Medicinal bandage

FIELD: medicine.

SUBSTANCE: invention relates to dressing materials based on polymeric compositions and can be used in surgery and traumatology for closing wounds of different etiology. The polyol component-base medicinal bandage based on propylene oxide or ethylene oxide comprises water, catalyst for urethane formation and isocyanate complex consisting of isomers of diphenylmethane diisocyanate. High-molecular simple polyetherpolyol with molecular mass 3000-10000 Da is used, and isocyanate complex comprises additionally oligourethane isocyanate based on low-chain oligoetherpolyol with the content of isocyanate groups 26.0-29.5 wt.-%. Also, the bandage comprises activation additive consisting of polyurethane chain lengthener, foam-opening agent and foam-hardening agent. Bandage provides exclusion additional pain senses in the patient, enhancing absorption effect and provides absence of skin sticking.

EFFECT: valuable medicinal properties of bandage.

7 ex

 

The present invention relates to medicine, namely to the bandages on the basis of polymer compositions, and may find application in surgery and traumatology for the closure of wounds of different etiology.

In recent years, special interest dressings on the basis of polyurethane compositions. This is due to the fact that medical bandage receive immediately before use, which provides a sterile wound closure in extreme conditions. In addition, the bandage on the basis of polyurethane compositions has a porous structure that provides the absorption properties of the dressing material. Such a bandage can easily be formed on the entire surface of the wound, no matter how complicated it was not (configuration and dimensions). In present - time of climatic disasters and local wars, the creation of such a bandage is the most urgent task.

Known polyurethane composition for dressing material (RF №2069291, A 61 L 15/26, publ 20.11.96, bull. No. 32), comprising a polyol as one component as hydroxycholesterol with molm 1000-6000 mm. in combination with a simple oligopyrroles with molm 200-1000, catalyst retinoblastoma and isocyanate component, which is used as a solution of the product of the interaction of simple oligoesterdiol and oligoarthritis with tolui invitationto (TDI) or its mixture with polyvinylpolypyrrolidone in excess of diisocyanate with a content of isocyanate groups 16,8-of 34.5 wt.%. It further contains water in the following ratio of the components of the composition, wt.%:

Simple polyetherdiol with molm-6000 100

Simple oligoamnios with molm 200-1000 1,0-3,0

Water 1,5-5,3

Catalyst retinoblastoma 0,3-0,8

Isocyanate component 29,4-163,6.

The positive effect of its use is that on the basis of the formation of the flexible polyurethane foam is happening in the environment without the use of halogenated hydrocarbons as auxiliary blowing agents.

However, a disadvantage of the known polyurethane compositions is that as the isocyanate component used highly toxic TDI belonging to the first group of highly toxic substances, so it is impossible to use in medical practice.

A prototype of the invention is selected known medical bandage of flexible polyurethane foam (RF №2053795, IPC A 61 L 15/26, publ 10.02.1996,, bull. No. 4), consisting of a polyol as one component, including oligoarticular based on propylene oxide and ethylene oxide and isocyanate component comprising oligomerization based nismapname oligoarticular and mixtures of isomers diphenylmethanediisocyanate.

The composition has a content of isocyanate groups of 19.2-to 26.0 wt.% in the following ratio and is gredients, parts by weight of:

High-molecular-weight oligomerisation 100

Low-molecular oligoamnios 1-5

Water and 2.3-4.0

Catalyst retinoblastoma 0,40-0,50

Isocyanate component 35,3-54,1

The positive aspect of this arrangement is that in the known invention use non-lethal 4,4-MDI or its derivatives, however, recommended recipe when multiple verification not received a positive evaluation by a health professional for the following reasons:

- the shelf life of 4,4’-MDI and his oligomerisation not exceed 1-2 months at room temperature even in a tightly closed container; in response retinoblastoma temperature foam rises to 60 degrees C and above, which leads to additional pain in a patient (especially in the burn patient);

- you must specifically prepare oligomerization on the basis of 4,4-MDI in the laboratory, because industrial production is not available;

- based on MDI foamed polyurethanes possess hardness, have a large percentage of closed pores, and for this reason give small absorption effect (i.e. low outflow exudate from the wound).

The task of the invention is to lengthening the shelf life of the composition, the elimination of pain in a patient, increasing the absorption EF the project and ensuring the absence of adhesion to the wound.

The problem is solved in that in the known medical dressing consisting of a polyol as one component, including oligoarticular based on propylene oxide and ethylene oxide, water, catalyst retinoblastoma and isocyanate component comprising oligomerization based nismapname oligoarticular and mixtures of isomers of diphenylmethanediisocyanate, polyol as one component further comprises an activation additive consisting of chain extension of the polyurethane. pootkryvali and penitences, as a polyol as one component using macromolecular simple polyetherpolyols, isocyanate component contains named oligomerization and an excess of a mixture of isomers diphenylmethanediisocyanate and has a content of isocyanate groups 26,0-to 29.5 wt.%. In the isocyanate component is also present carbodiimide oligomer, which is obtained by a special heat treatment of the isocyanate by the reaction of decarboxylation of the latter in the industrial production. Specified oligomer acts as hydrostability and photostabilization as isocyanate component during storage, and the resulting foamed polyurethane when applied to the wound surface.

The present invention meets the criterion of “novelty”, because in the process of patent information and the research is not identified sources, prejudicial to the novelty of the invention. The present invention meets the criterion of “inventive step”, because it is not identified sources containing significant differences of the present invention.

The proposed composition consists of two liquid components: polyol as one (a) and isocyanate (B).

The components are mixed immediately prior to use in a glass beaker or plastic bag and pour on the wound surface during foaming of the resulting polyurethane (PU).

For 3-15 min, polyurethane foam hardens on the wound and provides its closure, significantly reduces pain, promotes flow of exulta and rapid epithelialization of the wound surface.

Component And includes a simple high polyetherpolyols with a molecular mass of 3000-10000 derived from propylene oxide or ethylene oxide, in particular produced by domestic industry products under the name of LAPROL brand 3003, 3603, 5003, 6003.

To accelerate the formation of the polyurethane component And make the activation additive where, in addition to the catalyst ustanavlivaniya and water additionally contains: chain extension polyurthane, pootkryvali and periotoneal.

As a catalyst retinoblastoma use different tertiary aliphatic amines.

As UD is initely chain use alkanolamine.

As penitences use polymethylsiloxane, such as Dabco 2525 manufactured by air PRODUCS or Agosta In 8715 LF manufactured by GOLDSCHMIDT. For adjustable pootkryvali use of high molecular weight polyols, which are produced by the domestic industry.

Component B consists of prepolymers diisocyanatobutane. As a final use of Suprasec 2456 (firm HUNTSMAN), including two prepolymer: prepolymer obtained from a mixture of 4,4’-2,4’- and 2,2-isomers of diphenylmethanediisocyanate and low molecular weight polyol of propylene oxide with molm 240-250-units (4% wt.), and prepolymer synthesized by heat treatment of this mixture of isomers diphenylmethanediisocyanate. The latter reaction leads to the formation of isocyanatobenzene derivatives having the group - N=C=N-. The exact etiology of obtaining prepolymer and their contents in Suprasec 2456 are secret HUNTSMAN. The presence of these prepolymers in Suprasec 2456 contributes to the stabilization of this product during storage, and also reduces the exothermic effect of the reaction of formation of the polyurethane foam used as a dressing tool. The above components are mixed in the ratios of a and B from 4.0:1 to 2.0:1,

The number of components in the composition are selected in such a way that the s to ensure optimum foaming composition and physical-mechanical properties and structure of the obtained polyurethane foam.

By reducing or increasing the content of each component of the composition is impossible to achieve the desired positive effect. This position is illustrated by examples 1-7.

Example 1.

Polyol as one component (A) is prepared by thoroughly mixing 100 maschiogabriele and 5 parts by weight of the activation of the additive, which includes:

catalyst retinoblastoma 1.5 parts by weight of

water 4.1 parts by weight of

extension chain 1.3 parts by weight of

periotoneal 1.5 parts by weight of

pootkryvali 1.5 parts by weight of

As the isocyanate component (B) used Suprasec 2456 manufactured by huntsman (USA), containing 29.5% of NCO-groups. In the manufacture of PU composition per 100 parts by weight of polyol as one component And is added to 33 parts by weight of isocyanate component (B). The composition is prepared by mixing polyol as one of the component (A) with the isocyanate (B) in a plastic bag with a capacity of 350-400 ml) followed by manual grinding (or mixing) of these products. After 50-60 seconds after mixing the composition to be applied on the wound surface. After 3-5 minutes after application, the composition is transformed into a porous sponge, which is firmly held on the surface of the wound. Over the next 14-17 minutes PU composition is characterized by a relatively high viscosity, decreases with time and almost disappears in 18-25 minutes after the application.

PA is ometry expansion:

Start - 25 sec,

Lift - 140 sec,

Hanging - 21 min,

Temperature - 50 degrees C.

Example 2.

Polyol as one component is prepared by mixing 100 parts by weight of oligopyrroles and 6,87 parts by weight of the activation of the additive, including:

catalyst retinoblastoma - 3.1 parts by weight of

- water - 4.3 parts by weight of

extension chain - 1.4 parts by weight of

- pootkryvali - 1.4 parts by weight of

- prestabilization - 1.5 parts..

PU composition is prepared and used as in example 1, except that the coating on the wound surface is 15-25 seconds after mixing. The viscosity in this case is practically disappears after 5 min, but the temperature rises up to 57-58 degrees C.

Parameters:

- start - 10 sec,

- ascent - 30 sec,

- touch - 5 minutes

Example 3.

Polyol as one component is prepared by mixing 100 parts by weight of oligopyrroles and lower than the 5.37 parts by weight of the activation of the additive, which is similar to the activation of the additive of example 2 except that the proportion of catalyst retinoblastoma is 0,706 parts by weight of PU composition is prepared and used as in example 1, except that the coating on the wound surface is made through 50-75 seconds after mixing.

Parameters:

start - 22 sec,

lift - 100 sec,

the tackiness is 16.5 minutes

temperature is 52 degrees C.

Example 4.

Polyol as one component is prepared analogously to example 3, n is additive activation is 3,295 parts by weight of PU composition is prepared and used as in example 1, except that the printing on the wound occurs through 120-150 seconds from the moment of mixing. The composition exhibits a sufficiently high viscosity for about 35 minutes

Parameters:

- start 35 sec,

- lift - 230 sec,

- hanging - 35 min,

- temperature is 47 degrees C.

Example 5.

Polyol as one component is prepared analogously to example 3, except. in the composition of the activation of the additive contained 0.95 parts by weight of the catalyst retinoblastoma. PU composition is prepared and used as in example 1 except that the coating on the wound surface is made through 45-70 seconds from the moment of mixing.

Parameters:

- start - 18 sec,

- ascent - 80 sec,

- touch to 10.5 min,

the temperature is 54 degrees C.

Example 6.

Polyol as one component is prepared analogously to example 2. PU composition is prepared analogously to example 1, but on 100 parts by weight of polyol as one component And 50 parts by weight of isocyanate component (B). While drawing on the wound clean through 18-30 seconds, but the temperature of the foam rises to 62 degrees C.

Parameters:

- start - 13 sec,

- lift - 32 sec,

- hanging - 9 minutes

Example 7.

Polyol as one component is prepared analogously to example 3. PU composition is prepared analogously to example 1, but on 100 parts of the underground component (A) is necessary to 28.57 parts by weight and ocyanate component (B). While drawing on the wound surface is possible through 50-75 seconds from the moment of mixing.

Parameters:

- start - 23 sec,

- lift - 105 sec,

- hanging - 14,5 min,

temperature - 48 ° C.

Thus, the optimum composition is the following: polyol as one component contains macromolecular simple polyetherpolyols, activation mixture comprising water, a catalyst retinoblastoma and chain extension of the polyurethane, periodrachel, periotoneal and isocyanate component contains named oligometastases, the excess mixture of isomers diphenylmethanediisocyanate, which has a content of NCO-groups to 29.5 wt.%.

Medical bandage of the flexible polyurethane foam is produced as follows.

Components a and B immediately before application, mix in a Cup or a plastic bag, or fray them in this bag. Formed polyurethane mass, which is at the stage of gel formation pour on the wound surface. Mass flow, foams and solidifies on the wound in the form of a flexible polyurethane foam, cover it completely with a layer thickness of 10-15 mm

The present invention provides for the use of the following positive effects.

Formed directly on the wound, the bandage ensures it is fully sterile closure, provided the AET effect of anesthesia, that noted in many patients, primary disinfection of wounds and the absorbance exudate, requires no additional dressing devices. In addition, the proposed composition gives foamed polyurethane "sponge", stickiness which stops after 15-20 minutes after pouring onto the wound, the temperature of the foam is not increased more than 45-50 degrees C.

The most important advantage of the above composition is painless removal of foam dressings in 3-5 days after using it, what happens offline, in fact without the assistance of medical personnel.

In addition to this we can add that the obtained flexible polyurethane foam "sponge" provides:

good protective properties, allowing to protect the wound from sagasti external environment and secondary microbial contamination, secure fit to the healthy skin due to the high adhesive properties of the foamed polymer;

the lack of adhesion to the wound due to the formation of polyurea directly on the border of the wound and bandage (polyurea does not have adhesive properties)that allows you to painlessly remove the bandage during ligation,

- full congruence to the relief wounds:

the possibility of applying a bandage on any surface of the body, particularly in the area of large joints without restricting range of motion, without additional fixat and bandages;

good absorption capacity;

- semesterisation at the time of education;

- achieve analgesic effect.

Moreover, in contrast to previous patents armband received on the proposed composition, remains stickiness no more than 15-20 minutes.

The resulting polyurethane foams do not cause allergic reactions in patients and medical personnel and can be used in any climatic conditions. Clinical examples are given in the form of extracts from the history.

Patient Andrienko, S., 34 years. case history No. 1147924. He entered the first burn Department 18.10.01 was diagnosed with Thermal bitumen II-III And Art. the right foot”. Injury received 18.10.01, as a result of accidental boiling bitumen on the right foot. After 6 hours of injury imposed a band of flexible polyurethane foam, which is not filmed in 12 days. After expiration of this period, the bandage was easily removed with kapitalizirovana burn the surface. Antibiotic therapy was not carried out. The patient was discharged in satisfactory condition.

As an example, here is an extract from a case history. Patient Timoshin M.I., 62 years history No. 1000. received second surgical ward Road clinical hospital on shoriki 09.02.01, with a diagnosis of “Long-term healing the wound of the upper third of the plumage is it the surface of the left tibia”. The wound caused by the injury for about 2.5 months ago, one week after injury, the wound fester. Before entering the hospital for 2 months were treated “home remedies” and within 2 weeks under the supervision of a surgeon clinics. In the Department within 30 days provodilos conservative treatment with the purpose of preparation for skin plastic surgery. At the time of inspection (10.03.01,) wound with uneven, saped callous edges and pale grayish patches of granulations, covered with necrotic strikes, sizes 5×4 see the Skin around the wound hyperpigmented. After using the toilet wounds 3% solution of hydrogen peroxide to the wound inflicted by the medical bandage of elastic polyurethane foam, for 4 days were conducted daily change of dressing polyurethane foam with toilet wounds. On the 5th day the wound was cleansed from raids, revived granulation tissue appeared marginal epitelizatia. The bandage was applied from flexible polyurethane foam, which is observed within 3 days, the bandage has kept its original appearance, signs of swelling and peeling was not observed. 22.03.01, the patient was discharged to outpatient treatment. On the 15th day after the last of the bandage, marked her self-discharge. The wound is fully epithelials. The need for surgery fell.

Medical bandage-based polyol as one component based on propylene oxide or ethylene oxide, combine water, catalyst retinoblastoma and isocyanate component comprising a mixture of isomers of diphenylmethanediisocyanate, characterized in that as a polyol as one component using macromolecular simple polyetherpolyols with a molecular mass of 3000-10000, and isocyanate component further comprises oligomerization based nismapname oligoarticular with the content of isocyanate groups 26,0-to 29.5 wt.% and the bandage further comprises activation additive consisting of chain extension of the polyurethane, of pootkryvali and penitences at a ratio in parts by weight:

Macromolecular simple polyetherpolyols

with a molecular mass of 3000-10000 100

Activation additive 3,295-6,87



 

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7 ex

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