IL287589A - Method and kit for treating abnormal hollowed space - Google Patents
Method and kit for treating abnormal hollowed spaceInfo
- Publication number
- IL287589A IL287589A IL287589A IL28758921A IL287589A IL 287589 A IL287589 A IL 287589A IL 287589 A IL287589 A IL 287589A IL 28758921 A IL28758921 A IL 28758921A IL 287589 A IL287589 A IL 287589A
- Authority
- IL
- Israel
- Prior art keywords
- blood
- hollowed space
- space
- kit
- coagulation
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims description 59
- 230000002159 abnormal effect Effects 0.000 title claims description 44
- 239000008280 blood Substances 0.000 claims description 72
- 210000004369 blood Anatomy 0.000 claims description 72
- 230000015271 coagulation Effects 0.000 claims description 36
- 238000005345 coagulation Methods 0.000 claims description 36
- 239000003146 anticoagulant agent Substances 0.000 claims description 22
- 239000003795 chemical substances by application Substances 0.000 claims description 16
- 208000004680 Rectal Fistula Diseases 0.000 claims description 12
- 206010002156 anal fistula Diseases 0.000 claims description 12
- 238000002347 injection Methods 0.000 claims description 10
- 239000007924 injection Substances 0.000 claims description 10
- 238000007789 sealing Methods 0.000 claims description 9
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 8
- DEFVIWRASFVYLL-UHFFFAOYSA-N ethylene glycol bis(2-aminoethyl)tetraacetic acid Chemical compound OC(=O)CN(CC(O)=O)CCOCCOCCN(CC(O)=O)CC(O)=O DEFVIWRASFVYLL-UHFFFAOYSA-N 0.000 claims description 8
- 150000003904 phospholipids Chemical class 0.000 claims description 8
- 229960004494 calcium gluconate Drugs 0.000 claims description 7
- 239000004227 calcium gluconate Substances 0.000 claims description 7
- 235000013927 calcium gluconate Nutrition 0.000 claims description 7
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 claims description 7
- 239000005995 Aluminium silicate Substances 0.000 claims description 6
- 235000012211 aluminium silicate Nutrition 0.000 claims description 6
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 claims description 6
- 230000003187 abdominal effect Effects 0.000 claims description 5
- IJRKANNOPXMZSG-SSPAHAAFSA-N 2-hydroxypropane-1,2,3-tricarboxylic acid;(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanal Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O.OC(=O)CC(O)(C(O)=O)CC(O)=O IJRKANNOPXMZSG-SSPAHAAFSA-N 0.000 claims description 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 4
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims description 4
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 claims description 4
- 102000007327 Protamines Human genes 0.000 claims description 4
- 108010007568 Protamines Proteins 0.000 claims description 4
- 229960002897 heparin Drugs 0.000 claims description 4
- 229920000669 heparin Polymers 0.000 claims description 4
- 229950008679 protamine sulfate Drugs 0.000 claims description 4
- 239000000243 solution Substances 0.000 claims description 4
- 238000001356 surgical procedure Methods 0.000 claims description 4
- -1 Calcium Gluconate) Chemical class 0.000 claims description 3
- 229940127219 anticoagulant drug Drugs 0.000 claims description 3
- 159000000007 calcium salts Chemical class 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 230000000977 initiatory effect Effects 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 239000000843 powder Substances 0.000 claims description 2
- 206010016717 Fistula Diseases 0.000 description 10
- 230000003890 fistula Effects 0.000 description 10
- 230000001112 coagulating effect Effects 0.000 description 7
- 230000035876 healing Effects 0.000 description 4
- 210000000664 rectum Anatomy 0.000 description 3
- 206010053567 Coagulopathies Diseases 0.000 description 2
- 230000035602 clotting Effects 0.000 description 2
- 239000011796 hollow space material Substances 0.000 description 2
- 208000000528 Pilonidal Sinus Diseases 0.000 description 1
- 206010035043 Pilonidal cyst Diseases 0.000 description 1
- 239000000701 coagulant Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
Landscapes
- Crystals, And After-Treatments Of Crystals (AREA)
- Materials For Medical Uses (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 9,180,142Acknowledgement 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, e.g. an anal fistula or a stoma space. The term "abnormal hollowed space" in the context of the present disclosure should be interpreted as an abnormal cavity that is formed in human or nonhuman animal due to or in a result of a certain medical condition. 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.Typically, the hollowed space treated, in accordance with this disclosure, includes at least one opening at the external surface of the body. Namely, the hollowed space is accessible through an opening that is formed at a portion of the skin of the subject.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 comprises: (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. The clot may be maintained in the space into which it was injected for a defined period of time, e.g., hours or days, or maintained throughout the healing process, whereupon it is either absorbed or naturally pushed out of the healing hollowed space.In some embodiments of the method, comprises withdrawing whole blood from the subject and mixing it with an anticoagulation agent prior to introduction of the blood into the hollow space to be treated. This allows a control of the coagulation process, e.g., fine-tuning of the coagulation time and the physical properties of the resulting coagulated blood by the nature of the anticoagulant or its concentration.In some embodiments of the method, the anticoagulant is selected from a group 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 comprises, 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), above.In some embodiments, the method further comprises (iv) 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, the method further comprises sealing one of the openings of the abnormal hollowed space by inflating an inflatable element to occlude one of the openings. For example, in the case of an annal fistula, such inflation of an inflatable element may be in the rectum; the walls of the inflatable element thereby sealing the fistula's opening into the rectal lumen. After the opening is sealed by the inflated element, the coagulating blood is introduced into the abnormal hollowed space through a nonoccluded opening. The inflatable element may, in some cases, maintained in situ for a limited time, e.g. after permitting the blood to coagulate within the abnormal hollowed space to a sufficient degree, the inflatable element may be deflated and retrieved. This is particularly relevant in the case of anal fistula, wherein one of the openings of the anal fistula is in the wall of the rectal lumen, while the blood is introduced from the opening formed on the external skin near the annus. Thus, the inflatable element is introduced via the rectum in a non-inflatable state and once in position is inflated to the inflated state to seal the opening into the rectal lumen and only after such sealing the coagulating blood is introduced via the external opening. The blood is then allowed to be coagulated within the hollowed space of the anal fistula, e.g. for several minutes and the inflatable element may then be deflated and removed. Once the blood is sufficiently coagulated, the inflatable element may not be required to retain the coagulant within the anal fistula is deflated to the non-inflated state and retrieved via the rectum and the coagulated blood remains within the hollowed space of the anal fistula.By some embodiments of the method, a medical dressing or a seal is applied onto an opening of the treated hollowed space, which may be immediately or after a time period following the introduction of the coagulating blood thereinto, e.g., 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 typically the time frame for permitting the blood to coagulate within 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 hollowed space is a pilonidal sinus.In some embodiments of the method, the blood is introduced or injected into the abnormal hollowed space in defined injection profile. The injection profile comprises first injecting the blood to a distal end of the hollowed space until filling the entire space, namely until the blood fills said space up to its proximal end. This profile allows to prevent inflation of the abnormal hollowed space, e.g. the fistula, in case it is flexible and to ensure that the injected blood fills the entire volume 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 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.In some embodiments of the method, at least one of the openings of the abnormal hollowed space is formed at an external surface portion of the body of the subject. Thus, said at least one opening is accessible to the introduction of coagulating blood thereto without the need to penetrate through a skin portion. Depending on the site of the abnormal hollow space to be treated, the opening can be formed, for example, on a rectal portion, an abdominal portion, or any other exposed portion on the body of the subject.In some embodiments of the method, said hollowed space is an abdominal space. The abdominal space can for as a result of a stoma or stoma reversal surgery and the blood can be introduced through the stoma opening that constitutes an opening of the abnormal hollowed space. In a stoma reversal surgery, the coagulating blood that is introduced into the abdominal space contacts the stoma opening and also the rejoined bowel ends that were separated during the stoma surgery. The blood is then coagulated on the tissues to be healed, i.e. the stoma opening and the attachment interface between the two rejoined bowel ends, and enhances the healing process.Yet another aspect of the present disclosure provides a kit of parts or a system for use in the treatment an abnormal hollowed space or cavity of a subject. The kit or system comprising one or more blood withdrawal devices for blood withdrawal from the subject; one or more blood collection receptacles for receiving the blood withdrawn from the subject; a coagulation assembly configured for mixing of the withdrawn blood with one or more coagulation agents for initiating coagulation process of the withdrawn blood; and an applicator for introducing the coagulating blood into the hollowed space.In some embodiments of the kit or system, the one or more collection receptacles are vacuum tubes.In some embodiments of the kit or system, the coagulation assembly comprises an enclosure for receiving the withdrawn blood and mixing it with one or more coagulation agents or anti-anticoagulation agents.In some embodiments, the kit further comprises one or more anticoagulation agents for mixing with the withdrawn blood to prevent its natural coagulation process and allow to controllably induce its coagulation 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. Figs. 3A-3Eare schematic illustrations presenting different stages of a procedure for treating an anal fistula.
Claims (31)
1. A method for treating an abnormal hollowed space of a subject, the methodcomprising:(i) withdrawing 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 abnormal hollowed space.
2. The method of claim 1, wherein (i) comprises withdrawing whole blood from thesubject and mixing it with an anticoagulation agent.
3. The method of claim 2, wherein the anticoagulant is selected from a groupconsisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate.
4. The method of any one of claims 1-3, comprising, where said hollowed space hastwo or more openings, sealing one or more openings of the hollowed space for the creation of sinus.
5. The method of any one of claims 1-4, wherein (iv) comprises applying a medicaldressing or a seal onto an opening of the hollowed space.
6. The method of claim 5, wherein said applying is performed after a period of timeless than 10 minutes from said introducing.
7. The method of any one of claims 1-6, wherein the one or more coagulation agentsare in a liquid or powder form.
8. The method of any one of claims 1-7, wherein said one or more coagulation agentsor 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.
9. The method of any one of claims 1-8, wherein (ii) comprises first mixing the bloodwith calcium gluconate followed by mixing the blood and calcium gluconate mixture with Kaolin. - 10 -
10. The method of any one of claims 1-9, comprising, prior to (iii), sealing the abnormal hollowed space with a seal having an injection port, followed by (iii), wherein said introducing is via the injection port.
11. The method of any one of claims 1-10, wherein said hollowed space comprises at least one opening that is formed on an external surface of the body.
12. The method of any one of claims 1-11, wherein said hollowed space is anal fistula.
13. The method of any one of claims 1-12, wherein said hollowed space is a sinus.
14. The method of any one of claims 1-11, wherein said hollowed space is anabdominal space.
15. The method of claim 14, wherein said hollowed space is a stoma space formed in a result of a stoma surgery.
16. The method of claim 14 or 15, wherein at least one opening of the hollowed space is a stoma opening.
17. The method of any one of claims 1-16, wherein said abnormal hollowed space comprises two or more openings and the method further comprises, prior to (iii), bringing an inflatable/deflatable element in its deflated state adjacent to one of the openings and inflating it to seal the opening to thereby allow maintaining of the blood in the hollowed space when it is introduced thereto via a non-sealed opening.
18. The method of claim 17, further comprising deflating the inflatable/deflatable element following sufficient coagulation of the blood within the hollowed space and retrieving the inflatable/deflatable element.
19. A kit for use in the treatment an abnormal hollowed space 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; andan applicator for introducing the incomplete coagulated blood into the hollowed space. - 11 -
20. The kit of claim 19, wherein said one or more collection receptacles are vacuum tubes.
21. The kit of claim 19 or 20, 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.
22. The kit of any one of claims 19-21, comprising one or more anticoagulation agents for mixing with the withdrawn blood.
23. The kit of claim 22, wherein the one or more anti-coagulation agents are comprised within said one or more blood collection receptacles.
24. The kit of claim 22 or 23, wherein the anticoagulation agent is selected from agroup consisting of: ACD-A (Anticoagulant Citrate Dextrose, Solution A), EDTA (ethylenediaminetetraacetic Acid), EGTA (ethylene glycol tetraacetic acid), a citrate, Heparin and oxalate.
25. The kit of any one of claims 19-24, said one or more coagulation agents or anti- anticoagulating agents are selected from: Kaolin, Ca2+, Mg2+, negatively charged phospholipid (PL) and protamine sulfate.
26. The kit of any one of claims 19-25, comprising a seal for sealing an opening of said abnormal hollowed space, said seal comprises an injection port for allowing injection of blood to the abnormal hollowed space via said seal.
27. The kit of any one of claims 19-26, wherein said abnormal hollowed space is an anal fistula.
28. The kit of any one of claims 19-27, wherein said abnormal hollowed space is a sinus.
29. The kit of any one of claims 19-27, wherein said abnormal hollowed space is an abdominal space.
30. The kit of any one of claims 19-29, for use in a method for treating an abnormal hollowed space of a subject, the method comprising:(i) withdrawing whole blood from the subject;(ii) mixing the subject's blood with one or more coagulation agentsor anti-anticoagulation agents;(iii) prior to complete coagulation of the blood, introducing theblood with the coagulation agent into said hollowed space; and(iv) permitting the blood to coagulate in said space. - 12 -
31. The kit of any one of claims 19-29, for use in a method according to any one of claims 1-18.
Priority Applications (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IL287589A IL287589A (en) | 2021-10-26 | 2021-10-26 | Method and kit for treating abnormal hollowed space |
| CN202280013479.5A CN117295504A (en) | 2021-02-08 | 2022-02-06 | Method and kit for treating abnormal hollow spaces |
| JP2023547065A JP2024509696A (en) | 2021-02-08 | 2022-02-06 | Methods and kits for treating abnormal cavity spaces |
| EP22705596.9A EP4288070A1 (en) | 2021-02-08 | 2022-02-06 | 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 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IL287589A IL287589A (en) | 2021-10-26 | 2021-10-26 | Method and kit for treating abnormal hollowed space |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| IL287589A true IL287589A (en) | 2023-05-01 |
Family
ID=86850829
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IL287589A IL287589A (en) | 2021-02-08 | 2021-10-26 | Method and kit for treating abnormal hollowed space |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN117295504A (en) |
| IL (1) | IL287589A (en) |
-
2021
- 2021-10-26 IL IL287589A patent/IL287589A/en unknown
-
2022
- 2022-02-06 CN CN202280013479.5A patent/CN117295504A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| CN117295504A (en) | 2023-12-26 |
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