IL280733B2

IL280733B2 - Method and kit for treating abnormal hollowed space

Info

Publication number: IL280733B2
Application number: IL280733A
Authority: IL
Original assignee: Reddress Ltd
Priority date: 2021-02-08
Filing date: 2021-02-08
Publication date: 2023-07-01
Also published as: IL280733B1; IL280733A

Description

METHOD AND KIT FOR TREATING ABNORMAL HOLLOWED SPACE TECHNOLOGICAL FIELD The present disclosure is in the field of medical treatment of abnormal hollowed space in a subject, in particular fistula or anal fistula.

BACKGROUND ART References considered to be relevant as background to the presently disclosed subject matter are listed below:- WO 2019/058373- WO 2019/058375- US 9,180,142Acknowledgement 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.

GENERAL DESCRIPTION The present disclosure provides a method and a kit for treating an abnormal hollowed space of a subject, such as a fistula or anal fistula. The method utilizes the blood of the subject by introducing it into the abnormal hollowed space and let it clot within the abnormal hollowed space thereby forming a clot therein that enhances healing process of the abnormal hollowed space.Thus, a first aspect of the present disclosure provides a method for treating an abnormal hollowed space or a cavity of a subject. The method includes: (i) obtaining or withdrawing whole blood from the subject. This may be performed by any known manner in the art. The method further includes (ii) mixing the subject's blood with one or more coagulation agents or anti-anticoagulation agents to thereby initiate clotting process of the blood. Then, (iii) prior to complete coagulation of the blood, introducing, e.g. injecting, the blood with the coagulation agent into said hollowed space and (iv) permitting the blood to coagulate in said abnormal hollowed space until a complete coagulation is obtained, and a clot is formed within the abnormal hollowed space.

In some embodiments of the method, (i) comprises withdrawing whole blood from the subject and mixing it with an anticoagulation agent. This allows to control the coagulation process and controllably induce the coagulation process at any desired time.In some embodiments of the method, the anticoagulant is selected from a list consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate.In some embodiments, the method further comprising, in the instance that said hollowed space has two or more openings, sealing one or more openings of the hollowed space, e.g. a distal opening of the fistula, thus creating a sinus, namely maintaining only one opening open. This step is carried out any time prior to (iii).In some embodiments of the method, (iv) comprises applying a medical dressing or a seal onto an opening of the hollowed space to prevent leakage of blood from the abnormal hollowed space or sinus, therefore ensuring its clotting therein.In some embodiments of the method, said applying a medical dressing or a seal onto an opening of the hollowed space is performed after a period of between 3-minutes from said introducing, or after a period of between 1, 2, 3, 4, 5, 6, 7, 8 and 10, 11, 12, 13, 14, 15, 16 minutes, or about 9 minutes. It is to be noted that this period is the time frame for permitting the blood to coagulate with the abnormal hollowed space. In some embodiments, this time frame can be less than 10, 9, 8, 7, 6, 5, 4, 3, 2 or at times less than 1 minute.The term "about" should be understood as a deviation of up to 20% from the nominated value. For example, a period of about 10 minutes is referred to any period of between 8-12 minutes.In some embodiments of the method, the one or more coagulation agents are in a liquid or a powder form.In some embodiments of the method, the one or more coagulation agents or anti- anticoagulating agents are selected from: Kaolin, Ca2+ (e.g. in the form of calcium salts such as Calcium Gluconate), Mg2+, negatively charged phospholipid (PL) and protamine sulfate.In some embodiments of the method, (ii) comprises first mixing the blood with Calcium Gluconate followed by mixing the blood and Calcium Gluconate mixture with Kaolin.

In some embodiments of the method, said hollowed space is a fistula. In some embodiments of the method, said fistula is an anal fistula.In some embodiments of the method, the hollowed space is a sinus.In some embodiments of the method, the blood is introduced or injected into the abnormal hollowed space in an injection profile. The injection profile comprises first injecting the blood to a distal end of the hollowed space and terminating the injection at a proximal end of the abnormal hollowed space. This profile allows to prevent the inflation of the abnormal hollowed space, e.g. the fistula, in case it is flexible and to ensure that blood is injected to any part of the abnormal hollowed space.In some embodiments of the method, (ii) and (iii) are performed simultaneously. Namely, while introducing or injecting the blood into the abnormal hollowed space, the blood is being mixed with one or more coagulation agents or anti-anticoagulation agents.In some embodiments of the method, prior to (iii), the method further comprising sealing the opening of the abnormal hollowed space with a seal having an injection port, and then performing (iii) wherein the introducing is carried out via the injection port.Yet another aspect of the present disclosure provides a kit for use in the treatment an abnormal hollowed space or cavity of a subject. The kit comprising one or more blood withdrawal devices for allowing withdrawal of blood from the subject; one or more blood collection receptacles for receiving the blood withdrawn from the subject; a coagulation assembly configured for permitting mixture of the withdrawn blood with one or more coagulation agents for initiating coagulation process of the withdrawn blood; and an applicator for introducing the incomplete coagulated blood into the hollowed space.In some embodiments of the kit, the one or more collection receptacles are vacuum tubes.In some embodiments of the kit, the coagulation assembly comprises a volume for introducing the withdrawn blood, said volume is contactable or mixable with one or more coagulation agents or anti-anticoagulation agents for facilitating the mixture of the one or more coagulation agents or anti-anticoagulation agents with the blood within the volume.In some embodiments, the kit further comprising one or more anticoagulation agents for mixing with the withdrawn blood to prevent its natural coagulation process and allow to controllably induce its coagulation process at a desired time.

In some embodiments of the kit, the one or more anti-coagulation agents are comprised within said one or more blood collection receptacles.In some embodiments of the kit, the anticoagulation agent is selected from a list consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate.In some embodiments of the kit, the one or more coagulation agents or anti- anticoagulating agents are selected from: Kaolin, Ca2+ (e.g. in the form of calcium salts such as Calcium Gluconate), Mg2+, negatively charged phospholipid (PL) and protamine sulfate.In some embodiments, the kit further comprising a seal for sealing an opening of the abnormal hollowed space. The seal comprises an injection port for allowing injection of the coagulating blood into the abnormal hollowed space via the seal.In some embodiments of the kit, the abnormal hollowed space is a fistula. In some embodiments of the kit, the fistula is an anal fistula.In some embodiments of the kit, the abnormal hollowed space is a sinus.It is to be noted that the term "sinus" refers to a sac or cavity in any organ or tissue, or an abnormal cavity or passage caused by the destruction of tissue.In some embodiments, the kit is intended for use in a method for treating an abnormal hollowed space or cavity of a subject. The method comprising:(i) withdrawing or obtaining whole blood from the subject;(ii) mixing the subject's blood with one or more coagulation agents or antianticoagulation agents;(iii) prior to complete coagulation of the blood, introducing the blood with the coagulation agent into said hollowed space; and(iv) permitting the blood to coagulate in said space until a complete coagulation is obtained, and a clot is formed within the abnormal hollowed space.In some embodiments, the kit is intended to be used in any of the above embodiments of the method.

BRIEF DESCRIPTION OF THE DRAWINGS 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: Figs. 1A-1Dare schematic illustrations presenting different stages of a nonlimiting example of the method according to an aspect of the present disclosure. Figs. 2A-2Bare flow diagrams of non-limiting examples of different embodiments of the method according to an aspect of the present disclosure.

Claims

- 7 - CLAIMS:

1. A kit for use in the treatment of an abnormal hollowed space of a subject, the kitcomprising:one or more blood withdrawal devices for allowing withdrawal of blood from the subject;one or more blood collection receptacles for receiving the blood withdrawn from the subject;a coagulation assembly configured for permitting mixture of the withdrawn blood with one or more coagulation agents for initiating coagulation process of the withdrawn blood; andan applicator for introducing the incomplete coagulated blood into the hollowed space;wherein the kit is for use in a method for treating said abnormal hollowed space of the subject, the method comprising(i) withdrawing whole blood from the subject;(ii) mixing the subject's blood with said one or more coagulationagents or anti-anticoagulation agents;(iii) following said mixing and while the blood is still in a flowableform, introducing the blood with the coagulation agent into said hollowed space; andpermitting the blood to coagulate in said space;wherein said abnormal hollowed space is a fistula or anal fistula.

2. The kit of claim 1, wherein said one or more collection receptacles are vacuumtubes.

3. The kit of claim 1 or 2, wherein the coagulation assembly comprises a volume forintroducing the withdrawn blood, said volume is contactable with one or more coagulation agents or anti-anticoagulation agents.

4. The kit of any one of claims 1-3, comprising one or more anticoagulation agentsfor mixing with the withdrawn blood.

5. The kit of claim 4, wherein the one or more anti-coagulation agents are comprisedwithin said one or more blood collection receptacles. - 8 -

6. The kit of claim 4 or 5, wherein the anticoagulation agent is selected from agroupd consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate.

7. The kit of any one of claims 1-6, said one or more coagulation agents or anti-anticoagulating agents are selected from: Kaolin, Ca2+ (e.g. in the form of calcium salts such as Calcium Gluconate), Mg2+, negatively charged phospholipid (PL) and protamine sulfate.

8. The kit of any one of claims 1-7, comprising a seal for sealing an opening of saidabnormal hollowed space, said seal comprises an injection port for allowing injection of blood to the abnormal hollowed space via said seal.

9. The kit of any one of claims 1-8, wherein said abnormal hollowed space is an analfistula.

10. The kit of any one of claims 1-9, wherein said abnormal hollowed space is a sinus. 15