WO2019149139A1

WO2019149139A1 - Delivery device for implant

Info

Publication number: WO2019149139A1
Application number: PCT/CN2019/073055
Authority: WO
Inventors: 赵涵饴; �田�浩; 雷文斌
Original assignee: 微创神通医疗科技（上海）有限公司
Priority date: 2018-02-02
Filing date: 2019-01-25
Publication date: 2019-08-08
Also published as: CN110123406A

Abstract

A delivery device (10) for an implant (20), able to achieve recovery and multiple releases of the implant (20) after the same has been completely released. The recovery operation is easy and convenient. The delivery device (10) comprises a delivery tube (131), a delivery rod (132), and a disengagement member (111). The delivery rod (132) can be inserted into the delivery tube (131). The disengagement member (111) has an elastic or shape memory feature and can be placed inside the delivery tube (131). A first end of the disengagement member (111) is connected to the delivery rod (132), and a second end can pass through at least one through-hole at a proximal end of the implant (20). The disengagement member (111) is bent after passing through the at least one through-hole and being constrained by the delivery tube (131), recovering in shape after the constraint of the delivery tube (131) is removed, such that the second end of the disengagement member (111) can be drawn out from the at least one through-hole.

Description

Implant delivery device

Technical field

The invention belongs to the field of medical equipment, and in particular relates to a delivery device for an implant.

Background technique

Microtrauma intervention is a treatment for vascular aneurysms, usually involving the placement of vascular implants, such as but not limited to stents, coils, aneurysm occlusion devices, through the delivery device to the location of the lesion, usually through delivery The wire reaches the lesion location along the delivery tube.

Most of the delivery devices are released immediately after the implant is pushed out of the distal end of the delivery tube, separated from the delivery device, and cannot be recycled to the delivery tube for re-release. For example, the delivery method described in U.S. Patent No. 5,506,615 B2 to Leynov Alexander et al. There is also a delivery device, such as that described in German Patent No. DE 10 2013 014 523 A1 to Monstadt Hermann et al., which has a connection portion that is connected to the delivery system and remains compressed after the microduct is fully introduced. The connecting portion is then self-expanded and released into the blood vessel. With this protocol, the implant can not be completely released until the release (ie, the implant is fully deployed), and if the release is found to be incomplete (eg, the joint is not fully expanded), it can no longer be recovered or re-released. Therefore, with the existing delivery device and delivery method, if the initial release of the implant occurs incorrectly or the release of the implant is incomplete, including the incomplete release of the connection portion of the implant with the push rod, it is impossible to Adjust by re-release the implant. This problem of incorrect release position and incomplete release of the implant can cause adverse complications and increase the risk of surgery.

Summary of the invention

In view of this, the present invention provides an implant delivery device that not only delivers the implant to the lesion site, but also enables recovery and multiple release of the implant after complete release, while the implant is accurate. Disengagement can be achieved after positioning and complete release, allowing the implant to be accurately released at a specific location.

According to an aspect of the invention, there is provided an implant delivery device comprising a delivery tube, a delivery rod and a release member; the delivery rod being insertable into the delivery tube, the release member having elastic or shape memory properties and The first end of the release member is connected to the delivery rod, and the second end of the release member can pass through at least one through hole at the proximal end of the implant;

Wherein the release member is curved under the restriction of the delivery tube after passing through the at least one through hole, and rebounds after the restriction of the delivery tube is eliminated, so that the first part of the release member The two ends can be separated from the at least one through hole.

Optionally, the conveying device further comprises a driving member disposed on the conveying rod and configured to drive the movement of the implant.

Optionally, the drive member drives the implant motion by its friction against the implant.

Optionally, the driving member is selected from materials having a static friction coefficient greater than 0.2.

Optionally, the conveying device further comprises a marker disposed at the second end of the release member, the marker being made of a developing material.

Optionally, the release member is made of a shape memory material.

Optionally, the release member has a tensile strength greater than 150 MPa, or the release limit has a spring limit strain greater than 5%.

Optionally, the release member is a spring structure or a spiral structure.

Optionally, the distal end of the delivery tube is provided with a release critical point, and the release critical point is made of a developing material.

Optionally, the conveying device further includes a developing section disposed at the first end of the releasing member.

Optionally, the proximal end of the implant is provided with a connector having a hole for allowing the second end of the release member to pass therethrough.

Optionally, the connector is coupled to the proximal end of the implant by a visualization structure.

In summary, the delivery device of the implant provided by the present invention has the following advantages:

The delivery device provided by the invention can re-inject the implant to the delivery device through the connection relationship between the release member and the implant and the delivery rod when the release position of the implant is incorrect or the release of the implant is incomplete. Inside the tube, the implant's release position is precisely adjusted to ensure complete release of the implant (ie, the implant is fully deployed), thereby reducing surgical complications and reducing the risk of surgery. Moreover, the delivery device only releases its connection to the implant by means of the deformation of the release member, which is not only simple in construction but also easy to operate.

DRAWINGS

1 is a schematic view of a delivery device according to an embodiment of the present invention when delivering an implant;

2 is a schematic view of a delivery device according to an embodiment of the present invention for recovering an implant;

3 is a schematic view of the delivery device according to an embodiment of the present invention when the implant is released;

4 is a schematic view of the delivery device of the embodiment of the present invention when the implant is completely released.

Detailed ways

The delivery device of the implant of the present invention will be further described in detail below with reference to Figures 1 to 4, as well as specific embodiments. Advantages and features of the present invention will become more apparent from the description. It should be noted that the drawings are in a very simplified form and all use non-precise proportions, and are only for convenience and clarity to assist the purpose of the embodiments of the present invention.

As used in the specification, the singular forms " The term "or" is used in the meaning of "and/or" as used in this specification unless the context clearly dictates otherwise. The term "proximal" generally refers to the end of the corresponding member that is adjacent to the operator, and "distal" refers to the end of the corresponding member that is remote from the operator. As used in this specification, the term "complete release" means that the implant is fully stretched out and released into the blood vessel. The term "complete release" means that the implant and delivery system are separated and completely released into the blood vessel.

1 is a schematic view of a delivery device 10 according to an embodiment of the present invention, wherein the delivery device 10 includes a release mechanism 110 and a delivery mechanism 130 coupled to the release mechanism 110, wherein The release mechanism 110 is additionally coupled to the implant 20, but the connection of the release mechanism 110 to the implant 20 can be mechanically released. Here, the implant 20 may be a stent, but is not limited thereto, and may be other blood vessel or lumen implants, such as a coil, an aneurysm occlusion device, a prosthetic valve prosthesis, and a cardiac septal defect occlusion device. Wait.

The detachment mechanism 110 includes a release member 111 having elastic or shape memory properties in the present embodiment, and the release member 111 can be restored from a bent state to a flat state to a large extent after being unbound, or is conveyed. The restraining force of the mechanism 130 can be largely compressed from a flat state to a curved state.

Preferably, the material of the release member 111 is selected from a high elastic material or a super elastic material, for example, a high elastic material or a super elastic material selected from an elastic limit strain amount greater than 5%. It is also possible that the material of the release member 111 is selected from fibrous materials having a tensile strength of more than 150 MPa. Alternatively, the release member 111 may also have a resilient structure such as a spring structure or a spiral structure. Still further, the release member 111 is made of a shape memory material and may be selected from one of a shape memory alloy or a shape memory polymer, such as a nickel titanium alloy, which has good biocompatibility in the human body. The release member 111 made of the shape memory material is in a flat state at a normal temperature or at a specific production temperature, and is bent when subjected to the binding force of the conveying mechanism 130, and is released into the human body environment and releases the conveying mechanism 130. After the restraint, it can return from the bent state to the straight state due to the change in temperature.

The delivery mechanism 130 includes a delivery tube 131 and a delivery rod 132 that passes through the delivery tube 131, the delivery rod 132 including a proximal portion 132a and a distal portion 132b, the distal portion 132b being located at the distal end of the proximal portion 132a The distal portion 132b is coupled to the proximal portion 132a at the distal end of the proximal portion 132a. Preferably, the delivery rod 132 can further include a flexible section 132c and a head end portion 132d, the flexible section 132c being between the proximal end portion 132a and the distal end portion 132b, the head end portion 132d being located at the distal end portion 132b At the distal end, the delivery rod 132 includes a proximal end portion 132a, a flexible section 132c, a distal end portion 132b, and a head end portion 132d that are sequentially connected from the proximal end to the distal end.

The release member 111 is placed in the cavity of the delivery tube 131, and the release member 111 is coupled to the delivery rod 132. Further, one end (defined as a first end) of the release member 111 is coupled to the distal end portion 132b of the delivery rod 132. Specifically, the first end of the release member 111 may be opposite to the distal end portion 132b. The proximal end is connected while the other end of the release member 111 (defined as the second end) penetrates into the at least one through hole at the proximal end of the implant 20 and passes in the same direction, and the second end of the release member 111 After passing through the at least one through hole, the shape is bent under the constraint of the inner wall of the conveying pipe 131. However, the release member 111 is not limited to the U-bend as long as the axis of the release member 111 is not in a straight line and cannot be separated from the at least one through hole. Optionally, the second end of the releasing member 111 is bent toward the proximal end of the conveying rod 132 after passing through the at least one through hole.

2 is a schematic view of the delivery device 10 in accordance with an embodiment of the present invention for recovering the implant 20, as shown in FIG. 2, by pushing the delivery rod 132 toward the distal end of the delivery device 10 or pulling the delivery tube toward the proximal end of the delivery device 10. 131, the implant 20 can be disengaged from the inner cavity of the delivery tube 131. At this time, since the release member 111 is still in the cavity of the delivery tube 131 (specifically, the second end of the release member 111 is in the delivery tube 131), Re-recycling of the implant 20 is achieved. Specifically, after the implant 20 is disengaged from the delivery tube 131, its proximal end is still constrained by the release member 111, and correspondingly, it remains attached to the delivery rod 132, in which case the implant 20 is found. If the release position is incorrect or the release is incomplete, the entire or partial implant 20 can be retracted by pulling the delivery rod 132 toward the proximal end of the delivery device 10 or pushing the delivery tube 131 toward the distal end of the delivery device 10. Go into the delivery tube 131. Further, after the release position of the implant 20 is adjusted into position, or after the complete implant 20 is not replaced, the implant 20 can be re-delivered and released.

3 is a schematic view of the delivery device 10 of the embodiment of the present invention when the implant 20 is released, as shown in FIG. 3, by pulling the delivery tube 131 toward the proximal end of the delivery device 10 or pushing it toward the distal end of the delivery device 10. The conveying rod 132 can retract the releasing member 111 away from the constraint of the conveying pipe 131. During the rebounding process, the releasing member 111 can be rebounded from bending to straight or nearly straight, thereby withdrawing from the releasing member 111. The at least one through hole at the proximal end of the implant 20 provides convenience.

4 is a schematic view of the delivery device 10 according to an embodiment of the present invention when the implant 20 is completely released (ie, the implant is separated from the delivery system), as shown in FIG. 4, when the release member 111 rebounds to, for example, near flat After straight, the delivery rod 132 can be pulled in the proximal direction of the delivery device 10, so that the release member 111 can be gradually separated from the at least one through hole, thereby releasing the restraining relationship between the release member 111 and the implant 20, so that the implant 20 can be completely released.

Obviously, the delivery device 10 provided by the embodiment can be connected to the implant 20 and the delivery rod 132 by the release member 111 when the position of the release of the implant 20 is incorrect or the release of the implant 20 is incomplete. The implant 20 is re-incorporated into the delivery tube 131 to precisely adjust the release position of the implant 20 to ensure complete release of the implant 20, thereby reducing surgical complications and reducing the risk of surgery. Moreover, the conveying device 10 of the present embodiment releases the connection with the implant 20 only by the deformation of the releasing member 111, which is not only simple in structure but also convenient in operation.

Further, the delivery mechanism 130 further includes a drive member 133 disposed on the distal end portion 132b of the delivery rod 132 for driving the implant 20 to move. Specifically, the driving member 133 may be connected to the distal end of the distal end portion 132b. Further, the driving member 133 may be located between the distal end portion 132b and the head end portion 132d, that is, the A proximal end of the driving member 133 is coupled to the distal end portion 132b, and a distal end of the driving member 133 is coupled to the head end portion 132d. In an embodiment, the driver 133 is adapted to contact the surface (eg, the inner surface) of the implant 20 and to drive the implant 20 to move in a frictional manner. The driving member 133 is selectively a film disposed on the distal end portion 132b of the conveying rod 132. The material of the film is selected from materials having a large friction coefficient, including but not limited to PTFE, silica gel, PEBAX, etc., and the shape is not It is limited to a tubular shape, a spiral shape or a sheet shape, and the connection manner is not limited to cementation, thermal deformation, or the like, and is fixed to the conveying rod 132. Preferably, the driving member 133 is selected from materials having a static friction coefficient greater than 0.2. In other embodiments of the invention, the driver 133 is used to urge the implant 20 from proximal to distal. In still another embodiment, the release member 111 has a certain rigidity, and the proximal or distal movement of the implant 20 to the delivery mechanism 130 is directly driven by its connection with the implant 20 and the delivery rod 132. There is no need to additionally provide the driver 133.

Further, the detaching mechanism 110 further includes a marker 112 disposed on the second end of the detaching member 111, and the identifier 112 is used to indicate the position of the second end of the detaching member 111 in the conveying pipe 131, thereby judging Whether the release member 111 reaches the release threshold 134 and whether the constraint of the release member 111 is released. The release threshold 134 is disposed at a distal end of the delivery tube 131. Specifically, during the process of the delivery rod 132 being pushed toward the distal end of the delivery device 10 or the delivery tube 131 being retracted toward the proximal end of the delivery device 10, when the marker 112 is observed to gradually approach and reach from the proximal end of the delivery tube 131 When the critical point 134 is released, it indicates that the implant 20 has been released but has not yet been released. At this time, it can be observed whether the position of the implant 20 is released accurately and whether the release is complete (whether the implant is fully deployed); The position at which the object 20 is released is less accurate or incompletely released, and the delivery tube 131 can be pulled toward the distal end of the delivery device 10 or the delivery tube 131 can be pushed toward the distal end of the delivery device 10 to recover the implant 20 to delivery. Within the tube 131, the implant 20 can be released again after further adjustment of the position of the delivery device 10, this step being repeatable until the implant 20 is fully released at the desired location; thereafter, continuing to withdraw proximally of the delivery device 10 The delivery tube 131, once the marker 112 is observed to exceed the release threshold 134 or the distal end of the delivery tube 131, can determine that the constraint of the release member 111 in the delivery tube 131 is released and rebounds, at this time, the operator Retracement can feed rod 132, release member 111 pulled in order to make a through hole 20 at the proximal end of the implant, thereby completing the implant 20 Separation from the delivery device 130 completely release the implant 20.

The identifier 112 is preferably made of a developing material including, but not limited to, a developing material such as platinum, iridium, gold or ruthenium. In addition, the identifier 112 may be a tubular member, a spring or a combination sleeve, etc., and may be welded or glued to be fixed on the second end of the release member 111. The release critical point 134 is preferably made of a developing material including, but not limited to, a developing material such as platinum, ruthenium, gold, or rhodium. The release critical point 134 may be symmetrically disposed, or may extend along the circumferential direction of the delivery tube 131 and extend for a length less than or equal to the circumference of the delivery tube 131.

Further, the first end of the release member 111 is provided with a developing section 113 made of a developing material and used to indicate the position of the first end of the releasing member 111. Further, by observing the relative position of the second end of the releasing member 111 and the first end by X-ray development, the deformation state of the releasing member 111 such as bending or rebound can be judged. Preferably, the first end of the release member 111 is coupled to the distal end portion 132b of the delivery rod 132 by the development section 113. The developing section 113 may be a tubular structure that is hollowly wound around the distal end portion 132b, or may be a separate tubular structure that is coupled to the distal end portion 132b. Here, the delivery rod 132 may be a bare metal rod of reduced diameter.

Further, the side of the developing section 113 away from the release member 111 is coupled to the flexible section 132c to connect the first end of the release member 111 with the delivery rod 132 through the developing section 113 and the flexible section 132c. The flexible section 132c provides support for the delivery of the implant 20 and compliance in the tortuous vessel to better transport the implant 20 in vivo, particularly in distal blood vessels such as intracranial blood vessels. The material of the flexible section 132c is not limited to metal, polymer material, and the structure is not limited to a spring or a spiral structure. For example, the flexible section 132c can be a spring structure wound around the proximal portion 132a and/or the distal portion 132b, or it can be a separate spring segment that is coupled to the proximal portion 132a and/or the distal portion 132b.

The outer diameter at the flexible section 132c of the delivery rod 132 can be selected between 0.01 inches and 0.05 inches, preferably between 0.01 inches and 0.029 inches. The outer end portion 132a of the delivery rod 132 may have an outer diameter of between 0.012 inches and 0.05 inches, preferably between 0.013 inches and 0.032 inches. The distal end portion 132b of the delivery rod 132 can be a bare tapered metal rod or a soft spring having an outer diameter of between 0.009 inches and 0.05 inches, preferably between 0.009 inches and 0.025 inches.

Further, the head end portion 132d of the delivery rod 132 may be a spring or a spiral structure, and the head end portion 132d may be a spring structure wound on the distal end portion 132b, or may be a separate spring portion, and the distal end portion 132b. connected. The head end portion 132d provides a certain flexibility and support for the delivery of the implant 20 in the tortuous vessel to better transport the implant 20 in vivo, particularly in distal vessels such as intracranial vessels, materials Not limited to metal, polymeric materials, the outer diameter may range from 0.008 inches to 0.03 inches, preferably between 0.012 inches and 0.017 inches. Additionally, the drive member 133 can be disposed at the proximal end of the head end portion 132d. In this embodiment, in addition to the head end portion 132d and the flexible segment 132c, the conveying rod 132 may be selected from a metal material having a good strength such as stainless steel, nickel titanium, nickel titanium cobalt alloy, etc., for providing the implant 20 with delivery. Good force transmission.

Further, the proximal end of the implant 20 is provided with a connector 114 having a hole, the hole in the connector 114 allowing the second end of the release member 111 to pass therethrough. The connector 114 is preferably coupled to the proximal end of the implant 20 by a visualization structure 115. The material of the developing structure 115 includes, but is not limited to, a developing material such as platinum, ruthenium, gold or ruthenium. The structure may be a tubular, spring or a combined sleeve. The connection of the implant 20 and the connecting member 114 may be welding or cementing. The connecting member 114 may be selected from the group consisting of a wire, a belt, a rope, a ring, and the like.

In addition, based on the above embodiments, an embodiment of the present invention further provides a method for transporting the implant 20 using the delivery device 10, including:

Step 1: driving the delivery rod 132 or the delivery tube 131 to move the implant 20 out of the delivery tube 131 and placing the second end of the release member 111 in the delivery tube 131; Specifically, the delivery rod 132 is driven to the distal end of the delivery device 10, or the delivery tube 131 is withdrawn toward the proximal end of the delivery device 10, or the delivery rod 132 is driven toward the distal end of the delivery device 10 while returning to the proximal end of the delivery device 10 Withdrawing the delivery pipe 131;

Step 2: The transport tube 131 or the delivery rod 132 is driven in the opposite direction to the first step to pull the implant 20 back into the delivery tube 131. Specifically, the delivery tube 131 is driven to the distal end of the delivery device 10, or the delivery rod 132 is withdrawn toward the proximal end of the delivery device 10, or the delivery tube 131 is driven toward the distal end of the delivery device 10 to the proximal end of the delivery device 10 The delivery rod 132 is withdrawn.

Wherein, steps one and two can be repeated until the implant 20 is completely released at the desired position. If the implant 20 fails to release completely, after performing step two, the implant 20 can be withdrawn and replaced with a new implant, and steps one and two are repeated to re-release.

Preferably, after step two, the method further comprises:

Step 3: driving the delivery rod 132 or the delivery tube 131 in the same direction as in the first step to disengage the implant 20 from the delivery tube 131 and simultaneously disengage the release member 111 from the delivery The constraint of the tube 131;

Step 4: The conveying rod 132 is driven to move in the same direction as the second step, so that the second end of the releasing member 111 is pulled away from the at least one through hole.

Finally, preferred embodiments of the invention are described above, but are not limited to the scope disclosed in the above embodiments, for example, not limited to driving the implant 20 by friction through the membrane, and further, at the implant 20. Holes are provided in the proximal body to facilitate the passage of the release member, such as directly preparing the hole on the support rod of the stent (here, the implant 20 is a stent), or the release member directly passes through the braided stent (here, implanted) The object 20 is a mesh of a braided stent. In addition, the proximal end of the implant is not limited to one through hole, and may be plural.

In summary, the delivery device 10 provided by the embodiment of the present invention can pass through the release member 111 and the implant 20 and the delivery rod 132 when the release position of the implant 20 is incorrect or the implant 20 is not completely released. Connecting, re-injecting the implant 20 into the delivery tube 131, thereby precisely adjusting the release position of the implant 20, ensuring complete release of the implant 20 (ie, the implant is fully deployed), thereby reducing surgical complications, Reduce the risk of surgery. Moreover, the conveying device 10 of the present embodiment releases the connection with the implant 20 only by the deformation of the releasing member 111, which is not only simple in structure but also convenient in operation.

The various embodiments in the present specification are described in a progressive manner, and each embodiment focuses on differences from other embodiments, and the same similar parts between the various embodiments may be referred to each other.

The above description is only for the description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes and modifications made by those skilled in the art in light of the above disclosure are all within the scope of the appended claims.

Claims

A delivery device for an implant, comprising:

a delivery tube;

a delivery rod insertable into the delivery tube;

a release member having elastic or shape memory properties and disposed within the delivery tube, the first end of the release member being coupled to the delivery rod, the second end of the release member being permeable to the implant At least one through hole at the proximal end;

Wherein the release member is curved under the restriction of the delivery tube after passing through the at least one through hole, and rebounds after the restriction of the delivery tube is eliminated, so that the first part of the release member The two ends can be separated from the at least one through hole.
The delivery device of the implant of claim 1 further comprising:

A drive member is disposed on the delivery rod and configured to drive the implant to move.
The delivery device of the implant of claim 1 further comprising:

An identifier is disposed on the second end of the release member, the marker being made of a developing material.
The delivery device for an implant according to claim 1, wherein the release member is made of a shape memory material.
The delivery device for an implant according to claim 1, wherein said release member has a tensile strength greater than 150 MPa, or said release member has an elastic limit strain greater than 5%.
The delivery device for an implant according to claim 1, wherein the release member is a spring structure or a spiral structure.
The delivery device for an implant according to claim 1, wherein a distal end of said delivery tube is provided with a release critical point, said release threshold being made of a developing material.
The delivery device of the implant of claim 1 further comprising:

A developing section is disposed on the first end of the release member.
The delivery device for an implant according to claim 1, wherein said implant has a proximal end provided with a connector having a hole for allowing said second end of said release member Pass through.
The implant delivery device of claim 9 wherein said connector is coupled to the proximal end of said implant by a visualization structure.