CA2375319A1 - Clotting cascade initiating apparatus and methods of use - Google Patents
Clotting cascade initiating apparatus and methods of use Download PDFInfo
- Publication number
- CA2375319A1 CA2375319A1 CA002375319A CA2375319A CA2375319A1 CA 2375319 A1 CA2375319 A1 CA 2375319A1 CA 002375319 A CA002375319 A CA 002375319A CA 2375319 A CA2375319 A CA 2375319A CA 2375319 A1 CA2375319 A1 CA 2375319A1
- Authority
- CA
- Canada
- Prior art keywords
- blood fluid
- agent
- negatively charged
- coagulating
- coagulating agent
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements 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
- A61B2017/00637—Implements 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 sealing trocar wounds through abdominal wall
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements 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
- A61B2017/00646—Type of implements
- A61B2017/0065—Type of implements the implement being an adhesive
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Informatics (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Cardiology (AREA)
- Materials For Medical Uses (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Physical Or Chemical Processes And Apparatus (AREA)
- Control For Baths (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Wound closure methods and apparatus are provided which utilize blood fluid by activating the clotting cascade of blood fluid outside the body within a substantially enclosed sterile container then introducing the blood fluid to the wound site to complete clotting. Methods and apparatus for providing ways of inhibiting anticoagulating agents in slowing fibrin clot degradation are also disclosed. Kits for practicing the invention singularly or in combination with and/or associated with preferred procedures are also disclosed. The present invention provides improved methods of creating hemostasis or control of bleeding at the site of wounds, particularly wounds created in arteries during procedures employing percutaneous access.
Claims (20)
1. A method of closing a wound in a patient, the method comprising the steps of:
a) treating a blood fluid with an agent which substantially reduces the anti-coagulating effect of a negatively charged anti-coagulating agent present in the blood fluid prior to treatment, the agent interacting with a negatively charged anti-coagulating agent in the blood fluid in a manner selected from the group consisting of binding the negatively charged anti-coagulating agent so as to substantially remove the negatively charged anti-coagulating agent from the blood fluid, degrading a negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent ineffective as an anti-coagulating agent and binding to the negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent substantially ineffective as an anti-coagulating agent which inhibits or impedes either the initiation or the continuance of a clotting cascade within the blood fluid;
and b) transporting the treated blood fluid to the wound in the patient such that the blood fluid comes into contact with the patient proximate the wound and the clotting cascade comes generally to a conclusion and a clot forms proximate the wound such that the clot prevents fluid from passing through the wound.
a) treating a blood fluid with an agent which substantially reduces the anti-coagulating effect of a negatively charged anti-coagulating agent present in the blood fluid prior to treatment, the agent interacting with a negatively charged anti-coagulating agent in the blood fluid in a manner selected from the group consisting of binding the negatively charged anti-coagulating agent so as to substantially remove the negatively charged anti-coagulating agent from the blood fluid, degrading a negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent ineffective as an anti-coagulating agent and binding to the negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent substantially ineffective as an anti-coagulating agent which inhibits or impedes either the initiation or the continuance of a clotting cascade within the blood fluid;
and b) transporting the treated blood fluid to the wound in the patient such that the blood fluid comes into contact with the patient proximate the wound and the clotting cascade comes generally to a conclusion and a clot forms proximate the wound such that the clot prevents fluid from passing through the wound.
2. The method of claim 1, wherein the step of treating the blood fluid includes treating the blood fluid with a procoagulating agent to initiate a clotting cascade during a first time period such that at least a portion of the blood fluid will form a clot of blood during a second time period subsequent to the first time period, the blood fluid containing sufficient blood components to enable a portion of the blood fluid to clot during the second time period subsequent to the initiation of the clotting cascade during the first time period; the blood fluid being selected from the group consisting of whole blood, natural components of whole blood, whether derived from whole blood, blood extracts, or products of ex-vivo cell cultures, and procoagulating agents which assist in or enhance the clotting or coagulation of the blood fluid.
3. The method of claim 1, wherein the negatively charged anti-coagulating agent is selected from the group consisting of heparin and hirudin.
4. The method of claim 1, wherein the negatively charged anti-coagulating agent is heparin.
5. The method of claim 2, wherein the procoagulating agent within the sterile containment chamber is sufficient to initiate a clotting cascade within the blood fluid and the step of treating the blood fluid will result in a blood fluid which contains up to about 25 micrograms of thrombin per milliliter of blood fluid.
6. The method of claim 1, wherein the agent which substantially reduces the anti-coagulating effect of the negatively charged anti-coagulating agent is a positively charged functional group bound to a surface within the sterile containment chamber.
7. The method of claim 1, wherein the agent which substantially reduces the anti-coagulating effect of the negatively charged anti-coagulating agent is positively charged polymer which is surface coated upon an exposed surface within the sterile containment chamber
8. The method of claim 1, wherein the agent which substantially reduces the anti-coagulating effect of the negatively charged anti-coagulating agent is a surface coated polymer selected from the group consisting of PEI and dPEI.
9. The method of claim 1, wherein the agent which substantially reduces the anti-coagulating effect of the negatively charged anti-coagulating agent is surface coated PEI.
10. An apparatus within which a blood fluid can be received, the blood fluid being useful for treatment of a wound within a patient, said apparatus comprising:
a substantially enclosed sterile containment chamber within which the blood fluid can be received, the substantially enclosed sterile containment chamber containing an agent which substantially reduces the anti-coagulating effect of a negatively charged anti-coagulating agent present in the blood fluid prior to treatment, the agent interacting with a negatively charged anti-coagulating agent in the blood fluid in a manner selected from the group consisting of binding the negatively charged anti-coagulating agent so as to substantially remove the negatively charged anti-coagulating agent from the blood fluid, degrading a negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent ineffective as an anti-coagulating agent and binding to the negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent substantially ineffective as an anti-coagulating agent which inhibits or impedes either the initiation or the continuance of a clotting cascade within the blood fluid.
a substantially enclosed sterile containment chamber within which the blood fluid can be received, the substantially enclosed sterile containment chamber containing an agent which substantially reduces the anti-coagulating effect of a negatively charged anti-coagulating agent present in the blood fluid prior to treatment, the agent interacting with a negatively charged anti-coagulating agent in the blood fluid in a manner selected from the group consisting of binding the negatively charged anti-coagulating agent so as to substantially remove the negatively charged anti-coagulating agent from the blood fluid, degrading a negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent ineffective as an anti-coagulating agent and binding to the negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent substantially ineffective as an anti-coagulating agent which inhibits or impedes either the initiation or the continuance of a clotting cascade within the blood fluid.
11. The apparatus of claim 10 further comprising a procoagulating agent within the sterile containment chamber; wherein a clotting cascade is initiated when the blood fluid is received in the sterile containment chamber and exposed to the procoagulating agent within the chamber, and the blood fluid can be delivered to a wound subsequent to the initiation of the clotting cascade, such that the clotting cascade, initiated within the sterile containment chamber prior to the delivery of the blood fluid to the wound, can be completed within the wound and a clot can form within the wound when the clotting cascade is completed.
12. The apparatus of claim 10, wherein the negatively charged anti-coagulating agent is selected from the group consisting of heparin and hirudin.
13. The apparatus of claim 10, wherein the negatively charged anti-coagulating agent is heparin.
14. The apparatus of claim 11, wherein the procoagulating agent within the sterile containment chamber is sufficient to initiate a clotting cascade within the blood fluid and the step of treating the blood fluid will result in a blood fluid which contains up to about 25 micrograms of thrombin per milliliter of blood fluid.
15. The apparatus of claim 10, wherein the agent which substantially reduces the anti-coagulating effect of the negatively charged anti-coagulating agent is a positively charged functional group bound to a surface within the sterile containment chamber.
16. The apparatus of claim 10, wherein the agent which substantially reduces the anti-coagulating effect of the negatively charged anti-coagulating agent is positively charged polymer which is surface coated upon an exposed surface within the sterile containment chamber
17. The apparatus of claim 10, wherein the agent which substantially reduces the anti-coagulating effect of the negatively charged anti-coagulating agent is a surface coated polymer selected from the group consisting of PEI and dPEI.
18. The apparatus of claim 10, wherein the agent which substantially reduces the anti-coagulating effect of the negatively charged anti-coagulating agent is surface coated PEI.
19. A method of closing a wound in a patient, said method comprising the steps of:
a) providing a clotting cascade initiation apparatus within which a blood fluid can be received, said apparatus including a substantially enclosed sterile containment chamber within which the blood fluid can be received; the containment chamber containing a procoagulating agent within the substantially enclosed sterile containment chamber; wherein a clotting cascade can be initiated when the blood fluid is placed into the sterile containment chamber and thereby exposed to the procoagulating agent; the containment chamber further containing an agent which substantially reduces the anti-coagulating effect of a negatively charged anti-coagulating agent present in the blood fluid prior to treatment, the agent interacting with a negatively charged anti-coagulating agent in the blood fluid in a manner selected from the group consisting of binding the negatively charged anti-coagulating agent so as to substantially remove the negatively charged anti-coagulating agent from the blood fluid, degrading a negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent ineffective as an anti-coagulating agent and binding to the negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent substantially ineffective as an anti-coagulating agent which inhibits or impedes either the initiation or the continuance of a clotting cascade within the blood fluid;
b) placing a sufficient amount of blood fluid into the containment chamber to provide a sufficient amount of blood fluid to enable the blood fluid to knit together to form a clot proximate the wound once the clotting cascade is initiated; and c) delivering the blood fluid to the wound subsequent to the initiation of the clotting cascade in the containment chamber such that the clotting cascade can be completed and a clot can form within the wound after the blood fluid is delivered to the wound.
a) providing a clotting cascade initiation apparatus within which a blood fluid can be received, said apparatus including a substantially enclosed sterile containment chamber within which the blood fluid can be received; the containment chamber containing a procoagulating agent within the substantially enclosed sterile containment chamber; wherein a clotting cascade can be initiated when the blood fluid is placed into the sterile containment chamber and thereby exposed to the procoagulating agent; the containment chamber further containing an agent which substantially reduces the anti-coagulating effect of a negatively charged anti-coagulating agent present in the blood fluid prior to treatment, the agent interacting with a negatively charged anti-coagulating agent in the blood fluid in a manner selected from the group consisting of binding the negatively charged anti-coagulating agent so as to substantially remove the negatively charged anti-coagulating agent from the blood fluid, degrading a negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent ineffective as an anti-coagulating agent and binding to the negatively charged anti-coagulating agent so as to make the negatively charged anti-coagulating agent substantially ineffective as an anti-coagulating agent which inhibits or impedes either the initiation or the continuance of a clotting cascade within the blood fluid;
b) placing a sufficient amount of blood fluid into the containment chamber to provide a sufficient amount of blood fluid to enable the blood fluid to knit together to form a clot proximate the wound once the clotting cascade is initiated; and c) delivering the blood fluid to the wound subsequent to the initiation of the clotting cascade in the containment chamber such that the clotting cascade can be completed and a clot can form within the wound after the blood fluid is delivered to the wound.
20. The method of claim 19, wherein the procoagulating agent within the sterile containment chamber is sufficient to initiate a clotting cascade within the blood fluid and the step of treating the blood fluid will result in a blood fluid which contains up to about 25 micrograms of thrombin per milliliter of blood fluid.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13683799P | 1999-06-01 | 1999-06-01 | |
| US60/136,837 | 1999-06-01 | ||
| PCT/US2000/015068 WO2000074575A1 (en) | 1999-06-01 | 2000-06-01 | Clotting cascade initiating apparatus and methods of use |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2375319A1 true CA2375319A1 (en) | 2000-12-14 |
| CA2375319C CA2375319C (en) | 2010-01-12 |
Family
ID=22474590
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002375319A Expired - Fee Related CA2375319C (en) | 1999-06-01 | 2000-06-01 | Clotting cascade initiating apparatus and methods of use |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US6482223B1 (en) |
| EP (1) | EP1180977B1 (en) |
| AT (1) | ATE538730T1 (en) |
| AU (1) | AU5311700A (en) |
| CA (1) | CA2375319C (en) |
| WO (1) | WO2000074575A1 (en) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000062828A1 (en) * | 1996-04-30 | 2000-10-26 | Medtronic, Inc. | Autologous fibrin sealant and method for making the same |
| JP2000509307A (en) * | 1996-04-30 | 2000-07-25 | メドトロニック，インコーポレイテッド | Method for producing autologous fibrin sealant |
| US6159232A (en) | 1997-12-16 | 2000-12-12 | Closys Corporation | Clotting cascade initiating apparatus and methods of use and methods of closing wounds |
| US6478808B2 (en) | 1997-12-17 | 2002-11-12 | Closys Corporation | Clotting cascade initiating apparatus and methods of use and methods of closing wounds |
| US20030069601A1 (en) * | 1998-12-15 | 2003-04-10 | Closys Corporation | Clotting cascade initiating apparatus and methods of use |
| AU5311700A (en) * | 1999-06-01 | 2000-12-28 | Closys Corporation | Clotting cascade initiating apparatus and methods of use |
| ES2491866T3 (en) | 1999-11-15 | 2014-09-08 | Piramal Healthcare (Canada) Limited | Temperature-controlled, pH-dependent, self-gelling aqueous biopolymer solution |
| DK1294414T3 (en) * | 2000-06-29 | 2006-07-24 | Biosyntech Canada Inc | Preparation and method of healing and regenerating cartilage and other tissues |
| ES2342048T3 (en) * | 2001-05-09 | 2010-07-01 | Biointeractions Ltd. | SYSTEM AND METHOD FOR SUTURING WOUNDS. |
| US20050228417A1 (en) * | 2004-03-26 | 2005-10-13 | Teitelbaum George P | Devices and methods for removing a matter from a body cavity of a patient |
| US20080045881A1 (en) * | 2004-03-26 | 2008-02-21 | University Of Southern California | Devices and methods for removing a matter from a body cavity of a patient |
| US8382794B2 (en) * | 2006-01-04 | 2013-02-26 | St. Jude Medical Puerto Rico Llc | Balloon insertion apparatus and method of sealing a tissue puncture |
| US20080280310A1 (en) * | 2007-05-09 | 2008-11-13 | Louis Panagopoulos | Testing for Blood Group Immunological Reaction Without the Use of Anti-Human Globulin |
| WO2010018447A1 (en) * | 2008-08-13 | 2010-02-18 | Del Corso, Andrea | Occlusion device for vascular surgery |
| EP2430982B1 (en) | 2008-08-26 | 2020-06-24 | St. Jude Medical, Inc. | System for sealing percutaneous punctures |
| US10231721B2 (en) | 2010-06-24 | 2019-03-19 | St. Croix Surgical Systems, Llc | Failsafe percutaneous wound barrier |
| CA2868862C (en) | 2012-09-25 | 2017-06-27 | Stem Cell Partners Llc | Method and apparatus for preparing single donor thrombin serum |
| WO2016105575A1 (en) | 2014-12-23 | 2016-06-30 | Siemens Healthcare Diagnostics Inc. | Proteolytic digestion of cardiac troponin i |
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| US3223083A (en) * | 1960-09-09 | 1965-12-14 | President And Directors Of Geo | Method for adhesively securing together skin and other soft tissue and bone |
| DE2834320A1 (en) | 1978-08-04 | 1980-02-28 | Tomic Dobrivoje | MEDICINES WITH ANTI-INFLAMMATORY AND BLOODSTILLING EFFECT |
| US4347243A (en) | 1979-10-04 | 1982-08-31 | Research Corporation | Acid soluble, pepsin resistant platelet aggregating material |
| AT366916B (en) | 1980-04-02 | 1982-05-25 | Immuno Ag | DEVICE FOR APPLICATING A TISSUE ADHESIVE BASED ON HUMAN OR ANIMAL PROTEINS |
| US4373023A (en) * | 1980-10-14 | 1983-02-08 | Massachusetts Institute Of Technology | Process for neutralizing heparin |
| US4852568A (en) | 1987-02-17 | 1989-08-01 | Kensey Nash Corporation | Method and apparatus for sealing an opening in tissue of a living being |
| US5330445A (en) | 1988-05-26 | 1994-07-19 | Haaga John R | Sheath for wound closure caused by a medical tubular device |
| NL8901350A (en) | 1989-05-29 | 1990-12-17 | Wouter Matthijs Muijs Van De M | CLOSURE ASSEMBLY. |
| US5000854A (en) | 1989-06-14 | 1991-03-19 | The University Of Michigan | Protamine-based filter device for removal of heparin from blood samples |
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| US5151192A (en) | 1990-07-13 | 1992-09-29 | Pall Corporation | Method for removing heparin from blood or plasma |
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| DK83092D0 (en) | 1992-06-24 | 1992-06-24 | Unes As | PROCEDURE FOR THE EXTRACTION OF THROMBIN |
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| US5510102A (en) | 1995-01-23 | 1996-04-23 | The Regents Of The University Of California | Plasma and polymer containing surgical hemostatic adhesives |
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| US6197289B1 (en) * | 1997-07-01 | 2001-03-06 | Terumo Cardiovascular Systems Corporation | Removal of biologically active agents |
| US6146771A (en) | 1997-07-01 | 2000-11-14 | Terumo Cardiovascular Systems Corporation | Process for modifying surfaces using the reaction product of a water-insoluble polymer and a polyalkylene imine |
| US6033427A (en) | 1998-01-07 | 2000-03-07 | Lee; Benjamin I. | Method and device for percutaneous sealing of internal puncture sites |
| AU5311700A (en) * | 1999-06-01 | 2000-12-28 | Closys Corporation | Clotting cascade initiating apparatus and methods of use |
-
2000
- 2000-06-01 AU AU53117/00A patent/AU5311700A/en not_active Abandoned
- 2000-06-01 CA CA002375319A patent/CA2375319C/en not_active Expired - Fee Related
- 2000-06-01 US US09/585,488 patent/US6482223B1/en not_active Expired - Lifetime
- 2000-06-01 EP EP00938020A patent/EP1180977B1/en not_active Expired - Lifetime
- 2000-06-01 AT AT00938020T patent/ATE538730T1/en active
- 2000-06-01 WO PCT/US2000/015068 patent/WO2000074575A1/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| US6482223B1 (en) | 2002-11-19 |
| EP1180977A4 (en) | 2007-08-22 |
| EP1180977A1 (en) | 2002-02-27 |
| CA2375319C (en) | 2010-01-12 |
| AU5311700A (en) | 2000-12-28 |
| WO2000074575A1 (en) | 2000-12-14 |
| ATE538730T1 (en) | 2012-01-15 |
| EP1180977B1 (en) | 2011-12-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20150601 |