MEDICAL DEVICE AND PROCESS OF PREPARING A MEDICAL DEVICE

Abstract

The present invention relates to a medical device to be applied to a body of a human or animal being. The medical device comprises a contact surface to contact the body of the human or animal being when the medical device is applied to the body of the human or animal being. The contact surface is covered with a soluble surface sealing. The surface sealing is composed of an organic compound.

Claims

1-49. (canceled)

50. A medical device to be applied to a body of a human or animal being, comprising: a contact surface configured to contact the body of the human or animal being when the medical device is applied to the body of the human or animal being, wherein the contact surface is covered with a soluble surface sealing, and the surface sealing is composed of an organic compound.

51. The medical device of claim 50, wherein the organic compound is a carbohydrate, wherein the carbohydrate is one of a di- or a trisaccharide, such as trehalose, maltotriose, lactose, lactulose, palatinose, or sucrose, or a monosaccharide, or a sugar alcohol, such as threitol, erythritol, glucose, fructose, sorbitol, galactose, galactitol, mannose, mannitol, xylitol, myo-inositol, or similar, organic acids, such as citric acid, or other substances such as vitamin C.

52. The medical device of claim 50, wherein the surface sealing comprises a combination of at least two different carbohydrates.

53. The medical device of claim 50, wherein the surface sealing is configured to withstand sterilization, wherein the sterilization comprises gamma radiation, e-beam provision, or ethylene oxide provision, and/or dissolve within 30 seconds when being in contact with an aqueous solution.

54. The medical device of claim 50, wherein the surface sealing is homogeneous, seamlessly covering the contact surface, and/or gas-tight.

55. The medical device of claim 50, wherein the medical devices is an implant configured to replace a natural biological structure of the body of the human or animal being, or physically support a damaged biological structure.

56. The medical device of claim 55, wherein the implant is configured to functionally support a damaged biological structure, the implant is essentially rigid, the surface sealing is configured to be dissolved when the implant is implanted at a target location, and/or the surface sealing is configured to be dissolved when the implant arrives a target location.

57. The medical device of claim 50, wherein at least a portion of the medical device forming the contact surface is made of a metal, a metal alloy, a ceramic material, glass, a metal oxide, or a polymeric material.

58. The medical device of claim 50, wherein the contact surface is a roughed surface, or a plain surface lacking a substantial roughness or waviness of its topology, or any substantial texture, or a coating, or a combination thereof.

59. The medical device of claim 50, wherein the contact surface is configured to provide target characteristics, wherein the target characteristics comprise a hydration, and/or a functionalization obtained by the contact surface being provided with double or more charged ions such that the ions are exposed to a bodily fluid when the medical device is applied to the body of the human or animal being, 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 the ions are phosphate ions.

60. The medical device of claim 59, wherein the surface sealing comprises a combination of at least two different carbohydrates, wherein the target characteristics comprise a hydration, wherein the surface sealing comprises a combination of at least a monosaccharide, such as glucose, and a disaccharide, such as trehalose, and wherein the surface sealing comprises the monosaccharide at a relative concentration of about 50% or more.

61. A process of preparing a medical device, comprising: obtaining a medical device having a contact surface configured to contact a body of a human or animal being, submerging the contact surface in an aqueous solution, providing a sealing agent into the aqueous solution, removing the contact surface from the aqueous solution, and drying the contact surface to form a surface sealing covering the contact surface.

62. The process of claim 61, wherein the contact surface is submerged in the aqueous solution prior to sealing agent being provided into the aqueous solution, or after the sealing agent being provided into the aqueous solution.

63. The process of claim 61, comprising a step of providing the contact surface with double or more charged ions such that the ions are exposed to a bodily fluid when the medical device is applied to the body of the human or animal being, 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 wherein the ions are phosphate ions.

64. The process of claim 61, wherein the sealing agent comprises an organic compound, and the organic compound is a carbohydrate.

65. The process of claim 64, wherein the carbohydrate is one of a di- or a trisaccharide, such as trehalose, maltotriose, lactose, lactulose, palatinose, or sucrose, or a monosaccharide, or a sugar alcohol, such as threitol, erythritol, glucose, fructose, sorbitol, galactose, galactitol, mannose, mannitol, xylitol, myo-inositol or similar, organic acids such as citric acid, or other substances, such as vitamin C.

66. The process of claim 61, wherein the sealing agent comprises a combination of at least two different carbohydrates, with one being a monosaccharide, such as glucose, and one being a disaccharide, such as trehalose, wherein the sealing agent comprises the monosaccharide at a relative concentration of about 50% or more.

67. The process of claim 61, wherein the contact surface of the medical device is treated to remove contaminants prior to being submerged into the aqueous solution, and/or the surface sealing covering the contact surface of the medical device is soluble and composed of an organic compound.

68. The process of claim 61, comprising sterilizing the medical device after drying the contact surface.

69. A set comprising: a medical device according to claim 50, and a package configured to protect the contact surface of the medical device, wherein the package is configured to maintain the contact surface of the medical device in a dry condition.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0059] The medical device according to the invention, as well as set according to the invention are described in more detail herein below by way of an exemplary embodiment and with reference to the attached drawings, in which:

[0060] FIG. 1 shows a schematic cross sectional view of a bone implant as an embodiment of a medical device according to the invention;

[0061] FIG. 2 shows a schematic cross sectional view of the bone implant of FIG. 1, wherein a contact surface is hydrated;

[0062] FIG. 3 shows a schematic cross sectional view of the bone implant of FIG. 2, wherein the contact surface together with its hydration is covered by a surface sealing; and

[0063] FIG. 4 shows a schematic cross sectional view of the bone implant of FIG. 3 when being applied to a body of a patient by implantation into a jaw bone of the patient.

DESCRIPTION OF EMBODIMENTS

[0064] In the following description certain terms are used for reasons of convenience and are not intended to limit the invention. The terms “right”, “left”, “up”, “down”, “under” and “above” refer to directions in the figures. The terminology comprises the explicitly mentioned terms as well as their derivations and terms with a similar meaning. Also, spatially relative terms, such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like, may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the devices in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the exemplary term “below” can encompass both positions and orientations of above and below. The devices may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes include various special device positions and orientations.

[0065] 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.

[0066] As explained above, given the relevant influence of contact surfaces of medical devices on critical aspects of healing or biological acceptance, such as inflammatory and hyperplastic responses, it has been found that preventively assigning certain target surface characteristics to the medical devices, before application, is advantageous.

[0067] FIG. 1 shows a cross sectional view of a bone implant 1 as an embodiment of a medical device according to the invention. Such a bone implant can, e.g., be a hip implant or a dental implant or the like. It is to be understood that, even though the invention is exemplified by means of a bone implant, it is applicable to a variety of other medical devices as well. For example, the invention is suitable for various implantable devices such as bone plates, artificial joints, artificial support structures, dental implants, catheters or the like, or devices applied to or introduced into a patient's body for a certain time such as catheters, surgical instruments or the like.

[0068] The circumference of an implantable body of the bone implant 1 forms a contact surface 10. Typically, the implantable body of the bone implant 1 is provided with a thread (not visible in the Figs.) to be screwed into a jaw bone. The bone implant 1 is made of titanium. The contact surface 10 is roughened to allow efficient grow-in into the bone tissue after the implant being set into the jaw bone. In FIG. 1 the bone implant 1 is shown after manufactured where the contact surface is cleaned and pre-processed.

[0069] For preparing the bone implant 1, the contact surface is submerged in a bath of an aqueous solution. Thereby, as can be seen in FIG. 2, a hydration 2 is provided to the contact surface 10. Then, Trehalose or a combination of at least two different carbohydrates is provided as sealing agent into the aqueous solution such that the aqueous solution has a predefined concentration of Trehalose or each of the different carbohydrates. The Trehalose or combination of different carbohydrates adheres at the hydration 2 and stabilizes it. Then the contact surface 10 is removed from the aqueous solution and dried.

[0070] In FIG. 3, the bone implant 1 is shown after drying the contact surface 10. It can be seen that a surface sealing 3 consisting of Trehalose or the combination of different carbohydrates is generated. The surface sealing 3 completely covers the hydration 2 of the contact surface 10. The surface sealing 3 protects the contact surface 10 including its hydration 2. In particular, it allows to maintain the hydration 2 until the bone implant 1 is set into the jaw bone.

[0071] FIG. 4 shows the bone implant 1 when being applied. In particular, the surface sealing 3 is dissolved by an aqueous solution and like this removed from the contact surface 10 and hydration 2. In one possible application, the bone implant 1 is flushed by the aqueous solution prior to setting into the jaw bone. Like this, the surface sealing 3 can efficiently be removed shortly before being set. In another possible application, the bone implant 1 is set together with its surface sealing 3. The surface sealing 3 is then dissolved while setting the implant by blood or another fluid as the aqueous solution. Like this, the surface sealing 3 can efficiently be removed in one step while setting the implant without requiring any previous preparation.

[0072] In any case, as can be seen in FIG. 4, at the end of the dissolving the surface sealing 3, the hydration 2 still is on the contact surface 10. When being applied or implanted, the hydration 2 and its preferred properties are exposed to the bone tissue.

[0073] In addition to maintaining the hydration 2 on the contact surface 10 up to the implant being applied, the surface sealing 3 allows to maintain the hydration 2 and the contact surface 10 clean. Like this, it can be prevented that preventively engineered surface characteristics are compromised by environment or other contaminants, such as hydrocarbon deposits or deposits of other undesired organic matter, machining impurities, fibers, dust or the like. All such contaminants would be located on the surface sealing 3 and removed together with it.

[0074] 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, and operational changes may be made without departing from the spirit and scope of this description and the claims. 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.

[0075] 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.

[0076] 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.