accommodated in the cavity between the outer sheath tube and the inner sheath tube, the locking portion 422 is not expanded in a direction away from the inner sheath tube, and the deformed portion 421 and the locking portion 422 can be kept in engagement with the inner sheath tube to form an anchor. Meanwhile, the length L2 of the locking part 422 in the axial direction of the inner sheath core tube is preferably more than 0.1mm and less than 15mm to ensure the stability of the locking part 422 in the anchoring state, and when the deforming part 421 and the locking part 422 are released from the cavity between the outer sheath tube 12 and the inner sheath core tube 13, the locking parts 422 do not contact each other, thereby preventing the plurality of anchoring members 22 from interfering with each other and affecting the smooth separation between the anchoring member 42 and the lumen stent.

The diameter of the locking portion 422 is smaller than the gap w between the inner sheath core tube and the outer sheath tube so that the locking portion 422 can be accommodated in the cavity between the inner sheath core tube and the outer sheath tube.

When the delivery system of the present embodiment is used to deliver the luminal stent 200, the loading process of the luminal stent 200 is as follows: referring to fig. 8a, the deformable portion 421 and the locking portion 422 of the anchoring member 42 are first inserted into the metal frame at the valley of the proximal end of the lumen stent 200, and then the locking portion 222 is pressed toward the inner sheath core tube to bend the deformable portion 421 towards the proximal end, at which time the locking portion 222, the deformable portion 221 and the inner sheath core tube are engaged to form an anchor to hook the lumen stent 200. Then, the inner sheath tube is driven to move axially toward the proximal end with respect to the outer sheath tube, and the locking portion 422 and the deforming portion 421 of the anchor 42 are received in the cavity between the outer sheath tube and the inner sheath tube. Referring to fig. 8b, the inner sheath tube is withdrawn until the stent is gradually compressed and accommodated in the cavity between the outer sheath tube and the inner sheath core tube.

in the delivery system of the embodiment, the deformation portion of the anchoring member has a U-shaped structure, and the tubular locking portion is sleeved at the distal end of the U-shaped structure and binds two straight rods of the U-shaped structure together, so that the anchoring member can be prevented from falling off from the tightening member, and the reliability of connection between the lumen stent and the anchoring unit is improved.

It will be appreciated that in other embodiments, the fastener 41 may be provided with only one pair of guide holes 411, with only one anchor member 42 being fixedly connected to the fastener guide holes.

EXAMPLE III

The structure of the lumen stent delivery system provided in this embodiment is substantially the same as the structure of the lumen stent delivery system 100 provided in the first embodiment. The difference is that in this embodiment, the structures of the inner sheath core tube and the tightening member, and the number and the structures of the anchoring members are different from those of the inner sheath core tube and the tightening member, and the number and the structures of the anchoring members in the first embodiment.

Specifically, referring to fig. 9a, in the present embodiment, the anchoring unit 50 includes a sleeve-shaped tightening member 51 and five anchoring elements 52 connected to the tightening member 51. The anchor member 52 includes a deformable portion 521 connected to the fastener member 51 and a spherical locking portion 522 connected to the deformable portion 521.

The anchoring unit 50 is laser engraved from a nickel titanium tube having a tube wall thickness in the range of 0.05 mm to 2 mm. During the engraving, five straight rods are firstly engraved at one end of the nitinol tube to form a deformed part 521 (as shown in fig. 9 b), and then one end of the deformed part 521 is welded into a spherical locking part 522 (as shown in fig. 9 a) through a laser spot welding process.

Referring to fig. 10, in the present embodiment, the inner diameter of the inner sheath tube 61 near the distal end is larger than the inner diameter of the inner sheath tube 61 near the proximal end. Referring also to fig. 11, the band 51 of the anchoring unit 50 is inserted between the proximal end of the inner sheath tube 61 and the inner sheath core tube (not shown) in the direction indicated by the arrow in fig. 11. After the proximal end surface of the fastening member 51 abuts against the distal end surface of the inner sheath core tube, the fastening member 51 is fixed with the inner sheath tube 61 and the inner sheath core tube by means of techniques commonly used in the art, such as dispensing.

Referring to fig. 12a and 12b, the outer surface of the inner sheath tube 61 is provided with a receiving groove 611 for receiving the deformation portion 521 and a receiving hole 612 for receiving the locking portion 522. Therefore, after the deformable portion 521 and the locking portion 522 are bent with respect to the inner sheath 61 and the deformable portion 521 is accommodated in the accommodating groove 611 on the outer surface of the inner sheath 61, the locking portion 522 is accommodated in the accommodating hole 612 on the outer surface of the inner sheath 61, and the movement of the locking portion 522 is further restricted, thereby improving the reliability of the connection between the lumen stent 200 and the anchor 52.

In this embodiment, the length of the locking portion 522 in the radial direction should be larger than the gap between the inner sheath 61 and the accommodating groove 611 and the outer sheath to prevent the locking portion 522 from being accidentally removed.

It will be appreciated that in other embodiments, the anchoring unit 50 may be disposed on the outer surface of the body of the inner sheath tube closer to the distal end, so that the proximal end face of the gripping member 51 does not abut against the distal end face of the inner sheath tube 61. In this embodiment, a receiving groove for receiving the deformation portion 521 and a receiving hole for receiving the locking portion 522 may be provided on the outer surface of the band 51.

Referring to fig. 13a, in other embodiments, the number of the anchors may be only one. Referring to fig. 13b, the length of the deformed portion of the anchor member in a natural state (i.e., when not accommodated in the outer sheath tube) should be greater than the outer diameter of the inner sheath tube to ensure that the deformed portion can be smoothly bent and that the locking portion can be attached to the outer wall of the inner sheath tube after the deformed portion is bent. Referring to fig. 13c, after the deformation portion and the locking portion sequentially pass through the metal framework at the valley of the proximal end of the luminal stent, the deformation portion is bent, the locking portion is attached to the outer wall of the inner sheath-core tube, and the outer sheath tube limits the movement of the locking portion, thereby achieving the purpose of fixing the luminal stent. The deformation part and the locking part preferably sequentially penetrate through the metal frameworks at two symmetrically arranged wave troughs at the proximal end of the luminal stent. It is understood that the deformation portion and the locking portion may pass through only the skeleton at 1 wave trough or more.

In such an embodiment having only one anchor, the outer wall of the inner sheath core tube is preferably provided with a receiving groove for receiving the locking portion of the anchor, and the receiving groove is preferably provided in the vicinity of the opposite side of the anchor. Thus, during the loading of the luminal stent, the operator passes the deformed portion and the locking portion of the anchor through the metal framework at the proximal end valley of the luminal stent, then bends the deformed portion and the locking portion, and then receives the locking portion into the receiving groove. At this time, the accommodating groove is matched with the inner wall of the outer sheath tube, so that the movement of the locking part and the deformation part can be better limited, and the deviation of the lumen stent in the conveying process can be avoided. Compared with the prior art, the conveying system provided by the embodiment has at least the following beneficial effects:

the deformation part and the locking part are accommodated in an accommodating space on the outer surface of the inner sheath core tube, the accommodating space is matched with the inner wall of the outer sheath tube, the movement of the locking part and the deformation part is further limited, and the reliability of connection between the lumen stent and the anchoring piece is improved. Example four

The structure of the delivery system of the implant 800 provided in this embodiment is substantially the same as the structure of the luminal stent delivery system 100 provided in the third embodiment. The difference is that in this embodiment, the conveyor does not have the inner sheath tube and the tightening member, and the number of the anchoring members and the structure for connecting the anchoring members with the inner sheath tube are different from those of the third embodiment.

Specifically, referring to fig. 14a and 14b, in the present embodiment, the anchoring unit 70 includes 4 anchoring members 71 connected to the inner sheath core tube 13. The anchor member 71 includes a deforming portion 711 connected to the inner sheath core tube 13 and a locking portion 712 connected to the deforming portion 711. The deformation portion 711 is connected to the inner sheath core tube 13 by laser welding (not limited).

Referring to fig. 14c, in the present embodiment, the gap between the inner sheath core tube 13 and the outer sheath tube 12 forms an accommodating space for accommodating the anchor 71, and the deformed portion 711 and the locking portion 712 are folded with respect to the inner sheath core tube 13 and then accommodated between the inner sheath core tube 13 and the outer sheath tube 12.

Referring to fig. 14d, in order to ensure that the anchor member 71 is not released prematurely due to the resilience of the deformation portion 711, the axial length L1 of the anchor member locking portion 712 along the inner sheath core tube should be greater than the gap w between the inner sheath core tube 13 and the outer sheath tube 12, and in order to smoothly unlock the anchor member 71 after the outer sheath tube 12 is withdrawn, the axial length L1 of the anchor member locking portion 712 along the inner sheath core tube should preferably be greater than 0.1mm and less than 15 mm.

It is understood that in other embodiments, the number of the anchoring units may be only one, or a plurality of anchoring units may be distributed on the inner sheath core tube. The embodiment further simplifies the conveying system, reduces necessary parts on the premise of ensuring that the anchoring unit is not loosened in advance, and reduces the production and assembly difficulty.

EXAMPLE five

The structure of the implant delivery system provided in this example is substantially the same as the structure of the luminal stent delivery system provided in the first example. The difference is that in the present embodiment, the locking portion of the anchor is a polymer ball, and it is understood that in other embodiments, other materials with certain hardness, such as metal, can be adopted, and fixed to one end of the deformation portion by injection molding or the like, and the other end of the deformation portion is fixed to the clamping member.

Referring to fig. 15, the locking portion is accommodated in the proximal end surface of the band member after the deformation portion is bent, and when the deformation portion receives an external force, the locking portion is restricted by the band member and cannot be released. To achieve this effect, the clearance W of the grip member from the outer sheath should be smaller than the warp length W1 of the locking portion.

It will be appreciated that in other embodiments the locking portion may be irregularly shaped but in the stowed condition it will be radially more linear than the gap between the grip member and the sheath.

It is understood that in other embodiments, the number of the anchoring units may be only one, or a plurality of anchoring units may be distributed on the inner sheath core tube.

First to fifth embodiments are only examples of the delivery system of the luminal stent, and the specific implementation of the invention is explained, it is understood that when the delivery system of the invention is used for delivering other implants, the deformation part and the locking part can pass through the skeleton, the through hole, the recovery hook, the ring or other hollow parts at the proximal end or the distal end of the implant. For example, when the temporary filter is transported, the deformable portion and the locking portion may be connected to the filter by a recovery hook at the proximal end of the filter. When the device is used for conveying the heart occluder, the device can be connected with the heart occluder through a tip at the proximal end of the heart occluder.

The conveying system provided by the invention is suitable for conveying the vascular stent, for example, a chimney stent or a hat stent is placed in the left subclavian artery for opening the aortic arch stenosis and the left subclavian artery stenosis simultaneously, or a tracheal stent and an esophageal stent are conveyed, so that the adjustment and recovery of the product release position are realized.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. The implant delivery system comprises an inner sheath core tube and an outer sheath tube which is movably sleeved outside the inner sheath core tube and provided with a cavity; the delivery system is characterized by further comprising at least one anchoring unit fixed on the outer surface of the inner sheath core tube, wherein the anchoring unit comprises a clamping piece sleeved on the outer surface of the inner sheath core tube and at least one anchoring piece connected with the clamping piece, the anchoring piece comprises a deformation part capable of bending relative to the inner sheath core tube and a locking part connected with the deformation part, when the deformation part and the locking part are accommodated in a cavity between the outer sheath tube and the inner sheath core tube, the deformation part is bent towards the proximal end to be matched with the clamping piece to form an anchoring piece, and one end, away from the deformation part, of the locking part is bent towards the proximal end to be away from the implant; when the deformation portion and the locking portion are subjected to the same external force, the amount of elastic deformation of the locking portion is smaller than that of the deformation portion.

2. The implant delivery system of claim 1, wherein the locking portion is made of a material having a modulus of elasticity less than or equal to the modulus of elasticity of the material of which the deformation portion is made.

3. The implant delivery system of claim 1, wherein the diameter of the locking portion is greater than or equal to the diameter of the deformation portion.

4. The delivery system of claim 3, wherein the locking portion is a hollow tubular body or a spheroid fitted over a distal end of the deformation portion.

5. The implant delivery system according to claim 1, wherein a length of the lock portion in an axial direction of the inner sheath core tube is larger than a gap between the grip member and the outer sheath tube when the lock portion is accommodated in the outer sheath tube.

6. A delivery system according to claim 1, wherein the length of the locking portion is greater than 0.1mm and less than 15 mm.

7. The delivery system of claim 1, wherein the anchor further comprises a securing portion connected between the gripping member and the deformation portion.

8. The delivery system of claim 1, wherein the anchoring unit comprises 1 to 12 anchors.

9. The delivery system of claim 8, wherein the anchor is disposed symmetrically or asymmetrically about a central axis of the inner sheath core tube.

10. The delivery system according to claim 1, wherein an outer surface of the collar member or an outer surface of the inner sheath core tube is provided with a housing space for accommodating the locking portion and the deforming portion.

11. The delivery system of claim 1, wherein at least one pair of guide holes are formed between any two end surfaces or outer walls of the hoop member, and the anchor member has a U-shaped structure of twin wires, and both ends of the U-shaped structure extend through the pair of guide holes.

12. The delivery system of claim 1, further comprising an inner sheath tube positioned between the inner sheath core tube and the outer sheath tube, wherein the inner diameter of the inner sheath tube near the distal end is larger than the inner diameter of the inner sheath tube near the proximal end, and wherein the grip member of the anchoring unit is embedded between the inner sheath tube near the distal end and the inner sheath core tube.

13. The implant delivery system is characterized by further comprising at least one anchoring unit fixed on the outer surface of the inner sheath core tube, wherein the anchoring unit comprises at least one anchoring piece connected with the inner sheath core tube, the anchoring piece comprises a deformation part capable of being bent relative to the inner sheath core tube and a locking part connected with the deformation part, when the deformation part and the locking part are accommodated in the cavity between the outer sheath tube and the inner sheath core tube, the deformation part is bent towards the proximal end to be matched with the inner sheath core tube to form an anchoring piece, and one end, away from the deformation part, of the locking part is bent towards the proximal end to be away from the implant; when the deformation portion and the locking portion are subjected to the same external force, the amount of elastic deformation of the locking portion is smaller than that of the deformation portion.

14. The implant delivery system according to claim 13, wherein a length of the lock portion in an axial direction of the inner sheath core tube is larger than a gap between the inner sheath core tube and the outer sheath tube when the lock portion is accommodated in the outer sheath tube.