AN IMPLANTABLE OBJECT AND A METHOD OF PREPARING IT TECHNOLOGICAL FIELD The present disclosure is in the medical field, in particular in the field of implantable objects intended to implanted in a patient by a medical procedure.
BACKGROUND ART References considered to be relevant as background to the presently disclosed subject matter are listed below: - US 9,180,1 Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.
GENERAL DESCRIPTION The present disclosure provides an implantable object and a method of preparing it. The implantable object may be any object or device that is intended to be implanted in a medical procedure to a patient. The implantable device is coated, at least partially, with coagulated whole blood, typically autologous whole blood that is withdrawn from the subject prior to the procedure. The coating of coagulated whole blood aims to improve the reception of the implantable object in the body of the patient, induce recovery in the area of the implantation and prevent infection reaction. Therefore, an aspect of the present disclosure provides a method for preparing an implantable object intended to be implanted in a subject. The method comprising contacting at least a portion of said implantable object with a mixture of whole blood and at least one coagulation initiator, prior to complete coagulation of said mixture. Namely, a portion of the implantable object contacts the whole blood when it is still in a flowable non-coagulated state to allow the blood to adhere to the portion of the implantable object. Then, the method further comprises allowing said mixture to coagulate on said portion.
It is to be noted that any combination of the described embodiments with respect to any aspect of this present disclosure is applicable. In other words, any aspect of the present disclosure can be defined by any combination of the described embodiments. In some embodiments of the method, said whole blood is autologous blood of the subject. In some embodiments, the method further comprising impregnating or immersing the implantable object within said mixture. In some embodiments the implantable object is fully immersed in the whole blood, and in other embodiments the implantable object is only partially immersed in the whole blood such that only a portion thereof contact the whole blood. In some embodiments of the method, said implantable object comprises pores and said contacting comprises introducing said mixture into said pores. In some embodiments of the method, the implantable object comprises a fabric portion, and said contacting comprises contacting the mixture with said fabric portion. In some embodiments of the method, said implantable object is a surgical mesh. The surgical mesh may be any kind known in the art that may be made of organic materials, biological material, inorganic materials, or any combination thereof. In some embodiments of the method, said implantable object is a cardiac implantable device. In some embodiments of the method, said cardiac implantable device is a pacemaker. In some embodiments, the method further comprising, prior to said contacting, adding one or more antibiotic agents with said mixture. In some embodiments of the method, said contacting comprises introducing said implantable object into a receiving space of a receptacle device and filling said coagulation mold with said mixture. It is to be noted that the introduction of the implantable object and the filling of the mixture can be in any order, namely the steps order is interchangeable. In some embodiments of the method, said receiving volume is defined by a contour of the receptacle device conforming with a contour, typically the external contour, of said implantable object. Typically, the implantable object is fitted into the receiving volume leaving a small gap between its external contour and the walls of the coagulation mold for allowing the filling of the mixture in said gap.
In some embodiments of the method, said at least one coagulation initiator is selected from any one of: Kaolin, Ca2+, Mg2+, negatively charged phospholipid (PL) and protamine sulfate, or any combination thereof. In some embodiments, the method further comprising, prior to said contacting, withdrawing whole blood from the subject and mixing it with at least one coagulation initiator. In some embodiments of the method, following said withdrawing, the method further comprising mixing the whole blood with one or more anti-coagulation agents. In some embodiments of the method, said one or more anti-coagulation agents are selected from a group consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate. In some embodiments, the method further comprises roughening said portion of the implantable device to increase a surface roughness index of said portion to improve the adherence of the whole blood to said portion. In some embodiments, the method further comprises perforating said portion of the implantable device to increase a surface roughness index of said portion to improve the adherence of the whole blood to said portion. Yet another aspect of the present disclosure provides a method for implanting an implantable object in a subject. The method comprising (i) performing the method of any one of the above-described embodiments, or any combination thereof; and (ii) implanting said object in the subject. Yet another aspect of the present disclosure provides a kit for preparing an implantable object prior to implantation in a subject. The kit comprising: (i) one or more blood withdrawal devices for allowing withdrawal of blood from the subject; (ii) at least one coagulation initiator for mixing with the withdrawn whole blood for obtaining a mixture of whole blood and at least one coagulation initiator; and (iii) a receptacle device comprises a receiving volume for receiving said object and permitting a contact of said object with said mixture. In some embodiments of the kit, the receiving volume is defined by a contour of the receptacle device conforming with a contour of said implantable object. Typically, the implantable object is fitted into the receiving volume leaving a small gap between its external contour and the walls of the coagulation mold for allowing the filling of the mixture in said gap. In some embodiments, the kit further comprises one or more anti-coagulation agents. In some embodiments of the kit, said more anti-coagulation agents are selected from a group consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate. In some embodiments, the kit is intended for use in a method according to any one of the above-described embodiments, or any combination thereof. Yet another aspect of the present disclosure provides an implantable object intended to be implanted in a subject, wherein said implantable object comprises at least a portion coated with coagulated whole blood. In some embodiments of the implantable object, said whole blood is autologous blood of the subject. In some embodiments of the implantable object, a vast majority or the entire external surface of the implantable object is coated with said whole blood. In some embodiments of the implantable object, said whole blood comprises antibiotic agents. In some embodiments, the implantable object is being prepared for implantation according to the method of any one of the above-described embodiments, or any combination thereof.
BRIEF DESCRIPTION OF THE DRAWINGS In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which: Figs. 1A-1B are flow diagrams exemplifying different embodiments of the method for preparing an implantable device according to an aspect of the present disclosure.
DETAILED DESCRIPTION The following figures are provided to exemplify embodiments and realization of the invention of the present disclosure. Figs. 1A-1B are non-limiting examples of flow diagrams of different embodiments of a method for preparing an implantable device according to an aspect of the present disclosure. Fig. 1Aexemplifies a method that comprises withdrawing whole blood form the subject 100and contacting an implantable object with the whole blood 102 . Following the contact of the implantable object and the whole blood, the whole blood is allowed to be coagulated on the implantable object 104 . The coagulation of the blood can be initiated, e.g. by mixing the whole blood with one or more coagulation initiators, prior to the contact of the implantable object with the whole blood, requiring that the contact is made not long after the coagulation initiation. Alternatively, the initiation of the coagulation can be made while the implantable object contact the whole blood. Fig. 1Bexemplifies a method that comprises withdrawing whole blood form the subject 110 . The method further comprises placing an implantable object in a receptacle device 112that is shaped and sized to receive the implantable object while leaving space for filling blood such that it contacts all the portions that are desired to be coated with coagulated whole blood. The whole blood is mixed with one or more coagulation initiators 114and optionally with one or more antibiotic agents (namely, the antibiotic agents are not mandatory) to obtain a coagulation mixture. The method further comprises filling the receptacle device with the coagulation mixture 116 to allow contact of the mixture with portions or the entire external surface of the implantable device 116 and allowing the whole blood to coagulate on the implantable object 118 . It is to be noted that the method steps 110 , 112 , 114 , 116 , are interchangeable, namely the order of their appearance in the description is not binding and they can be performed in various different orders.