JP2013005945A - Adhesive patch - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an adhesive patch applied to a peripheral arterial occlusion part for the treatment of peripheral arterial occlusive disease which is attached to the upper limb, lower limb or the like to specify injection positions.SOLUTION: An injection position guiding adhesive patch 1 is provided, which includes a substrate sheet having an adhesive part on a part or all of one surface of the substrate sheet and a peeling material 6 covering the surface of the adhesive part. The adhesive patch has a plurality of injection holes 2 arranged in the longitudinal and transverse directions at regular intervals. The adhesive patch is composed of the substrate sheet, the adhesive part on an adhesive side of the substrate sheet 4 and the peeling material 6 covering the adhesive part. A non-adhesive side of the substrate sheet has a support body for protecting and giving predetermined strength to the substrate sheet.

Description

  The present invention relates to a patch, and more particularly to a patch for treating peripheral vascular disease.

  Treatments for peripheral arterial occlusion diseases include removal of risk factors, exercise therapy, drug therapy with antiplatelet drugs and vasodilators, and percutaneous angioplasty and surgical bypass therapy. However, when there is a diffuse stenosis of a blood vessel or a lesion beyond the knee joint, the restenosis rate is high, and it is difficult to apply not only endovascular treatment but also surgical treatment. The number of cases that are resistant to such existing treatments is also increasing, and there are many cases ranging from ulcers and infections to leg amputations as the lesion progresses. Recently, by promoting angiogenesis using the patient's own bone marrow cells and peripheral blood cells, ulcer disappearance of the lower limbs, pain relief and disappearance can be obtained, and the quality of life of the patient is greatly improved by avoiding amputation of the lower limbs (Non-patent Documents 1 and 2).

  Patent document 1 discloses a tape template for neck lift surgery, but it is necessary to perform injection at regular intervals at a large number of positions in the treatment for peripheral artery occlusion disease, and such a tape template has a large number of injection positions. Cannot be used to accurately determine.

Special table 2011-502549

Matoba Seimei et al., Kyoto Prefectural University of Medicine 117 (10), 783-792, 2008 Satoaki Matoba and Hiroaki Matsubara, Current Pharmaceutical Design, 2009, 15, 2769-2777

  When injecting the patient's own bone marrow cells or peripheral blood cells into an arterial occlusion site such as the lower limb, it is necessary to inject them at regular intervals, and it is necessary to show the mark.

  Previously, the injection position was written with a magic at the artery occlusion site, or a hard plastic sheet was wrapped around the artery occlusion site to provide a guide for the injection position, but it is difficult to properly indicate the injection position when writing with the magic Even when the sheet is wound, it is difficult to appropriately wind and fix the sheet around an artery occlusion site such as the lower limb or the upper limb.

  An object of this invention is to provide the medical device which can recognize easily the injection | pouring positions, such as a bone marrow cell and a peripheral blood cell.

The present invention provides the following patch.
Item 1. An adhesive for guide at an injection position, having a pressure-sensitive adhesive part on one side or the whole surface of a base sheet, the surface of the pressure-sensitive adhesive part being covered with a release material. A patch for guiding an injection position, comprising a plurality of injection holes arranged at regular intervals in the direction.
Item 2. Item 2. The patch according to Item 1, wherein a longitudinal and / or lateral line is formed on the base sheet between the adjacent injection holes.
Item 3. Item 3. The patch according to Item 2, wherein the base sheet has vertical and horizontal lines in a lattice shape or a substantially lattice shape, and the injection hole is located at or near the intersection of the lattice lines.
Item 4. Item 4. The patch according to any one of Items 1 to 3, wherein the base sheet is flexible.
Item 5. Item 5. The patch according to any one of Items 1 to 4, further comprising a support on the non-adhesive side of the base sheet, wherein the support and the base sheet are detachably bonded.
Item 6. Item 6. The patch according to any one of Items 1 to 5, wherein the release material is provided in at least two directions at an outer edge of the patch.
Item 7. Item 7. The patch according to any one of Items 1 to 6, wherein the release material is provided so as to be separately peelable on a central portion of the patch and both sides thereof, and the adhesive portion can be exposed stepwise.
Item 8. The entire surface of the base sheet is covered with a release material, and the base sheet has a non-adhesive portion in the vertical direction and / or the horizontal direction at the end of the base sheet, and the base material is held with the release material corresponding to the non-adhesive portion Item 8. The patch according to any one of Items 1 to 7, wherein a sheet can be pasted.
Item 9. Item 9. The patch according to any one of Items 1 to 8 for treating peripheral artery occlusion disease.
Item 10. Item 10. The patch according to any one of Items 1 to 9, which is used by being wound around a part of an upper limb or a lower limb.

  Since the patch of the present invention has a hole corresponding to the injection position, the injection position can be easily understood, and part of the base sheet and the adhesive does not enter the body at the time of injection.

  Further, since the flexible patch of the present invention can be deformed according to the shape of the body surface, it can be easily fixed to the artery occlusion site.

It is a figure which shows preferable embodiment of the adhesive material of this invention. It is a figure which shows preferable embodiment of the adhesive material of this invention. It is a figure which shows preferable embodiment of the adhesive material of this invention. It is a figure which shows preferable embodiment of the adhesive material of this invention. It is a figure which shows preferable embodiment of the adhesive material of this invention by which the adhesive is arrange | positioned at the grid | lattice form. It is a figure which shows preferable embodiment of the adhesive material of this invention which provided the peeling material which can be divided | segmented and peeled in 2 directions at a peripheral part. It is a figure which shows preferable embodiment of the adhesive material of this invention which provided the center part and the peeling material divided | segmented into 3 on both sides. In the patch of FIG. 5, the state when the peeling material at the center is turned is shown. It is a figure which shows preferable embodiment of the adhesive material of this invention in which the peeling material of a center part occupies a big ratio. It is a figure which shows embodiment whose patch material is 4 layer structure of the base material sheet 4, the adhesion part 5, the peeling material 6, and the support body 7. FIG. It is a figure which shows embodiment whose patch material is 3 layer structure of the base material sheet 4, the adhesion part 5, and the peeling material 6. FIG.

  The patch 1 of the present invention is for sticking to a peripheral artery occlusion site for the treatment of peripheral artery occlusion disease. The place where the patch is applied is a place where the peripheral artery is occluded, and includes the upper limbs (upper arm, forearm), lower limbs (upper leg, lower leg), etc., and is often wound around the lower leg (calf).

  The hole 2 provided in the patch 1 indicates the injection position, and by opening the hole 2, a piece or adhesive derived from the patch 1 is prevented from entering the body when the injection needle is stabbed. (FIGS. 1-3). In FIG. 1, (A) shows an embodiment in which injection holes are formed at the intersections of grid-like lines. FIG. 1 (B) further shows the adhesive portion by shading, and FIG. 1 (C) shows an embodiment in which injection holes are further formed in addition to the grid-like intersections.

  Injected by injection are cells capable of regenerating blood vessels, such as the patient's own bone marrow cells, hematopoietic cells, umbilical cord blood cells, and mobilized peripheral blood cells, and bone marrow cells are preferred. In addition to bone marrow cells, cells that can be differentiated into vascular endothelial cells, such as stem cells, iPS cells, ES cells, or cells differentiated therefrom, which are effective for vascular regeneration, and can regenerate blood vessels, It can be injected at the site of peripheral artery occlusion.

  In order to treat peripheral arterial occlusion disease, it is necessary to regenerate blood vessels over a wide area on the part where the peripheral artery is occluded or is occluded. Therefore, it is necessary to perform injection at regular intervals (equal intervals or almost equal intervals) in the horizontal direction and the vertical direction. If there is a part where the injection site is dense (the interval between injections is narrow) and a part where the injection site is sparse (the interval between injections is wide), the part where the injection was performed at a narrow interval will form a dense blood vessel, but the injection will be wide This is because the density of the blood vessel in the part performed in the step becomes low, and the blood circulation disorder is caused in the part. For this reason, in the patch 1 of the present invention, the injection holes 2 are opened at regular intervals in the vertical and horizontal directions.

  It is desirable to form a line 3 between the holes 2 for injection. This is because injection is performed also in the vicinity where the patch 1 is pasted, and if there is a line 3, it is easy to predict injection positions at equal intervals on the extension line. This line 3 does not have to connect all injection holes (FIG. 1C). The line is preferably in the vertical direction (for example, the direction from the knee to the ankle in the case of the lower leg) for recognizing the extension line of the hole of the patch, and the line 3 in the lateral direction (for example, the direction wound around the lower leg) is the distance between the holes 2 It is effective to recognize

  When wound around the lower leg, the portion close to the ankle is thinner than the portion near the knee, so when the entire lower leg is wound, the adhesive material 1 may be slightly left in the lower thin portion. In such a case, the end portion of the patch 1 may be appropriately cut and used. The bandage of the patch 1 is usually up to the top of the ankle, and below it (from the ankle to the heel or toe), or above (from the upper end of the patch to the knee, if necessary) Cells that can form blood vessels such as bone marrow cells can be injected by predicting equally spaced injection positions from the positions of the injection holes 2 regularly arranged on the patch.

  The patch 1 of the present invention is composed of a base sheet 4, an adhesive part 5 on the adhesive side of the base sheet 4, and a release material 6 that covers the adhesive part 5 (FIG. 9), and the non-adhesive part side of the base sheet 4. In order to protect the base material sheet or to give a certain strength, a support 7 can be provided (FIG. 8). When the base material sheet 4 is a flexible thin film, the support body 7 can reinforce the film and can be easily applied.

  The base material sheet 4 of the patch 1 of the present invention has an adhesive side surface having the adhesive portion 5 and a non-adhesive side surface. The adhesive part 5 may be formed on the entire surface of the adhesive side, and the peripheral part of the base sheet 4 or a part thereof (the part other than the peripheral part may not have the adhesive part, at regular intervals or at the peripheral part. May be partially formed on the portion close to the surface. It is preferable to form an adhesive portion around the hole 2 because the position of the hole 2 is fixed. As this embodiment, for example, as shown in FIG. 3, the adhesive portions can be provided in a lattice shape. Since the patch 1 of the present invention can be adhered so that the position of injection can be shown by wrapping around the forearm, lower limbs (especially the lower limbs), the adhesive portions may adhere to each other when the adhesive portions are formed on the entire surface. . When forming the adhesion part 5 in the whole surface of the base material sheet 4, in order to prevent adhesion part 5 adhere | attaching, it is preferable to divide the peeling material 6 so that it can peel. Alternatively, the pressure-sensitive adhesive portion may be formed using a pressure-sensitive adhesive that can be peeled off and bonded again even when the pressure-sensitive adhesives are bonded to each other when wound around the forearm, lower limb, or the like.

  FIG. 4 shows a preferred embodiment of the adhesive material of the present invention provided with a release material that can be divided and peeled in two directions at the peripheral edge. In FIG. 4, the reason why the release materials 6a and 6b are provided in the vertical direction and the horizontal direction is because the thickness of the affixed (injection) site is different between the upper limb and the lower limb, and the thickness of the upper limb or the lower limb to be wound is also large. This is because the wrapping is performed according to the size. In the embodiment of FIG. 4, either the longitudinal or lateral release material (6 a or 6 b) is first peeled to fix the end of the sticking material, and then the remaining release material is peeled to remove the whole leg. Or just stick it to the upper limbs. It is preferable to form a gripping portion 6c on the release material. Note that the sticking material can be attached by two people, for example, one person holding the sticking site such as the lower limb or the upper limb at a position where it is easy to wind, and the other person sticking (wrapping) the patch material. In this case, a part of the peripheral part as shown in FIG. 4 may be attached and the remaining part may be wound. As shown in FIG. 5 to FIG. It is one preferred embodiment to secure the part later.

  Since the patch 1 of the present invention is peeled off from the body after injection, it can be temporarily adhered like a curing tape rather than a pressure sensitive adhesive that is difficult to peel off and shows the position of injection, An adhesive that can be easily peeled off after use, does not leave an adhesive on the skin, and does not damage the skin when peeled is preferred. When such an adhesive is used, even when the adhesive portions of the adhesive material adhere to each other when applying to an application site (lower limb, upper limb, etc.), it can be peeled off once and attached to the application site.

  The material which forms the base material sheet 4 is not specifically limited, All the materials conventionally used in this field | area can be used. In particular, a material having flexibility and stretchability is preferable from the viewpoints of adaptability and followability to a peripheral artery occlusion site. Examples of the material constituting the base sheet 4 and the support 7 include a synthetic resin film formed of a synthetic resin such as polyurethane, polyester, polyamide, polyethylene, polypropylene, acrylic polymer, and olefin copolymer. Can do.

  The thickness of the base material sheet 4 is not particularly limited as long as the object of the present invention is not impaired, but from the viewpoint of flexibility and stretchability, a range of about 1 to 1000 μm is preferable, more preferably about 3 to 300 μm, and particularly 5 A range of about ˜150 μm is preferable.

  The adhesive part 5 can be formed using an adhesive composition. For example, the adhesive composition can be applied to the adhesive side of the base sheet 4 to form the adhesive part 5.

  The support 7 can be easily peeled off, and can be applied to a base sheet by applying a pressure-sensitive adhesive composition that does not leave any adhesive. The application of the pressure-sensitive adhesive composition can be appropriately controlled by using a coating method such as a knife coater or a gravure coater according to the purpose. The support 7 and the base sheet 4 can be adhered to the entire surface, but the support 7 is considered to be peeled off from the base sheet 4 after the sticking material 1 is attached. And can be easily peeled off.

  As the adhesive composition that can be used for the adhesive part 5, any adhesive composition used in this field can be freely selected and used. For example, natural rubber-based, synthetic rubber-based, acrylic-based, urethane-based, vinyl ether-based, silicone-based pressure-sensitive adhesive bases, and oils, polyhydric alcohols, hydrophilic polymer compounds, etc. The adhesive composition to contain can be mentioned. As the pressure-sensitive adhesive layer of the pressure-sensitive adhesive part 5, it is preferable to use a gel pressure-sensitive adhesive or a hydrocolloid pressure-sensitive adhesive, which can reduce peeling irritation. The gel adhesive may be a hydrogel adhesive containing water or an organogel adhesive containing an organic solvent, and a silicone gel adhesive or an acrylic gel adhesive is preferred.

  Sphingolipids, urea, glycolic acid, amino acids and derivatives thereof, protein hydrolysates, mucopolysaccharides and derivatives thereof, vitamin B group, ascorbic acid, retinoid, vitamin D, vitamin E and the like Additives such as derivatives, carotenoids, enzymes, coenzymes, and γ-oryzanol may be added, anti-inflammatory agents, or cytokines that promote vascular regeneration (granulocyte colony stimulating factor, granulocyte / macrophage colony stimulating factor) Erythropoietin, bFGF, EGF, NGF, VEGF, LIF, hepatocyte growth factor, macrophage colony stimulating factor, etc.).

  The thickness of the adhesive layer which comprises the adhesion part 5 will not be specifically limited unless the objective of this invention is impaired, It can design freely according to a use. Considering the cohesive force of the adhesive and the stability in production, the thickness is preferably in the range of 0.001 to 1.5 mm, more preferably 0.005 to 0.5 mm, and still more preferably 0.01 to 0.3 mm. .

  The support 7 is provided as necessary in order to prevent adhesion between the adhesive portions 5 and generation of wrinkles of the base sheet 4 when the patch 1 is applied to a peripheral artery occlusion site. If the injection position of the patch 1 of the present invention is indicated by the hole 2, the base material sheet of the patch 1 does not necessarily have to be adhered to the entire surface, and the flexibility and followability of the base sheet 4 are so high. Not required at level. In the case where the base sheet 4 has sufficient strength or thickness to prevent wrinkles and suppress adhesion between the adhesive portions 5, the support 7 is not required.

  As a material for forming the support 7, a material used in this field can be appropriately selected and used. For example, forms, such as a synthetic resin film, a foam sheet, a nonwoven fabric, a woven fabric, a knitted fabric, paper, are mentioned. In the present invention, among these, a synthetic resin film having appropriate support and transparency is particularly preferable. Examples of the material of the synthetic resin film constituting the support 7 include synthetic resins such as polyester, polyamide, polyethylene, polypropylene, and ethylene / vinyl acetate copolymer. These can be made into a single form by a single material, but can be formed into a composite form by using two or more kinds of materials.

  The form of the support 7 is not particularly limited as long as the object of the present invention is not impaired. The support 7 may have the same size as the base sheet 4, and the support 7 is formed larger than the base sheet 4. It is also possible to extend the outer edge of the substrate sheet 4 to the outside of the base sheet 4 to form a grip portion.

  In the present invention, peripheral occlusive arterial diseases include, for example, inflammation, diabetes, coronary artery disease, myocardial infarction (MI), atrial fibrillation, transient ischemic stroke, stroke, limb ischemia, kidney disease and the like. As well as conditions resulting from disturbances in the peripheral circulation (ie, blood vessels outside the blood vessels of the heart and brain). Specifically, peripheral vascular disease includes occlusion in the carotid or femoral artery, occlusion in the iliac artery, or an artery on the distal side of the femoral or carotid artery (eg, the tibial artery and its branches in the lower limbs, And vascular disorders with blockages in the brachial artery and its branches in the upper limbs. Smaller blood vessels (such as a capillary bed of tissue on the distal side of the occlusion) are also affected. Occlusions in the peripheral arteries cause pain and limited movement, loss of vitality of the affected tissue and anoxia, and may result in necrosis and secondary infection. One specific disorder associated with obstructive peripheral vascular disease is a diabetic foot that affects diabetics, often resulting in amputation of the foot.

A method for treating peripheral occlusive arterial disease using the patch of the present invention will be described below.
First, the patch 1 of the present invention is wound around a site where a peripheral artery such as the forearm, lower leg or upper leg is blocked. In that case, a part of the peeling material is peeled off, and a part such as an end part or a central part is attached to the peripheral artery occlusion site. Thereafter, the patch is wound little by little while peeling the release material. At the time of winding, the base sheet 4 is attached with care so as not to wrinkle. The reason why the patch is wound little by little is to prevent the adhesive portions 5 of the patch 1 from sticking to each other. In this way, the patch is distally so that the holes 2 for injection are equally spaced and the line between the holes is in the vertical direction (direction from the joint to the tip) and in the horizontal direction (winding direction). Adhere to the site of obstructive arterial disease. Next, regenerative cells (for example, bone marrow cells) of the patient's own blood vessels are injected into the injection hole 2. At that time, since there is little necessity for regeneration of blood vessels in the bone portion, injection is not performed in the hole corresponding to the bone, but is performed in the injection hole 2 corresponding to the muscle. For example, in the case of the lower leg, the adhesive material of the present invention is wrapped from the lower part of the knee to the upper part of the ankle. Injections are made on the line at similar intervals. At this time, if there are lines in the vertical direction and the horizontal direction (winding direction), the injection positions at equal intervals can be easily determined. The interval between adjacent injection holes is not particularly limited, but is, for example, about 10 to 50 mm, preferably about 12 to 40 mm, and more preferably about 15 to 35 mm.

  In a preferred embodiment of the present invention, when bone marrow cells are used as cells that can regenerate blood vessels injected by injection, about 600 ml of autologous bone marrow fluid is collected in general anesthesiology and bone marrow mononuclear cells are promptly separated. About 2 billion cells are divided and injected into about 120 sites in the muscle of the ischemic limb. When using peripheral blood mononuclear cells, there is no need for general anesthesia, and about 10 billion mononuclear cells are collected from a peripheral vein or central vein under awakening for about 3 to 4 hours. Divide and inject into approximately 120 muscle sites. Divide and inject. These cell numbers are just an example, and there are individual differences in the number of cells and their breakdown (such as the number of CD34 positive cells that serve as an indicator of vascular endothelial progenitor cells), the size of the muscle part of the ischemic limb, the surface area, etc. The number of cells and the number of injection sites vary depending on the age and condition of the patient. The above is an example in the case of bone marrow cells (bone marrow mononuclear cells), peripheral blood mononuclear cells, etc., but referring to these descriptions, cells that can regenerate other blood vessels (for example, hematopoietic cells, cord blood cells, Similarly, stem cells, iPS cells, ES cells, or differentiated cells thereof can be injected into peripheral occlusive arterial diseases such as ischemic limbs to regenerate blood vessels.

  After the injection is finished, the patch of the present invention is peeled off to finish the treatment. The adhesive material only needs to have the injection hole fixed at a certain position only during the injection, so it is not necessary to adhere firmly to the skin, and it is a pressure sensitive adhesive (adhesive pressure sensitive enough to peel easily) Adhesives, gel adhesives, hydrocolloid adhesives, etc.) can be preferably used.

EXAMPLES Hereinafter, although this invention is demonstrated according to an Example, this invention is not limited to these Examples.
Example 1
1A was used for the 42-year-old male obstructive arteriosclerosis upper right limb and 89-year-old female right lower limb, and was separated from the patient himself into a number of injection holes 2. Bone marrow cells were injected to regenerate blood vessels.

  As a result, the guide patch at the injection position of the present invention was excellent in visibility and adhesion, had little skin irritation, and was able to obtain an effect of shortening the time compared to conventional cell transplantation during regenerative medicine. In addition, the progress of blood vessel regeneration is also good.

DESCRIPTION OF SYMBOLS 1 Patch material 2 Hole 3 for injection Line 4 Base material sheet 5 Adhesive part 6 Release material 6a Release material (longitudinal edge)
6b Release material (lateral edge)
6c Gripping part 7 Support 7a Gripping part

Claims (10)

An adhesive for guide at an injection position, having a pressure-sensitive adhesive part on one side or the whole surface of a base sheet, the surface of the pressure-sensitive adhesive part being covered with a release material. A patch for guiding an injection position, comprising a plurality of injection holes arranged at regular intervals in the direction. The patch according to claim 1, wherein a longitudinal and / or lateral line is formed on the base sheet between the adjacent holes for injection. The patch according to claim 2, wherein the base material sheet has vertical and horizontal lines in a lattice shape or a substantially lattice shape, and the holes for injection are located at or near the intersection of the lattice lines. . The patch according to any one of claims 1 to 3, wherein the base sheet is flexible. The patch according to any one of claims 1 to 4, further comprising a support on the non-adhesive side of the base sheet, wherein the support and the base sheet are detachably bonded. The patch according to any one of claims 1 to 5, wherein the release material is provided in at least two directions at an outer edge of the patch. The adhesive material according to any one of claims 1 to 6, wherein the release material is provided on the central part of the adhesive material and both sides of the adhesive material so as to be separately removable, and the adhesive part can be exposed stepwise. The entire surface of the base sheet is covered with a release material, and the base sheet has a non-adhesive portion in the vertical direction and / or the horizontal direction at the end of the base sheet, and the base material is held with the release material corresponding to the non-adhesive portion. The patch according to any one of claims 1 to 7, wherein a sheet can be stuck. The patch according to any one of claims 1 to 8, for treating peripheral artery occlusion disease. The patch according to any one of claims 1 to 9, wherein the patch is used by being wound around a part of an upper limb or a lower limb.

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