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EP-4132441-B1 - BLOOD EXTRACTION

EP4132441B1EP 4132441 B1EP4132441 B1EP 4132441B1EP-4132441-B1

Inventors

  • KUSHNIR, ALON
  • ILAN, Ohad

Dates

Publication Date
20260506
Application Date
20210407

Claims (14)

  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; transferring blood from the test tube to a molding space of a blood-clotting mold device, with a blood clot-support matrix within said space, said transferring comprising propelling a fluid into said tube through at least one first conduit that extends through the stopper between a first distal and a first proximal end within said tube and at the same time permitting blood to flow out of the tube through at least one second conduit between a second proximal end within said tube and a second distal end, and collecting the blood egressing out of the second distal end in said molding space; and permitting the blood to clot while in contact with said matrix to thereby obtain a wound dressing comprising a blood clot integrated with said matrix.
  2. The method of claim 1, wherein said propelling is by a syringe coupled to said first distal end.
  3. The method of claim 1 or 2, comprising prior to said propelling and said collecting inserting, through the stopper, at least one first proximal elongated element defining a proximal segment of the first conduit and at least one second proximal elongated element defining a proximal segment of the second conduit; wherein the elongated elements have each a sharp tip for penetrating through the stopper; wherein optionally, said inserting comprises engaging the stopper with a tube-coupling member of a coupling device comprising said elongated elements projecting off said device, thereby causing said elements to penetrate through the stopper.
  4. The method of claim 3, wherein said tube-coupling member comprises a generally cylindrical receptacle with an opening and a closed end with said proximal elongated elements projecting therefrom into the receptacle, and wherein the method comprises introducing the test tube into a cylindrical test tube receptacle with the stopper facing an end wall of said receptacle, whereupon after full insertion of the test tube into the receptacle, the two elongated elements penetrate through the stopper; wherein said coupling device comprises a syringe-coupling member for coupling a syringe with said first distal end to permit to propel fluid out of the syringe and into the first conduit.
  5. The method of claim 4, wherein the second distal end is at an end of a tubular projection configured for piercing a wall of said molding space; and wherein the second conduit is constituted by a metal tube integrated in the coupling device with one end projecting from the tube-coupling member and the other projecting in another direction.
  6. The method of any one of claims 3-5, wherein said first proximal elongated element is longer than said second proximal elongated element.
  7. The method of any one of claims 1-6, comprising: coupling the first distal end with a syringe; inserting the two proximal ends through the stopper into said test tube; inserting said second distal end through a wall of said molding space; transferring the blood from said test tube to said molding space by pushing air by the syringe into the first conduit and collecting blood in said molding space; and following said collecting, maintaining the mold device such that the blood is in contact with said matrix for a time sufficient for the blood to clot to thereby obtain a wound dressing comprising a blood clot integrated with said matrix.
  8. A coupling device, comprising: a first coupling member and a second coupling member, the first coupling member being configured for coupling with a fluid propelling device and the second coupling member being configured for coupling with a blood-collection test tube with an elastic stopper; and fluid conduits defined in the device that comprise at least one first fluid conduit extending between a first distal end in the first coupling member and a first proximal end formed at an end of a first proximal elongated element, and at least one second fluid conduit extending between a second distal end at an end of a distal elongated element and a second proximal elongated element, the first and second proximal elongated elements projecting off the device at said tube-coupling member and configured for piercing through the test-tube' stopper; the coupling of the first coupling member with said propelling device permits fluid communication between the syringe and said first distal end; whereby upon coupling of said coupling device to said propelling device and to said test tube filled with a liquid, actuation of the propelling device propels fluid into the first conduit which in turn causes the liquid to be drained out of said test tube through said second conduit.
  9. The coupling device of claim 8, wherein said propelling device is a syringe; wherein the elongated elements have each a sharp tip for penetrating through the stopper.
  10. The coupling device of claim 8 or 9, wherein said first coupling member has female-type Luer fitment for coupling with a male-type Luer fitment of a syringe; and optionally, wherein said second coupling member comprises a generally cylindrical receptacle with an opening and a closed end with the proximal elongated elements projecting therefrom into the receptacle, wherein said cylindrical receptacle being configured for receiving the stopper-fitted end of said test tube such that the two proximal elongated elements pierce through the stopper to bring their proximal end to be within the tube.
  11. The coupling device of any one of claims 8-10, wherein said second conduit is constituted by a metal tube integrated in the coupling device with one segment at one end constituting said second proximal elongated element and an opposite segment constituting said distal elongated element; and optionally, wherein said first proximal elongated element is longer than said second proximal elongated element; and wherein the first conduit comprises a first segment constituted by a bore in a portion of said device and extending between the first distal end in said first coupling member to a bore inner end, and a second segment constituted by a first metal tube integrated in the device and extending from said inner end to an external portion constituting said first proximal elongated element; wherein said bore linearly extend along bore axis, and said metal tube is straight and defines a tube axis angled with respect to said bore axis.
  12. The coupling device of claim 11, wherein said second conduit is constituted by a second, straight metal tube, the second metal tube is integrated in the coupling device and is parallel to said first metal tube, and one segment at one end of said second tube constituting said second proximal elongated element and an opposite segment constituting said distal elongated element; wherein the device further comprising: a central body portion accommodating said first and said second metal tube that extend along said tube axis and comprising said second coupling member; a grip portion extending from said central body in one radial direction of said tube axis for holding by a user; and a syringe coupling portion extending at an opposite radial direction from said central body to said syringe-coupling member.
  13. A system for forming a blood clot-based wound dressing, comprising: a blood-collection test tube with an elastic stopper; a blood-clotting mold device defining a molding space with a blood clot-support matrix within said space; a fluid propelling device; and a coupling device according to any one of claims 8-12; having a first coupling member and a second, tube-coupling member for coupling with said test tube, fluid conduits defined in the device that comprise at least one first fluid conduit extending between a first distal end in the first coupling member and a first proximal end at an end of a first proximal elongated element, and at least one second fluid conduit extending between a second distal end at an end of a distal elongated element and a second proximal end at an end of an elongated element, the first and second proximal elongated elements projecting off the device at said tube-coupling member and configured for piercing through said stopper, the distal elongated element being configured for piercing a wall of said molding space, and the first coupling member being configured for coupling to said fluid propelling device to permit said propelling device to propel fluid into said first conduit through said first distal end.
  14. The system of claim 13, wherein said propelling device is a syringe.

Description

TECHNOLOGICAL FIELD The present disclosure concerns a method and system for the preparation of a blood clot-based wound dressing as well as kits of parts of said system and a device useful in said method and system. BACKGROUND References considered to be relevant as background to the presently disclosed subject matter are listed below: US 9,180,142US 10,111,979WO 2019/058375WO 2019/150355US 4,327,746US 6,110,160 Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter. US patents 9,180,142 and 10,111,979 disclose a wound treatment procedure by which blood is coagulated and the so-formed blood clot is applied onto a wound with a dressing material. PCT publications WO 2019/058373, WO 2019/058375 and WO 2019/150355 disclose methods, devices and systems for dressing wounds with a blood clot-comprising dressing. The blood clot-comprising dressing is, typically, prepared from blood taken from the patient. As the blood sample to be withdrawn is of a relatively small amount (as compared to that of a blood donation to a blood bank), e.g. 10-20 ml, it is typically drawn into a vacutainer (a vacuum-holding test tube that is sealed by an elastic, typically rubber, stopper) of the kind used in blood tests and then has to be withdrawn from there. As the tube is sealed, the blood withdrawal, typically with a syringe has to be against the vacuum inside the tube and this may be challenging. US 4,327,746 discloses a blood extraction device that uses a relatively thin and simple sealing material, in combination with a screw closure. US 6,110,160 discloses a blood extraction device comprise: a holder having a chamber; a hollow cannula fixed in the holder and having a sharpened pointed end externally of the chamber and adapted to pierce a blood vessel and another end extending into the chamber; a closed-end flexible rubber valve tube surrounding the other end of the hollow cannula and defining an air-filled space between the valve tube and the other end of the cannula; and means on the holder engaging the valve tube from an outer side thereof and including a deformable member deformed inwardly into engagement with the valve tube to retain the valve tube in position in the chamber and on the housing. GENERAL DESCRIPTION Provided by this disclosure is a method and system for the preparation of a blood clot-based wound dressing whereby a fluid, typically gas such as air is propelled through one conduit into a sealed, blood-containing test tube, and at the same time blood is permitted to flow out of the test through a second conduit and thereby transferred into a blot clot molding space where the blood is permitted to coagulate forming a clot of a shape defined by the molding space. The propelling fluid is typically air that is propelled to flow in the first conduit by a syringe. Provide by this disclosure is also a coupling device useful in said method and system; as well as a kit of parts comprising elements needed for carrying out the method of this disclosure. According to the method for forming a blood clot-based wound dressing of this disclosure, a blood is first accumulated in a test tube with an opening sealed by an elastic stopper (e.g. rubber stopper). This test tube is typically a vacutainer that maintains a vacuum seal inside the tube and this vacuum is the driving force for drawing blood thereinto. The blood needs then to be transferred from the test tube to a blood molding space of a mold device where the blood is permitted to clot and integrate in this process with a support matrix (which may be a wound dressing material such as gauze) that is comprised in said space, to form the blood clot-based wound dressing. The method is set out in claim 1. The transfer of the blood from the test tube to the molding space is by propelling a fluid (e.g. gas) into said test tube through at least one first conduit that extends through the stopper between a first distal and a first proximal end within said tube and at the same time permitting blood to flow out of the tube through at least one second conduit between a second proximal end within said tube and a second distal end. The blood egressing out of said second distal end is then channeled to and collected in said molding space. By one embodiment, prior to said propelling and said collecting at least one first proximal elongated element defining a proximal segment of the first conduit and at least one second proximal elongated element defining a proximal segment of the second conduit is inserted through the stopper to thereby establish fluid communication between said first and said second conduits and the test tube's interior. By one embodiment said elongated elements have each a sharp tip for penetrating through the stopper. By one embodiment, use is made of a coupling device with said conduits being defined within the coupling device. Said elongated elemen