JP6718680B2 - Hemostatic material - Google Patents

Description

The present invention relates to a hemostatic material.

The wound site of the bleeding skin is stopped by the hemostatic material. Patent Document 1 discloses a hemostatic material having a three-layer structure in which a soluble hemostatic material layer, an adhesive layer, and a fixing sheet are laminated. The adhesive layer adheres to the soluble hemostatic material layer and the fixing sheet. When applied to the wound site, the soluble hemostatic layer absorbs blood and swells and dissolves. The dissolved hemostatic material promotes the activation of blood coagulation factors and the production of blood coagulation catalysts. This blood coagulation catalyst rapidly converts fibrinogen in plasma to fibrin. Fibrin forms a clot block, resulting in hemostasis on the wound surface.

Patent Document 2 discloses a wound dressing material having a hemostatic effect and capable of maintaining a wet state suitable for wound healing. This wound dressing can fix the alginate aggregate to the wound site. The alginate aggregates gel well at the wound site and remain moist. According to Patent Document 2, the apparent density of a non-woven fabric or the like, which is an alginate aggregate, is set to 3.5×10 ⁻² g/cm ³ or less in order to enhance the water absorption of the alginate aggregate.

JP, 09-294765, A JP-A-07-136240

The non-woven fabric containing alginate has an excellent hemostatic effect. However, according to the test conducted by the inventor of the present application, when a non-woven fabric is applied to a bleeding wound site and the non-woven fabric is removed from the wound site after hemostasis, the non-woven fabric is not easily peeled from the blood coagulated at the wound site May cause pain to the patient. Therefore, there is room for improvement in the non-woven fabric containing alginate from the viewpoint of reducing the pain given to the patient.

Patent Document 1 discloses, as an example of the soluble hemostatic material layer, a woven, non-woven, or sponge-like layer formed of oxycellulose, oxidized collagen, sodium cellulose, calcium alginate, or the like. However, Patent Document 1 does not mention the pain given to the patient when the nonwoven fabric is applied to the wound site. Therefore, the hemostatic material disclosed in Patent Document 1 is not a hemostatic material improved so as to reduce the pain given to the patient.

Patent Document 2 also does not mention pain caused to a patient when a nonwoven fabric, which is an alginate aggregate, is applied to a wound site. Furthermore, since the apparent density (bulk density) of the nonwoven fabric of Patent Document 2 is 3.5×10 ⁻² g/cm ³ or less, most of the fibers constituting the nonwoven fabric are oriented in the thickness direction of the nonwoven fabric. .. As a result, the surface of the non-woven fabric is in a state where many fiber ends are outward, that is, in a fluffy state. Further, on the surface of the non-woven fabric, the ends of the plurality of fibers facing outward are intertwined with each other and/or form a bundle to form a large number of fiber lumps. This clot of fibers is likely to be taken into the clot when blood coagulates. Further, since this fiber lump is composed of a plurality of fibers, the rigidity and the breaking strength are high. Therefore, when attempting to remove the wound dressing from the wound site, the non-woven fabric is not easily peeled from the blood clot, which may cause pain to the patient, and the blood clot may be peeled from the wound site to cause bleeding.

An object of the present invention is to provide a hemostatic material that hardly causes pain at a wound site.

According to one aspect of the present invention, the hemostatic material includes a non-woven fabric, the non-woven fabric includes a fibrous alginate, and the non-woven fabric has a smooth front surface in which a lump of fibers formed by a plurality of fibers is substantially absent. Have.

According to another aspect of the present invention, the hemostatic material includes a non-woven fabric, the non-woven fabric includes fibrous alginate, and the non-woven fabric has a bulk density of 4.0×10 ⁻² g/cm ³ or more.
According to still another aspect of the present invention, there is provided a method of manufacturing the hemostatic material. This method includes a step of pressing the nonwoven fabric in the thickness direction by passing the nonwoven fabric between a pair of rolls.

The hemostatic material according to the present invention hardly causes pain at the wound site.

Sectional drawing of the hemostatic material of one Embodiment. Sectional drawing of the hemostatic material of FIG. 1 attached to the wound site|part. The photograph which expands and shows a part of nonwoven fabric of an Example. The photograph which expands and shows a part of nonwoven fabric of a comparative example. The photograph which expands and shows a part of nonwoven fabric of a comparative example. The figure which shows the model of the nonwoven fabric of a comparative example.

[1] A hemostatic material according to an aspect of the present invention includes a non-woven fabric, the non-woven fabric includes a fibrous alginate, and the non-woven fabric is smooth and does not substantially have a lump of fibers formed by a plurality of fibers. Has a front.

Here, the "non-woven front surface" refers to the surface that contacts the wound site when applied to a patient. The term "substantially no fiber lumps" means that when a non-woven fabric having a predetermined width is folded in half so that the length of the non-woven fabric is half, the number of fiber lumps outward from the fold is the fold. It means less than 5 per 5 cm in length. The number of lumps of fibers is preferably less than 1 per 5 cm of fold length.

According to the present hemostatic material, since there is substantially no lump of fibers on the front surface of the nonwoven fabric, when the hemostatic material is peeled off from the wound site after blood is coagulated, the nonwoven fabric is unlikely to peel off the blood clot. As a result, bleeding and pain due to the blood clot being peeled off from the wound site are less likely to occur.

[2] According to another aspect of the present invention, the non-woven fabric contains fibrous alginate, and the non-woven fabric has a bulk density of 4.0×10 ⁻² g/cm ³ or more.
This form of hemostatic material is less likely to cause pain at the wound site.

The inventor of the present application has found that when the bulk density of the non-woven fabric is less than 4.0×10 ⁻² g/cm ³ , many fluffs are formed on the front surface of the non-woven fabric, that is, the end portions of the fibers directed outward are formed. In contrast, when the bulk density is 4.0×10 ⁻² g/cm ³ or more, fluff is hardly formed on the front surface of the nonwoven fabric, and fiber lumps are substantially present. I confirmed not to do it. The reason is considered as follows. When the bulk density of the non-woven fabric is low, the number of fibers of the fibers constituting the non-woven fabric that are oriented in the thickness direction of the non-woven fabric, that is, in the direction intersecting the surface of the non-woven fabric, is larger than that in the case where the bulk density is high. The ends of these fibers tend to form fluff and outward masses of fibers on the surface of the nonwoven. On the other hand, when the bulk density of the non-woven fabric increases due to the non-woven fabric being pressed in the thickness direction by calendering or the like passing between a pair of rolls, the fibers forming the non-woven fabric become parallel to the surface of the non-woven fabric. It becomes easy to be oriented. As a result, the outward fiber ends are reduced, and the fiber clumps are dissociated.

For the above-mentioned reason, in the hemostatic material of this form, there is substantially no lump of fibers formed by a plurality of fibers on the front surface of the nonwoven fabric. As a result, when the hemostatic material is peeled from the wound site, pain caused by the blood clot being peeled from the wound site is less likely to occur.

The upper limit of the bulk density of the nonwoven fabric is not particularly limited. However, the upper limit of the bulk density of the non-woven fabric is preferably 20.0×10 ⁻² g/cm ³ in order to achieve sufficient absorption of blood and appropriate flexibility that can easily follow the wound site. Yes, more preferably 10.0×10 ⁻² g/cm ³ and further preferably 8.0×10 ⁻² g/cm ³ .

[3] In the hemostatic material, it is preferable that the thickness of the nonwoven fabric is included in a range of 1.0 to 3.5 mm.
The hemostatic material in this form can absorb an appropriate amount of blood and exert an excellent hemostatic effect, and can easily follow along without being strongly pressed against the wound site, further suppressing the occurrence of pain at the wound site. be able to.

The thickness of the non-woven fabric is preferably in the range of 1.5 to 3.0 mm, more preferably 1.9 to 2.7 mm.
[4] In the hemostatic material, the basis weight of the non-woven fabric is preferably included in the range of 80 to 200 g/m ² .

The hemostatic material in this form can absorb an appropriate amount of blood and exert an excellent hemostatic effect, and can easily follow along without being strongly pressed against the wound site, further suppressing the occurrence of pain at the wound site. be able to.

The basis weight of the above nonwoven fabric is preferably in the range of 100 to 170 g/m ² , and more preferably in the range of 120 to 145 g/m ² .
[5] Preferably, the hemostatic material is sheet-shaped, and the hemostatic material further includes a protective sheet laminated on the non-woven fabric, wherein the liquid permeability of the protective sheet is lower than the liquid permeability of the non-woven fabric. ..

According to the hemostatic material of this form, even if the nonwoven fabric swells and dissolves by absorbing body fluid, the hemostatic material is held at the wound site by the protective sheet, so that the wound site can be protected. Further, since the protective sheet has low liquid permeability, the body fluid absorbed in the nonwoven fabric is suppressed from leaking to the outside, and as a result, the clothes of the patient are prevented from being soiled.

The protective sheet is preferably fixed to the non-woven fabric by heat welding, an adhesive such as a hot melt adhesive, or an adhesive. Adhesive conditions such as the amount of adhesive applied are set so that the protective sheet is firmly fixed to the dry nonwoven fabric and that the protective sheet can be peeled off from the nonwoven fabric that has absorbed body fluid with relatively weak force. Preferably. This facilitates handling of the hemostatic material in a dry state, and the protective sheet can be easily peeled from the nonwoven fabric when the hemostatic material is removed from the wound.

[6] The method for producing the hemostatic material includes a step of pressing the non-woven fabric in the thickness direction by passing the non-woven fabric between a pair of rolls.
When the non-woven fabric is pressed in the thickness direction by passing it between a pair of rolls, the fibers forming the non-woven fabric are easily oriented parallel to the surface of the non-woven fabric. As a result, the formation of fluff on the surface of the non-woven fabric is suppressed, and thus the formation of a lump of fibers in which the ends of a plurality of fibers are gathered in a bundle and/or intertwined with each other is suppressed.

[7] The method may further include a step of laminating a protective sheet on one surface of the nonwoven fabric, and the step of laminating the protective sheet may be performed before, after, or after the step of pressurizing the nonwoven fabric in the thickness direction, or It can be performed simultaneously with the step of pressing the nonwoven fabric in the thickness direction.

The above-mentioned pressurizing step may be applied to the nonwoven fabric only once, or may be applied multiple times. When the pressurizing step is performed a plurality of times, the pressurizing step can be performed before, after laminating, simultaneously with laminating the protective sheets, or in any combination thereof.

Next, one form of the hemostatic material 1 will be described with reference to FIG.
The main use of the hemostatic material 1 is to cover the bleeding wound site 200 (see FIG. 2) and to stop the bleeding site 200. The hemostatic material 1 is in the form of a sheet and has the flexibility to easily fit the skin. As an example, the hemostatic material 1 has a laminated structure in which a nonwoven fabric 10, an adhesive layer 30, and a protective sheet 20 are laminated in this order, and the nonwoven fabric 10 and the protective sheet 20 are fixed to each other via the adhesive layer 30.

When applied to the wound site 200, the non-woven fabric 10 absorbs the body fluid flowing out from the wound site 200. By absorbing the body fluid, a part of the non-woven fabric 10 is dissolved and gelated, and calcium ions and the like are released. Body fluids primarily include blood and exudates. The non-woven fabric 10 is made of fibrous alginate. The cations that make up the alginate include, for example, calcium, sodium, or both.

The non-woven fabric 10 preferably has flexibility that easily fits on the skin. The function of the non-woven fabric 10 is mainly provided by the non-woven fabric 10 having a preferable range of bulk density and thickness. The front surface 11 of the non-woven fabric 10 is exposed. When the hemostatic material 1 is used for hemostasis of the wound site 200, the front surface 11 of the nonwoven fabric 10 is applied to the wound site 200.

The protective sheet 20 has a role of preventing bodily fluid absorbed by the nonwoven fabric 10 from seeping out from the back surface 12 of the nonwoven fabric 10 and preventing external liquid or the like from entering the wound site 200. The function of the protective sheet 20 is provided by the material of the protective sheet 20 having low liquid permeability. As an example, the liquid permeability of the protective sheet 20 is so low that the protective sheet 20 does not substantially permeate the liquid.

The protective sheet 20 preferably has flexibility that easily fits on the skin and strength that can sufficiently hold the nonwoven fabric 10. Examples of the material forming the protective sheet 20 include a resin film, a cloth, a non-woven fabric, and a material obtained by combining some or all of these. Examples of the resin film include a film of an olefin resin (polyethylene resin, polypropylene resin, etc.), a polyester resin, a polyamide resin, or a polyurethane resin. It is preferable that these films have stretchability so that the hemostatic material 1 can easily fit on the skin. The thickness of the protective sheet 20 is not particularly limited and can be set as appropriate in consideration of flexibility, strength and the like. The thickness of the protective sheet 20 may be set to 25 to 30 μm, for example.

The adhesive layer 30 has a role of firmly adhering the protective sheet 20 to the back surface 12 of the nonwoven fabric 10. However, the adhesive layer 30 may allow the protective sheet 20 to be easily peeled from the non-woven fabric 10 when the non-woven fabric 10 is gelled with a body fluid. The adhesive layer 30 is formed between the back surface 12 of the non-woven fabric 10 and the inner surface 21 of the protective sheet 20, and adheres the non-woven fabric 10 and the protective sheet 20 to each other. The adhesive layer 30 is made of an adhesive such as a synthetic rubber hot melt adhesive. The synthetic rubber hot melt adhesive contains, for example, a styrene-butadiene-styrene copolymer.

In this embodiment, the above-mentioned adhesive is used in layers, but the above-mentioned adhesive used in the present invention may be in any form as long as it can fix the nonwoven fabric 10 and the protective sheet 20 to each other. Well, it is not limited to layered ones. For example, the adhesive may be applied to the protective sheet 20 in a predetermined pattern of a line or a dot, and the non-woven fabric 10 and the protective sheet 20 may be fixed to each other via the adhesive.

The configuration of the nonwoven fabric 10 will be described.
The bulk density of the nonwoven fabric 10 of the present embodiment is 4.0×10 ⁻² g/cm ³ or more, and the preferable range of the bulk density of the nonwoven fabric 10 is 4.0×10 ^{−2 to} 20.0×10 ^{−. It is 2} g/cm ³ . The upper limit of the bulk density is preferably 10.0×10 ⁻² g/cm ³ , and more preferably 8.0×10 ⁻² g/cm ³ .

The preferred range of the thickness of the non-woven fabric 10 is 1.0 to 3.5 mm, more preferably 1.5 to 3.0 mm, and further preferably 1.9 to 2.7 mm. The preferable range of the basis weight of the nonwoven fabric 10 is 80 to 200 g/m ² , more preferably 100 to 170 g/m ² , and further preferably 120 to 145 g/m ² . When the thickness and basis weight of the non-woven fabric 10 are within the above-described preferred ranges, respectively, an appropriate hemostatic effect can be exerted, and the hemostatic material 1 can be easily followed without strongly pressing the wound site 200. Pain is unlikely to occur in the part 200.

A method of using the hemostatic material 1 will be described with reference to FIG.
According to an example of the method of using the hemostatic material 1, the hemostatic material 1 is attached to the skin with the tape 40 so as to cover the wound site 200. By attaching the hemostatic material 1 to the skin, the front surface 11 of the non-woven fabric 10 comes into contact with the wound site 200 and its peripheral site. The non-woven fabric 10 absorbs the body fluid flowing out from the wound site 200. The nonwoven fabric 10 swells and gels by absorbing body fluid. The nonwoven fabric 10 releases calcium ions as it gelates. The calcium ions promote the coagulation of blood at the wound site 200.

When the wound site 200 is hemostasis, the hemostatic material 1 is peeled from the skin by the following procedure. First, the tape 40 is stripped from the skin. Next, the protective sheet 20 and the nonwoven fabric 10 are peeled off from the wound site 200. At this time, since there is substantially no lump of fibers formed by a plurality of fibers on the front surface 11 of the nonwoven fabric 10, the nonwoven fabric 10 is smoothly removed from the wound site 200. Some gelled fibers of the nonwoven fabric 10 are separated from the protective sheet 20 and other fibers of the nonwoven fabric 10 and remain at the wound site 200. Next, the non-woven fabric 10 remaining on the wound site 200 is washed away with physiological saline.

The hemostatic material 1 has the following effects.
(1) The non-woven fabric 10 has a smooth front surface 11 substantially free of fiber lumps formed by a plurality of fibers.

According to the hemostatic material 1, the non-woven fabric 10 has a bulk density of 4.0×10 ⁻² g/cm ³ or more. The inventor of the present application has confirmed that large fluffs are scarcely formed on the front surface 11 of the nonwoven fabric 10 and that the surface is smooth. The reason is considered as follows. If the bulk density of the non-woven fabric is increased by pressing the non-woven fabric from the thickness direction by calendering or the like for passing between a pair of rolls, the fibers forming the non-woven fabric are likely to be oriented parallel to the surface of the non-woven fabric. As a result, the formation of fluff on the surface of the non-woven fabric is suppressed, and thus the formation of a lump of fibers in which the ends of a plurality of fibers are gathered in a bundle and/or intertwined with each other is suppressed.

Of the above-mentioned pair of rolls, at least the roll applied to the front surface 11 of the nonwoven fabric 10 preferably has a smooth surface. In this case, the front surface 11 of the nonwoven fabric 10 can be made smoother.

(2) According to the hemostatic material 1, the occurrence of pain at the wound site 200 is suppressed when the hemostatic material 1 is peeled off from the wound site 200. The reason is considered as follows. On the front surface 11 of the nonwoven fabric 10 of the hemostatic material 1, there is substantially no lump of fibers formed by a plurality of fibers. Therefore, when the hemostatic material 1 is removed from the wound site 200, the nonwoven fabric 10 is easily peeled from the blood clot. As a result, since the non-woven fabric 10 does not easily peel off the blood clot, the occurrence of pain due to the blood clot being peeled from the wound site 200 is suppressed.

(3) According to the hemostatic material 1, the fibrous alginate contained in the non-woven fabric 10 provides a sufficient hemostatic effect.
The bulk density of the nonwoven fabric 10 is 20.0×10 ⁻² g/cm ³ or less. The thickness of the non-woven fabric 10 is 1.0 mm or more, and the basis weight of the non-woven fabric 10 is 80 g/m ² or more. The inventor of the present application has found that the nonwoven fabric 10 satisfying these conditions has sufficient water absorption to satisfactorily absorb blood and the like flowing out from the wound site 200 that requires hemostasis, and has a sufficient amount to hemostasis. It was confirmed that the fibers were dissolved and gelled. Therefore, the hemostatic material 1 can appropriately stop the wound site 200.

(4) The hemostatic material 1 has flexibility that easily fits on the skin.
The bulk density of the nonwoven fabric 10 is 20.0×10 ⁻² g/cm ³ or less. The thickness of the non-woven fabric 10 is 3.5 mm or less, and the basis weight of the non-woven fabric 10 is 200 g/m ² or less. The inventor of the present application has confirmed that the non-woven fabric 10 satisfying these conditions has sufficient flexibility to conform to the skin of the wound site 200. For this reason, when the front surface 11 of the nonwoven fabric 10 contacts the wound surface of the wound site 200, the front surface 11 is suppressed from being excessively strongly pressed against the wound surface, so that the occurrence of pain at the wound site 200 is further suppressed. To be done.

(5) According to the hemostatic material 1, there is no risk that body fluid from the wound site 200 will stain clothes or the like of the patient.
In the hemostatic material 1, the protective sheet 20 is laminated on the back surface of the nonwoven fabric 10. Since the liquid permeability of the protective sheet 20 is lower than that of the non-woven fabric 10, the body fluid absorbed by the non-woven fabric 10 is blocked by the protective sheet 20 and prevented from leaking to the outside. As a result, there is no possibility that the patient's clothes will be contaminated by body fluid. Further, when the wound site 200 is pressed with a hand or a finger in order to promote hemostasis, there is no possibility that the finger will be contaminated with body fluid from the wound site 200.

(Example)
The inventor of the present application carried out a comparative test using the hemostatic material 1 of the example and the hemostatic material of the comparative example to confirm the relationship between the type of nonwoven fabric and the pain felt by the patient.

(Example 1)
The structure of the nonwoven fabric 10 of Example 1 is as follows. The type of alginate is calcium alginate. The thickness is 1.9 mm. The basis weight is 125 g/m ² . The bulk density is 6.58×10 ⁻² g/cm ³ .

The protective sheet 20 of Example 1 is a low-density polyethylene film having a thickness of 30 μm. The protective sheet 20 was adhered to the back surface 12 of the nonwoven fabric 10 of Example 1 with a hot melt adhesive. The hot melt adhesive used is a synthetic rubber adhesive.

(Example 2)
The structure of the nonwoven fabric 10 of Example 2 is as follows. The type of alginate is calcium alginate. The thickness is 2.7 mm. The basis weight is 120 g/m ² . The bulk density is 4.44×10 ⁻² g/cm ³ .

The protective sheet 20 having the same material and the same thickness as the protective sheet 20 of Example 1 was adhered to the back surface 12 of the nonwoven fabric 10 of Example 2 with the same kind of adhesive as the adhesive of Example 1.
(Example 3)
The structure of the nonwoven fabric 10 of Example 3 is as follows. The type of alginate is calcium alginate. The thickness is 1.9 mm. The basis weight is 145 g/m ² . The bulk density is 7.63×10 ⁻² g/cm ³ .

The protective sheet 20 having the same material and the same thickness as the protective sheet 20 of Example 1 was adhered to the back surface 12 of the nonwoven fabric 10 of Example 3 with the same kind of adhesive as the adhesive of Example 1.
(Comparative Example 1)
The composition of the nonwoven fabric A of Comparative Example 1 is as follows. The type of alginate is calcium alginate. The thickness is 3.8 mm. The basis weight is 145 g/m ² . The bulk density is 3.82×10 ⁻² g/cm ³ .

A protective sheet having the same material and the same thickness as the protective sheet 20 of Example 1 was adhered to the back surface of the nonwoven fabric A by the same kind of adhesive as the adhesive of Example 1.
(Comparative example 2)
The composition of the nonwoven fabric B of Comparative Example 2 is as follows. The type of alginate is calcium alginate. The thickness is 4.3 mm. The basis weight is 145 g/m ² . The bulk density is 3.37×10 ⁻² g/cm ³ .

A protective sheet having the same material and the same thickness as the protective sheet 20 of Example 1 was adhered to the back surface of the nonwoven fabric B with the same kind of adhesive as the adhesive of Example 1.
The thickness of the non-woven fabric is measured as follows.

From the original non-woven fabric, 10 pieces of samples cut into a size of 100 mm×120 mm by a cutter are prepared. Next, the 10 samples are stacked and the height thereof is measured, and the thickness of one nonwoven fabric is determined from the measurement result.

The basis weight of the non-woven fabric is measured as follows.
From the raw non-woven fabric, three pieces of sample cut into a size of 100 mm×100 mm with a cutter are prepared. Next, the weight of each sample is measured by an electronic balance. The measurement result is multiplied by 100 to calculate the average value. This average value is used as the basis weight of the nonwoven fabric.

The smoothness of the surface of the non-woven fabric, that is, whether or not there are lumps of fibers on the surface of the non-woven fabric is confirmed by the following procedure.
A sample having a length of 200 mm and a width of 100 mm is sampled from the original fabric, and the sample is folded in two so that the front surface is on the outside and the length is half. Next, the fold line of the folded non-woven fabric is photographed by a camera from a direction orthogonal to one surface of the non-woven fabric. Next, using the obtained image, the state of the fibers at the folds is visually observed, and the number of fiber lumps existing within the fold length of 5 cm is measured.

The photograph in FIG. 3 shows an example of the front surface 11 of the fold of the nonwoven fabric 10 of Example 1. As a result of photographing the fold lines of each of the non-woven fabrics 10 of Example 2 and Example 3, almost the same photo as the photo of the non-woven fabric 10 of Example 1 shown in FIG. 3 was obtained.

The photograph of FIG. 4 shows an example of the front surface A1 of the fold of the nonwoven fabric A of Comparative Example 1. As a result of photographing the fold line of the nonwoven fabric B of Comparative Example 2, a photograph substantially the same as the photograph of the nonwoven fabric A of Comparative Example 1 shown in FIG. 4 was obtained.

As shown in the photographs of FIGS. 3 and 4, the smoothness of the front surface 11 of the nonwoven fabric 10 of Example 1 and the smoothness of the front surface A1 of the nonwoven fabric A of Comparative Example 1 are visually different from each other. From these photographs, the following differences can be confirmed.

In Example 1, a small number of fluffed portions are formed on the front surface 11 of the fold of the nonwoven fabric 10. However, the length of fluffed fibers protruding outward is relatively shorter than that of surrounding fibers, and the number of fluffed fibers is also small. The front surface 11 is substantially free of fiber lumps. Thus, the front surface 11 of the fold of the nonwoven fabric 10 of Example 1 is smooth as a whole. These characteristics were the same in each of the nonwoven fabrics 10 of Example 2 and Example 3.

On the other hand, a large number of fluffed portions A2 are formed on the front face A1 of the fold of the nonwoven fabric A of Comparative Example 1. Further, the length of the fluffed fibers protruding further than the surrounding fibers is longer than that of the nonwoven fabric 10 of each example, and the number of fluffed fibers is also large. On this front surface A1, there are a large number of fiber lumps A3 of 10 or more per fold length of 5 cm.

The photograph in FIG. 5 shows the front surface A1 of the nonwoven fabric A of Comparative Example 1 in a further enlarged manner. As shown in the photograph of FIG. 5, each fiber lump A3 is formed by forming a bundle of the ends of a plurality of fibers and entwining some of the fibers with each other. The end of each fiber lump A3 is directed outward on the surface of the nonwoven fabric. The number of the plurality of fibers constituting one fiber lump A3 is, for example, 10 or more, and specifically, is several tens or more. The thickness of the fiber lump A3, that is, the width of the fiber lump A3 in the direction orthogonal to the protruding direction of the fiber lump is 100 μm or more, and specifically about 200 to 2000 μm.

As described above, the front surface A1 of the fold line of the nonwoven fabric A of Comparative Example 1 is generally rougher than the front surface 11 of the fold line of the nonwoven fabric 10 of each example. These characteristics were the same for the nonwoven fabric B of Comparative Example 2 as well.

In order to confirm the relationship between the type of non-woven fabric and the pain when applied to the wound site of a patient, a comparative test of the hemostatic material 1 of each example and the hemostatic material of each comparative example was performed. The hemostatic material 1 of each example is the hemostatic material 1 including the nonwoven fabric 10 of Example 1, the hemostatic material 1 including the nonwoven fabric 10 of Example 2, and the hemostatic material 1 including the nonwoven fabric 10 of Example 3. The hemostatic material of each comparative example is a hemostatic material containing the nonwoven fabric A of Comparative Example 1 and a hemostatic material containing the nonwoven fabric B of Comparative Example 2.

A plurality of patients used the hemostatic material 1 of each example or the hemostatic material of each comparative example. Use herein includes the act of applying a hemostat to the bleeding wound site and after the hemostasis is removed, the hemostat is removed from the skin. The pain felt by each patient by using the hemostatic material was confirmed by an interview survey.

According to the results of the interview survey, all the patients who used the hemostatic material 1 of each Example did not feel the pain caused by the use of the hemostatic material 1 of each Example. On the other hand, all the patients who used the hemostatic material of each comparative example felt the pain (the pain at the time of removing the hemostatic material of each comparative example from the wound site) due to the use of the hemostatic material of each comparative example. As described above, the results of the interview survey show that the non-woven fabric 10 of each example eliminates or reduces the pain experienced by the patient as compared with the non-woven fabric of each comparative example.

FIG. 6 shows a model of the nonwoven fabric A of Comparative Example 1. With reference to this model and the results of the above comparative tests, the reason why the nonwoven fabric A is more likely to cause a patient to feel pain as compared with the nonwoven fabric 10 of each example is presumed as follows.

On the front surface A1 of the nonwoven fabric A, there are many fluffed portions A2 and many lumps A3 of fibers. The fiber lump A3 is formed by a plurality of fibers being strongly entangled or bundled, and therefore has higher rigidity and higher breaking strength than other fluffy fibers.

After the non-woven fabric A of Comparative Example 1 is applied to the wound site 200, the fibers of the non-woven fabric swell and dissolve by absorbing the exudate. Calcium ions are released from the dissolved fibers of the nonwoven fabric, and the blood at the wound site 200 is coagulated. Since the fluffed portion A2 and the lump A3 of fibers are present on the front surface A1 of the nonwoven fabric A, they are taken into the blood clot.

After the wound site 200 is hemostasis, the hemostatic material containing the nonwoven fabric A of Comparative Example 1 is peeled off from the wound site 200. At this time, since the fluffed portion A2 and the fiber lump A3 are taken into the blood clot, the portion of the blood clot that is bonded to a part of the non-woven fabric A together with the fluffed portion A2 and the fiber lump A3 is wound site 200. Is about to be peeled off. At this time, the fibers of the fluffed portion A2 are thin and thus easily cut, but the lump A3 composed of a plurality of fibers has a high breaking strength, and thus is not easily cut. For this reason, the blood clot is partially peeled off together with the nonwoven fabric A from the wound site 200, and the patient may feel a strong pain and bleeding may occur.

On the other hand, the non-woven fabric 10 of the hemostatic material 1 of each example has the smooth front surface 11 in which the fiber clot is substantially absent, so that the fiber clot is taken into the blood clot when the blood coagulates. There is no. Therefore, when the hemostatic material 1 is removed from the wound site 200, the nonwoven fabric 10 is easily peeled off from the wound site 200. As a result, the patient does not feel pain due to the use of the hemostatic material 1 of each example.

In the above Examples 1 to ³ , the nonwoven fabric 10 having a bulk density of 4.44×10 ^{−2 to} 7.63×10 ⁻² g/cm ³ was used. However, the bulk density of the nonwoven fabric may be 8.0×10 ⁻² g/cm ³ or more, or 10.0×10 ⁻² g/cm ³ or more. The bulk density of the nonwoven fabric is preferably set to 20.0×10 ⁻² g/cm ³ or less. Depending on the bulk density and the thickness or basis weight of the nonwoven fabric, an excellent hemostatic effect and fit to the skin can be obtained.

(Modification)
The hemostatic material according to the present invention is not limited to the above embodiments and examples. The hemostatic material according to the present invention can take various forms different from the above-described embodiments and examples within the range in which the object of the present invention is achieved. The modifications shown below are examples of various forms that the hemostatic material according to the present invention can take.

In the hemostatic material 1 of the modified example, the protective sheet 20 has a larger area than the nonwoven fabric 10. Therefore, a part of the protective sheet 20 extends to the outside of the nonwoven fabric 10. The portion of the protective sheet 20 extending to the outside of the nonwoven fabric 10 has an adhesive layer capable of adhering to the skin on the inner surface 21 thereof. Therefore, according to the hemostatic material 1 including the protective sheet 20 of this modification, the hemostatic material 1 can be attached to the skin without using the tape 40.

According to the hemostatic material 1 of another modified example, the protective sheet 20 is bonded to the nonwoven fabric 10 by an adhesive different from the hot melt adhesive or an adhesive.
According to the hemostatic material 1 of still another modified example, the protective sheet 20 and the adhesive layer 30 are omitted. That is, only the non-woven fabric 10 constitutes the hemostatic material 1. In this case, the non-woven fabric 10 can be formed into various shapes such as a sheet shape and a string shape.

DESCRIPTION OF SYMBOLS 1... Hemostatic material 10... Nonwoven fabric 11... Front surface 12... Back surface 20... Protective sheet 21... Inner surface 30... Adhesive layer 40... Tape

Claims (6)

A hemostatic material including a non-woven fabric,
The non-woven fabric contains fibrous alginate,
When the non-woven fabric is folded in half so that the length thereof is halved, the number of fiber lumps extending outward from the fold is less than 5 per 5 cm of the fold length,
A hemostatic material in which the bulk density of the non-woven fabric is 4.0×10 ⁻² g/cm ³ or more. The hemostatic material according to claim 1 , wherein the thickness of the non-woven fabric is included in a range of 1.0 to 3.5 mm. The basis weight of the nonwoven fabric is in the range from 80 to 200 g / ^{m 2,} hemostatic material according to claim 1 or 2. The hemostatic material according to any one of claims 1 to 5 ,
The hemostatic material is a sheet,
The hemostatic material further comprises a protective sheet laminated to the nonwoven fabric,
A hemostatic material in which the liquid permeability of the protective sheet is lower than the liquid permeability of the nonwoven fabric. A method for producing the hemostatic material according to any one of claims 1 to 5 , comprising:
A method comprising pressing the non-woven fabric in the thickness direction so that the non-woven fabric has a bulk density of 4.0×10 ⁻² g/cm ³ or more by passing the non-woven fabric between a pair of rolls. Further comprising the step of laminating a protective sheet on one side of the nonwoven fabric,
The method according to claim 5 , wherein the step of laminating the protective sheet is performed before, after, or simultaneously with the step of pressing the nonwoven fabric in the thickness direction, the step of pressing the nonwoven fabric in the thickness direction.