Blood extraction

Abstract

To provide a system for forming blood clot-based wound dressing, and a binding device.SOLUTION: A system for forming blood clot-based wound dressing comprises: a blood-sampling test tube having an elastic stopper; a blood clot forming device defining a forming space in which a blood clot support matrix is in the space; a fluid propulsion device; a first binding member and a second tube binding member for being bound to the test tube; and a binding device having fluid conduits defined in binding device, which include at least one first fluid conduit extending between a first distal end in the first binding member and a first proximal end at an end of a first proximal elongate element, and at least one second fluid conduit extending between a second distal end at an end of a distal elongate element and a second proximal end at an end of an elongate element.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to methods and systems for the preparation of blood clot-based wound dressings, and kits of parts of such systems, and devices useful in such methods and systems.

Background Art

[0002] References considered relevant as background to the subject matter of the present disclosure are listed below. U.S. Patent No. 9,180,142 U.S. Patent No. 10,111,979 International Publication No. 2019 / 058375 International Publication No. 2019 / 150355

[0003] Approval of the above references in this specification should not be construed as any presumption that they are relevant to the patentability of the subject matter of the present disclosure.

[0004] U.S. Patent Nos. 9,180,142 and 10,111,979 disclose wound treatment procedures by which blood is coagulated and the blood clot thus formed is applied over a wound with a dressing material. PCT Publication International Publication Nos. 2019 / 058373, 2019 / 058375 and 2019 / 150355 disclose methods, devices and systems for dressing a wound with a dressing containing a blood clot. Dressings containing blood clots are typically prepared from blood taken from a patient. Since the blood sample withdrawn is relatively small (compared to the amount of blood donated to a blood bank), e.g., 10 - 20 mL, the blood sample is typically drawn into a type of vacutainer (an evacuated test tube sealed by an elastic stopper, typically a rubber stopper) used in blood tests and then needs to be withdrawn from the vacutainer. Since the tube is sealed, it is typically difficult to draw blood out with a syringe as it requires counteracting the vacuum inside the tube.

Summary of the Invention

[0005] The present disclosure provides a method and system for the preparation of a blood clot-based wound dressing. By the method and system, a fluid, typically a gas such as air, is propelled through one conduit into a sealed test tube containing blood, and at the same time, the blood is enabled to flow out of the test for through a second conduit, whereby it is transferred into a blot mass forming space, where the blood is enabled to coagulate to form a blood clot in the shape defined by the forming space. The propelling fluid is typically air propelled to flow through the first conduit by a syringe. The present disclosure also provides a coupling device useful in the method and system, and a kit of parts comprising the elements necessary to carry out the method of the present disclosure.

[0006] According to the method for forming a blood clot-based wound dressing of the present disclosure, blood is first accumulated in a test tube with an opening sealed by an elastic stopper (e.g., a rubber stopper). This test tube is typically a vacutainer that maintains a vacuum seal inside the tube, and this vacuum is the propelling force for drawing blood into the test tube. Next, the blood needs to be transferred from the test tube to the blood forming space of the forming device, where the blood coagulates, and in this process, the blood is enabled to integrate with a support matrix (which can be a wound dressing material such as gauze) contained within the space to form a blood clot-based wound dressing.

[0007] The transfer of blood from the test tube to the forming space is by allowing a fluid (e.g., a gas) to propel the fluid through at least one first conduit extending between a first distal end and a first proximal end within the test tube through the stopper and into the tube, while simultaneously allowing the blood to flow out of the tube through at least one second conduit between a second proximal end and a second distal end within the tube. The blood exiting the second distal end is then channeled to the forming space and collected therein.

[0008] According to one embodiment, prior to the propelling and the collecting, at least one first proximal elongate element defining a proximal section of the first conduit and at least one second proximal elongate element defining a proximal section of the second conduit are inserted into the stopper, thereby establishing fluid communication between the first conduit and the second conduit and the interior of the test tube.

[0009] According to one embodiment, each of the elongate elements has a sharp tip for piercing the stopper.

[0010] According to one embodiment, the coupling device is used with the conduits defined within the coupling device. The elongate elements project from the device at the test tube coupling member of the device, and upon proximity and engagement of the test tube with this coupling member, the elongate elements penetrate the stopper to establish the fluid communication.

[0011] The tube coupling member may comprise a generally cylindrical container having an opening and a closed end, and the proximal elongate element projects from the tube coupling member into the container. For engagement, the test tube is introduced into the container with the stopper facing the end wall of the cylindrical test tube container, and when the test tube is introduced into the container, after complete insertion of the test tube into the container, the two elongate elements penetrate the stopper.

[0012] The coupling device also typically comprises a syringe coupling member for coupling the syringe to the first distal end so as to enable the fluid to be propelled into the first conduit from the syringe.

[0013] The second distal end is typically at the end of a tubular projection configured to penetrate the wall of the shaping space. According to some embodiments, the second conduit may be constructed of a metal tube integrated into the coupling device, with one end protruding from the tube coupling member and the other end protruding in another (typically, opposite) direction.

[0014] The first proximal elongate element is typically longer than the second proximal elongate element. The second proximal elongate element is typically dimensioned such that after being inserted into the stopper, the second proximal end of the second proximal elongate element is adjacent to the stopper inside the test tube. Thus, after coupling, the test tube may be positioned such that the stopper-fitting end of the test tube is at the bottom of the test tube, whereby blood accumulates at that end and is propelled into the tube through the first conduit when the propelling fluid is propelled in, whereby the blood flows out through the second conduit into the blood shaping space. The arrangement may also be different, the second proximal elongate element being longer than the first proximal elongate element and optionally dimensioned to extend substantially the entire length of the test tube, in which case, after such coupling, the test tube is positioned such that the stopper-fitting end of the test tube is at the top.

[0015] The method comprises (i) coupling the first distal end to the syringe, (ii) inserting the two proximal ends through the stopper into the test tube such that the two proximal ends enter the test tube, (iii) inserting the second distal end into the wall of the shaping space, (iv) transferring blood from the test tube to the shaping space and collecting the blood in the shaping space by pushing air into the first conduit by means of the syringe, (V) Subsequently to said collection, maintain the shaping device so that the blood is in contact with the matrix for a time sufficient for the blood to coagulate, thereby obtaining a wound dressing comprising a blood clot integrated with the matrix. may comprise.

[0016] Steps (i), (ii) and (iii) may be carried out in said order or in any other order.

[0017] The shaping space may be of the kind disclosed in published PCT application WO 2019 / 058373, the shaping space being an enclosure defined between walls constructed by a body and a removable planar closure on an opening, the matrix being adjacent to the closure. Said maintaining may comprise placing the shaping device on the planar closure of the shaping device.

[0018] The second distal end may have a tip configured to penetrate the wall of the shaping space, and prior to the transfer of blood, the wall portion is penetrated by the tip. Prior to the transfer of blood, during the transfer of blood or subsequent to the transfer of blood, a coagulation initiator may be introduced into the shaping space. The coagulation initiator may be a powder or granular substance and may comprise kaolin and / or a calcium salt (e.g., calcium gluconate).

[0019] The system of the present disclosure comprises a blood collection test tube having an elastic stopper (e.g., a vacutainer), a fluid propulsion device, a shaping device, and a coupling device. The shaping device comprises a blood shaping space having a blood clot support matrix. The fluid propulsion device may be any device such as a pressurized gas canister or a coupling arrangement for a central pressurized gas source. According to one embodiment, the fluid propulsion device is a syringe and the propulsion fluid is air.

[0020] The system also includes a coupling device having a first coupling member, a second tube coupling member for coupling to the test tube, and a fluid conduit defined within the device. The fluid conduit includes at least one first fluid conduit extending between a first distal end within the first coupling member and a first proximal end at an end of the first proximal elongate element, and at least one second fluid conduit extending between a second distal end at an end of the distal elongate element and a second proximal end at an end of the proximal elongate element. The first proximal elongate element and the second proximal elongate element project from the device at the tube coupling member and are configured to penetrate the stopper. After such penetration, fluid communication is established between the conduit and the interior of the test tube. A distal elongate element configured to penetrate through the wall of the forming space and thereby establish fluid communication between the conduit and the interior of the test tube. A first coupling member configured to couple to a fluid propulsion device to enable propulsion of fluid through the first distal end and into the first conduit. The first coupling member typically has a female luer fitting for coupling to a male luer fitting of a syringe.

[0021] As described above, the present disclosure also provides a kit of parts of the system, as well as a coupling device useful in the method and system.

[0022] Embodiments The following numbered paragraphs enumerate embodiments of the present disclosure. These embodiments, presented in the form of claims, are intended to augment the above general description.

[0023] 1. A method for forming a blood clot-based wound dressing, comprising: accumulating a volume of blood in a test tube with an opening sealed by an elastic stopper (e.g., a rubber stopper); transferring the blood from the test tube to a forming space of a blood clot forming device, wherein a blood clot support matrix (e.g., a wound dressing material such as gauze) is within the space, and the transferring A fluid (e.g., a gas) is propelled through at least one first conduit that extends between a first distal end and a first proximal end within the tube through a stopper so that the fluid enters the tube, and at the same time, blood is enabled to flow out of the tube through at least one second conduit between a second proximal end and a second distal end within the tube, collecting blood emerging from the second distal end into the shaping space including transferring enabling the blood to clot while in contact with the matrix, thereby obtaining a wound dressing including a blood clot integrated with the matrix A method including transferring an amount of blood to a shaping space of a blood clot forming device, wherein a blood clot supporting matrix is within the space enabling the blood to clot while in contact with the matrix, thereby obtaining a wound dressing including a blood clot integrated with the matrix A method for forming a blood clot-based wound dressing including transferring, wherein the transferring accumulating a volume of blood in a test tube sealed by an elastic stopper (e.g., a rubber stopper) A fluid (e.g., a gas) is propelled through a first conduit that extends between a first distal end and a first proximal end of at least one first conduit within the tube through a stopper so that the fluid enters the tube, and at the same time, blood is enabled to flow out of the tube through a second conduit between a second proximal end and a second distal end of at least one second conduit within the tube collecting blood emerging from the second distal end into the shaping space A method including 3. The method according to embodiment 1 or 2, wherein the propelling is by a syringe coupled to the first distal end. 4. Before the propelling and the collecting, the method The method according to any one of Embodiments 1 to 3, comprising inserting at least one first proximal elongate element defining a proximal section of the first conduit and at least one second proximal elongate element defining a proximal section of the second conduit into a stopper. 5. Each of the elongate elements has a sharp tip for penetrating the stopper. The method according to Embodiment 4. 6. Said inserting comprises engaging the stopper with a pipe coupling member of the device comprising the elongate element protruding from the coupling device, whereby the element penetrates the stopper. The method according to Embodiment 4 or 5. 7. The pipe coupling member comprises a generally cylindrical container having an opening and a closed end, the proximal elongate element protrudes from the pipe coupling member into the container, and the method comprises introducing a test tube into the container with the stopper facing the end wall of the cylindrical test tube container, and when the test tube is introduced into the container, after complete insertion of the test tube into the container, the two elongate elements penetrate the stopper. The method according to Embodiment 6. 8. The method according to Embodiment 6 or 7, wherein the coupling device comprises a syringe coupling member for coupling a syringe to the first distal end to enable fluid to be propelled so that fluid enters the first conduit from the syringe. 9. The method according to any one of Embodiments 6 to 8, wherein the second distal end is at the end of a tubular protrusion configured to penetrate the wall of the forming space. 10. The method according to any one of Embodiments 6 to 9, wherein the second conduit is constructed by a metal tube integrated with the coupling device, one end protrudes from the pipe coupling member, and the other end protrudes in another (typically, opposite) direction. 11. The method according to any one of Embodiments 4 to 10, wherein the first proximal elongate element is longer than the second proximal elongate element. 12. The method comprises coupling the first distal end to a syringe Inserting the two proximal ends such that the two proximal ends enter the test tube through the stopper; inserting the second distal end into the wall of the shaping space; transferring blood from the test tube to the shaping space by pushing air into the first conduit by means of a syringe and collecting the blood in the shaping space; subsequent to the collecting, maintaining the shaping device such that the blood is in contact with the matrix for a time sufficient for the blood to clot, thereby obtaining a wound dressing comprising a blood clot integrated with the matrix; The method according to any one of Embodiments 1 to 11, comprising: 13. The shaping space is an enclosure defined between a body and a wall constructed by a removable planar closure on the opening, and the matrix is adjacent to the closure; The maintaining includes placing the shaping device on the planar closure of the shaping device; The method according to Embodiment 12. 14. The second distal end has a tip configured to penetrate the wall of the shaping space; The inserting includes the tip penetrating the wall of the enclosure; The method according to Embodiment 11 or 12. 15. The method according to any one of Embodiments 1 to 14, wherein the method includes introducing a clotting initiator into the shaping space. 16. The introducing is before, simultaneous with, or after the collecting according to Embodiment 15. 17. The method according to Claim 16, wherein the clotting initiator is a powder or granular substance that is introduced separately or that is present a priori in the space before the transfer. 18. The method according to Embodiment 17, wherein the clotting initiator includes kaolin and a calcium salt (e.g., calcium gluconate). 19. The method according to any one of Embodiments 1 to 18, wherein the test tube is a vacutainer. 20. A blood collection test tube (e.g., a Vacutainer) having an elastic stopper, A blood clot forming device that defines a forming space, wherein a blood clot support matrix is within the space, A fluid propulsion device, A first coupling member and a second tube coupling member for coupling to the test tube, A fluid conduit defined within the coupling device, including at least one first fluid conduit extending between a first distal end within the first coupling member and a first proximal end at an end of a first proximal elongate element, and at least one second fluid conduit extending between a second distal end at an end of the distal elongate element and a second proximal end at an end of the elongate element. A coupling device having A system for forming a blood clot-based wound dressing, comprising A first proximal elongate element and a second proximal elongate element are configured to project from the device at the tube coupling member and penetrate the stopper, The distal elongate element is configured to penetrate the wall of the forming space, The first coupling member is configured to couple to the fluid propulsion device such that the propulsion device is capable of propelling fluid such that the fluid enters the first conduit through the first distal end. System. 21. The system according to embodiment 20, wherein the propulsion device is a syringe. 22. The system according to embodiment 21, wherein each of the proximal elongate elements has a sharp (e.g., needle-like) tip for penetrating the stopper. 23. The tube coupling member comprises a generally cylindrical container having an opening and a closed end, and the proximal elongate element projects into the container from the tube coupling member. The system according to embodiment 21 or 22. 24. The system according to any one of embodiments 20 to 23, wherein the second conduit is constructed by a metal tube integrated with the coupling device, the proximal section is the second proximal elongate element, and the distal section projects in another (typically, opposite) direction. 25. The system according to any one of embodiments 20 to 24, wherein the first proximal elongate element is longer than the second proximal elongate element. 26. The system according to any one of embodiments 20 to 25, comprising the coupling device. 27. The shaping space is an enclosure defined between a wall constructed by a main body and a removable planar closure onto an opening, and the matrix is adjacent to the closure. The system according to any one of embodiments 20 to 26. 28. The system according to any one of embodiments 20 to 27, wherein the shaping space contains a solidification initiator. 29. The system according to embodiment 28, wherein the solidification initiator is a powder or granular substance. 30. The system according to embodiment 29, wherein the solidification initiator contains kaolin and a calcium salt (e.g., calcium gluconate). 31. A first coupling member configured to couple with a fluid propulsion device, and a second coupling member configured to couple with a stopper-sealed test tube. A fluid conduit defined within the coupling device. At least one first fluid conduit extending between a first distal end within the first coupling member and a first proximal end formed at an end of the first proximal elongate element, and at least one second fluid conduit extending between a second distal end at an end of the distal elongate element and the second proximal elongate element. A coupling device comprising: The first proximal elongate element and the second proximal elongate element are configured to project from the device at the tube coupling member and penetrate through the test tube's stopper. When the coupling of the first coupling member with the propulsion device enables fluid communication between the syringe and the first distal end, whereby when the coupling device couples the propulsion device and the test tube filled with liquid, the operation of the propulsion device propels the fluid such that the fluid enters the first conduit, whereby then the liquid is discharged from the test tube through the second conduit Coupling device. 32. The coupling device according to embodiment 31, wherein the propulsion device is a syringe. 33. The coupling device according to embodiment 31 or 32, wherein the elongated elements each have a sharp tip for penetrating the stopper. 34. The coupling device according to any one of embodiments 31 to 33, wherein the first coupling member has a female luer fitting for coupling with a male luer fitting of the syringe. 35. The second coupling member includes a generally cylindrical container having an opening and a closed end, and the proximal elongated element projects into the container from the second coupling member, the cylindrical container is configured to receive the stopper fitting end of the test tube such that two proximal elongated elements penetrate the stopper and the proximal ends of the two proximal elongated elements enter the tube. The coupling device according to any one of embodiments 31 to 34. 36. The coupling device according to any one of embodiments 31 to 35, wherein the second conduit is constructed by a metal tube integrated with the coupling device, one section at one end constructs the second proximal elongated element, and the opposite section constructs the distal elongated element. 37. The coupling device according to any one of embodiments 31 to 36, wherein the first proximal elongated element is longer than the second proximal elongated element. 38. The first conduit is constructed by a bore within a portion of the device, and includes a first section extending from the first distal end within the first coupling member to the inner end of the bore, and is constructed by a first metal tube integrated with the device, and a second section extending from the inner end to the outer portion constructing the first proximal elongated element The coupling device according to any one of Embodiments 31 to 37, comprising 39. The bore linearly extends along the bore axis, The metal tube is linear and defines a tube axis that forms an angle with the bore axis, The coupling device according to Embodiment 38. 40. The second conduit is constructed of a straight second metal tube, The second metal tube is integrated into the coupling device and is parallel to the first metal tube, One section at one end of the second tube constructs the second proximal elongate element, and the opposite section constructs the distal elongate element, The coupling device according to Embodiment 39. 41. The coupling device comprises A central body portion that houses the first metal tube and the second metal tube extending along the tube axis and comprises the second coupling member, A gripping portion extending in one radial direction of the tube axis configured to be held by a user from the central body, A syringe coupling portion extending in the opposite radial direction from the central body to the syringe coupling member The coupling device according to Embodiment 40. 42. The coupling device according to Embodiment 41, wherein the syringe coupling portion is substantially cylindrical and abuts the bore axis. 43. The coupling device according to Embodiment 41 or 42, wherein the gripping portion is substantially planar. 44. The coupling device according to any one of Embodiments 31 to 43 for use in the method according to any one of Embodiments 1 to 20 and the system according to any one of Embodiments 21 to 30. 45. A kit of parts comprising the elements of the system according to any one of Embodiments 21 to 30.

Brief Description of the Drawings

[0024] For a better understanding of the subject matter disclosed herein and to illustrate how the subject matter disclosed herein can actually be implemented, embodiments will be described here only as non-limiting examples with reference to the accompanying drawings.

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Figure 9F

[0025] The disclosure of this specification is illustrated in the following description. It should be understood that, as can be clearly understood, the embodiments illustrated below and shown in the accompanying drawings are merely examples of the innumerable embodiments made possible by the present disclosure.

[0026] In the following description, for ease of explanation, terms such as "upper", "lower", "vertical", "horizontal", etc. are used according to the orientation and relative position shown in the drawings. It should be understood that the elements may be oriented such that, for example, a "lower" element may be an upper element, or the "vertical orientation may be horizontal" when in use.

[0027] FIGS. 1 and 2 show a coupling device 100 according to one embodiment of the present disclosure. The coupling device 100 has a central body portion 102, a gripping portion 104, and a syringe coupling portion 106.

[0028] The central body portion 102 has a generally cylindrical vertically oriented shape and houses a first metal tube 108 and a second metal tube 110. The first metal tube 108 and the second metal tube 110 have upwardly projecting sections that respectively define a first elongated element 112 and a second elongated element 114. The first elongated element 112 and the second elongated element 114 each have a needle-like tip 116, 118. Tubes 108 and 110 are parallel and extend along a vertical tube axis 120 (which is also the axis defined by the essentially cylindrical body portion 102). Tube 110 also has a downwardly projecting section that constructs a second proximal elongated element 122.

[0029] The gripping portion 104 is essentially planar and extends in one radial direction of the axis 120 from the central body portion 102, and the syringe coupling portion extends in the opposite direction. The gripping portion is generally configured to be held or gripped by the user, and the abutment 124 on the surface of the gripping portion further enhances this function.

[0030] The axial bore 126 is defined within the portion 106, and the axial bore 126 extends along the bore axis 128 from the opening at the first distal end 130 of the bore within the first coupling member 132, which is a female Luer fitting, to the narrow bore inner end 134 in several constricted sections. The inner end 136 of the tube 108 is in fluid communication with the bore inner end 122. The bore 116 and the lumen of the tube 108 together construct a single continuous first conduit, and the single continuous first conduit extends between the first distal end 130 and the first proximal end at the needle tip of the tube 116.

[0031] The threaded member 140 projects upward from the central body, and the elongated elements 112, 114 project upward from the threaded member 140. The member 140 typically functions to engage with a test tube, together with the cylindrical test tube container 150 shown in FIGS. 3 and 4, and the cylindrical test tube container 150 is threadedly fitted to the member 140. The container 150 has an opening 152 at the upper end of the container, and the two proximal elongated elements 112, 114 project into the interior of the container. The cylindrical container 150 can receive the stopper-fitting end of the test tube, whereby the two proximal elongated elements 112, 114 penetrate through the stopper and insert the proximal ends of the two proximal elongated elements 112, 114 into the tube, thereby establishing fluid communication between the interior of the tube and the first conduit and the second conduit. This will be described below with reference to FIGS. 5 - 7.

[0032] FIGS. 5 - 7 show the syringe 160, the test tube 162 that fits onto the stopper, typically coupled to a vacutainer, and the coupling device 100 engaged with the forming device 164.

[0033] The coupling of the syringe is by means of a luer-type engagement between the female luer fitting of the coupling device and the corresponding male luer fitting of the syringe. The downward displacement of the plunger 162 of the syringe by pressing the lever 164 pushes the contents of the syringe, typically air, into the distal end of the first conduit, propelling the fluid contents of the syringe (typically air as described above) so that the fluid contents of the syringe move through the first conduit.

[0034] The test tube 162, typically a vacutainer, has an opening that mates with the stopper 168. For engagement, the stopper-fitting end of the test tube is inserted into a cylindrical container such that the two sharp tips 116, 118 penetrate the stopper and the proximal ends of the two sharp tips 116, 118 are placed inside the tube. Thereby, the first conduit and the second conduit are in fluid communication with the interior of the tube. Thus, by the downward displacement of the plunger of the syringe, air (typically) is pushed into the first conduit, whereby the blood in the test tube flows out of the second conduit. As shown, the elongate element 108 is longer than the elongate element 110, and the elongate element 110 is dimensioned such that after insertion into the stopper, the second proximal end of the elongate element 110 is adjacent to the stopper inside the test tube. This allows for substantially the entire blood content of the test tube to be transferred from the second conduit.

[0035] Also as shown in FIGS. 5 - 7, the second proximal elongate element 122 can be made to penetrate the wall of the molding space 170 of the molding device such that by the discharge of blood from the second conduit, the blood is transferred into the space where, within the space, the blood clots and, as disclosed in International Publication No. WO 2019 / 058373 the contents of which are incorporated herein by reference, is enabled for blood clot-based wound dressings.

[0036] Elements of a system 200 according to one embodiment of the present disclosure are shown in FIG. 8. The system 200 includes a coupling device 202 having a cylindrical test tube container 204 coupled to a syringe 206, a vacutainer 208 already filled with blood withdrawn from a patient, and a molding device 210 having a blood molding space 212 as an enclosure, defined between a wall 214 and a removable planar closure 216. The molding device 210 also included a piece of gauze 218 adjacent to the closure, and a portion of the piece of gauze 218 was within the enclosure. For the preparation of a blood clot-based wound dressing, blood is introduced into the space 212, and then the blood is enabled to clot when the mold is placed on the planar closure of the mold, whereby the formed blood clot integrates with the gauze to form the wound dressing.

[0037] A sequence of steps in the implementation of a method according to one embodiment of the present disclosure is shown in FIGS. 9A-9F. Note that this sequence of steps is exemplary. For example, rather than as shown, the coupling device may first be coupled to a vacutainer that stores blood, at which time it may be engaged with the molding device.

[0038] FIG. 9A shows the engagement of the coupling device with a syringe to which a t-molding device is attached, the engagement being effected by a second proximal elongate element (not shown in this figure) of the coupling device penetrating the wall of the molding space. Then, the vacutainer filled with blood is coupled as described above (FIGS. 9B-9C), and then the plunger of the syringe is displaced, whereby the blood is transferred from the vacutainer to the molding space (FIGS. 9D-9F). Typically, an incubation is followed to enable blood clotting, using a blood clotting initiator that is present a priori within the space or introduced before, during, or subsequent to the introduction of blood into the space.

Claims

1. A method for forming a blood clot-based wound dressing, comprising: accumulating a volume of blood in a test tube with an opening sealed by an elastic stopper (e.g., a rubber stopper); transferring the blood from the test tube to a forming space of a blood clot forming device, wherein a blood clot supporting matrix (e.g., a wound dressing material such as gauze) is within the space, and the transferring is enabled by propelling a fluid (e.g., a gas) through the stopper and into the tube through at least one first conduit extending between a first distal end and a first proximal end within the tube, while enabling the blood to flow out of the tube through at least one second conduit between a second proximal end and a second distal end within the tube; collecting the blood exiting from the second distal end into the forming space; including the transferring; enabling the blood to clot while in contact with the matrix, thereby obtaining a wound dressing including a blood clot integrated with the matrix; A method including the above steps.

2. A method for forming a blood clot-based wound dressing, comprising: transferring an amount of blood to a forming space of a blood clot forming device, wherein a blood clot supporting matrix is within the space, and enabling the blood to clot while in contact with the matrix, thereby obtaining a wound dressing including a blood clot integrated with the matrix, and the transferring is enabled by accumulating a volume of blood in a test tube sealed by an elastic stopper (e.g., a rubber stopper); propelling a fluid (e.g., a gas) through the stopper and into the tube through at least one first conduit extending between a first distal end and a first proximal end within the tube, while enabling the blood to flow out of the tube through at least one second conduit between a second proximal end and a second distal end within the tube; collecting the blood exiting from the second distal end into the forming space; A method including the above steps.

3. The method according to claim 1 or 2, wherein the propelling is by a syringe coupled to the first distal end.

4. The method, before the propelling and the collecting,

5. The method, before the propelling and the collecting, The method according to any one of claims 1 to 3, comprising inserting at least one first proximal elongate element defining a proximal section of the first conduit and at least one second proximal elongate element defining a proximal section of the second conduit into the stopper.

5. Each of the elongate elements has a sharp tip for penetrating the stopper. The method according to claim 4.

6. Said inserting comprises engaging the stopper with a tube coupling member of the device comprising the elongate element protruding from the coupling device, whereby the element penetrates the stopper. The method according to claim 4 or 5.

7. The tube coupling member comprises a generally cylindrical container having an opening and a closed end, the proximal elongate element protruding from the tube coupling member into the container, the method comprising introducing the test tube into the container with the stopper facing an end wall of a cylindrical test tube container, and when the test tube is introduced into the container, after complete insertion of the test tube into the container, the two elongate elements penetrate the stopper. The method according to claim 6.

8. The method according to claim 6 or 7, wherein the coupling device comprises a syringe coupling member for coupling the syringe to the first distal end to enable the fluid to be propelled so that the fluid enters the first conduit from the syringe.

9. The method according to any one of claims 6 to 8, wherein the second distal end is at the end of a tubular protrusion configured to penetrate the wall of the forming space.

10. The method according to any one of claims 6 to 9, wherein the second conduit is constructed by a metal tube integrated with the coupling device, one end protruding from the tube coupling member and the other end protruding in a different (typically, opposite) direction.

11. The method according to any one of claims 4 to 10, wherein the first proximal elongate element is longer than the second proximal elongate element.

12. The method comprises coupling the first distal end to a syringe; inserting the two proximal ends so that the two proximal ends enter the test tube through the stopper; inserting the second distal end into the wall of the forming space; transferring the blood from the test tube to the forming space and collecting the blood in the forming space by pushing air into the first conduit by the syringe. Subsequent to said collection, maintaining the molding device such that the blood is in contact with the matrix for a time sufficient for the blood to clot, thereby obtaining a wound dressing comprising a blood clot integrated with the matrix The method according to any one of claims 1 to 11, comprising **Claim 13** The method according to any one of claims 1 to 12, wherein the test tube is a vacutainer **Claim 14** A blood collection test tube (e.g., a vacutainer) having an elastic stopper, A blood clot forming device defining a forming space, wherein a blood clot supporting matrix is within said space, A fluid propulsion device, A first coupling member and a second tube coupling member for coupling to said test tube, A fluid conduit defined within a coupling device, comprising at least one first fluid conduit extending between a first distal end within the first coupling member and a first proximal end at an end of a first proximal elongate element, and at least one second fluid conduit extending between a second distal end at an end of a distal elongate element and a second proximal end at an end of the elongate element And a coupling device having A system for forming a blood clot-based wound dressing, comprising The first proximal elongate element and the second proximal elongate element are configured to project from the device at the tube coupling member and penetrate the stopper, The distal elongate element is configured to penetrate a wall of the forming space, The first coupling member is configured to couple to the fluid propulsion device such that the propulsion device enables fluid to be propelled into the first conduit through the first distal end, System **Claim 15** The system according to claim 14, wherein the propulsion device is a syringe **Claim 16** A first coupling member configured to couple to a fluid propulsion device, and a second coupling member configured to couple to a stopper-sealed test tube, A fluid conduit defined within a coupling device, Comprising at least one first fluid conduit extending between a first distal end within the first coupling member and a first proximal end formed at an end of a first proximal elongate element, and at least one second fluid conduit extending between a second distal end at an end of a distal elongate element and a second proximal elongate element And a coupling device comprising The first proximal elongate element and the second proximal elongate element project from the device at the tube coupling member and are configured to penetrate the test tube's stopper, the coupling of the first coupling member with the propulsion device enables fluid communication between the syringe and the first distal end, whereby, when the coupling device couples the propulsion device and the test tube filled with liquid, the operation of the propulsion device propels the fluid so that the fluid enters the first conduit, whereby, in turn, the liquid is discharged from the test tube through the second conduit, coupling device. **Claim 17** The coupling device according to claim 16, wherein the propulsion device is a syringe. **Claim 18** The coupling device according to claim 16 or 17, wherein each of the elongate elements has a sharp tip for penetrating the stopper. **Claim 19** The coupling device according to any one of claims 16 to 18, wherein the first coupling member has a female Luer fitting for coupling with a male Luer fitting of a syringe. **Claim 20** The second coupling member comprises a generally cylindrical container having an opening and a closed end, and the proximal elongate element projects into the container from the second coupling member, the cylindrical container is configured to receive the stopper fitting end of the test tube such that the two proximal elongate elements penetrate the stopper and insert the proximal ends of the two proximal elongate elements into the tube, The coupling device according to any one of claims 16 to 19. **Claim 21** The second conduit is constructed by a metal tube integrated with the coupling device, with one section at one end constructing the second proximal elongate element and the opposite section constructing the distal elongate element, The coupling device according to any one of claims 16 to 20. **Claim 22** The coupling device according to any one of claims 16 to 21, wherein the first proximal elongate element is longer than the second proximal elongate element. **Claim 23** The first conduit is constructed by a bore within a portion of the device, with a first section extending from the first distal end within the first coupling member to the inner end of the bore, and constructed by a first metal tube integrated with the device, with a second section extending from the inner end to the outer portion constructing the first proximal elongate element The coupling device according to any one of claims 16 to 22, comprising

24. The bore linearly extends along a bore axis, The metal tube is linear and defines a tube axis that forms an angle with respect to the bore axis, The coupling device according to claim 23.

25. The second conduit is constructed of a straight second metal tube, The second metal tube is integrated into the coupling device and is parallel to the first metal tube, One section at one end of the second tube constructs the second proximal elongate element, and the opposite section constructs the distal elongate element, The coupling device according to claim 24.

26. The coupling device is A central body portion that houses the first and second metal tubes extending along the tube axis and includes the second coupling member, A gripping portion extending in a radial direction of the tube axis configured to be held by a user from the central body, A syringe coupling portion extending in the opposite radial direction from the central body to the syringe coupling member The coupling device according to claim 25, comprising

27. The coupling device according to claim 26, wherein the syringe coupling portion is substantially cylindrical and abuts the bore axis, and the gripping portion is substantially planar.

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