METHOD AND APPARATUS FOR EMBEDDING AN IMPLANT IN A BALLOON SURFACE BY INDUCTIVE HEATING OF THE IMPLANT

Abstract

A method fixes an implant on a balloon. The balloon, together with an implant, which is crimped onto a balloon surface of the balloon such that the implant by an inner side contacts a contact region of the balloon surface, is provided in the interior of a mold. The balloon interior is acted on by a pressure and the implant is inductively heated so that the contact region over the implant is heated and plastically deformed. The inner side of the implant is embedded in the balloon surface. Additionally, an assembly is produced by the method and an apparatus are provided for carrying out the method.

Claims

1. A method for fixing an implant on a balloon, which comprises the steps of: providing the balloon, together with the implant which is crimped onto a balloon surface of the balloon such that the implant by means of an inner side contacts a contact region of the balloon surface, in an interior of a mold; applying pressure to a balloon interior; and inductively heating the implant so that the contact region between the balloon and the implant is heated and plastically deformed, wherein the inner side of the implant is embedded in the balloon surface.

2. The method according to claim 1, which further comprises inductively heating the implant by means of an inductor.

3. The method according to claim 1, wherein the mold is formed from an electrically non-conductive material.

4. The method according to claim 1, which further comprises forming the mold from at least one material selected from the group consisting of glass, a ceramic, and a heat-resistant plastic.

5. The method according to claim 1, which further comprises heating the implant to a target temperature during the inductive heating.

6. The method according to claim 5, which further comprises: measuring a current temperature of the implant during the inductive heating of the implant; and controlling an actual temperature of the implant during the inductive heating of the implant until it reaches the target temperature.

7. The method according to claim 6, which further comprises measuring and controlling the actual temperature of the implant during the inductive heating of the implant with an aid of a measurement of heat radiation emitted by the implant.

8. The method according to claim 7, wherein the mold has a through-opening for a transmission of the heat radiation to be measured.

9. The method according to claim 1, wherein the pressure in the balloon interior lies in a range of from 10 bar to 30 bar.

10. The method according to claim 5, which further comprises selecting the target temperature to be in a range of: 40 C. to 150 C.; 40 C. to 140 C.; 60 C. to 150 C.; 50 C. to 110 C.; 100 C. to 110 C.; 102 C. to 107 C.; 50 C. to 60 C.; or 53 C. to 57 C.

11. The method according to claim 5, which further comprises manufacturing the balloon from a balloon material which has a glass transition temperature, wherein the target temperature is greater than or equal to the glass transition temperature, and wherein the target temperature deviates by no more than 10% from the glass transition temperature.

12. The method according to claim 5, which further comprises manufacturing the balloon from a balloon material which has a glass transition temperature, wherein the target temperature is greater than or equal to the glass transition temperature, and wherein the target temperature deviates by no more than 5% from the glass transition temperature.

13. The method according to claim 5, which further comprises manufacturing the balloon from a balloon material which has a glass transition temperature, wherein the target temperature is greater than or equal to the glass transition temperature, and wherein the target temperature deviates by no more than 1% from the glass transition temperature.

14. The method according to claim 5, wherein the implant, with the balloon interior acted on by the pressure, is exposed to the target temperature being constant over a period of time of at least 10 s to 100 s.

15. The method according to claim 5, wherein the implant, with the balloon interior acted on by the pressure, is exposed to the target temperature being constant over a period of time of at least 20 s to 80 s.

16. The method according to claim 5, wherein the implant, with the balloon interior acted on by the pressure, is exposed to the target temperature being constant over a period of time of at least 30 s to 60 s.

17. The method according to claim 5, wherein the implant, with the balloon interior acted on by the pressure, is exposed to the target temperature being constant over a period of time of at least 25 s to 35 s.

18. The method according to claim 5, wherein the implant, with the balloon interior acted on by the pressure, is exposed to the target temperature being constant over a period of time of at least 55 s to 65 s.

19. An assembly, comprising: a balloon having a balloon surface; and an implant crimped onto said balloon surface of said balloon, wherein the implant is fixed to said balloon by means of the method according to claim 1.

20. An apparatus for fixing an implant to a balloon, the apparatus comprising: a mold having an interior for receiving the implant crimped onto the balloon; a device which can be brought into fluidic connection to a balloon interior of the balloon and configured to act on the balloon interior of the balloon with pressure; and an inductor configured to heat the implant when the balloon and the implant crimped thereon are disposed in an interior of said mold.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

[0056] FIG. 1 is a diagrammatic, perspective view of an apparatus which can be used to carry out the method according to the invention;

[0057] FIG. 2 is a schematic sectional depiction of a stent to be fixed to a balloon; and

[0058] FIG. 3 is a perspective view of an inductor of the apparatus for carrying out the method according to the invention, wherein the inductor surrounds the mold of the apparatus helically.

DETAILED DESCRIPTION OF THE INVENTION

[0059] Referring now to the figures of the drawings in detail and first, particularly to FIGS. 1 and 2 thereof, there is shown an embodiment of an apparatus 10 which is configured to carry out a method according to the invention. The apparatus 10 therefore has, for example, a cylindrical mold 3 with an inner side 3a, which faces an interior 7 of the mold 3. The inner side 3a forms a contact face for a stent 1 which can be arranged in the interior 7 and which is crimped onto a balloon surface 2a of an in particular folded balloon 2 and which in addition is to be embedded in the balloon surface 2a by use of the apparatus 10 so as to produce an interlocking fit increasing the stent-holding force. The apparatus 10 furthermore has in particular a device 8 which can be brought into fluidic connection to an interior 6 of the balloon 2 and is configured to act on the interior 6 of the balloon 2 with a pressure. The device can be configured for example as a compressed gas source, in particular a compressed air source 8, which is configured to introduce a gas, in particular compressed air, in the balloon interior 6 in order to generate the pressure in the balloon interior 6.

[0060] The apparatus 10, as shown by way of example in FIG. 3, furthermore has at least one inductor 12, which is configured to heat the stent 1 directly, more specifically contactlessly, when the balloon 2 and the stent 1 crimped thereon are arranged in the interior 7 of the mold 3. The inductor 12 is configured to generate a magnetic field M, which generates in the stent 1 an electric current, which in turn generates Joule heat, which heats the stent 1. In accordance with FIG. 3, the inductor 12 is helical, wherein the inductor 12 extends helically around the mold 3, such that the stent 1 arranged therein is heatable by means of the inductor 12. Instead of a helical inductor 12, other inductors known to a person skilled in the art can also be used, for example a fork inductor or a folding inductor. In the case of a fork inductor the conductor of the inductor is arranged such that the inductor has an open side, on which the object to be heated can be arranged in relation to the inductor such that the inductor extends on two sides of the object facing away from one another. A folding inductor allows the inductor to be opened via a hinge, such that the object can be placed in the inductor in the open state of the folding inductor and is surrounded by the inductor when it is closed.

[0061] By directly heating the stent 1, this heats the balloon surface 2a or a corresponding balloon material merely in a contact region 21 between an inner side 1a of the stent 1 and the balloon surface 2a,

[0062] The stent 1 or the contact region 21 is heated here such that it is plastically deformable. The stent 1 is pressed or embedded via its inner side 1a into the balloon surface by way of the applied pressure in the balloon interior

[0063] Outside the contact region 21 the balloon is not heated or is heated to a considerably smaller extent, and therefore the material outside the contact region can remain at least in part in a plastically non-deformable state,

[0064] As can also be seen with reference to FIG. 2, the stent 1 can have multiple through-openings 101, which each extend from the inner side 1a of the stent 1 to an outer side 1c of the stent 1. Each through-opening 101 has a circumferential lateral wall or delimitation 1b formed by the stent 1, via which wall or delimitation the inner side 1a of the stent 1 is connected to the outer side 1c of the stent 1, so that, by embedding the inner side 1a of the stent 1 in the balloon surface 2a, regions 22 of the balloon 2 or the balloon surface 2a associated with the through-openings 101 protrude into the through-openings 101 (this is indicated by arrows in the schematic depiction according to FIG. 2), wherein an interlocking fit is produced between the balloon 2 and the stent 1, The balloon surface 2a in particular also nestles closely at least in some sections against the lateral wall or delimitation 1b of the through-openings 101, as is shown in particular in the detail A of FIG. 2. The through-openings 101 can each be delimited in particular by struts 100 of the stent 1, which then also form the lateral walls or delimitations 1b.

[0065] In order to be able to adjust or control the temperature of the stent 1 in the method according to the invention, it is provided in particular to measure the temperature by means of a temperature sensor 9. The temperature sensor in particular is a temperature sensor which, in order to determine the temperature of the stent 1, is configured to measure heat radiation (for example infrared radiation) emitted by the stent 1. To this end, a wall of the mold 3 can have a through-opening 30, which allows heat radiation of the stent 1 to escape unhindered, in such a way that it can be detected by the temperature sensor 9 and can be evaluated in order to determine the actual temperature of the stent 1. The temperature sensor 9 is preferably connected to the inductor 12 via a control unit (not shown) in order to control the temperature of the stent 1.

[0066] By way of the solution according to the invention an optimal interlocking connection between the stent 1 and balloon 2 is thus produced, which increases the stent-holding force, wherein in particular the balloon material is warm and flexible only in the contact region 21 with the stent 1. The stent 1 hereby can be embedded deep in the balloon material. The risk of the stent shifting (see Stent Displacement according to ASTM F2394-07) and the risk of the stent detaching from the balloon (see Stent Dislodgment according to ASTM F2394-07) thus reduces, advantageously.

[0067] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teaching. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention.