VASCULAR DEVICE AND METHOD FOR MANUFACTURING A VASCULAR DEVICE

Abstract

A vascular device for insertion in a body lumen, wherein the device includes a surface including at least a portion that is a functionalized surface provided with double or more charged ions such that the ions are exposed to a bodily fluid when the vascular device is inserted in the body lumen. The vascular device allows for reducing complications in its use and, particularly, for improving a desired healing in the body and preventing restenosis. At the same time, it allows for being manufactured at comparably low effort and for a convenient handling.

Claims

1. A vascular device for insertion in a body lumen, the device comprising: a surface comprising at least a portion that is a functionalized surface provided with double or more charged ions such that the ions are exposed to a bodily fluid when the vascular device is inserted in the body lumen.

2. The vascular device of claim 1, wherein the ions are anions comprising phosphate, sulfate, borate or carbonate groups or organic acids, a combination thereof, or molecules with more than one charged group.

3. The vascular device of claim 1, wherein the ions are Phosphate ions, and/or the ions are bound to the at least a portion of the surface.

4. The vascular device of claim 1, wherein the at least a portion of the surface is made of Titanium, a Titanium alloy such as Nitinol, or a Chromium alloy such as Cobalt-Chromium or Platinum-Chromium, Tantalum, Platinum, or Zirconium oxide.

5. The vascular device of claim 1, wherein the device is a vascular stent, a flow diverter, an ocular stent, a coil or web-like structure for treatment of vascular aneurysm, a heart valve, a cage of a heart valve, a part of a cardiac pacemaker, a flow disruptor, a web or web-like coil, a neck bridging device, an intra-aneurysmal stent, an occluder, an adjustable remodelling mesh, an aneurism clip, a vena cava filter, or a shunt.

6. (canceled)

7. The vascular device of claim 1, wherein at least a portion of the functionalized surface is covered with a surface sealing which is soluble when inserting the vascular device in the body lumen, wherein the surface sealing is preferably configured to dissolve within 30 seconds.

8. (canceled)

9. The vascular device of claim 7, wherein the surface sealing is provided with double or more charged ions, wherein the ions of the surface sealing preferably are of the same type as the ions of the at least a portion of the surface.

10. (canceled)

11. The vascular device of claim 7, wherein: the surface sealing comprises a soluble carbohydrate, a soluble polymer, a soluble ionic compound, or a combination thereof; the soluble carbohydrate preferably is a monosaccharide such as Glucose, Galactose, Fructose, Mannose or similar; a sugar alcohol such as Threitol, Erythritol, Sorbitol, Galactitol, Mannitol, Xylitcol, Myo-inositol or similar; an organic acid such as citric acid, vitamin C or similar, or; the soluble carbohydrate preferably is a di- or a trisaccharide, such as Trehalose, Maltotriose, Lactose, Lactulose, Palatinose, Sucrose or similar.

12. (canceled)

13. (canceled)

14. The vascular device of claim 7, wherein the surface sealing seamlessly covers the at least a portion of the surface, and/or the surface sealing is gas-tight.

15. (canceled)

16. The vascular device of claim 1, wherein the at least a portion of the surface is a plain surface which preferably lacks a substantial roughness, waviness of its topology, any substantial texture, a coating, or a combination thereof.

17. The vascular device of claim 1, wherein the at least a portion of the surface: has predefined target characteristics, wherein the predefined target characteristics preferably comprise hydrophilicity; and/or is a contact surface configured to contact the bodily fluid when the vascular device is inserted in the body lumen.

18. (canceled)

19. (canceled)

20. A method of manufacturing a vascular device for insertion in a body lumen, the method comprising obtaining a vascular device with a surface; preparing at least a portion of the surface of the vascular device; and providing double or more charged ions to the at least a portion of the surface such that the at least a portion of the surface is functionalized.

21. The method of claim 20, wherein providing the double or more charged ions to the at least a portion of the surface comprises: obtaining an ion solution of the double or more charged ions; and immersing the at least a portion of the surface in the ion solution, spraying the ion solution on the at least a portion of the surface, or rinsing the at least a portion of the surface with the ion solution.

22. The method of claim 20, wherein preparing the at least a portion of the surface of the vascular device comprises: removing contaminants, wherein removing contaminants preferably comprises plasma treatment, sterilization, etching, electro-polishing, or a combination thereof; and/or generating hydrophilicity.

23. (canceled)

24. (canceled)

25. The method of claim 20, comprising covering at least a portion of the functionalized surface with a surface sealing which is soluble when inserting the vascular device in the body lumen, wherein covering the at least a portion of the functionalized surface with a surface sealing preferably comprises: obtaining a sealing solution of a sealing agent; immersing the at least a portion of the functionalized surface in the solution, spraying the sealing solution on the at least a portion of the functionalized surface, or rinsing the at least a portion of the functionalized surface with the sealing solution; and drying the sealing agent on the functionalized surface.

26. (canceled)

27. The method of claim 25, comprising sterilising the vascular device by applying a radiation or a gas subsequently to covering the at least a portion of the surface together with the ions.

28. The method of claim 25, wherein the surface sealing comprises a soluble or particularly water-soluble carbohydrate, wherein the soluble carbohydrate preferably is: a monosaccharide such as Glucose, Galactose, Fructose, Mannose or similar; a sugar alcohol such as Threitol, Erythritol, Sorbitol, Galactitol, Mannitol, Xylitol, Myo-inositol or similar; an organic acid such as citric acid, vitamin C or similar; or a di- or a trisaccharide, such as Trehalose, Maltotriose, Lactose, Lactulose, Palatinose, Sucrose or similar.

29. (canceled)

30. (canceled)

31. The method of claim 25, wherein covering the functionalized surface with the surface sealing comprises configuring the surface sealing to be dissolved when the at least a portion of the surface is inserted to a target location in the body lumen.

32. The method of claim 20, wherein the ions are; anions comprising phosphate, sulfate, borate or carbonate groups or organic acids, any combination thereof, or molecules with more than one charged group; and/or Phosphate ions.

33. (canceled)

34. The method of claim 20, wherein the at least a portion of the surface is: made of Titanium, a Titanium alloy such as Nitinol, a Chromium alloy such as Cobalt-Chromium or Platinum-Chromium, Tantalum, Platinum, or Zirconium oxide; and/or a contact surface configured to contact a bodily fluid when the vascular device is inserted in the body lumen.

35. The method of claim 20, wherein the vascular device is a vascular stent, a flow diverter, an ocular stent, a coil or web-like structure for the treatment of vascular aneurysm, a heart valve, a cage of a heart valve, a part of a cardiac pacemaker such as an electrode, a flow disruptor, a web or web-like coil, a neck bridging device, an intra-aneurysmal stent, an occluder, an adjustable remodelling mesh, an aneurism clip, a vena cava filter, or a shunt.

36. (canceled)

37. A method of using a vascular device, wherein the device comprises a surface comprising at least a portion that is a functionalized surface provided with double or more charged ions such that the ions are exposed to a bodily fluid when the vascular device is inserted in the body lumen, the method comprising: making the vascular device ready for implantation by a pre-implantation preparation, and implanting the made ready vascular device, wherein the pre-implantation preparation comprises flushing the vascular device with a bodily fluid or with a simulated bodily fluid; or making the vascular device ready for implantation by a pre-implantation preparation, and implanting the made ready vascular device, wherein the pre-implantation preparation comprises flushing the vascular device with a fluid preserving the surface properties of the vascular device; or implanting the vascular device, wherein flushing, the vascular device prior to implantation is excluded.

38. (canceled)

39. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0064] The vascular device according to the invention and the method of manufacturing a vascular device according to the invention are described in more detail herein below by way of exemplary embodiments and with reference to the attached drawings, in which:

[0065] FIG. 1 shows a vascular stent as a vascular device according to the invention;

[0066] FIG. 2 shows a surface of the vascular stent of FIG. 1 after preparation while being manufactured in a method according to the invention;

[0067] FIG. 3 shows the surface of FIG. 2 exposed to an ion solution while being manufactured;

[0068] FIG. 4 shows the surface of the vascular stent of FIG. 1 provided with ions while being manufactured;

[0069] FIG. 5 shows the surface of FIG. 4 exposed to a sealing solution while being manufactured;

[0070] FIG. 6 shows the surface of the vascular stent of FIG. 1 having a surface sealing after being manufactured;

[0071] FIG. 7 shows the surface of FIG. 6 contaminated with various substances;

[0072] FIG. 8 shows the surface of the vascular sent of FIG. 1 after the surface sealing is dissolved; and

[0073] FIG. 9 shows the surface of the vascular stent being implanted.

DETAILED DESCRIPTION

[0074] In the following description of embodiments of the invention, to avoid repetition in the figures and the descriptions of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from a description or figure does not imply that the aspect is missing from embodiments that incorporate that aspect. Instead, the aspect may have been omitted for clarity and to avoid prolix description. In this context, the following applies to the rest of this description: If, in order to clarify the drawings, a figure contains reference signs which are not explained in the directly associated part of the description, then it is referred to previous or following description sections. Further, for reason of lucidity, if in a drawing not all features of a part are provided with reference signs it is referred to other drawings showing the same part. Like numbers in two or more figures represent the same or similar elements.

[0075] FIG. 1 shows a vascular stent 1 as an embodiment of a vascular device according to the invention. The stent 1 is manufactured in an embodiment of a method according to the invention as described in more detail below. In particular, the stent 1 is a self-expanding stent having a pattern of webs 11 forming dosed cells. More specifically, the multiplicity of webs 11 is made of Nitinol (NiTi) and the webs 11 together establish plural dosed cells, which form a tubular shape. The stent length and, as a passage, the stent lumen with a compressible diameter extend between a proximal and a distal end. The stent 1 has an expanded diameter in the dilated or released state, which is dimensioned for supporting a blood vessel as a body lumen into which the stent 1 is intended to be inserted or implanted.

[0076] As can be seen in FIG. 2, the webs 11 of the stent 1 establish a contact surface 111 of the stent 1 which is a portion of the complete surface of the stent 1 designed to contact blood as a bodily fluid when the stent 1 is inserted in a blood vessel. For example, the contact surface 111 is prepared by applying a plasma treatment in order to remove contaminants and generate a plain surface. Furthermore, within preparing the stent 1, hydrophilicity is generated on the contact surface 111.

[0077] In a next step shown in FIG. 3, the stent 1 is immersed in an ion (i.sup.n+(−)) solution 3 including an inactive counter ion cm). Thereby, a (i.sup.m+(−)) species 112 is bound to the contact surface 111 as can be seen in FIG. 4. This results, the contact surface being established as functionalized surface. In a preferred embodiment, the ion solution is a NaH.sub.2PO.sub.4 or KH.sub.2PO.sub.4 aqueous solution at pH 4.5, wherein the (i.sup.n+(−)) ion 3 is mainly H.sub.2PO.sub.4.sup.− and the ion (i.sup.m+(−)) 112 is a Phosphate species bound to the contact surface 111 of Nitinol. Thus, in the preferred embodiment, the Nitinol contact surface is functionalized with Phosphate ions.

[0078] As depicted in FIG. 5, the stent 1 is then immersed again in a sealing solution 4. Such a sealing solution can comprise a sugar (such as e.g. Glucose, Trehalose, etc.) as a sealing agent and i.sup.n+(−) ions. The i.sup.n+(−) ions 3 as well as the inactive counter ions c.sup.k+(−) can be contained in the sealing solution 4 in order to potentially prevent that the i.sup.m+(−) ions 112 on the contact surface 111 are transferred into the sealing solution 4. In the preferred embodiment, the sealing agent is Trehalose.

[0079] In a next step, the sealing solution is dried on the contact surface 111 such that a surface sealing 5 is generated covering the contact surface 111 with the i.sup.m+(−) ion 112 as can be seen in FIG. 6. The pure hydrophilized contact surface 111 provided with the i.sup.m+(−) ions 112, i.e., the functionalized surface, is thereby protected by the surface sealing 5.

[0080] FIG. 7 shows that in further processing, such as mounting onto the delivery device, packaging, sterilizing, storing and handling of the stent 1 before insertion into a body lumen, the surface sealing 5 is contaminated. In particular, hydrocarbon deposits or deposits of other undesired organic matter 62, machining impurities 63 such as fibers, dust, etc. can adhere to the sealing layer.

[0081] Before being inserted, the stent 1 and particularly its contact surface 111 is flushed by an appropriate liquid. Thereby, the sealing layer 5 is dissolved and removed together with the contaminants 62, 63 from the contact surface 111. As can be seen in FIG. 8, the highly purified plain contact surface 111 together with the i.sup.m+(−) ions 112, i.e., the functionalized surface, is now in the same state as after the drying step of its manufacture (FIG. 4). The stent 1 is inserted into a blood vessel 7 and implanted at a target location thereof. FIG. 9 shows that the blood vessel 7 has a tubular shape with a wall 72. Inside the blood vessel 7 blood 71 flows. The contact surface 111 is directed towards the blood 71 such that the i.sup.m+(−) ions 112 are exposed to the blood 71. Thereby, the i.sup.m+(−) ions 112 reduce or prevent the adherence of thrombocytes onto the stent surface 111 inside the blood vessel 7.

[0082] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limiting-the claims defining the protected invention. In other words, while the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical, compositional, structural, electrical, ion charge, and operational changes may be made without departing from the spirit and scope of this description and the claims. In particular ions with their charges are purely illustrative and do not indicate actual charges. In some instances, well-known circuits, structures and techniques have not been shown in detail in order not to obscure the invention. Thus, it will be understood that changes and modifications may be made by those of ordinary skill within the scope and spirit of the following claims. In particular, the present invention covers further embodiments with any combination of features from different embodiments described above and below.

[0083] Even though the inventive concept is particularly useful or beneficial for vascular devices as described above, it can also be useful in other applications where the formation of thrombi or general foreign body reaction, such as e.g., inflammatory reaction, is to be prevented or reduced. In particular, surfaces of other implants or portions thereof can be functionalized by being provided with double or more charged ions. For example, in dentistry, often implants extend through the soft tissue or gingiva when being set into the bone of a jaw. Thereby, within the gingiva it can be desired to have as few thrombus formation, reduced inflammatory reactions or similar effects as possible. Thus, the sections of such implants which are designed to be located within the gingiva typically are prepared, such as polished or the like. Other sections of the surface of the implant are not polished or even roughened for allowing an efficient osseointegration. Applying the concept of the invention to such dental implants, the section to be located in the soft tissue can be functionalized by providing double of more charged ions. Also, other dental elements intended for being positioned in the gingiva such as abutments or healing caps can be surface treated accordingly. Additionally, other aspects described in connection with the vascular device according to the invention above can be applied to other implants when it is desired to reduce thrombus formation, inflammatory reactions or to achieve similar effects.

[0084] The disclosure also covers all further features shown in the Figs. individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description and single alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter. The disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features.

[0085] Furthermore, in the claims the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single unit or step may fulfil the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms “essentially”, “about”, “approximately” and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. The term “about” in the context of a given numerate value or range refers to a value or range that is, e.g., within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. Any reference signs in the claims should not be construed as limiting the scope.