ASSEMBLY AND METHOD FOR THE PREPARATION OF A WOUND DRESSING

Abstract

The present disclosure provides a wound dressing assembly comprising (i) a blood-clotting mold device with a mold cavity for forming a molded blood clot for use in dressing a wound. Prior to extraction, the molded blood clot is pushed towards the mold cavity's interior, which causes the molded blood clot to disassociate from the cavity walls and thereafter it can be removed with none or only minimal damage to its integrity.

Claims

1.-33. (canceled)

34. An assembly for preparing a blood clot-comprising wound dressing, the assembly comprises a blood-clotting mold device having a mold cavity defined between walls of a main body and a removable closure over an opening and is configured for introduction of blood thereinto, a coagulation initiator in an amount sufficient to coagulate blood introduced into the enclosure to form a molded blood clot, and an auxiliary device configured for pushing the molded blood clot in a direction towards the interior of the mold cavity.

35. The assembly of claim 34, wherein said auxiliary device has a circumferential clot engaging member.

36. The assembly of claim 35, wherein said clot-engaging member has dimensions corresponding to those of the mold cavity for engaging the periphery of the molded blood clot.

37. The assembly of claim 35, wherein said member projects from a body of said device.

38. The dressing assembly of claim 34, wherein said coagulation initiator is comprised within the mold cavity, wherein at least one of the walls of the mold cavity and closure is pierceable by needle, and wherein the mold cavity contains a blood-clot support matrix.

39. A method for preparing a wound dressing, comprising: introducing a volume of blood into a mold cavity of a blood-clotting mold device; maintaining the blood within the enclosure for a time sufficient to permit clotting of the blood to thereby obtain a molded blood clot; removing said closure to open the mold cavity; pushing the molded blood clot in a direction towards the mold cavity's interior to thereby separate the molded blood clot's periphery from walls of the mold cavity; and extracting the blood clot from the mold cavity and combining it with a wound dressing material.

40. The method of claim 39, wherein said pushing is carried out with an auxiliary device configured for that purpose.

41. The method of claim 40, wherein said auxiliary device has a circumferential clot engaging member.

42. The method of claim 41, wherein said clot-engaging member has dimensions corresponding to those of the mold cavity for engaging the periphery of the molded blood clot.

43. The method of claim 41, wherein said member projects from a body of said device.

44. The method of claim 43, comprising combining the blood clot onto a dressing material.

45. The method of claim 41, wherein the mold cavity comprises a blood clot-support matrix and said clotting causes said matrix to become integrated within the molded blood clot, where said extracting comprises removal of the clot with said matrix, wherein at least one of (i) the walls of the mold cavity and (ii) the removable closure, is pierceable by a needle, and wherein said introducing comprises piercing at least one of the wall and closure and injecting the blood therethrough.

46. The method of claim 41, wherein the closure is a removable film, wherein the enclosure has the general shape of a blister, and wherein the enclosure is first pierced to form a vent and then the blood is injected.

47. A method for dressing a wound, comprising: introducing a volume of blood into a mold cavity of a blood-clotting mold device; maintaining the blood within the enclosure for a time sufficient to permit clotting of the blood to thereby obtain a molded blood clot; removing said closure to open the mold cavity; pushing the molded blood clot in a direction towards the mold cavity's interior to thereby separate the molded blood clot's periphery from walls of the mold cavity; extracting the blood clot from the mold cavity and combining it with a wound dressing material; and fixing the blood clot onto the wound.

48. The method of claim 47, wherein said pushing is carried out with an auxiliary device configured for that purpose.

49. The method of claim 48, wherein said auxiliary device has a circumferential annular, clot engaging member.

50. The method of claim 49, wherein said clot-engaging member has dimensions corresponding to those of the mold cavity for engaging the periphery of the molded blood clot.

51. The method of claim 48, wherein said member projects from a body of said device.

52. The method of claim 47, further comprising combining the blood clot onto a dressing material, wherein the mold cavity comprises a blood clot-support matrix and said extracting comprised removal of the clot with said matrix, wherein said fixing is with a dressing material, wherein the mold cavity comprises a blood clot-support matrix and said clotting cause said matrix to become integrated within the molded blood clot, and wherein said extracting comprises removal of the clot with said matrix.

53. The method of claim 47, wherein at least one of (i) the walls of the mold cavity and (ii) the removable closure, is pierceable by a needle, wherein said introducing comprises piercing at least one of the wall and closure and injecting the blood therethrough, wherein the closure is a film that is removably adhered to rims of the enclosure walls, wherein the enclosure has the general shape of a blister, and wherein the enclosure is first pierced to form a vent and then the blood is injected into the enclosure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0034] 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:

[0035] FIG. 1 is a picture of a bottom perspective view of a mold device, according to an embodiment of this disclosure, which is in the form of a blister.

[0036] FIG. 2A-2E show a drawings of an auxiliary device according to an embodiment of this disclosure including, respectively, a top perspective view, a bottom perspective view, a side view, a top view and a cross-section through lines A-A in in FIG. 2D.

[0037] FIGS. 3A and 3B are pictures of side perspective views showing the injection of blood into the mold cavity.

[0038] FIGS. 4A and 4B are shows the removal of the closure revealing the molded blood clot formed within the mold cavity.

[0039] FIG. 5A-5C shows the manner in which an auxiliary device, according to an embodiment of this disclosure, is used to push the molded blood clot towards the interior of the mold cavity to thereby free the molded blood clot from the walls of the mold cavity.

[0040] FIGS. 6A and 6B show the manner of extraction of the molded blood clot from the mold cavity.

DETAILED DESCRIPTION OF EMBODIMENTS

[0041] The embodiments illustrated in the annexed drawings include an enclosure in the form of a blister, which is an exemplary embodiment of the broader context of the present disclosure. Thus, this description of specific embodiments is intended for illustration of the more general principle of this disclosure and is not intended to be limiting. The disclosure of the specific embodiment below

[0042] Referring first to FIG. 1, shown is a picture of a mold device generally designated 100 and in the form of a blister, having a main body 102 with a depression constituting the mold cavity 104 and a flat rim 106. Fitted onto the rim is a removable closure 108 in the form of a laminate/film. Contained within the enclosure 100 is a coagulating initiator substance 110 which may be in the form of a liquid, powder, granulate, etc. Also contained in the enclosure is a blood clot-supporting (scaffold) matrix 112 which may be made of gauze, of a polymeric mesh, etc., held at its peripheral portions between the rim and the closure and having a central portion within the enclosure.

[0043] The mold device is part of an assembly, e.g. in the form of kits of parts, that comprises also an auxiliary device such as that illustrated in FIGS. 2A-2E. The assembly may also include other elements such as blood withdrawal components for extraction of venous blood from the patient, one or more syringes, one or needles, gauze or other dressing material, plasters, a container with a coagulation initiator in addition or in alternative to that comprised within the mold cavity (element 110). The coagulation initiator may, for example, be kaolin.

[0044] The auxiliary device 200 shown in FIGS. 2A-2E has an annular body 202 that can be held by the user; and an annular, clot-engaging member 204 projecting from body 202. Clot-engaging member 204 has dimensions corresponding to those of the mold cavity for engaging the periphery of the molded blood clot; namely the projections trace the periphery of mold cavity. As can be seen, body 202 defines planar shoulders 206 extending peripherally from the base of member 204 in FIG. 2C and member 204 extends essentially normal from the plane defined by shoulders 206. As can best be seen in FIG. 2E, the projection, is constituted by a flap internally folded to define a tapered end 208.

[0045] As can also be noted, the peripheral wall 210 of the clot-engaging member 204 is slightly slanted off a full normal orientation. The tapering, the flap-based structure and the slight off-normal orientation allow the clot-engaging member 204 to gently separate the molded blood clot formed within the mold cavity 104 from the cavities wall, while pushing it in the direction of the cavity's interior, with the flexibility to trace the converging walls of the mold cavity.

[0046] Blood, typically whole blood, is withdrawn and then injected into the mold cavity, as shown in FIGS. 3A and 3B. Specifically, a needle 120 of a syringe 122 that contains the whole blood pierces the closure 108 and blood is injected until it fills a significant portion of the enclosure, sufficient to cover the support matrix 112, as seen in FIG. 2B. It is possible, also, to initially pierce the closure so as to form a vent opening, e.g. by the blood injection needle, and inject the blood only subsequently. In some embodiments, a blood coagulation initiator is already a priori present in the mold cavity, as in the case of the embodiment of FIG. 1. In other embodiments, a coagulation initiator is introduced into the mold cavity before or after the introduction of the blood. The device is typically agitated to mix the blood and the coagulation initiator and is incubated for a time sufficient to permit blood coagulation and the formation of the molded blood clot. During incubation the mold device would be best placed on top of closure 108 to permit integration of the support matrix into the molded blood clot.

[0047] As can be seen in FIGS. 4A and 4B, after incubation, the closure 108 is removed revealing the molded blood clot 130, as best seen in FIG. 4B and FIG. 5A. The molded blood clot may be integrated with the support matrix, the peripheral portions of which 132 extend peripheral to the molded blood clot.

[0048] As can be seen in FIGS. 5A-5C, the auxiliary device 200, can then be taken (FIG. 5A) and pushed against the clot with the blood engaging member 210 facing the molded blood clot 130 (FIG. 5B) and after fully pushing the auxiliary device against the molded blood clot (FIG. 5C) the clot edges become separated from the walls of the mold cavity. As can be seen in FIGS. 6A and 6B, the molded blood clot 130 can then be removed from the mold cavity through the cavity's opening 140, by holding the matrix's peripheral portions 132.