CN101778623A

CN101778623A - Hemostatic agent composition and method of delivery

Info

Publication number: CN101778623A
Application number: CN200880103237A
Authority: CN
Inventors: 杰克·曼特科; 利萨·曼特科
Original assignee: Individual
Current assignee: Individual
Priority date: 2007-08-16
Filing date: 2008-08-18
Publication date: 2010-07-14
Also published as: RU2010109699A; WO2009025782A2; EP2197422A2; BRPI0817049A2; ZA201001845B; JP2010536762A; CA2696400A1; MX2010001820A; AU2008289571A1; WO2009025782A3

Abstract

A hemostatic agent composition that includes a clay hemostatic agent which is inert and non-reactive relative to blood clotting proteins and platelets, yet is capable of accelerating the formation of a stable clot when applied to an actively bleeding wound.

Description

Hemorrhage compositions and applying method

United States Patent (USP) trademark office

General patent application

Title: hemorrhage compositions and applying method

Inventor: Jack Man Teke, Florida State, Wellington

Li Samanteke, Florida State, Wellington

The related application index

This application is the part continuity application of the U.S. Patent application flowing water 11/453,524 of submission on June 15th, 2006, and this application is the prioity claim of doing according to the 35th piece of the 119th (e) bar of U.S.'s method, and its flowing water is 60/757,459, submits on January 9th, 2006.In addition, this applies for also according to the 35th piece of the 119th (e) bar of federal law, in the general patent application flowing water 60/964,955 of the U.S. that on August 16th, 2007 submitted to, makes prioity claim.It all discloses file all for referencial use and lists in herein.

Background of the present invention field of the present invention

This invention is that hemorrhage applies compositions and system.Compositions includes HECTABRITE DP and acceptable Jie's compositions.In the middle of application system comprise an accessory that applies that the sack that loads hemorrhage or container are arranged, this sack is minimum wants the local releasing unit that a supporting assembly connects same covering with the soluble material manufacturing that define.The another one characteristics are, hemostatic agent delivery system is a structure that is directly used in hemorrhage source, and hemorrhage can concentrate in this position and rest on hemorrhage source to become grumeleuse and termination is hemorrhage.

Another application system includes the syringe or the ejector that are mounted with compositions.Compositions can directly be put into wound from syringe, or near conduit, pipeline and similar object are put into hemorrhage position or its.

2. related art techniques is described

If for a long time people all know and be proved injured back go out hyperhematosis and don't fast or appropriate location comprehend and cause death.Unfortunately, collect the existence that the data that get are confirming this situation always in armed conflict.For example have 2,500 soldiers to die from the wound that is subjected to severe trauma in the Vietnam War, reason is pure to be to bleed till death.Military-specific data shows that also nearly 50% battle casualty is bleed to death, and great majority are dead in 30 minutes in injured back.Have report to show that this has 60% in first death in 5 minutes in 50%, and other there not be the people who accepts suitably processing to die from one hour yet.

In addition, there are every year 70000000 people of surpassing to enter casualty department because of bleeding according to estimates.The same with the above, injured in the war, hemorrhage or acute hemorrhage is the principal element that causes traumatic death in population among the people.

So fast and effectively just can to save life apparent for control over bleeding.Satisfy this fast and effectively demand of control over bleeding for repaying examination, the result has developed various so-called tourniquet bandages and other products to provide quick control hemorrhage effectiveness.

In the middle of a kind of granular zeolite grain material product of taking from volcano lava stone that includes is arranged.This material is the hydrone in its meeting absorbing blood when being put in bleeding wounds, so just can produce the platelet aggregation that promotes blood coagulation.Even so, find in the observation that a kind of highly exothermic reactions can appear in the absorption process of this kind zeolite, thereby can produce quite big heating power, believe this minimum be partly because due to the reaction of the iron content of zeolite.Brighter ground really, there is report to point out to use this kind material temperature Celsius 90 ° to 100 ℃ can occur afterwards, thereby can cause that the people who accepts the wounded soldier of this kind treatment and manage this product in Iraq has the second degree burn situation, must accept training and can manage this kind product even manage the personnel of this product through authentication.

It is that the packing of zeolite material just simply is poured on the open wound that another of this product crossed shortcoming, but for any serious hemorrhage situation about for example being cut because of aorta, the pressure of blood outflow wound can cause significantly that the coagulability of this material in this position dissipates so that effectiveness lowers and/or remove.Another disadvantage be zeolite when a contact blood effect exhaust, thereby condense and may depart from real wound source and do not stop bleeding.Another shortcoming of this product is that the zeolite material is a group graininess matter, in case when the wounded is sent to operating room or implements other facility of such treatment, for example wash and/or absorption can be difficult to this material is removed from the wound supernatant with commonsense method.

Another kind of product is then made with spherical chitosan, and this kind material is taken from the outer Shell of first Shell class animal.To be full of weighing apparatus prominent in report about the control over bleeding effectiveness of this material, under the situation especially for the wounded's hypothermia, for example is situation about may suffer a shock after losing blood seriously, and reports that its effectiveness can reduce or disappear greatly.In addition, other reports that product has incorrect operating position, for example is to use the product mouthful Bing that causes injury and do not touch the product activity face owing to reversing.Because this product takes from organic-biological, its shelf life is very limited, during this period of time or use, or discards, and that cost of just making each product is quite high, and this is a quite disadvantageous condition.

Another kind of tourniquet bandage is made by unicellular algae, and product includes chitosan.The structure of this product is to make things convenient for user only to need a small amount of training just can be fast and control effectively and/or stop the hemorrhage of severe trauma.Its another special feature when material touches blood, it is said that it can be assembled and activation by stimulating platelet, and that will cause that health divides the secret thromboxane that stimulates near the blood vessel compression of wound.Different sayings are that the chitosan material quickens normal condensation process with the effect of catalyst, thereby has quickened the hemorrhage control of health.Equally, because this product is taken from organic-biological, shelf life is very limited, interior during this period of time or use, or discard.In addition, under the example of above-mentioned the wounded's hypothermia, its effectiveness is suspicious.

Another kind of material is directly to put wound into through structure with what use, the synthetic made from potato starch.It is said that this molecule is condensed into gel to the blood solids of wound circumference and solidifies with promotion, thereby the acceleration nature condenses.Characteristics wherein are to be set in synthetic potato starch product surface than macromole in the blood constituent, thereby promote to solidify.Observe thus and find that this also is the material of powder-form, use the utensil of a corrugated tube shape directly to annotate on wound.As above-mentioned zeolite material, if the situation of bleeding profusely is to be risen by incised wound because of main tremulous pulse, the pressure that blood flows out wound can be enough to powder is dispersed, be exactly that wound is covered by the binder of standard, Bing and having exerted pressure when applying synthetic potato starchy material, material still can dissipate in the coagulability of this position.

But also have another kind of by hydrophilic polymer and potassium salt in conjunction with the powder that with cattle only be basic hemopexin material, this kind powder it is said and can stop to export that central the need covers with binder when the various slight wounds research of contact.But as the product of above-mentioned direct " injection " wound, when being used for severe haemorrhage, the pressure of blood itself also can disperse this product, and that will lower or eliminate itself hemostatic intention effectiveness.

It is a kind of that (TraumaCure-Bethesda, what MD) obtain patent is a kind of balloon-system product from trauma care.The sacculus that quilt has been let out gas expands in hole, wound chamber after the opening part of wound is put into and gives wound wall and hemorrhage source pressure.

Situation clearly provide quick, an effective and high hemorrhage control efficiency to comprise that the system of the hemorrhage situation of aorta can bring great benefit, and this system can just can suitably be used by the personage who only accepts a little training in view of the above.Its another one characteristics are to have to use one can directly inject effective hemorrhage deal to the wound, also provide one to be maintained at wound and to use the benefit of effective hemorrhage deal with the system of the mechanism of control over bleeding simultaneously.Simultaneously, just more favourable if this kind system includes the hemorrhage that can not produce reaction and tool subsensitivety when wound uses.In addition, the hemorrhage that is used in this system can promote blood coagulation in not producing under the response situation, that is to say the situation that can not have blood exothermic reaction and local heating at wound.And another kind of vantage provides a system that includes inorganic hemorrhage, and that just can be obtained and have or not the benefit of limitting shelf life.

The present invention's summary

The present invention seeks a hemorrhage compositions and application system, and its structure is directly in hemorrhage position, and for example the tremulous pulse that is hurt applies hemorrhage, thereby blood vessels are condensed and stops wound bleeding.Therefore, hemostatic agent delivery system structure of the present invention further concentrates and rest on hemorrhage position to hemorrhage, and is same, and this also is clotted blood and stops hemorrhage function.

Compositions of the present invention is to be easy to and to make economically, so price is that the public is affordable, so the invention that consumer just can more this kind of use redemption life.

The rarest embodiment of application system of the present invention be include minimum a kind of be the hemorrhage compositions that is configured to make blood clotting.Another special feature is, among the present invention the rarest a kind of be the hemorrhage that includes the montmorillonitic clay material.In the rarest one further embodiment, HECTABRITE DP is as hemorrhage.The present invention includes clay material, or use separately, or use in conjunction with one or more additives as hemorrhage, can be in following discussion.Be applied to hemorrhage position to hemorrhage, application system of the present invention further includes an accessory that applies that is configured to the minimum hemorrhage that can transience loads one-component, can be loaded at least in the direct acting time of hemorrhage position.Apply the rarest embodiment of accessory and comprise a releasing unit that is configured to cover relevant supporting assembly.The another one characteristics are, releasing unit and supporting assembly are common structures to minimum can of short duration hemorrhage being loaded into therebetween when releasing unit and supporting assembly are attached to its related artery.

For but the accessory that applies of the present invention can reach to the release property of one or more hemorrhages and loads, releasing unit includes soluble material makes it be released into hemorrhage up to small part solubilized Bing until being assigned to nearest hemorrhage position.In the rarest embodiment, releasing unit includes soluble polymeric material, just for example, for example is the polyvinyl alcohol material.

For the function that directly applies the hemorrhage deal in hemorrhage position further is provided, the accessory that applies of the present invention may comprise that a Handleset that is mounted to the supporting assembly surface uses application system to make things convenient for user.But the rarest a kind of embodiment of the present invention is to include a visual identification can look for or the identification Handleset to make things convenient for user.This function is very critical in noisy and chaotic environment; Because of hemostatic agent delivery system of the present invention may be to be used for battlefield, battlefield medical institutions or hospital-based outpatient emergency room.

The present invention more includes the method for using hemorrhage in hemorrhage position, in the middle of include the step that applies hemorrhage dose of component, and hemorrhage wherein includes synergic HECTABRITE DP material, directly uses in hemorrhage position.Method more comprises to be had being concentrated into of hemorrhage enough compatibility relations with hemorrhage positional structure and keeps the component of analgesic to rest on hemorrhage position with closing form, it is condensed and stops hemorrhage.In case method further comprises when the wounded settles out or is transferred, available standards flushing or absorption program are removed the performance of hemorrhage when for example being transferred to the operating room of fixation means or battlefield operation unit for the wounded's autohemorrhage position.Just as above-mentioned situation, the structure of hemorrhage of the present invention is to form stable condensing, and just can be moved so that the wounded stops the back in a single day hemorrhage situation.

Referring to picture will be clearer with other object, function and advantage to part of the present invention after describing in detail with it excessively.

The picture simple declaration:

To have more fully the present invention and understand, please refer to following picture and related description:

Fig. 1 is the perspective view of the embodiment of the preferential hemostatic agent delivery system of recommending of a present invention.

Fig. 2 is the exploded view of Fig. 1 embodiment.

Fig. 3 is the diagram according to hemorrhage application process of the present invention.

The Ref. No. of chart shows that the numbering of chart is relative with each.

The preferential embodiment of recommending is described in detail

As above narration, the present invention seeks hemostatic agent delivery system, generally shows with 10 in chart, is directly to apply hemorrhage and construct for serving as hemorrhage position.The another one characteristics are, the present invention seeks one can use hemostatic agent delivery system 10 to make the wounded by the personage who only was subjected to a small amount of training, and injured soldier on the battlefield for example plays fast and effectively and condenses and control and/or stop hemorrhage effect.As obviously seeing from following situation, hemostatic agent delivery system 10 of the present invention be for make only be subjected to a little using method indication the people just identification immediately apply the situation of accessory 20, thereby can directly dispose and apply accessory 20 and construct to hemorrhage position.

Lower and/or to stop hemorrhage position excessive hemorrhage, application system 10 of the present invention includes a minimum hemorrhage 12.Certainly, hemorrhage is to include multiple hemorrhage 12 according to scope of the present invention and intention, or in conjunction with one or more hemorrhage 12 and one or more additives, for example is to have to be beneficial to the additive that promotes one or more hemorrhage 12 performances.One of them example is that the rarest embodiment of hemorrhage of the present invention is to include the hydroxyethyl-cellulose additive to absorb to promote the moisture content of hemorrhage 12 in blood, thereby increase is solidified formation and stopped hemorrhage ratio.Just as above-mentioned situation, hemorrhage is a principal element of the injured and civilian injury death of war, and the present invention can impel fast and control effectively and/or stop hemorrhage to reach to attested redemption life.

In the rarest embodiment of the present invention, the rarest a kind of hemorrhage 12 includes montmorillonitic clay.Montmorillonitum is a spontaneous stratiform expanded clay family, in the middle of include bentonite, also claim to cover holder mud, HECTABRITE DP and saponite.Kaolinite is relevant clay, and the more aforementioned clay of water absorbing force and swelling degree is low.The another one characteristics are that montmorillonitic clay is to meet the dilatable phyllosilicate Bing of water and extensively do the rheologic additive use.Be apparent that silicate plate includes three layers, two silicate dioxide layers that are included in metal oxide layer.As for bentonite bed, metal oxide layer mainly is an aluminum, in HECTABRITE DP and bentonite are arranged, metal oxide layer includes magnesium.The another one characteristics are that bentonite may include the chalybeate and the ferrous oxide of general 4% weight; HECTABRITE DP is iron content not substantially, generally comprises the ferrum that is less than half percentage rate (＜0.50%) weight.This point is extremely important, because ferrum can produce exothermic reaction between hemorrhage and body fluid in absorption process.Another benefit of HECTABRITE DP is, has the height benefit when together using with the present invention, and that is through purifying and grinding, so the particle size of HECTABRITE DP approximately is 10% of similar HECTABRITE DP.The hemorrhage that includes a kind of synergic HECTABRITE DP in the preferential embodiment of recommending of the present invention.The another one characteristics are, a kind of HECTABRITE DP Bentone EW.RTM. of the height gain that is provided by this special auxiliary agent company of U.S.'s hamming of New Jersey Hai Cizhen may be provided in the present invention.This kind material has about 2.5 density in every cubic centimetre, simultaneously, what is more important, in the distribution of a particle size about 94% or above material less than 200 screen sizes.

Certainly, just as above-mentioned situation, the hemostatic agent delivery system 10 that the present invention includes includes multiple hemorrhage 12, and one of example is that the rarest a kind of embodiment may include bentonite or the HECTABRITE DP of the various performances of tool and bentonitic combination.And for example above-mentioned situation, hemorrhage 12 may be in conjunction with one or more additives to promote its anthemorrhagic performance.A central example is that the hemorrhage 12 in the further preferential embodiment of recommending of the present invention includes the HECTABRITE DP of tool height gain in conjunction with the hydroxyethyl-cellulose additive.The another one characteristics are that it also is the Bentone LT.RTM that is provided by this special auxiliary agent company of U.S.'s hamming that the hemorrhage 12 that comprises in the embodiment of a preferential recommendation includes.

It is to be can not react when being configured to when contacting with wound, blood or other body fluid that hemorrhage used in the present invention is considered in the important consideration of selecting.The another one characteristics are that just as above-mentioned situation, HECTABRITE DP can not contain the iron content of the order of severity, so basically can the development of heat when becoming thing or body fluid to contact with moisture, blood, other water.In addition, set, just help the stable formation of solidifying when using in hemorrhage position like this because the gain HECTABRITE DP is a powdered physical.Bentone EW.RTM. be gain during process through purify and barreling to attritive powder, therefore can strengthen the effectiveness of material active surface, the result has strengthened its water absorbing capacity, makes it can remove the moisture in the blood and platelet concentrated, and this just can form in hemorrhage position to stablize and condense.When being that pig is only tested, when hemostatic agent delivery system 10 used according to the invention when being applied hemorrhage 12 because of femoral artery by the hemorrhage hemorrhage position of incised wound to one, realize that hemorrhage position can form stable condensing.

Hemostatic agent delivery system 10 of the present invention has more comprised and is configured to one and applies accessory 20 as what the hemorrhage 12 of one-component directly is configured to hemorrhage position.The another one characteristics are, are to be configured to release property to load hemorrhage 12 components that can directly be assigned to hemorrhage position but apply accessory.At a preferential embodiment of recommending, apply accessory 20 include a releasing unit 24 with the covering relation configuration to the opposite position of a supporting assembly 22, releasing unit can append to the outer rim of supporting assembly 22.The another one characteristics are that releasing unit 24 and supporting assembly 22 are to be configured to jointly as loading hemorrhage 12 components that are applied to hemorrhage position, referring to Fig. 1.In a minimum embodiment, supporting assembly 22 includes aseptic dressing, just for example, and an anti-glutinous gauze pad.Wish that everybody notes, with character of the present invention, each assembly that includes application system 10 all is to guarantee that to reach to cause hemorrhage position can not be subjected to extraneous contamination through sterilization and packing.Wish that everybody notes again, supporting assembly includes the structure about wound that the detoxicating gauze pad can hemostatic agent delivery system 10 enough according to the invention, makes sealing and lowers or to stop this place hemorrhage to reach to cause.

In another situation of releasing unit 24 of the present invention, releasing unit 24 includes the structure of soluble material, and that is will reach this material to become solution for example can partly dissolve at least during wound bleeding at contact water.When dissolving, releasing unit 24 of the present invention can directly apply the deal that accessory 20 discharges hemorrhage 12 quick and effectively certainly in hemorrhage position.In a minimum embodiment, of the present inventionly apply the releasing unit 22 that accessory 20 includes tool soluble polymeric material structure, the structure of those materials is to dissolve in blood and body fluid.

In a preferential embodiment of recommending, releasing unit 22 includes a kind of meeting dissolved polyvinyl alcohol material when hemorrhage position contacts blood.The polyvinyl alcohol material of releasing unit 22 may be with any thickness structure, and ratio that thus can sustained release assembly 22 material dissolutions can be applied to hemorrhage 12 ratios of hemorrhage position exactly, is a factor that can influence the liquid volume of appearance.Therefore, hemostatic agent delivery system 10 of the present invention may be customized for the wound of the different orders of severity.

One of example, hemorrhage 12 may be to be directly used in epidermis to hinder, and the releasing unit 22 of this situation preferably can comprise a kind of extremely thin material to allow quick dissolving and to discharge hemorrhage 12.More serious is hemorrhage, for example be that main tremulous pulse is cut, releasing unit 22 can include thicker material, to guarantee that hemostatic agent delivery system 10 may directly be configured to hemorrhage position is to be configured to will do earlier before removing releasing unit 24 adapt to the wound program simultaneously, just hemorrhage 12 is released into hemorrhage position then.

Attach to supporting assembly 22 to releasing unit 24, the accessory that applies of the present invention more comprises a structure that seals mechanism 27, provides depending on to two assemblies.The another one characteristics are that sealing mechanism 27 of the present invention includes a black box 28 that is configured to releasing unit 24 black boies 28 are sealed to as total closed type supporting assembly 22.Among at least one embodiment of the present invention, black box 28 is thermo-responsive gluings.Among a further embodiment, black box includes a kind of Yun Tian adhesive plaster.Importantly the structure of the black box in the embodiment 28 is bonding two kinds of different classes of materials, and every kind of material is to be configured to non-adhibit quality separately, but central meeting forms the total closed type sealing bag 21 that a release property loads one or more hemorrhages 12.Among at least one embodiment, the accessory 20 that applies of the present invention more includes one as above illustrated Handleset 29.Handleset 29 has several purposes, and first purposes is to be configured to hemorrhage position and to locate to this to apply hemorrhage applying accessory 20.The another one characteristics are, the structure of Handleset is in order to allow user hold assembly fast and effectively the surface that applies accessory 20 that includes releasing unit 24 is directly guided to hemorrhage position with one, for example the tremulous pulse that is hurt.Demonstration as Fig. 1 and 2, Handleset 29 is mounted in the surface of supporting assembly 22, Bing and be configured in the position opposite with the outer surface of releasing unit 24, Handleset 29 just can allow user can hold with the hands that may be wet and slippery or be stained with bloodstain so that be difficult to contact releasing unit 24 and apply accessory 20 so, and that just can prevent to discharge because of carelessness or too early hemorrhage 12.Among at least one embodiment, Handleset includes a visual identification 29 and looks for handle to make things convenient for user.The another one characteristics are that it for example is letter, symbol, striped etc. that visual identification 29 ' may include a sign, as Fig. 2 it directly is attached to Handleset.Among at least one embodiment, visual identification 29 ' may be contained between the supporting assembly 22 color contrast, generally be the antiseptic gauze pad of white, and Handleset 29 just includes strong color or color decorative pattern, for example is the stripe pattern that Fig. 2 shows.Just as mentioned above, the present invention more includes the method that hemorrhage is applied to hemorrhage position, generally can be as 100 the demonstration of Fig. 3.The another one characteristics are, method 100 of the present invention include directly apply 110 1 hemorrhages that include the HECTABRITE DP that gains component to hemorrhage position.Method 100 more includes one has the hemorrhage that enough meets relation to concentrate 120 with hemorrhage position, Bing and hemorrhage component and hemorrhage position are kept 130 enough closed relationship in hemorrhage position, thereby can reach and condense and stop hemorrhage function.Among at least one embodiment, in case more comprising the wounded, method of the present invention 100 settles out, need use the method autohemorrhage position of washing and drawing to remove the step of 140 hemorrhage components when for example being transferred to FAMB or casualty department

The present invention is more all thickly to consider a kind of wound blood coagulation of assisting with compositions that has when being applied to wound, simultaneously again can be in body or the operation of wound track with the compositions of the blood coagulation of assisting other wound.

Prescription

Following chart can provide the information of the exploitation of prescription.

First hurdle is the numbering of sign prescription.The explanatory notes of chart below the different formulations compositions for use.

Chart 2

Each fills a prescription chart 2 demonstrations in the assessment of relevant concordance and segregational stability.

Cold Frozen/the thaw cycle of 3x of prescription 48-end formulation-, 3x150,3 months～75 test does not separate.The water absorption rate is tested.Observe to such an extent that the remarkable water absorbing force of octuple is arranged in＜1 fen clock time.

Compositions display is in 32-150 tool stability.

One 48 is that the compositions of basis is according to the test of following method to fill a prescription.

Compositions is after tested and demonstrate following characteristic:

Bonding strength

Use a spot of prescription 48 compositionss with of the test of four coatings, a spring type tonometer (Hunter Spring brand) is connected to a wood particle that has two even surfaces to spread compositions (each 2.25 squares of inch) as products with adhesive intensity.Test can be concluded the pulling force (psi) that can drop compositions.

The general view of ointment degree of adhesion test data

Coating degree of adhesion *

Test No. thickness (psi)

1＜15 mil (0.015 inch) 1.078

2 1/32 inch (0.0312 inch) 0.542

2 1/16 inch. (0.0625 inch) 0.258

4 1/8 inch (0.125 inch) 0.230

(1) the hemorrhage compositions shows good viscosity (every side's inch is greater than a pound) in the extremely thin coating of two wooden unit test surfaces.

(2) pulling force in the coating viscosity degradation of 1/32 inch to 0.542psi.

(3) further descend in 1/16 inch or bigger coating viscosity.

Stickiness

The compositions of prescription 48 is done the test of dynamic viscosity with Brookfield viscometer model RVF in room temperature (25 ℃).

The result

Dynamic viscosity: 356,000cps

(Spindle 7, and per minute 4 changes)

The cps=centipoise

Method of testing and result

Test 1

First application process is that product is put on pig femur only because of the hemorrhage tiny wound opening part of being wounded by stabbing, and this is to simulate by the knife injury or the situation of be wound by howitzer.The wound that two inch of having an appointment on the pig skin are long, It was stung skin to make arteries and veins blood flow situation by pocket knife.The syringe that 60cc carries full hemorrhage compositions is placed to the wound, and the internal hemorrhage situation had stopped in three minutes.

Test 2

Second test is to be used in a trajectory wound track that shot wounded by shotgun.What tried is buttocks outside the cattle that had been subjected to hinder, and skin is torn, and more inner injured stages of cell pro-degree go to pot.As the wound of product test is to use usually with the door lock that pops with anti-terrorism Special Police Unit one by one to enter within doors round thing, and shotgun is from about six inch of skin.Explosion is made big wound as the nickel coin at skin, and stays the vestige of being burnt around the wound opening, and behind the five seconds, wound site has hemorrhage situation.The syringe that two 60cc have carried the hemorrhage compositions is placed to wound track place, adds direct pressure at wound simultaneously.Add pressure after five minutes hemorrhage situation controlled, wound is examined to watch it to be wound situation and product usefulness after half an hour approximately.Find until the wound track of going to shank the opposing party in standardized otch of wound opening with pocket knife, product has suitably been added and followed the wound track moves to the opposing party.

Test 3

Research purpose: check that the hemorrhage compositions is in by the usefulness of Shotshell guiding drug to fatal groin injury.

Methods: method: the hemorrhage compositions of a kind of (checking and approving without U.S. food and FAD) is used for the Femur blood vessel of an animal model that complicated groin injury arranged with emulation.Experimental animal feeding management and guide for use (ILAR are stood fast in this test check, the U.S.] NRC, American National institute periodical, 1996) described policy and principle are carried out, and this is tested employed method and has obtained special upright mechanism animal and look after and use committee (IACUC), and 2007 check and approve.

Utilize free from worries (ketamine and tired peaceful 30mg/kg) that a Yorkshire pig (～82 kilograms) is anaesthetized.With surgical technic intravenous tube is put into left external jugular vein, and add an air tube.Intravenous tube is crossed to keep it logical with normal saline flushing when beginning.Behind intravenously administrable often the syringe normal saline washing.Veterinary office worker goes to keep the animal calmness in whole 180 minutes clock time supervision on the scene animals to make pain management.

Authorize the injured 1 black X mark that on skin, draws that just the femoribus internus near-end of animal is exposed in the weapon scope and requiring with thick pen in case place with staff.Be to penetrate to black X mark from the 6-8 inch then with the shotgun of 12 bores.The only bullet of this traditional shotgun (per second 1500-1700 Foot) can bring out femoral artery and phleborrhexis, and certain inlet wound and outlet wound are made in the hole, wound chamber hemorrhage uncontrollably.The inspector observes has the severe haemorrhage situation after only bullet passes health immediately, and the injured time goes on record.The technician who puts on one's gloves uses at the inlet wound and is equal to～the artificial compressing of 150mmHg (Arnuad et al 2007).In 20-30 in time second artificial compressing stopped, and hole, wound chamber just is covered with gauze, the artificial compressing of using a minute thereafter again is with can control over bleeding before applying hemorrhage.Since can not be before applying hemorrhage control over bleeding, the inspector falls with regard to observing most hemorrhage after five minutes in artificial compressing (J.Hagmann personal communication).During this period of time, artificial compressing stops, all gauze is eliminated, and the syringe of a 60cc is expelled to the hemorrhage that is stated from the suspension in the hole, wound chamber in being less than in 5 seconds, covers the medication position with the wound dressing gauze then and can on average be configured to disruptive Femur blood vessel to guarantee hemorrhage.And then directly apply in wound site immediately and do not have the artificial compressings in five minutes interrupted (～150mmHg), just stop artificial compeling afterwards at once, and then be to observe the wound bleeding situation.Owing to all do not show hemorrhage situation after two minutes, so a gauze that covers hemorrhage being removed and continuing to observe hemorrhage situation.In subsequently ten minutes, do not seen situation a small amount of or that bleed profusely.In ten minutes, testing crew is decided by that left side femoribus internus near-end repeats this and injuredly brings out action.Two piece of 12 bore shotgun to pig only solely launched in several seconds, because the only bullet of first does not cause the situation of bleeding in a large number immediately.And then just make above-mentioned action, hemorrhage situation did not all appear in this second and first wound at once.

Training center is got back in the ramp that pig had only lifted 200 yards injustice by military stretcher afterwards, and is central not hemorrhage again.It is placed under the tent, and is covered with to prevent losing temperature by a fluid-tight glue blanket, and It was supervised 120 minutes.The sign of life of It (heart rate, breathing rate, arterial oxygen saturation, anus temperature) afterwards and after by veterinary's administration was noted by lasting DIYU from injured in per 30 minutes.In this elongated segment the nurse time in the neither one wound the hemorrhage situation that continues is arranged.

Summary: after injured 180 minutes, the hemorrhage that is applied to hole, two wound chambeies adds that artificial compressing has subsequently stoped the fatal hemorrhage situation of sound thing in five minutes.The hemorrhage that is apparent that most the unique haemostatic properties of this tool successfully shows and has stoped the arterial hemorrhage that is caused by the only bullet mechanism of 12 bores.The applying method of this hemorrhage is used as hemorrhage by single or multiple 60CC syringes that to apply as the liquid medicine be very unique, the potentiality of the militancy injury that has very big being applied to treat simultaneously to make the wound track.

Example

In one embodiment, this prescription includes:

Propylene glycol (PPG) 55.56%

Strese Hofmann's hectorite. 27.78%

Water 8.34%

Carbomer

(

Aqua?SF-1))4.17％

Triethanolamine (TEA) 4.17%

Compositions is prepared by following method:

1. mixed carbomer and water

2. add ethanolamine and mixed

3. add propylene glycol and mixed

4. add Strese Hofmann's hectorite. and mixed

Final mixture has above 50, the viscosity of 000CPs.

The acid-base value of compositions is 7.68, and proportion is 1.2773.This proportion be prevent mixture or even the hemorrhage wound of aorta on the gain of dissipating.

First-selected Strese Hofmann's hectorite. has 95% to be particle less than 0.076mm (less than 76 μ m or 76 microns) size.

Benefit of the present invention is that compositions can not intervened the chemophysiology process in the coagulation process.Which is to say, the chemistry of endogenous and exogenous blood coagulation mechanism, and physics and physiological processes are not influenced by the hemostatic composition of this invention can.

It is that compositions is in being less than the moisture content that absorbs its weight octuple of as many as in one minute that a kind of mechanism is arranged in the observation.Therefore, the platelet enrichment will increase with the protein that solidifies and make compositions the capability improving of quickening and keeping blood clotting.

Propylene glycol in the compositions is moistening and can gives the compositions hydrophilic group to promote the water absorbing force acceleration capacity of each aspect.

The prescription of compositions has shown itself provides suitable moisture content Jie thing to apply the problem of clay to wound, because it can not make clay swell thereby subdue and inhaled the part of anhydrating earlier with the hemostatic performance before applying.

Prescription of the present invention has successfully been handled and has been solved this difficulty, and method is to have prepared not make go down liquid Jie compositions of stable stickiness of its water absorbing capacity of clay when applying clay to wound site.Moisture percentage in the prescription is as promoting suspension to scatter the benefit of adding many times of wetting agent propylene glycol p to remedy.Therefore the highest moisture content percentage ratio is to be less than 10%, though can not influence composition stable quite less.

We further mature deliberation be that compositions of the present invention can be assisted exogenous and endogenous position effectively simultaneously.Mouthful blood coagulation, simultaneously again can be in body or the operation of wound track with the compositions of the blood coagulation of assisting other wound.The trajectory wound may be made at same wound track to be had more than an agglomerative hemorrhage source of needs.In the middle of have the inlet wound that can see and the internal wounds that is not easy to see.The wounded's health can be attempted seeing through endogenous blood clotting mechanism and go internal wounds is condensed.It is extremely important to condense with a plurality of wounds of single suction medicine location assistance, because use current science and technology and treatment procedure all to be difficult to enter the non-wound track that connects usually.

In addition, the compositions of using this proof is no matter in being with or without the outlet wound or still can assisting to condense in the hemorrhage position of the wound of compositions run location.

Compositions has the elasticity of the wound site that can meet some F-SP, in addition, based on this elasticity factor, condenses and can keep stability and can not break.

Though the compositions viscosity has promoted, realize the action that is eliminated after forming of blood clotting that do not had overslaugh of the viscosity of composition I and adhesion speciality in the observation.Reduce widely and/or stopped in case observing blood flow, use and like traditional wound irrigation technology of usefulness to be enough to composition removing.

In an implementation method, compositions may be inhaled the moisture content of 24 times of its weight.This water absorbing force is noticeable, because compositions has included moisture content.Compositions can absorb water, in an implementation method, it can inhale the moisture content of 24 times of its weight, in a first-selected implementation method, it can remove the moisture content of its weight octuple being less than in one minute to inhale, and just the compositions that is provided at last includes 10 moisture content.This point is very important when aorta is hemorrhage, and when particularly sweltering heat or dry climate were treated wound down, patient extremely needed moisture content.Traditional treatment program and agreement do not provide the liquid medicine for the aorta hemorrhage.

Compositions of the present invention does not singly only provide quick and key assistance in the blood coagulation process, and allows the liquid administration, does key to patient's existence tool to patient's administration with interference-free without interruption not influence the treatment effectiveness of using compositions yet.According to a lot of conventional medicament agreements and program, the patient that traumatic wound is arranged can not give him moisture content, because probably thing followed blood pressure adds and rises meeting to be directed at patient hemorrhage once more.

This compositions keeps in touch in wound site and/or near and cell, although under enhanced hydrostatic pressure also in this way, just in time showed suitable bonding strength.This bonding strength offers this compositions has condense with promotion enough times of contact, in the hemorrhage situation of aorta also in this way.This cement properties provides the additional benefit that need not use the pressure of blood clotting for compositions of the present invention.

In an implementation method, compositions of the present invention is to be loaded in a syringe or the ejector.Syringe may be as compositions directly is put into the wound.The another one usage is that syringe can further attach a conduit, pipeline or other guidance quality instrument compositions is aimed at wound and apply.Syringe or ejector apply provides a lot of benefits.Syringe may apply compositions through narrow opening.Actual hemorrhage position is can't see, and compositions still can believe that the opening near hemorrhage position is introduced into through one; Hemorrhage place be positioned at body and on skin object, for example bullet, howitzer or analog enter intravital entrance, may be the positions that gives compositions, thereby cannot see hemorrhage position and also can treat it.Compositions moves to hemorrhage position in vivo, and the blood of wound does not need to find time, and uses syringe also need not enlarge wound site, and that just need not be because applying compositions making wound add wound.

Use syringe to go to apply compositions, patient may be also can own use compositions, he can hold compositions and apply with a hands.Singlehanded medication is very important when oneself applies medicine.A lot of current agreements and program need enlarge wound and extract blood out, and in some situations that is not to use this application system, applying hemorrhage may need more than one medical personnel.The further benefit that syringe applies is that medication does not need special training.Most of current other wound treatment methods of using are medical trainings and cannot self-administer widely.As above-mentioned said, compositions of the present invention also provides it not need working pressure to impel agglomerative favourable function.

In another implementation method, compositions can be combined into a patch.Basically, the therapeutic combination that applies of patch is to have comprised layer of polyethylene alcohol (PVA) thin film in patch.The PVA thin film can dissolve when contacting with moisture content or liquid, thereby the active ingredient that comprises in the middle of the handle distributes.This inventive compositions is to be formulated into one to apply HECTABRITE DP and become in thing Jie thing to the water of wound site.It is to be unsuitable for to be used in the patch applying method that uses the PVA thin film basically that water becomes the system system.Even so, the propylene glycol of this compositions is a wetting agent, and this composite formula had showed that small amount of moisture in the prescription can not filtered when tying up to wherein and contacting with PVA with dissolving films in advance.PVA is favourable especially, because near not being close to hemorrhage position the time, the cell around PVA can be attached on is providing extra water absorbing force, thereby the usefulness that helps to keep this blood agent and promote the present invention's hemorrhage.

Owing to the present invention is with its preferred forms or embodiment and adds some characteristics and describe, those are described and make to add some way of illustration only is apprehensible.As for structure, assembling and use, comprise that the combination of parts and the details of arrangement have to make multiple variation without departing from the spirit and scope of the present invention.

Claims

1. the hemorrhage compositions includes: the rarest a kind of clay hemorrhage and one are mounted with Jie of blood clotting compositions are provided thing.

2. the compositions of the hemorrhage that Syria states in the claim 1 includes montmorillonitic clay.

3. the compositions of the hemorrhage that Syria states in the claim 1 includes HECTABRITE DP.

4. the Strese Hofmann's hectorite. that Syria states in the claim 1 has 95% to be particle less than 76 microns sizes.

5. the compositions that Syria states in the claim 1 absorbs the big liquid of weight ratio composition weight.

6. the compositions that Syria states in the claim 1 absorbs the big 24 times liquid of weight ratio composition weight.

7. the compositions that Syria states in the claim 1 absorbed the liquid of the big approximately octuple of weight ratio composition weight in about one minute.

8. the compositions that Syria states in the claim 1 is inactive for blood clotting albumen and platelet, is inactive for exogenous and endogenous blood clotting mechanism.

9. the compositions that Syria states in the claim 1 directly applies to external wounds.

10. the compositions that Syria states in the claim 1 is to directly apply to position external wounds and move to the two or two wound in body.

11. the compositions that Syria states in the claim 1 is the position that directly applies to external wounds and move to second wound in body, this second wound can be outside or internal wounds.

12. the hemorrhage compositions includes:

(a) 40-70% propylene glycol;

(b) 20-40% HECTABRITE DP;

(c) 5-15% water;

(d) 1-10% carbomer; With

(e) 1-10% triethanolamine.

13. the compositions that Syria states in the claim 12 includes:

(a) 55.56% propylene glycol;

(b) 27.78% HECTABRITE DP

(c) 8.34% water;

(d) 4.17% carbomer; With

(e) 4.17% triethanolamine; Said composition is showed greater than 100, the dynamic viscosity of 000cps.

14. the agglomerative method of accelerate blood includes following step:

(a) look for wound;

(b) provide and comprise the hemorrhage of rare a kind of montmorillonitic clay;

(c) compositions is put in the wound.

15. the described method of claim 14 is the method more than a wound source.

16. the described method of claim 14 is the external wounds that a minimum internal wounds is arranged, central internal wounds is condensed and more is put into external wounds and has moved to the after-acceleration of internal wounds position in body in compositions.

17. the internal wounds in the middle of the described method of claim 16 is to be not easy to see from the patient body outside or look for.

18. the compositions that provides in the described method of claim 14 include apply as many as 250cc stickiness liquid compositions to wound.

19. having, the stickiness liquid compositions in the described method of claim 14 surpasses 100, the dynamic viscosity of 000cps.

20. in the described method of claim 14, montmorillonitic clay is a Strese Hofmann's hectorite..

21. in the described method of claim 14, central more comprised the flushing applied the position of hemorrhage compositions to remove all hemorrhage compositionss.

22. in the described method of claim 14, mentioned compositions is used and is to use syringe or ejector to carry out.

23. hemorrhage and application system include:

The minimum a kind of hemorrhage that can make blood clotting; With an accessory that applies that can directly be applied to above-mentioned hemorrhage component hemorrhage position, above-mentionedly apply that accessory is minimum can transience to keep the above-mentioned hemorrhage of above-mentioned component so that it directly is configured to hemorrhage position.

24. system according to claim 23, the central described accessory that applies can allow user with singlehanded the above-mentioned component of above-mentioned hemorrhage directly is applied to hemorrhage position.

25. system according to claim 24, the central described accessory that applies can allow user use syringe or ejector with one hand, or the patch of Bao Hanyou Xi blood agent directly is applied to hemorrhage position to the above-mentioned component of above-mentioned hemorrhage.