Device and method for treating and preventing disease in livestock animals

Abstract

The invention is a pharmaceutical device (1) for use with animals, comprising a body (10) made of one or more solid metals selected from those on which ions have a biocidal effect. The body (10) comprises an inner porous matrix (11) having a porosity of at least 1%, from which biocidal metal ions can be released, and an outer surface of the body (10) is configured to be located at a treatment site (20) of the animal (2).

Description

Technical Field

[0001] This invention relates to apparatus and / or methods for treating and preventing diseases in livestock. More specifically, but not exclusively, this invention relates to pharmaceutical apparatus and / or methods for treating and preventing diseases in cattle. Background Technology

[0002] For livestock farmers, animal health is a critical issue. Lameness, mastitis, and reproductive problems are the most common health problems in cattle, and they often lead to sharp financial costs that significantly impact farm profits. Mastitis is most commonly caused by bacteria invading the udder, while lameness is sometimes caused by infections of the hooves and surrounding area.

[0003] Because the cost of identifying and treating these problems is considerable, preventative solutions that can be administered in large quantities together are often the most economical. Antibiotics are widely used for this purpose. To prevent or treat hoof problems such as hoof dermatitis or foot rot, antibiotics are sometimes used in combination with irritating chemical baths for the hooves. To prevent mastitis, antibiotics are used in combination with nipple sealants, which are usually administered via syringes. These syringes are typically single-dose, generating large amounts of plastic waste on a large scale.

[0004] A major problem with the widespread use of antibiotics as preventative medicines for livestock diseases is that it accelerates the development of antibiotic resistance in target bacterial strains. This gradually renders common antibiotics ineffective, ultimately leaving farmers with poor livestock health and no available cost-effective and effective preventative medicines. This problem is now beginning to significantly impact the industry, leading to a growing desire for alternative solutions for the prevention and / or treatment of common health issues such as mastitis and lameness. These alternative solutions will need to remain effective against bacteria while also being cost-effective and easy to manufacture and administer.

[0005] One approach that has begun to be explored is the use of metals with biocidal properties. Metals such as copper are known to kill bacteria and other microorganisms, which is generally understood to be the result of metal ions disrupting the cell walls of microorganisms.

[0006] There is existing research on the use of aqueous copper solutions for animal medical purposes, and U.S. Patent 4,418,686 discloses an animal implant device that uses a metal band to generate a galvanic cell that releases ions for antibacterial action. However, these existing attempts to utilize the antibacterial properties of this metal have drawbacks, namely that the amount of biocidal ions provided is not very high, meaning they are not a good alternative to antibiotics, which will be more effective, at least until resistance eventually develops. Additionally, devices such as those shown in U.S. Patent 4,418,686 have high manufacturing complexity, making them more expensive and less economical compared to the large-scale application of antibiotics. They also have a short lifespan, and the components left behind when the implant is depleted may cause damage to the treatment site.

[0007] Where external sources (including patent specifications and other documents) are referenced in this specification, they are generally for the purpose of providing context for discussing the features of the invention. Unless otherwise stated, references to such sources should not be construed as an admission that such sources are prior art or constitute part of common general knowledge in the art to any jurisdiction.

[0008] For the purposes of this specification, where method steps are described in sequence, such sequence does not necessarily mean that the steps are ordered chronologically, unless there is no other logical way to explain the sequence.

[0009] One object of the present invention is to provide an apparatus and method that overcomes or at least partially improves some of the above-mentioned disadvantages or at least provides the public with a useful alternative. Summary of the Invention

[0010] According to a first aspect, the present invention broadly includes a drug delivery device for use in animals, the drug delivery device comprising:

[0011] A body made of one or more solid metals, selected from those whose ions have a biocidal effect on them;

[0012] The main body comprises an internal porous matrix with a porosity of at least 1%, from which biocidal metal ions can be released, and

[0013] The outer surface of the main body is configured to be located at the treatment site of the animal.

[0014] According to another option, the one or more solid metals are selected from copper, cobalt, zinc, nickel, zirconium, molybdenum, and alloys thereof.

[0015] On the other hand, the one or more solid metals are pure metals, making them not alloys.

[0016] According to another perspective, the body is made of only a single solid metal.

[0017] According to another source, the body is made of pure copper.

[0018] According to another aspect, the internal porous matrix has a porosity of at least 10%.

[0019] According to another aspect, the internal porous matrix has a porosity between 20% and 80%.

[0020] According to another aspect, the internal porous matrix has an average pore size of 50 micrometers or less.

[0021] According to another aspect, the body has one or more flow channels passing through it.

[0022] According to another aspect, the present invention broadly includes implants, and the length of the body in any dimension does not exceed 20 mm.

[0023] On the other hand, the body has multiple grooves on its outer surface.

[0024] On the other hand, the main body is a spiral structure.

[0025] According to another aspect, the internal porous matrix has a porosity of at least 50%.

[0026] An elongated plug suitable for insertion into the nipple ducts of mammals, wherein the elongated plug is a drug delivery device.

[0027] According to another aspect, the elongated plug includes a port at each of its proximal and distal ends to facilitate fluid discharge in one direction and drug administration in the other.

[0028] According to another perspective, the internal porous matrix has a porosity of 20% or less.

[0029] A patch suitable for application to external treatment sites for use in animals, wherein the patch is a drug delivery device and the body is formed as a thin layer.

[0030] On the other hand, the thin layer has multiple grooves on its outer surface.

[0031] According to another aspect, the thin layer presents or forms a cross-shaped grid.

[0032] According to another aspect, the thin layer exhibits one or more rough sections with high-density peaks.

[0033] According to another aspect, the present invention broadly includes a method for manufacturing a pharmaceutical device, wherein the method is an additive manufacturing process and includes a metal 3D printing step.

[0034] On the other hand, the additive manufacturing process involves the spraying of a binder onto metal powder.

[0035] According to another perspective, the particle size of the metal powder is 50 micrometers or smaller.

[0036] According to another aspect, the purity of the metal powder is at least 99.95%.

[0037] On the other hand, the sintering cycle that completes the binder spraying process has low intensity, which allows most of the voids in the internal porous matrix to be retained.

[0038] According to another approach, before the binder is sprayed, the space-holding material is mixed with metal powder, and then the space-holding material is removed by sintering, thereby creating pores in the internal porous matrix.

[0039] On the other hand, the space-retaining materials are selected from potassium carbonate, sodium chloride, and carbodiamine.

[0040] On the other hand, the material used to maintain this space is needle-shaped.

[0041] According to another aspect, the present invention broadly includes a method for treating or preventing infections in livestock using a pharmaceutical device, wherein the method includes applying the pharmaceutical device to a treatment site for use in the animal.

[0042] According to another aspect, the method includes injecting the drug device into the skin near the animal's hoof to prevent or treat foot rot, toe dermatitis, interdigital dermatitis, white line disease, and / or plantar ulcers.

[0043] According to another aspect, the method includes inserting a drug device into the nipple duct of an animal to prevent or treat mastitis and / or myiasis, to prevent contaminants from entering the nipple duct, or as a cannula, nipple straightener, internal nipple duct skin adjuster, or nipple end closure device.

[0044] According to another method, the method includes externally attaching a drug device to an animal's wound to prevent or treat infection.

[0045] According to another definition, animals are mammals selected from cows, goats, pigs, deer, buffalo, sheep, and camels.

[0046] According to another aspect, the present invention broadly includes a drug delivery device for use in animals, the drug delivery device comprising:

[0047] Installation components;

[0048] One or more subjects, each subject being made of one or more solid metals selected from those whose ions have a biocidal effect on them;

[0049] The one or more subjects are mounted on the mounting member, and the outer surface of each subject is configured to be located at the treatment site of the animal.

[0050] According to another aspect, the drug device is formed as an elongated plug suitable for insertion into the nipple ducts of mammals.

[0051] According to another option, the mounting component is a shaft, and the one or more bodies are mounted along the length of the shaft.

[0052] According to another aspect, the axis defines a widened area toward one end.

[0053] According to another perspective, the widened region is defined by the diverging and reconverging adjacent branches of the axis.

[0054] According to another aspect, the drug delivery device also includes an end stop fixed at the opposite end of the shaft.

[0055] According to another aspect, the one or more bodies include bead-like features mounted on the shaft.

[0056] According to another aspect, the one or more bodies include wire wound on a shaft.

[0057] On the other hand, the mounting component is flexible and elastic.

[0058] On the other hand, the mounting component is made of shape memory alloy.

[0059] According to another perspective, the mounting component is made of Nitinol.

[0060] According to another option, the one or more solid metals are selected from copper, cobalt, zinc, nickel, zirconium, molybdenum, and alloys thereof.

[0061] On the other hand, the one or more solid metals are pure metals, making them not alloys.

[0062] According to another perspective, each of the one or more bodies is made of only a single solid metal.

[0063] According to another perspective, each component in the main body is made of pure copper.

[0064] Other aspects of the invention will become apparent from the following description, which is given by way of example only and with reference to the accompanying drawings.

[0065] As used in this article, the term “and / or” means “and”, or “or”, or both.

[0066] As used in this article, “multiple” before a noun refers to the plural and / or singular forms of the noun.

[0067] As used in this specification and claims, the term "comprising" means "consisting of at least partially...". When interpreting a statement that includes this term in this specification and claims, all features preceded by the term must be present in each statement, but other features may also be present. Related terms such as "comprising" and "including" will be interpreted in the same manner. Attached Figure Description

[0068] The invention will now be described by way of example only and with reference to the accompanying drawings, in which:

[0069] Figure 1 A close-up cross-sectional view of the internal porous matrix is ​​shown;

[0070] Figure 2A A perspective view of a first embodiment of the implant is shown;

[0071] Figure 2B A perspective cross-sectional view of a first embodiment of the implant is shown, in which the internal flow channels are visible;

[0072] Figure 3A A perspective view of a second embodiment of the implant is shown;

[0073] Figure 3B A side cross-sectional view of a second embodiment of the implant is shown;

[0074] Figure 4 A perspective view of a third embodiment of the implant is shown;

[0075] Figure 5 A perspective view of a longer variant of a third embodiment of the implant is shown;

[0076] Figure 6 An X-ray view of the implant injected into a treatment site near the hoof of a dairy cow is shown.

[0077] Figure 7A A perspective view of a first embodiment of the plug is shown;

[0078] Figure 7B A top view of a first embodiment of the plug is shown;

[0079] Figure 8A A perspective view of a second embodiment of the plug is shown;

[0080] Figure 9 B shows a top view of the second embodiment of the plug;

[0081] Figure 8C A side cross-sectional view of a second embodiment of the plug is shown;

[0082] Figure 9 An X-ray view of a plug inserted into the teat canal of a cow is shown;

[0083] Figure 10A A top perspective view of a first embodiment of the patch is shown;

[0084] Figure 10B A bottom perspective view of a first embodiment of the patch is shown;

[0085] Figure 11A A top perspective view of a second embodiment of the patch is shown;

[0086] Figure 11B A bottom perspective view of a second embodiment of the patch is shown;

[0087] Figure 12 A top perspective view of a third embodiment of the patch is shown;

[0088] Figure 13A A top view of a third embodiment of the plug is shown; and

[0089] Figure 13B A top view of the fourth embodiment of the plug is shown. Detailed Implementation

[0090] According to such Figures 1 to 9 The various aspects of the present invention shown in B provide a pharmaceutical device 1, a method of manufacturing it, and a method of treating and preventing animal diseases, which will now be described.

[0091] It will be understood that these figures illustrate the general principles of structure and construction, and that the invention is not limited to the precise configuration shown.

[0092] General structure and composition

[0093] The drug device 1 includes a body 10 made of one or more solid metals selected from those whose ions have a biocidal effect on them. For example... Figure 1 As shown, the main body 10 includes an internal porous matrix 11 from which biocidal metal ions can be released. Figure 1 This is a close-up image of a cross-section of the main body 10 having an internal cavity, the upper and lower sections being the walls of the main body 10, which include a porous copper internal porous matrix 11. Preferably, the main body 10 is integral.

[0094] Biocidal action is defined as the effective killing or other inactivation of harmful microorganisms such as bacteria, viruses, and parasites by ions. This can be achieved through contact between an organism and a metal surface, or by removing ions from the metal, for example, by suspending them in body fluids, thereby affecting harmful microorganisms that may not necessarily be present on the metal surface.

[0095] The outer surface of the main body 10 is configured to be located at the treatment site 20 of the animal 2. This treatment site 20 can be an external treatment site, such as on a wound or other external site, or an internal treatment site, such as inside the nipple duct or under the skin near the hoof. The drug delivery device 1 can be placed at the treatment site 20 manually or with the aid of appropriate instruments.

[0096] Figure 2 to Figure 9 B illustrates various embodiments of the drug delivery device 1 suitable for various treatment sites 20, including variations of the implant 3, the elongated plug 4, and the patch 5. Each embodiment is further described below.

[0097] The terms "medicine" and "treatment site" are used broadly in this specification to cover uses such as prevention of infection, treatment of active infection, and / or provision of other health benefits. The animal 2 receiving the drug device 1 is intended to be a livestock animal, and preferably a bovine animal, i.e., a cow, but the invention can be applied to a wider range of animals as will be described.

[0098] By providing a biocidal metal ion source, the drug device 1 kills or at least inhibits invasive bacteria from entering the treatment site 20, thereby preventing infection. It can also kill bacteria already infected at the treatment site 20, thus treating the infection to some extent. By acting through a different mechanism than antibiotic drugs, it inhibits the development of antibiotic resistance in bacterial strains. Additionally, prior to application to the treatment site 20, the internal porous matrix 11 may optionally be filled with a drug or other useful substance, such as silver, zinc, solid, liquid, gel, antibiotic, micronutrient, or growth hormone, which will be slowly released into the treatment site 20 over time. These substances may also coat the exterior of the body 10. This provides another mechanism for killing invasive bacteria or promoting healing.

[0099] For example, in addition to the metal in the internal porous matrix 11 itself, the internal porous matrix 11 may be filled with 1 ppm to 22,000 ppm of colloidal silver as a secondary source of biocidal metal ions.

[0100] Many metallic elements are known to possess biocidal properties, and in particular, they possess ions with biocidal properties. For the purposes of this invention, the solid metal used to form the host due to these biocidal properties is preferably selected from copper, zinc, silver, cobalt, nickel, zirconium, molybdenum, and alloys thereof. Some such metals may be less preferred than others, especially those that may be toxic in small amounts, such as lead.

[0101] Preferably, one or more solid metals are pure metals, rather than alloys or other molecular compounds. The term "pure metal" is intended only to mean, as opposed to alloys or molecular compounds, that the metal is a chemical element and does not preclude the possibility that other compounds may be present in the metal in negligible amounts without forming an alloy. Compounds that may be present in small amounts may include residues from liquid binders used in the manufacturing process, or minor impurities in the metal powder used in the process. For the purposes of this specification, a metal having a purity of 99.95% will be considered, for example, "pure".

[0102] Preferably, the body 10 is made of only a single solid (and preferably pure) metal to simplify the manufacturing process, reduce costs, and provide better control over the release of biocidal ions. However, if the body 10 is made of multiple solid metals (pure or alloyed), interfaces may be present between them, allowing the body 10 to be divided into multiple segments. These interfaces may be mechanical connections, such as press fits, or the different segments may be fused together using other manufacturing processes.

[0103] The preferred metal for body 10 is pure copper because copper ions have a particularly strong biocidal effect. Copper is well-known and approved as a biocide, and it is a micronutrient for most animals. Copper is also widely available and suitable for various manufacturing processes because it is easy to shape and form, has a long shelf life, and is highly recyclable without damage or impairment. Since silver and zinc ions also have particularly strong biocidal activity, the next most preferred metals are pure zinc, pure silver, and any combination of two to three of copper, zinc, and silver.

[0104] The release of biocidal metal ions is facilitated by the internal porous matrix 11, which provides numerous sites for ion release due to its high internal surface area. These ions are naturally and gradually released to the treatment site, effectively creating a slow-release mechanism. The internal porous matrix 11 also allows bodily fluids (such as water, blood, or mucus) in the treatment site to enter the pores, and the release of ions is stimulated by the presence of aqueous electrolytes. The rate of ion release is influenced by the properties of the internal porous matrix 11, namely its porosity / density, pore size, and other such factors. Generally, the rate of ion release increases when the internal porous matrix 11 has a larger internal surface area.

[0105] The increased porosity of the internal porous matrix 11 increases the internal surface area, so maximizing porosity is generally desirable. Porosity can be expressed as a percentage of the volume comprised of voids in a material. It is related to the bulk density or effective density of the material, which is a measure of the density of the material including the void / pore volume. Higher porosity corresponds to lower bulk density.

[0106] The internal porous matrix 11 has a porosity of at least 1%, and preferably at least 10%. The applicant has experimentally known that matrix porosities of 20% and 30% provide fairly good structural integrity; however, porosities up to 67% are known to be possible for some applications without being too fragile.

[0107] Maximizing porosity is a significant manufacturing challenge, and preferred methods for producing high-porosity metals will be described. Care must be taken to ensure the structural integrity of the metal is maintained. It should be understood that optimization of manufacturing techniques and parameters can allow porosities even higher than 67%, for example, as will be described, porosities up to 80% can be achieved using space-retaining materials. This invention provides a general principle of application that is not limited to any particular maximum porosity beyond physical limitations.

[0108] The surface roughness of the outer surface of the body 10 is another property that can affect the outer surface area and thus the rate of ion release. Generally, higher surface roughness leads to a higher rate of ion release, and is therefore desirable. Surface roughness can also be related to the porosity of the internal porous matrix 11.

[0109] Preferably, the internal porous matrix has micron-sized pores, such as an average pore diameter of about 50 micrometers. The pore diameter will depend on the type of metal used and the manufacturing method described herein. Generally, smaller pore diameters increase the internal surface area, so minimizing the pore diameter is desirable.

[0110] A potential limiting factor for the desired ion release rate is the consideration of metal toxicity in the target animal 2. Regardless of the metal used in the body 10, excessive release of metal ions could be toxic to the animal 2 and cause health complications, thereby undermining the intended purpose of the drug delivery device 1. Therefore, the internal porous matrix 11 is preferably designed to release metal ions at a rate far below what could be toxic to the target animal 2. The drug delivery device 1 is also preferably designed so that it does not become toxic even if the entire structure is rapidly released into the animal 2.

[0111] The drug delivery device 1 can be configured for a specific animal or animal selection. For example, if the drug delivery device 1 is intended for use in cattle, it may have an internal porous matrix 11 with higher porosity, but if the drug delivery device is intended for use in smaller animals, such as sheep, it may have an internal porous matrix with lower porosity.

[0112] method

[0113] Having described the structure of the present invention above, a general description of the method for forming an apparatus for treating and preventing diseases in dairy cows will now be described.

[0114] The drug delivery device 1 is preferably manufactured using a metal additive manufacturing process, i.e., a process involving metal 3D printing steps. This allows the body 10 and the internal porous matrix 11 to be precisely manufactured with customized density / porosity and surface roughness characteristics, thereby achieving the desired rate of biocidal ion release, and allows the body 10 to be formed with suitable flow channels 13 at any desired shape factor. The specific additive manufacturing process used is preferably binder jet printing (i.e., binder jetting), as briefly described.

[0115] Other manufacturing processes can be applied to the production of drug device 1, provided that the process can produce porous metal structures. For example, CNC tools can be used to create pores in a subtractive manner, but compared to the additive manufacturing processes described herein, sufficiently precise control will be more difficult, and the customization of porosity will be more limited. Molds can also be used in conjunction with space-holding materials to cast porous metal structures; however, it is difficult to achieve internal features such as flow channels 13 on a small scale. Large-scale production may also be more challenging.

[0116] In a preferred manufacturing process for binder jet printing, rollers deposit a layer of metal powder particles onto a print bed. An inkjet printhead then deposits a liquid binder onto this layer to bond the particles. The print bed can then be lowered (or its relative height adjusted in other ways), and the process can be repeated multiple times, with rollers depositing another layer and the printhead bonding it together. A batch of parts can be printed and undergo subsequent steps simultaneously.

[0117] Once printing is complete, a de-powdering step is preferably performed to remove unbonded metal powder from the component using compressed air and / or under a specific controlled vacuum. The internal geometry of the drug device 1 is configured to ensure that unbonded metal powder can be completely removed. De-powdering is preferably automated, but can also be performed manually.

[0118] Next, the adhesive can be cured by heating to give the component sufficient strength to allow for processing.

[0119] Finally, the component undergoes one or more sintering cycles, which remove the binder and densify the component into its final structure, further increasing its strength. Preferably, the component is placed on a ceramic tray during sintering. The sintering cycles can be customized to achieve the desired porosity / density, surface roughness, or other properties of the component. The resulting solid metal component is then ready for end-use applications.

[0120] The choice of metal powder used influences factors such as the pore size and internal surface area of ​​the internal porous matrix 11. The pore size will be largely determined by the particle size of the powder; for example, 50-micron powder produces pores of a similar size. The internal surface area increases as the particle size decreases. Therefore, it is generally desirable to choose powders with small particle sizes.

[0121] One of the other factors affecting the porosity of the internal porous matrix 11 is the choice of liquid binder. Various binder compositions are possible, and the selection occurs in conjunction with the selection of an appropriate sintering cycle.

[0122] Prior to sintering, a liquid binder is present in the metal. When this liquid binder is removed from the structure during sintering, voids are created. Therefore, high porosity can be promoted by selecting an appropriately low-intensity sintering cycle that does not over-densify the metal. This is contrary to the conventional goal of sintering, where strength is typically a primary consideration and maximizing densification (i.e., removing voids) is desired. For the present invention, the aim of sintering is to remove the liquid binder, but only to densify the material to the minimum degree required for the component to have sufficient structural stiffness. Therefore, voids will be largely retained, resulting in high porosity.

[0123] Optionally, prior to sintering, a space-holding material (in addition to the liquid binder) can be dispersed within the component to further promote increased porosity. The space-holding material can be a material such as potassium carbonate, sodium chloride, or carbamate, preferably in needle-like form. The space-holding material can be mixed with the metal powder prior to binder spraying and subsequently removed from the component during sintering by sintering cycles at appropriate temperatures. The shape, size, and proportion of the space-holding material used can help tailor pore shape and size, allowing for higher porosity than when using the liquid binder alone.

[0124] The applicant has discovered that copper is well-suited for binder jet printing and sintering to achieve high porosity, and therefore, combined with its desired biocidal properties, it is a preferred metal for the additive manufacturing process described in this invention.

[0125] The preferred metal powder used in the manufacturing process is copper powder of about 50 micrometers or smaller. Preferably, it also has a purity of at least 99.95%, more preferably about 99.99%.

[0126] Additive manufacturing is relatively low-cost, low-energy, and pollution-free, which are advantages over alternative manufacturing methods. The metal used to manufacture each drug device can also be recycled into other products at the end of its life, as it can be converted back into powder through appropriate smelting / melting or grinding processes.

[0127] implants

[0128] like Figures 2A to 4 As shown, in some embodiments of the invention, the body 10 is formed as an implant 3 suitable for use at an internal treatment site 20. It can be implanted under the skin using an implant syringe, implant gun, or any other suitable mechanical, electric, or pneumatic injection device. Preferably, the intended treatment site 20 is near the hoof of the target animal 2, such that the implant can prevent or treat infections around the hoof / foot of the animal 2.

[0129] When the body 10 is formed as an implant 3 for insertion under the skin, the body 10 preferably has a suitably small size to facilitate easy insertion. Preferably, the length of the body 10 in any dimension does not exceed 20 mm, that is, it can fit into a boundary sphere with a diameter of 20 mm. More preferably, it does not exceed 10 mm in any dimension.

[0130] In such Figures 2A to 2B In the first embodiment of the implant 3 shown, it is formed as a cuboid with rounded edges. Preferably, it has dimensions of approximately 6 mm in length, 3 mm in width, and 2 mm in height.

[0131] In such Figures 3A to 3B In a second embodiment of the implant 3 shown, it is formed as a cylinder with rounded edges. Preferably, it has a length of about 6 mm and a diameter of about 2.2 mm.

[0132] These sizes allow the implant 3 to be injected via a needle, such as a syringe or gun. Larger sizes can still be injectable, but would require larger needles, which would be less comfortable for the animal. Therefore, it is preferable to inject multiple implants 3 to achieve the desired effect rather than using a larger implant. Figure 4 Multiple implants injected under the skin near the hoof are shown 3.

[0133] For the implant 3, the outer surface of the body 10 preferably has a groove 30 to increase the outer surface area, thereby increasing the release rate of biocidal metal ions. The groove 30 also helps to retain the implant within the treatment site, thereby allowing tissue to grow around the groove 30 and secure the body 10.

[0134] The body 10 may also have one or more flow channels 13 passing through the body to allow fluid to pass through. This ensures that the flow of excess tissue fluid in the treatment site is not blocked, while also using the fluid channels to further activate the internal porous matrix and increase the rate of release of biocidal metal ions. Tissue may also grow into the flow channels 13 to better secure the implant 3 in place, and the flow channels 13 may act as traps for bacteria.

[0135] In such Figures 2A to 2B In the first embodiment shown, two flow channels 13 pass through the body 10 longitudinally, and four flow channels 13 pass through the body horizontally. In such a way... Figures 3A to 3B In the second embodiment shown, one flow channel 13 passes through the body 10 longitudinally, and four flow channels 13 pass through the body horizontally.

[0136] In such Figure 4 In the third embodiment of the implant 3 shown, the body 10 has a spiral structure, and the flow channel 13 is part of the spiral. Figure 5 An extended variant of the third embodiment is shown. This spiral structure has high strength, high surface area, and is easily 3D printed as part of a preferred manufacturing process.

[0137] For implant 3, providing growth hormones, other metal ions / colloids, and / or micronutrients within the internal porous matrix 11 may be particularly beneficial, as the slow release of these substances can promote the growth and hardening of hoof keratin, thereby improving hoof thickness and formation. This may be especially useful in treating existing hoof conditions, as it can accelerate recovery, for example, if the existing condition has led to partial hoof rot or deformity.

[0138] Copper is an essential micronutrient for livestock (such as dairy cows) and is typically provided as a nutritional supplement added to animal feed. Therefore, an implant 3 made of copper can provide some or all of the nutritional copper intake to the animal 2 by directly and gradually releasing copper ions into the treatment site 20 via an internal porous matrix 11. The implant 3 can be inserted into various sensitive locations on the dairy cow to ensure adequate copper absorption, thereby helping to replace nutritional supplements added to the feed.

[0139] The implant 3 can inactivate invasive bacteria and other microorganisms through its internal porous matrix 11. For example, when the implant 3 is injected near the hoof of the animal 2, it can prevent white line disease, foot rot, plantar ulcers, and other diseases that are usually caused by bacterial infections.

[0140] Over time, due to the small size of implant 3 and the gradual release of material in the form of biocidal metal ions, implant 3 will completely dissolve in treatment site 20. Factors such as the size and porosity of implant 3 will affect the time taken for its complete dissolution, which can be monitored via X-ray scanning to determine the appropriate reapplication interval for a given implementation of implant 3. For example, X-ray monitoring of dissolution can indicate that annual reapplication is appropriate for a specific implementation of implant 3.

[0141] Due to the small size of implant 3 and its expected dissolution over time, high structural integrity is not required after insertion into treatment site 20. Therefore, a particularly high porosity of the internal porous matrix 11 is desirable for implant 3, provided it maintains the minimum strength required to be injected into treatment site 20. For example, this porosity level may be suitable for implant 3 when 50% or higher porosity might not be appropriate for other applications.

[0142] The use of the implant 3 near the hoof of the present invention has many advantages over existing hoof care solutions. Currently, foot baths containing irritating chemicals are typically applied regularly to prevent or treat hoof problems in livestock. These chemicals can be hazardous and must be transported and handled with care.

[0143] In contrast, the implant 3 according to the invention is non-toxic and can be safely handled and transported without any associated dangers. The implant 3 according to the invention will also require less frequent application; for example, once a year can replace two to seven foot baths with chemical solutions per year. Given that standard chemicals are used only once, waste is also significantly reduced.

[0144] The use of implant 3 can also reduce the need for antibiotics as a preventative measure against the aforementioned hoof diseases, thereby hindering the development of antibiotic resistance, and also reduce or eliminate the downtime in the sale of animals or their dairy products caused by waiting for antibiotics to be administered through the system.

[0145] plug

[0146] like Figures 7A to 9 As shown, in some embodiments of the invention, the body 10 is formed as an elongated plug 4 suitable for insertion into the nipple canal of a mammal. The mammal is preferably a cow, but may also be a goat, pig, deer, buffalo, sheep, camel, or any other mammal.

[0147] In this construction, the main body 10 has features that are the same as or similar to those described in the first embodiment (implant), such as the flow channel 13. Therefore, similar features are generally indicated by the same reference numerals.

[0148] The main difference in these embodiments is that the shape and size of the body 10 are designed so that it can effectively serve as a nipple plug 4. This preferably means that the shaft 40 is provided with a generally circular cross-section. For use with dairy cows, the shaft 40 preferably has a diameter of about 2 mm.

[0149] In such Figures 7A to 7B In the first embodiment of the shown plug 4, the plug 4 is approximately 20 mm long. This size is suitable for use with cow teats.

[0150] In such Figures 8A to 8C In the second embodiment of the plug 4 shown, the plug 4 is approximately 27 mm long. This size is also suitable for use with cow teats.

[0151] It will be understood that many variations in length and size are possible; however, such variations must conform to the size of the teat of the target animal 2. For example, the plug 4 for sheep can be smaller than that for dairy cows. For dairy cows, the size range is preferably between 15 mm and 40 mm.

[0152] One flange end 41 can be used as an end stop, while the other end can be a tapered end 42 for easy insertion. The flange end 41 can be located outside the nipple and allows for easy removal, as well as acting as a barrier against dirt and bacteria.

[0153] For the plug 4, the longitudinal flow channel 13 facilitates the drainage of excess milk from the breast through the nipple ducts via the plug 4, thereby relieving pressure and reducing the risk of infection. The longitudinal flow channel 13 can also be used in the opposite direction to deliver medication deeply into the nipple and breast, for example, when the nipple or breast is damaged. The plug 4 preferably has a proximal port 45 and a distal port 46 to facilitate these functions.

[0154] Additionally, an intermediate port 44 leading to the longitudinal flow channel 13 can be provided in the shaft 40. For example, in... Figure 7B In the first embodiment shown, an intermediate port 44 is provided, while in... Figure 8B In the second embodiment shown, two intermediate ports 44 are provided, one approximately in the middle of the shaft 40 and the other facing the end.

[0155] like Figures 7A to 8C As shown, the conical end 42 preferably has a spherical part 43, which can be positioned directly inside the nipple cisternives to help retain the plug 4 within the nipple duct. The spherical part 43 can be pear-shaped, spherical, or other similar shapes. The spherical part 43 may include additional horizontal flow channels 13 passing through it to allow it to act as a collection point for milk and other fluids, thus facilitating drainage. The spherical part 43 can also act as a bacterial trap, where more biocidal ions are released. Figure 8C As shown, the flow channel 13 in the sphere 42 is preferably cross-shaped. The distal port 46 is preferably located further away from the sphere 43 along the conical end 42.

[0156] The plug 4 can be manually installed in the nipple tube, or a suitable tool can be provided for pushing the plug 4 into the nipple tube. The plug 4 can be coated with a suitable lubricant to facilitate easy installation.

[0157] When installed in the teat duct, the plug 4 prevents invasive bacteria from entering the teat duct through the internal porous matrix 11, thereby preventing the development of mastitis in animals (i.e., bovine mastitis in dairy cows). It can also be used to prevent parasitic diseases that can afflict the teats, such as myiasis by preventing blowflies and maggots from entering.

[0158] Therefore, plug 4 can be inserted in the early weeks of the dry period when the animal 2 is not producing milk, typically when mastitis infection is likely to develop. However, even during lactation, plug 4 can be inserted between milking stages to prevent infection or myiasis, which may be particularly beneficial for cows that are leaking milk. Plug 4 can be removed approximately 60 days after application, before re-application at the start of the next cycle, prior to calving.

[0159] Because the plug 4 is designed to maintain the blockage of the nipple duct for an extended period, it is important that it possesses sufficient structural integrity to prevent premature or easy dissolution or damage / deformation. Therefore, a lower porosity level of the internal porous matrix 11 is preferred compared to applications such as implant 3. For example, a porosity of around 20% might be suitable for the plug 4 as a balance between a high release rate and structural strength.

[0160] The plug 4 may also have additional benefits resulting from the regulation of the skin in the nipple duct by ion release, which prevents the nipple from drying out, cracking, and deforming. Because the plug 4 is essentially self-cleaning, it can be used as a tool during surgery or treatment of damaged nipples, nipple cisterns, or nipple ducts.

[0161] Plug 4 serves as an alternative to nipple sealant, which is typically administered via syringe during the dry period to prevent mastitis. However, Plug 4 is easier to remove, making it more suitable for use between milkings during lactation. Installation is simpler and less wasteful because it does not require a pre-filled disposable syringe; instead, any installation tool can be reused. Furthermore, Plug 4 itself can be recycled, cleaned, and reused.

[0162] patch

[0163] like Figures 10A to 10BAs shown, in some embodiments of the invention, the body 10 is formed as a thin layer 50, which can be applied as a patch 5 to an external treatment site. This embodiment may be particularly suitable for treating wounds or existing infections by direct application to the affected treatment site.

[0164] The patch 5 can be round, square, rectangular, or any necessary shape to suit a specific application and has a standard diameter of approximately 5 mm. However, it will be understood that many variations in size and shape are possible; for example, the patch 5 can be some other polygonal shape. Patches can be made in various sizes; for example, the diameter of the patch can be up to 100 mm to cover larger wounds.

[0165] In such Figures 10A to 10B In a first embodiment of the patch 5 shown, the thin layer 50 has a plurality of grooves 51 formed therein. The grooves 51 help increase the outer surface area and can also help retain tissue at the treatment site 20 by allowing tissue to grow into the grooves 51. Preferably, the grooves 51 are in a cross pattern.

[0166] In such Figures 11A to 11B In the second embodiment of the patch 5 shown, the thin layer 50 presents a cross-shaped grid 52, which contributes to high mechanical stability under pressure. The thin layer 50 may have annular edges 52 to provide support to the grid 52. The grid 52 itself may form the thin layer 50 such that the grid 52 is supported only by its edges 52.

[0167] In such Figure 12 In the third embodiment of the patch 5 shown, on one side, the thin layer 50 presents a plurality of rough segments 54 with a high peak density. The rough segments 54 are separated by radial grooves 51 with smoother surfaces. However, the rough segments 54 may also be separated in some other way, or one rough segment 54 may exist across some or all of the thin layer 50. The rough segments 54 have a particularly high surface area, which is beneficial for the release of biocidal ions, and tissue growth may also occur in the peaks to better hold the patch 5 in place.

[0168] Preferably, the patch 5 is flexible (i.e., can be easily elastically and / or plastically deformed) and can conform to the contours of the external treatment site. It can be secured with some kind of adhesive, such as glue or tape, or the plastic deformation of the patch may be sufficient to hold it in place—for example, it can be wrapped around the leg or hoof and held in place by the rigidity of metal.

[0169] The thickness of the patch 5 is preferably in the millimeter or micrometer range, but can depend on the structure of the thin layer 50. For example, when the mesh 52 forms the thin layer 50, the thin layer 50 preferably has a relatively high thickness of a smaller number of millimeters. If the thin layer 50 is formed with a more robust structure rather than as the mesh 52, a smaller thickness in the micrometer range may be appropriate.

[0170] In patch 5, the internal porous matrix 11 can be filled with micronutrients or growth hormones to stimulate tissue growth, thereby closing the underlying wound. While it can function independently, patch 5 can also be used in combination with other therapeutic aids to accelerate the healing process.

[0171] The patch 5 inactivates bacteria and other microorganisms in the treatment site 20 through its internal porous matrix 11, and thus can serve as an alternative to irritating chemicals sometimes used to treat external infections. Another advantage of the patch 5 is that it leaves no residue. Due to the small and thin nature of the patch 5 and its intended use as a therapeutic aid, it is suitable as a single-use, disposable, and recyclable aid.

[0172] When manufactured using additive manufacturing processes such as adhesive spraying, the thin layer 50 can be constructed in a relatively small number of roller passes. This makes the patch 5 particularly suitable for rapid mass production.

[0173] Composite device

[0174] like Figures 13A to 13B As shown, in another embodiment, the medical device is not composed of a single monolithic body 10. Instead, the medical device is a “composite” medical device 100 comprising multiple parts assembled together.

[0175] The composite medical device 100 includes a mounting member 60 and one or more bodies 62 mounted on the mounting member 60. The bodies 62 are made of one or more solid metals selected from those whose ions have a biocidal effect on them, in the same manner as described above. The outer surface of each body 62 is configured to be located at a treatment site in the animal 2.

[0176] Preferably, the composite medical device 100 is formed as an elongated plug 4 suitable for insertion into the nipple ducts of a mammal. Therefore, Figure 13A and Figure 13B Third and fourth embodiments of the elongated plug 4 as described above are provided respectively. The dimensions of the third and fourth embodiments are preferably similar to those of the previous embodiments of the elongated plug 4, for example, the length is between 15 mm and 40 mm.

[0177] Mounting member 60 is preferably a shaft to provide the basic shape of the elongated plug 4, although the shape of the shaft may be more complex than a simple axial range. One or more bodies 62 are mounted along the length of the shaft, but not necessarily along its entire length.

[0178] In such Figure 13A In the third embodiment shown, at least some of the one or more bodies 62 are formed as beaded edges, which are slidably movable to a certain extent along the axis. Some of the bodies 62 may be similar in shape but fixed in place, for example at either end of the axis, to act as end stops to prevent the slidably movable bodies 62 from disengaging from the axis. The end stops may alternatively be formed in the axis itself or made of some other material from the bodies 62.

[0179] In such Figure 13B In the fourth embodiment shown, one or more bodies 62 are formed as wires wound on a shaft, such as Figure 13B As shown. The wire can be supplied pre-wound and slides on the shaft during manufacturing, for example as a helical spring, or wound on the shaft during manufacturing.

[0180] One or more bodies 62 can be manufactured in a manner equivalent to body 10 of the previously described embodiments, for example, by additive manufacturing to create an internal porous matrix 11. However, one or more bodies 62 can also be made by other methods (e.g., conventional machining) and may not necessarily include an internal porous matrix 11. Because the presence of mounting member 60 provides structural strength, the shape of one or more bodies 62 can provide an increased surface area (which might otherwise be achieved through porosity) without compromising the structure of the drug delivery device 100.

[0181] In a third embodiment, the body 62 formed as a beaded edge has through-holes, which increase the available surface area for the release of biocidal ions, especially when loosely fitted so that the beaded edge can slide along an axis. In a fourth embodiment, forming as a fine wire inherently increases the exposed surface area for a given amount of material compared to a solid body such as a cylinder.

[0182] Preferably, the shaft defines a widened region 64 toward one end. The widened region 64 serves an equivalent purpose to the sphere 43 of the previous embodiment, as it helps retain the elongated plug 4 within the nipple tube while still allowing discharge. The widened region 64 is preferably defined by adjacent branches of the shaft diverging and reconverging, which is particularly effective in terms of material usage. Preferably, one or more bodies 62 are not present in the widened region 64 and are only mounted on one or both sides of the widened region 64.

[0183] Preferably, the mounting member 60 is flexible and elastic. This allows the widened area 64 to contract and expand at least to some extent. The use of beaded edges or wires for one or more bodies 62 also facilitates the flexure of the elongated plug 4. If the animal 2 lies on its nipples, the bending of the elongated plug 4 can prevent internal injury or bruising. It also allows for easier manual insertion of the elongated plug 4 without the use of any specialized instruments and reduces fragility.

[0184] Preferably, the material of the mounting component 60 is inert, non-corrosive, and resistant to bacterial growth, but is a different material from one or more of the main bodies 62.

[0185] Mounting member 60 can be made of shape memory alloy, preferably nitinol (i.e., nickel-titanium), which provides a sufficient degree of elasticity and strength. Utilizing the material properties of the shape memory alloy, mounting member 60 can be taught to "memorize" the desired shape during manufacturing through appropriate heat treatment. This allows for the formation of a widened region 64 by adjacent branches of the bending axis, and the subsequent fixation of the resulting geometry to bring mounting member 60 to a resting state. The shape memory is preferably configured to maintain a high number of bending cycles, such as one million or more, so that the desired shape will be maintained over an extended insertion period (e.g., two months, which is typical for the dry period of dairy cows).

[0186] Preferably, the composite drug delivery device 100 further includes an end stop 66 fixed to the end of the shaft opposite the widened region 64. The end stop 66 may be, for example, spherical or pear-shaped, and may itself be one of the bodies 62 made of one or more biocidal ion-releasing metals. It may be enlarged compared to a beaded rim. However, various other shapes of the end stop 66 are possible. The end stop 66 may be located precisely outside the nipple and act as a barrier against bacteria, corresponding to the flanged end 41 of the previous embodiment.

[0187] As with previous embodiments, one or more bodies 62 may optionally be filled / coated with a drug or other useful substance before application to the treatment site 20. These substances may also coat the mounting member 60. This provides another mechanism for killing invasive bacteria or promoting healing.

[0188] Summary

[0189] By providing an internal porous matrix 11 within a body 10 made of a suitable metal, the drug delivery device 1 achieves a high rate of release of biocidal metal ions into the treatment site 20 of the target animal 2. The release rate increases with higher porosity and lower pore size, as these factors increase the internal surface area from which the ions can be released.

[0190] Additive manufacturing, particularly binder jet printing, can be used to create a body 10 with an internally porous matrix 11 by bonding metal powder particles together. Various steps can be taken to promote high porosity and small pore size, such as using small particles, using liquid binders that create many pores, and using low-intensity sintering cycles to avoid closing too many pores.

[0191] The drug delivery device 1 can be formed in various embodiments, such as the implant 3, plug 4, and patch 5 already described. Other drug delivery devices 1, such as ear tags, can be manufactured in the same manner to benefit from the release of biocidal ions. It is also possible that other devices can be manufactured in whole or in part in the same manner, such as surgical instruments, milking cup liners, or water supply filters.

[0192] The applicant has conducted experiments to test the rate of release of biocidal metal ions from the pharmaceutical device 1 according to the invention.

[0193] In the first experiment, the drug device 1 in the form of a plug 4 was immersed in a water sample for several days, after which the volume of residual copper in the water sample was measured. The results are summarized below.

[0194] For the control sample of distilled water, the residual copper level was 0.6 μg / L after 11 days.

[0195] For a sample containing eleven low-porosity plugs 4, after immersion for 9 days, the residual copper level was 3130 μg / L.

[0196] For a sample containing four plugs with lower porosity 4, after immersion for 9 days, the residual copper level was 958 μg / L.

[0197] For a sample containing a highly porosity plug 4, after immersion for 6 days, the residual copper level was 2380 μg / L.

[0198] The results clearly show that when applied to treatment site 20 in animal 2, the increased porosity of plug 4 significantly increased the rate of ion release, thereby increasing efficacy.

[0199] In the second experiment, the drug delivery device 1 in the form of implant 3 underwent the same experiment. The results are summarized below.

[0200] For the control sample of distilled water, the residual copper level was 10.7 μg / L after 7 days.

[0201] For a sample containing an implant with low porosity 3, after immersion for 7 days, the residual copper level was 86.9 μg / L.

[0202] For a sample containing two low-porosity implants 3, after immersion for 7 days, the residual copper level was 151 μg / L.

[0203] For a sample containing three low-porosity implants 3, after immersion for 7 days, the residual copper level was 205 μg / L.

[0204] For a sample containing four low-porosity implants 3, after immersion for 7 days, the residual copper level was 261 μg / L.

[0205] For a sample containing five low-porosity implants 3, after immersion for 7 days, the residual copper level was 327 μg / L.

[0206] These results clearly show that using multiple implants 3 can increase the rate of release of biocidal ions within the treatment site 20, but not necessarily in a linear manner.

[0207] The composite drug delivery device 100 can also achieve a high rate of biocidal ion release from one or more subjects 62 to the treatment site 20, and is particularly suitable for use as an elongated plug 4. It also provides flexibility to prevent harm to the animal 2.

[0208] Many structural modifications and a wide range of different embodiments and applications of the invention will be apparent to those skilled in the art without departing from the scope of the invention as defined by the appended claims.

[0209] The invention may also be broadly defined as including, individually or collectively, any or all combinations of any two or more of the portions, elements or features mentioned or indicated in the description of this application, and where specific integers of known equivalents in the field to which this invention relates are mentioned herein, such known equivalents are considered to be incorporated herein as if set forth separately.

Claims

1. A drug delivery device for use in animals, the drug delivery device comprising: A body made of one or more solid metals, wherein the metals are selected from those whose ions have a biocidal effect on them; The main body comprises an internal porous matrix with a porosity of at least 1%, from which biocidal metal ions can be released, and The outer surface of the subject is configured to be located at the treatment site of the animal.

2. The pharmaceutical device according to claim 1, wherein the one or more solid metals are selected from copper, cobalt, zinc, nickel, zirconium, molybdenum, and alloys thereof.

3. The pharmaceutical device of claim 2, wherein the one or more solid metals are pure metals such that they are not alloys.

4. The pharmaceutical device according to any one of the preceding claims, wherein the body is made of only a single solid metal.

5. The pharmaceutical device according to claim 4, wherein the body is made of pure copper.

6. The pharmaceutical device according to any one of the preceding claims, wherein the internal porous matrix has a porosity of at least 10%.

7. The pharmaceutical device of claim 6, wherein the internal porous matrix has a porosity between 20% and 80%.

8. The pharmaceutical device according to any one of the preceding claims, wherein the internal porous matrix has an average pore size of 50 micrometers or less.

9. The pharmaceutical device according to any one of the preceding claims, wherein the body has one or more flow channels through the body.

10. The pharmaceutical device according to any one of the preceding claims, wherein the pharmaceutical device is formed as an implant suitable for use in an internal treatment site in an animal, and the length of the body in any dimension does not exceed 20 mm.

11. The pharmaceutical device of claim 10, wherein the body has a plurality of grooves in the outer surface.

12. The pharmaceutical device according to claim 10, wherein the main body is a helical structure.

13. The pharmaceutical device according to any one of claims 10 to 12, wherein the internal porous matrix has a porosity of at least 50%.

14. The drug device according to any one of claims 1 to 9, wherein the drug device is formed as an elongated plug adapted for insertion into the nipple duct of a mammal.

15. The drug device of claim 14, wherein the elongated plug includes a port at each of its proximal and distal ends to facilitate fluid discharge in one direction and drug administration in the other direction.

16. The pharmaceutical device according to claim 14 or 15, wherein the internal porous matrix has a porosity of 20% or less.

17. The pharmaceutical device according to any one of claims 1 to 9, wherein the pharmaceutical device is formed as a patch suitable for application to an external treatment site of an animal, and the body is formed as a thin layer.

18. The pharmaceutical device of claim 17, wherein the thin layer has a plurality of grooves in the outer surface.

19. The pharmaceutical device of claim 17, wherein the thin layer is presented or formed as a cross-shaped grid.

20. The pharmaceutical device of claim 17, wherein the thin layer exhibits one or more rough sections with high-density peaks.

21. A method of manufacturing a pharmaceutical device according to any one of claims 1 to 20, wherein the method is an additive manufacturing process and the method includes a metal 3D printing step.

22. The method of claim 21, wherein the additive manufacturing process is binder spraying of metal powder.

23. The method of claim 22, wherein the particle size of the metal powder is 50 micrometers or smaller.

24. The method according to claim 22 or 23, wherein the purity of the metal powder is at least 99.95%.

25. The method according to any one of claims 22 to 24, wherein the sintering cycle that completes the binder spraying process has a low intensity, such that most of the voids in the internal porous matrix are retained.

26. The method according to any one of claims 22 to 25, wherein the space-retaining material is mixed with the metal powder and then the space-retaining material is removed by sintering, thereby creating pores in the internal porous matrix.

27. The method of claim 26, wherein the space-retaining material is selected from potassium carbonate, sodium chloride, and carbodiamine.

28. The method of claim 26 or 27, wherein the space-retaining material is needle-shaped.

29. A method for treating or preventing an infection in a livestock animal using a pharmaceutical device according to any one of claims 1 to 20, wherein the method comprises applying the pharmaceutical device to a treatment site on the animal.

30. The method of claim 29, wherein the method comprises injecting the pharmaceutical device into the skin near the hoof of the animal to prevent or treat foot rot, hoof dermatitis, interdigital dermatitis, white line disease and / or plantar ulcers.

31. The method of claim 29, wherein the method comprises inserting the pharmaceutical device into the nipple duct of the animal to prevent or treat mastitis and / or myiasis, to prevent contaminants from entering the nipple duct, or as a cannula, nipple straightener, internal nipple duct skin adjuster, or nipple end closure device.

32. The method of claim 28, wherein the method comprises externally adhering the drug device to the wound of the animal to prevent or treat infection.

33. The method according to any one of claims 29 to 32, wherein, The animals mentioned are mammals selected from dairy cows, goats, pigs, deer, buffalo, sheep, and camels.

34. A drug delivery device for use in animals, the drug delivery device comprising: Installation components; One or more bodies, each body being made of one or more solid metals selected from those whose ions have a biocidal effect on them; The one or more of the subjects are mounted on the mounting member, and the outer surface of each of the subjects is configured to be located at the treatment site of the animal.

35. The pharmaceutical device of claim 34, wherein the pharmaceutical device is formed as an elongated plug adapted for insertion into the nipple duct of a mammal.

36. The pharmaceutical device of claim 35, wherein the mounting member is a shaft, and the one or more bodies are mounted along the length of the shaft.

37. The pharmaceutical device of claim 36, wherein the shaft defines a widened region toward one end.

38. The pharmaceutical device of claim 37, wherein the widened region is defined by adjacent branches of the axis that diverge and reconverge.

39. The pharmaceutical device according to claim 37 or 38, wherein the pharmaceutical device further comprises an end stop fixed at opposite ends of the shaft.

40. The pharmaceutical device according to any one of claims 36 to 39, wherein one or more bodies include beaded flanges mounted on the shaft.

41. The pharmaceutical device according to any one of claims 36 to 39, wherein one or more bodies comprise wire wound around the axis.

42. The pharmaceutical device according to any one of claims 34 to 41, wherein the mounting member is flexible and elastic.

43. The pharmaceutical device of claim 42, wherein the mounting member is made of a shape memory alloy.

44. The pharmaceutical device according to claim 43, wherein, The mounting components are made of nickel-titanium.

45. The pharmaceutical device according to any one of claims 34 to 44, wherein the one or more solid metals are selected from copper, cobalt, zinc, nickel, zirconium, molybdenum, and alloys thereof.

46. ​​The pharmaceutical device of claim 45, wherein the one or more solid metals are pure metals such that they are not alloys.

47. The pharmaceutical device according to any one of claims 34 to 46, wherein each of the one or more bodies is made of only a single solid metal.

48. The pharmaceutical device of claim 47, wherein each of the bodies is made of pure copper.

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