IL280733A - Method and kit for treating abnormal hollowed space - Google Patents

Method and kit for treating abnormal hollowed space

Info

Publication number
IL280733A
IL280733A IL280733A IL28073321A IL280733A IL 280733 A IL280733 A IL 280733A IL 280733 A IL280733 A IL 280733A IL 28073321 A IL28073321 A IL 28073321A IL 280733 A IL280733 A IL 280733A
Authority
IL
Israel
Prior art keywords
blood
kit
abnormal
coagulation
agents
Prior art date
Application number
IL280733A
Other languages
Hebrew (he)
Other versions
IL280733B1 (en
IL280733B2 (en
Original Assignee
Reddress Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Reddress Ltd filed Critical Reddress Ltd
Priority to IL280733A priority Critical patent/IL280733B2/en
Priority to PCT/IL2022/050154 priority patent/WO2022168099A1/en
Priority to US18/275,782 priority patent/US20240100091A1/en
Priority to KR1020237029653A priority patent/KR20230146552A/en
Priority to EP22705596.9A priority patent/EP4288070A1/en
Priority to JP2023547065A priority patent/JP2024509696A/en
Publication of IL280733A publication Critical patent/IL280733A/en
Publication of IL280733B1 publication Critical patent/IL280733B1/en
Publication of IL280733B2 publication Critical patent/IL280733B2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/40Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof, e.g. plant or animal extracts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0057Ingredients of undetermined constitution or reaction products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/005Medical syringes, e.g. enemata; Irrigators comprising means for injection of two or more media, e.g. by mixing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • A61B2017/00495Surgical glue applicators for two-component glue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00641Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closing fistulae, e.g. anorectal fistulae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00884Material properties enhancing wound closure

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Anesthesiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Vascular Medicine (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)

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 9,180,142 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.
GENERAL DESCRIPTION The present disclosure provides a method and a kit for treating an abnormal 15 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 20 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. 25 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 5 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 10 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 3-15 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 20 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 30 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 5 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, 15 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 20 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 5 (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 10 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 15 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 20 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 anti­ anticoagulation agents; (iii) prior to complete coagulation of the blood, introducing the blood with the 25 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 30 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 5 which: Figs. 1A-1D are schematic illustrations presenting different stages of a non­ limiting example of the method according to an aspect of the present disclosure.
Figs. 2A-2B are flow diagrams of non-limiting examples of different embodiments of the method according to an aspect of the present disclosure.
DETAILED DESCRIPTION The method of the present disclosure is directed for treating abnormal hollowed space existing in a subject, e.g. anal fistula. The method first requires obtaining whole blood from the subject having an abnormal hollowed space to be treated. This is 15 performed by withdrawing blood from the subject in any known method. After the blood is obtained, it is typically mixed with anti-coagulation agent for allowing to preserve the blood in a non-coagulated liquid form until it is desired to be coagulated to form a clot. Reference is now made to Figs. 1A-1C, which are schematic illustrations presenting different stages of an embodiment of the method according to an aspect of the present 20 disclosure, following the withdrawal of the blood from the patient. Fig. 1A shows a coagulation assembly 102 that includes a sealed blister 104 confining a sterile volume 106 for receiving drawn blood from the subject. The sealed blister 104 is formed of a blood injection portion 108, that can be transparent or semi-transparent to allow visualization of the process, and a coagulant-containing surface 110 that holds a liquid or 25 powder form of one or more coagulating agents or anti-anticoagulating agents. By using a piercing element 111, e.g. a syringe with an adapted needle, the blood injection portion 108 is pierced at two different locations to form two openings, as can be seen in Fig. 1A, thereby allowing the introduction of blood into the sterile volume 106 from a first opening while air escapes from the second opening. The drawn blood is then injected into the 30 sterile volume 106, as is exemplified in Fig. 1B, and the coagulating agents or anti- anticoagulating agents are mixed with the subject's blood to initiate the clotting process. The mixing can be enhanced by shaking the coagulation assembly 102, following sealing the openings in the blood injection portion 108 to prevent leakage of blood while shaking. The blister 104 is then unsealed, e.g. by removing the sealing base 112 at the bottom of the blister 104, as is exemplified in Fig. 1C, or by piercing the blood injection portion 108 to allow withdrawal of the coagulating blood into a syringe. The process then includes 5 withdrawing the coagulating blood from the blister and then inject it into the abnormal hollowed space, e.g. fistula or into the sinus cavity in the instance that one or more of the openings of the abnormal hollowed space is sealed, e.g. by suturing procedure. This is exemplified in Fig. 1D, which shows blood with coagulating agents or anti- anticoagulating agents stored in a syringe 114 that is injected into a fistula FIS to permit 10 its coagulation therein.
Reference is now being made to Figs. 2A-2B, which are flow diagrams exemplifying different embodiments of a method according to an aspect of the present disclosure. The method being exemplified in Fig. 2A includes withdrawing whole blood from a subject 250 having an abnormal hollowed space to be treated, e.g. a fistula or an 15 anal fistula. The method further includes mixing the withdrawn blood with one or more coagulation agents or anti-anticoagulation agents 252. Then, the method includes introducing the blood and coagulation agent mixture into the abnormal hollowed space 254. This is performed while the blood is still in a flowable form, namely prior to its complete coagulation. While the blood is in the hollowed space, the method includes 20 permitting the blood to coagulate in the abnormal hollowed space 256, thereby forming a blood clot withing the abnormal hollowed space.
Reference is now being made to Fig. 2B, which differs from Fig. 2A by including after withdrawing whole blood from the subject 250 mixing the blood with one or more anti coagulation agents, thus inhibiting the natural clotting process of the blood and 25 allowing to controllably induce the clotting process thereof at a desired timing.
It is to be noted that in the instance it is required to seal one or more openings of the abnormal hollowed space, the method further includes sealing one or more of the openings to create a sinus into which the clotting blood is introduced.

Claims (10)

CLAIMED IS:
1. A kit for use in the treatment of an abnormal hollowed space of a subject, the kit comprising: one or more blood withdrawal devices for allowing withdrawal of blood from the 5 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 10 blood; and an 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 15 (i) withdrawing whole blood from the subject; (ii) mixing the subject's blood with said one or more coagulation agents or anti-anticoagulation agents; (iii) following said mixing and while the blood is still in a flowable form, introducing the blood with the coagulation agent into said hollowed space; 20 and permitting 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 vacuum tubes. 25
3. The kit of claim 1 or 2, wherein the coagulation assembly comprises a volume for introducing 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 agents for mixing with the withdrawn blood. 30
5. The kit of claim 4, wherein the one or more anti-coagulation agents are comprised within said one or more blood collection receptacles. - 8 -
6. The kit of claim 4 or 5, wherein the anticoagulation agent is selected from a groupd consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate. 5
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 said 10 abnormal 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 anal fistula.
10. The kit of any one of claims 1-9, wherein said abnormal hollowed space is a sinus. 15
IL280733A 2021-02-08 2021-02-08 Method and kit for treating abnormal hollowed space IL280733B2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
IL280733A IL280733B2 (en) 2021-02-08 2021-02-08 Method and kit for treating abnormal hollowed space
PCT/IL2022/050154 WO2022168099A1 (en) 2021-02-08 2022-02-06 Method and kit for treating abnormal hollowed space
US18/275,782 US20240100091A1 (en) 2021-02-08 2022-02-06 Method and kit for treating abnormal hollowed space
KR1020237029653A KR20230146552A (en) 2021-02-08 2022-02-06 Methods and kits for treating abnormal empty spaces
EP22705596.9A EP4288070A1 (en) 2021-02-08 2022-02-06 Method and kit for treating abnormal hollowed space
JP2023547065A JP2024509696A (en) 2021-02-08 2022-02-06 Methods and kits for treating abnormal cavity spaces

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IL280733A IL280733B2 (en) 2021-02-08 2021-02-08 Method and kit for treating abnormal hollowed space

Publications (3)

Publication Number Publication Date
IL280733A true IL280733A (en) 2022-09-01
IL280733B1 IL280733B1 (en) 2023-03-01
IL280733B2 IL280733B2 (en) 2023-07-01

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
IL280733A IL280733B2 (en) 2021-02-08 2021-02-08 Method and kit for treating abnormal hollowed space

Country Status (1)

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IL (1) IL280733B2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL286333A (en) * 2021-09-13 2022-12-01 Reddress Ltd Device and method for vaginal tissue treatment

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019150355A1 (en) * 2018-01-30 2019-08-08 Reddress Ltd. Blood applicator for tissue treatment

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019150355A1 (en) * 2018-01-30 2019-08-08 Reddress Ltd. Blood applicator for tissue treatment

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
GIOVANNI BISCEGLIA, MICHELE SANTODIROCCO, AUGUSTA FAIENZA, NICOLA MASTRODONATO, FILOMENA URBANO, ANGELA TOTARO, FRANCESCA BAZZOCCH, BISCEGLIA, 12 February 2020 (2020-02-12) *
KUSHNIR, IGAL ET AL., KUSHNIR ET AL., 9 September 2016 (2016-09-09) *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL286333A (en) * 2021-09-13 2022-12-01 Reddress Ltd Device and method for vaginal tissue treatment
IL286333B2 (en) * 2021-09-13 2023-04-01 Reddress Ltd Device and method for vaginal tissue treatment

Also Published As

Publication number Publication date
IL280733B1 (en) 2023-03-01
IL280733B2 (en) 2023-07-01

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