Method and kit for treating a wound

Abstract

Wounds are treated by contacting the wound with a porous matrix made of a biodegradable material containing coagulating or coagulated whole blood, and maintaining the porous matrix in such contact for a time sufficient for induction of wound healing process.

Description

[0001] METHOD AND KIT FOR TREATING A WOUND

[0002] TECHNOLOGICAL FIELD

[0003] The present disclosure is generally in the field of wound treatment and particularly concerns a method and kit for treating a wound by using clotted blood.

[0004] BACKGROUND ART

[0005] Chronic wounds and skin ulcers are serious medical conditions and effective wound treatment approaches is a recognized medical need.

[0006] U.S. Pat. No. 9,180,142 discloses a wound treatment procedure by which blood is coagulated, and the so-formed blood clot is applied onto a wound with a dressing material.

[0007] U.S. Pub. No. 2024 / 0100091 discloses a method for treating abnormal hollowed spaces by using autologous blood.

[0008] Pub. WO 99 / 15209 describes a fibrin sponge containing blood clotting activators or proactivators and is used for hemostasis, tissue adhesion, and wound healing.

[0009] Pub. WO 2009 / 120432 describes a fibrin foam wound dressing created by mixing fibrinogen solution and thrombin solution with air.

[0010] Pub. WO 2010 / 086848 discloses wound dressings comprising sheets of clotted whole blood that are applied onto skin injuries and methods for preparing these dressings by collecting whole blood, allowing it to clot ex vivo and forming it into sheets, which may include embedded support structures such as gauze.

[0011] KUSHNIR I ET AL.: "Efficacy and Safety of aNovel Autologous Wound Matrix in the Management of Complicated, Chronic Wounds: A Pilot Study"; Wounds, vol. 28, no. 9, pages 317-27 (2016 / 09 / 30) discloses a study of an autologous whole blood clot product for treating chronic wounds.

[0012] RAM E ET AL.: "A Prospective, Single-Arm Study to Evaluate the Safety and Efficacy of an Autologous Blood Clot Product in the Treatment of Anal Fistula"; Dis Colon Rectum, vol. 67, no. 4, pages 541-548, (2023 / 12 / 27) examines using an autologous blood clot product for treating transsphincteric anal fistulas.

[0013] PERRONE GS ET AL.: "Bench-to-bedside: Bridge-enhanced anterior cruciate ligament repair"; J Orthop Res, vol. 35, no. 12, pages 2606-2612, DOI: 10.1002 / jor.23632 (2017 / 07 / 09) describes the development of a tissue engineering strategy to improve ACL healing and how a collagen-based scaffold combined with blood forms a provisional scaffold that enhances ACL healing in preclinical studies and its translation to clinical trials.

[0014] HAIM N ET AL.: "The Use of Active Coagulation Whole Blood- An Innovative Treatment Strategy for Hard-To-Heal Wounds"; Am Surg, vol. 90, no. 4, pages 710-716 (internal pages 1-7), DOI: 10.1177 / 00031348231207293 (2023 / 10 / 25) examines Active Coagulation Whole Blood (ACWB) treatment for challenging wounds.

[0015] The BEAR Implant by Miach Orthopedics (https: / / miachortho.com / healthcare- is a matrix made of a biocompatible material, primarily composed of a decellularized, bovine derived Type I collagen, that is soaked with blood and placed within the joint assisting in the ligament healing process.

[0016] GENERAL DESCRIPTION

[0017] The present disclosure concerns wound treatment through use of coagulated blood. Specifically provided, by embodiments of this disclosure, are wound treatment methods, kits-of-parts, systems and combinations for use in wound treatment. The wound to be treated may be selected from surface wounds, wound in a body cavity, cyst and fistulae.

[0018] The coagulated blood that is used according to this disclosure is typically formed from autologous blood, i.e. blood withdrawn from the same subject whose wound is to be treated by the teaching of this disclosure, withdrawn in any manner acceptable in medical practice for blood withdrawal. However, the use of blood from a different source, e.g. blood obtained from a blood bank, is also contemplated in accordance with this disclosure.

[0019] Throughout this disclosure, the term "whole blood" should be understood as referring to (i) blood taken from venous or arterial circulation; (ii) blood that has not been modified (except for the addition of an anticoagulant) by chemical or biological substances; (iii) blood from which there was no removal of one or more blood components (e.g. a portion of the plasma; or (vi) blood containing all its components, such as red and white blood cells, platelets and more, particularly all components required for clot formation. It should be noted that the term "whole blood" does not necessarily mean that the blood used as a source for the clotted blood is identical to the blood withdrawn from an individual. At times, the withdrawn blood may be subject to procedures such as dialysis, passage through a column, etc., to remove certain, e.g. undesired, components before being used in therapy for treating wounds according to this disclosure (an example is the removal of certain immunogenic or anti-sera components in the case of the use of non-autologous blood). Also, according to some exemplary embodiments of this disclosure, the whole blood is supplemented with one or more additives. Additives may include, but are not limited to, coagulation-inducing or otherwise influencing agents, physical property changing additives and medically active additives.

[0020] The term “wound” that is treatable according to this disclosure includes a surface wound on the skin or a skin ulcer (for example, pressure wounds or diabetic -related skin ulcer, such as diabetic foot ulcer), cyst such as pilonidal cyst, a fistula such as anal fistula or a wound in a body cavity such as in the rectum or vagina. The wound may be naturally occurring, wound resulting from an injury, wound resulting from disease processes, wounds occurring as a result of a surgery, etc.

[0021] Skin wounds treatable in accordance with this disclosure include all kinds of injuries of the skin where skin is missing or where the therapy targets, among others, skin re-growth. These include both non-bleeding wounds (e.g. bums and ulcers) and bleeding wounds (e.g. abrasions).

[0022] According to this disclosure, a porous matrix made of a biodegradable material with whole blood is contacted with the wound, namely placed onto (in the case of a skin wound, for example) or into (in the case of a cyst, fistula or body cavity) the wound.

[0023] The whole blood may, by some embodiments, be contacted with said matrix before the matrix is brought into contact with the skin.

[0024] By other embodiments, said matrix is first brought into contact with the wound and blood may then be introduced into the matrix, for example by instilling it onto the matrix from a syringe or injecting, e.g. through a needle attached to the syringe, into the matrix.

[0025] By some embodiments, the whole blood may be mixed prior to contact with said matrix with a coagulation-inducing agent (also referred to herein as "coagulationinducer") to initiate the blood coagulation process. Coagulation inducers are known in the art and this disclosure is not limited to any specific agents, and any such agent that is medically acceptable may be used. Examples are kaolin and calcium ions (e.g. in the form of calcium gluconate).

[0026] By other embodiments the coagulation may rely on the coagulation-inducing activity of said matrix, e.g. induced by the collagen in said matrix.

[0027] By yet other embodiments, said matrix may contain one or more coagulationinducers such as kaolin or calcium ion.

[0028] The matrix is typically shaped for the type of wound, for example may be generally planar in the case of a skin wound or having a space-fitting form in the case of a cyst or a fistula. The matrix may, by some embodiments, be a priori contacted with the blood, for example to be soaked thereby, and the blood-comprising matrix, either after a time period to permit the blood to coagulate or prior to complete coagulation, is then contacted with the wound. The matrix may be fixed onto the wound in the case of a surface wound on the skin or introduced into the wound in the case of a cyst or a fistula. By other embodiments the matrix is first contacted with the wound and then, for example using a syringe, the blood is instilled onto or into the matrix and the matrix may then be fixed in position.

[0029] Thus, according to one broad aspect of the present disclosure there is provided a method for treating a wound of a subject, comprising (i) contacting the wound with a porous matrix made of a biodegradable material containing coagulating or coagulated whole blood (the whole blood being optionally pre-mixed with one or more coagulationinducers), and (ii) maintaining said porous matrix in such contact for a time sufficient for induction of wound healing process.

[0030] As noted above, the wound to be treated may be selected from surface wounds, wound in a body cavity, cyst and fistulae.

[0031] Said biodegradable material, by one embodiment, is a collagen-comprising matrix.

[0032] Said biodegradable material, by one embodiment, is a collagen-based matrix, for example made of synthetically produced collagen.

[0033] Said biodegradable material, by one embodiment, is an extracellular matrix (ECM). ECM may be derived from tissue or organ (e.g. skin, heart, liver) that is harvested, from an animal or human cadaver, and may then be subjected to a process of decellularization, where cells are removed using detergents, enzymes or mechanical means for the purpose of leaving behind an ECM scaffold. The term "surface wound” is used herein to denote a wound formed on a skin surface (e.g. skin ulcer), or on the surface of a body cavity such an ulcer in a digestive tract.

[0034] In some embodiments, the porous matrix is maintained in contact with the wound for a period of several days.

[0035] In some embodiments, the method further comprises removing said porous matrix after a time period, e.g. after 1 week, and repeating steps (i) and (ii).

[0036] In some embodiments, said repeating is repeated several times, e.g. 2 to 20 times.

[0037] In some embodiments, the method comprises (a) withdrawing whole blood from a subject; (b) contacting the porous matrix with the withdrawn whole blood and allowing the whole blood to be absorbed in said porous matrix, and optionally permitting the absorbed blood to coagulate within said porous matrix (the whole blood being optionally pre-mixed with one or more coagulation-inducers); (c) bringing the matrix with the coagulating or coagulated blood into contact with the wound and, typically, fixing said porous matrix in this state (i.e. so that said matrix will be retained in its position in which it is in contact with the wound for a sufficient time period until it is removed or replaced by another blood-comprising matrix); and (d) maintaining said porous matrix in contact with the wound for a time sufficient for induction of wound healing process.

[0038] In some embodiments, step (b) above comprises (bl) transferring the withdrawn whole blood into a receptacle, and (b2) at least partially submerging the porous matrix in the whole blood within the receptacle.

[0039] In some embodiments, such a receptacle may be a dish or an enclosure with said porous matrix being a priori contained therein.

[0040] In some embodiments, the method comprises (a) withdrawing whole blood from a subject; (b) bringing the porous matrix into contact with the wound and thereafter instilling withdrawn whole blood (the whole blood being optionally pre-mixed with a one or more coagulation-inducers) onto the porous matrix to cause it to being absorbed in said matrix while maintaining said contact and, typically, fixing said porous matrix on the wound; and (c) maintaining said porous matrix in contact with the wound for a time sufficient for induction of wound healing process.

[0041] In some embodiments, the instilling comprises soaking the porous matrix with the whole blood. In other embodiments, the instilling comprises injecting the withdrawn whole blood onto or into the porous matrix. This may be achieved using a syringe and the blood may be instilled onto the matrix or a needle fitted onto the syringe may be inserted into the matrix and the blood may then be injected into the matrix.

[0042] In some embodiments, the matrix that is intended for fixing over a surface wound may comprise an attachment rim surrounding the porous matrix through which the matrix may be fixed onto skin portions surrounding the wound, e.g. using an adhesive on the skin-facing surfaces of the rim.

[0043] In some embodiments, the porous matrix has a planar configuration for application onto a surface wound or a skin ulcer.

[0044] In some embodiments, the porous matrix has an elongated cylinder-like configuration for application into a body cavity, pilonidal cyst or a fistula.

[0045] According to another broad aspect of the present disclosure there is provided a method for treating a wound in a body cavity, comprising inserting into the cavity a biodegradable porous matrix that comprises coagulated or coagulating blood and shaped for application into said body cavity. In the cavity, the matrix with the coagulated blood assumes contact with the wound and induces healing processes.

[0046] In some embodiments, the method comprises (a) withdrawing whole blood form a subject; (b) contacting the porous matrix with the withdrawn whole blood (the whole blood being optionally pre-mixed with one or more coagulation-inducers) and allowing the whole blood to be absorbed in said porous matrix; (c) permitting at least partial coagulation of the absorbed blood within the porous matrix; (d) introducing the porous matrix with the at least partially coagulated blood (optionally after compete coagulation) into the body cavity; and (e) maintaining the porous matrix within the body cavity.

[0047] In some embodiments, the body cavity is an anal fistula or a pilonidal cyst.

[0048] According to another broad aspect of the present disclosure, there is provided a kit of parts for use in a method described above.

[0049] In some embodiments, the kit of parts comprises (i) at least one porous matrix configured for application onto or into a wound or into a body cavity, (ii) one or more blood-collection receptacles configured for receiving whole blood withdrawn from a subject and for allowing contact between at least a portion of said porous matrix and the withdrawn whole blood to permit the blood to be absorbed into said matrix. In some embodiments, the kit of parts comprises (iii) one or more syringes for applying whole blood withdrawn from a subject onto the porous matrix in a manner to cause the porous matrix to absorb the whole blood.

[0050] In some embodiments, the kit of parts further comprises (iv) one or more blood withdrawal devices for allowing withdrawal of blood from a treated subject

[0051] EMBODIMENTS

[0052] The following numbered paragraphs describe optional embodiments of the present disclosure. Any combination of these embodiments is applicable in accordance with this disclosure:

[0053] 1. A method for treating a wound of a subject comprising (i) contacting the wound with a porous matrix made of a biodegradable material containing coagulating or coagulated whole blood, and (ii) maintaining said porous matrix in such contact for a time sufficient for induction of wound healing process.

[0054] 2. The method of embodiment 1, wherein said biodegradable material is a collagen- comprising matrix.

[0055] 3. The method of embodiment 2, wherein the matrix is a collagen matrix or an extracellular matrix.

[0056] 3A. The method of any one of embodiments 1 to 3, wherein the whole blood is mixed with one or more coagulation inducers prior to contact with said matrix.

[0057] 4. The method of any one of embodiments 1 to 3A, comprising removing said porous matrix after said period and repeating steps (i) and (ii).

[0058] 5. The method of any one of embodiments 1 to 4, comprising:

[0059] (a) withdrawing whole blood from a subject;

[0060] (b) contacting the porous matrix with the withdrawn whole blood and allowing the whole blood to be absorbed in said porous matrix;

[0061] (c) bringing the matrix with the absorbed blood into contact with the wound; and

[0062] (d) maintaining said porous matrix in contact with the wound for a time sufficient for induction of wound healing process.

[0063] 6. The method of embodiment 5, wherein (b) comprises permitting the absorbed blood to coagulate within said porous matrix before (c).

[0064] 7. The method of embodiments 5 or 6, wherein (c) comprises fixing said porous matrix such as to maintain contact with the wound. 8. The method of any one of embodiments 5 to 7, wherein (b) comprises:

[0065] (bl) transferring the withdrawn whole blood into a receptacle, and

[0066] (b2) at least partially submerging the porous matrix in the whole blood within the receptacle.

[0067] 9. The method of embodiment 8, wherein the receptacle is at least one of a dish or an enclosure with said porous matrix being a priori contained therein.

[0068] 9A. The method of embodiment 8 or 9, wherein the receptacle comprises one or more coagulation inducers that is mixed with the whole blood after its introduction into the receptacle (e.g. through agitation of the receptacle) or becomes mixed through the introduction process.

[0069] 9B. The method of any one of embodiments 1 to 9A, wherein said matrix comprises one or more coagulation inducers.

[0070] 10. The method of any one of embodiments 1 to 4, comprising:

[0071] (a) withdrawing whole blood from a subject;

[0072] (b) bringing the porous matrix into contact with the wound and thereafter instilling withdrawn whole blood onto the porous matrix to cause it to being absorbed in said matrix while maintaining said contact; and

[0073] (c) maintaining said porous matrix in contact with the wound for a time sufficient for induction of wound healing process

[0074] 11. The method of embodiment 10, wherein said biodegradable material is a collagen- comprising matrix.

[0075] 12. The method of embodiment 11, wherein the matrix is a collagen matrix or an extracellular matrix.

[0076] 13. The method of any one of embodiments 10 to 12, wherein (b) comprises fixing the matrix in its position.

[0077] 14. The method of any one of embodiments 10 to 13, wherein said instilling comprises soaking said porous matrix with the whole blood.

[0078] 15. The method of embodiment 14, wherein said instilling comprises injecting the withdrawn whole blood onto or into the porous matrix.

[0079] 16. The method of any one of the preceding embodiments, wherein the wound is selected from surface wounds, wound in a body cavity, cyst and fistulae.

[0080] 17. The method of any one of the preceding embodiments, wherein the porous matrix has a planar configuration for application onto a surface wound or a skin ulcer. 18. The method of any one of embodiments 1 to 16, wherein the porous matrix has an elongated cylinder-like configuration for application into a pilonidal cyst or a fistula.

[0081] 19. The method of any one of the preceding embodiments, wherein the whole blood is autologous whole blood.

[0082] 20. A method for treating a wound in a body cavity, comprising inserting into the body cavity a biodegradable porous matrix that comprises coagulated or coagulating blood and shaped for application into said body cavity.

[0083] 21. The method of embodiment 21, comprising:

[0084] (a) withdrawing whole blood from a subject;

[0085] (b) contacting the porous matrix with the withdrawn whole blood and allowing the whole blood to be absorbed in said porous matrix;

[0086] (c) permitting at least partial coagulation of the absorbed blood within the porous matrix;

[0087] (d) introducing the porous matrix with the at least partially coagulated blood into the body cavity; and

[0088] (e) maintaining the porous matrix within the body cavity.

[0089] 22. The method of embodiment 12, wherein said introducing is carried out prior to complete coagulation of the whole blood within said porous matrix.

[0090] 23. The method of any one of embodiments 21 to 23, wherein the body cavity is an anal fistula or a pilonidal cyst.

[0091] 24. A porous biodegradable matrix for use in combination with whole blood in treating a wound of a subject, the treatment is carried out by the method of any one of the preceding embodiments.

[0092] 25. A kit of parts for use in a method of any one of embodiments 1 to 23.

[0093] 26. The kit of parts of embodiment 25, comprising (i) at least one biodegradable porous matrix configured for application onto a surface wound or into a body cavity, (ii) one or more blood-collection receptacles configured for receiving whole blood, e.g. whole blood withdrawn from the subject, and for allowing contact between at least a portion of said porous matrix and the withdrawn whole blood to permit the blood to be absorbed into said matrix.

[0094] 27. The kit of parts of embodiment 25, comprising (i) at least one biodegradable porous matrix configured for application onto a surface wound or into a body cavity, and (iii) one or more syringes for instilling whole blood withdrawn from a subject onto the porous matrix in a manner to cause the porous matrix to absorb the whole blood.

[0095] 27 A. The kit of parts of any one of embodiments 25 to 27, comprising one or more coagulation inducers for mixing with the whole blood.

[0096] 27B. The kit of parts of embodiment 27A, wherein said one or more coagulation inducers are comprised in a blood-collection receptacle configured for receiving the whole blood and for allowing contact between at least a portion of said porous matrix and the withdrawn whole blood to permit the blood to be absorbed into said matrix; when the whole blood is introduced into the receptacle it is first permitted to mix with the least one blood coagulation agent.

[0097] 27C. The kit of parts of any one of embodiments 25 to 27B, wherein said matrix comprises one or more coagulation inducers.

[0098] 28. The kit of parts of any one of embodiments 25 to 27C, comprising (iv) one or more blood withdrawal devices for allowing withdrawal of blood from a treated subject.

[0099] 29. A combination or system for use in a method if any one of claims 1 to 23.

[0100] 30. The combination or system of embodiment 29, comprising (i) at least one biodegradable porous matrix configured for application onto a surface wound or into a body cavity, (ii) one or more blood-collection receptacles configured for receiving whole blood withdrawn from a subject and for allowing contact between at least a portion of said porous matrix and the withdrawn whole blood to permit the blood to be absorbed into said matrix.

[0101] 31. The combination or system of embodiment 29, comprising (i) at least one biodegradable porous matrix configured for application onto a surface wound or into a body cavity, and (iii) one or more syringes for instilling whole blood withdrawn from a subject onto the porous matrix in a manner to cause the porous matrix to absorb the whole blood.

[0102] 32. The combination of any one of embodiments 29 to 31, comprising (iv) one or more blood withdrawal devices configured for withdrawing blood from a treated subject.

[0103] 33. The combination of any one of embodiments 29 to 32, comprising one or more coagulation inducers for mixing with the whole blood. 34. The combination of embodiment 33, wherein said one or more coagulation inducers are comprised in a blood-collection receptacle configured for receiving the whole blood and for allowing contact between at least a portion of said porous matrix and the withdrawn whole blood to permit the blood to be absorbed into said matrix; when the whole blood is introduced into the receptacle it is first permitted to mix with the least one blood coagulation agent.

[0104] 35. The combination of any one of embodiments 29 to 34, wherein said matrix comprises one or more coagulation inducers.

[0105] BRIEF DESCRIPTION OF THE DRAWINGS

[0106] 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:

[0107] Figs. 1A and IB schematically illustrate a method for treating a surface wound according to some embodiments of the present disclosure;

[0108] Figs. 2A to 2C exemplify different stages of a method for treating a surface wound according to some embodiments of the present disclosure;

[0109] Fig. 2D shows a different example for treating a surface wound according to some embodiments of the present disclosure;

[0110] Fig. 3 is a flow diagram of a method for treating a wound according to some embodiments of the present disclosure;

[0111] Fig. 4 exemplifies a method for treating a wound in a body cavity according to some embodiments of the present disclosure; and

[0112] Fig. 5 is a flow diagram of a method for treating a wound in a body cavity according to some embodiments of the present disclosure.

[0113] DETAILED DESCRIPTION

[0114] One or more specific and / or alternative embodiments of the present disclosure will be described below with reference to the drawings, which are to be considered in all aspects as illustrative only and not restrictive in any manner. It shall be apparent to one skilled in the art that these embodiments may be practiced without such specific details. To provide a concise description of these embodiments, not all features or details of an actual implementation are described at length in the specification. Elements illustrated in the drawings are not necessarily to scale, or in correct proportional relationships, which are not critical. Emphasis is instead being placed upon clearly illustrating the principles of the disclosure such that persons skilled in the art will be able to make and use once they understand its features. This disclosure may be provided in other specific forms and embodiments without departing from the essential characteristics described herein.

[0115] The method of the present disclosure is directed to treating different wounds, for example surface wounds and wounds in body cavities of a subject. To this end, a biodegradable porous matrix shaped for the type of wound to be treated is being used. For example, the porous matrix may be generally planar in the case of skin wounds or shaped to fit into a cyst or a fistula. The method first requires obtaining whole blood, for example autologous whole blood withdrawn from the subject in any known method.

[0116] In some embodiments, after the blood is obtained it can be contacted with the porous matrix and thereby absorbed. The absorbed blood is thereafter allowed to coagulate to form a blood clot in the porous matrix. In the next stage, the porous matrix containing the coagulated blood is placed on the wound to establish contact therewith. In other embodiments, the matrix with the withdrawn blood can be prepared a priori and then contacted with the wound. The matrix is then maintained in contact with the wound for a time required to complete the healing process of the wound.

[0117] Reference is made to Fig. 1A and IB illustrating an exemplary embodiment 10 of the present disclosure in which a portion of a skin surface 11 of a subject, including a wound, is covered with a porous biodegradable matrix 12 (e.g., a collagen-comprising matrix) with coagulated blood prepared specifically for inducing a healing process of the wound. The coagulation of the whole blood in the porous matrix 12 can be carried out in advance, before mounting the porous matrix 12 on the skin surface 11, i.e., before the porous matrix 12 is in contact with the wound, or alternatively, coagulation of the whole blood in the porous matrix 12 may be allowed at the treatment area once the porous matrix 12 is brought to be in contact with the wound. The porous matrix 12 is maintained on the skin surface 11 in contact with the wound for a time sufficient for induction of the wound healing process. In some embodiments, the porous matrix 12 includes rim 12p surrounding it and adapted for attachment (e.g. through a proper adhesive on its skinbearing face) of the porous matrix 12 to skin portions around the wound.

[0118] Alternatively, or additionally, as shown in Fig. IB, to fix the porous matrix 12 to the wound, the porous matrix 12 may be dressed by a suitable dressing material 12g such as a gauze or any other material suitable or commonly used for dressing wounds.

[0119] Reference is made to Figs. 2A to 2D and to the flow diagram of Fig. 3 exemplifying different stages of a wound treatment method 100 according to some possible embodiment of the present disclosure. As shown, in Fig. 2A, the treatment method 100 commences by withdrawing (step 101) blood, typically whole blood, from a subject. As shown, in this non-limiting example this is carried out by an intravenous catheter 20, however this can be performed by any blood withdrawing manner known in the art (e.g., using a syringe). In Fig. 2B, the porous matrix 12 can be contacted (step 102A) with the withdrawn whole blood for allowing the whole blood to be absorbed in the porous matrix 12. Prior to contacting the withdrawn blood and the porous matrix 12, the withdrawn blood may be transferred (step 103A) into a receptacle 22, e.g., a dish. However, as can be appreciated a dish is but an example and other receptacles, such as that disclosed in WO 2019 / 058373, the relevant portion of which being incorporated herein by reference. In case of a sealed receptacle such as that of WO 2019 / 058373, the matrix may be a priori contained in said receptacle.

[0120] In some embodiments, the contact between the withdrawn blood and the porous matrix 12 is implemented by at least partially submerging (step 104A) the porous matrix 12 in the whole blood within the receptacle 22. The method further includes permitting (step 105A) the absorbed blood to coagulate within the porous matrix 12 until a clot is formed therein. As shown in Fig. 2C, once the blood in the porous matrix 12 is coagulated, the porous matrix 12 with the coagulated blood brought to brought to (step 106A) the wound W and can be fixed (step 107A) thereon to maintain contact with wound W.

[0121] Alternatively, before or after the blood is withdrawn from the subject (step 101), as shown in Fig. 2D, the porous matrix 12 can be brought into contact (step 102B) with the wound W and can be fixed (step 107B) thereon to maintain contact with the wound W. Thereafter, the withdrawn blood can be instilled (step 103B) on the porous matrix 12 to cause it to be absorbed thereby while the porous matrix 12 is maintained in contact with the wound W. This can be carried out for example by soaking the porous matrix 12 with the withdrawn blood or by injecting the withdrawn blood into the porous matrix 12 by any suitable means such as syringe 14. After the porous matrix 12 with the whole blood is in contact with the wound W, the method 100 further comprises maintaining (step 108) said matrix in contact with the wound W for a time sufficient for induction of the wound W healing process.

[0122] Reference is made to Fig. 4 and to the flow diagram of Fig. 5 exemplifying a method 200 for treating a wound in a body cavity (e.g., a cyst or a fistula) according to some possible embodiment of the present disclosure. Fig. 3 shows the initial pathology of the subject having an anal fistula FIS and a porous matrix 12a comprising coagulated or coagulating blood and shaped for application into the body cavity, namely the anal fistula FIS. In this non-limiting example, the porous matrix 12a has a generally elongated cylinder-like configuration.

[0123] The method includes withdrawing (step 201) whole blood from a subject and contacting (step 202) the porous matrix 12a with the withdrawn whole blood and allowing a whole blood to be absorbed in the porous matrix 12a. Then, permitting (step 203) partial coagulation of the absorbed blood within the porous matrix 12a (namely when the blood is still in a flowable state) and introducing / inserting the porous matrix 12a with the partially coagulated blood into the body cavity FIS. Finally, when the porous matrix 12a is situated inside the body cavity FIS, the method 200 includes permitting complete coagulation of the whole blood while maintaining the porous matrix 12a within the body cavity FIS.

[0124] Relative terms such as "lower," "upper," "horizontal," "vertical," "above," "below," "up," "down," "top" and "bottom", as well as derivatives thereof (e.g., "horizontally," "downwardly," "upwardly," etc.), and similar adjectives in relation to orientation of the described elements / components refer to the manner in which the illustrations are positioned on the paper, not as any limitation to the orientations in which these elements / components can be used in actual applications.

[0125] It should also be understood that throughout this disclosure, where a process or method is shown or described, the steps / acts of the method may be performed in any order and / or simultaneously, and / or with other steps / acts not illustrated / described herein, unless it is clear from the context that one step depends on another being performed first. In possible embodiments not all the illustrated / described steps / acts are required to carry out the method. While particular embodiments of this disclosure have been described, it will be understood, however, that the disclosure is not limited thereto, since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. As will be appreciated by the skilled person, the disclosure can be carried out in a great variety of ways, employing more than one technique from those described above, all without exceeding the scope of the claims.

Claims

CLAIMS:

1. A method for treating a wound of a subject comprising (i) contacting the wound with a porous matrix made of a biodegradable material containing coagulating or coagulated whole blood, and (ii) maintaining said porous matrix in such contact for a time sufficient for induction of wound healing process.

2. The method of claim 1, wherein said biodegradable material is a collagen- comprising matrix.

3. The method of claim 2, wherein the matrix is a collagen matrix or an extracellular matrix.

4. The method of any one of claims 1 to 3, comprising removing said porous matrix after said period and repeating steps (i) and (ii).

5. The method of any one of claims 1 to 4, comprising:(a) withdrawing whole blood from a subject;(b) contacting the porous matrix with the withdrawn whole blood and allowing the whole blood to be absorbed in said porous matrix;(c) bringing the matrix with the absorbed blood into contact with the wound; and(d) maintaining said porous matrix in contact with the wound for a time sufficient for induction of wound healing process.

6. The method of claim 5, wherein (b) comprises permitting the absorbed blood to coagulate within said porous matrix before (c).

7. The method of claims 5 or 6, wherein (c) comprises fixing said porous matrix in such a manner so as to maintain contact with the wound.

8. The method of any one of claims 5 to 7, wherein (b) comprises:(bl) transferring the withdrawn whole blood into a receptacle, and(b2) at least partially submerging the porous matrix in the whole blood within the receptacle.

9. The method of claim 8, wherein the receptacle is at least one of a dish or an enclosure with said porous matrix being a priori contained therein.

10. The method of any one of claims 1 to 4, comprising:(a) withdrawing whole blood from a subject;(b) bringing the porous matrix into contact with the wound and thereafter instilling withdrawn whole blood onto the porous matrix to cause it to being absorbed in said matrix while maintaining said contact; and(c) maintaining said porous matrix in contact with the wound for a time sufficient for induction of wound healing process11. The method of claim 10, wherein said biodegradable material is a collagen- comprising matrix.

12. The method of claim 11, wherein the matrix is a collagen matrix or an extracellular matrix.

13. The method of any one of claims 10 to 12, wherein (b) comprises fixing the matrix in its position.

14. The method of any one of claims 10 to 13, wherein said instilling comprises soaking said porous matrix with the whole blood.

15. The method of claim 14, wherein said instilling comprises injecting the withdrawn whole blood onto or into the porous matrix.

16. The method of any one of the preceding claims, wherein the wound is selected from surface wounds, wound in a body cavity, cyst and fistulae.

17. The method of any one of the preceding claims, wherein the porous matrix has a planar configuration for application onto a surface wound or a skin ulcer.

18. The method of any one of claims 1 to 16, wherein the porous matrix has an elongated cylinder-like configuration for application into a pilonidal cyst or a fistula.

19. The method of any one of the preceding claims, wherein the whole blood is autologous whole blood.

20. A method for treating a wound in a body cavity, comprising inserting into the body cavity a biodegradable porous matrix that comprises coagulated or coagulating blood and shaped for application into said body cavity.

21. The method of claim 20, comprising:(a) withdrawing whole blood from a subject;(b) contacting the porous matrix with the withdrawn whole blood and allowing the whole blood to be absorbed in said porous matrix;(c) permitting at least partial coagulation of the absorbed blood within the porous matrix;(d) introducing the porous matrix with the at least partially coagulated blood into the body cavity; and(e) maintaining the porous matrix within the body cavity.

22. The method of claim 12, wherein said introducing is carried out prior to complete coagulation of the whole blood within said porous matrix.

23. The method of any one of claims 20 to 22, wherein the body cavity is an anal fistula or a pilonidal cyst.

24. A porous biodegradable matrix for use in combination with whole blood in treating a wound of a subject, the treatment being carried out by the method of any one of the preceding claims.

25. A kit of parts for use in a method of any one of claims 1 to 23.

26. The kit of parts of claim 25, comprising (i) at least one biodegradable porous matrix configured for application onto a surface wound or into a body cavity, (ii) one or more blood-collection receptacles configured for receiving whole blood withdrawn from a subject and for allowing contact between at least a portion of said porous matrix and the withdrawn whole blood to permit the blood to be absorbed into said matrix.

27. The kit of parts of claim 25 or 26, comprising (iii) one or more syringes for instilling whole blood withdrawn from a subject onto the porous matrix in a manner to cause the porous matrix to absorb the whole blood.

28. The kit of parts of any one of claims 25 to 27, comprising (iv) one or more blood withdrawal devices for allowing withdrawal of blood from a treated subject.

29. A combination or system for use in the method according to any one of claims 1 to 23.

30. The combination or system of claim 29, comprising (i) at least one biodegradable porous matrix configured for application onto a surface wound or into a body cavity, (ii) one or more blood-collection receptacles configured for receiving whole blood withdrawn from a subject and for allowing contact between at least a portion of said porous matrix and the withdrawn whole blood to permit the blood to be absorbed into said matrix.

31. The combination or system of claim 29, comprising (i) at least one biodegradable porous matrix configured for application onto a surface wound or into a body cavity, and (iii) one or more syringes for instilling whole blood withdrawn from a subject onto the porous matrix in a manner to cause the porous matrix to absorb the whole blood.

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