CA1199275A - Method of achieving hemostasis - Google Patents
Method of achieving hemostasisInfo
- Publication number
- CA1199275A CA1199275A CA000397650A CA397650A CA1199275A CA 1199275 A CA1199275 A CA 1199275A CA 000397650 A CA000397650 A CA 000397650A CA 397650 A CA397650 A CA 397650A CA 1199275 A CA1199275 A CA 1199275A
- Authority
- CA
- Canada
- Prior art keywords
- chitosan
- blood
- vascular
- hemostasis
- carrier
- 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.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
- A61L33/06—Use of macromolecular materials
- A61L33/08—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/04—Materials for stopping bleeding
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/915—Method or apparatus for preparing biological material
Abstract
Abstract of the Disclosure The method of achieving hemostasis in wounds, vascular grafts, vascular patches, cardiac valves and the like is described. Hemostasis is achieved in open wounds by topically administering chitosan, in liquid or powder form, to the wound. Hemostasis is achieved in vascular grafts, vascular patches, cardiac valves and areas to be sutured by either topically administering chitosan to the grafts, patches, valves and sutures or incorporating chitosan in the material of the grafts, patches, valves and sutures.
Description
METHOD OF ~CHIEVING ~-IEMOS'I'ASIS
Medicine has lol-g sought for a surface hemostatic agent which will act independently of normal clotting n~echanisms.
Present hemostatic agents such as gelatin sponges and purified blood proteins depenci upon the natural clotting mechanisms for hemostasis. Patients who require an-ticoagulation for hypercoagulability and who are in danger o embolus are at high risk~ Patlents undergoing open heart operations must be anticoagulated during the period that they lO are dependent upon the pump oxgenator which leads to extensive blood loss during the procedure and during the immediate recovery period. Patients with hemophilia must be given highly expensive blood fractions during the surgical period.
Chitosan is a collective term applied -to deacetylated chitins in various stages of deacetylation and depolymeriza~
tion~ Chitin is the structural polymer of the exo-skeleton of arthropods and cell walls of fungi~ It is composed of poly-N Acetyl glucosamine units. These are 11nked by Beta 1-20 4 glycosidic bonds into a linear polymer containing 2,000 to3r000 units. United States Patent No. 3,533,940 describes the technology for the preparation of chitosan~
Chitosan is a derivative o solid waste from sllell fish processing and can be extractd from fungus culture. Chitin is generally isolated and purified by first dissolving away the inorganic material, calcium carbonate, by treatment with hydrochloric acid. ~fter the protein material is removed by digestion with hot diluted alkali, the chitin i5 bleached with permanganate followed by treatment with oxalic acid.
30 Partial deacetyli~ation o chitin by treatment with concell-,~ ., ~1~a~ A9 trated alkali solution at 130 to 150 degrees centlgrade yields products which are soluable in dilute acetic acid~
A common method to convert crab shell is as follows:
The calciu~ carbonate is removed by immersiny the shell in cold dilute hydrochloric acid, two to three hours are allowed for the reactionO The shell is then thoroughly rlnsed with water. Protein is removed by treating the shell with caustic soda (3~ strength) The shell is cooked in a 3~ sodium hydroxide solution for a period of two hours at a temperature lO of 100C and at atsnospheric pressure~ The remains are rinsed thoroughly with water to remove all traces of sodium hydroxide and protein. The material is then bleached with potassium permanyanate solution and rinsed with water. The material is then treated with oxalic acid to remove the permanganate solution. The rnaterial is then treated with a 40% caustic soda solution at 150Q C to partially deacetylate the chitinn This results ln the forrnation of chitosan. By varying the amount of deacetylation, var;ous viscosities of chitosan can be producedO The final pH of the chitosan 20 solution is in the range of 4-5. It is possible to utiliæe chitosan in the following applications in various pHIs and viscosities. However~ the ideal mode is a solution of 2gms.
of chitosan per liter of acetic acid solution.
The prior art teaches that chitosan, when sulfated, acts as a weak anticoagulant in vitro and when given to animals. However~ the experiments conducted by the inventors herein have found that chitosan (not sulfated) acts co~pletely differently frorn that described in the prior art and that it does ac~ as a fast and firm coagulating agent.
Therefore, it is a principal object of the invention to ~3~'~7~
provide a method of achieving hemostasis in the absence of the normal clotting mechanisms.
A further object oE the invention is ~o provide a method of achieving hemostasis in open wounds.
A further ob ject of the invention is to provide a method of achieving hemostasis in vascular grafts, vascular patches, cardiac valves and areas to be sutured~
A still further object of the inven~ion is to provide a method of achieving hernostasis through the use of chi-tosan.
These and other ob jects will be apparent to those skilled in the art~
Hemostasis is achieved in open wounds by placing chitosan, in liquid or powder form, in contact with the wound. Hemostasis in vascular grafts and vascular patches is achieved by either topically administering chitosan to the graft or patch or by incorporating chitosan in the material of the graft or patch. In areas to be sutured, hemostasis is achieved by either topically administering chitosan to the suture or by incorporating the chitosan into the suture or by 20 incorporating the chitosan in the material of the suture.
Further, hemostasis is achieved in cardiac valve surgery by topically administering chitosan to the valve or by incorporating chitosan in the material of the valve.
The inventors herein have discovered that chitosan, in li~uid or powder ormr does act as a fast and firm coagulating agent. The following experiments were conducted which supports the theory that chitosan is a coagulating agentO
EXAMPLE I
Normal human blood, without anticoagulation/ was drawn ~ 3~ 9 al~d placed in s~?v~ral tt`s~ tubes. Normcil bloocl wi~hout chitosan was founcl to Lorm a clot irl ten minutes. One milli-liter (ml.) aliquots o bloocl were placed ir, the test tuhes with descendillg aliquots of chitosan placed therein. It was ound that the blood having one milliliter of chitosan solution therein clotted in less ~han two minutes. Eight-tenths of a milliliter of chitosan solution in one milliliter of blood clotted in three and one-half minutes. Six-tenths of a milliliter of chitosan solution in one milliliter of lG blood clotted in four minutesO
EXAMPLE II
Five test tubes containing 1 ml. of heparinized blood were inltially prepared. Chitosan solution was added to four of the test tubes in the amounts of 1 ml.~ 8/10ths of a mlO, 6/10ths of a ml., and ~/10ths of a ml., respectively~ One of the heparinized blood samples was not -treated with chitosan so that the sample would act as a control sample. In the test tube containing 1 ml. of chitosan, the heparinized blood clotted in one minute and fifteen seconds. The 8/10ths of a 20 ml. sample clotted in one minute and forty-five seconds. The 6/10ths and 4/10ths samples required more time to clot. The control tube containing the heparinized blood without chitosan did not clotO This experiment reveals that the normal clotting mechanism o the blood is not necessary for the coagulum prod~ced by chi-tosan.
EXAMPLE III
Blood that has physically been de'-ibrinated contains none of the clotting factors of normal blood. Blood, being defibrinated, eliminates all of the factors in normal blood 30 clotting. One ml. of chitosan solution was added to 1 ml~ of defibrinatecl blood at~c1 a firm bl~od clot was achieved in forty seconds. A con~.rol. tube cont.aining the same blood ~ut without chitosan did not clot. Irhi.s experiment: reveals ~hat neither fibrinogen nor any of the other clotting factors need be present in the coagulation reaction of chitosan in blood.
EXAMPLE I_ This experiment was conducted to determine whether serum proteins could in some way be involved i.n the clot formed by chitosan and blood~ A 5~ human serum albumin in 10 aliquots was combined with a chitosan solution with no observable clot being formed.
EXAMPLE V
_ Human serum globulin (165 my~ per ml) was mixed with a chitosan solution with no resultant clot being formed. The results of Examples IV and V reveal that the coagulation observed with chitosan and blood is not dependent upon albumin or globulin.
EXAMPLE VI
The cellular components of blood were washed four times in saline to remove the plasma and suspended in saline to their normal hematocrit. Washed red cells at a 40~
hematocrit mixture was mixed one to one with chitosan. A
firm clot was obtained in thirty seconds. This experiment indica~es that the presence of cellular components in blood are active in forming the coagulum induced by chitosanO
~ hus, the experiments or examples listed above indicate that chitosan inay be employed to achieve hemos~asis.
Chitosan may be employed in medicine and surgery by either direc~ application of the viscous liquid chitosan~
lyophilized powder of such a solution or driedt firlely groulld material~ The dry ~orrns of ct~itosan may be applied by insufflation~ dusting or direct appliccltion. Ihe chitosan may also be applied to such prostheses as vascular yrafts, heart valves, vascular patches or other prostheses. When the chitosan material is applied to open wounds, as described above, hemostasis will be achievedO Further, the incorpora-tion of or the application to vascular graLts, heart valves, vascular patches, etc. w;ll enhance the hemo~tatic action.
Thus it can be seen that a novel method of achieving 10 hemostasis through the use of chitosan has been described~
Medicine has lol-g sought for a surface hemostatic agent which will act independently of normal clotting n~echanisms.
Present hemostatic agents such as gelatin sponges and purified blood proteins depenci upon the natural clotting mechanisms for hemostasis. Patients who require an-ticoagulation for hypercoagulability and who are in danger o embolus are at high risk~ Patlents undergoing open heart operations must be anticoagulated during the period that they lO are dependent upon the pump oxgenator which leads to extensive blood loss during the procedure and during the immediate recovery period. Patients with hemophilia must be given highly expensive blood fractions during the surgical period.
Chitosan is a collective term applied -to deacetylated chitins in various stages of deacetylation and depolymeriza~
tion~ Chitin is the structural polymer of the exo-skeleton of arthropods and cell walls of fungi~ It is composed of poly-N Acetyl glucosamine units. These are 11nked by Beta 1-20 4 glycosidic bonds into a linear polymer containing 2,000 to3r000 units. United States Patent No. 3,533,940 describes the technology for the preparation of chitosan~
Chitosan is a derivative o solid waste from sllell fish processing and can be extractd from fungus culture. Chitin is generally isolated and purified by first dissolving away the inorganic material, calcium carbonate, by treatment with hydrochloric acid. ~fter the protein material is removed by digestion with hot diluted alkali, the chitin i5 bleached with permanganate followed by treatment with oxalic acid.
30 Partial deacetyli~ation o chitin by treatment with concell-,~ ., ~1~a~ A9 trated alkali solution at 130 to 150 degrees centlgrade yields products which are soluable in dilute acetic acid~
A common method to convert crab shell is as follows:
The calciu~ carbonate is removed by immersiny the shell in cold dilute hydrochloric acid, two to three hours are allowed for the reactionO The shell is then thoroughly rlnsed with water. Protein is removed by treating the shell with caustic soda (3~ strength) The shell is cooked in a 3~ sodium hydroxide solution for a period of two hours at a temperature lO of 100C and at atsnospheric pressure~ The remains are rinsed thoroughly with water to remove all traces of sodium hydroxide and protein. The material is then bleached with potassium permanyanate solution and rinsed with water. The material is then treated with oxalic acid to remove the permanganate solution. The rnaterial is then treated with a 40% caustic soda solution at 150Q C to partially deacetylate the chitinn This results ln the forrnation of chitosan. By varying the amount of deacetylation, var;ous viscosities of chitosan can be producedO The final pH of the chitosan 20 solution is in the range of 4-5. It is possible to utiliæe chitosan in the following applications in various pHIs and viscosities. However~ the ideal mode is a solution of 2gms.
of chitosan per liter of acetic acid solution.
The prior art teaches that chitosan, when sulfated, acts as a weak anticoagulant in vitro and when given to animals. However~ the experiments conducted by the inventors herein have found that chitosan (not sulfated) acts co~pletely differently frorn that described in the prior art and that it does ac~ as a fast and firm coagulating agent.
Therefore, it is a principal object of the invention to ~3~'~7~
provide a method of achieving hemostasis in the absence of the normal clotting mechanisms.
A further object oE the invention is ~o provide a method of achieving hemostasis in open wounds.
A further ob ject of the invention is to provide a method of achieving hemostasis in vascular grafts, vascular patches, cardiac valves and areas to be sutured~
A still further object of the inven~ion is to provide a method of achieving hernostasis through the use of chi-tosan.
These and other ob jects will be apparent to those skilled in the art~
Hemostasis is achieved in open wounds by placing chitosan, in liquid or powder form, in contact with the wound. Hemostasis in vascular grafts and vascular patches is achieved by either topically administering chitosan to the graft or patch or by incorporating chitosan in the material of the graft or patch. In areas to be sutured, hemostasis is achieved by either topically administering chitosan to the suture or by incorporating the chitosan into the suture or by 20 incorporating the chitosan in the material of the suture.
Further, hemostasis is achieved in cardiac valve surgery by topically administering chitosan to the valve or by incorporating chitosan in the material of the valve.
The inventors herein have discovered that chitosan, in li~uid or powder ormr does act as a fast and firm coagulating agent. The following experiments were conducted which supports the theory that chitosan is a coagulating agentO
EXAMPLE I
Normal human blood, without anticoagulation/ was drawn ~ 3~ 9 al~d placed in s~?v~ral tt`s~ tubes. Normcil bloocl wi~hout chitosan was founcl to Lorm a clot irl ten minutes. One milli-liter (ml.) aliquots o bloocl were placed ir, the test tuhes with descendillg aliquots of chitosan placed therein. It was ound that the blood having one milliliter of chitosan solution therein clotted in less ~han two minutes. Eight-tenths of a milliliter of chitosan solution in one milliliter of blood clotted in three and one-half minutes. Six-tenths of a milliliter of chitosan solution in one milliliter of lG blood clotted in four minutesO
EXAMPLE II
Five test tubes containing 1 ml. of heparinized blood were inltially prepared. Chitosan solution was added to four of the test tubes in the amounts of 1 ml.~ 8/10ths of a mlO, 6/10ths of a ml., and ~/10ths of a ml., respectively~ One of the heparinized blood samples was not -treated with chitosan so that the sample would act as a control sample. In the test tube containing 1 ml. of chitosan, the heparinized blood clotted in one minute and fifteen seconds. The 8/10ths of a 20 ml. sample clotted in one minute and forty-five seconds. The 6/10ths and 4/10ths samples required more time to clot. The control tube containing the heparinized blood without chitosan did not clotO This experiment reveals that the normal clotting mechanism o the blood is not necessary for the coagulum prod~ced by chi-tosan.
EXAMPLE III
Blood that has physically been de'-ibrinated contains none of the clotting factors of normal blood. Blood, being defibrinated, eliminates all of the factors in normal blood 30 clotting. One ml. of chitosan solution was added to 1 ml~ of defibrinatecl blood at~c1 a firm bl~od clot was achieved in forty seconds. A con~.rol. tube cont.aining the same blood ~ut without chitosan did not clot. Irhi.s experiment: reveals ~hat neither fibrinogen nor any of the other clotting factors need be present in the coagulation reaction of chitosan in blood.
EXAMPLE I_ This experiment was conducted to determine whether serum proteins could in some way be involved i.n the clot formed by chitosan and blood~ A 5~ human serum albumin in 10 aliquots was combined with a chitosan solution with no observable clot being formed.
EXAMPLE V
_ Human serum globulin (165 my~ per ml) was mixed with a chitosan solution with no resultant clot being formed. The results of Examples IV and V reveal that the coagulation observed with chitosan and blood is not dependent upon albumin or globulin.
EXAMPLE VI
The cellular components of blood were washed four times in saline to remove the plasma and suspended in saline to their normal hematocrit. Washed red cells at a 40~
hematocrit mixture was mixed one to one with chitosan. A
firm clot was obtained in thirty seconds. This experiment indica~es that the presence of cellular components in blood are active in forming the coagulum induced by chitosanO
~ hus, the experiments or examples listed above indicate that chitosan inay be employed to achieve hemos~asis.
Chitosan may be employed in medicine and surgery by either direc~ application of the viscous liquid chitosan~
lyophilized powder of such a solution or driedt firlely groulld material~ The dry ~orrns of ct~itosan may be applied by insufflation~ dusting or direct appliccltion. Ihe chitosan may also be applied to such prostheses as vascular yrafts, heart valves, vascular patches or other prostheses. When the chitosan material is applied to open wounds, as described above, hemostasis will be achievedO Further, the incorpora-tion of or the application to vascular graLts, heart valves, vascular patches, etc. w;ll enhance the hemo~tatic action.
Thus it can be seen that a novel method of achieving 10 hemostasis through the use of chitosan has been described~
Claims (7)
1. A means for achieving hemostasis, comprising, a carrier, said carrier including chitosan.
2. The means of claim 1 wherein the chitosan is applied to the carrier in liquid form.
3. The means of claim 1 wherein the chitosan is applied to the carrier in powder form.
4. The means of claim 1 wherein the carrier is a vascular graft and the chitosan is incorporated in the material of the vascular graft.
5. The means of claim 1 wherein the carrier is a vascular patch and the chitosan is incorporated in the material of the vascular patch.
6. The means of claim 1 wherein the carrier is a suture and the chitosan is incorporated in the material of the suture.
7. The means of claim 1 wherein the carrier is a cardiac valve and the chitosan is incorporated in the material of the cardiac valve.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US06/251,321 US4394373A (en) | 1981-04-06 | 1981-04-06 | Method of achieving hemostasis |
| US251,321 | 1981-04-06 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1199275A true CA1199275A (en) | 1986-01-14 |
Family
ID=22951443
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000397650A Expired CA1199275A (en) | 1981-04-06 | 1982-03-05 | Method of achieving hemostasis |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US4394373A (en) |
| CA (1) | CA1199275A (en) |
| GB (1) | GB2095995B (en) |
| MX (1) | MX7556E (en) |
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Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3903268A (en) * | 1968-02-12 | 1975-09-02 | Lescarden Ltd | Chitin and chitin derivatives for promoting wound healing |
| US3911116A (en) * | 1970-04-13 | 1975-10-07 | Leslie L Balassa | Process for promoting wound healing with chitin derivatives |
| US3914414A (en) * | 1973-06-14 | 1975-10-21 | Abbott Lab | Method of increasing coronary pO{HD 2 {B in mammals |
-
1981
- 1981-04-06 US US06/251,321 patent/US4394373A/en not_active Expired - Lifetime
-
1982
- 1982-03-05 CA CA000397650A patent/CA1199275A/en not_active Expired
- 1982-03-08 GB GB8206698A patent/GB2095995B/en not_active Expired
- 1982-03-29 MX MX82101996U patent/MX7556E/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| GB2095995B (en) | 1984-12-05 |
| US4394373A (en) | 1983-07-19 |
| GB2095995A (en) | 1982-10-13 |
| MX7556E (en) | 1989-09-28 |
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