Embolism coil conveying device and preparation method therefor

Abstract

An embolic coil conveying device and a preparation method thereof are disclosed. The embolic coil conveying device includes a pusher and an embolic coil. A distal end of the pusher and a proximal end of the embolic coil are connected to serve as a detachment section. A stretch-resistant thread is disposed in the embolic coil. The stretch-resistant thread is fixed at the proximal end of the embolic coil. A conductive wire is disposed in the pusher. The stretch-resistant thread is connected to the conductive wire. Compared with the prior art, the present invention has the advantages that the stretch-resistant thread is fixed at the proximal end of the embolic coil, so that the stretch-resistant thread is connected to the conductive wire, thereby reducing the length of the detachment section, making the detachment section more flexible, and avoiding kick-out of a microcatheter due to release of the embolic coil.

Claims

1. An embolic coil conveying device, comprising a pusher and an embolic coil, wherein a section where a distal end of the pusher and a proximal end of the embolic coil are connected is a detachment section; wherein the embolic coil conveying device further comprises: a stretch-resistant thread disposed in the embolic coil, the stretch-resistant thread being fixed on a ring at the proximal end of the embolic coil; and a conductive wire configured to pass through an inside of the pusher, wherein the conductive wire is covered by an insulating layer, and a detachment point that is not covered by the insulating layer is provided on a distal end of the conductive wire, and wherein the distal end of the conductive wire and a proximal end of the stretch-resistant thread are directly cross-connected.

2. The embolic coil conveying device according to claim 1, wherein the stretch-resistant thread is fixed on any one of a second to a sixth ring at the proximal end of the embolic coil.

3. The embolic coil conveying device according to claim 1, wherein the detachment section has a bending modulus of elasticity of 150-220 Mpa.

4. The embolic coil conveying device according to claim 1, wherein the detachment section has a length of 0.3 mm-1.0 mm.

5. The embolic coil conveying device according to claim 1, wherein the distal end of the conductive wire is “J”-shaped, “U”-shaped, or “T”-shaped; the proximal end of the stretch-resistant thread is “J”-shaped or “U”-shaped; and the conductive wire and the stretch-resistant thread are in UU-shaped cross connection, UJ-shaped cross connection, JU-shaped cross connection, JJ-shaped cross connection, TU-shaped cross connection, or TJ-shaped cross connection.

6. The embolic coil conveying device according to claim 1, wherein a section where the conductive wire and the stretch-resistant thread are in cross connection is coated with a polymer adhesive.

7. The embolic coil conveying device according to claim 1, wherein a material of the insulating layer comprises at least one of polytetrafluoroethylene, polyethylene terephthalate, polyetheramide, and polyimide.

8. The embolic coil conveying device according to claim 1, further comprising a detachment device, wherein a proximal end of the pusher is inserted into the detachment device, and the detachment device is configured to apply a direct current of 0.5-5.0 mA to the conductive wire.

9. The embolic coil conveying device according to claim 1, wherein the embolic coil is in an “Ω” basket-like shape or a helical shape.

10. A preparation method of the embolic coil conveying device according to claim 1, comprising: providing the pusher and the embolic coil; disposing the stretch-resistant thread in the embolic coil, and fixing the stretch-resistant thread at the proximal end of the embolic coil; passing the conductive wire through an interior of the pusher, covering the conductive wire by the insulating layer, and providing the detachment point that is not covered by the insulating layer at the distal end of the conductive wire; and directly cross-connecting a proximal end of the stretch-resistant thread to the distal end of the conductive wire.

11. The preparation method of the embolic coil conveying device according to claim 10, wherein the stretch-resistant thread is fixed onto any one of a second to a sixth ring at the proximal end of the embolic coil.

12. The preparation method of the embolic coil conveying device according to claim 10, wherein the distal end of the conductive wire is “J”-shaped, “U”-shaped, or “T”-shaped; the proximal end of the stretch-resistant thread is “J”-shaped or “U”-shaped; and the conductive wire and the stretch-resistant thread are in UU-shaped cross connection, UJ-shaped cross connection, JU-shaped cross connection, JJ-shaped cross connection, TU-shaped cross connection, or TJ-shaped cross connection.

13. The preparation method of the embolic coil conveying device according to claim 10, further comprising coating the cross-connection with a polymer adhesive.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a schematic structural diagram of an embolic coil conveying device according to the present invention;

(2) FIG. 2 is a schematic structural diagram of a detachment section and an embolic coil in FIG. 1;

(3) FIG. 3 is a schematic diagram of the connection between a stretch-resistant thread and a conductive wire according to an embodiment of the present invention;

(4) FIG. 4 is a schematic diagram of the connection between a stretch-resistant thread and a conductive wire according to an embodiment of the present invention;

(5) FIG. 5 is a schematic diagram of the connection between a stretch-resistant thread and a conductive wire according to an embodiment of the present invention;

(6) FIG. 6 is a schematic diagram of the connection between a stretch-resistant thread and a conductive wire according to an embodiment of the present invention;

(7) FIG. 7 is a schematic diagram of the connection between a stretch-resistant thread and a conductive wire according to an embodiment of the present invention;

(8) FIG. 8 is a schematic diagram of an embolic coil according to an embodiment of the present invention;

(9) FIG. 9 is a schematic diagram of an embolic coil according to an embodiment of the present invention; and

(10) FIG. 10 is a schematic diagram of the measurement of a bending modulus of elasticity of a detachment section according to an embodiment of the present invention.

DETAILED DESCRIPTION

(11) The embolic coil conveying device and the preparation method thereof of the present invention are described in detail below with reference to the schematic diagrams, in which the preferred embodiments of the present invention are shown. It should be understood that those skilled in the art can modify the present invention described herein, while still achieving the advantageous effects of the present invention. Therefore, the following description should be understood to be widely known to those skilled in the art, but not to limit the present invention.

(12) The present invention is described in more detail by way of example in the following paragraphs with reference to the drawings. Advantages and features of the present invention will be apparent from the description and appended claims below. It should be noted that the drawings are in a very simplified form and use non-precise proportions, and are only intended to conveniently and clearly assist in describing the objectives of embodiments of the present invention.

(13) The present invention provides an embolic coil conveying device, including: a pusher; an embolic coil; an stretch-resistant thread disposed in the embolic coil, the stretch-resistant thread being fixed on a ring at the proximal end of the embolic coil; and a conductive wire configured to pass through an inside of the pusher. The conductive wire is covered by an insulating layer, a detachment point that is not covered by the insulating layer is provided on a distal end of the conductive wire, and the stretch-resistant thread and the conductive wire are in cross connection. Such a structural design omits an intermediate module between the conductive wire and the embolic coil, which reduces the length of the detachment section and makes the detachment section more flexible, thereby basically avoiding kick-out of a microcatheter due to the release of the embolic coil, and improving the success rate of the operation.

(14) The preferred embodiments of the embolic coil conveying device are listed below to clearly illustrate the content of the present invention. It should be understood that the content of the present invention is not limited to the following embodiments. Other improvements made through the conventional technical measures of those skilled in the art are also within the scope of the present invention.

(15) Referring to FIG. 1, the embolic coil conveying device of the present invention includes a pusher 106 and an embolic coil 107, and a section where a distal end of the pusher 106 and a proximal end of the embolic coil 107 are connected is a detachment section 103. The so-called detachment section refers to a section starting from the point of sudden softness change at the distal end of the pusher to the point of sudden softness change at the proximal end of the embolic coil and located at the point where the pusher and the embolic coil are connected, and a detachment point that is disconnected through electrolysis is located in this section. A stretch-resistant thread is provided inside the embolic coil. The stretch-resistant thread is fixed at the proximal end of the embolic coil 107. A conductive wire 104 passes through the center of the pusher 106, and the conductive wire 104 is covered by an insulating layer. The material of the insulating layer is at least one of Polytetrafluoroethylene (PTFE), Polyethylene Terephthalate (PET), Polyetheramide (PEBAX), and polyimide. The stretch-resistant thread and the conductive wire 104 are in cross connection.

(16) It should be noted that a “distal end” and a “proximal end” are relative concepts of the respective ends of each component or module. For example, the end close to the operator is defined as the “proximal end”, and the end away from the operator is defined as the “distal end”, which is common knowledge in the art and is not explained here in detail.

(17) Specifically, referring to FIG. 2, the stretch-resistant thread 108 is fixed onto any one of the second to sixth rings at the proximal end 1071 of the embolic coil.

(18) In view of the above, in the present invention, the stretch-resistant thread 108 and the conductive wire 104 are connected, without using an intermediate adapter module. Moreover, the stretch-resistant thread 108 is fixed on the embolic coil 107, which can also achieve steadiness without falling off. In this way, the flexibility of the detachment section can be ensured, and the length of the detachment section can be reduced as much as possible. The terminal end of the microcatheter in the aneurysmal cavity can effectively be prevented from being kicked out of the aneurysmal cavity by the embolic coil 107 that has been released. In one embodiment, the length of the detachment section 103 is 0.3 mm to 1.0 mm.

(19) In the present invention, the distal end of the conductive wire 104 and the proximal end of the stretch-resistant thread 108 are in cross connection. Referring to FIGS. 3-7, various optional solutions are shown.

(20) For example, the distal end of the conductive wire 104 is “J”-shaped, “U”-shaped, or “T”-shaped. The proximal end of the stretch-resistant thread 108 is “J”-shaped or “U”-shaped.

(21) As shown in FIG. 3, the distal end of the conductive wire 104 is “U”-shaped, and the proximal end of the stretch-resistant thread 108 is “U”-shaped, so that the conductive wire 104 and the stretch-resistant thread 108 are in UU-shaped cross connection.

(22) As shown in FIG. 4, the distal end of the conductive wire 104 is “J”-shaped, and the proximal end of the stretch-resistant thread 108 is “U”-shaped, so that the conductive wire 104 and the stretch-resistant thread 108 are in UJ-shaped cross connection.

(23) As shown in FIG. 5, the distal end of the conductive wire 104 is “J”-shaped, and the proximal end of the stretch-resistant thread 108 is “J”-shaped, so that the conductive wire 104 and the stretch-resistant thread 108 are in JJ-shaped cross connection.

(24) As shown in FIG. 6, the distal end of the conductive wire 104 is “T”-shaped, and the proximal end of the stretch-resistant thread 108 is “J”-shaped, so that the conductive wire 104 and the stretch-resistant thread 108 are in TJ-shaped cross connection.

(25) As shown in FIG. 7, the distal end of the conductive wire 104 is “T”-shaped, and the proximal end of the stretch-resistant thread 108 is “U”-shaped, so that the conductive wire 104 and the stretch-resistant thread 108 are in TU-shaped cross connection.

(26) By means of the cross connection between the distal end of the conductive wire 104 and the proximal end of the stretch-resistant thread 108, the embolic coil 107 and the pusher 106 can maintain certain connection strength, and meanwhile, the force is effectively transmitted to the embolic coil 107 to ensure the delivery of the embolic coil 107.

(27) Certainly, the connection between the conductive wire 104 and the stretch-resistant thread 108 is not limited to the forms listed in the present invention, and those skilled in the art can flexibly choose other feasible ways.

(28) In one embodiment, a section where the stretch-resistant thread 108 and the conductive wire 104 are connected is coated with a polymer adhesive to enhance the connection strength. For example, the polymer adhesive may be a UV adhesive, an epoxy adhesive, or the like.

(29) Taking FIG. 3 as an example, in the present invention, the conductive wire 104 includes a coating section 1042 (i.e., an insulating layer) and an exposed section 1041. The exposed section 1041 is a narrow section at the distal end of the conductive wire 104, and is disconnected in the body fluid by means of electrolysis, so that the pusher 106 is separated from the embolic coil 107, and thus it is also called a detachment point.

(30) The coating material of the coating section 1042 includes at least one of PTFE, PET, PEBAX, and polyimide.

(31) In one embodiment, the material of the conductive wire 104 is a metal, for example, a metal with good biopotency, such as stainless steel, gold, silver, and iron.

(32) Still referring to FIG. 1, the embolic coil conveying device further includes a detachment device 105. A proximal end of the pusher 106 is inserted into the detachment device 105, and the detachment device 105 applies a direct current of 0.5 mA-5.0 mA to the conductive wire 104, more specifically, for example, a current of 1.0 mA-3.0 mA, so that the embolic coil 107 and the pusher 106 can be separated safely and quickly. The detachment device 105 may be hand-held to facilitate operation.

(33) Still referring to FIG. 1, the pusher 106 includes a metal tube 101 and a metal spring tube 102 connected to each other. The metal spring tube 102 has a length of 40-50 cm, and can smoothly pass through the tortuous intracranial vessels above the aortic arch. Accordingly, the distal end 1021 of the metal spring tube 102 is the distal end of the pusher 106, and the proximal end of the metal tube 101 can be inserted into the detachment device 105.

(34) The embolic coil 107 is in an approximately straight state when passing through an introduction sheath and a matching microcatheter (not shown), and the embolic coil 107 is conveyed to the lesion site by means of the pusher 106. After entering the lesion site through the microcatheter, the embolic coil 107 restores its secondary form and conforms to the shape of the lesion site. The embolic coil 107 can be detached from the distal end of the pusher to complete the implantation by means of the detachment device 105 outside of the body.

(35) Referring to FIGS. 8 and 9, the secondary form of the embolic coil 107 is in an “Ω” basket-like shape or a helical shape. Certainly, according to different needs, embolic coils 107 of other shapes may be provided to adapt to aneurysms of different sizes.

(36) The present invention further provides a preparation method of an embolic coil conveying device, including:

(37) providing a pusher and an embolic coil;

(38) disposing a stretch-resistant thread in the embolic coil, and fixing the stretch-resistant thread onto a ring at a proximal end of the embolic coil;

(39) disposing a conductive wire in the pusher, and providing an insulating layer on the conductive wire and a detachment point that is not covered by the insulating layer at the distal end of the conductive wire; and

(40) connecting the stretch-resistant thread to the conductive wire, so that the distal end of the pusher and the proximal end of the embolic coil are connected to serve as a detachment section.

(41) In one embodiment, the stretch-resistant thread is fixed onto any one of the second to sixth rings of the embolic coil.

(42) In one embodiment, after connecting the stretch-resistant thread to the conductive wire, the method further includes: coating a section where the stretch-resistant thread and the conductive wire are connected with a polymer adhesive to enhance the connection strength.

(43) The embolic coil can be wound with platinum alloy wires, and the platinum alloy coils can have various lengths and diameters. For example, a platinum alloy wire can be wound around a mandrel to form a primary coil, and then the wound primary coil can further be wound on a mold according to a preset shape and subject to a shaping process, for example, to obtain a structure with the secondary form of an “Ω” basket-like shape or a helical shape.

(44) In one embodiment, the platinum alloy coil is made of a wire with a diameter of 0.003 inch, and is wound on a metal mandrel to form compact primary coils. These primary coils are used as the embolic coil 107. The wound primary coil is wound according to a preset secondary form of an “Ω” basket-like shape and subject to a shaping process, that is, the obtained secondary form of the embolic coil 107 is in an “Ω” basket-like shape.

(45) The distal end of the conductive wire 104 is made into a “U” shape (as shown in FIG. 3). The stretch-resistant thread 108 is axially extended inside the embolic coil 107 along the primary coil (as shown in a partial cross-sectional view in FIG. 2), and the stretch-resistant thread 108 is in cross connection with the “U”-shaped distal end of the conductive wire 104 to form a U-shaped proximal end (as shown in FIG. 3). One side of the “U”-shape of the proximal end of the stretch-resistant thread 108 is fixedly wound around any one of the second to sixth rings of the proximal end of the embolic coil 107 (as shown in FIG. 2), and the other side returns to the distal end of the embolic coil 107, and optionally, a ball cap is formed at the distal end of the embolic coil 107 for fixation. An insulating layer 1042 is disposed on the conductive wire 104, and a detachment point 1041 (as shown in FIG. 3) that is not covered by the insulating layer is provided on the distal end of the conductive wire 104. A detachment section 103 is formed in a section where the conductive wire 104 and the stretch-resistant thread 108 are in cross connection. The length of the detachment section 103 is 0.5 mm. According to the three-point bending method shown in FIG. 10, the bending modulus of elasticity of the detachment section 103 is 150 Mpa.

(46) The three-point bending method shown in FIG. 10 includes: clamping the metal spring tube 102 and the embolic coil 107 respectively by a fixing device 200 after the conductive wire 104 and the stretch-resistant thread 108 are in cross connection to form the detachment section 103, and then applying a certain force to the detachment section 103, for example, pressing down by 10 mm, so as to calculate the bending modulus of elasticity.

(47) In one embodiment, the embolic coil 107 has a helical structure (as shown in FIG. 9). The platinum alloy coil is made of a wire with a diameter of 0.00125 inch, and is similarly wound on the metal mandrel to form compact primary coils. The wound primary coils are subject to a shaping process according to a preset “helical” shape.

(48) The distal end of the conductive wire 104 is made into a “J” shape (as shown in FIG. 4). The stretch-resistant thread 108 is axially extended along the primary coil, and the stretch-resistant thread 108 is in cross connection with the “J”-shaped distal end of the conductive wire 104 to form a U-shaped proximal end (as shown in FIG. 4). One side of the “U”-shape of the proximal end of the stretch-resistant thread 108 is fixedly wound around any one of the second to the sixth rings at the proximal end of the embolic coil 107 (as shown in FIG. 2), the other side returns to the distal end of the embolic coil 107. An insulating layer is disposed on the conductive wire, and a detachment point that is not covered by the insulating layer is provided on the distal end of the conductive wire. A detachment section 103 is formed in a section where the conductive wire 104 and the stretch-resistant thread 108 are in cross connection. The length of the detachment section 103 is 1.0 mm. According to the three-point bending method shown in FIG. 10, the bending modulus of elasticity of the detachment section 103 is 210 Mpa.

(49) In one embodiment, the embolic coil 107 has a helical structure (as shown in FIG. 9). The platinum alloy coil is made of a wire with a diameter of 0.002 inch, and is similarly wound on the metal mandrel to form compact primary coils. The wound primary coils are subject to a shaping process according to a preset “helical” shape.

(50) The distal end of the conductive wire 104 is made into a “J” shape (as shown in FIG. 5). The stretch-resistant thread 108 is axially extended along the primary coil, and the stretch-resistant thread 108 is in cross connection with the “J”-shaped distal end of the conductive wire 104 to form a J-shaped proximal end (as shown in FIG. 5). One side of the “J”-shaped proximal end of the stretch-resistant thread 108 is fixedly wound around the third ring at the proximal end of the embolic coil 107. An insulating layer is disposed on the conductive wire, and a detachment point that is not covered by the insulating layer is provided on the distal end of the conductive wire. A detachment section 103 is formed in a section where the conductive wire 104 and the stretch-resistant thread 108 are in cross connection. The length of the detachment section 103 is 0.5 mm. According to the three-point bending method shown in FIG. 10, the bending modulus of elasticity of the detachment section 103 is 150 Mpa.

(51) In one embodiment, the distal end of the conductive wire 104 is designed to a “T” shape (as shown in FIGS. 6 and 7). The stretch-resistant thread 108 is axially extended along the primary coil, and the proximal end of the stretch-resistant thread 108 is designed to a “J” shape (as shown in FIG. 6) or a “U” shape (as shown in FIG. 7). An insulating layer is disposed on the conductive wire, and a detachment point that is not covered by the insulating layer is provided on the distal end of the conductive wire, and the conductive wire 104 and the stretch-resistant thread 108 are in cross connection.

(52) For the cross connection mode shown in FIGS. 4-7, preferably, a section where the stretch-resistant thread 108 and the conductive wire 104 are in cross connection is coated with a polymer adhesive to enhance the connection strength.

(53) It can be known from the foregoing description that in the embolic coil conveying device and the preparation method provided by the present invention, the embolic coil conveying device includes a pusher and an embolic coil. A distal end of the pusher and a proximal end of the embolic coil are connected to serve as a detachment section. A stretch-resistant thread is disposed in the embolic coil. The stretch-resistant thread is fixed at the proximal end of the embolic coil. A conductive wire is disposed in the pusher. An insulating layer is disposed on the conductive wire, and a detachment point that is not covered by the insulating layer is provided at the distal end of the conductive wire. The stretch-resistant thread is connected to the conductive wire. Compared with the prior art, the present invention fixes the stretch-resistant thread at the proximal end of the embolic coil, so that the stretch-resistant thread is connected to the conductive wire, which reduces the length of the detachment section and makes the detachment section more flexible, thereby basically avoiding the kick-out of a microcatheter due to release of the embolic coil, and improving the success rate of the operation.

(54) Various modifications and variations can be made to the present invention by those skilled in the art without departing from the spirit and scope of the present invention. In this way, if the modifications and variations made to the present invention fall within the scope of the claims and equivalent techniques thereof of the present invention, the present invention is also intended to include the modifications and variations.