Solidification mold and its manufacturing process

Abstract

The present disclosure provides a blood clotting mold assembly and a method for manufacturing the same. The blood clotting mold assembly is intended to be filled with whole blood and to allow the blood to coagulate in the mold cavity of the blood clotting mold assembly to obtain a blood clot, which is then applied to a damaged area, e.g., a skin lesion, to aid in its recovery. The clotting mold assembly comprises a clotting mold having a mold cavity containing one or more clotting initiators into which blood is introduced to form a blood clot, thereby constituting a clotting space. The clotting mold comprises a peripheral portion extending from the wall of the mold cavity in an outward direction relative to the mold cavity. A blood clot support matrix is ​​formed above the opening of the mold cavity to allow contact with the blood in the cavity such that the blood clot formed in the mold cavity adheres to the support matrix. A removable closure suitable for maintaining sterility in the mold cavity is attached to the clotting mold at two attachment portions, including an inner attachment portion and an outer attachment portion. The inner mounting portion surrounds the mold cavity and a portion of the support matrix is ​​disposed within the inner mounting portion, i.e., the support matrix is ​​sandwiched between the solidification mold and the removable closure and held in a desired position. The inner mounting portion also provides a seal for blood introduced into the mold cavity to keep the blood trapped in the mold cavity. Note that this attachment is not required to provide an airtight seal, but only to ensure that the majority of the blood remains within the mold cavity. The outer mounting portion surrounds the inner mounting portion and provides a sterile seal to keep the mold cavity sterile.

Description

[Technical field]

[0001] TECHNICAL FIELD The present disclosure is in the field of medical devices, particularly blood-utilizing medical devices. [Background technology]

[0002] The following references are considered relevant background to the subject matter of this disclosure: -U.S. Patent No. 9,180,142 -International Publication No. 2019 / 058375 -International Publication No. 2021 / 124317

[0003] Acknowledgement of the above references herein should not be inferred as meaning that they are in any way relevant to the patentability of the subject matter of the present disclosure. Summary of the Invention

[0004] The present disclosure provides a blood clotting mold assembly and a method for manufacturing the same. The blood clotting mold assembly is intended to be filled with whole blood and to allow the blood to coagulate in the mold cavity of the blood clotting mold assembly to obtain a blood clot, which is later applied to a damaged area to aid in its recovery. For example, the blood clot formed in the blood clotting mold assembly can be applied to any type of skin lesion to enhance its recovery. The coagulation mold assembly includes a coagulation mold having a mold cavity containing one or more coagulation initiators into which blood is introduced to form a blood clot, thereby constituting a coagulation space. The coagulation mold includes a peripheral portion extending from the wall of the mold cavity in an outward direction relative to the mold cavity. The clot support matrix is ​​formed above the opening of the mold cavity to allow contact with the blood in the cavity such that the blood clot formed in the mold cavity adheres to the support matrix. A removable closure suitable for maintaining sterility in the mold cavity is attached to the coagulation mold at two attachment portions including an inner attachment portion and an outer attachment portion. The inner attachment portion surrounds the mold cavity, and a portion of the support matrix is ​​disposed within the inner attachment portion, i.e., the support matrix is ​​sandwiched between the solidification mold and the removable closure and held in a desired position. The inner attachment portion also provides a seal for blood introduced into the mold cavity to keep the blood trapped in the mold cavity. Note that this attachment is not required to provide an airtight seal, but only to ensure that the majority of the blood remains within the mold cavity. However, in some embodiments, the inner attachment seals blood from migrating from the mold cavity through the inner attachment to the peripheral portion. The outer attachment portion surrounds the inner attachment portion and provides a sterile seal to keep the mold cavity sterile.

[0005] Thus, a first aspect of the present disclosure provides one of the following two configurations.

[0006] The first arrangement provides a solidification mold assembly. The solidification mold assembly comprises a solidification mold with a mold cavity defined between walls of a body and having an opening defined by an end of the walls of the body. The mold cavity is configured to allow introduction of blood therein. Introduction of blood can be by injecting blood through the walls defining the mold cavity or through an intended port formed in the walls defining the mold cavity. The solidification mold further comprises a peripheral portion extending from the entire periphery of the ends of the walls of the body, integral with the body, and being generally planar. The peripheral portion extends outwardly from the mold cavity and forms a suitable placement surface for placement of the solidification mold assembly.

[0007] A removable closure is formed over the opening of the mold cavity and over at least a portion of the periphery, the removable closure being intended to be removed after the blood has clotted within the mold cavity, thereby exposing the clot and allowing it to be applied onto a desired target, such as a skin lesion.

[0008] The solidification mold assembly further includes a clot support matrix or sheet held between the mold cavity and the removable closure such that at least a first portion thereof is positioned over the opening and at least a second portion thereof is positioned over the peripheral portion. The removable closure is attached to the peripheral portion of the solidification mold at two attachment portions surrounding the mold cavity, including an outer attachment portion, the attachment being direct between the removable closure and the solidification mold to obtain a sterile condition within the mold cavity, and an inner attachment portion between the outer attachment portion and the body, and the clot support matrix interposes at least a portion of the inner attachment portion to hold the clot support matrix in a desired position over the opening while forming a clot within the mold cavity.

[0009] This structure allows blood to be introduced into the sterile mold cavity by piercing the body with a syringe or through the wall of the body via an intended port, allowing a clot to form therein. The clot can attach to and be carried along with the clot support matrix. Once the clot has formed, the removable closure is removed and the exposed clot can be easily lifted by lifting the clot support matrix away from its surrounding portion that remains outside the mold cavity, i.e., the portion that is held by and at the periphery of the inner attachment portion. Once the clot has been lifted, it can be placed on any desired target, such as a skin lesion.

[0010] The second arrangement provides a solidification mold assembly comprising a solidification mold including a mold cavity defined between walls of a body and having an opening, the ends of the body walls defining the opening. The mold cavity is configured for introduction of blood therein. The solidification mold further includes a peripheral portion extending from an entire periphery of the ends of the body walls, integral with the body, and generally planar. The peripheral portion extends outwardly from the mold cavity and forms a suitable location surface for location of the solidification mold assembly.

[0011] A removable closure is formed over the opening and over at least a portion of the peripheral portion and is attached to the solidification mold at at least two attachment portions at the peripheral portion including an inner attachment portion and an outer attachment portion. Each of the attachment portions forms a closed frame, i.e., each of the attachment portions encloses an interior space or portion. The inner attachment portion is formed between the outer attachment portion and the body, and the outer attachment portion provides a sterile separation between the environment and the mold cavity.

[0012] The clot support matrix or sheet is held between the mold cavity within the inner mounting portion and the removable closure such that at least a first portion thereof is positioned above the opening and at least a second portion thereof is positioned above the peripheral portion.

[0013] After blood is introduced into the mold cavity through perforations in the wall of the body or through intended ports formed in the wall, the blood is allowed to clot within the mold cavity and at least a portion of it is retained by or attached to the clot support matrix or sheet. The removable closure is then removed to expose the clot and allow it to be applied, along with the clot support matrix or sheet, to a desired target, such as a skin lesion.

[0014] It should be noted that any combination of the described embodiments may be applicable for any aspect or configuration of the present disclosure, in other words, any aspect of the present disclosure may be defined by any combination of the described embodiments.

[0015] In some embodiments of the solidification mold assembly, the mold cavity includes a clot initiator for initiating the coagulation of blood introduced therein.

[0016] In some embodiments of the solidification mold assembly, the solidification initiator is in powder form.

[0017] In some embodiments of the solidification mold assembly, the solidification initiator includes a coagulant, an anticoagulant, or both.

[0018] In some embodiments of the solidification mold assembly, the anticoagulant is selected from the group consisting of ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), citrate, heparin, and oxalate.

[0019] In some embodiments of the solidification mold assembly, the coagulant or anti-anticoagulant is kaolin, Ca 2+ , Mg 2+, negatively charged phospholipids (PL) and protamine sulfate.

[0020] In some embodiments of the solidification mold assembly, the walls of the body defining the mold cavity are designed to allow the introduction of blood therethrough into the mold cavity, for example by injecting blood through the walls with a syringe.

[0021] In some embodiments of the solidification mold assembly, a port is formed in the wall of the body to allow the introduction of blood therethrough into the mold cavity.

[0022] In some embodiments of the solidification mold assembly, the peripheral portion is integral with the body.

[0023] In some embodiments of the solidification mold assembly, the peripheral portion is generally planar, making it suitable for placement on a surface to effect the solidification process.

[0024] In some embodiments of the solidification mold assembly, the clot support matrix is ​​a sheet or gauze.

[0025] In some embodiments of the solidification mold assembly, at least a portion of the clot support matrix is ​​held or retained over the entire opening of the mold cavity.

[0026] In some embodiments of the solidification mold assembly, the inner mounting portion is defined about the periphery of the wall of the body, i.e., the inner mounting portion is adjacent to and surrounds the wall of the body.

[0027] In some embodiments of the solidification mold assembly, the peripheral portion includes a first abutment extending peripherally from the wall of the body, specifically from an end of the wall. The first abutment extends to a point and defines a width of the first abutment. The first abutment defines an inner attachment portion, i.e., attachment is made to an upper portion of the first abutment.

[0028] In some embodiments of the solidification mold assembly, the peripheral portion includes a second abutment portion defining an outer attachment portion, ie, attachment occurs on top of the first abutment portion.

[0029] In some embodiments of the solidification mold assembly, the removable closure is a synthetic flash spun high density polyethylene fiber sheet.

[0030] In some embodiments of the solidification mold assembly, the removable closure is a nonwoven product made of spun bonded olefin fibers.

[0031] In some embodiments of the solidification mold assembly, the attachment portion is formed by heat welding.

[0032] In some embodiments of the solidification mold assembly, the attachment portion is formed by ultrasonic welding.

[0033] In some embodiments of the solidification mold assembly, at least one of the walls of the mold cavity and the closure is pierceable by a needle or includes a port, e.g., a one-way port, to allow the introduction of blood into the cavity.

[0034] In some embodiments of the solidification mold assembly, the outer attachment portion seals contaminants from ingressing between the removable closure and the peripheral portion toward the mold cavity. Contaminants are considered to be particles or organic matter above a certain size that may adversely affect the blood clot that forms in the mold cavity. The seal formed by the outer attachment portion ensures that the mold cavity remains sterile until blood is introduced therein.

[0035] In some embodiments of the solidification mold assembly, the outer attachment portion provides a sterile separation between the environment and the mold cavity. The solidification mold and removable closure are made from materials suitable for providing a sterile barrier, and the outer attachment provides attachment between the peripheral portion and the removable closure in a sterile manner, ensuring that the mold cavity remains sterile until blood is introduced therein.

[0036] Yet another aspect of the present disclosure provides a method for manufacturing a solidification mold assembly, the method comprising: (i) providing a solidification mold comprising a mold cavity defined between walls of a body and having an opening defined by an end of the body wall, the mold cavity being configured for introduction of blood therein, the solidification mold further comprising a peripheral portion extending in an outward direction from the entire periphery of the end of the body wall to the mold cavity, the peripheral portion being unitary with the body and generally planar. (ii) placing a clot support matrix onto the solidification mold such that at least a first portion thereof is disposed over the opening and at least a second portion thereof is disposed over the peripheral portion; (iii) attaching the removable closure to the peripheral portion at two attachment portions forming a closed frame surrounding the mold cavity, including an outer attachment portion, the attachment being direct between the removable closure and the solidification mold to obtain a sterile condition in the mold cavity, and an inner attachment portion formed between the outer attachment portion and the body, the clot support matrix being sandwiched between the peripheral portion and the removable closure at at least a portion of the inner attachment portion to hold the clot support matrix in a desired position above the opening while forming a clot in the mold cavity.

[0037] In some embodiments, the method includes introducing a solidification initiator into the mold cavity prior to said attaching.

[0038] In some embodiments of the method, the clot initiator is in powder form.

[0039] In some embodiments of the method, the clotting initiator comprises a clotting agent, an anticoagulant, or both.

[0040] In some embodiments of the method, the anticoagulant is selected from the group consisting of ACD-A (anticoagulant citrate dextrose, solution A), EDTA (ethylenediaminetetraacetic acid), EGTA (ethylene glycol tetraacetic acid), citrate, heparin, and oxalate.

[0041] In some embodiments of the method, the coagulant or anticoagulant is kaolin, Ca 2+ , Mg 2+ , negatively charged phospholipids (PL) and protamine sulfate.

[0042] In some embodiments of the method, the walls of the body defining the mold cavity are designed to allow the introduction of blood therethrough into the mold cavity, for example by injecting blood through the walls with a syringe.

[0043] In some embodiments of the method, a port is formed in the wall of the body to allow the introduction of blood therethrough into the mold cavity.

[0044] In some embodiments of the method, the peripheral portion is integral with the body.

[0045] In some embodiments of the method, the peripheral portion is substantially planar.

[0046] In some embodiments of the method, the clot support matrix is ​​a sheet or gauze.

[0047] In some embodiments of the method, the placing is performed such that at least a portion of the clot support matrix is ​​disposed entirely over the opening of the mold cavity.

[0048] In some embodiments of the method, the inner attachment portion is defined about the periphery of the wall of the body, ie, the inner attachment portion is adjacent to and surrounds the wall of the body.

[0049] In some embodiments, the method includes pressing the solidified mold against the removable closure, thereby forming a first abutment extending circumferentially from a wall of the body, the inner mounting portion being defined in the first abutment.

[0050] In some embodiments, the method includes pressing the solidified mold against the removable closure, thereby forming a second abutment, the outer attachment portion being defined at the second abutment.

[0051] In some embodiments of the method, the removable closure is a flash spun high density polyethylene fiber sheet.

[0052] In some embodiments of the method, the removable closure is a nonwoven product made of spun-bonded olefin fibers.

[0053] In some embodiments of the method, the attaching includes heat welding the attachment portion.

[0054] In some embodiments of the method, the attaching includes ultrasonically welding the attachment portion.

[0055] In some embodiments of the method, at least one of the walls of the mold cavity and the closure is pierceable by a needle or includes a port, e.g., a one-way port, to allow the introduction of blood into the cavity.

[0056] In some embodiments of the method, the attaching provides a seal between the removable closure and the peripheral portion that seals contaminants from infiltrating toward the mold cavity. Contaminants are considered to be particles or organic matter above a certain size that may adversely affect a blood clot formed in the mold cavity. The seal formed by the outer attachment portion ensures that the mold cavity remains sterile until blood is introduced therein.

[0057] In some embodiments of the method, the attaching provides a sterile separation between the environment and the mold cavity: the solidification mold and the removable closure are made from materials suitable for providing a sterile barrier, and the exterior attachment provides attachment between the periphery and the removable closure in a sterile manner, ensuring that the mold cavity remains sterile until blood is introduced therein. [Brief description of the drawings]

[0058] In order to better understand the subject matter disclosed herein, and to illustrate 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: [Figure 1A]1A-1C are schematic diagrams of different views of a non-limiting example of an embodiment of a solidification mold assembly according to the present disclosure; [Figure 1B] 1A-1C are schematic diagrams of different views of a non-limiting example of an embodiment of a solidification mold assembly according to the present disclosure; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] The following drawings are provided to illustrate embodiments and implementations of the invention of the present disclosure.

[0060] 1A and 1B, which are schematic diagrams of different views of a non-limiting example of an embodiment of a solidification mold assembly according to the present disclosure. The solidification mold assembly 100 comprises a solidification mold 101 comprising a mold cavity 102 defined between walls 104 of a body 105, which in this example are concave. It should be noted that the walls may be of any shape that confines a space. An opening 106 of the mold cavity 102 is defined by an end 108 of the wall 104. The solidification mold 101 further comprises a peripheral portion 110 extending from the end 108 of the wall 104 in a direction away from the mold cavity 102, i.e., the peripheral portion 110 extending laterally away from the mold cavity 102. The peripheral portion 110 is generally planar, except for an attachment portion as described in more detail below.

[0061] A removable closure 112, such as a flash spun high density polyethylene fiber sheet film, is attached to the peripheral portion 110 at two attachment portions, an inner attachment portion 114 and an outer attachment portion 116. The two attachment portions form a closed path, i.e., the attachment portions completely surround the mold cavity 102 and are each at a different distance from the mold cavity. The removable closure 112 is required to provide a sterile separation between the environment and the interior of the mold cavity 102 prior to use of the solidified mold assembly 100.

[0062] One or more clotting initiators 118 are contained within the confined space of the mold cavity 102 to enable clotting of blood when blood is introduced into the mold cavity 102. The blood may be introduced by perforating a portion of the wall 104 of the mold cavity 102 or through a port, for example a one-way port formed in the wall 104.

[0063] A clot support matrix 120 is disposed between the removable closure 112 and the solidification mold 101 such that at least a first portion 121 thereof is positioned over the opening 106 and a second portion 123 thereof is positioned on a portion of the inner attachment portion 114. In this example, the clot support matrix 120 is positioned along the entire circumference of the inner attachment portion 114. Thus, the attachment between the removable closure 112 and the solidification mold 101 holds the clot support matrix 120 in one or more portions. This configuration facilitates maintaining the clot support matrix 120 in a preferred position such that when blood is introduced to form a clot, the clot support matrix 120 is submerged in, or at least in contact with, the blood that is coagulating in the mold cavity 102. The clotting process is carried out when the clotting mold assembly 100 is placed on a surface such that the removable closure faces and engages the surface, so that blood is found on the side of the clot support matrix 120 and the formed clot adheres to the clot support matrix 120 to facilitate conversion of the clot onto the desired therapeutic target.

[0064] In this example, each of the two attachment parts 114 and 116 is constituted by abutments 124 and 126, respectively, which are formed by a heat press welding technique. It should be noted that other attachment techniques, such as ultrasonic welding, gluing, etc., may also be used. The inner attachment part 114 is circular and is formed around the end 108 of the wall 104 of the mold cavity 102. The outer attachment part 116 is rectangular, but it should be understood that any part that is inward relative to the outer attachment part 116 in the direction of the mold cavity 102, i.e., all parts between the outer attachment part 116 and the mold cavity 102, may be any closed shape that provides a sealed sterile space between the removable closure 112 and the solidified mold 101, including parts of them that are sandwiched between the removable closure 112 and the peripheral part 110.

[0065] The purpose of the outer mounting portion 116 is to keep the mold cavity sterile until it is to be used, and the purpose of the inner mounting portion 114 is to hold the clot support matrix 120 and prevent blood from leaking out of the mold cavity 102 during the clotting process.

[0066] To use the coagulation mold assembly, whole blood is introduced into the mold cavity 102 and the clotting process is initiated. After the blood has coagulated and the clot support matrix 120 has adhered thereto, the removable closure 112 is removed and the clot supported on the clot support matrix 120 is transferred and placed onto the treatment target, e.g., a skin lesion.

Claims

1. A blood coagulation mold assembly, A molded cavity defined between the walls of the main body and having an opening, wherein the molded cavity is configured to introduce blood into it, A solidified mold comprising a peripheral portion extending from the entire circumference of the end of the wall of the main body, A removable closure, the removable closure being formed above the opening and at least a portion of the peripheral portion, and attached to the coagulation mold at at least two attachment points in the peripheral portion, including an inner attachment point and an outer attachment point, each forming a closed frame, wherein the inner attachment point is formed between the outer attachment point and the body, and provides a seal for the blood introduced into the mold cavity to maintain the blood trapped in the mold cavity; A blood clot support matrix is ​​provided, wherein the blood clot support matrix is ​​held between the mold cavity in the inner mounting portion and the removable closure such that at least a first portion of the blood clot support matrix is ​​positioned above the opening and at least a second portion of the blood clot support matrix is ​​positioned above the peripheral portion. A blood coagulation mold assembly in which the external mounting portion provides sterile separation between the environment and the mold cavity.

2. The coagulation mold assembly according to claim 1, wherein the mold cavity includes a coagulation initiator for initiating the coagulation of blood introduced therein.

3. The solidification mold assembly according to claim 1 or 2, wherein the peripheral portion is integrated with the main body.

4. The solidification mold assembly according to claim 1 or 2, wherein the peripheral portion is substantially flat.

5. The coagulation mold assembly according to claim 1 or 2, wherein the blood clot support matrix is ​​a sheet or gauze.

6. The coagulation mold assembly according to claim 1 or 2, wherein at least a portion of the blood clot support matrix is ​​kept above the entire opening of the mold cavity.

7. The solidification mold assembly according to claim 1 or 2, wherein the inner mounting portion is defined around the wall of the main body.

8. The solidification mold assembly according to claim 1 or 2, wherein the peripheral portion comprises a first contact portion that extends peripherally from the wall of the main body, and the first contact portion defines the inner mounting portion.

9. The solidification mold assembly according to claim 1 or 2, wherein the peripheral portion comprises a second contact portion that defines the outer mounting portion.

10. The solidified mold assembly according to claim 1 or 2, wherein the removable closure is a flash-spun high-density polyethylene fiber sheet.

11. The solidified mold assembly according to claim 1 or 2, wherein the mounting portion is formed by heat welding.

12. The solidification mold assembly according to claim 1 or 2, wherein the mounting portion is formed by ultrasonic welding.

13. The coagulation mold assembly according to claim 1 or 2, wherein at least one of the walls of the mold cavity and the closure is perforated by a needle or has a port for allowing blood to be introduced into the cavity.

14. The solidified mold assembly according to claim 1 or 2, wherein the external mounting portion seals off the intrusion of contaminants into the mold cavity between the removable closure and the peripheral portion.

15. A method for manufacturing a blood coagulation mold assembly, A molded cavity defined between the walls of the main body and having an opening, wherein the molded cavity is configured to introduce blood into it, To provide a solidification mold comprising a peripheral portion extending from the entire circumference of the end of the wall of the main body, The blood clot support matrix is ​​placed on the coagulation mold such that at least a first portion of the blood clot support matrix is ​​positioned above the opening, and at least a second portion of the blood clot support matrix is ​​positioned above the peripheral portion. The invention includes attaching a removable closure to the peripheral portion of two mounting portions surrounding the mold cavity, including an outer mounting portion and an inner mounting portion, wherein the inner mounting portion is formed between the outer mounting portion and the body and provides a seal for the blood introduced into the mold cavity to maintain the blood trapped in the mold cavity, and the blood clot support matrix is ​​sandwiched between the peripheral portion and the removable closure in at least a portion of the inner mounting portion, thereby being held in place. A method for mounting such an installation that results in sterile separation between the environment and the mold cavity.

16. The method according to claim 15, comprising introducing a coagulation initiator into the mold cavity before the aforementioned installation.

17. The method according to claim 15 or 16, wherein the peripheral portion is integrated with the main body.

18. The method according to claim 15 or 16, wherein the peripheral portion is substantially flat.

19. The method according to claim 15 or 16, wherein the blood clot support matrix is ​​a sheet or gauze.

20. The method according to claim 15 or 16, wherein the arrangement is carried out such that at least a portion of the blood clot support matrix is ​​positioned above the entire opening of the mold cavity.

21. The method according to claim 15 or 16, comprising pressing the solidified mold onto the removable closure, thereby forming a first contact portion that peripherally extends from the wall of the body, wherein the inner mounting portion is defined by the first contact portion.

22. The method according to claim 15 or 16, comprising pressing the solidified mold onto the removable closure to form a second contact portion, wherein the outer mounting portion is defined as the second contact portion.

23. The method according to claim 15 or 16, wherein the peripheral portion comprises a second contact portion that defines the outer mounting portion.

24. The method according to claim 15 or 16, wherein the removable closure is a flash-spun high-density polyethylene fiber sheet.

25. The method according to claim 15 or 16, wherein the mounting includes heat welding the mounting portion.

26. The method according to claim 15 or 16, wherein the mounting includes ultrasonic welding of the mounting portion.

27. The method according to claim 15 or 16, wherein the installation provides a seal that prevents contaminants from entering the mold cavity between the removable closure and the surrounding portion.

28. The method according to claim 15 or 16, wherein at least one of the walls of the mold cavity and closure is perforated by a needle or has a port for allowing blood to be introduced into the cavity.

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