US-12623007-B2 - Surface sealing for implants

Abstract

The present invention relates to an implant for insertion in a body lumen, wherein at least a portion of the surface is arranged to contact a wall of the body lumen and/or bodily fluid flowing through the lumen when the implant is inserted in the body lumen. The abovementioned portion of surface is covered with a surface sealing which is designed to dissolve within about 30 seconds when inserting the implant in the body lumen, such that this portion of surface is exposed to the body lumen. The present invention also relates to a method of manufacturing an implant as above described, comprising the steps of obtaining an implant with a surface; providing at least a portion of such surface with target characteristics; and covering such at least a portion of surface with a surface sealing to preserve the target characteristics. The present invention also refers to an implant set comprising an implant as defined and to a use of such an implant for treating an animal or a human body, wherein the treatment procedure comprises dissolving the surface sealing covering at least a portion of a surface of the implant by flushing the surface with a dissolving solution.

Inventors

• Arik Zucker
• Armin W. Mäder
• Stefano Buzzi

Assignees

• QVANTEQ AG

Dates

Publication Date

20260512

Application Date

20180223

Priority Date

20170224

Claims (20)

1. 1 . An implant for insertion in a body lumen, the implant comprising: a surface, at least a portion of the surface being arranged to contact a wall of the body lumen and/or bodily fluid flowing therethrough when the implant is inserted in the body lumen at a target location, wherein the at least a portion of the surface is a plain surface provided with assigned target characteristics comprising at least hydrophilicity, wherein the at least a portion of the surface and thus the plain surface is made of a metal or of a metal alloy, or of a ceramic material, or of a combination thereof, wherein the at least a portion of the surface is covered with a gas-tight surface sealing which adheres directly to the plain surface and is configured to dissolve during insertion of the implant in the body lumen, such that the surface sealing has been dissolved and at least a hydrophilic portion of the plain surface is exposed to the body lumen prior to the target location being reached, wherein the surface sealing consists of a soluble carbohydrate being a monosaccharide or a sugar alcohol, or being a disaccharide, or a combination thereof, and wherein a thickness of the surface sealing is in a range of up to a few hundred micrometers and is thinner than a structure of the implant it coats, the surface sealing configured to provide elasticity that supports flexibility and deformability of the implant capable of preserving the assigned target characteristics of the at least a portion of the surface.
2. 2 . The implant of claim 1 , wherein the monosaccharide or the sugar alcohol is one or more of Threitol, Erythritol, Glucose, Fructose, Sorbitol, Galactose, Galactitol, Mannose, Mannitol, Xylitol, or Myo-inositol.
3. 3 . The implant of claim 1 , wherein the implant is a vascular stent; or a flow diverter; or an ocular stent; or a coil or web-like structure for the treatment of vascular aneurysm; or a heart valve; or a cage of a heart valve; or a part of a cardiac pacemaker such as an electrode; or a shunt.
4. 4 . The implant of claim 1 , wherein the target characteristics further comprise an antithrombotic property and/or a surface charge.
5. 5 . The implant of claim 1 , wherein the surface sealing is homogeneous.
6. 6 . The implant of claim 1 , wherein the plain surface lacks a roughness or waviness of its topology, or a texture, or a combination thereof.
7. 7 . The implant of claim 1 , wherein the surface sealing seamlessly covers the at least a portion of the surface.
8. 8 . The implant of claim 1 , wherein the metal or the metal alloy is one of a cobalt chrome alloy, a platinum chrome alloy, Nitinol or stainless steel.
9. 9 . The implant of claim 1 , wherein the wherein the plain surface lacks a coating.
10. 10 . The implant of claim 1 , wherein the disaccharide is one or more of Trehalose, Lactose, Lactulose, Palatinose, or Sucrose.
11. 11 . The implant of claim 1 , wherein the surface sealing is dissolvable within 30 seconds.
12. 12 . An implant for insertion in a body lumen, the implant comprising: a surface, at least a portion of the surface being arranged to contact a wall of the body lumen and/or bodily fluid flowing therethrough when the implant is inserted in the body lumen at a target location, wherein the at least a portion of the surface is a plain surface provided with assigned target characteristics comprising at least hydrophilicity, wherein the at least a portion of the surface and thus the plain surface is made of a metal or of a metal alloy, or of a ceramic material, or of a combination thereof, wherein the at least a portion of the surface is covered with a gas-tight surface sealing which adheres directly to the plain surface and is configured to dissolve no later than the final deposition of the implant at the target location, such that the-at least a hydrophilic portion of the plain surface is exposed to the body lumen, wherein the surface sealing consists of a soluble carbohydrate being a monosaccharide or a sugar alcohol, or being a disaccharide, or a combination thereof, and wherein a thickness of the surface sealing is in a range of up to a few hundred micrometers and is thinner than a structure of the implant it coats, the surface sealing configured to provide elasticity that supports flexibility and deformability of the implant capable of preserving the assigned target characteristics of the at least a portion of the surface.
13. 13 . The implant of claim 12 , wherein the monosaccharide or the sugar alcohol is one or more of Threitol, Erythritol, Glucose, Fructose, Sorbitol, Galactose, Galactitol, Mannose, Mannitol, Xylitol, or Myo-inositol.
14. 14 . The implant of claim 12 , wherein the implant is a vascular stent; or a flow diverter; or an ocular stent; or a coil or web-like structure for the treatment of vascular aneurysm; or a heart valve; or a cage of a heart valve; or a part of a cardiac pacemaker such as an electrode; or a shunt.
15. 15 . The implant of claim 12 , wherein the target characteristics further comprise antithrombotic property and/or a surface charge.
16. 16 . The implant of claim 12 , wherein the surface sealing is homogeneous.
17. 17 . The implant of claim 12 , wherein the plain surface lacks a roughness or waviness of its topology, or a texture, or a combination thereof.
18. 18 . The implant of claim 12 , wherein the surface sealing seamlessly covers the at least a portion of the surface.
19. 19 . The implant of claim 12 , wherein the metal or the metal alloy is one of a cobalt chrome alloy, a platinum chrome alloy, Nitinol or stainless steel.
20. 20 . The implant of claim 12 , wherein the plain surface lacks a coating.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is the U.S. National Phase of, and Applicant claims priority from, International Application No. PCT/EP2018/054564, filed on 23 Feb. 2018, and European Patent Application No. 17157918.8, filed on 24 Feb. 2017, both of which are incorporated herein by reference in their entirety. TECHNICAL FIELD The present invention relates to an implant for insertion in a body lumen according to the preamble of the independent claims and more particularly to an implant which, when inserted, comprises at least a portion of a surface arranged to contact a wall of a tubular structure corresponding to the body lumen to and/or to contact bodily fluids flowing therethrough. The present invention also relates to a use of such an implant involving flushing a surface thereof; to a set of such an implant together with a package for storage and/or with a device for the insertion of the implant; and to a method of manufacturing such an implant. Such an implant for insertion in a body lumen can be a vascular prosthesis, as in the case of a stent. Implants according to the present invention are not exclusively limited to an application to tissues of blood vessels, but can take several forms aptly modified to comply with the anatomic structure of cavities and/or body lumina in different body organs, whether on an inside or on an outside wall of such cavities and/or body lumina. Therefore, an implant according to the present invention can also be an intracranial stent or a flow diverter; or an ocular stent; or a coil or a web-like structure for vascular aneurysm; or a heart valve; or a part of a cardiac pacemaker such as an electrode. Preferably, an implant according to the present invention is designed to come into contact with bodily fluids and employed in anatomical areas which allow a dynamic passage of bodily fluids. BACKGROUND ART The surface characteristics of implants configured to be inserted on or in soft tissue of the body, such as stents, are paramount to the success of a treatment of a body lumen by application or insertion of the implant. In fact, treatment by such implants entails risks for the patient due to, among other things, inflammatory reactions and/or to deposition of unwanted substances from the bodily fluids and/or uncontrolled cell proliferation and/or to the development of thromboses on the structures of the implants leading, in their turn, to abnormal narrowing or contractions of body passages or openings, generally named stenosis. Implant surfaces are also liable to contamination by deposits of organic (e.g., natural hydrocarbon molecules present in the atmosphere of cleanroom production facilities, as well as on work gloves in cleanrooms, and/or on production equipment in cleanrooms) or non-organic (e.g., residuals deriving from manufacturing processes such as electro-polishing) matter. Implants such as above introduced, and the respective insertion devices, should be as free as possible of any such contamination. Furthermore, their surfaces should carry no dust, no fibers, chemical impurities or particles in general. It is consequently a common practice to impart targeted surface characteristics to the implants such as stents, e.g., in order to grant their surface antithrombotic properties preventing the build-up of thrombi. One way to receive antithrombotic properties is to achieve and preserve high hydrophilicity of the implant surfaces as this reduces platelet adhesion and can additionally foster frictionless, accurate implant insertion—consequently limiting potential tissue damage—and promote early tissue healing. Surfaces which ensure biocompatibility of the implants and their ability to favor fast and complete healing of the body tissue at the place of application are highly desirable. In order to provide implant surfaces with such pre-assigned target properties, a number of techniques are currently in use, which can comprise—inter alia—surface coating methods and/or providing implant surfaces with specific macro-, micro- or nano-structures or similar. It is also a known practice to adjusting the implant surface charge state in order to selectively regulate protein deposits, trying to allow only those to adhere, which can prove advantageous and excluding undesired ones during healing process after implantation. A further known practice to make an implant surface hydrophilic is the removal of earlier mentioned contaminants from the implant surface, including also the natural organic contaminants (e.g., hydrocarbon deposits) from the atmosphere. This particular practice does not involve a coating or any other substances adhering to the implant surface. Instead, it is considered a highly purified implant surface, which needs to be preserved from recontamination in order to stay highly hydrophilic and therefore, anti-thrombotic. Such a protection of the surface should not interact with or modify the surface in order to maintain the originally created