• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Formable piece of material (1), malleable by rolling into a plug-shaped body (2) for insertion into a nasal passage or an ear canal of a user, wherein said piece of material after rolling into said plug-shaped body (2) and inserting into said nasal passage or ear canal has a ability to expand against a wall surface enclosing said nasal passage or ear canal to thereby generate a surface pressure against the wall surface. The piece of material (1) has a thickness that can be rolled up and rolled up, which after rolling up gives said plug-shaped body (2) an outer diameter (OD) in the range 3-50 mm. The piece of material (1) has a flexural stiffness in the range 0.000015-0.0000040 Nm2 before rolling. (Figure 2)
    公开号:SE1300587A1
    申请号:SE1300587
    申请日:2013-09-09
    公开日:2014-05-09
    发明作者:Svante Syk
    申请人:Medinasus Ab；
    IPC主号:
    专利说明:

    Thus, US 5,383,891 discloses a kit of material with a hemostatic plug comprising an oval-shaped plug adapted for easy insertion into the nasal passage of a layman. The plug consists of a compressed synthetic sponge which is arranged to expand on contact with an aqueous liquid. The plug has a strap attached to it to be able to be fixed to a nose patch that is placed over the user's nostrils. The nasal patch comprises an absorbent cloth for catching a drip and a fastening element for holding the strap. Also included is a closable container for liquid, vasoconstrictive medicine to wet the stopper and cause it to swell, as well as a container for antibacterial ointment to lubricate the stopper upon insertion.
    A disadvantage of several of the prior art devices intended to stop or inhibit nosebleeds is that they comprise airtight patches and / or nasal plugs which block the user's normal breathing through the nostrils.
    US 6,666,211 B1 describes a device for treating nosebleeds which attempts to eliminate the risk of the user's breathing being blocked. This device comprises a binder-coated foam cap designed to conform to a patient's nose and a pair of open cell foam tubular plugs. The inner surface of the cover adjacent the nose is coated with a synthetic acrylic latex adhesive for temporary adhesion to the nose in use and has a peelable protective film over the adhesive coated surface during assembly. Each of the nasal plugs is made of a hypoallergenic material and has a semi-rigid tube that keeps a continuous air passage in an open condition even when the plug has swelled up with liquid during use.
    The above type of device reduces the risk of the user's normal breathing through the nostrils being blocked, but requires the use of a cap or mask over the face, which can be uncomfortable for the user and even perceived as frightening by other people. Such a face mask can also lead to problems with contact allergies or sweating.
    In the international patent application WO2008 / O66459 A1, the present inventors describe a plug device which is intended to solve all the above-mentioned problems. The plug device described is intended to provide a barrier in a passage such as a nose passage. The plug device is made of a material that can be compressed and then expand against the walls in the passage and thereby exert a pressure against them. The plug device has at least one through hole for breathing air and is designed so that it stays in place in the nose but can still be easily removed. The plug device is made of materials that are selected so as not to irritate the mucous membranes. The plug device can also function as a carrier for fragrances for counteracting undesirable odors, as a carrier for anti-bleeding preparations and / or for medication via inhaled air and / or uptake of preparations via superficial blood vessels. The plug device described does not require costly and disruptive face masks or adhesive patches or any skin adhesive. The plug device also opens up new possibilities for medication in that it can be designed, for example, to administer active substances to the superficial blood vessels in the nose, or to deliver substances which can be used by the inhaled air to medicate the larynx or lungs. The plug device can also be used to widen narrow nasal passages and thereby counteract snoring.
    In the international patent application WO2010 / 085196 A1, the present inventors further describe a mouldable absorbent, which is designed as or can be formed into a plug for insertion into a passage such as a nasal passage or an ear canal. The plug comprises a material which can be rolled up or compressed and which can then expand against an enclosing wall (such as in a nasal passage or in an ear canal) to thereby generate a pressure against said wall, the plug being able to have a through hole for air passage, and wherein the plug may also contain medicinal preparations for various purposes, which preparations are delivered via air or via being taken up by superficial blood vessels. Plugs consisting of the moldable absorbent can be used to inhibit nosebleeds, to secrete substances such as insulin or nicotine into blood vessels in the nose, to secrete substances such as allergy medicines to the inhaled air and further to the lungs, to secrete odorants which counteract troublesome odors into the inhaled air. to filter pollen and similar small particles from the inhaled air, to dilate the nasal passages and to prevent snoring, and to administer substances such as painkillers to the ear canals.
    Several different plug devices for stopping or inhibiting bleeding in the nose are thus already known. It is also known to use such devices to administer various substances to a user, to filter the inhaled air and to counteract snoring. As has been seen before, the prior art plug devices often have certain drawbacks. A common problem for plug devices intended to be inserted into a passage such as a nasal passage is that it may be difficult for some users to have a sufficiently tight contact between the inserted plug device and the wall enclosing the passage, which can lead to inadequate absorption and unwanted leakage of blood, leakage of inhaled air, or leakage of substance to be administered, between the plug device and the enclosing wall. Another problem is that the plug devices of the prior art often expand more than is desirable after insertion into the passage, after they have absorbed a liquid such as blood or a medicinal substance to be administered. This can cause pain in the user and make it difficult to remove an inserted plug device from the passage and, in the case of nosebleeds, cause new bleeding from the nose.
    SUMMARY OF THE INVENTION A first object of the present invention is therefore to provide a device which can be used by different types of users to stop or inhibit nasal blood, to administer substances to superficial blood vessels in the nose, to secrete substances into the inhaled air and further to the inner parts of the nose and to the lungs, to secrete fragrances which counteract troublesome odor to the inhaled air, to filter the inhaled air, to counteract snoring and / or to administer various substances to the ear canals and this while the device is at the same time cheap to manufacture in a reproducible manner, is easy to use in a visually discreet manner and the device ensures a sufficiently tight contact with the wall enclosing the nasal or ear canal into which the device is inserted to avoid leakage of blood, other fluid, air and / or or substance to be administered, while ensuring that the device can be removed from the nasal or ear canal after use.
    This first object is achieved with a moldable piece of material according to claim 1, which is moldable by rolling into a plug-shaped body for insertion into a nasal passage or an ear canal of a user, said piece of material after rolling into said plug-shaped body and inserting into said nasal passage or ear canal has an ability to expand against a wall surface enclosing said nasal passage or ear canal to thereby generate a surface pressure against the wall surface, and wherein the piece of material has a thickness and coilable length which after coil gives said plug-shaped body an outer diameter. 35 ter in the interval 3-50 mm, and wherein the piece of material has a bending stiffness in the interval 0.00000015-0.0000040 Nmz before rolling up.
    Because the moldable piece of material has been designed with a thickness and rollable length which after the roll-up gives the plug-shaped body an outer diameter in the range 3-50 mm, it becomes possible to utilize the invention for users of different types and sizes, for example for adults. , small children, or non-human animals. The moldable piece of material can be given a thickness and rollable length which, after rolling, gives the plug-shaped body an outer diameter within the specified range which is adapted to the size of the nasal passage or the ear canal of the intended user, which ensures that the plug-shaped body can inserted into the nasal passage or ear canal and function there as intended without risk of leakage, and that the plug-shaped body can be removed from the nasal passage or ear canal after use. The moldable piece of material is thus given already at the time of manufacture or immediately before use the dimensions which, after rolling up, give an outer diameter suitable for a specific type of user, e.g. a larger outer diameter when the intended user is an adult and a smaller outer diameter when the intended user is a small child.
    Because the formable piece of material has been designed so that, in accordance with the above range 0.00001515-0.0000040 Nmz, it has a flexural stiffness above 0.000000015 Nm2 (ie modulus of elasticity * Torque of inertia during bending = 1.5 * 10 ” Nmz) before rolling up, a sufficient expansion or resilience of the plug-shaped body to the wall surface enclosing the nasal passage or ear canal in which the plug-shaped body has been inserted is ensured and thus a good fit and contact between the outside of the plug-shaped body and the wall surface. A bending stiffness above 0.00000015 Nmz of the piece of material, after rolling up, gives a plug-shaped body which can exert a sufficient abutment pressure against the mucous membrane to inhibit the blood flow in the case of nosebleeds. A flexural stiffness above 0.000000015 Nm2 of the piece of material ensures a sufficiently good contact, after rolling and insertion, between the outside of the plug-shaped body and the wall surface so that medicinal substances can be administered to superficial blood vessels in the nasal mucosa or the ear in an ear canal blood circulation effectively. In addition, by shaping the piece of material so that the bending stiffness, in accordance with the above range, is lower than 0.0000040 Nmz before rolling, it is ensured that the user or an assisting person can roll the piece of material together without difficulty. to shape the plug-shaped body and minimizes the risk that the plug-shaped body will generate an excessive abutment pressure against the wall surface enclosing the nasal passage or ear canal after insertion. Excessive contact pressure could complicate the removal of the plug-shaped body after use and lead to discomfort or pain in the user, or even lead to recurrent bleeding in the case of nosebleeds. A moldable piece of material with a flexural stiffness in the range 0.000015-0.000004O Nm2, even more advantageously within 0.000000070-0.000003O Nmz, also provides a plug-shaped body which can range in stopping nosebleeds in a sufficiently short time for nose sizes within a very wide size range.
    A second object of the present invention is to provide a moldable piece of material which, after being rolled up into a plug-shaped body and inserted into a nasal passage or ear canal of a user, gives the plug-shaped body an abutment pressure against a wall surface enclosing the nasal passage or ear canal at a level The plug-shaped body can be easily and safely removed from the nasal passage or ear canal after use without discomfort or problems for the user.
    This second object is achieved with a moldable piece of material according to claim 3, wherein the flexural stiffness of the piece of material, after rolling and insertion into said nasal passage or ear canal, gives said plug-shaped body an ability to generate a surface pressure not exceeding 15000 N / m2 against the wall surface enclosing said nasal passage or ear canal.
    Because the moldable piece of material has been designed so that the plug-shaped body after insertion will generate a surface pressure of at most 15000 N / m2 against the wall surface enclosing the nasal passage or the ear canal, an abutment pressure is ensured against, for example, a nasal mucosa which is not so high that it prevents a sufficient flow passage for blood or other body fluid to be absorbed between the mucosa from which the fluid is excreted and the outer, absorbent surface of the plug-shaped body to be absorbed by the fluid. An external pressure of no more than 15000 N / mz also ensures that the plug-shaped body is easy to remove from the nasal passage or ear canal without the user experiencing discomfort or pain, or having new bleeding in the case of nosebleeds. Additional objects of the invention and the features which make it possible to achieve these objects will become apparent from the following description.
    BRIEF DESCRIPTION OF THE DRAWINGS The invention will be described in the following by a number of different embodiments with reference to the accompanying drawings, in which Figure 1 is a schematic view illustrating a moldable piece of material according to a preferred embodiment of the invention before rolling, Figure 2 is a schematic view illustrating the moldable piece of material of Fig. 1 after rolling into a plug-shaped body, Fig. 3 is a schematic view illustrating the plug-shaped body of Fig. 2 after insertion into a nasal passage of a user, Fig. 4 is a diagram showing a imagined relationship between the time until the blood flow stops at nosebleeds and the surface pressure as a plug-shaped body rolled up of a moldable piece of material inserted into a nasal passage of a person affected by nosebleeds exercises against the walls of the nasal passage, Figure 5 is a diagram illustrating results from laboratory measurements for determination of the surface pressure as one of a rolled-up moldable piece of material e shaped plug-shaped body inserted into a tube with a 10 mm inner diameter exerts in the direction of the inner mantle surface of the tube, and Figure 6 is a diagram showing the time until blood flow stops at nosebleeds of a medium nasal passage subject to the flexural stiffness of the tube. moldable piece of material rolled up to obtain the plug-shaped body inserted into the nasal passage. DESCRIPTION OF EMBODIMENTS OF THE INVENTION In the following, a number of embodiments of the invention will be described in more detail with reference to the accompanying Figures 1-6.
    Fig. 1 is a schematic view illustrating a moldable piece of material 1 according to a preferred embodiment of the invention. The moldable piece of material 1 is moldable by rolling into a plug-shaped body 2, as illustrated in Fig. 2, which body is intended for insertion into a nasal passage P or an ear canal of the user, as illustrated in Fig. 3. shaped body 2 and insertion into the nasal passage P or ear canal, said piece of material has an ability to expand towards a wall surface W enclosing the nasal passage P or ear canal, thereby generating a surface pressure SP against the wall surface, as schematically indicated in Fig. 3.
    The moldable piece of material 1 according to the invention has a thickness T and curlable length L (Fig. 1) which, after curling, gives the plug-shaped body 2 an outer diameter OD (Fig. 2) in the range 3-50 mm. A thickness and roll-up length which, after roll-up, gives the plug-shaped body an outer diameter in the range of 3-50 mm, makes it possible to use the invention for users of different types and sizes, for example for adults, small children or non-human animals. The moldable piece of material can already be given a thickness and curled length already during manufacture or immediately before use, which after curling gives the plug-shaped body an outer diameter within the specified range which is adapted to the size of the nasal passage P or the ear canal of the intended user. Such dimensions of the piece of material ensure that the plug-shaped body can be inserted into a nasal passage P or ear canal of a intended user and function there as intended without risk of leakage and that the plug-shaped body can be removed from the nasal passage P or ear canal after use. The desired dimensions of the piece of material can be achieved, for example, by cutting, cutting or punching pieces of material from one or more sheet, web or disc-shaped, optionally bonded or laminated, materials consisting of fibrous material, foam material, polymeric material and / or possibly binder or thermoplastic material . Formable pieces of material according to the invention can advantageously be given such a size that a user can store one or more flat, flexible moldable pieces of material with any protective cover in a normal-sized wallet or pocket of an item of clothing. The roll-up length L 15 is selected depending on the thickness T of the type of moldable material piece used in the present case and may, for example, be in the range 25-50 mm when the intended user is a human.
    The moldable piece of material according to the invention is preferably provided in the form of a sheet, a cloth or a disc, the piece of material having a thickness which is substantially less than the extent of the piece of material in a plane perpendicular to the thickness. In one embodiment, the moldable piece of material may, for example, have a thickness of the order of 1 mm, a length perpendicular to the thickness which is 40 mm, and a width perpendicular to the thickness and length which is 10 mm, while the piece of material may have other dimensions in other embodiments.
    The moldable piece of material 1 according to the invention has a bending stiffness in the range 0.000015-0.000004O Nmz before rolling up. Such bending rigidity can be achieved by selecting suitable fibrous materials, foam materials and / or polymeric materials, together with suitable forming, lamination and / or bonding techniques, in the manufacture of the piece of material. A bending stiffness higher than 0.00000015 Nmz ensures a sufficient expansion or resilience of the plug-shaped body against the wall surface enclosing the nasal passage or ear canal into which the plug-shaped body has been inserted and thus a good fit and contact between the outside of the plug-shaped body and the wall surface, which is advantageous both for minimizing leakage in inhibiting blood flow in nasal blood and in administering medicinal substances and in being able to achieve an efficient administration of medicinal substances to superficial blood vessels in a nasal mucosa or in the skin of an ear canal. . A bending stiffness lower than 0.000004O Nmz ensures that the user or an assistant can easily roll up the material thickness to form the plug-shaped body and minimizes the risk that the plug-shaped body will generate an excessive contact pressure. against the wall surface enclosing the nasal or ear canal after insertion. Excessive contact pressure could make it difficult to remove the plug-shaped body after use and lead to discomfort or pain in the user, or even lead to recurrent bleeding in the case of nosebleeds. A flexural stiffness in the range 0.00001515-0.0000040 Nm2, even more advantageously 0.000000070-0.0000030 Nmz, gives a plug-shaped body that can stop nosebleeds in a sufficiently short time for nose sizes within a very wide size range. In a particularly preferred embodiment of the moldable piece of material 1 according to the invention, the bending stiffness of the piece of material, after rolling and insertion into said nasal passage P or ear canal, gives said plug-shaped body 2 an ability to generate a surface pressure SP which is a maximum of 15000 N / m2 against the wall surface W which encloses the nasal or ear canal. Because the piece of material has been designed so that the plug-shaped body 2 after insertion will generate a surface pressure of at most 15000 N / m2 against the wall surface enclosing the nasal or ear canal, an abutment pressure is ensured against, for example, a nasal mucosa which still provides sufficient blood flow or other body fluid to be absorbed between the mucous membrane and the plug-shaped body.
    An external pressure of no more than 15000 N / m2 also ensures that the plug-shaped body is easy to remove from the nasal or ear canal without the user experiencing discomfort or pain, or having new bleeding in the case of nosebleeds.
    The desired, size-limited surface pressure can be achieved, for example, by selecting one or more suitable materials for the manufacture of the piece of material 1, and by suitable choice of thickness T of the piece of material, as well as number of turns and degree of compression when rolling the plug-shaped body.
    Because the moldable piece of material has been designed and dimensioned on the basis of the bending stiffness and the maximum surface pressure that is desired in the use of the piece of material or of the plug-shaped body, a goal-oriented, reproducible and quality-assured production of moldable material pieces according to the invention is possible.
    In another embodiment of the invention, the moldable piece of material 1 comprises at least one elastically expanding material 3 which, after rolling and inserting into said nasal passage P or ear canal, contributes to generating said surface pressure SP against the wall surface W enclosing the nasal passage or ear canal. Such an elastically expanding material may, for example, consist of an absorbent fibrous material, foam material and / or a material with superabsorbent-like properties. In this embodiment, the properties of the elastically expanding material and the amount of this material in the material thickness should be carefully adjusted to ensure that the plug-shaped body after swelling will not exert too high a surface pressure on the wall surface enclosing the passage in which it has introduced. The moldable piece of material 1 preferably has a width B (Fig. 1) within a range selected to give, after coiling, the plug-shaped body 2 an insertable length IL adapted to the size of the nasal passage P or the ear passage of the intended user (Figs. 2 and 3).
    In a particularly advantageous embodiment of the invention, the moldable piece of material 1 has a width B which decreases in the direction of at least one end 5 of the same. In the embodiment shown schematically in Figures 1 and 2, the width B decreases towards the end 5 of the piece of material which is intended to face outwards after the curling into a plug-shaped body 2. Such a width taper in the direction of at least one end facilitates the insertion of a of the piece of material rolled up plug-shaped body in the nasal or ear canal where the plug-shaped body is to be used and minimizes the risk that the surface pressure that the body exerts against the wall surface that encloses the passage becomes too high at some point. In another advantageous embodiment (not shown in the figures), the moldable piece of material has a width which decreases from the middle part of the piece of material towards both ends, which after rolling results in a plug-shaped body with a coil shape which makes both insertion and removal of the plug-shaped body lighter for the user. The resulting coil shape after rolling can be controlled in the desired manner already in the manufacture of moldable pieces of material by varying the rate and degree of width narrowing in the longitudinal direction of the pieces of material.
    In another advantageous embodiment of the invention, the moldable piece of material 1 has an ability to form at least one continuous air duct C (Figs. 2 and 3) which runs inside the plug-shaped body 2 in a longitudinal direction thereof after the curling. This advantageous embodiment of the invention provides a plug-shaped body which ensures an adequate air passage for the user's breathing after insertion into a nasal passage and also enables the plug-shaped body to be used to widen the nasal passage and counteract snoring, or to filter inhaled air. One or more continuous air ducts can, for example, be formed in the transverse direction of the piece of material already during the manufacture thereof, for example by integrating transverse strips or rods of an open, porous foam material inside the piece of material. After rolling such a piece of material into a plug-shaped body, it will have one or more continuous air channels between its two ends. Embodiments of the invention are also conceivable in which continuous air ducts are formed by the coil of the piece of material taking place around one or more several, preferably flexible pipes, hoses or air-permeable rods which are allowed to remain inside the finished plug-shaped body at use, or by rolling up the piece of material around a stick or spindle which, after possible drying of binder or thermal bonding of thermoplastic material in the piece of material, is removed to leave a continuous air channel in the longitudinal direction of the plug-shaped body.
    In an advantageous embodiment of the present invention, the moldable piece of material 1 comprises at least one layer of material 4 which, after being rolled up and inserted into the nasal passage P or ear canal of a user, gives the plug-shaped body 2 an ability to absorb blood and other body fluids released inside the nasal passage. P or the ear canal. This advantageous embodiment enables, for example, the use of the plug-shaped body to inhibit nosebleeds.
    In a particularly advantageous embodiment of the present invention, the moldable piece of material 1 comprises at least one material layer 4 which, after rolling up, gives the plug-shaped body 2 an ability to contain and release and / or to first absorb and then release one or more substances to be administered to a user directly through the wall surface W enclosing the nasal passage P or the ear canal and / or via inhalation air IA (Fig. 3) passing through one or more air ducts C in the longitudinal direction of the plug-shaped body 2 when it is inserted into the nasal passage P. Substances to be administered to a user can thus be applied to the moldable piece of material before and / or after the roll-up, depending on which is most advantageous in the present case. Furthermore, substances to be administered can be applied and absorbed inside one or more absorbent material layers and / or applied and supported on one or more non-absorbent material layers of the moldable piece of material. This particularly advantageous embodiment of the invention provides a plug-shaped body which can be used for administering various substances or medicinal preparations to a user via superficial blood vessels in the nasal mucosa and / or via the inhaled air, or via superficial blood vessels in the skin in the ear canal. Examples of such applications include administration of anti-hemorrhagic agents to a nasal mucosa, administration of nicotine or insulin to superficial blood vessels in the mucosa of a nasal passage, administration of allergens via inhaled air to the lungs, administration of fragrances to inhaled air to counteract discomfort. odors, as well as administration of analgesics to superficial blood vessels in the skin of an ear canal. 10 15 20 25 30 35 13 Absorbent pieces of material according to the invention can be tailored to enable the rolling of plug-shaped bodies which are specially adapted to different types of users and areas of use.
    Thus, in a first alternative embodiment, the moldable piece of material according to the invention is moldable by rolling into a plug-shaped body 2 for insertion into a nasal passage P or ear canal in a human, the piece of material 1 having a thickness T and curling length L giving said plug-shaped body 2 an outer diameter OD within the interval 5-20 mm after rolling. In this first alternative embodiment, the piece of material 1 has a particularly advantageous width B in the range 5-20 mm in order to give the plug-shaped body 2 a length IL which can be inserted into the nasal passage or ear canal in the range 5-20 mm after rolling.
    Instead, in a second alternative embodiment, the moldable piece of material according to the invention is malleable by rolling into a plug-shaped body for insertion into a nasal passage P or ear canal of a non-human animal, the piece of material having a thickness and curling length which gives said plug-shaped body an outer diameter in the range 3-50 mm after rolling up. In this second alternative embodiment, the piece of material has a particularly advantageous width in the range 3-50 mm in order to give the plug-shaped body a length which can be inserted into the nasal passage or the ear canal within the range 3-50 mm after rolling. Depending on the animal species and size of animal intended to use the plug-shaped body after rolling, the dimensions of the piece of material can vary within wide ranges in this second alternative embodiment.
    EXPERIMENTAL RESULTS AND LABORATORY MEASUREMENTS Figure 4 is a diagram showing an imaginary relationship between the time until blood flow stops at nosebleeds and the surface pressure that a plug-shaped body rolled from a mouldable piece of material inserted into a nasal passage of a person suffering from nosebleeds exerts against the walls of the nasal passage. The curve illustrating the relationship has been calculated based on studies of literature and discussions with experts in the field, study of subjects, as well as careful analyzes of what happens when the plug-shaped body is inserted into the nasal passage of a person suffering from nosebleeds and the plug-shaped body absorbs nosebleeds. 10 15 20 25 30 35 14 Measurement of the pressure of a hair-rolled oluo-shaped body A mouldable piece of material according to the invention is rolled up to form a plug-shaped body which is inserted into a tube, for example a tube with a diameter of 10 mm. In the mantle surface of the hole there is a hole with a diameter of 4 mm which during the measurement should lie midway between the ends of the plug-shaped body and in a position as far from the ends of the rolled-up piece of material as possible. The plug-shaped body inside the tube is then loaded by inserting a mandrel with a diameter of 2.5 mm in the direction straight towards the center of the hole. In this way, measurement data can be collected to obtain a curve of the force exerted on the mandrel as a function of the indentation of the mandrel end through the hole into the tube.
    Figure 5 is such a diagram illustrating results from laboratory measurements for determining the surface pressure exerted by a plug-shaped body inserted into a tube with an inner diameter of 10 mm in the direction of the inner surface of the tube. The diagram in Figure 5 shows a slow increase in the force at the beginning and then changes to a linear increase in the force with the depression. The linear increase has been marked with the straight line denoted by "stiffness". The slow increase in initial force is due to the fact that parts of the fluffy surface layer of the rolled piece of material, which are for absorbing blood, have expanded out through the hole in the mantle surface of the tube and only begin to compress when the mandrel is pushed into the hole. The subsequent linear increase in force is due to the material in the rolled-up piece of material forming the plug-shaped body being bent away by the indentation of the mandrel.
    The surface pressure exerted by the plug-shaped body in the direction of the inner mantle surface of the tube can be determined in two different ways from the experimental results illustrated in Figure 5. One way is to read the force when the mandrel is level with the mantle surface of the tube during the indentation process. Another way is to read the force where the straight line "stiffness" drawn in the diagram in Figure 5 intersects the x-axis.
    Both readings give a force of 0.03 N. With a diameter of 2.5 mm of the mandrel, this means that the plug-shaped body inserted in the tube in the example in Figure 5 exerts a surface pressure of 6112 N / m2 against the inner jacket surface of the tube.
    The present inventors have come to the conclusion that the magnitude of the surface pressure generated against the walls of an actual nasal or ear canal is mainly determined by the flexural stiffness of the rolled piece of material from which the plug-shaped body has been formed, but also to some extent by the actual the inner diameter and shape of the nasal or ear canal. In order to be able to reproducibly produce pieces of material which, after coiling, give plug-shaped bodies which generate a suitable surface pressure after insertion into nasal passages or ear canals with different inner diameters and shapes, the present inventors have concluded that the flexural stiffness of the moldable the piece of material must both be able to be measured and controlled during manufacture. The inventor has therefore performed flexural stiffness measurements on moldable pieces of material with different stiffness using the following method.
    Measurement of flexural stiffness of a moldable piece of material A moldable piece of material is placed on top of first and second support edges which are placed at a distance of about 25 mm from each other. The moldable piece of material is loaded with a loading edge in the middle between the support edges which press against the top of the piece of material and the deflection of the piece of material at different loading forces is measured. Different loads can be achieved with small weights placed on top of the load edge, for example straight steel wire pieces of 0.25, 0.5 and 1 gram. The flexural stiffness can then be calculated using beam theory according to the formula DELTA = F * L * L * L / (48 * E * I), where DELTA is the deflection, F is the force, L is the distance between the support edges and E * I is the flexural stiffness.
    Figure 6 is a graph showing the time until blood flow stops at nosebleeds as a function of the flexural stiffness of the moldable piece of material rolled together to obtain the plug-shaped body inserted into the nasal passage of a medium nasal passage subject. As can be seen from the diagram in Figure 6, the time until the blood flow is stopped is shortest when the plug-shaped body is rolled up by a moldable piece of material with a flexural stiffness of approximately 0.000008O N / m2.
    Based on the experimental results illustrated in Figure 6, it may appear that a flexural stiffness somewhere in the range 0.0000070-0.000009O Nmz would be optimal as a guide in the production of moldable pieces of material to be used to stop nosebleeds as quickly and efficiently as possible.
    However, the present inventors have come to the conclusion that it is more advantageous if the moldable piece of material is instead given a flexural stiffness in the range 0.00000015-0.0000040 Nmz. By designing the moldable piece of material so that it exhibits a bending stiffness in the range 0.000015-0.0000040 Nm2, even more advantageously 0.000000070-0.0000030 Nm2, a smaller increase in the time before the blood flow is stopped in the outer areas of the range is obtained compared to what Which is the case with the above-mentioned range 0.0000070-0.0000090, as is also apparent from Fig. 6. A moldable piece of material with a flexural stiffness in the range 0.000000015-0.0000040 Nm2 gives a plug-shaped body which can stop nosebleeds in a sufficiently short time for nose sizes within a very wide size range.
    The conclusions, relationships, test results and ranges for flexural stiffness and surface pressure described here and illustrated in the figures are also based on a study in which a dozen people with a nosebleed had access to malleable material thicknesses with different flexural stiffness and were able to measure time until blood flow was stopped. . The time until the blood flow was stopped was measured in some by observing the outer end of the plug-shaped body inserted into the nasal passage and measuring the time until the blood stain of absorbed blood formed on the outer end no longer grew in size. In other cases, the person with nosebleeds started a stopwatch when the plug-shaped body was inserted into the nasal passage and stopped the stopwatch when he / she felt or otherwise felt that the nosebleed had stopped.
    As has been seen above, the present invention relates to a moldable piece of material which is moldable by rolling into a plug-shaped body for insertion into a nasal passage or an ear canal of a user.
    The term "moldable material | piece", as used herein, means that the piece of material according to the invention is bendable to enable such rolling into a plug-shaped body. The term "coil", as used herein, is also intended to include various forms of folding of a moldable piece of material and also a combination of folding and coiling of the piece of material to form a plug-shaped body. The piece of material according to the invention is thus also foldable to enable such folding of the piece of material to form a plug-shaped body. The rolling / folding of a piece of material can be done manually by the user or by a person assisting the user.
    The present invention thus also comprises a plug-shaped body 2 which is formed by rolling together a moldable piece of material 1 according to one of the embodiments of the invention by a human user before insertion into the nasal passage P or the ear canal.
    The present invention also encompasses a plug-shaped body 2 formed by rolling together a moldable piece of material 1 according to any of the embodiments of the invention by a physician, nurse or other assistant prior to insertion into the nasal passage P or ear canal.
    The present invention further comprises a plug-shaped body, formed by rolling up a moldable piece of material according to any one of the embodiments of the invention by an animal owner, keeper, veterinarian or other assistant before insertion into the nasal passage or ear canal.
    Embodiments of the invention are also conceivable where plug-shaped bodies ready for use are provided to the user or delivered to the place where the plug-shaped bodies are to be used, without requiring any rolling up of the user or other persons.
    The present invention thus also comprises a plug-shaped body 2, which is formed by rolling together a moldable piece of material 1 according to one of the embodiments of the invention and subsequent fixing of the plug shape by thermal bonding and / or by using adhesive.
    In embodiments where the moldable piece of material according to the invention comprises thermoplastic fibers or other thermoplastic material, the plug-shaped body can be subjected to a suitable heat treatment after the roll-up to create thermal bonds which, in addition to fixing the shape of the plug-shaped body and giving it stability, can also be used. to control the maximum swelling capacity and thus the generated surface pressure for the finished plug-shaped body during use. In embodiments where the moldable piece of material does not comprise any thermoplastic material, the shape of the plug-shaped body can be fixed using adhesive, or by enclosing it in a dense year-round pleasure during manufacture.
    The present invention has been described above with the aid of a number of different embodiments and with reference to the accompanying drawings. It must be understood, however, that the invention is not limited to the described embodiments and to what is shown in the drawings, but that other embodiments within the scope of the invention as it is defined by the following claims are also conceivable.
    权利要求:
    Claims (13)
    [1]
    Mouldable piece of material (1), mouldable by rolling into a plug-shaped body (2) for insertion into a nasal passage (P) or an ear canal of a user, said piece of material after rolling into said plug-shaped body (2) and inserting into said nasal passage (P) or ear canal has an ability to expand against a wall surface (W) enclosing said nasal passage (P) or ear canal to thereby generate a surface pressure (SP) against the wall surface, characterized in that the piece of material (1) has a thickness (T) and coilable length (L) which after coiling gives said plug-shaped body (2) an outer diameter (OD) in the range 3-50 mm, and that the piece of material (1) has a flexural stiffness in the range 0.000015 0.0000040 Nmz before rolling up.
    [2]
    Formable piece of material (1) according to claim 1, characterized in that the piece of material (1) has a flexural stiffness in the range 0.00007070-0.0000030 Nmz before rolling.
    [3]
    Mouldable piece of material (1) according to claim 1 or 2, characterized in that the flexural stiffness of the piece of material, after rolling and insertion into said nasal passage (P) or ear canal, gives said plug-shaped body (2) an ability to generate a surface pressure (SP) which is at most 15000 N / m2 against the wall surface (W) enclosing said nasal passage (P) or ear canal.
    [4]
    Mouldable piece of material (1) according to claim 3, characterized in that the piece of material (1) comprises at least one elastically expanding material (3) which, after curling and insertion into said said nasal passage (P) or ear canal, contributes to generating said surface pressure. (SP) against the wall surface (W) enclosing said nasal passage or ear canal.
    [5]
    Mouldable piece of material according to one of the preceding claims, characterized in that the piece of material (1) has a width (B) which decreases in the direction of at least one end (5) thereof.
    [6]
    Mouldable piece of material according to one of the preceding claims, characterized in that the piece of material (1) has an ability to form at least one continuous air duct (C) which runs inside the plug-shaped body (2) in a longitudinal direction thereof after the curling. 10 15 20 25 30 35 19
    [7]
    Mouldable piece of material according to any one of the preceding claims, characterized in that the piece of material (1) comprises at least one layer of material (4) which after rolling and insertion into said nasal passage (P) or ear passage of a user gives the plug-shaped body (2 ) an ability to absorb blood and other body fluids released within said nasal passage (P) or ear canal.
    [8]
    Mouldable piece of material according to one of the preceding claims, characterized in that the piece of material (1) comprises at least one material layer (4) which, after rolling up, gives the plug-shaped body (2) an ability to contain and dispense and / or to first absorb and then release one or more substances to be administered to a user directly through the wall surface (W) enclosing said nasal passage (P) or ear passage and / or via inhaled air (IA) passing through one or more air ducts (C) in the longitudinal direction of the plug-shaped body (2) when it is inserted into said nasal passage (P).
    [9]
    Mouldable piece of material (1) according to one of Claims 1 to 8, mouldable by rolling it into a plug-shaped body (2) for insertion into a nasal passage (P) or ear canal in a human, characterized in that the piece of material (1 ) has a thickness (T) and a curable length (L) which gives said plug-shaped body (2) an outer diameter (OD) in the range 5-20 mm after the curling.
    [10]
    Mouldable piece of material (1) according to claim 9, characterized in that the piece of material (1) has a width (B) in the range 5-20 mm to give the plug-shaped body (2) into said nasal passage (P) or ear canal. - movable length (IL) in the range 5-20 mm after rolling.
    [11]
    Mouldable piece of material according to any one of claims 1-8, mouldable by rolling into a plug-shaped body for insertion into a nasal passage (P) or ear canal of a non-human animal, characterized in that the piece of material has a thickness and can be rolled up. length which gives said plug-shaped body an outer diameter in the range 3-50 mm after rolling up.
    [12]
    A moldable piece of material according to claim 11, characterized in that the piece of material has a width in the range 3-50 mm to give the plug-shaped body a length insertable in said nasal passage (P) or ear canal in the range 3-50 mm after rolling .
    [13]
    Plug-shaped body (2), formed by rolling up a moldable piece of material (1) according to any one of claims 1-12 and subsequently fixing the plug-shape by thermo-bonding and / or using adhesive.
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    同族专利:
    公开号 | 公开日
    SE538298C2|2016-05-03|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    法律状态:
    2017-05-02| NUG| Patent has lapsed|
    优先权:
    申请号 | 申请日 | 专利标题
    SE1200683|2012-11-08|
    SE1300587A|SE538298C2|2012-11-08|2013-09-09|Moldable material piece and plug-shaped body formed from such material piece for insertion into a nasal passageway or ear canal of a user|SE1300587A| SE538298C2|2012-11-08|2013-09-09|Moldable material piece and plug-shaped body formed from such material piece for insertion into a nasal passageway or ear canal of a user|
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