BIOCOMPATIBLE HEMOSTATIC PRODUCT AND PREPARATION METHOD THEREOF

Abstract

Provided herein are a biocompatible hemostatic product and a tissue sealant, including polyethylene oxide particles with a viscosity-average molecular weight ranging from 100,000 to 7,000,000 Daltons, a particle size ranging from 0.5 μm to 2000 μm and a water absorbency capacity ranging from 1 to 500 times of its own weight. Also provided herein is a method for preparing biocompatible hemostatic product and tissue sealant and the use of the biocompatible hemostatic product and tissue sealant in hemostasis, preventing adhesion, avoiding infection, promoting tissue healing, and sealing wound of tissues and organs either on animal's body surface, or inside body's cavity.

Claims

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25. A method of using a biocompatible hemostatic product to treat a wound within a body cavity of a patient, comprising applying an amount of the biocompatible hemostatic product to said wound, wherein the biocompatible hemostatic product comprises polyethylene oxide particles and wherein said amount is sufficient to cause at least one of hemostasis in said wound, sealing said wound, reducing exudation of said wound, promoting tissue healing around said wound, protecting a surface of said wound, and avoiding infection of said wound.

26. The method of claim 25 wherein the wound is located in at least one of the patient's respiratory tract, digestive tract, genital tract, and gastrointestinal tract.

27. The method of claim 25 wherein the polyethylene oxide particles have a viscosity-average molecular weight ranging from 100,000 to 7,000,000 Daltons.

28. The method of claim 27 wherein the polyethylene oxide particles have a particle size ranging from 0.5 μm to 2000 μm and a water absorbency capacity ranging from 1 to 500 times of its own weight.

29. The method of claim 27 wherein the biocompatible hemostatic product further comprises a biocompatible modified starch and wherein a ratio of a mass of said biocompatible modified starch to a mass of said polyethylene oxide particles ranges from 9:1 to 1:9.

30. The method of claim 29 wherein the biocompatible modified starch is selected from a group consisting of at least one of pre-gelatinized starch, acid modified starch, esterified starch, etherified starch, graft starch, cross-linked starch and composite modified starch.

31. The method of claim 30, wherein: the etherified starch comprises carboxymethyl starch and hydroxyethyl starch; the cross-linked starch comprises cross-linked carboxymethyl starch; the composite modified starch comprises pre-gelatinized hydroxypropyl distarch phosphate; the esterified starch comprises hydroxypropyl distarch phosphate; and the graft starch comprises crylic acid-carboxymethyl starch grafted copolymer and propylene ester-carboxymethyl starch grafted copolymer.

32. The method of claim 29, wherein the biocompatible modified starch is carboxymethyl starch and the sodium salt thereof.

33. The method of claim 27, wherein the biocompatible hemostatic product further comprises a biocompatible modified starch and polyvinylpyrrolidone, wherein a mass percentage of the biocompatible modified starch ranges from 5% to 90%, a mass percentage of polyvinylpyrrolidone ranges from 1% to 90%, and a mass percentage of the polyethylene oxide particles ranges from 99% to 10%.

34. The method of claim 25, wherein applying the biocompatible hemostatic product comprises: passing a catheter through a channel of an endoscope, wherein the catheter is in fluid communication with an enclosed vessel and wherein said enclosed vessel contains the biocompatible hemostatic product; and applying air flow pressure so as to direct said biocompatible hemostatic product from the vessel, through the catheter, and to said wound.

35. The method of claim 25, wherein the biocompatible hemostatic product further comprises at least one of pharmaceutically acceptable excipients, coagulants, anti-infectious medicament and anti-inflammation medicament, wherein: the pharmaceutically acceptable excipients are selected from one of solvents, dispersion media, coating agents, surfactants, anti-oxidants, preservatives, isosmotic agents, delaying absorption agents, binding agents, lubricants, pigments and a combination thereof or analogues thereof; the coagulants are selected from one of gelatin, collagen, oxidized cellulose, carboxymethylcellulose, chitosan, hyaluronic acid, sodium alginate, kaolin, thrombin, fibrous proteins, calcium, protamine, polypeptides, peptides, amino acids and a combination thereof; the anti-infectious medicament is selected from one of antibiotics, anti-bacterial agents, anti-virus agents, anti-fungal agents, anti-ulcer agents, traditional Chinese medicine preparation and propolis, and a combination thereof; and the anti-inflammation medicament is selected from one of non-steroid and steroid medicaments, anti-ulcer medicaments, traditional Chinese medicine preparation and propolis and a combination thereof.

36. The method of claim 25, wherein a particle size of the polyethylene oxide particles ranges from 10 μm to 500 μm and a viscosity-average molecular weight of the polyethylene oxide particles ranges from 800,000 to 4,000,000 Daltons.

37. A method of using a biocompatible product to treat a wound within at least one of a patient's upper respiratory tract, digestive tract, genital tract, and gastrointestinal tract, comprising using air pressure to apply an amount of the biocompatible product to said wound, wherein the biocompatible product comprises polyethylene oxide particles and wherein said amount is sufficient to cause at least one of hemostasis in said wound, sealing said wound, reducing exudation of said wound, promoting tissue healing around said wound, protecting a surface of said wound, and avoiding infection of said wound.

38. The method of claim 37 wherein said wound is at least one of an intestinal fistula, a biliary fistula, a thoracic fistula, and a lymphatic fistula.

39. The method of claim 37 wherein the polyethylene oxide particles have a viscosity-average molecular weight ranging from 100,000 to 7,000,000 Daltons.

40. The method of claim 39 wherein the polyethylene oxide particles have a particle size ranging from 0.5 μm to 2000 μm and a water absorbency capacity ranging from 1 to 500 times of its own weight.

41. The method of claim 37 wherein the biocompatible product further comprises a biocompatible modified starch and wherein a ratio of a mass of said biocompatible modified starch to a mass of said polyethylene oxide particles ranges from 9:1 to 1:9.

42. The method of claim 41 wherein the biocompatible modified starch is selected from a group consisting of at least one of pre-gelatinized starch, acid modified starch, esterified starch, etherified starch, graft starch, cross-linked starch and composite modified starch.

43. The method of claim 42, wherein: the etherified starch comprises carboxymethyl starch and hydroxyethyl starch; the cross-linked starch comprises cross-linked carboxymethyl starch; the composite modified starch comprises pre-gelatinized hydroxypropyl distarch phosphate; the esterified starch comprises hydroxypropyl distarch phosphate; and the graft starch comprises crylic acid-carboxymethyl starch grafted copolymer and propylene ester-carboxymethyl starch grafted copolymer.

44. The method of claim 41, wherein the biocompatible modified starch is carboxymethyl starch and the sodium salt thereof.

45. The method of claim 37, wherein the biocompatible product further comprises a biocompatible modified starch and polyvinylpyrrolidone, wherein a mass percentage of the biocompatible modified starch ranges from 5% to 90%, a mass percentage of polyvinylpyrrolidone ranges from 1% to 90%, and a mass percentage of the polyethylene oxide particles ranges from 99% to 10%.

46. The method of claim 37, wherein applying the biocompatible product comprises: using a catheter in fluid communication with an enclosed vessel, wherein said enclosed vessel contains the biocompatible hemostatic product; passing the catheter through an endoscope; and applying air flow pressure so as to direct said biocompatible hemostatic product from the vessel, through the catheter, and to said wound.

47. The method of claim 37, wherein the biocompatible product further comprises at least one of pharmaceutically acceptable excipients, coagulants, anti-infectious medicament and anti-inflammation medicament, wherein: the pharmaceutically acceptable excipients are selected from one of solvents, dispersion media, coating agents, surfactants, anti-oxidants, preservatives, isosmotic agents, delaying absorption agents, binding agents, lubricants, pigments and a combination thereof or analogues thereof; the coagulants are selected from one of gelatin, collagen, oxidized cellulose, carboxymethylcellulose, chitosan, hyaluronic acid, sodium alginate, kaolin, thrombin, fibrous proteins, calcium, protamine, polypeptides, peptides, amino acids and a combination thereof; the anti-infectious medicament is selected from one of antibiotics, anti-bacterial agents, anti-virus agents, anti-fungal agents, anti-ulcer agents, traditional Chinese medicine preparation and propolis, and a combination thereof; and the anti-inflammation medicament is selected from one of non-steroid and steroid medicaments, anti-ulcer medicaments, traditional Chinese medicine preparation and propolis and a combination thereof.

48. The method of claim 37, wherein a particle size of the polyethylene oxide particles ranges from 10 μm to 500 μm and a viscosity-average molecular weight of the polyethylene oxide particles ranges from 800,000 to 4,000,000 Daltons.

49. A method of using a biocompatible product to treat a wound within at least one of a patient's upper respiratory tract, digestive tract, genital tract, and gastrointestinal tract, comprising: passing a catheter through an endoscope, wherein the catheter is in fluid communication with an enclosed vessel, said enclosed vessel contains the biocompatible product, the biocompatible product comprises polyethylene oxide particles, and the polyethylene oxide particles have a viscosity-average molecular weight ranging from 100,000 to 7,000,000 Daltons; and applying air flow pressure so as to direct an amount of said biocompatible product from the vessel, through the catheter, and to said wound, wherein said amount is sufficient to cause at least one of hemostasis in said wound, sealing said wound, reducing exudation of said wound, promoting tissue healing around said wound, protecting a surface of said wound, and avoiding infection of said wound.

50. The method of claim 49 wherein the polyethylene oxide particles have a particle size ranging from 0.5 μm to 2000 μm and a water absorbency capacity ranging from 1 to 500 times of its own weight.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0050] FIG. 1A shows a first step for applying the biocompatible hemostatic product and tissue sealant described herein through a spraying instrument according to the examples herein;

[0051] FIG. 1B shows a second step for applying the biocompatible hemostatic product and tissue sealant described herein through a spraying instrument according to the examples herein;

[0052] FIG. 1C shows a third step for applying the biocompatible hemostatic product and tissue sealant described herein through a spraying instrument according to the examples herein;

[0053] FIG. 1D shows a fourth step for applying the biocompatible hemostatic product and tissue sealant described herein through a spraying instrument according to the examples herein;

[0054] FIG. 2 is structural schematic diagram of EndoClot™ Hemostatic Powder and Spraying System.

[0055] FIG. 3A shows a step for applying the biocompatible hemostatic product and tissue sealant described herein onto bleeding wound surface formed within body's cavity during minimally invasive surgery in the gastrointestinal tract using the system shown in FIG. 2, in an embodiment of the present specification;

[0056] FIG. 3B shows a step for applying the biocompatible hemostatic product and tissue sealant described herein onto bleeding wound surface formed within body's cavity during minimally invasive surgery in the gastrointestinal tract using the system shown in FIG. 2, in an embodiment of the present specification;

[0057] FIG. 3C shows a step for applying the biocompatible hemostatic product and tissue sealant described herein onto bleeding wound surface formed within body's cavity during minimally invasive surgery in the gastrointestinal tract using the system shown in FIG. 2, in an embodiment of the present specification; and,

[0058] FIG. 3D shows a step for applying the biocompatible hemostatic product and tissue sealant described herein onto bleeding wound surface formed within body's cavity during minimally invasive surgery in the gastrointestinal tract using the system shown in FIG. 2, in an embodiment of the present specification.

DETAILED DESCRIPTION

[0059] Respective aspects of the present invention will be described in details as follows by referring to the following specific examples. Such examples merely intend to illustrate the present invention but not to limit the scope and the spirit of the present invention.

EXAMPLES

Example 1

Biocompatible Hemostatic Products Comprising PEO Particles

[0060] This example provides a series of biocompatible hemostatic products #1 to #4 comprising PEO particles with a wide range of viscosity-average molecular weight. The physicochemical parameters of PEO particles contained in these biocompatible hemostatic products and the particle sizes of the biocompatible hemostatic products are listed in Table 1.

TABLE-US-00001 TABLE 1 No. Chemical and physical characteristics of PEO particles #1 Viscosity-average molecular weight: 600,000D; particle size: 0.5 μm-2000 μm; water absorbency capacity: 5~15 times of its own weight #2 Viscosity-average molecular weight: 1,000,000D; particle size: 0.5 μm-2000 μm; water absorbency capacity: 5~15 times of its own weight #3 Viscosity-average molecular weight: 2,000,000D; particle size: 0.5 μm-2000 μm; water absorbency capacity: 5~15 times of its own weight #4 Viscosity-average molecular weight: 4,000,000D; particle size: 0.5 μm-2000 μm; water absorbency capacity: 5~15 times of its own weight control Arista ™ hemostatic powder (produced by American Medafor Inc.); Molecular weight: 5,000D-200,000D; particle size: 10 μm-350 μm, average particle size: 100 μm, water absorbency capacity: 5~10 times of its own weight Arista is a hemostatic powder proven by the FDA to use on the body surface or use within body, comprising microporous polysaccharide derived from plant starch, which is an effective hemostatic powder known in the art.

[0061] The biocompatible hemostatic products #1 to #4 as mentioned above are prepared through following steps: [0062] (a) placing the PEO particles with various viscosity-average molecular weight as raw materials into a granulator, [0063] (b) adding distilled water into the raw materials that are placed into granulator in step (a), and [0064] (c) granulating at 40° C. to 50° C., and then sieving to obtain biocompatible hemostatic products with a particle size ranging from 50 μm to 250 μm.

[0065] The biocompatible hemostatic products of this example and following examples can be sprayed onto a bleeding wound using a common method in the art, to detect the efficacy for hemostasis. Preferably, the biocompatible hemostatic products provided herein can be sprayed according to the steps as shown in FIGS. 1A to 1D. In particular, the biocompatible hemostatic products provided herein were firstly contained in a vessel 6 and the lid 7 of the vessel 6 was removed (as shown in FIG. 1A), next the vessel 6 in which the biocompatible hemostatic products were contained was connected with an applicator head 8 (as shown in FIG. 1B), then the applicator head was screwed on the vessel (as shown in FIG. 1C), the distal end 8a of the applicator head 8 was directed to the bleeding wound surface and the vessel 6 in which the biocompatible hemostatic products were contained was pressured, so that the biocompatible hemostatic products was sprayed to the bleeding wound (as shown in FIG. 1D).

[0066] The efficacy of the biocompatible hemostatic products #1 to #4 as mentioned above and control sample for hemostasis are detected using following method.

[0067] 5 New Zealand white rabbits (provided by the animal experiment centre of The Second Military Medical University) were anesthetized by sodium pentobarbital via auricular vein and were fixed on overhead position, followed by deplumation and then the abdominal cavity was opened to completely expose the liver. A bleeding wound with a length of about 1 cm, width of about 1 cm and depth of about 0.3-0.4 cm was made on the surface of the liver of each rabbit by using a scalpel. After wiping the blood from the wound by gauze, samples #1 to #4 and control sample as listed in table 1 were immediately sprayed onto the wound, the dosage per spraying was about 1 g, and then the time and efficacy for hemostasis of samples #1 to #4 and control sample were observed.

[0068] In the above experiments on the liver, bleeding from the wound was stopped within 15 to 30 seconds after applying samples #3 and #4 and bleeding from the wound surface was stopped within 45 seconds to 1 minute after applying samples #1 and #2, while bleeding from the wound surface was stopped within 3 to 5 minutes after applying the control sample.

[0069] According to the observation and the experiments for efficacy of hemostasis, it can be seen that PEO particles with high viscosity-average molecular weight (e.g., samples #3 and #4) are able to rapidly concentrate blood to form a clot after contacting with blood, and the clot formed from PEO-blood has high viscosity and can be immediately adhered to the wound to seal the wound and effectively achieve hemostasis of vein. PEO particles with low viscosity-average molecular weight concentrate blood at a lower speed than PEO particles with high viscosity-average molecular weight after contact with blood and the clot formed thereafter has a lower viscosity than that of PEO particles with high viscosity-average molecular weight. Therefore, PEO particles with low viscosity-average molecular weight will take a longer time for hemostasis. However, the control sample concentrates blood at a much lower speed than PEO particles with high viscosity-average molecular weight and low viscosity-average molecular weight after contacting with blood, and the clot formed after contacting blood has a much lower viscosity, with poor efficacy for sealing. Therefore, the control sample takes a much longer time to achieve hemostasis.

[0070] In addition, the hemostatic products and the clot formed after the hemostatic products contacts blood will not be degraded by the amylase in the organism (while the hemostatic material of control sample can be rapidly degraded by amylase) and thus it is able to adhere on the wound surface for a long time. Therefore, the hemostatic products provided herein exhibit great efficacy on sealing wounds.

Example 2

Biocompatible Hemostatic Products Comprising PEO Particles and Carboxymethyl Starch (CMS)

[0071] This example provides a series of biocompatible hemostatic products #5 to #8 comprising PEO particles and carboxymethyl starch (CMS) particles with a wide range of mass ratios there between, wherein PEO particles have a viscosity-average molecular weight of 2,000,000 D, a particle size ranging from 0.5 μm to 2000 μm and water absorbency capacity ranging from 5 to 15 times of its own weight, and CMS particles have a viscosity-average molecular weight ranging from 3,000 D to 200,000 D, a particle size ranging from 0.5 μm to 1000 μm, and water absorbency capacity ranging from 10 to 30 times of its own weight. The mass ratios between PEO particles and CMS particles contained in the biocompatible hemostatic products #5 to #8 of this example are listed in table 2. The control sample of this example is Arista hemostatic powder (produced by American Medafor Inc.) with a molecular weight ranging from 5,000 D to 200,000 D, a particle size ranging from 10 μm to 350 μm, and an average particle size of 100 μm, and water absorbency capacity ranging from 5 to 10 times of its own weight.

TABLE-US-00002 TABLE 2 mass ratio between PEO particles and CMS No. particles #5 6:1 #6 3:1 #7 1:3 #8 1:6

[0072] The biocompatible hemostatic products #5 to #8 as mentioned above are prepared through following steps: [0073] (a) placing the PEO particles and CMS particles as raw materials in terms of a certain mass ratio into a granulator, [0074] (b) adding distilled water into the raw materials that are placed into granulator in step (a), and [0075] (c) granulating at 40° C. to 50° C., and then sieving to obtain biocompatible hemostatic products with a particle size ranging from 50 μm to 250 μm.

[0076] The efficacy of the biocompatible hemostatic products #5 to #8 as mentioned above and the control sample for hemostasis are detected using following method.

[0077] 5 New Zealand white rabbits (provided by the animal experiment centre of The Second Military Medical University) were anesthetized by sodium pentobarbital via auricular vein and were fixed on overhead position followed by deplumation and then the abdominal cavity was opened to completely expose the liver. A bleeding wound with length of about 1 cm, width of about 1 cm and depth of about 0.3-0.4 cm was made on the surface of the liver of each rabbit by using a scalpel. After wiping the blood on the wound surface with gauze, samples #5 to #8 as listed in table 2 and the control sample were immediately sprayed onto the wound, the dosage per spraying is about 1 g, and then the efficacy of samples #5 to #8 and control sample for hemostasis was observed.

[0078] In the above experiments on the liver, bleeding from the wound was stopped within 15 seconds after applying samples #5 and #8 and bleeding from the wound was stopped within 3 to 5 minutes after applying the control sample. According to the experiments about efficacy for hemostasis, it can be seen that the hemostatic products comprising PEO particles and CMS particles rapidly concentrates blood after contacting with blood to form a clot and that the resulting clot has a high viscosity and thus can immediately attach to the bleeding wound to seal the wound and achieve hemo stasis of the vein. However, the control sample concentrates blood at a lower speed than the experimental group after contact with the blood and the resulting clot has a lower viscosity than the experimental group, and thus it will take a long time for hemostasis.

Example 3

Biocompatible Hemostatic Products Comprising PEO Particles and Polyvinylpyrrolidone (PVP) Particles

[0079] This example provides a series of biocompatible hemostatic products #9 to #11 comprising PEO particles and polyvinylpyrrolidone (PVP) particles with a wide range of mass ratios there between, wherein PEO particles have a viscosity-average molecular weight of 2,000,000 D, a particle size ranging from 0.5 μm to 2000 μm and a water absorbency capacity ranging from 5 to 15 times of its own weight, and PVP particles have a viscosity-average molecular weight of 90,000 D, a particle size ranging from 0.5 μm to 1000 μm, and a water absorbency capacity ranging from 5 to 15 times of its own weight. The mass ratios between PEO particles and PVP particles contained in the biocompatible hemostatic products #9 to #11 of this example are listed in table 3.

TABLE-US-00003 TABLE 3 Mass Ratio between PEO particles and PVP No. particles #9 6:1 #10 3:1 #11 1:3

[0080] The biocompatible hemostatic products #9 to #11 as mentioned above are prepared through following steps: [0081] (a) placing the PEO particles and PVP particles as raw materials in terms of a certain mass ratio into granulator, [0082] (b) adding distilled water into the raw materials that are placed into granulator in step (a), and [0083] (c) granulating at 40° C. to 50° C., and then sieving to obtain biocompatible hemostatic products with a particle size ranging from 50 μm to 250 μm.

[0084] The efficacies of the biocompatible hemostatic products #9 to #11 for hemostasis are detected using the method as described in Example 1. After applying samples #9 and #10 of this example, the bleeding from the wound was stopped within 30 seconds, while it took 3 to 5 minutes to completely achieve hemostasis for sample #11. By using samples #9 and #10, blood was concentrated rapidly and a clot was formed rapidly, while by using #11, blood was concentrated at a reduced speed and thus the clot was formed at a reduced speed as well. This may be because a large ratio of PVP has an influence on water absorbency. As a result, sample #11 took a long time to concentrate blood and thus had an influence on efficacy for hemostasis. Clots formed by samples #9 to #11 have high viscosity and can attach onto wounds for hemostasis of veins.

Example 4

Biocompatible Hemostatic Products Comprising PEO Particles, CMS Particles and PVP Particles

[0085] This example provides a series of biocompatible hemostatic products #12 and #13 comprising PEO particles and PVP particles as well as CMS particles with a wide range of mass ratios, wherein PEO particles have a viscosity-average molecular weight of 2,000,000 D, a particle size ranging from 0.5 μm to 2000 μm and a water absorbency capacity ranging from 5 to 15 times of its own weight, CMS particles have a viscosity-average molecular weight ranging from 3,000 D to 200,000 D, a particle size ranging from 0.5 μm to 1000 μm and a water absorbency capacity ranging from 10 to 30 times of its own weight, and PVP particles have a viscosity-average molecular weight of 90,000 D, a particle size ranging from 0.5 μm to 1000 μm, and a water absorbency capacity ranging from 5 to 15 times of its own weight. The mass ratios among PEO particles, CMS particles and PVP particles contained in the biocompatible hemostatic products #12 and #13 of this example are listed in table 4.

TABLE-US-00004 TABLE 4 Mass Ratio among PEO particles, CMS particles and PVP No. particles #12 1:3:1 #13 6:3:1

[0086] The biocompatible hemostatic products #12 and #13 as mentioned above are prepared through following steps: [0087] (a) placing PEO particles, CMS particles and PVP particles as raw materials in terms of a certain mass ratio into granulator, [0088] (b) adding distilled water into the raw materials that are placed into granulator in step (a), and [0089] (c) granulating at 40° C. to 50° C., and then sieving to obtain biocompatible hemostatic products with a particle size ranging from 50 μm to 250 μm.

[0090] The efficacy of the biocompatible hemostatic products #12 and #13 for hemostasis are detected by using the method as described in Example 1. After applying samples #12 and #13 of this example, the bleeding from the wound was stopped within 30 seconds. Blood was concentrated and a clot was formed immediately after samples #12 and #13 made contact with blood. Clots formed by samples #12 and #13 have a high viscosity and can rapidly attach onto a bleeding wound for hemostasis of veins.

[0091] The biocompatible hemostatic products of the above Examples 1 to 4 also can be prepared through the coating method, which includes the following steps: [0092] (a) placing PEO particles as raw material into a granulator; [0093] (b) adding water to the raw material of step (a) to cause the raw material to be swollen, [0094] (c) adding a certain mass ratio of CMS particles and/or PVP particles to the swollen PEO particles obtained in step (b), and [0095] (d) granulating at 40° C. to 50° C., and then sieving to obtain biocompatible hemostatic products with a particle size ranging from 50 μm to 250 μm.

[0096] The biocompatible hemostatic products of the above Examples 1 to 4 also can be prepared through the graft method commonly used in the art, including the following steps: [0097] (a) modifying the surface of PEO particles using a common grafting compound such as silicane so that the surface of PEO particle adapts for covalent bonding or ionic bonding; [0098] (b) dissolving or swelling the surface-modified PEO particles obtained in step (a) in water, [0099] (c) adding at least one of a biocompatible modified starch and a PVP to the solution of dissolved or swollen PEO particles obtained in step (b), so that the at least one of biocompatible modified starch and PVP is connected to the surface of PEO particles by covalent bonding or ionic bonding, thereby obtaining composite particles, and [0100] (d) washing, drying and sieving the composite particles, to obtain biocompatible hemostatic products with a particle size ranging from 30 μm to 500 μm.

Conclusion

[0101] Provided herein is a series of biocompatible hemostatic products, comprising PEO particles with a wide range of chemical and physical characteristics (e.g., water absorbency capacity and viscosity) and viscosity-average molecular weight as well as other polymers with certain chemical and physical characteristics (e.g., water absorbency capacity and viscosity and the like), such as biocompatible modified starch and PVP. From the efficacy for hemostasis of a series of biocompatible hemostatic products prepared in the above Examples 1 to 4, the biocompatible hemostatic products provided herein exhibit the efficacy of quick hemostasis after applying onto the bleeding wound. They exhibit efficacy for hemostasis and wound-sealing superior to commercial Arista™ hemostatic powder (produced by American Medafor Inc.) which is believed to have clinic effectiveness as is well known in the art.

Example 5

Application of Biocompatible Hemostatic Products Provided Herein Within Body's Cavity

[0102] During minimally invasive surgery performed in the gastrointestinal tract, the biocompatible hemostatic products provided herein are applied onto a bleeding wound formed during minimally invasive surgery performed in the gastrointestinal tract by using EndoClot™ Hemostatic Powder and Spraying System (provided by US based company EndoClot Plus, Inc, usage method thereof sees J Patel et al., PTU-029 The Use Of Endoclot™ Therapy In The Endoscopic Management Of Gastrointestinal Bleeding, Gut, 2014 63: A50-51 and K Halkerston et al., PWE-046 Early Clinical Experience of Endoclot™ in the Treatment of Acute Gastro-Intestinal Bleeding, Gut, 2013 62: A149) via gastroscope and colonoscope for hemostasis and sealing wounds. The structural schematic diagram of the above EndoClot™ Hemostatic Powder and Spraying System is shown in FIG. 2. This Hemostatic Powder Spraying System includes a gas filter 1 that is connected to an air source 5 (or air pump), an air delivery catheter 2, a gas/powder mixing chamber 3 and attachments 4. The process for applying the the biocompatible hemostatic products of through this Hemostatic Powder and Spraying System via endoscope such as gastroscope and colonoscope includes following steps: [0103] (a) adding the biocompatible hemostatic products provided herein to the sterilized vessel 6 (as shown in FIG. 3A) and removing the lid 7 of the vessel to connect to the EndoClot™ Hemostatic Powder and Spraying System 11 (as shown in FIG. 3B); [0104] (b) switching on the air source 5 (or air pump) that is connected to the EndoClot™ Hemostatic Powder and Spraying System to keep the air flow pressure in the catheter into which biopsy forceps of gastro(colono)scope 12 is to be inserted in this system higher than the pressure in the patient's digestive tract (as shown in FIG. 3C); [0105] (c) after performing biopsy on the lesion or removing the tissues (such as polyps or cancerous tissues) located on the inner wall of patient's digestive tract by the doctor using gastro(colono)scope 12, or after a wound occurs on the digestive tract (such as ulcer and inflammation wound surface), immediately inserting the catheter in this system into the biopsy passage of the gastro(colono)scope 12 and directing the distal end of the catheter 14 to the bleeding site (as shown in FIG. 3D); [0106] (d) spraying the biocompatible hemostatic products to the bleeding wound in the digestive tract through the catheter (as shown in FIG. 3D) to rapidly concentrate blood and form a clot, such that the formed glue and glue-like clot will seal the wound to prevent further bleeding from the wound; and [0107] (e) withdrawing the catheter from the biopsy passage of the gastro(colono)scope after achieve hemostasis.

[0108] The present disclosure is described in details by referring to the specific examples. These examples are merely illustrative, but not intent to limit the scope of the present invention. One having the ordinary skill in the art would understand that many modifications, changes or substitutions may be made without departing from the spirit thereof. Thus, the equivalent variations according to the present invention come within the scope of the present invention.